Clinical trial NCT02553330
Conditions: Alopecia Areata
Keywords: Hair loss alopecia areata alopecia totalis alopecia universalis JAK inhibitors topical hair growth
Sponsor: Incyte Corporation
Start date: 2015-11-18; Completion date: 2017-10-03
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the skin.

Detailed description:

Arms: arm 1: Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks;

Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks. arm 2: Part B: Double-blind treatment is 24 weeks (and/or treatment with Ruxolitinib Phosphate Cream if eligible) and follow-up is an additional 12 weeks.
Interventions: intervention 1: Placebo Cream intervention 2: Ruxolitinib Phosphate Cream
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
Incyte Corporation 
Page 1 of 73 
Protocol INCB 18424-204 Amendment 4 
12 OCT 2016 
CONFIDENTIAL 
 
Clinical Study Protocol 
 
INCB 18424-204 
An Open-Label (Part A) and a Double-Blind, Randomized, 
Placebo-Controlled (Part B) Study, With an Open-Label Extension, 
of INCB018424 Phosphate Cream Applied Topically to Subjects 
With Alopecia Areata 
 
 
 
 
Product: 
INCB018424 
IND Number: 
77101 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Date of Protocol: 
08 MAY 2015 
Date of Amendment 1: 
14 JUL 2015 
Date of Amendment 2: 
04 FEB 2016 
Date of Amendment 3: 
29 APR 2016 
Date of Amendment 4: 
12 OCT 2016 
 
 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, Good Clinical Practices as defined in Title 21 of the US 
Code of Federal Regulations Parts 50, 54 56, 312, and Part 11 as well as ICH GCP consolidated guidelines (E6) and 
applicable regulatory requirements. 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without the prior 
written consent of Incyte Corporation. 


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Protocol INCB 18424-204 Amendment 4 
12 OCT 2016 
CONFIDENTIAL 
INVESTIGATOR'S AGREEMENT 
I have received and read the Investigator's Brochure for INCB018424 Cream.  I have read 
INCB 18424-204 Protocol Amendment 4 (dated 12 OCT 2016) and agree to conduct the study as 
outlined.  I agree to maintain the confidentiality of all information received or developed in 
connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 


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Protocol INCB 18424-204 Amendment 4 
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CONFIDENTIAL 
SYNOPSIS 
Name of Investigational Product:  INCB018424 phosphate 1.5% cream (INCB018424 cream) 
Title of Study:  An Open-Label (Part A) and a Double-Blind, Randomized, Placebo-Controlled 
(Part B) Study, With an Open-Label Extension, of INCB018424 Phosphate Cream Applied Topically 
to Subjects With Alopecia Areata 
Protocol Number:  INCB 18424-204 
Study Phase:  2 
Primary Objectives: 
• To evaluate preliminary efficacy of INCB018424 cream when applied twice daily (BID) to subjects 
with alopecia areata (AA). 
Secondary Objectives: 
• To evaluate the safety and tolerability of INCB018424 cream when applied BID to subjects with 
AA. 
Overall Study Design: 
This is a 2-part study in subjects with AA, with Part A being open-label and Part B being double-blind, 
randomized, and placebo-controlled. 
In Part A, approximately 10 subjects will be treated with open-label topical INCB018424 1.5% cream 
BID for 24 weeks to examine efficacy, safety, and tolerability.  Subjects with alopecia totalis, which 
includes alopecia universalis, will not be allowed in Part A.  After completion of the Week 24 efficacy 
assessments, eligible subjects in Part A will be offered an additional 24 weeks of open-label treatment.  
To be eligible for an additional 24 weeks of open-label treatment in Part A, subjects must have 
completed the baseline and Week 24 Severity of Alopecia Tool (SALT) scores.  Also, eligible subjects 
must have adequate laboratory parameters (must meet entry criteria regarding cytopenias and liver 
assessments) and, in the opinion of the investigator, have no additional safety concerns related to an 
additional 24 weeks of open-label treatment. 
Part B is double-blind, randomized, and placebo-controlled, with an open-label extension in up to 
68 subjects.  Initially, 34 subjects will be randomized to INCB018424 1.5% cream or placebo cream, 
stratified by baseline percentage of scalp involvement with AA (25% to < 50% or 50% to 100%) using 
the revised Alopecia Areata Investigational Guidelines (rAAIG).  Subjects will be treated for 24 weeks 
to examine efficacy, safety, and tolerability.  Subjects with alopecia totalis, which includes alopecia 
universalis, will be limited to Part B and no more than 10% of the randomized population.  Subjects 
with 25% to < 50% scalp involvement will be limited to no more than 70% of the randomized 
population in Part B.  Part B will complete randomization of an additional 34 subjects if sufficient 
evidence of terminal hair growth is demonstrated in Part A or the interim analysis of Part B. 
Sites will remain blinded to study drug, but some personnel at Incyte without direct contact with sites 
will be unblinded.  An internal committee at Incyte will be charged with evaluating the unblinded 
interim results based on the futility rule, as well as considering interim safety results. 
After the completion of the efficacy assessments for the primary endpoint (Week 24) in the 
double-blind portion of the study, treatment assignment in Part B will not be unblinded; however, all 
eligible subjects will be dispensed INCB018424 cream for an additional 24 weeks of open-label 


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Protocol INCB 18424-204 Amendment 4 
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CONFIDENTIAL 
treatment.  To be eligible for an additional 24 weeks of open-label treatment in Part B, subjects must 
have completed the baseline and Week 24 SALT scores.  Also, eligible subjects must have, in the 
opinion of the investigator, no additional safety concerns related to an additional 24 weeks of 
open-label treatment.  All areas identified at baseline should continue to be treated through the end of 
the open-label extension, unless the subject has a complete clinical response. 
During the first 24 weeks of treatment in Part A, if new areas of AA develop or existing areas of AA 
expand after baseline, subjects are NOT to apply study drug to those areas.   
In Part B and in the open-label extension, if new areas of AA develop or existing areas of AA expand 
after baseline, subjects are permitted to apply study drug BID to those areas after a visit to document 
the SALT score.  The visit to document the new or expanded areas may be unscheduled. 
After completion of the open-label extension (48 weeks of treatment), subjects who, in the opinion of 
the investigator, are deriving benefit (some hair regrowth) from INCB018424 will be eligible to enter 
the long-term extension period for an additional 48 weeks of treatment with open-label INCB018424.  
Also, eligible subjects must have, in the opinion of the investigator, no additional safety concerns 
related to an additional 48 weeks of open-label treatment.  During the long-term extension period, 
subjects may stop treating areas that have sufficient regrowth in the opinion of the investigator.  
Further, after discussion with the investigator, subjects may decrease the application rate to once daily 
(QD) in areas with sufficient hair regrowth. 
In the open-label extension of Parts A and B or in the long-term extension, subjects who have a 
complete clinical response (defined as 100% terminal hair regrowth and no evidence of active hair loss) 
at 2 consecutive visits will stop administration and continue the open-label visits as scheduled.  
Subjects who have a complete clinical response who subsequently have evidence of hair loss after 
stopping treatment may restart treatment after a visit to document the SALT score.  The visit to 
document the SALT score may be unscheduled. 
Concomitant oral vitamins, shampoos, and hair products should remain stable during the study. 
Study Drug, Dosage, and Mode of Administration: 
In Parts A and B, study drug will be supplied as INCB018424 1.5% cream or placebo and will be 
applied topically as a thin film to the affected areas and up to 1 inch (2.5 cm) into the surrounding 
scalp, where evidence of a decrease in hair density or active loss as evidenced by exclamation point 
hairs or positive hair pull is present.  Study drug should be applied in the morning and in the evening at 
least 10 hours apart and at least 1 hour before bedtime.  All areas identified at baseline should continue 
to be treated through the end of the open-label extension, unless the subject has a complete clinical 
response.  If there are new areas to be treated (either in the open-label extension of Part A or in Part B), 
study drug should be applied to these areas in addition to the areas identified at baseline through the 
end of the open-label extension.  During the long-term extension period, subjects may stop treating 
areas that have sufficient regrowth in the opinion of the investigator.  Further, after discussion with the 
investigator, subjects may decrease the application rate to QD in areas with sufficient hair regrowth. 
Application instructions will be provided at study visits and via a diary card given to the subjects.  
When subjects wash the treatment areas, it should be with mild soap or shampoo and water and should 
be pat dry before application of study drug.  If used, occlusive camouflage or other contact should be 
avoided for at least 1 hour after an application.  Subjects will be instructed to thoroughly wash hands 
with soap and warm water immediately after application of study drug. 
Duration of Participation: 
In Part A, screening is up to 28 days; open-label treatment is 24 weeks, with an additional optional 
24 weeks of treatment in the open-label extension and an optional 48 weeks of treatment in the 
long-term extension if eligible; and follow-up is 12 weeks.  Total duration is up to 112 weeks. 
In Part B, screening is up to 28 days, double-blind treatment is 24 weeks, an optional open-label 
treatment is 24 weeks in the open-label extension and an optional 48 weeks of treatment in the 
long-term extension if eligible, and follow-up is 12 weeks.  Total duration is up to 112 weeks. 


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Protocol INCB 18424-204 Amendment 4 
12 OCT 2016 
CONFIDENTIAL 
Study Population:   
Men or women, aged 18 to 70 years, who have been diagnosed with AA for at least 12 months with 
25% to < 50% scalp involvement or for at least 6 months with 50% to 100% scalp involvement. 
Key Inclusion Criteria: 
A subject who meets all of the following criteria may be included in the study: 
• 
Healthy adult subjects aged 18 to 70 years, inclusive. 
• 
Subjects diagnosed with AA and, in the opinion of the investigator, reason to believe that regrowth 
is possible. 
• 
Subjects with a current episode of AA for the following durations: 
− At least 12 months before screening and involving 25% to < 50% of the scalp at baseline. 
− At least 6 months before screening and involving 50% to 100% of the scalp at baseline. 
• 
Subjects with a positive hair pull test and/or presence of exclamation point hairs, unless subject has 
alopecia totalis, including alopecia universalis. 
• 
Subjects who agree to discontinue all agents used to treat AA from screening through the final 
follow-up visit; use of over-the-counter preparations (including vitamins, minerals, 
phytotherapeutic/herbal/plant-derived preparations, and other hair products) deemed acceptable by 
the investigator are permitted. 
Key Exclusion Criteria: 
A subject who meets any of the following criteria will be excluded from the study: 
• 
Part A only:  Subjects with a current diagnosis of alopecia universalis, alopecia totalis, or only 
ophiasis type AA. 
• 
Subjects with a current episode of alopecia universalis or alopecia totalis of more than 2 years in 
duration. 
• 
Subjects with evidence of diffuse, spontaneous terminal hair regrowth at screening and/or baseline. 
• 
Subjects with a history of complete spontaneous remission in the prior 2 years. 
• 
Subjects who have received treatment known to potentially affect the course of AA within 1 month 
before the baseline visit (eg, topical and intralesional corticosteroids, oral or topical minoxidil). 
• 
Subjects taking immunosuppressive medications (including topical agents) for any concurrent 
illness, except inhaled corticosteroids for asthma and allergic rhinitis, and 1% topical 
hydrocortisone or alternate Class 7 topical steroid for atopic dermatitis/eczema for areas outside the 
scalp any time after screening. 
• 
Subjects taking systemic retinoids, etanercept, adalimumab, efalizumab, alefacept, other biological 
therapies, or immunosuppressives (eg, corticosteroids [oral or injectable], methotrexate, 
cyclosporine) within 6 weeks before the baseline visit. 
• 
Subjects taking systemic potent CYP3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, 
whichever is longer, before the baseline visit. 
• 
Subjects with a history of medical disorders (eg, autoimmune diseases) whose treatments could 
complicate the assessment of hair loss on the scalp, except for: 
− 
Thyroid disease on stable treatment for at least 6 months before screening. 
− 
Asthma on stable treatment for at least 3 months before screening. 
• 
Subjects with an abnormal TSH or free T4 at screening. 
• 
Subjects with cytopenias at screening, defined as: 
− 
Leukocytes < 3 × 109/L. 
− 
Neutrophils < lower limit of normal. 


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Protocol INCB 18424-204 Amendment 4 
12 OCT 2016 
CONFIDENTIAL 
− 
Lymphocytes < lower limit of normal. 
− 
Hemoglobin < 10 g/dL. 
− 
Platelets < 100 × 109/L. 
• 
Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on 
dialysis or at least 1 of the following: 
− 
Serum creatinine > 1.5 mg/dL. 
− 
Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal. 
• 
Positive serology test results for hepatitis B surface antigen or core antibody, or for hepatitis C 
virus antibody with detectable hepatitis C RNA at screening. 
Study Schedule/Procedures: 
All subjects in Parts A and B will have visits at screening, baseline, and Weeks 4, 8, 12, 18, and 24.  
All subjects in Parts A and B will have similar assessments, except as noted below. 
Adverse events (AEs), medication history, clinical assessments, physical exam, vital signs, and clinical 
safety laboratories (including reticulocyte count) will be performed at each visit.  All laboratory 
assessments will be performed using a central laboratory except for urine pregnancy tests (as 
applicable). 
Scalp photography will be performed at baseline and Weeks 12 and 24, and also at Week 4 in Part A. 
Study drug will be applied in the clinic on the day of a study visit based on the scalp surface area 
involved with AA and up to 1 inch (2.5 cm) into the surrounding scalp, where evidence of a decrease in 
hair density or active loss as evidenced by exclamation point hairs or positive hair pull is present.  
Subjects will be instructed to bring all study drug tubes with them to each visit so that compliance can 
be assessed.  At Week 24, compliant subjects with baseline and Week 24 SALT scores will be offered 
an optional 24 weeks of open-label treatment. 
Subjects in the open-label extension period of Part A will have study visits every 6 weeks during 
Weeks 30 to 48.  Subjects in Part B who enter the open-label extension period will have study visits at 
Weeks 28, 32, 36, 42, and 48.  Scalp photography will be performed at Weeks 36 and 48. 
During the open-label extension period, following the Week 24 visit, subjects with a complete clinical 
response (defined as 100% terminal hair regrowth and no evidence of active hair loss at 2 consecutive 
visits, which may include visits during the double-blind period) will stop applying study drug and will 
continue the scheduled visits in the open-label period.  These subjects will then have the follow-up 
assessments 1 and 3 months after the Week 48 visit. 
Subjects in the long-term extension period will have study visits at Weeks 60, 72, 84, and 96.  
After the end-of-treatment visit, subjects will have follow-up assessments 1 and 3 months later to 
monitor for 
 AE, medication history, vital signs, and clinical assessments, and scalp 
photography at the 3-month follow-up visit.  If other treatment for AA is started, an earlier 3-month 
follow-up visit will be performed as a final, and thus end of study visit.  If needed, a follow-up phone 
call will be conducted to determine any AEs or serious adverse events during the 30 days after the last 
dose of study drug.   


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Protocol INCB 18424-204 Amendment 4 
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CONFIDENTIAL 
Part A: 
Primary Endpoints:  
• 
Percentage of subjects achieving a ≥ 50% improvement in Severity of Alopecia Tool 
(SALT50) response in terminal hair (pigmented and nonpigmented) at any visit up to Week 24 
(inclusive). 
Secondary Endpoints: 
• 
Percentage of subjects with 50% to 100% scalp involvement at baseline achieving a SALT50 
response in terminal hair at any visit through Week 24.   
• 
Percentage of subjects achieving a SALT90 response in terminal hair at Weeks 4, 8, 12, 18, 
and 24. 
• 
Safety and tolerability assessed by monitoring the frequency, duration, and severity of AEs; 
performing physical examinations; collecting vital signs; and collecting laboratory data for 
hematology, serum chemistry, and urinalysis. 
Part B: 
Primary Endpoint: 
• 
Percentage of subjects achieving a SALT50 response in terminal hair (pigmented and 
nonpigmented) at Week 24. 
Secondary Endpoints: 
• 
Percentage of subjects whose AA lesions treated since baseline achieved a Physician's Global 
Assessment of Regrowth (PGARG) score of at least 3 (0, no regrowth; 1, < 25% of regrowth; 
2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of regrowth; 5, 100% of 
regrowth) using live evaluations compared to baseline photographs at Week 24. 
• 
Percentage of subjects with 50% to 100% scalp involvement at baseline achieving a SALT50 
response in terminal hair (pigmented and nonpigmented) at Week 24. 
• 
Percentage of subjects achieving a SALT50 in terminal hair (pigmented and nonpigmented) at 
Weeks 4, 8, 12, and 18. 
• 
Percentage of subjects achieving a SALT90 in terminal hair (pigmented and nonpigmented) at 
Weeks 4, 8, 12, 18, and 24. 
• 
Mean change from baseline in SALT score at Weeks 4, 8, 12, 18, and 24. 
• 
Safety and tolerability assessed by monitoring the frequency, duration, and severity of AEs; 
performing physical examinations; collecting vital signs; and collecting laboratory data for 
hematology, serum chemistry, and urinalysis. 


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Protocol INCB 18424-204 Amendment 4 
12 OCT 2016 
CONFIDENTIAL 
Planned Number of Subjects:  Part A will enroll up to approximately 10 subjects.  Part B will enroll 
up to approximately 68 subjects. 
Planned Number of Study Sites:  Part A will include 1 to 5 sites.  Part B will include 10 to 20 sites. 
Principal Coordinating Investigator:  
, MD, 
 
Statistical Methods: 
In Part A, the sample size is based on the demonstration of preliminary findings of hair regrowth.  It is 
anticipated that a sample of 10 subjects will permit sufficient data to decide to enroll more than 
34 subjects in Part B (required for interim analysis). 
In Part B, the sample size calculation is based on the Fisher exact test for the primary efficacy endpoint 
assuming a small expected frequency of responders in the placebo group, given the low response rate.  
For subjects with 25% to < 50% and 50% to 100% scalp involvement, the response rate is assumed to 
be 61% for active versus 25% for placebo, and 35% for active versus 5% for placebo, respectively.  
Using a 2-sided alpha of 0.05 with a continuity correction, 34 subjects per group will have an 80% 
power to detect a difference between treatment groups. 
The response rate assessed based on SALT50 between active- and placebo-treated subjects will be 
compared using a logistic regression with covariates of baseline SALT score and stratification factor of 
rAAIG group.  The clinical safety data (vital signs, routine laboratory tests, and AEs) will be analyzed 
using descriptive statistics (eg, mean, frequency). 
The INCB018424 plasma concentration data collected at study visits will be analyzed using summary 
statistics. 
All secondary 
 efficacy measures will be evaluated using descriptive statistics.  
Subjects will be stratified at randomization into 2 groups:  25% to < 50% scalp involvement (rAAIG 
Group S2) and 50% to 100% scalp involvement (rAAIG Groups S3, S4, and S5).   
Subjects with alopecia totalis (group S5), which includes alopecia universalis, will not be allowed in 
Part A and will be limited to no more than 10% of the randomized population in Part B. 
Subjects with 25% to < 50% scalp involvement will be limited to no more than 70% of the randomized 
population in Part B. 
An interim analysis will be performed when 34 subjects in Part B have 12-week data available and a 
test for futility will be performed.  Sites will remain blinded to study drug but some personnel at the 
sponsor (without direct contact with sites) will be unblinded.  Part B will complete randomization of 
additional subjects if sufficient evidence of terminal hair growth is demonstrated either at the interim 
analysis in Part A or at one of the interim analyses of Part B, or in an additional interim analysis if 
1 group of subjects is under represented in the first interim analysis of Part B.  An additional interim 
analysis may be conducted when 24-week data are available for half of the subjects in Part B.  The 
interim analysis will not include any testing for futility or efficacy. 


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TABLE OF CONTENTS 
SYNOPSIS ......................................................................................................................................3 
LIST OF ABBREVIATIONS ........................................................................................................14 
1. 
INTRODUCTION ......................................................................................................16 
1.1. 
Alopecia Areata ..........................................................................................................16 
1.2. 
Autoimmunity and Alopecia Areata ...........................................................................16 
1.3. 
Role of JAKs in Alopecia Areata ...............................................................................17 
 
18 
 
18 
 
19 
1.7. 
Clinical Experience .....................................................................................................21 
1.7.1. 
Clinical Efficacy With Oral INCB018424 in Alopecia Areata ..................................21 
1.7.2. 
Clinical Efficacy With Topical INCB018424 in Psoriasis .........................................21 
 
22 
 
22 
 
22 
 
24 
1.7.5. 
Oral INCB018424 (Ruxolitinib) Safety......................................................................26 
 
27 
 
28 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................28 
2.1. 
Objectives ...................................................................................................................28 
2.1.1. 
Primary Objective .......................................................................................................28 
2.1.2. 
Secondary Objectives .................................................................................................28 
 
29 
2.2. 
Study Endpoints ..........................................................................................................29 
2.2.1. 
Primary Endpoints ......................................................................................................29 
2.2.1.1. 
Part A ..........................................................................................................................29 
2.2.1.2. 
Part B ..........................................................................................................................29 
2.2.2. 
Secondary Endpoints ..................................................................................................29 
2.2.2.1. 
Part A ..........................................................................................................................29 
2.2.2.2. 
Part B ..........................................................................................................................29 


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30 
 
30 
 
30 
3. 
SUBJECT ELIGIBILITY ...........................................................................................31 
3.1. 
Subject Inclusion Criteria ...........................................................................................31 
3.2. 
Subject Exclusion Criteria ..........................................................................................32 
4. 
INVESTIGATIONAL PLAN .....................................................................................34 
4.1. 
Overall Study Design ..................................................................................................34 
4.2. 
Measures Taken to Avoid Bias ...................................................................................35 
4.3. 
Number of Subjects ....................................................................................................35 
4.4. 
Study Termination ......................................................................................................35 
5. 
TREATMENT OF SUBJECTS ..................................................................................36 
5.1. 
Treatment Groups and Administration of Study Drug ...............................................36 
5.1.1. 
Open-Label Extension Period .....................................................................................37 
5.1.2. 
Long-Term Extension Period .....................................................................................37 
5.2. 
Treatment Compliance ................................................................................................37 
5.3. 
Randomization and Blinding ......................................................................................38 
5.4. 
Duration of Treatment and Subject Participation .......................................................38 
5.5. 
Rationale for Dose Modification ................................................................................38 
5.6. 
Dose Modifications of Study Drug .............................................................................38 
5.6.1. 
Planned Dose Modifications .......................................................................................38 
5.6.2. 
Criteria and Procedures for Interruption .....................................................................39 
5.6.3. 
Criteria for Permanent Discontinuation of Study Drug ..............................................39 
5.7. 
Withdrawal of Subjects From the Study .....................................................................40 
5.7.1. 
Withdrawal Criteria ....................................................................................................40 
5.7.2. 
Withdrawal Procedures ...............................................................................................40 
5.8. 
Concomitant Medications and Measures ....................................................................41 
5.8.1. 
Permitted Medications and Measures .........................................................................41 
5.8.2. 
Restricted Medications and Measures ........................................................................41 
5.8.3. 
Prohibited Medications and Measures ........................................................................41 
6. 
STUDY ASSESSMENTS ..........................................................................................41 
6.1. 
Screening ....................................................................................................................46 
6.2. 
Baseline .......................................................................................................................47 


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6.3. 
Treatment ....................................................................................................................47 
6.4. 
End of Treatment ........................................................................................................48 
6.5. 
Follow-Up Phase ........................................................................................................48 
6.6. 
Unscheduled Visits .....................................................................................................48 
6.7. 
Early Termination .......................................................................................................48 
7. 
CONDUCT OF STUDY ASSESSMENTS AND PROCEDURES ...........................49 
7.1. 
Administration of Informed Consent Form ................................................................49 
7.2. 
Interactive Response Technology Procedure ..............................................................49 
7.3. 
Demography and History ............................................................................................49 
7.3.1. 
Demographics and Medical History ...........................................................................49 
7.3.2. 
Prior and Concomitant Medications ...........................................................................49 
7.4. 
Safety Assessments .....................................................................................................49 
7.4.1. 
Adverse Events ...........................................................................................................49 
7.4.2. 
Comprehensive Physical Examination .......................................................................50 
7.4.3. 
Targeted Physical Examination ..................................................................................50 
7.4.4. 
Vital Signs ..................................................................................................................50 
7.4.5. 
Twelve-Lead Electrocardiograms ...............................................................................50 
7.4.6. 
Laboratory Assessments .............................................................................................50 
7.4.6.1. 
Chemistry ....................................................................................................................51 
7.4.6.2. 
Hematology .................................................................................................................51 
7.4.6.3. 
Urinalysis ....................................................................................................................51 
7.4.6.4. 
Fertility Testing ..........................................................................................................51 
7.4.6.5. 
Pregnancy Testing ......................................................................................................51 
7.4.6.6. 
Hepatitis Screening Tests ...........................................................................................51 
7.5. 
Efficacy Assessments .................................................................................................51 
7.5.1. 
Severity of Alopecia Tool Scoring System ................................................................51 
7.5.2. 
Terminal Hair Regrowth Assessment .........................................................................52 
7.5.3. 
Physician's Global Assessment of Regrowth ..............................................................52 
7.5.4. 
Photographs ................................................................................................................52 
7.5.5. 
Hamilton-Norwood Scale ...........................................................................................53 
7.6. 
Performance and Quality of Life Assessments ...........................................................53 
 
53 
 
53 


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53 
 
53 
7.8. 
Pharmacodynamic Assessments .................................................................................53 
7.9. 
Other Study Procedures ..............................................................................................53 
7.9.1. 
Administration of Study Drug ....................................................................................53 
7.9.2. 
Dispensing of Study Drug ..........................................................................................54 
7.9.3. 
Assessment of Compliance With Study Drug ............................................................54 
7.9.4. 
Distribution of Subject Reminder Cards and Diaries .................................................54 
8. 
SAFETY MONITORING AND REPORTING .........................................................55 
8.1. 
Adverse Events ...........................................................................................................55 
8.1.1. 
Definitions ..................................................................................................................55 
8.1.2. 
Reporting ....................................................................................................................55 
8.2. 
Laboratory Test Abnormalities ...................................................................................56 
8.3. 
Serious Adverse Events ..............................................................................................57 
8.3.1. 
Definitions ..................................................................................................................57 
8.3.2. 
Reporting ....................................................................................................................57 
8.4. 
Emergency Unblinding of Treatment Assignment .....................................................58 
8.5. 
Pregnancy ...................................................................................................................59 
8.6. 
Warnings and Precautions ..........................................................................................59 
8.7. 
Product Complaints ....................................................................................................59 
9. 
STATISTICS ..............................................................................................................60 
9.1. 
Study Populations .......................................................................................................60 
9.1.1. 
Part A ..........................................................................................................................60 
9.1.2. 
Part B ..........................................................................................................................60 
9.2. 
Selection of Sample Size ............................................................................................60 
9.3. 
Level of Significance ..................................................................................................60 
9.4. 
Statistical Analyses .....................................................................................................61 
9.4.1. 
Primary Analyses ........................................................................................................61 
9.4.2. 
Secondary Analyses ....................................................................................................61 
9.4.3. 
Other Analyses ............................................................................................................61 
9.5. 
Data Monitoring Committee .......................................................................................61 
9.6. 
Interim Analysis ..........................................................................................................61 
9.6.1. 
Part A ..........................................................................................................................61 




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LIST OF ABBREVIATIONS 
Term 
Explanation 
AA 
alopecia areata 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
AST 
aspartate aminotransferase 
BID 
twice daily 
BSA 
body surface area 
CFR 
Code of Federal Regulations 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECG 
electrocardiogram 
eCRF 
electronic case report form  
EOS 
end of study 
EOT 
end of treatment 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase 
HCV-RNA 
hepatitis C virus ribonucleic acid 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
informed consent form  
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IFN-γ 
interferon-γ 
IL 
interleukin 
IN 
Investigator Notification 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
ITT 
intent-to-treat 
JAK 
Janus kinase 
LC/MS/MS 
liquid chromatography-tandem mass spectrometry 


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Term 
Explanation 
MedDRA 
Medical Dictionary for Regulatory Activities 
NK 
natural killer 
NOAEL 
no-observed-adverse-effect level 
PGARG 
Physician's Global Assessment of Regrowth  
PK 
pharmacokinetic 
PV 
polycythemia vera 
QD 
once daily 
rAAIG 
revised Alopecia Areata Investigational Guidelines 
SAE 
serious adverse event 
SALT 
Severity of Alopecia Tool 
SALT50 
≥ 50% improvement in Severity of Alopecia Tool 
SALT90 
≥ 90% improvement in Severity of Alopecia Tool 
STAT 
signal transducers and activators of transcription 
SUSAR 
suspected unexpected serious adverse reaction 
ULN 
upper limit of normal 


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1. 
INTRODUCTION 
INCB018424 cream is a topical formulation of INCB018424 phosphate under development for 
the treatment of patients with psoriasis and alopecia areata (AA).  INCB018424 phosphate is an 
inhibitor of the Janus kinase (JAK) family of protein tyrosine kinases.  Isogenic and 
inflammatory cytokines are strongly implicated in the pathogenesis of psoriasis and AA.  
Because JAKs serve to translate extracellular signals from a number of relevant cytokines and 
growth factors upregulated in inflammatory diseases such as psoriasis and AA, JAK inhibitors 
represent potential therapeutic agents for these disease states. 
1.1. 
Alopecia Areata 
Alopecia areata is the most frequent cause of inflammation-induced hair loss, affecting an 
estimated 4.5 million people in the United States (Gilhar et al 2012).  Alopecia areata was noted 
to have a prevalence of approximately 0.1% to 0.2%, with a lifetime risk of 1.7% 
(Safavi et al 1995), and the vast majority of affected individuals are 30 years old or younger at 
the time of disease onset.  Although not life threatening, the disease is an affliction, particularly 
to people with extensive disease including complete hair loss of the scalp (alopecia totalis) and 
scalp and body (alopecia universalis).  In general, hair is lost from the scalp in bald patches.  In 
most cases, the loss of hair is in well-circumscribed patches of normal-appearing skin, most 
commonly on the scalp and in the region of the beard.  The number of people with AA who go 
on to develop alopecia totalis or alopecia universalis is unknown, but estimates range from 7% to 
30% (Bolduc 2014). 
Individuals with AA are subject to rapid and dramatic changes in their appearance caused by the 
sporadic hair loss.  The aesthetic repercussions can lead to profound negative changes in patient's 
psychological status and relationships, with a high prevalence of anxiety and depressive 
symptoms in AA patients (Ghanizadeh and Ayoobzadehshirazi 2014). 
Curative therapy does not exist, and there is a lack of long-term, controlled studies evaluating 
therapy for AA and its effect on quality of life.  There are 2 principal management options:  use 
of an immunosuppressive regimen, such as intralesional injections or topical application of 
glucocorticoids, or an immune-deviation strategy that manipulates the intracutaneous 
inflammatory milieu through the induction of contact allergy.  Topical glucocorticoids lead to at 
least 50% regrowth in 41% of those with at least 50% loss at baseline (Olsen 1997).  However, 
treatment is associated with side effects such as glucocorticoid-induced folliculitis and localized 
skin atrophy.  The use of systemic glucocorticoids is also limited because of the adverse event 
(AE) profile.  All treatments for AA have the potential for further loss after discontinuation of 
therapy in the cases where regrowth is incomplete at the time of discontinuation of treatment.  
New approaches that increase regrowth in cases of AA without introducing safety issues are 
needed. 
1.2. 
Autoimmunity and Alopecia Areata 
In acute AA, histologic examination reveals a characteristic pattern of dense, perifollicular 
lymphocytic infiltrates around anagen hair follicles, suggesting an immunological basis for the 
hair loss.  CD4+ T cells predominate in the perifollicular infiltrates, while CD8+ T cells appear 


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to be the first lymphocytes to enter the proximal follicular epithelium.  In addition, the numbers 
of natural killer (NK) cells and mast cells are greatly increased in the perifollicular infiltrates.  It 
has been found that individuals with AA have higher rates of other autoimmune diseases, 
supporting an underlying immune activation that leads to hair loss (Petukhova and Christiano 
2013).  Alopecia areata occurs more frequently in people who have affected family members, 
suggesting heredity may be a factor (Bolduc 2014).  Alopecia areata has been linked with certain 
human leukocyte antigen class II alleles, as have many autoimmune diseases.  A genome-wide 
association study (Jagielska et al 2012) showed a strong association of predisposition to AA with 
polymorphisms of ligands for the NK cell–activating receptor NKG2D.  In this analysis, 
T lymphocytes, as well as members of the γc cytokine-receptor pathway and interferon-γ 
(IFN-γ), which signal through the JAK–signal transducers and activators of transcription (STAT) 
pathway, were also implicated in AA.   
Xing et al (2014) has presented further evidence supporting autoimmunity as the underlying 
cause using a spontaneous mouse model of AA.  Using this model, they demonstrated that AA is 
mediated by CD8+NKG2D+ T cells via an interleukin (IL)-15 positive feedback loop.  The AA 
phenotype could be adoptively transferred to normal mice via transfer of lymph node 
preparations or positively selected CD8+NKG2D+ T cells.   
1.3. 
Role of JAKs in Alopecia Areata 
Xing et al (2014) performed comparative genomics of the transcriptional profiles of skin from 
both AA model mice and humans with AA.  This study provided evidence for the involvement of 
γc cytokines, including IL-2, IL-7, IL-15, and IL-21, and IFN-γ response elements with increased 
JAK1 and JAK3 expression in diseased human and mouse skin.  In the mouse model, they 
demonstrated that systemic administration of antibodies to the JAK-dependent cytokines IL-2, 
IL-15R, or IFN-γ blocked AA development.  Notably, blocking antibodies against IL-2, IL-15R, 
and IFN-γ, when given individually, did not reverse established AA in mice, and therefore a 
broader inhibition strategy that modulates multiple cytokines may represent a viable treatment 
strategy.  Since each of these cytokines signals through the JAK-STAT pathway, treatment of 
AA with JAK inhibitors may represent a preferred treatment strategy.  Xing et al (2014) 
investigated small-molecule inhibitors of JAK both systemically and topically and showed that 
they could arrest and reverse AA in the mouse model.  Global transcriptional analysis showed 
reduced inflammation in skin of mice treated with JAK inhibitors.  Supporting human data for 
this has come from treatment of subjects with AA with oral JAK1/2 inhibitors.  Treatment 
reversed established AA and resulted in a reduction in inflammation in the subjects' skin 
biopsies. 
The unpredictable course of AA with localized hair loss and spontaneous remissions frequently 
occurring makes it challenging to design and conduct studies, particularly with systemic 
therapies.  Because AA is a skin-associated disease and there are hematological liabilities 
associated with systemic JAK inhibition, topical JAK inhibitors seem to be a very promising 
approach, particularly for localized disease.  To date, a topical JAK inhibitor with sufficient skin 
penetration has not yet been developed in AA.  The JAK1/2 inhibitor INCB018424 has been 
used systemically successfully in myeloproliferative disorders, and a topical formulation of 
INCB018424 has been developed and demonstrated to be active in patients with psoriasis. 


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1.7. 
Clinical Experience 
1.7.1. 
Clinical Efficacy With Oral INCB018424 in Alopecia Areata 
Three subjects treated with oral INCB018424 (ruxolitinib) achieved near-complete hair regrowth 
within 5 months of treatment (Xing et al 2014).  A photograph of 1 patient with > 80% AA at 
baseline is pictured below at baseline and after 12 weeks of treatment. 
 
1.7.2. 
Clinical Efficacy With Topical INCB018424 in Psoriasis 
In a double-blind, vehicle- or comparator-controlled, ascending dose, safety, tolerability, PK, and 
preliminary efficacy study of INCB018424 cream in subjects with plaque psoriasis 
(Study INCB 18424-201), efficacy was demonstrated with both the 1% cream applied QD and 
the 1.5% cream applied BID with a trend toward a dose response.  Improvement in lesion 
thickness, erythema, scaling, and reduction in total lesion area were observed in comparison to 
the vehicle.  Reductions in mean lesion scores were 53% for 1% cream QD versus 32% for 
vehicle (p ≤ 0.05); 54% for 1.5% cream BID versus 27% for vehicle (p ≤ 0.05); 46% for 1.5% 
cream BID versus 40% for Dovonex® cream; and 58% for 1.5% cream BID versus 44% for 
Diprolene AF® cream. 
In an open-label, multicenter, sequential-cohort, dose-escalation, safety, tolerability, PK, 
pharmacodynamic, and preliminary efficacy study of INCB018424 1% or 1.5% cream applied to 
2% to 20% BSA QD or BID for 4 weeks in subjects with active, stable plaque psoriasis 
(Study INCB 18424-202), the efficacy analyses collectively revealed that all 5 regimens of 
INCB018424 cream, when applied for 28 days, were effective in decreasing the individual signs 
of lesion severity, lesion area, and the overall disease severity of psoriatic plaques.  Within each 
cohort, the mean individual and total psoriasis assessment scores for the treated lesions decreased 
from baseline to each subsequent assessment, indicating an overall lessening of disease severity.  


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The total lesion scores for the control lesions within each cohort either increased from baseline, 
indicating a worsening of disease severity, or decreased marginally from baseline. 
Study INCB 18424-203 was a 12-week, randomized, multicenter, parallel-group, 
vehicle-controlled, double-blind, dose-ranging study designed to evaluate the safety and efficacy 
of QD application of  INCB018424 cream (0.5%, 1.0%, or 1.5%) relative to vehicle cream in 
subjects with stable plaque psoriasis.  Within each active treatment group, the mean scores for 
the individual and total psoriasis lesion assessments, the PASI, the PGA, and the mean treatable 
percent BSA decreased from baseline to each subsequent assessment, which indicated an overall 
lessening of disease severity.  Thus, the efficacy analyses collectively revealed that all 3 doses of 
INCB018424 cream, when applied topically QD for 12 weeks, were effective in decreasing the 
individual signs of lesion severity, lesion area, and the overall disease severity of psoriatic 
plaques. 


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1.7.5. 
Oral INCB018424 (Ruxolitinib) Safety 
In the randomized period of the 2 pivotal studies in myelofibrosis, COMFORT-I and 
COMFORT-II, discontinuation because of AEs regardless of causality was observed in 11.3% of 
subjects.  The most frequently reported adverse drug reactions were thrombocytopenia and 
anemia.  Hematological adverse reactions (any CTCAE grade) included anemia (82.4%), 
thrombocytopenia (69.8%), and neutropenia (16.6%).  Anemia, thrombocytopenia, and 
neutropenia are dose-related effects.  The 3 most frequent nonhematological adverse reactions 


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were bruising (21.6%), dizziness (15.3%), and headache (14.0%).  The 3 most frequent 
nonhematological laboratory abnormalities were increased alanine aminotransferase (ALT; 
27.2%), increased aspartate aminotransferase (AST; 18.6%), and hypercholesterolemia (16.9%). 
Long-term follow-up in subjects with myelofibrosis (including 615 subjects treated with 
ruxolitinib during the controlled and extension phases of Studies INCB 18424-251 cut-off 
01 OCT 2012; COMFORT-I:  02 SEP 2012; and COMFORT-II:  01 SEP 2012) has shown that, 
as expected, the numbers and proportions of AEs and SAEs has increased; however, no new 
safety signals have emerged (median duration of exposure for this population is 27.6 months, 
with 1345.78 patient-years of exposure). 
In Study INCB 18424-258, in subjects with myelofibrosis with a platelet count between 50 and 
100 × 109/L, beginning treatment with 5 mg BID was well tolerated, avoided levels of 
thrombocytopenia associated with a high risk of significant bleeding, and provided an 
opportunity to increase the dose of ruxolitinib in a safe manner. 
Overall, the safety profile of ruxolitinib in the polycythemia vera (PV) population is generally 
consistent with that observed in the myelofibrosis population.  Ruxolitinib was generally well 
tolerated in subjects with PV, and only a small proportion of subjects discontinued ruxolitinib 
because of AEs (3.6%).  Most of the AEs were managed by dose modifications.  Hematological 
toxicities were less frequent and less severe in subjects with PV as compared with those 
observed in subjects with myelofibrosis.  No new safety signals emerged from a study in 
pancreatic cancer in combination with capecitabine.   
The AE profile of ruxolitinib was also assessed in 198 healthy subjects, subjects with various 
degrees of renal (n = 32) or hepatic (n = 24) impairment, and subjects with RA (n = 59).  
Adverse events were, in general, mild and resolved without interventions. 
A thorough QT study was conducted in 50 healthy subjects.  There was no indication of a 
QT/QTc-prolonging effect of ruxolitinib in single doses up to a supratherapeutic dose of 200 mg, 
indicating that ruxolitinib has no effect on cardiac repolarization. 




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2.2. 
Study Endpoints 
2.2.1. 
Primary Endpoints 
2.2.1.1. 
Part A 
• Percentage of subjects achieving a ≥ 50% improvement in Severity of Alopecia Tool 
(SALT50) response in terminal hair (pigmented and nonpigmented) at any visit up to 
Week 24 (inclusive). 
2.2.1.2. 
Part B 
• Percentage of subjects achieving a SALT50 response in terminal hair (pigmented and 
nonpigmented) at Week 24. 
2.2.2. 
Secondary Endpoints 
2.2.2.1. 
Part A 
• Percentage of subjects with 50% to 100% scalp involvement at baseline achieving a 
SALT50 response in terminal hair at any visit through Week 24. 
• Percentage of subjects achieving a SALT90 response in terminal hair at Weeks 4, 8, 
12, 18, and 24. 
• Safety and tolerability assessed by monitoring the frequency, duration, and severity of 
AEs; performing physical examinations; collecting vital signs; and collecting 
laboratory data for hematology, serum chemistry, and urinalysis. 
2.2.2.2. 
Part B 
• Percentage of subjects whose AA lesions treated since baseline achieved a Physician's 
Global Assessment of Regrowth (PGARG) score of at least 3 (0, no regrowth; 1, 
< 25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% 
of regrowth; 5, 100% of regrowth) using live evaluations compared to baseline 
photographs at Week 24. 
• Percentage of subjects with 50% to 100% scalp involvement at baseline achieving a 
SALT50 response in terminal hair (pigmented and nonpigmented) at Week 24. 
• Percentage of subjects achieving a SALT50 in terminal hair (pigmented and 
nonpigmented) at Weeks 4, 8, 12, and 18. 
• Percentage of subjects achieving a SALT90 in terminal hair (pigmented and 
nonpigmented) at Weeks 4, 8, 12, 18, and 24. 


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• Mean change from baseline in SALT score at Weeks 4, 8, 12, 18, and 24.   
• Safety and tolerability assessed by monitoring the frequency, duration, and severity of 
AEs; performing physical examinations; collecting vital signs; and collecting 
laboratory data for hematology, serum chemistry, and urinalysis. 


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3. 
SUBJECT ELIGIBILITY 
Deviations from eligibility criteria are not allowed, because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or subject safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential. 
3.1. 
Subject Inclusion Criteria 
A subject who meets all of the following criteria may be included in the study: 
1. Healthy adult subjects aged 18 to 70 years, inclusive. 
2. Subjects diagnosed with AA and, in the opinion of the investigator, reason to believe that 
regrowth is possible. 
3. Subjects with a current episode of AA for the following durations: 
a. At least 12 months before screening and involving 25% to < 50% of the scalp at 
baseline. 
b. At least 6 months before screening and involving 50% to 100% of the scalp at 
baseline. 
4. Subjects with a positive hair pull test and/or presence of exclamation point hairs, unless 
subject has alopecia totalis, including alopecia universalis. 
5. Subjects who agree to discontinue all agents used to treat AA from screening through the 
final follow-up visit; use of over-the-counter preparations (including vitamins, minerals, 
phytotherapeutic/herbal/plant-derived preparations, and other hair products) deemed 
acceptable by the investigator are permitted per Sections 5.8.2 and 5.8.3. 
6. Willingness to avoid pregnancy or fathering children based on the criteria below: 
a. Woman of nonchildbearing potential (surgically sterile with a hysterectomy and/or 
bilateral oophorectomy OR postmenopausal, defined by last menstrual period 
> 12 months before screening). 
b. Woman of childbearing potential who has a negative serum pregnancy test at 
screening and a negative urine pregnancy test before the first dose on Day 1 and who 
agrees to take appropriate precautions to avoid pregnancy (with at least 99% 
certainty) from screening through safety follow-up.  Permitted methods that are at 
least 99% effective in preventing pregnancy (see Appendix A) should be 
communicated to the subject and their understanding confirmed. 
c. Man who agrees to take appropriate precautions to avoid fathering children (with at 
least 99% certainty) from screening through safety follow-up.  Permitted methods that 
are at least 99% effective in preventing pregnancy (see Appendix A) should be 
communicated to the subject and their understanding confirmed. 
7. Ability to comprehend and willingness to sign an informed consent form (ICF). 


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3.2. 
Subject Exclusion Criteria 
A subject who meets any of the following criteria will be excluded from the study: 
1. Part A only:  Subjects with a diagnosis of alopecia universalis, alopecia totalis, or only 
ophiasis type AA. 
2. Subjects with a current episode of alopecia universalis or alopecia totalis of more than 
2 years in duration. 
3. Subjects with evidence of diffuse, spontaneous terminal hair regrowth at screening and/or 
baseline. 
4. Subjects with a history of complete spontaneous remission in the prior 2 years. 
5. Subjects who have received treatment known to potentially affect the course of AA 
within 1 month before the baseline visit (eg, topical and intralesional corticosteroids, oral 
or topical minoxidil). 
6. Subjects taking immunosuppressive medications (including topical agents) for any 
concurrent illness, except inhaled corticosteroids for asthma and allergic rhinitis, and 
1% topical hydrocortisone or alternate Class 7 topical steroid for atopic 
dermatitis/eczema for areas outside the scalp any time after screening. 
7. Subjects taking systemic retinoids, etanercept, adalimumab, efalizumab, alefacept, other 
biological therapies, or immunosuppressives (eg, corticosteroids [oral or injectable], 
methotrexate, cyclosporine) within 6 weeks before the baseline visit. 
8. Subjects taking systemic potent CYP3A4 inhibitors or fluconazole within 2 weeks or 
5 half-lives, whichever is longer, before the baseline visit (see Appendix C). 
9. Subjects with a history of medical disorders (eg, autoimmune diseases) whose treatments 
could complicate the assessment of hair loss on the scalp, except for: 
a. Thyroid disease on stable treatment for at least 6 months before screening. 
b. Asthma on stable treatment for at least 3 months before screening. 
10. Subjects with an abnormal TSH or free T4 at screening. 
11. Subjects with cytopenias at screening, defined as: 
a. Leukocytes < 3 × 109/L. 
b. Neutrophils < lower limit of normal. 
c. Lymphocytes < lower limit of normal. 
d. Hemoglobin < 10 g/dL. 
e. Platelets < 100 × 109/L. 
12. Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal 
disease on dialysis or at least 1 of the following: 
a. Serum creatinine > 1.5 mg/dL. 
b. Alanine aminotransferase or AST ≥ 1.5 × upper limit of normal (ULN). 
13. Positive serology test results for hepatitis B surface antigen or core antibody, or for 
hepatitis C virus antibody with detectable hepatitis C RNA at screening. 


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14. Women who were pregnant or breastfeeding within 4 months before screening. 
15. Current or recent history (< 30 days before screening and/or < 45 days before 
randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial 
infection. 
16. Current clinically meaningful viral infection, including known human immunodeficiency 
virus infection. 
17. History of unstable ischemic heart disease (including percutaneous cardiac intervention, 
myocardial infarction, or anginal acceleration within the past 6 months) or uncontrolled 
hypertension (blood pressure > 150/90 mmHg). 
18. History of alcoholism or drug addiction within 1 year before screening, or current alcohol 
or drug use that, in the opinion of the investigator, will interfere with the subject's ability 
to comply with the administration schedule and study assessments. 
19. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before 
the baseline visit with another investigational medication or current enrollment in another 
investigational drug protocol. 
20. Use of any prohibited medications (see Section 5.8.3) within 14 days or 5 half-lives 
(whichever is longer) of the baseline visit. 
21. Donation of blood within 6 weeks before screening or of plasma within 2 weeks before 
screening and unwillingness to forego further blood product donation during the study. 
22. Receipt of blood products within 2 months before screening. 
23. Subjects who have previously received JAK inhibitors. 
24. Subjects with a history of malignancy, except for the following adequately treated, 
nonmetastatic malignancies:  basal cell skin cancer not involving the scalp, squamous cell 
carcinomas of the skin not involving the scalp, or in situ cervical cancer. 
25. Subjects who have received chemotherapy. 
26. Subjects who anticipate receiving a live or live-attenuated vaccination from screening 
through the final follow-up visit. 
27. Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the 
administration schedule and study evaluations. 


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4. 
INVESTIGATIONAL PLAN 
4.1. 
Overall Study Design 
This is a 2-part study in subjects with AA, with Part A being open-label and Part B being 
double-blind, randomized, and placebo-controlled. 
In Part A, approximately 10 subjects will be treated with open-label topical INCB018424 1.5% 
cream BID for 24 weeks to examine efficacy, safety, and tolerability.  Subjects with alopecia 
totalis, which includes alopecia universalis, will not be allowed in Part A.  After completion of 
the Week 24 efficacy assessments, eligible subjects in Part A will be offered an additional 
24 weeks of open-label treatment.  To be eligible for an additional 24 weeks of open-label 
treatment in Part A, subjects must have completed the baseline and Week 24 SALT scores.  
Also, eligible subjects must have adequate laboratory parameters (must meet entry criteria 
regarding cytopenias and liver assessments) and, in the opinion of the investigator, have no 
additional safety concerns related to an additional 24 weeks of open-label treatment. 
Part B is double-blind, randomized, and placebo-controlled, with an open-label extension in up 
to 68 subjects.  Initially, 34 subjects will be randomized to INCB018424 1.5% cream or placebo 
cream, stratified by baseline percentage of scalp involvement with AA (25% to < 50% or 50% to 
100%) using the revised Alopecia Areata Investigational Guidelines (rAAIG).  Subjects will be 
treated for 24 weeks to examine efficacy, safety, and tolerability.  Subjects with alopecia totalis, 
which includes alopecia universalis, will be limited to Part B and no more than 10% of the 
randomized population.  Subjects with 25% to < 50% scalp involvement will be limited to no 
more than 70% of the randomized population in Part B.  Part B will complete randomization of 
an additional 34 subjects if sufficient evidence of terminal hair growth is demonstrated in Part A 
or the interim analysis of Part B. 
Sites will remain blinded to study drug, but some personnel at Incyte without direct contact with 
sites will be unblinded.  An internal committee at Incyte will be charged with evaluating the 
unblinded interim results based on the futility rule, as well as considering interim safety results. 
After the completion of the efficacy assessments for the primary endpoint (Week 24) in the 
double-blind portion of the study, treatment assignment in Part B will not be unblinded; 
however, all eligible subjects will be dispensed INCB018424 cream for an additional 24 weeks 
of open-label treatment.  To be eligible for an additional 24 weeks of open-label treatment in 
Part B, subjects must have completed the baseline and Week 24 SALT scores.  Also, eligible 
subjects must have adequate laboratory parameters (must meet entry criteria regarding 
cytopenias and liver assessments) and, in the opinion of the investigator, have no additional 
safety concerns related to an additional 24 weeks of open-label treatment.  All areas identified at 
baseline should continue to be treated through the end of the open-label extension, unless the 
subject has a complete clinical response. 
During the first 24 weeks of treatment in Part A, if new areas of AA develop or existing areas of 
AA expand after baseline, subjects are NOT to apply study drug to those areas.   
In Part B and the open-label extension, if new areas of AA develop or existing areas of AA 
expand after baseline, subjects are permitted to apply study drug BID to those areas after a visit 


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to document the SALT score.  The visit to document the new or expanded areas may be 
unscheduled. 
After completion of the open-label extension (48 weeks of treatment), subjects who, in the 
opinion of the investigator, are deriving benefit (some hair regrowth) from INCB018424 will be 
eligible to enter the long-term extension period for an additional 48 weeks of treatment with 
open-label INCB018424.  Also, eligible subjects must have, in the opinion of the investigator, no 
additional safety concerns related to an additional 48 weeks of open-label treatment.  During the 
long-term extension period, subjects may stop treating areas that have sufficient regrowth in the 
opinion of the investigator.  Further, after discussion with the investigator, subjects may decrease 
the application rate to QD in areas with sufficient hair regrowth. 
In the open-label extension of Parts A and B or in the long-term extension, subjects who have a 
complete clinical response (defined as 100% terminal hair regrowth and no evidence of active 
hair loss) at 2 consecutive visits will stop administration and continue the open-label visits as 
scheduled.  Subjects who have a complete clinical response who subsequently have evidence of 
hair loss after stopping treatment may restart treatment after a visit to document the SALT score.  
The visit to document the SALT score may be unscheduled. 
Concomitant oral vitamins, shampoos, and hair products should remain stable during the study. 
4.2. 
Measures Taken to Avoid Bias 
The study will be double-blind, randomized, and placebo-controlled.  An interim analysis will be 
performed in Part B.  Sites will remain blinded to study drug, but some personnel at the sponsor 
(without direct contact with sites) will be unblinded.  Details are provided in Section 9. 
4.3. 
Number of Subjects 
Part A will enroll approximately 10 subjects, and Part B will enroll up to approximately 
68 subjects.  Subjects who discontinue will not be replaced. 
4.4. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator is to notify the IRB or IEC in writing of 
the study's completion or early termination, and send a copy of the notification to the sponsor or 
sponsor's designee and retain 1 copy for the site study regulatory file. 
The sponsor may terminate the study electively or if required by regulatory decision.  If the study 
is terminated prematurely, the sponsor will notify the investigators, the IRBs and IECs, and 
regulatory bodies of the decision and reason for termination of the study. 


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5. 
TREATMENT OF SUBJECTS 
5.1. 
Treatment Groups and Administration of Study Drug 
In Parts A and B, study drug will be supplied as INCB018424 1.5% cream or placebo and will be 
applied topically as a thin film to the affected areas and up to 1 inch (2.5 cm) into the 
surrounding scalp, where evidence of a decrease in hair density or active loss as evidenced by 
exclamation point hairs or positive hair pull is present.  Study drug should be applied in the 
morning and in the evening at least 10 hours apart and at least 1 hour before bedtime.  All areas 
identified at baseline should continue to be treated through the end of the open-label extension, 
unless the subject has a complete clinical response.  If there are new areas to be treated (either in 
the open-label extension of Part A or in Part B), study drug should be applied to these areas in 
addition to the areas identified at baseline through the end of the open-label extension. 
Application instructions will be provided at study visits and via a diary card given to the subjects 
and are also provided below.  At each visit, an estimate of the percentage of scalp surface area to 
be treated is used to dispense study drug.  The prescribed dose is to be determined by weighing a 
tube before and after the subject applies a thin film of study drug to the affected scalp.  For each 
10% of scalp surface area to be treated, approximately 1 inch of study drug may be used.  
Subjects will be advised to limit the use of the cream to ≤ 3.75 grams (1/4 tube) per application 
or ≤ 1 tube every 2 days. 
The subject must be instructed in the handling of study drug as follows: 
• Before applying the medicine, wash the area(s) with mild soap or shampoo and water 
and pat it dry. 
• Study drug should be applied topically as a thin film to the affected areas and up to 
1 inch (2.5 cm) into the surrounding scalp and rubbed in gently. 
• Apply study drug in the morning and in the evening at least 1 hour before bedtime, 
with applications at least 10 hours apart. 
• Wash hands thoroughly with soap and warm water immediately after application of 
study drug. 
• If the study drug is applied by a helper, the helper should wear gloves so they are not 
exposed to study drug.  If exposed, the helper should immediately wash hands 
thoroughly with soap and warm water. 
• Do not cover the application area(s) with a bandage or dressing.  If used, occlusive 
camouflage or other contact should be avoided for at least 1 hour after an application. 
• Do not shower afterwards or lie in the sun. 
• Do not wash the treatment area(s) for at least 8 hours after application of study drug. 
• If topical anti-infectives or other topical treatments are used, these treatments should 
be avoided for at least 1 hour before and after application of study drug to an area. 
• Study drug cream is for dermatological use only and not for ophthalmic use. 


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• Store the study drug at room temperature. 
• Make every effort to take doses on schedule. 
• Report any missed doses. 
• Keep study drug in a safe place and out of reach of children. 
• Bring all used and unused study drug to the site at each visit. 
5.1.1. 
Open-Label Extension Period 
In Parts A and B, subjects who have baseline and Week 24 SALT scores will be eligible for an 
additional 24 weeks of open-label treatment.  Eligible subjects must also have adequate 
laboratory parameters (must meet entry criteria regarding cytopenias and liver assessments) and, 
in the opinion of the investigator, have no additional safety concerns related to an additional 
24 weeks of open-label treatment. 
Subjects in Part B who elect to enter the open-label extension will not be unblinded.  All eligible 
subjects will be dispensed INCB018424 cream for the additional 24 weeks of open-label 
treatment.  All areas identified at baseline should continue to be treated through the end of the 
open-label extension, unless the subject has a complete clinical response. 
5.1.2. 
Long-Term Extension Period 
After completion of the open-label extension (48 weeks of treatment), subjects who, in the 
opinion of the investigator, are deriving benefit (some hair regrowth) from INCB018424 will be 
eligible to enter the long-term extension period for an additional 48 weeks of treatment with 
open-label INCB018424.  Also, eligible subjects must have, in the opinion of the investigator, no 
additional safety concerns related to an additional 48 weeks of open-label treatment.  During the 
long-term extension period, subjects may stop treating areas that have sufficient regrowth in the 
opinion of the investigator.  Further, after discussion with the investigator, subjects may decrease 
the application rate to QD in areas with sufficient hair regrowth. 
5.2. 
Treatment Compliance 
Compliance will be assessed by reviewing the subject diaries and by weighing the study drug 
tubes.  Subjects will also be questioned regarding study drug application technique, missing 
doses, and use of any additional topical or systemic prescriptions of other products or 
over-the-counter products.  Starting at the Day 1 visit and each visit thereafter, a diary will be 
given to each subject in order to record use of the study product.  The completed diary will be 
collected during each visit.  Qualified clinical staff will review the subjects' entries for 
compliance.  Subjects who are noncompliant with study drug (defined as < 80% or > 120% 
compliant based on expected application regimen and weight of study drug tubes) will have their 
administration instructions reinforced by the investigator or a qualified designee.  Subjects will 
be considered compliant with the treatment regimen if they apply at least 80% but no more than 
120% of the expected applications during participation in the treatment phase of the study.  
Subjects who are noncompliant on more than 1 occasion will be reinstructed by the investigator 
or a qualified designee, and the sponsor should be consulted by the investigator for instruction on 
the proper handling of the subject. 


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5.3. 
Randomization and Blinding 
For subjects who have met all study entry criteria and none of the exclusion criteria, contact the 
IRT at baseline to obtain the study drug assignment. 
The study will utilize an IRT for management of study enrollment.  In Part A, the IRT will be a 
simple subject study number assignment and visit tracking configuration, as this is the open-label 
portion of the study.  For Part B, the IRT setup is more complex.  The system will assign the 
subject study number, track subject visits, randomize according to the defined parameters, and 
maintain the blind.  Additionally, the system will employ a configurable stratification algorithm 
with limits set for the baseline percent scalp involvement (25% to < 50% and 50% to 100%) and 
alopecia areata type.  In Part B, subjects with 25% to < 50% scalp involvement will be limited to 
no more than 70% of the randomized population, and subjects with alopecia totalis (which 
includes alopecia universalis) will be limited to no more than 10% of randomized population.  If 
1 or both of the limits is reached, the IRT will stop assigning randomization numbers to that 
group, and no additional subjects will be enrolled in that group. 
5.4. 
Duration of Treatment and Subject Participation 
After signing the ICF, screening assessments may be completed over a period of up to 28 days in 
both Part A and Part B.  In Part A, screening is up to 28 days; open-label treatment is 24 weeks, 
with an additional optional 24 weeks of treatment in the open-label extension and an optional 
48 weeks of treatment in the long-term extension if eligible; and follow-up is 12 weeks.  In Part 
B, screening is up to 28 days, double-blind treatment is 24 weeks, an optional open-label 
treatment is 24 weeks in the open-label extension, and an optional 48 weeks of treatment in the 
long-term extension if eligible, and follow-up is 12 weeks.  Total duration of the study is up to 
112 weeks in both Part A and Part B. 
5.5. 
Rationale for Dose Modification 
Subjects may have new areas emerge during treatment or have existing areas increase in size.  
Subjects will be allowed to apply additional study drug according to the details in Section 5.6.1.  
5.6. 
Dose Modifications of Study Drug 
5.6.1. 
Planned Dose Modifications 
During the first 24 weeks of Part A, if new areas of AA develop or existing areas of AA expand 
after baseline, subjects are NOT to apply study drug to those areas. 
In Part B and in the open-label extension, if new areas of AA develop or existing areas of AA 
expand after baseline, subjects are permitted to apply study drug BID to those areas after a visit 
to document the SALT score.  All areas identified at baseline should continue to be treated 
through the end of the open-label extension, unless the subject has a complete clinical response.  
If there are new areas to be treated (either in the open-label extension of Part A or in Part B), 
study drug should be applied to these areas in addition to the areas identified at baseline through 
the end of the open-label extension.  The visit to document the new or expanded areas may be 
unscheduled. 


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During the long-term extension period, subjects may stop treating areas that have sufficient 
regrowth in the opinion of the investigator.  Further, after discussion with the investigator, 
subjects may decrease the application rate to QD in areas with sufficient hair regrowth. 
In the open-label extension or the long-term extension, subjects with a complete clinical response 
(defined as 100% terminal hair regrowth and no evidence of active hair loss at 2 consecutive 
visits, which may include visits during the double-blind period) will stop administration and 
continue to be followed in the study.  Subjects who have a complete clinical response who 
subsequently have evidence of hair loss after stopping treatment may restart treatment after a 
visit to document the SALT score. 
5.6.2. 
Criteria and Procedures for Interruption 
In some circumstances, it may be necessary to temporarily interrupt treatment as a result of AEs 
or laboratory abnormalities that may have an unclear relationship to study drug.  Except in cases 
of emergency, it is recommended that the investigator consult with the sponsor medical monitor 
(or other representative of the sponsor) before temporarily interrupting study drug.  Additionally, 
the investigator must obtain approval from the sponsor before restarting study drug that was 
temporarily interrupted because of an AE or laboratory abnormality. 
Individual subjects may have administration interrupted at the discretion of the investigator, in 
consultation with the sponsor, for AEs or laboratory abnormalities until these have resolved.  
Subjects MUST have administration interrupted in the following situations. 
• The subject develops a Grade 2 increase in ALT (> 3 × ULN) or AST (> 3 × ULN) or 
a Grade 2 decrease in absolute lymphocyte count (< 0.8 × 109/L), ANC 
(< 1.5 × 109/L), or platelets (< 75 × 109/L).  Laboratory abnormalities should be 
confirmed with repeat testing within 48 hours whenever possible and STAT delivery 
of the laboratory results requested. 
• The subject develops a Grade 3 or higher laboratory abnormality, with the exceptions 
of lipase (Grade 4, > 5 × ULN) or any asymptomatic triglyceride, cholesterol, or 
amylase elevations.  Laboratory abnormalities should be confirmed with repeat 
testing within a medically indicated timeframe, based upon the investigator's 
judgment and in collaboration with the sponsor’s medical monitor, and STAT 
delivery of the laboratory results requested. 
• The subject had a Grade 3 or 4 drug-related AE as determined by the investigator. 
5.6.3. 
Criteria for Permanent Discontinuation of Study Drug 
Subjects who have administration interrupted based on above criteria will be followed until the 
parameters return to the normal range or to baseline values.  Laboratory evaluations can be 
repeated as frequently as daily.  A subject who has had their dose interrupted based on these 
criteria may resume administration with study drug at a later time if the subject no longer meets 
the criteria for interrupting the dose with the sponsor’s approval in consultation with the 
investigator.  Subjects who meet withdrawal criteria (see Section 5.7) during study drug 
interruption will be withdrawn from the study and may not resume administration. 


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5.7. 
Withdrawal of Subjects From the Study 
5.7.1. 
Withdrawal Criteria 
Subjects must be withdrawn from the study for the following reasons: 
• Further participation would be injurious to the subject's health or well-being, in the 
investigator's medical judgment. 
• The subject becomes pregnant. 
• Consent is withdrawn. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority or IRB or IEC. 
A subject may be withdrawn from the study as follows: 
• If, during the course of the study, a subject is found not to have met eligibility 
criteria, the medical monitor, in collaboration with the investigator, will determine 
whether the subject should be withdrawn from the study. 
• If a subject is noncompliant with study procedures or study drug administration in the 
opinion of the investigator, the sponsor should be consulted for instruction on 
handling the subject. 
5.7.2. 
Withdrawal Procedures 
In the event that any subject discontinues study drug and, subsequently, withdraws from the 
study before completion, regardless of reason, reasonable efforts should be made to have the 
subject return for an early termination visit and have the end-of-treatment (EOT) procedures 
completed as described in Section 6.4.  The date the subject was withdrawn from the study and 
the specific reason for withdrawal will be recorded in the electronic case report form (eCRF). 
In the event that the decision is made to permanently discontinue the study drug, the subject will 
be withdrawn from the study and the EOT visit should be conducted.  Reasonable efforts should 
be made to have the subject return for the follow-up visits.  These visits are described in 
Section 6.  The last date of the last dose of study drug will be recorded in the eCRF, and the 
reason for subject withdrawal will be recorded. 
If a subject is withdrawn from the study: 
• The study monitor or sponsor must be notified. 
• The reason(s) for withdrawal must be documented in the subject's medical record and 
in the eCRF. 
• The EOT or early termination visit should be performed. 
• Subjects must be followed for safety until the time of the last follow-up visit or until 
study drug–related toxicities resolve, return to baseline, or are deemed irreversible, 
whichever is longer. 


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5.8. 
Concomitant Medications and Measures 
5.8.1. 
Permitted Medications and Measures 
All concomitant medications and treatments must be recorded in the eCRF and ideally should 
remain stable through the end of the treatment portion of the study.  Concomitant oral vitamins, 
shampoos, and hair products ideally should remain stable during the study. All prior medications 
for AA and any prior medications received up to 30 days before randomization will be recorded 
in the eCRF.  Concomitant treatments and/or procedures that are required to manage a subject's 
medical condition during the study will also be recorded in the eCRF. 
5.8.2. 
Restricted Medications and Measures 
• Use of any over-the-counter, nonprescription preparations (including vitamins, 
minerals, and phytotherapeutic, herbal, or plant derived preparations) within 7 days 
before the baseline visit, unless deemed acceptable by the investigator. 
• Use of any prescription medication (including immunizations, phytotherapeutic, 
herbal, or plant-derived preparations) within 14 days before the baseline visit, unless 
deemed acceptable by the investigator. 
5.8.3. 
Prohibited Medications and Measures 
The following medications are not permitted during the study: 
• Any investigational medication other than the study drugs. 
• Other topical agents for AA (including topical minoxidil and topical over-the-counter 
corticosteroids applied to the scalp), except for stable over-the-counter creams, 
makeup, and hair colorizers. 
• Treatment known to affect the course of AA. 
• Systemic minoxidil, corticosteroids, methotrexate, cyclosporine A, and biological 
therapies, or oral immunosuppressant agents. 
• Phototherapy involving ultraviolet light. 
• Potent systemic CYP3A4 inhibitors or fluconazole (see Appendix C), until after the 
last administration of study drug (topical agents with limited systemic availability are 
permitted). 
6. 
STUDY ASSESSMENTS 
All study assessments will be performed as indicated in the schedule of assessments tables.  
Table 2 presents the assessments for the initial 24 weeks of treatment in Parts A and B.  Table 3 
presents the assessments for the open-label extension of Part A.  Table 4 presents the 
assessments for the open-label extension of Part B.  Table 5 presents the assessments for the 
long-term extension period.  The order of assessments is suggested by the order of mention 
within the schedule.  For instructions on each assessment, see Section 7. 


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Table 2: 
Schedule of Assessments for the First 24 Weeks of Treatment in Parts A and B 
Evaluation 
Section 
Screening 
Treatment Parts A and B 
Follow-Up 
Day -28 to 
-1 
Day 1 
Week 4 
Day 29 
± 3 Days 
Week 8 
Day 56 
± 3 Days 
Week 12 
Day 84 
± 3 Days 
Week 18 
Day 126 
± 7 Days 
Week 24 EOT 
Day 168 
± 7 Days 
Month 1 
± 7 Days 
Month 3 
EOS 
± 7 Days 
Clinic visit 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Informed consent  
7.1 
X 
 
 
 
 
 
 
 
 
Contact IRT 
7.2 
X 
X 
X 
X 
X 
X 
X 
 
 
Inclusion/exclusion criteria 
3 
X 
X 
 
 
 
 
 
 
 
Medical history 
7.3 
X 
 
 
 
 
 
 
 
 
Prior/concomitant meds 
7.3.2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height and body weight 
7.3.1 
X 
 
 
 
 
 
 
 
 
Comprehensive physical exam 
7.4.2 
X 
 
 
 
 
 
X 
 
 
Targeted physical exam 
7.4.3 
 
X 
X 
X 
X 
X 
 
X 
X 
Vital signs 
7.4.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
7.4.6 
X 
X 
X 
X 
X 
X 
X 
 
X 
Hepatitis screening tests 
7.4.6.6  
X 
 
 
 
 
 
 
 
 
Urinalysis 
7.4.6.3 
X 
 
 
 
 
 
X 
 
 
FSHa 
7.4.6.4 
X 
 
 
 
 
 
 
 
 
Pregnancy testb 
7.4.6.5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
7.4.5 
X 
 
 
 
 
 
X 
 
 
Efficacy assessments 
7.5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hamilton-Norwood Scalec 
 
 
 
 
 
 
 
X 
 
 
Apply study drug 
7.9.1 
 
X 
X 
X 
X 
X 
 
 
 
Study drug and diary card dispensed 
7.9.4 
 
X 
X 
X 
X 
X 
 
 
 
Collect study drug tubes; collect and 
review diary cards 
 
 
 
X 
X 
X 
X 
X 
 
 
Assess compliance 
7.9.3 
 
 
X 
X 
X 
X 
X 
 
 
Photography of scalp 
7.5.4 
 
X 
Xe 
 
X 
 
X 
 
X 
Assess AEs 
7.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
FSH = follicle-stimulating hormone. 
a Serum FSH to be performed for all postmenopausal women only, defined by last menstrual period > 12 months before screening. 
b All women will have a serum pregnancy test conducted at the screening visit and urine pregnancy tests conducted at all other visits (including baseline). 
c Assessment of male pattern baldness in male subjects only. 
e For Part A only:  photography of scalp at Week 4. 


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Table 3: 
Schedule of Assessments for the Open-Label Extension of Part A 
Evaluation 
Section 
Open-Label Extension Part A 
Follow-Up 
Week 24 
Day 168 
± 7 Days 
Week 30 
Day 210 
± 7 Days 
Week 36 
Day 252 
± 7 Days 
Week 42 
Day 294 
± 7 Days 
Week 48 
EOT  
Day 336 
± 7 Days 
Month 1 
± 7 Days 
Month 3 
EOS 
± 7 Days 
Clinic visit 
 
 
X 
X 
X 
X 
X 
X 
Contact IRT 
7.2 
Xa 
X 
X 
X 
X 
 
 
Prior/concomitant medications 
7.3.2 
 
X 
X 
X 
X 
X 
X 
Comprehensive physical exam 
7.4.2 
 
 
 
 
X 
 
 
Targeted physical exam 
7.4.3 
 
X 
X 
X 
 
X 
X 
Vital signs 
7.4.4 
 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
7.4.6 
 
X 
X 
X 
X 
 
X 
Urinalysis 
7.4.6.3 
 
 
 
 
X 
 
 
Pregnancy testb 
7.4.6.5 
 
X 
X 
X 
X 
X 
X 
12-lead ECG 
7.4.5 
 
 
 
 
X 
 
 
Efficacy assessments 
7.5 
 
X 
X 
X 
X 
X 
X 
Hamilton-Norwood Scalec 
7.5.5  
 
 
 
 
X 
 
 
Apply study drug 
7.9.1 
Xa 
X 
X 
X 
 
 
 
Study drug and diary card 
dispensed 
7.9.4 
Xa 
X 
X 
X 
 
 
 
Collect study drug tubes; collect 
and review diary cards 
 
 
X 
X 
X 
X 
 
 
Assess compliance 
7.9.3 
 
X 
X 
X 
X 
 
 
Photography of scalp 
7.5.4 
 
 
X 
 
X 
 
X 
Assess AEs 
7.4.1 
 
X 
X 
X 
X 
X 
X 
EOS = end of study. 
a All assessments for the Week 24 visit noted in Table 2 as well as these additional activities must be performed before subjects who meet eligibility criteria (see Section 5.1.1) 
may enter the open-label extension. 
b Urine pregnancy tests during the open-label extension will be performed on all women. 
c Assessment of male pattern baldness in male subjects only. 


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Table 4: 
Schedule of Assessments for the Open-Label Extension of Part B 
Evaluation 
Section 
Open-Label Extension Part B 
Follow-Up 
Week 24 
Day 168 
± 7 Days 
Week 28 
Day 196 
± 7 Days 
Week 32 
Day 224 
± 7 Days 
Week 36 
Day 252 
± 7 Days 
Week 42 
Day 294 
± 7 Days 
Week 48 
EOT 
Day 336 
± 7 Days 
Month 1 
± 7 Days 
Month 3 
EOS 
± 7 Days 
Clinic visit 
 
 
X 
X 
X 
X 
X 
X 
X 
Contact IRT 
7.2 
Xa 
X 
X 
X 
X 
X 
 
 
Prior/concomitant medications 
7.3.2 
 
X 
X 
X 
X 
X 
X 
X 
Comprehensive physical exam 
7.4.2 
 
 
 
 
 
X 
 
 
Targeted physical exam 
7.4.3 
 
X 
X 
X 
X 
 
X 
X 
Vital signs 
7.4.4 
 
X 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
7.4.6 
 
X 
X 
X 
X 
X 
 
X 
Urinalysis 
7.4.6.3 
 
 
 
 
 
X 
 
 
Pregnancy testb 
7.4.6.5 
 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
7.4.5 
 
 
 
 
 
X 
 
 
Efficacy assessments 
7.5 
 
X 
X 
X 
X 
X 
X 
X 
Hamilton-Norwood Scalec 
7.5.5  
 
 
 
 
 
X 
 
 
Apply study drug 
7.9.1 
Xa 
X 
X 
X 
X 
 
 
 
Study drug and diary card 
dispensed 
7.9.4 
Xa 
X 
X 
X 
X 
 
 
 
Collect study drug tubes; 
collect and review diary cards 
 
 
X 
X 
X 
X 
X 
 
 
Assess compliance 
7.9.3 
 
X 
X 
X 
X 
X 
 
 
Photography of scalp 
7.5.4 
 
 
 
X 
 
X 
 
X 
Assess AEs 
7.4.1 
 
X 
X 
X 
X 
X 
X 
X 
EOS = end of study. 
a All assessments for the Week 24 visit noted in Table 2 as well as these additional activities must be performed before subjects who meet eligibility criteria (see Section 5.1.1) 
may enter the open-label extension. 
b Urine pregnancy tests during the open-label extension will be performed on all women. 
c Assessment of male pattern baldness in male subjects only. 
 


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Table 5: 
Schedule of Assessments for the Long-Term Extension Period 
Evaluation 
Section 
Week 48 
Day 336 ± 
7 Days 
Week 60 
Day 420 
± 7 Days 
Week 72 
Day 504 
± 7 Days 
Week 84 
Day 588 
± 7 Days 
Week 96 
EOT 
Day 672 
 ± 7 Days 
Follow-Up 
Month 1 
± 7 Days 
Month 3 
EOS 
± 7 Days 
Clinic visit 
 
 
X 
X 
X 
X 
X 
X 
Contact IRT 
7.2 
Xa 
X 
X 
X 
X 
 
 
Prior/concomitant medications 
7.3.2 
 
X 
X 
X 
X 
X 
X 
Comprehensive physical exam 
7.4.2 
 
 
 
 
X 
 
 
Targeted physical exam 
7.4.3 
 
X 
X 
X 
 
X 
X 
Vital signs 
7.4.4 
 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
7.4.6 
 
X 
X 
X 
X 
 
X 
Urinalysis 
7.4.6.3 
 
 
 
 
X 
 
 
Pregnancy testb 
7.4.6.5 
 
X 
X 
X 
X 
X 
X 
12-lead ECG1 
7.4.5 
 
 
 
 
X 
 
 
Efficacy assessments 
7.5 
 
X 
X 
X 
X 
X 
X 
Hamilton-Norwood Scalec 
7.5.5 
 
 
 
 
X 
 
 
Apply study drug 
7.9.1 
Xa 
X 
X 
X 
 
 
 
Study drug and diary card dispensed 
7.9.4 
Xa 
X 
X 
X 
 
 
 
Collect study drug tubes; collect and review 
diary cards 
 
 
X 
X 
X 
X 
 
 
Assess compliance 
7.9.3 
 
X 
X 
X 
X 
 
 
Photography of scalp 
7.5.4 
 
X 
X 
X 
X 
 
X 
Assess AEs 
7.4.1 
 
X 
X 
X 
X 
X 
X 
EOS = end of study. 
a All assessments for the Week 48 visit noted in Table 3 or Table 4 (Parts A and B, respectively) as well as these additional activities must be performed before subjects who meet 
eligibility criteria (see Section 5.1.2) may enter the long-term extension. 
b Urine pregnancy tests during the long-term extension will be performed on all women. 
c Assessment of male pattern baldness in male subjects only. 


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Table 6: 
Clinical Laboratory Assessments 
Serum Chemistries 
Hematology 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Bicarbonate 
Blood urea nitrogen 
Calcium 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Phosphorus 
Potassium 
Sodium 
Total bilirubin 
Total serum protein 
Hematocrit 
Hemoglobin 
Mean corpuscular volume 
Platelet count 
Red blood cell count 
Reticulocyte count 
White blood cell count 
White blood cell differential  (5 part): 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
Other 
Serology 
Urinalysis 
Serum pregnancy test 
FSH 
Free T4 
TSH 
Hepatitis B surface antigen 
Hepatitis B core antibody 
Hepatitis B core IgM antibody 
Hepatitis C virus antibody 
HCV-RNA (only performed if antibody positive) 
FSH = follicle-stimulating hormone; HCV-RNA = hepatitis C virus ribonucleic acid; IgM = immunoglobulin M. 
6.1. 
Screening 
Screening is the interval between the signing of the ICF and the day the subject is enrolled in the 
study.  Informed consent must be obtained before performing any study-specific procedures.  
Assessments that are required to demonstrate eligibility may be performed over the course of 
1 or more days during screening. 
Results from the screening evaluations will be reviewed to confirm subject eligibility before 
randomization or the administration of study drug.  Tests with results that fail eligibility 
requirements may be repeated once during screening if the investigator believes the results to be 
in error.  Additionally, a subject who fails screening may repeat the screening process 1 time if 
the investigator believes that there has been a change in eligibility status (eg, following recovery 
from an infection). 


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6.2. 
Baseline 
The results from the screening evaluations will be reviewed to determine if the subject continues 
to meet the eligibility requirements as specified in the Protocol. 
Subjects who have signed the ICF and meet all the entry criteria (see Section 3) may be enrolled 
or randomized in the study. 
6.3. 
Treatment 
Subjects who meet all the study entry criteria and none of the exclusion criteria will return to the 
study site on Day 1 of administration.  Dates for subsequent study visits will be determined 
based on this day and should occur within the visit windows outlined in the schedules of 
assessments (Table 2, Table 3, Table 4, and Table 5). 
The treatment period begins when the subject receives their first dose of study drug, which will 
be administered in the clinic.  At each visit, an estimate of the percentage of scalp surface area to 
be treated is used to dispense study medication.  At each visit, the prescribed dose is to be 
determined by weighing a tube before and after the subject applies a thin film of study drug to 
the affected areas and up to 1 inch (2.5 cm) into the surrounding scalp, where evidence of a 
decrease in hair density or active loss as evidenced by exclamation point hairs or positive hair 
pull is present.  For each 10% of treated scalp, approximately 1 inch of study drug may be used.  
Tubes of INCB018424 cream or placebo cream will be dispensed to subjects with detailed 
application instructions. 
All subjects in Parts A and B will be treated for 24 weeks.  At Week 24, eligible subjects will be 
offered the opportunity to receive an additional 24 weeks of treatment in the open-label 
extension.  After the completion of the efficacy assessments for the primary endpoint (Week 24) 
in the double-blind portion of the study, treatment assignment in Part B will not be unblinded; 
however, all subjects will be dispensed INCB018424 cream for an additional 24 weeks of 
open-label treatment.  All areas identified at baseline should continue to be treated through the 
end of the open-label extension, unless the subject has a complete clinical response. 
For subjects in Part A, any new areas of AA develop or existing areas of AA expand after 
baseline should not be treated until after Week 24.  At any time during treatment for subjects in 
Part B, and after Week 24 for subjects in Part A, if new areas of AA develop or existing areas of 
AA expand, subjects are permitted to apply study drug BID to those areas after a visit to 
document the SALT score.  The visit to document the new or expanded areas may be 
unscheduled. 
After completion of the open-label extension (48 weeks of treatment), subjects who, in the 
opinion of the investigator, are deriving benefit (some hair regrowth) from INCB018424 will be 
eligible to enter the long-term extension period for an additional 48 weeks of treatment with 
open-label INCB018424.  Also, eligible subjects must have, in the opinion of the investigator, no 
additional safety concerns related to an additional 48 weeks of open-label treatment.  During the 
long-term extension period, subjects may stop treating areas that have sufficient regrowth in the 
opinion of the investigator.  Further, after discussion with the investigator, subjects may decrease 
the application rate to QD in areas with sufficient hair regrowth. 


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In the open-label extension of Parts A and B or in the long-term extension, subjects who have a 
complete clinical response (defined as 100% terminal hair regrowth and no evidence of active 
hair loss at 2 consecutive visits, which may include visits at Weeks 18 and 24 in the double-blind 
portion) will stop administration and continue the open-label visits as scheduled.  Subjects who 
have a complete clinical response who subsequently have evidence of hair loss after stopping 
treatment may restart treatment after a visit to document the SALT score.  The visit to document 
the SALT score may be unscheduled. 
Information regarding a subject’s genome will not be collected.  Concomitant oral vitamins, 
shampoos, and hair products should remain stable during the study. 
If another person applies study drug, then that person should wear gloves when in contact with 
study drug. 
6.4. 
End of Treatment 
If a decision is made that the subject will permanently discontinue study drug, the EOT visit 
should be conducted.  If the EOT visit coincides with a regular study visit, the EOT evaluations 
will supersede those of that scheduled visit, and the data should be entered in the EOT page in 
the eCRF.  The subject should be encouraged to return for the follow-up visits. 
6.5. 
Follow-Up Phase 
Subjects will have follow-up assessments 1 and 3 months after the last application of study drug 
or after Week 48 for subjects with a complete clinical response.  If prohibited treatment for 
alopecia is started, an earlier follow-up visit may be performed.  A final and thus end-of-study 
visit should be performed, ideally no earlier than 30 days after the last dose of study drug.  
Adverse events and SAEs must be reported up until at least 30 days after the last dose of study 
drug, the date of the follow-up visit, or until toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longer.  Reasonable efforts should be made to have the subject return 
for the follow-up visits and report any AEs that may occur during this phase. 
6.6. 
Unscheduled Visits 
Unscheduled study visits may occur at any time medically warranted.  Any assessments 
performed at those visits should be recorded in the eCRF.  If there is worsening of AA at an 
unscheduled visit, then a SALT score and photography should be performed. 
6.7. 
Early Termination 
In the event that any subject discontinues the study drug and subsequently the study prior to 
completion, regardless of reason, reasonable efforts should be made to have the subject return for 
an early termination visit and have the EOT procedures completed as noted in Table 2. 
Subjects who are noncompliant with study drug (defined as < 80% compliant based on tube 
weight) will have the administration instructions reinforced by the investigator or a qualified 
designee.  After reinforcement, subjects who again fail to meet 80% compliance benchmarks in a 
subsequent visit will be considered for withdrawal from the study.  In such cases, the sponsor 
should be consulted by the investigator for instruction on the proper handling the subject prior to 
withdrawal. 


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7. 
CONDUCT OF STUDY ASSESSMENTS AND PROCEDURES 
7.1. 
Administration of Informed Consent Form 
Valid informed consent must be obtained from the study subject before conducting any 
study-specific procedures using an ICF approved by the local IRB/IEC that contains all elements 
required by ICH E6, and describes the nature, scope, and possible consequences of the study in a 
form understandable to the study subject.  Local and institutional guidelines for ICF content and 
administration must be followed; the original signed ICF must be retained by the investigator and 
a copy of the signed ICF must be provided to the study subject.  The informed consent process 
for each subject must be documented in writing within the subject source documentation.  
Subjects of childbearing potential must agree to take appropriate measures to avoid pregnancy in 
order to participate in the study (Appendix A). 
7.2. 
Interactive Response Technology Procedure 
The IRT will be contacted to obtain a subject ID number when a subject enters screening.  Upon 
determining that the subject is eligible for study entry, IRT will be contacted to obtain study drug 
assignment.  Additionally, IRT will be contacted at each regular study visit to update the study 
drug supply. 
7.3. 
Demography and History 
7.3.1. 
Demographics and Medical History 
Demographic data and a complete medical and medication history will be collected at screening. 
7.3.2. 
Prior and Concomitant Medications 
Prior and concomitant medications will be reviewed to determine study eligibility.  The 
medication record will be maintained after enrollment as documentation of concomitant 
medications, including any changes to the dose or regimen.  Concomitant medications include 
any prescription, over-the-counter, natural, or herbal preparations taken or administered during 
the study. 
7.4. 
Safety Assessments 
7.4.1. 
Adverse Events 
Adverse events will be monitored from the time the subject signs the ICF.  Subjects will be 
instructed to report all AEs during the study and will be assessed for the occurrence of AEs 
throughout the study.  In order to avoid bias in eliciting AEs, subjects will be asked general, 
nonleading questions such as "How are you feeling?"  All AEs (serious and nonserious) must be 
recorded on the source documents and eCRFs regardless of the assumption of a causal 
relationship with the study drug.  The definition, reporting, and recording requirements for AEs 
are described in Section 8. 


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7.4.2. 
Comprehensive Physical Examination 
Physical examinations must be performed by a medically qualified individual such as a licensed 
physician, physician's assistant, or an advanced registered nurse practitioner, as local law 
permits. 
A comprehensive physical examination will be performed on the days noted in Table 2, Table 3, 
Table 4, and Table 5.  The comprehensive physical examination will include the following organ 
or body system assessments:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; 
cardiovascular system; abdomen (liver, spleen); extremities; lymph nodes; and a brief 
neurological examination. 
7.4.3. 
Targeted Physical Examination 
A targeted physical examination will be a symptom-directed evaluation and will be performed as 
necessary on the days noted in Table 2, Table 3, Table 4, and Table 5.  The targeted physical 
examination will include assessments of the body systems or organs, as indicated by subject 
symptoms, AEs, or other findings as determined by the investigator or designee. 
7.4.4. 
Vital Signs 
Vital sign measurements (blood pressure, pulse, respiratory rate, and body temperature) will be 
taken with the subject in the recumbent, semirecumbent, or sitting position after 5 minutes of 
rest. 
7.4.5. 
Twelve-Lead Electrocardiograms 
All 12-lead ECGs will be performed with the subject in a recumbent position after 5 minutes of 
rest.   
The 12-lead ECGs will be interpreted by the investigator at the site and will be used for 
immediate subject management.  The decision to include or exclude a subject or withdraw a 
subject from the study based on an ECG flagged as "Abnormal, Clinically Significant" is the 
responsibility of the investigator, in consultation with the sponsor's medical monitor, as 
appropriate. 
7.4.6. 
Laboratory Assessments 
Clinical laboratory tests will be performed using a central laboratory.  A detailed description of 
the procedures for sampling, handling, storage, and shipment of the central laboratory samples 
and all material such as test tubes and labels is provided in the central Laboratory Manual.  If 
unscheduled local laboratory tests are performed and those results lead to a dose modification, 
delay, or dose interruption, or any additional non-Protocol–required test is performed because of 
an AE, those results and the normal reference ranges for those analytes must be documented in 
the eCRF.  Otherwise, unscheduled local laboratory test results need not be entered in the eCRF. 
Tests required at each visit are shown in Table 2, Table 3, Table 4, and Table 5.  Additional 
analytes may be requested based on emerging data, if indicated for safety of study subjects.  In 
addition, some subjects may receive additional assessments as medically indicated; results of 
nonrequired tests may also be entered in the eCRF. 


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7.4.6.1. 
Chemistry 
A panel of standard serum chemistries will be analyzed at times shown in Table 2, Table 3, 
Table 4, and Table 5.  A list of required analytes is found in Table 6.  All serum chemistries will 
be performed from blood samples collected without respect to food intake (ie, nonfasted). 
7.4.6.2. 
Hematology 
Hematology tests will be performed at each study visit indicated in Table 2, Table 3, Table 4, 
and Table 5.  A list of required analytes for scheduled visits is provided in Table 6. 
7.4.6.3. 
Urinalysis 
Urinalysis will be performed at each study visit indicated in Table 2, Table 3, Table 4, and 
Table 5. 
7.4.6.4. 
Fertility Testing 
Women who report being amenorrheic for ≥ 1 year will have FSH testing to confirm hormonal 
menopause; a result of > 30 IU/L will be considered confirmatory.  Female subjects thus 
confirmed as postmenopausal or those who are surgically sterile will be considered to be of 
nonchildbearing potential. 
7.4.6.5. 
Pregnancy Testing 
Pregnancy testing will be performed on all female subjects as noted in the schedules of 
assessments (Table 2, Table 3, Table 4, and Table 5).  Serum pregnancy test will be obtained at 
screening.  A urine pregnancy test will be obtained all other visits.  A positive urine pregnancy 
test should be confirmed by a serum pregnancy test. 
7.4.6.6. 
Hepatitis Screening Tests 
Hepatitis tests shown in Table 6 will be conducted during the screening period.  This thorough 
hepatitis testing is being obtained to better interpret any abnormalities in liver function tests that 
may develop during the course of the study; therefore, it is not mandatory that results of all tests 
be available before enrollment (Day 1) if clinical evaluation and medical history provide no 
reason to suspect ongoing active or subclinical hepatitis infection. 
7.5. 
Efficacy Assessments 
7.5.1. 
Severity of Alopecia Tool Scoring System 
Alopecia areata will be assessed using the SALT scoring system recommended by the National 
Alopecia Areata Foundation group published in the Journal of the American Academy of 
Dermatology by Olsen et al (2004). 
The scalp will be divided into 4 areas (see Appendix B): 
• Top of scalp is 40% (0.4) of scalp surface area. 
• Right side of scalp is 18% (0.18) of scalp surface area. 


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• Left side of scalp is 18% (0.18) of scalp surface area. 
• Back side of scalp is 24% (0.24) of scalp surface area. 
There are 2 acceptable methods of calculating percentage of hair loss in any of these areas: 
1. The percentage of hair loss in each area is multiplied by the percentage of surface area of 
the scalp in that area.  The SALT score is the sum of the percentage of hair loss in all of 
the above mentioned areas.  For example, if the percentages of hair loss in the top, right 
side, left side, and back are 20%, 30%, 40%, and 50%, respectively, the SALT score = 
(20 × 0.4) + (30 × 0.18) + (40 × 0.18) + (50 × 0.24) = 8 + 5.4 + 7.2 + 12 = 32.6. 
2. The SALT score may also be determined directly by assessing the overall hair loss in 
each section, knowing the percentage covered by each section.  For example, the hair loss 
may be determined to be 8% on the top, 5% on the right side, 7% on the left side, and 
12% in the back, or 32% total.  Because this method does not use a multiplication factor, 
the numbers are generally whole. 
Whichever method of assessment of the SALT score is used in an individual subject, it should be 
noted in the source document and used at subsequent visits. 
7.5.2. 
Terminal Hair Regrowth Assessment 
At each postbaseline visit, the estimated percentage of any hair regrowth that is terminal 
pigmented, terminal nonpigmented, or vellus/indeterminate is to be determined.  For example, if 
at baseline there is 50% scalp involvement and at a postbaseline visit there is only 25% scalp 
involvement, with hair regrowth in 25% of the scalp (a SALT50), and if all of that regrowth is 
pigmented terminal hair, then it would be recorded as 100% pigmented terminal hair regrowth 
(since it is 100% of the 25% of the scalp that has hair regrowth). 
7.5.3. 
Physician's Global Assessment of Regrowth 
In Part B only, a PGARG score (0, no regrowth; 1, < 25% of regrowth; 2, 25%-49% of regrowth; 
3, 50%-74% of regrowth; 4, 75%-99% of regrowth; 5, 100% of regrowth) using live evaluations 
and referencing baseline photographs will be determined. 
7.5.4. 
Photographs 
For each visit with photography, 5 photographs, with views similar to those for the SALT 
scoring, will be obtained using the Canfield methodology.  Photography will be done as follows: 
• Part A at baseline and Weeks 4, 12, and 24.  
• Part B at baseline and Weeks 12 and 24. 
• Open-label extension at Weeks 36 and 48. 
• Long-term extension at Weeks 60, 72, 84, and 96. 
• Follow-up period at Month 3 (or end-of-study visit). 


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7.5.5. 
Hamilton-Norwood Scale 
The Hamilton-Norwood Scale is an assessment of male pattern baldness that contains 
7 categories (Type I through Type VII; Norwood 1975).  Four of the categories have a Type A 
variant (Type IIa, Type IIIa, Type IVa, and Type Va).  Appendix D presents a pictorial 
representation of the 7 types as well as the 4 variants.  Assessment of male pattern baldness will 
be done by the investigator by examining the subject during the visit in male subjects only at 
Weeks 24, 48, and 96. 
7.6. 
Performance and Quality of Life Assessments 
Not applicable. 
7.8. 
Pharmacodynamic Assessments 
Not applicable. 
7.9. 
Other Study Procedures 
7.9.1. 
Administration of Study Drug 
INCB018424 cream will be applied as a thin film BID, with applications at least 10 hours apart.  
The dose strength is 1.5% INCB018424 phosphate (w/w free base equivalent) in a cream 


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formulation along with the matching placebo cream formulation containing only the vehicle.  
Application instructions will be provided at study visits and via a diary card given to the 
subjects.  Application instructions will state that the cream is for dermatological use only and not 
for ophthalmic use.  See Section 5.1 for further detail regarding application instructions. 
Study drug will be applied in the clinic on the day of a study visit.  The prescribed dose is to be 
determined by weighing a tube before and after the subject applies a thin film of study drug to 
the affected scalp.  For each 10% of affected scalp, approximately 1 inch of study drug may be 
used.  Subjects will be advised to limit the use of the cream to ≤ 3.75 grams (1/4 tube) per 
application or ≤ 1 tube every 2 days.  All areas identified at baseline should continue to be 
treated through the end of the open-label extension, unless the subject has a complete clinical 
response. 
7.9.2. 
Dispensing of Study Drug 
INCB018424 drug product will be provided as a topical cream, 1.5% (w/w free base equivalent) 
of INCB018424 phosphate cream and the matching placebo cream will be packaged as 15 grams 
per tube.  Tubes will include labeling "New Drug - Limited by Federal (USA) Law to 
Investigational Use Only." 
At each visit, an estimate of the percentage of scalp surface area to be treated will be used to 
dispense the number of tubes of study drug.  
7.9.3. 
Assessment of Compliance With Study Drug 
Compliance will be assessed by reviewing the subject diaries and by weighing the study drug 
tubes.  Subjects will also be questioned regarding study drug application technique, missing 
doses, and use of any additional topical or systemic prescriptions of other products or 
over-the-counter products. 
7.9.4. 
Distribution of Subject Reminder Cards and Diaries 
Starting at the Day 1 visit and each visit thereafter, a diary will be given to each subject in order 
to record use of the study product.  The completed diary will be collected during the subject's 
visit.  Qualified clinical staff will review the subjects' entries for compliance.  Subjects who are 
noncompliant with either their study drug (defined as < 80% or > 120% compliant based on 
prescribed application regimen and weight of study drug tubes) will have their administration 
instructions reinforced by the investigator or a qualified designee.  Subjects will be considered 
compliant with the treatment regimen if they apply at least 80% but no more than 120% of the 
expected applications during participation in the treatment phase of the study. 


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8. 
SAFETY MONITORING AND REPORTING 
8.1. 
Adverse Events 
8.1.1. 
Definitions 
For the purposes of this Protocol, an adverse event (AE) is defined as the appearance of or 
worsening of any pre-existing undesirable sign, symptom, or medical condition that occurs after 
a subject provides informed consent.  Abnormal laboratory values or test results occurring after 
informed consent constitute AEs only if they induce clinical signs or symptoms, are considered 
clinically meaningful, require therapy (eg, hematologic abnormality that requires transfusion), or 
require changes in the study drug. 
8.1.2. 
Reporting 
Adverse events that begin or worsen after informed consent should be recorded on the Adverse 
Events form of the eCRF.  Conditions that were already present at the time of informed consent 
should be recorded on the Medical History form in the eCRF.  Monitoring for the occurrence of 
new AEs should be continued for at least 30 days after the last dose of study drug.  Adverse 
events (including laboratory abnormalities that constitute AEs) should be described using a 
diagnosis whenever possible rather than by individual underlying signs and symptoms.  When a 
clear diagnosis cannot be identified, each sign or symptom should be reported as a separate AE. 
"Disease progression" should not be recorded as an AE itself unless there are no other 
identifiable AEs associated with the disease progression at the time of reporting.  For example, if 
it is determined that disease progression resulted either in hospitalization, a life-threatening 
event, or death, then the specific event that led to the subject's hospitalization, life-threatening 
event, or death should be reported as the AE instead of "disease progression." 
Adverse events will be assessed according to the CTCAE v4.03.  The CTCAE Grade 5 severity 
(death) will not be used in this study; rather, AEs with an outcome of death will be reported as 
CTCAE Grade 4, with an outcome of "fatal."  If an event is not classified by CTCAE, the 
severity of the AE will be graded according to the scale below to estimate the grade of severity. 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated. 
Grade 2 
Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate 
activities of daily living. 
Grade 3 
Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
The occurrence of AEs should be sought by nondirective questioning of the subject during the 
screening process after signing the ICF and at each visit during the study.  Adverse events may 
also be detected when they are volunteered by the subject during the screening process or 
between visits, or through physical examination, laboratory test, or other assessments.   


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To the extent possible, each AE should be evaluated to determine: 
• The severity grade (CTCAE Grade 1 to 4). 
• Whether there is at least a reasonable possibility that the AE is related to the study 
treatment:  suspected (yes) or not suspected (no). 
• The start and end dates, unless unresolved at final follow-up. 
• The action taken with regard to study drug. 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, 
recovering/resolving, recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per serious adverse event (SAE) definition provided in 
Section 8.3.1. 
Unlike routine safety assessments, SAEs are monitored continuously and have special reporting 
requirements (see Section 8.3.2). 
All AEs should be treated appropriately.  Concomitant medication or nondrug therapy used to 
treat an AE should be recorded on the Adverse Event form as well as the Prior/Concomitant 
Medications or Procedures and Non-Drug Therapy form in the eCRF. 
Once an AE is detected, it should be followed until it has resolved or until it is judged to be 
permanent; assessment should be made at each visit (or more frequently if necessary) of any 
changes in severity, the suspected relationship to the study drug, the interventions required to 
treat it, and the outcome. 
When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE until the event resolves.  For example, 
2 separate AEs will be reported if a subject has Grade 1 diarrhea, meeting the definition of an 
AE, which lasts for 3 days before worsening to a Grade 3 severity.  The Grade 1 event will be 
reported as an AE with a start date equal to the day the event met the Grade 1 AE definition and 
a stop date equal to the day that the event increased in severity from Grade 1 to Grade 3.  The 
Grade 3 event will also be reported as an AE, with the start date equal to the day the event 
changed in intensity from Grade 1 to Grade 3 and a stop date equal to the day that the event 
either changed severity again or resolved.  For analysis purposes, this will be considered 1 AE 
for this subject and the highest reported severity will be used. 
8.2. 
Laboratory Test Abnormalities 
Laboratory abnormalities that constitute an AE in their own right (considered clinically 
meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes 
in study drug) should be recorded on the Adverse Event form in the eCRF.  Whenever possible, a 
diagnosis rather than a symptom should be provided (eg, "anemia" instead of "low hemoglobin").  
Laboratory abnormalities that meet the criteria for AEs should be followed until they have 
returned to normal or an adequate explanation of the abnormality is found.  When an abnormal 
laboratory test result corresponds to a sign or symptom of a previously reported AE, it is not 
necessary to separately record the laboratory test result as an additional event. 
Laboratory abnormalities that do not meet the definition of an AE should not be reported as AEs.  
A Grade 3 or 4 (severe) AE does not automatically indicate an SAE unless it meets the definition 


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of serious, as defined in Section 8.3.1, and/or per the investigator's discretion.  A dose 
modification for the laboratory abnormality may be required (see Section 5.6.2) and should not 
contribute to the designation of a laboratory test abnormality as an SAE. 
8.3. 
Serious Adverse Events 
8.3.1. 
Definitions 
An SAE is defined as an event that meets at least 1 of the following criteria: 
• Is fatal or life-threatening. 
• Requires inpatient hospitalization or prolongation of existing hospitalization, unless 
hospitalization is a result of: 
− A routine treatment or monitoring of the studied indication not associated with 
any deterioration in condition. 
− An elective or preplanned treatment for a pre-existing condition that is unrelated 
to the indication under study and has not worsened since signing the ICF. 
− A treatment on an emergency outpatient basis for an event not fulfilling any of the 
definitions of a SAE and not resulting in hospital admission. 
− Any social reasons and respite care, in the absence of any deterioration in the 
subject's general condition. 
− Any SAEs that are expected due to the condition being treated, including whether 
the SAE is a primary outcome measure, or where there has been a clear agreement 
with regulators not to consider these as SAEs, provided the information is 
collected elsewhere. 
• Results in persistent or significant disability or incapacity or a substantial disruption 
of a person’s ability to conduct normal life functions. 
• Constitutes a congenital anomaly or birth defect. 
• Is considered to be an important medical event or a medically significant event that 
may not result in death, be immediately life-threatening, or require hospitalization but 
may be considered serious when, based upon appropriate medical judgment, the event 
may jeopardize the subject or may require medical or surgical intervention to prevent 
1 of the outcomes listed above. 
8.3.2. 
Reporting 
To ensure subject safety, every SAE, regardless of suspected causality, occurring after the 
subject has signed the ICF and up to the last study visit, or up to 30 days after the subject has 
stopped study treatment, whichever is later, must be reported to the sponsor (or designee) within 
24 hours of learning of its occurrence.  Any SAEs occurring more than 30 days after the last 
dose of study drug should be reported to the sponsor, or its designee, only if the investigator 
suspects a causal relationship to the study drug.  An SAE occurring at a different time interval or 
otherwise considered completely unrelated to a previously reported SAE should be reported 
separately as a new event.  Previously planned (ie, before providing informed consent) surgeries 


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should not be reported as SAEs unless the underlying medical condition worsens over the course 
of the study. 
Information about all SAEs is collected and recorded on the Adverse Event form of the eCRF.  
The investigator must assess and record the causal relationship of each SAE to the study 
treatment. 
The investigator must also complete the Incyte Serious Adverse Event Report Form, in English, 
and send the completed and signed form to the sponsor or designee within 24 hours of becoming 
aware of the SAE.  The investigator must provide a causality assessment, that is, assess whether 
there is at least a reasonable possibility that the SAE is related to the study treatment:  suspected 
(yes) or not suspected (no).  Refer to the Incyte Reference Guide for Completing the Serious 
Adverse Event Report Form. 
The contact information of the sponsor's study-specific representatives is listed in the 
investigator manual provided to each site.  The original copy of the SAE Report Form and the 
confirmation sheet must be kept at the study site. 
Investigational site personnel must report any new information regarding the SAE within 
24 hours of becoming aware of the information in the same manner that the initial SAE Report 
Form was sent.  Follow-up information is recorded on an amended or new SAE Report Form, 
with an indication that it is follow-up to the previously reported SAE and the date of the original 
report.  The follow-up report should include information that was not provided on the previous 
SAE Report Form, such as the outcome of the event (eg, resolved or ongoing), treatment 
provided, action taken with study drug because of the SAE (eg, dose reduced, interrupted, or 
discontinued), or subject disposition (eg, continued or withdrew from study participation).  Each 
recurrence, complication, or progression of the original event should be reported as follow-up to 
that event, regardless of when it occurs. 
If the SAE is not documented in the IB for the study drug (new occurrence) and is thought to be 
related to the sponsor's study drug, the sponsor or its designee may urgently require further 
information from the investigator for reporting to health authorities.  The sponsor or its designee 
may need to issue an Investigator Notification (IN) to inform all investigators involved in any 
study with the same drug that this SAE has been reported.  Suspected Unexpected Serious 
Adverse Reactions (SUSARs) will be collected and reported to the competent authorities and 
relevant ethics committees in accordance with Directive 2001/20/EC, or as per national 
regulatory requirements in participating countries. 
8.4. 
Emergency Unblinding of Treatment Assignment 
Emergency unblinding for AEs may be performed through IRT, which may supplement or take 
the place of emergency codes generated by a computer drug-labeling system.  This option may 
be used ONLY if the subject's well-being requires the investigator to be aware of the subject's 
treatment assignment.  All calls resulting in an unblinding event are recorded and reported by the 
IRT. 
The investigator should make every effort to contact the sponsor's (or its designee's) clinical 
research physician or medical monitor before unblinding a subject's treatment assignment.  If a 
subject's treatment assignment is unblinded, the sponsor or its designee must be notified 
immediately by telephone. 


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If an investigator, site personnel performing assessments, or subject is unblinded, the subject 
must be withdrawn from the study.  In cases where there are ethical reasons to have the subject 
remain in the study, the investigator must obtain specific approval from the sponsor's (or its 
designee's) clinical research physician or medical monitor for the subject to continue in the 
study. 
8.5. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that study drug may 
have interfered with the effectiveness of a contraceptive medication or method.  When a 
pregnancy has been confirmed in a subject during maternal or paternal exposure to study drug, 
the following procedures should be following in order to ensure subject safety: 
• The study drug must be discontinued immediately (female subjects only). 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome and breastfeeding are collected for regulatory reporting and drug safety 
evaluation.  Follow-up should be conducted for each pregnancy to determine outcome, including 
spontaneous or voluntary termination, details of the birth, and the presence or absence of any 
birth defects, congenital abnormalities, or maternal and/or newborn complications, by following 
until the first well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy form 
and reported by the investigator to the sponsor or its designee.  Pregnancy follow-up information 
should be recorded on the same form and should include an assessment of the possible causal 
relationship to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the 
first well-baby visit or the duration specified in local regulations, whichever is later.  Refer to the 
Incyte Reference Guide for Completing the Clinical Trial Pregnancy Form. 
Any SAE occurring during pregnancy must be recorded on the SAE Report form and 
submitted to the sponsor or designee. 
8.6. 
Warnings and Precautions 
Special warnings or precautions for the study drug, derived from safety information collected by 
the sponsor or its designee, are presented in the Investigator's Brochure (IB).  Additional safety 
information collected between IB updates will be communicated in the form of Investigator 
Notifications (INs).  Any important new safety information should be discussed with the subject 
during the study, as necessary.  If new significant risks are identified, they will be added to the 
ICF. 
8.7. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 


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The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be reported as described in Section 8.1.2 of this Protocol. 
9. 
STATISTICS 
9.1. 
Study Populations 
9.1.1. 
Part A 
All analyses for Part A will be conducted with the Part A evaluable population, which includes 
all subjects exposed to at least 1 dose of study drug in Part A. 
9.1.2. 
Part B 
The intent-to-treat (ITT) population includes randomized subjects who applied at least 1 dose of 
study drug in Part B.  Treatment groups for this population will be defined according to the 
treatment assignment at randomization. 
The per-protocol population includes randomized subjects who are considered to be sufficiently 
compliant with the Protocol in Part B. 
The safety-evaluable population includes all subjects who applied at least 1 dose of study drug in 
Part B.  Treatment groups for this population will be determined by the actual treatment received 
on Day 1. 
9.2. 
Selection of Sample Size 
In Part A, the sample size is based on the demonstration of preliminary findings of hair regrowth.  
It is anticipated that a sample of 10 subjects will permit sufficient data to decide to enroll more 
than 34 subjects in Part B (required for the interim analysis). 
In Part B, the sample size calculation is based on the Fisher exact test for the primary efficacy 
endpoint assuming a small expected frequency of responders in the placebo group, given the low 
response rate.  For subjects with 25% to < 50% and 50% to 100% scalp involvement, the 
response rate is assumed to be 61% for active versus 25% for placebo, and 35% for active versus 
5% for placebo, respectively.  Using a 2-sided alpha of 0.05 with a continuity correction, 
34 subjects per group will have an 80% power to detect a difference between treatment groups. 
9.3. 
Level of Significance 
The significance level for efficacy analysis will be 0.05 for 2-sided tests. 


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9.4. 
Statistical Analyses 
9.4.1. 
Primary Analyses 
In Part A, all efficacy endpoints will be summarized using descriptive statistics in the Part A 
evaluable population.  In Part B, subjects will be stratified at randomization into 2 strata:  25% to 
< 50% scalp involvement (rAAIG Group S2) and 50% to 100% (rAAIG Groups S3, S4, and S5).  
The response rate assessed based on SALT50 between active- and placebo-treated subjects will 
be compared in the ITT population, using a logistic regression with covariates of baseline SALT 
score and stratification factor of rAAIG group.  Exact logistic regression (Mehta and Patel 1995) 
will be used if any expected numbers are less than 5. 
9.4.2. 
Secondary Analyses 
Secondary efficacy analyses will be conducted for the ITT population.  Differences in 
proportions may be compared across treatment groups using similar logistic regression models as 
specified in the primary analysis.  Mean, change from baseline, and percentage change from 
baseline in quantitative variables will be summarized using descriptive statistics.  Mixed models 
with repeated measures will also be used if appropriate. 
9.4.3. 
Other Analyses 
Safety analyses will be conducted for the safety evaluable population.  Adverse events will be 
coded by the MedDRA dictionary, and incidences will be tabulated by preferred term and system 
organ class for all events, as well as related events.  Quantitative safety variables and their 
changes from baseline (laboratory, vital signs) will be summarized with descriptive statistics.  
The plasma concentration of INCB018424 data collected at study visits will be analyzed using 
summary statistics. 
Additional supportive endpoints will be summarized.  Descriptive statistics with 95% confidence 
intervals for means or proportions, where appropriate, will also be provided. 
9.5. 
Data Monitoring Committee 
There will be no external Data Monitoring Committee.  Sites will remain blinded to study drug, 
but some personnel at Incyte without direct contact with sites will be unblinded.  An internal 
committee in Incyte will be charged with evaluating the unblinded interim results based on the 
futility rule in Section 9.6, as well as considering interim safety results. 
9.6. 
Interim Analysis 
9.6.1. 
Part A 
In Part A, the decision to enroll more than 34 subjects in Part B will be mainly based on the 
number of responders observed or the number of subjects with evidence on other endpoints for 
hair regrowth.  The number of responders that are considered to have sufficient efficacy to 
complete enrollment of Part B depends on the proportion of subjects enrolled in the stratum for 
25% to < 50% scalp involvement and the stratum for 50% to 100% scalp involvement because of 
the different response rates.  For example, if all subjects are enrolled in the 25% to < 50% 
stratum, using likelihood-based function, applying a binomial distribution, and assuming the null 


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hypothesis rates of response in the 2 strata, then the probability of observing 5 or more responses 
in Part A in the 10 subjects is 66%, and so 5 responders will be sufficient to complete enrollment 
of Part B.  If all subjects are in the 50% to 100% stratum, then the probability of observing 2 or 
more responses is 74%, and so 2 responders will be sufficient to complete enrollment of Part B. 
9.6.2. 
Part B 
An interim analysis will be performed when 34 subjects, randomized in Part B, have 12-week 
data available, and a test for futility will be performed based upon conditional power.  The 
conditional power is the probability to reach significance at the end of the study given the data at 
the interim.  The conditional power will be approximated using the empirical estimates of the 
treatment effect under the observed trend for a 2-sided alpha of 0.05. 
If the conditional power is ≤ 30% and there are more than 10 subjects in each defined stratum, 
the study will be stopped for futility.  If conditional power is ≤ 30% but there is a stratum with 
≤ 10 subjects, enrollment of Part B will be continued for that stratum until a total of 20 subjects 
in that stratum have been randomized in Part B.  A second futility analysis will be conducted 
using the observed difference in SALT50 response rates between the 2 treatment groups in the 
expanded stratum.  If the difference between the 2 observed percentages for the expanded 
stratum is ≥ 20 percentage points, then randomization will be reopened to the underrepresented 
stratum until all subjects are randomized in Part B. 
Overall, Part B will complete randomization of additional subjects if sufficient evidence of 
terminal hair growth is demonstrated either at the interim analysis in Part A or at one of the 
interim analyses in Part B. 
An additional interim analysis may be conducted when 24-week data are available for half of the 
subjects in Part B.  The interim analysis will not include any testing for futility or efficacy. 
Sites will remain blinded to study drug, but some personnel at Incyte without direct contact with 
sites will be unblinded.  An internal committee in Incyte will be charged with evaluating the 
unblinded interim results based on the futility rule above, as well as considering interim safety 
results.  If the study is stopped for futility, investigators and subjects will be unblinded, and the 
decision to continue study drug will be made by the investigator in conjunction with the sponsor, 
based on an individual assessment of clinical benefit.  As there are no plans for stopping early for 
efficacy, no adjustments of alpha or final p-values for repeated testing are necessary. 


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10. 
ETHICAL CONSIDERATIONS AND ADMINISTRATIVE 
PROCEDURES 
10.1. 
Investigator Responsibilities 
This study will be performed in accordance with ethical principles that originate in the 
Declaration of Helsinki, and conducted in adherence to the study Protocol; GCPs as defined in 
Title 21 of the US CFR Parts 50, 54, 56, 312, and Part 11; ICH E6 GCP consolidated guidelines; 
and local regulatory requirements as applicable to the study locations. 
The investigator will be responsible for: 
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
subject records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all subjects. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
• Obtaining informed consent and ensuring that the study subjects' questions have been 
answered and the subjects fully understand study procedures: 
− Informed consent must be obtained before any study-related procedures are 
conducted. 
− Informed consent must be obtained using the IRB/IEC approved version in a 
language that is native and understandable to the subject.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to subject records. 


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• Obtaining approval from the IRB/IEC before the start of the study and for any 
changes to the clinical study Protocol, important protocol deviations, routine updates, 
and safety information in accordance with institutional requirements and local law. 
− The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements 
and with the policies and procedures established by the IRB/IEC. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling subjects who have met the 
specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws, but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study without 
receiving approval from the sponsor.  The investigator must notify the sponsor or 
its designee in the event of accidental loss or destruction of any study records.  If 
the investigator leaves the institution where the study was conducted, the sponsor 
or its designee must be contacted to arrange alternative record storage options. 
− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
10.2. 
Accountability, Handling, and Disposal of Study Drug 
The investigator is responsible for drug accountability at the study site; however, some of the 
drug accountability duties may be assigned to an appropriate pharmacist or other designee.  
Inventory and accountability records must be maintained and readily available for inspection by 
the study monitor and are open to inspection at any time by any applicable regulatory authorities.  
The investigator or designee must maintain records that document: 
• Delivery of study drug to the study site. 
• Inventory of study drug at the site. 
• Subject use of the study drug including pill or unit counts from each supply 
dispensed. 
• Return of study drug to the investigator or designee by subjects. 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the subjects were provided the specified 


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study drug.  These records should include dates, quantities, and any available batch or serial 
numbers or unique code numbers assigned to the investigational product and study subjects. 
Completed accountability records will be archived by the site.  The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study drug 
until verified by the study monitor (unless otherwise agreed to by the sponsor).  At the 
conclusion of the study, the investigator or designee will oversee shipment of any remaining 
study drug back to the sponsor or its designee for destruction according to institutional standard 
operating procedures.  If local procedures mandate on-site destruction of investigational supply, 
the site should (where local procedures allow) maintain the investigational supply until the study 
monitor inspects the accountability records in order to evaluate compliance and accuracy of 
accountability by the investigative site.  At sites where the study drug is destroyed before 
monitor inspection, the monitors rely on documentation of destruction per the site SOP. 
10.3. 
Data Management 
Data management will be performed in a validated database via an Electronic Data Capture 
(EDC) system.  All data entry, verification, and validation will be performed in accordance with 
the current standard operating procedures of the Data Management Department at the sponsor or 
its designee.  The database will be authorized for lock once all defined procedures are completed. 
The investigator will be provided with access to an EDC system so that an eCRF can be 
completed for each subject.  Entries made in the eCRF must be verifiable against source 
documents; if updates to the database are not possible, any discrepancies should be explained 
and documented.  The investigator will be responsible for reviewing all data and eCRF entries 
and will sign and date the designated forms in each subject's eCRF, verifying that the 
information is true and correct.  The investigator is responsible for the review and approval of all 
query responses. 
Protocol deviations will be identified and recorded in the Protocol Deviation form of the eCRF.  
The study monitor will reference the Monitoring Plan in order to ensure that each issue identified 
is appropriately documented, reported, and resolved in a timely manner in accordance with the 
plan's requirements. 
10.4. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor, or its designee, must adhere to applicable data privacy laws 
and regulations.  The investigator and the sponsor, or its designee, are responsible for ensuring 
that sensitive information is handled in accordance with local requirements (eg, HIPAA).  
Appropriate consent and authorizations for use and disclosure and/or transfer (if applicable) of 
protected information must be obtained. 
Subject names will not be supplied to the sponsor or its designee, if applicable.  Only the subject 
number and subject's initials will be recorded in the eCRF, where permitted; if the subject's name 
appears on any other document (eg, laboratory report), it must be obliterated on the copy of the 
document to be supplied to the sponsor or its designee.  Study findings stored on a computer will 
be stored in accordance with local data protection laws.  The subjects will be informed that 
representatives of the sponsor or its designee, IRB or IEC, or regulatory authorities may inspect 
their medical records to verify the information collected, and that all personal information made 


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available for inspection will be handled in strictest confidence and in accordance with local data 
protection laws. 
10.5. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 Code of Federal Regulations (CFR) Part 54 – Financial Disclosure by 
Clinical Investigators (ie, "covered studies") are required to submit a completed Clinical 
Investigator Financial Disclosure form that sufficiently details any financial interests and 
arrangements that apply.  For the purpose of this regulation, "clinical investigator" is defined as 
any investigator or subinvestigator who is directly involved in the treatment or evaluation of 
research subjects, including the spouse and each dependent child of the clinical investigator or 
subinvestigator.  These requirements apply to both US and foreign clinical investigators 
conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Investigator Financial Disclosure Form.  During a covered clinical study, 
any changes to the financial information previously reported by a clinical investigator must be 
reported to the sponsor or its designee.  At the conclusion of the covered clinical study, the 
clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
10.6. 
Publication Policy 
By signing the study Protocol, the investigator and his or her institution agree that the results of 
the study may be used by the sponsor, Incyte Corporation (Incyte), for the purposes of national 
and international registration, publication, and information for medical and pharmaceutical 
professionals.  Study results will be published in accordance with applicable local and national 
regulations.  If necessary, the authorities will be notified of the investigator's name, address, 
qualifications, and extent of involvement.  The terms regarding the publication of study results 
are contained in the agreement signed with the sponsor or its designee.  A signed agreement will 
be retained by the sponsor or its designee. 


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11. 
LITERATURE REFERENCES 
Bolduc C. Alopecia Areata. 2014. http://emedicine.medscape.com/article/1069931-overview. 
Accessed May 6, 2015. 
Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med 2012;366:1515-1525. 
Ghanizadeh A, Ayoobzadehshirazi A. A review of psychiatric disorders comorbitidities in 
patients with alopecia areata. Int J Trichol 2014;6:2-4. 
INCB018424 Phosphate Cream Investigator's Brochure (IB). Wilmington, DE: Incyte 
Corporation. 
Jagielska D, Redler S, Brockschmidt FF, et al. Follow-up study of the first genome-wide 
association scan in alopecia areata: IL13 and KIAA0350 as susceptibility loci supported with 
genome-wide significance. J Invest Dermatol 2012;132:2192-2197. 
Norwood OT.  Male pattern baldness: Classification and incidence. South Med J 1975;68:1359-
1365. 
Olsen EA. Topical and systemic corticosteroids in alopecia areata. Australian J Dermatol 
1997;38:20. 
Olsen EA, Hordinsky MK Price VH, et al. Alopecia areata investigational assessment 
guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol 
2004;51:440-447. 
Mehta CR, Patel NR. Exact logistic regression: theory and examples. Stat Med 
1995;14:2143-2160. 
Petukhova L, Christiano AM. The genetic architecture of alopecia areata. J Investig Dermatol 
Symp Proc 2013;16:S16-S22. 
Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in 
Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc 1995;70:628-633. 
Xing L, Dai Z, Jabbari A, et al. Alopecia areata is driven by cytotoxic T lymphocytes and is 
reversed by JAK inhibition. Nat Med 2014;20:1043-1049. 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For subjects participating in the study: 
The following methods that can achieve a failure rate of less than 1% per year when used 
consistently and correctly are considered as highly effective birth control methods.  
Such methods include: 
• Combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation1 
− oral 
− intravaginal 
− transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulation1 
− oral 
− injectable 
− implantable2 
• Intrauterine device (IUD)2 
• Intrauterine hormone-releasing system (IUS)2 
• Bilateral tubal occlusion2 
• Vasectomised partner2,3 
• Sexual abstinence4 
 
1  Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the 
contraception method. 
2  Contraception methods that in the context of this guidance are considered to have low user dependency. 
3  Vasectomised partner is a highly effective method provided of avoiding pregnancy that partner is the sole sexual 
partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the 
surgical success.  
4  In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the subject. 
Source:  Advisory non-binding guidance from the 15 SEP 2014 Clinical Trial Facilitation Group (CTFG) meeting in 
Rome. 


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APPENDIX B. SEVERITY OF ALOPECIA TOOL 
Alopecia areata investigational assessment guidelines 
SALT scoring system recommended by the National Alopecia Areata Foundation group 
published in the Journal of the American Academy of Dermatology by Olsen et al (2004) will be 
used. 
The scalp will be divided into 4 areas (see figure below): 
• Top of scalp is 40% (0.4) of scalp surface area. 
• Right side of scalp is 18% (0.18) of scalp surface area. 
• Left side of scalp is 18% (0.18) of scalp surface area. 
• Back side of scalp is 24% (0.24) of scalp surface area. 
There are 2 acceptable methods of calculating percentage of hair loss in any of these areas: 
1. The percentage of hair loss in each area is multiplied by the percentage of surface area of 
the scalp in that area.  The SALT score is the sum of the percentage of hair loss in all of 
the above-mentioned areas.  For example, if the percentages of hair loss in the top, right 
side, left side, and back are 20%, 30%, 40%, and 50%, respectively, the SALT score = 
(20 × 0.4) + (30 × 0.18) + (40 × 0.18) + (50 × 0.24) = 8 + 5.4 + 7.2 + 12 = 32.6. 
2. The SALT score may also be determined directly by assessing the overall hair loss in 
each section, knowing the percentage covered by each section.  For example, the hair loss 
may be determined to be 8% on the top, 5% on the right side, 7% on the left side, and 
12% in the back, or 32% total.  Because this method does not use a multiplication factor, 
the numbers are generally whole. 
Whichever method of assessment of the SALT score is used in an individual subject, it should be 
noted in the source document and used at subsequent visits. 


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Severity of Alopecia Tool Scoring System Schematic 
 
 


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APPENDIX C. POTENT SYSTEMIC CYP3A4 INHIBITORS AND 
FLUCONAZOLE 
In clinical studies with CYP3A4 inhibitors, elevated levels of INCB018424 of approximately 
2-fold have been observed after oral administration.  Additionally, simulations using 
physiologically-based pharmacokinetic models suggested that fluconazole (a dual CYP3A4 and 
CYP2C9 inhibitor) increases steady-state ruxolitinib AUC by approximately 1-to-3-fold after 
oral administration.  Thus, these concomitant medications should not be taken by subjects 
beginning 2 weeks or 5 half-lives (whichever is longer) before the first application of study drug 
until the last administration (either Week 24 or Week 48) ); however, topical use of these agents 
may be permitted on a case-by-case basis if the systemic bioavailability is low.  The following is 
a list of potent systemic CYP 3A4 inhibitors and fluconazole.  The sponsor should be contacted 
with any questions regarding concomitant medications that might be considered potent systemic 
CYP3A4 inhibitors but are not on this list. 
boceprevir 
clarithromycin 
cobicistat 
conivaptan 
danoprevir 
elvitegravir 
fluconazole 
grapefruit juice 
idelalisib 
indinavir 
itraconazole 
ketoconazole 
LCL161 
lopinavir 
mibefradil 
nefazodone 
nelfinavir 
posaconazole 
ritonavir 
saquinavir 
telaprevir 
telithromycin 
tipranavir 
troleandomycin 
voriconazole 


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APPENDIX D. HAMILTON-NORWOOD SCALE OF MALE PATTERN 
BALDNESS 
Source:  Norwood 1975. 
 


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SAP_001.pdf: 
Incyte Corporation 
Page 1 of 277 
INCB 18424-204 Statistical Analysis Plan 
27 OCT 2015 
CONFIDENTIAL 
 
STATISTICAL ANALYSIS PLAN 
 
INCB018424 CREAM 
INCB 18424-204 
An Open-Label (Part A) and a Double-Blind, Randomized, 
Placebo-Controlled (Part B) Study, With an Open-Label Extension, 
of INCB018424 Phosphate Cream Applied Topically to Subjects 
With Alopecia Areata 
 
IND Number: 
77101 
Date of Plan: 
27 OCT 2015 
Based on: 
Protocol dated 14 JUL 2015 
 
CRF version approved 08 SEP 2015 
 
 
SPONSOR: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
 
This study is being conducted in compliance with good clinical practice, 
including the archiving of essential documents. 




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TABLE OF CONTENTS 
STATISTICAL ANALYSIS PLAN APPROVAL ..........................................................................2 
LIST OF ABBREVIATIONS ..........................................................................................................6 
1. 
INTRODUCTION ........................................................................................................7 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................7 
2.1. 
Protocol and Case Report Form Version ......................................................................7 
2.2. 
Study Objectives ...........................................................................................................7 
2.2.1. 
Primary Objective .........................................................................................................7 
2.2.2. 
Secondary Objective .....................................................................................................7 
 
7 
2.3. 
Study Endpoints ............................................................................................................8 
2.3.1. 
Primary Endpoints ........................................................................................................8 
2.3.2. 
Secondary Endpoints ....................................................................................................8 
 
9 
3. 
STUDY DESIGN .......................................................................................................10 
3.1. 
Randomization ............................................................................................................10 
3.2. 
Control of Type I Error ...............................................................................................10 
3.3. 
Sample Size Considerations .......................................................................................11 
3.4. 
Schedule of Assessments ............................................................................................11 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................15 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................15 
4.1.1. 
Day 1, Baseline, and Last Available Value ................................................................15 
4.1.2. 
Study Day ...................................................................................................................16 
4.1.3. 
Scheduled Visits .........................................................................................................16 
4.2. 
Variable Definitions ....................................................................................................17 
4.2.1. 
Age ..............................................................................................................................17 
4.2.2. 
Body Mass Index ........................................................................................................17 
4.2.3. 
Prior and Concomitant Medication .............................................................................17 
5. 
STATISTICAL METHODOLOGY ...........................................................................18 
5.1. 
General Methodology .................................................................................................18 
5.2. 
Treatment Groups .......................................................................................................18 
5.3. 
Analysis Populations ..................................................................................................19 


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5.3.1. 
Part A ..........................................................................................................................19 
5.3.2. 
Part B ..........................................................................................................................19 
5.3.2.1. 
Intent-to-Treat Population ..........................................................................................19 
5.3.2.2. 
Per Protocol Population ..............................................................................................19 
5.3.2.3. 
Safety Population ........................................................................................................19 
5.3.2.4. 
Part B Evaluable Population in Extension Period ......................................................19 
 
19 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................20 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............20 
6.2. 
Disposition of Subjects ...............................................................................................21 
6.3. 
Protocol Deviations ....................................................................................................21 
6.4. 
Exposure .....................................................................................................................21 
6.5. 
Study Drug Compliance .............................................................................................22 
6.6. 
Medical History ..........................................................................................................22 
6.7. 
Prior and Concomitant Medication .............................................................................22 
7. 
EFFICACY .................................................................................................................23 
7.1. 
General Considerations ...............................................................................................23 
7.2. 
Analysis of the Primary Efficacy Parameter ..............................................................23 
7.2.1. 
Primary Efficacy Analysis ..........................................................................................23 
7.2.2. 
Subgroup Analyses for Primary Endpoint ..................................................................24 
7.2.3. 
Sensitivity and Supportive Analyses for Primary Endpoint .......................................24 
7.3. 
Analysis of the Secondary Efficacy Parameter ..........................................................24 
 
25 
 
26 
 
26 
 
26 
8. 
SAFETY AND TOLERABILITY ..............................................................................26 
8.1. 
General Considerations ...............................................................................................26 
8.2. 
Adverse Events ...........................................................................................................26 
8.2.1. 
Adverse Event Definitions ..........................................................................................26 
8.2.2. 
Adverse Event Summaries ..........................................................................................28 
8.3. 
Clinical Laboratory Tests ...........................................................................................30 


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8.3.1. 
Laboratory Value Definitions .....................................................................................30 
8.3.2. 
Laboratory Value Summaries .....................................................................................30 
8.4. 
Vital Signs ..................................................................................................................31 
8.5. 
Electrocardiograms .....................................................................................................32 
9. 
INTERIM ANALYSES ..............................................................................................33 
9.1. 
Overview of Interim Analyses ....................................................................................33 
9.1.1. 
Part A ..........................................................................................................................33 
9.1.2. 
Part B ..........................................................................................................................34 
9.2. 
Data Cut-Off for Interim Analysis ..............................................................................35 
9.3. 
Derivations and Calculations for Interim Analyses ....................................................35 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................36 
10.1. 
Changes to Protocol Defined Analyses ......................................................................36 
10.2. 
Changes to the SAP ....................................................................................................36 
11. 
REFERENCES ...........................................................................................................37 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ........................................38 
 
LIST OF TABLES 
Table 1: 
Schedule of Assessments for the First 24 Weeks of Treatment in Parts A and 
B ..................................................................................................................................12 
Table 2: 
Schedule of Assessments for the Open-Label Extension of Part A ............................13 
Table 3: 
Schedule of Assessments for the Open-Label Extension of Part B ............................14 
Table 4: 
Definition of Day 1, Baseline, and Last Available Value ..........................................15 
Table 5: 
Duration of Treatment ................................................................................................21 
Table 6: 
Definition of Treatment-Emergent Adverse Event .....................................................27 
Table 7: 
Laboratory Parameters to be Summarized ..................................................................31 
Table 8: 
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................32 
Table 9: 
Criteria for Clinically Notable Electrocardiogram Abnormalities .............................32 
Table 10: Part A Interim Analysis ..............................................................................................34 
Table 11: Dates for the SAP .......................................................................................................36 
 


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LIST OF ABBREVIATIONS 
Abbreviation 
Term 
AA 
alopecia areata 
AE 
adverse event 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase  
BMI 
body mass index 
BID 
twice daily 
CRF 
case report form 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECG 
electrocardiogram 
EOS 
end of study 
EOT 
end of treatment 
ITT 
intent-to-treat population 
MedDRA 
Medical Dictionary for Regulatory Activities  
MMRM 
mixed model repeated measures 
NRI 
nonresponder imputation 
PD 
pharmacodynamics 
PI 
percent improvement 
 
 
PP 
per protocol population 
rAAIG 
revised Alopecia Areata Investigational Guidelines 
SALT 
Severity of Alopecia Tool 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
TEAE 
treatment-emergent adverse event 
WHO 
World Health Organization  


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1. 
INTRODUCTION 
This is a 2-part study in subjects with alopecia areata (AA), with Part A being open-label and 
Part B being double-blind, randomized, and placebo-controlled and both followed by an 
open-label extension.  Section 1 of the Protocol provides a detailed description of the 
investigational product, target patient population, rationale for doses to be examined, and 
potential risks and benefits of treatment with INCB018424 cream.  The purpose of this Statistical 
Analysis Plan (SAP) is to define the methodology for analyzing and summarizing the data 
collected during the conduct of Study INCB 18424-204. 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on Protocol INCB 18424-204 Amendment 1 dated 14 JUL 2015 and case 
report forms (CRFs) approved 08 SEP 2015.  Unless superseded by an amendment, this SAP will 
be effective for all subsequent Protocol amendments and CRF versions. 
2.2. 
Study Objectives 
2.2.1. 
Primary Objective 
The primary objective of the study is to evaluate preliminary efficacy of INCB018424 cream 
when applied twice daily (BID) to subjects with AA. 
2.2.2. 
Secondary Objective 
The secondary objective of the study is to evaluate the safety and tolerability of INCB018424 
cream when applied BID to subjects with AA. 


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2.3. 
Study Endpoints 
2.3.1. 
Primary Endpoints 
Part A:  Percentage of subjects achieving a ≥ 50% improvement in Severity of Alopecia Tool 
(SALT50) response in terminal hair (pigmented and nonpigmented) at any visit up to Week 24 
(inclusive). 
Part B:  Percentage of subjects achieving a SALT50 response in terminal hair (pigmented and 
nonpigmented) at Week 24. 
2.3.2. 
Secondary Endpoints 
Part A: 
• Percentage of subjects with 50% to 100% scalp involvement at baseline achieving a 
SALT50 response in terminal hair at any visit through Week 24. 
• Percentage of subjects achieving a SALT90 response in terminal hair at Weeks 4, 8, 
12, 18, and 24. 
• Safety and tolerability assessed by monitoring the frequency, duration, and severity of 
adverse events (AEs); performing physical examinations; collecting vital signs; and 
collecting laboratory data for hematology, serum chemistry, and urinalysis. 
Part B: 
• Percentage of subjects with 50% to 100% scalp involvement at baseline achieving a 
SALT50 response in terminal hair (pigmented and nonpigmented) at Week 24. 
• Percentage of subjects achieving a SALT50 in terminal hair (pigmented and 
nonpigmented) at Weeks 4, 8, 12, and 18. 
• Percentage of subjects achieving a SALT90 in terminal hair (pigmented and 
nonpigmented) at Weeks 4, 8, 12, 18, and 24. 
• Mean change from baseline in SALT score at Weeks 4, 8, 12, 18, and 24. 
• Safety and tolerability assessed by monitoring the frequency, duration, and severity of 
AEs; performing physical examinations; collecting vital signs; and collecting 
laboratory data for hematology, serum chemistry, and urinalysis. 


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3. 
STUDY DESIGN 
This is a 2-part study in subjects with AA, with Part A being open-label and Part B being 
double-blind, randomized, and placebo-controlled. 
In Part A, 10 subjects will be treated with open-label topical INCB018424 1.5% cream BID for 
24 weeks to examine efficacy, safety, and tolerability.  After completion of the Week 24 efficacy 
assessments, eligible subjects in Part A will be offered an additional 24 weeks of open-label 
treatment. 
Part B is double-blind, randomized, and placebo-controlled, with an open-label extension in up 
to 68 subjects.  Initially, 34 subjects will be randomized to INCB018424 1.5% cream or placebo 
cream, stratified by baseline percentage of scalp involvement with AA (25% to < 50% or 50% to 
100%) using the revised Alopecia Areata Investigational Guidelines (rAAIG).  Up to 2 interim 
analyses, with conduct of the second interim analysis being contingent on the results of the first 
interim analysis, will be performed in Part B.  Overall, Part B will complete randomization of up 
to 68 subjects if sufficient evidence of terminal hair growth is demonstrated either in Part A or at 
1 of the 2 interim analyses in Part B.  In Part B, subjects will be treated for 24 weeks to examine 
efficacy, safety, and tolerability.  After the completion of the efficacy assessments for the 
primary endpoint (Week 24) in the double-blind portion of the study, treatment assignment in 
Part B will not be unblinded; however, all eligible subjects will be dispensed INCB018424 
cream for an additional 24 weeks of open-label treatment. 
For subjects in Part A treatment and Part B treatment periods, drug prescription will be based 
upon the baseline SALT score measured at either enrollment or randomization, and the 
prescribed dose will not be changed during the treatment periods.  In Part A extension and Part B 
extension periods, subjects may have their dose of study medication adjusted based on the SALT 
measured at each visit during the extension periods.   
3.1. 
Randomization 
In Part B of the study, subjects will be randomized 1:1 between the 2 treatment groups.  Subjects 
will be stratified at randomization into 2 strata:  25% to < 50% scalp involvement (rAAIG Group 
S2) and 50% to 100% (rAAIG Groups S3, S4, and S5).  Subjects with 25% to < 50% scalp 
involvement will be limited to no more than 70% of the randomized population , and subjects 
with alopecia totalis will be limited to no more than 10% of the randomized population in Part B.   
3.2. 
Control of Type I Error 
For the primary endpoint, the overall 2-sided Type I error is 0.05. 
No adjustment for alpha-spending is considered, as there are no plans to stop the study early for 
overwhelming efficacy.  An internal committee in Incyte will be charged with evaluating the 
unblinded interim results based on the efficacy results in interim analysis, as well as considering 
interim safety results. 


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3.3. 
Sample Size Considerations 
In Part A, the sample size is based on the demonstration of preliminary findings of hair regrowth.  
It is anticipated that a sample of 10 subjects will permit sufficient data to decide to enroll more 
than the 34 subjects required for the first interim analysis in Part B. 
In Part B, for subjects with 25% to < 50%  (Stratum A) and 50% to 100% scalp involvement 
(Stratum B), the response rate is assumed to be 61% for active versus 25% for placebo, and 35% 
for active versus 5% for placebo, respectively.  Using a 2-sided alpha of 0.05 with a continuity 
correction, 34 per group will have an 80% power to detect a difference between treatment 
groups. 
3.4. 
Schedule of Assessments 
Table 1, Table 2, and Table 3  provide the schedules for study visit assessments and laboratory 
sampling for the safety and efficacy variables defined for this study. 
Parameters for clinical laboratory assessments are provided in Table 7. 


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Table 1: 
Schedule of Assessments for the First 24 Weeks of Treatment in Parts A and B 
Evaluation 
Screening 
Treatment Periods A and B 
Follow-Up 
Day -28 
to -1 
Day 1 
Week 4 
Day 29 
± 3 days 
Week 8 
Day 56 
± 3 days 
Week 12 
Day 84 
± 3 days 
Week 18 
Day 126 
± 7 days 
Week 24 EOT 
Day 168 
± 7 days 
Month 1 
± 7 days 
Month 3 
EOS 
± 7 days 
Clinic visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Informed consent  
X 
 
 
 
 
 
 
 
 
Contact IRT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Prior/concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height and body weight 
X 
 
 
 
 
 
 
 
 
Comprehensive physical exam 
X 
 
 
 
 
 
X 
 
 
Targeted physical exam 
 
X 
X 
X 
X 
X 
 
X 
X 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
X 
X 
X 
X 
X 
X 
X 
 
X 
Hepatitis screening tests 
X 
 
 
 
 
 
 
 
 
Urinalysis 
X 
 
 
 
 
 
X 
 
 
FSHa 
X 
 
 
 
 
 
 
 
 
Pregnancy testb 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
X 
 
 
 
 
 
X 
 
 
Efficacy assessments 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Apply study drug 
 
X 
X 
X 
X 
X 
 
 
 
Study drug and diary card dispensed 
 
X 
X 
X 
X 
X 
 
 
 
Collect study drug tubes; collect and 
review diary cards 
 
 
X 
X 
X 
X 
X 
 
 
Assess compliance 
 
 
X 
X 
X 
X 
X 
 
 
Photography of scalp 
 
X 
Xd 
 
X 
 
X 
 
X 
Assess AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECG = electrocardiogram; EOS = end of study; FSH = follicle-stimulating hormone. 
a Serum FSH to be performed for all postmenopausal women only, defined by last menstrual period > 12 months before screening. 
b All women will have a serum pregnancy test conducted at the screening visit and urine pregnancy tests conducted at all other visits (including baseline)  
 For Part A only:  photography of scalp at Week 4. 


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Table 2: 
Schedule of Assessments for the Open-Label Extension of Part A 
Evaluation 
Open-Label Extension Part A 
Follow-Up 
Week 24 
Day 168 
± 7 daysa 
Week 30 
Day 210 
± 7 days 
Week 36 
Day 252 
± 7 days 
Week 42 
Day 294 
± 7 days 
Week 48 
EOT  
Day 336 
± 7 days 
Month 1 
± 7 days 
Month 3 
EOS 
± 7 days 
Clinic visit 
 
X 
X 
X 
X 
X 
X 
Contact IRT 
Xa 
X 
X 
X 
X 
X 
X 
Prior/concomitant medications 
 
X 
X 
X 
X 
X 
X 
Comprehensive physical exam 
 
 
 
 
X 
 
 
Targeted physical exam 
 
X 
X 
X 
 
X 
X 
Vital signs 
 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
 
X 
X 
X 
X 
 
X 
Urinalysis 
 
 
 
 
X 
 
 
Pregnancy testb  
 
X 
X 
X 
X 
X 
X 
12-lead ECG 
 
 
 
 
X 
 
 
Efficacy assessments 
 
X 
X 
X 
X 
X 
X 
Apply study drug 
Xa 
X 
X 
X 
 
 
 
Study drug and diary card dispensed 
Xa 
X 
X 
X 
 
 
 
Collect study drug tubes; collect and 
review diary cards 
 
X 
X 
X 
X 
 
 
Assess compliance 
 
X 
X 
X 
X 
 
 
Photography of scalp 
 
 
X 
 
X 
 
X 
Assess AEs 
 
X 
X 
X 
X 
X 
X 
EOT = end of treatment. 
a All assessments for the Week 24 visit as well as these additional activities must be performed before the subjects who meet eligibility criteria (refer to Protocol Section 5.2) may 
enter the open-label extension. 
b Urine pregnancy tests during the open-label extension will be performed on all women. 


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Table 3: 
Schedule of Assessments for the Open-Label Extension of Part B 
 
Open-Label Extension Part B 
Follow-Up 
Evaluation 
Week 24 
Day 168 
± 7 daysa 
Week 28 
Day 196 
± 7 days 
Week 32 
Day 224 
± 7 days 
Week 36 
Day 252 
± 7 days 
Week 42 
Day 294 
± 7 days 
Week 48 
EOT 
Day 336 
± 7 days 
Month 1 
± 7 days 
Month 3 
EOS 
± 7 days 
Clinic visit 
 
X 
X 
X 
X 
X 
X 
X 
Contact IRT 
Xa 
X 
X 
X 
X 
X 
X 
X 
Prior/concomitant medications 
 
X 
X 
X 
X 
X 
X 
X 
Comprehensive physical exam 
 
 
 
 
 
X 
 
 
Targeted physical exam 
 
X 
X 
X 
X 
 
X 
X 
Vital signs 
 
X 
X 
X 
X 
X 
X 
X 
Laboratory assessments 
 
X 
X 
X 
X 
X 
 
X 
Urinalysis 
 
 
 
 
 
X 
 
 
Pregnancy testb 
 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
 
 
 
 
 
X 
 
 
Clinical assessment 
 
X 
X 
X 
X 
X 
X 
X 
Apply study drug 
Xa 
X 
X 
X 
X 
 
 
 
Study drug and diary card 
dispensed 
Xa 
X 
X 
X 
X 
 
 
 
Collect study drug tubes; collect 
and review diary cards 
 
X 
X 
X 
X 
X 
 
 
Assess compliance 
 
X 
X 
X 
X 
X 
 
 
Photography of scalp 
 
 
 
X 
 
X 
 
X 
Assess AEs 
 
X 
X 
X 
X 
X 
X 
X 
a All assessments for the Week 24 visit noted in Table 1 as well as these additional activities must be performed before subjects who meet eligibility criteria may enter the open-
label extension. 
b All nonscreening visit urine pregnancy tests to be performed on all women. 


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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Day 1, Baseline, and Last Available Value 
Day 1, baseline, and last available value are defined in Table 4. 
Table 4: 
Definition of Day 1, Baseline, and Last Available Value 
 
Treatment Group 
Day 1 
Baseline 
Last Available Value 
Part A 
Treatment 
period 
INCB018424 
cream 
Date of first dose 
of INCB018424 
cream in treatment 
period 
The last nonmissing 
measurement 
obtained on or 
before the day of the 
first administration 
of INCB018424 
cream 
The last nonmissing measurement 
obtained after starting 
INCB018424 cream, and within 
30 days after the last dose of 
INCB018424 cream in treatment 
period or before the first dose of 
INCB018424 cream in extension 
period, whichever is earlier. 
Extension 
period 
INCB018424 
cream 
Date of first dose 
of INCB018424 
cream in treatment 
period 
The last nonmissing 
measurement 
obtained on or 
before the day of the 
first administration 
of INCB018424 
cream 
The last nonmissing measurement 
obtained after starting 
INCB018424 cream and within 
30 days after the last dose of 
INCB018424 cream. 
Part B 
Treatment 
period 
INCB018424 
cream 
Date of first dose 
of INCB018424 
cream or date of 
randomization for 
subjects 
randomized but not 
treated in treatment 
period 
The last nonmissing 
measurement 
obtained on or 
before the day of the 
first administration 
of INCB018424 
cream 
The last nonmissing measurement 
obtained after starting 
INCB018424 cream, and within 
30 days after the last dose of 
INCB018424 cream or before the 
first dose of INCB018424 cream 
in extension period, whichever is 
earlier. 
Placebo 
Date of first dose 
of placebo or date 
of randomization 
for subjects 
randomized but not 
treated in treatment 
period   
The last nonmissing 
measurement 
obtained on or 
before the day of the 
first administration 
of placebo 
The last nonmissing measurement 
obtained after starting placebo, 
and within 30 days after the last 
dose of placebo or before the first 
dose of INCB018424 cream in 
extension period, whichever is 
earlier. 


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Table 4: 
Definition of Day 1, Baseline, and Last Available Value (Continued) 
 
Treatment Group 
Day 1 
Baseline 
Last Available Value 
Part B 
Extension 
period 
INCB018424 
cream in treatment 
period 
Date of first dose 
of INCB018424 
cream in treatment 
period  
The last nonmissing 
measurement 
obtained on or 
before the day of the 
first administration 
of INCB018424 
cream in treatment 
period 
The last nonmissing measurement 
obtained after starting 
INCB018424 cream and within 
30 days after the last dose of 
INCB018424 cream. 
Placebo in 
treatment period 
Date of first dose 
of  INCB018424 
cream in extension 
period  
The last nonmissing 
measurement 
obtained on or 
before the day of the 
first administration 
of INCB018424 
cream in extension 
period 
The last nonmissing measurement 
obtained after starting 
INCB018424 cream and within 
30 days after the last dose of 
INCB018424 cream. 
For the baseline value, when scheduled assessments and unscheduled assessments occur on the 
same day and time of the assessment or first dose is not available, use the following convention 
to determine baseline: 
• If both a scheduled and an unscheduled visit are available on the day of the first dose 
and the time is missing, use the scheduled assessment as baseline. 
• If all scheduled assessments are missing on the day of the first dose and an 
unscheduled assessment is available, use the unscheduled assessment as baseline. 
4.1.2. 
Study Day 
Study Day 1 is used to calculate the study day for mapping scheduled visits.  Study Day 1 is the 
date of first dose of INCB018424 cream or placebo in the study. 
The study day at a visit/reporting date will be calculated by the visit/reporting date minus the 
study Day 1 date plus 1 (visit date – study Day 1 date + 1).  This study day will be subtracted by 
1 if it is less than or equal to zero, so that a study day of zero will never occur.  A study day of -1 
indicates 1 day before study Day 1. 
4.1.3. 
Scheduled Visits 
Study evaluations in weeks/days from study Day 1 are presented in Table 1. 


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4.2. 
Variable Definitions 
4.2.1. 
Age 
Subject age will be calculated as the integer part of the number of years from date of birth to the 
date of signing the informed consent form (ICF), using the following formula: 
Age = integer part of (date of informed consent – date of birth + 1)/365.25 
4.2.2. 
Body Mass Index 
Body mass index (BMI) will be calculated as follows: 
BMI (kg/m2) = [weight (kg)] / [height (m)]2 
4.2.3. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before Day 1 defined in Table 4.  
Concomitant medication is defined as any nonstudy medication that is:  
• Started before Day 1 and is ongoing throughout the study or ends on/after Day 1. 
• Started on/after Day 1 and is ongoing or ends during the course of study medication. 
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after Day 1.  In the listing, it will be indicated whether a medication is prior-only, 
concomitant-only, or both prior and concomitant medication. 
The start/stop dates recorded in the CRF by the investigator and his/her research staff will be 
used to identify when a concomitant medication was taken during the study.  Any missing start 
date must be queried for resolution.  Unresolved missing start dates will be handled as follows: 
• If the date is completely missing, the medication will be considered both prior and 
concomitant. 
• If only the day is missing, and the last day of the month is before the first dose date 
on Day 1, then the concomitant medication will be considered as starting before 
Day 1, and the incomplete date will be imputed as the last day of the month. 
• If only the day is missing, and the first day of the month is after the first dose date on 
Day 1, then the concomitant medication will be considered as starting after Day 1, 
and the incomplete date will be imputed as the first day of the month. 
• If only the day is missing, and the month is equal to the month of the first dose date 
on Day 1, then the incomplete date will be imputed as the first day of the month. 
• If both the month and day are missing, and the last day of the year is before the first 
dose date on Day 1, then the concomitant medication will be considered as starting 
before Day 1, and the incomplete date will be imputed as if it is the last day of the 
year.  Otherwise, the incomplete date will be imputed as if it is the first day of the 
year. 




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5.3. 
Analysis Populations 
5.3.1. 
Part A 
All analyses for Part A will be conducted with the Part A evaluable population in treatment 
period or extension period, which includes all subjects exposed to at least 1 dose of study drug in 
that period. 
5.3.2. 
Part B 
5.3.2.1. 
Intent-to-Treat Population 
All subjects who are randomized constitute the ITT population in the Part B treatment period.  
Treatment groups for this population will be defined according to the treatment assignment at the 
time of randomization regardless of the actual study drug that the subject might take during 
his/her participation in the study.  This population will be used for analyses of all efficacy data in 
the Part B treatment period. 
5.3.2.2. 
Per Protocol Population 
Subjects in the ITT population who are considered to be sufficiently compliant with the Protocol 
compose the per protocol (PP) population, which is defined for supportive sensitivity analyses 
for efficacy endpoints in the Part B treatment period. 
5.3.2.3. 
Safety Population 
The safety population in the Part B treatment period includes all enrolled subjects who received 
at least 1 dose of INCB018424 cream or placebo.  Treatment groups for this population will be 
determined according to the actual treatment that the subject received regardless of assigned 
study drug treatment.  All safety analyses will be conducted using the safety population. 
5.3.2.4. 
Part B Evaluable Population in Extension Period 
All analyses for the Part B extension period will be conducted with the Part B evaluable 
population in the extension period, which includes all subjects exposed to at least 1 dose of study 
drug in that period. 


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6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES 
Sample data displays are provided in Appendix A. 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease 
History 
The following demographic variables will be summarized for the Part A evaluable population, 
Part B ITT population, and Part B evaluable population in the extension period:  age, sex, race, 
ethnicity, weight, height, BMI. 
The following baseline disease characteristics will be summarized for the ITT population: 
• History of AA: 
− SALT scores:  continuous and categorical (25%-< 50%/50%-100%) 
− Predominant hair color (black/brown/red/blonde/gray/white) 
− Number of days since first onset of AA 
− Number of prior episodes of AA 
− Estimated maximum extent of hair loss due to AA 
− History of alopecia totalis at any time (yes/no) 
− History of alopecia totalis > or ≤ 2 years duration 
− History of alopecia universalis at any time (yes/no) 
− Duration of alopecia universalis:  > or ≤ to 2 years duration 
− History of male/female pattern baldness (yes/no) 
− Pattern baldness (anterior scalp/mid scalp/temporal scalp/vertex of scalp/other) 
− Prior therapy for AA (yes/no) 
• Current AA: 
− Number of days since onset of current AA 
− Duration of current episode (< 6 months/6-12 months/12-24 months/> 2-5 years/ 
> 5 years) 
− Type of hair remaining (terminal hair/vellus/indeterminant) 
− Pattern of scalp hair loss (patchy/totalis/ophiasis) 
− Body hair loss (no body hair loss/some body hair loss/100% body [excluding 
scalp] hair loss) 


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− Nail involvement (no nail involvement/some nail involvement/twenty nail 
dystrophy/trachyonychia) 
6.2. 
Disposition of Subjects 
The number and percentage of subjects who were treated, randomized (Part B treatment period 
only), complete the study through Week 24, complete the study through Week 48, discontinued 
from the study during the treatment period, and discontinued from the study during the extension 
period with a primary reason for withdrawal will be summarized for the Part A evaluable 
population, Part B ITT population, and Part B evaluable population in the extension period.   
6.3. 
Protocol Deviations 
Protocol deviations will be presented in the subject data listings. 
6.4. 
Exposure 
For subjects in the Part A evaluable population in the treatment period and extension period, 
Part B safety population, and Part B evaluable population in extension period, descriptive 
statistics will be provided by treatment group for duration of treatment, average daily dose, and 
total dose of INCB018424 cream/placebo. 
• Duration of treatment with INCB018424 cream or placebo:  the number of study days 
between Day 1 and the last record (defined in Table 5) of INCB018424 cream or 
placebo taken by the subject. 
Table 5: 
Duration of Treatment 
 
Treatment 
Group 
Day 1 
Last Record 
Part A 
Treatment 
period 
INCB018424 
cream 
Date of first dose of INCB018424 
cream in treatment period 
Date of last record of INCB018424 
cream in treatment period 
Extension 
period 
INCB018424 
cream 
Date of first dose of INCB018424 
cream in treatment period 
Date of last record of INCB018424 
cream in extension period 
Part B 
Treatment 
period 
INCB018424 
cream 
Date of first dose of INCB018424 
cream in treatment period 
Date of last record of INCB018424 
cream in treatment period 
Placebo 
Date of first dose of placebo in 
treatment period 
Date of last record of placebo in 
treatment period 
Extension 
period 
INCB018424 
cream in 
treatment period 
Date of first dose of INCB018424 
cream in treatment period  
Date of last record of INCB018424 
cream in extension period 
Placebo in 
treatment period 
Date of first dose of INCB018424 
cream in extension period 
Date of last record of INCB018424 
cream in extension period 


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6.5. 
Study Drug Compliance 
For subjects in the Part A evaluable population in the treatment period and Part B safety 
population in the treatment period, overall compliance (%) for INCB018424 cream or placebo 
will be calculated for all subjects as follows: 
Overall compliance (%) = 100 × [Total dose dispensed – Total dose returned] / [Intended 
dose]. 
• Total dose dispensed is the sum of the weights of tubes dispensed prior to the current 
visit. 
• Total dose returned is the sum of the tubes retuned prior to and on the current visit. 
• The intended dose will be based on the earliest study day of permanent 
discontinuation of the study drug (ie, AE discontinuation is the first AE with action 
taken = "drug withdrawn") or last study medication record in the database. 
A subject will be considered significantly noncompliant if he or she misses more than 20% of the 
intended doses during the study (ie, compliance < 80%).  Similarly, a subject will be considered 
significantly noncompliant if he or she is judged by the investigator to have intentionally or 
repeatedly taken more than the intended amount of medication (ie, compliance > 120%).  
Persistent noncompliance may result in the subject being discontinued from the study. 
6.6. 
Medical History 
For subjects in the Part A evaluable population in the treatment period and Part B ITT population 
in the treatment period, medical history will be summarized by assigned treatment group.  This 
summary will include the number and percentage of subjects. 
Subjects with significant medical history for each body system/organ class as documented on the 
CRF page.   
6.7. 
Prior and Concomitant Medication 
For subjects in the Part A evaluable population, Part B safety population, and Part B evaluable 
population in the extension period, prior medications and concomitant medications will be coded 
using the WHO Drug Dictionary and summarized by WHO drug class and WHO drug term.  In 
the data listing, each medication will be recorded as prior, concomitant, or both prior and 
concomitant.  Results will be summarized as number and percentage of subjects with prior and 
concomitant medications by preferred term and WHO drug class. 
Prior medication information for AA will also be used to identify medication received by 
subjects before enrollment into the study in the treatment periods of Part A and Part B.  Data of 
prior medication for AA will be summarized and presented by treatment group as well as by 
listings. 


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7. 
EFFICACY 
Sample data displays are provided in Appendix A. 
7.1. 
General Considerations 
Missing observations will be handled for specific endpoints as detailed in the sections addressing 
each analysis. 
Generally, for response endpoints on SALT50 and SALT90, all nonresponders in the Part B 
treatment period, as well as all subjects who discontinue study treatment at any time prior to the 
timepoint of interest or who discontinue from the study for any reason, will be defined as 
nonresponders for the nonresponder imputation (NRI) analysis.  Randomized subjects without at 
least 1 postbaseline observation will also be defined as nonresponders for the NRI analysis. 
For continuous endpoints, mixed model repeated measures (MMRM) implicitly adjusts for 
missing data through a variance-covariance structure. 
7.2. 
Analysis of the Primary Efficacy Parameter 
7.2.1. 
Primary Efficacy Analysis 
Alopecia areata will be assessed using the SALT scoring system recommended by the National 
Alopecia Areata Foundation group published in the Journal of the American Academy of 
Dermatology (Olsen et al 2004). 
The scalp will be divided into 4 areas: 
• Top of scalp is 40% (0.4) of scalp surface area. 
• Right side of scalp is 18% (0.18) of scalp surface area. 
• Left side of scalp is 18% (0.18) of scalp surface area. 
• Back side of scalp is 24% (0.24) of scalp surface area. 
Percentage of hair loss in any of these areas is percentage hair loss multiplied by the percentage 
of surface area of the scalp in that area.  Severity of Alopecia Tool score is the sum of the 
percentage of hair loss in all of the above mentioned areas. 
For example, if the percentages of hair loss in the top, right side, left side, and back are 20%, 
30%, 40%, and 50%, respectively, then the SALT score = (20 × 0.4) = (30 × 0.18) + (40 × 0.18) 
+ (50 × 0.24) = 8 + 5.4 + 7.2 + 12 = 32.6. 
The percent improvement (PI) in SALT scores from baseline will be computed as follows:  
 PI = 100 × (Baseline SALT score – Observed SALT score)/Baseline SALT score. 


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For improved outcome, this measure is positive, and for worsening outcome, this measure is 
negative.  
The categorical variable SALT50 is defined to be equal to 1 for PI from baseline in SALT scores 
of 50 or greater and 0 for less than 50.  This definition is introduced for the purpose of 
identifying subjects who respond to the treatment (1 – responder, 0 – nonresponder).  SALT90 is 
defined in a similar fashion. 
The primary efficacy endpoint in the Part A treatment period will be the best SALT50 
throughout the treatment period; that said, if a subject has positive SALT50 at any one visit, 
he/she will be counted as responder throughout the Part A treatment period.  The primary 
endpoint will be summarized using descriptive statistics in the Part A evaluable population in the 
treatment period. 
In the Part B treatment period, subjects will be stratified at randomization into 2 strata:  25% to 
< 50% and 50% to 100% scalp involvement.  The response rate assessed based on SALT50 
between active- and placebo-treated subjects will be compared in the ITT population in the 
treatment period, using a logistic regression with covariates of baseline SALT score and 
stratification factor of rAAIG group.  Exact logistic regression (Mehta and Patel 1995) will be 
used if any expected numbers are less than 5.  Treatment comparison at 24 weeks will be used to 
assess the primary objective.  The 2-sided 95% confidence interval for the odds ratio of the 
SALT50 (INCB018424 cream over placebo), along with p-value for the treatment comparison at 
Week 24 will be displayed. 
7.2.2. 
Subgroup Analyses for Primary Endpoint 
Subgroups will be formed based on the following baseline variables for those subjects whose 
data are available: 
• 25% to < 50% and 50% to 100% scalp involvement 
• Duration of current episode (< 6 months/ 6-12 months/12-24 months/> 2-5 years/ 
> 5 years) 
• Pattern of scalp hair loss (patchy/totalis/ophiasis) 
7.2.3. 
Sensitivity and Supportive Analyses for Primary Endpoint 
The primary endpoint will be analyzed using the PP population as a sensitivity analysis to the 
ITT population in treatment period. 
7.3. 
Analysis of the Secondary Efficacy Parameter 
Secondary efficacy analyses will be conducted for the Part A evaluable population and ITT 
population in Part B.  The following endpoints will be summarized using similar methods as 
specified in the primary analysis. 


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• Part A: 
− SALT50 responses for subjects with 50% to 100% scalp involvement at baseline 
in terminal hair at any visit through Week 24. 
− SALT90 response in terminal hair at Weeks 4, 8, 12, 18, and 24. 
• Part B: 
− SALT50 response in terminal hair (pigmented and nonpigmented) at Week 24, for 
subjects with 50%-100% scalp involvement at baseline. 
− SALT50 response in terminal hair (pigmented and nonpigmented) at Weeks 4, 8, 
12, and 18.   
− SALT90 response in terminal hair (pigmented and nonpigmented) at Weeks 4, 8, 
12, 18, and 24. 
All efficacy endpoints regarding the actual measurement, change from baseline, and percentage 
change from baseline in SALT will be summarized using descriptive statistics in the Part A 
evaluable population. 
In the Part B treatment period, the actual measurement, change from baseline, and percentage 
change from baseline in SALT score to Weeks 4, 8, 12, 18, and 24 will be analyzed by the 
MMRM model with repeated measures.  This model will include the fixed effects of treatment 
(INCB018424 cream vs placebo), stratification factor (25% to < 50% and 50% to 100% scalp 
involvement), visit, treatment by visit interaction, and baseline SALT scores as the fixed effects 
and subjects as the random effect.  In the MMRM model, the within-patient errors are modeled 
as an unstructured variance-covariance matrix. 


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8. 
SAFETY AND TOLERABILITY 
Sample data displays are provided in Appendix A. 
8.1. 
General Considerations 
The analyses for this section will be provided using Part A evaluable population in the treatment 
period and extension period, Part B safety evaluable population, and Part B evaluable population 
in the extension period.  Summary tables may be replaced with listings when appropriate.  For 
instance, an AE frequency table may be replaced with a listing if it only contains a few unique 
preferred terms reported on relatively few subjects.  Unless otherwise stated, table summaries 
will be limited to AEs occurring within 30 days of the last administration of study medication or 
the first dose of the next phase (extension period, if available) of the study, whichever is earlier. 
8.2. 
Adverse Events 
8.2.1. 
Adverse Event Definitions 
A treatment-emergent adverse event (TEAE) is any AE either reported for the first time or 
worsening of a pre-existing event after first dose of study medication.  Adverse events will be 
considered treatment emergent if they first occurred or worsened in severity after the first dose, 


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and on or prior to the date of the last visit of the period.  Maximum severity from previous 
period(s) will be considered as the baseline severity for TEAEs. 
Treatment-emergent AEs will be assigned to the study period according to the rules specified in 
Table 6. 
Table 6: 
Definition of Treatment-Emergent Adverse Event 
 
Treatment 
Group 
First Dose Date 
Last Visit 
Identification of 
Maximum Severity 
Part A 
Treatment 
period  
INCB018424 
cream 
Date of first dose of 
INCB018424 cream 
Date of last visit in 
treatment period  
Maximum severity 
from baseline  
Extension 
period  
INCB018424 
cream 
Date of first dose of 
INCB018424 cream 
Date of last visit in 
extension period 
Maximum severity 
from baseline  
Part B 
Treatment 
period 
INCB018424 
cream 
Date of first dose of 
INCB018424 cream 
Date of last visit in 
treatment period  
Maximum severity 
from baseline  
Placebo 
Date of first dose of 
placebo   
Date of last visit in 
treatment period  
Maximum severity 
from baseline  
Extension 
period 
INCB018424 
cream in 
treatment period 
Date of first dose of 
INCB018424 cream 
in treatment period  
Date of last visit in 
extension period 
Maximum severity 
from baseline  
Placebo in 
treatment period 
Date of first dose of  
INCB018424 cream 
in extension period  
Date of last visit in 
extension period 
Maximum severity 
from baseline and 
treatment period  
Analysis of AEs (as discussed below) will be limited to TEAEs, but data listings will include all 
AEs regardless of their timing to study drug administration. 
Adverse events will be tabulated by MedDRA preferred term and system organ class.  Severity 
of AEs will be described and graded using the NCI CTCAE.  The CTCAE version 4.03 is used 
for this Protocol.  The CTCAE reporting guidelines and grading details are available on the 
Cancer Therapy Evaluation Program (CTEP) website.  
A grading (severity) scale is provided for each AE term.  If the toxicity is not included in the 
CTCAE v4 criteria, it will be rated on a 1 to 4 scale as follows:  (1) mild, (2) moderate, 
(3) severe, (4) life-threatening.  All toxicities will be graded based on the worst level reached, 
not the level that they may have reached if they had not been treated.  When the intensity of an 
AE changes over time for a reporting period (eg, between visits), each change in intensity will be 
reported as an AE until the event resolves. 
The subset of AEs considered by the investigator to be related to INCB018424 cream/placebo 
will be considered to be treatment-related AEs.  If the investigator does not specify the 
relationship of the AE to study medication, the AE will be considered to be treatment-related.  


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The incidence of AEs and treatment-related AEs will be tabulated.  In addition, serious adverse 
events (SAEs) will also be tabulated. 
Any missing onset date, causality, or severity must be queried for resolution.  Unresolved 
missing values will be handled according to the following rules: 
• An unresolved missing causality will be considered treatment related. 
• An unresolved missing severity will be identified as an unknown severity.  
For purposes of analysis, all AEs will be considered TEAEs unless the AE can unequivocally be 
defined as not treatment emergent.  Therefore, a missing onset date will be considered treatment 
emergent, with the following examples illustrating exceptions: 
• If the stop/resolution date is prior to the first dose date, then the AE will be 
considered as not being treatment emergent. 
• If both the month and day are missing, and the last day of the year is prior to the first 
dose date, then the AE will not be considered treatment emergent.  
• If only the day is missing, and the last day of the month is before the first dose date, 
then the AE will not be considered treatment emergent. 
• If only the day is missing, and the first day of the month is after the first dose date, 
then the AE will be considered treatment emergent. 
8.2.2. 
Adverse Event Summaries 
An overall summary of AEs by treatment group will include the following: 
• Number (%) of subjects reporting any TEAEs 
• Number (%) of subjects reporting any treatment-related TEAEs 
• Number (%) of subjects reporting any SAEs 
• Number (%) of subjects reporting any Grade 3 or 4 TEAEs 
• Number (%) of subjects who temporarily interrupted study drug because of TEAEs 
• Number (%) of subjects who permanently discontinued study drug because of TEAEs 
• Number (%) of subjects who had a fatal TEAE 


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The following summaries will be produced by MedDRA term (if 2 or fewer subjects appear in a 
table, a listing may be appropriate): 
• Number (%) of subjects reporting TEAEs by system organ class and preferred term 
• Number (%) of subjects reporting TEAEs by preferred term in decreasing order of 
frequency 
• Number (%) of subjects reporting TEAEs by system organ class, preferred term, and 
maximum severity 
• Number (%) of subjects reporting TEAEs by system organ class, preferred term, and 
CTCAE grade group 
• Number (%) of subjects reporting treatment-related AEs by system organ class and 
preferred term 
• Number (%) of subjects reporting treatment-related AEs by preferred term in 
decreasing order of frequency 
• Number (%) of subjects reporting treatment-related AEs by system organ class, 
preferred term, and maximum severity 
• Number (%) of subjects reporting treatment-related AEs by system organ class, 
preferred term, and CTCAE grade group 
• Number (%) of subjects reporting TEAEs leading to death by system organ class and 
preferred term 
• Number (%) of subjects reporting treatment-emergent SAEs by system organ class 
and preferred term 
• Number (%) of subjects reporting treatment-related SAEs by system organ class and 
preferred term 
• Number (%) of subjects reporting TEAEs leading to interruption of drug by system 
organ class and preferred term 
• Number (%) of subjects reporting TEAEs leading to discontinuation of study drug by 
system organ class and preferred term 
• Number (%) of subjects reporting treatment-emergent non-SAEs by system organ 
class and preferred term.   
• Number (%) of subjects reporting TEAEs requiring concomitant medications by 
system organ class and preferred term 


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8.3. 
Clinical Laboratory Tests 
8.3.1. 
Laboratory Value Definitions 
All laboratory assessments will be performed using a central laboratory except for urine 
pregnancy tests (as applicable).  Laboratory values and change from baseline values will be 
summarized descriptively by visit.  The baseline value will be determined using the nonmissing 
values collected before the first dose defined in Section 4.1.1.  The last scheduled record before 
administration has higher priority, which will be considered the baseline record, compared with 
the unscheduled record.  For baseline laboratory candidates with the same date and time in the 
same priority category, additional rules may be provided after consultation with the medical 
monitor to delineate which value will be defined as baseline. 
Laboratory test values outside the normal range will be assessed for severity based on CTCAE 
grade or similar criteria where clinical intervention is required for CTCAE grading for laboratory 
grading criteria.  The incidence of abnormal laboratory values and shift tables relative to baseline 
will be tabulated. 
8.3.2. 
Laboratory Value Summaries 
Clinical laboratory tests, including hematology and serum chemistry (see Table 7), will be 
performed for each subject during the study in accordance with Table 1.  If specific safety issues 
arise, additional unscheduled laboratory tests/analyses may be performed at the discretion of the 
investigator. 
All test results and associated normal ranges from central laboratories will be reported in SI 
units.  All tests with numeric values will have a unique unit per test.  Any laboratory test results 
and associated normal ranges from local laboratories will be converted to SI units.  For the 
limited number of cases where the associated normal ranges from a local laboratory cannot be 
obtained despite due diligence, associated central laboratory normal ranges will be applied.  In 
the event that central laboratory normal ranges are not available, a set of standard normal ranges 
based upon documented reference ranges will be applied to facilitate reporting the test results. 
When there are multiple laboratory nonmissing values for a subject's particular test within a visit 
window, use the smallest laboratory sequence number to identify the record for postbaseline 
visits. 
Laboratory parameters identified in Table 7 will be summarized.  Shift tables based on the worst 
postbaseline value recorded will use all postbaseline values occurring within 30 days of stopping 
study treatment or the first dose of the next phase (extension period, if available) of the study, 
whichever is earlier.  Other laboratory parameters collected will only be listed in an appendix to 
the clinical study report (CSR) in their original units without SI conversions.   


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Table 7: 
Laboratory Parameters to be Summarized 
Panel 
Summary 
Serum chemistry 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Bicarbonate 
Blood urea nitrogen 
Calcium 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Sodium 
Total bilirubin 
Total protein 
Potassium 
Phosphorus 
Hematology 
Hematocrit 
Hemoglobin 
Mean corpuscular volume 
Platelet count 
Red blood cell count 
Reticulocyte count 
White blood cell count 
White blood cell differential  (5 part): 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
ALT = alanine aminotransferase; AST = aspartate aminotransferase. 
Numeric laboratory values will be summarized descriptively, and non-numeric test values will be 
tabulated when necessary. 
For test results that will be summarized with available normal ranges, the number and percentage 
of subjects with the laboratory values being low (but never high), normal, high (but never low), 
and both low and high will be calculated for each test.  This shift summary will be produced for 
each test for the Part A evaluable population and Part B safety population in the treatment 
period.  The denominator for the percentage calculation will use the number of subjects in the 
baseline category (ie, low, high, normal, missing) as the denominator for the percentage in each 
of the categories. 
For all gradable laboratory parameters identified in Table 7, the values will be classified into 
grade levels corresponding to CTCAE v4.03 criteria.  For specific laboratory parameters 
requiring clinical intervention to grade, the classification according to the quantitative 
component will be provided for laboratory grading criteria.  A listing of abnormal laboratory 
values, including the laboratory grade, will be provided. 
For safety population in the treatment period in Part A and Part B, the results of the lab tests of 
Free T4 and TSH obtained during the screening period will be summarized. 
8.4. 
Vital Signs 
Vital signs, including systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, 
and body temperature will be taken in the seated position for each subject during the study in 


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accordance with Table 1.  Change and percentage change from baseline will be calculated using 
the last nonmissing value before first dose of study medication (Day 1) as the baseline value 
defined in Table 4. 
Incidences of clinically notable vital sign abnormalities are defined in Table 8.  The abnormal 
values for subjects exhibiting clinically notable vital sign abnormalities will be listed along with 
their assigned treatment group.  Alert vital signs are defined as an absolute value outside the 
defined range and percentage change greater than 25%. 
Table 8: 
Criteria for Clinically Notable Vital Sign Abnormalities 
Vital Sign 
Raw Value 
Percentage Change 
Systolic blood pressure 
90-150 mmHg 
± 25% 
Diastolic blood pressure 
50-90 mmHg 
± 25% 
Heart rate 
45-100 beats/min 
± 25% 
Respiratory rate 
8-20 breaths/min 
± 25% 
Temperature 
35.5oC-38.0oC 
± 25% 
8.5. 
Electrocardiograms 
Twelve-lead ECGs including PR, QRS, QT, QTcF, QTcB, and RR intervals will be obtained for 
each subject during the study in accordance with Table 1.  Descriptive statistics and mean change 
from baseline will be determined for each ECG parameter at each assessment time.  Change and 
percentage change from baseline (defined in Table 9) will be calculated. 
Incidences of clinically notable ECG abnormalities are defined in Table 9.  Subjects exhibiting 
clinically notable ECG abnormalities will be listed with study visit and assigned treatment group.  
Abnormal values for subjects with alert ECG values, defined as both the absolute value and the 
percentage change from baseline being outside normal ranges, will be identified and listed. 
Table 9: 
Criteria for Clinically Notable Electrocardiogram Abnormalities 
Parameter  
High Threshold  
Low Threshold  
Percentage Change 
QTcF  
> 460 msec 
< 295 msec 
± 25% 
QTcB 
> 460 msec 
< 295 msec 
± 25% 
PR  
> 220 msec 
< 75 msec 
± 25% 
QRS  
> 120 msec 
< 50 msec 
± 30% 
QT  
> 500 msec 
< 300 msec 
± 25% 
RR  
> 1330 msec 
< 600 msec 
± 25% 
QTcF = Fridericia correction. 
Twelve-lead ECGs will be obtained for each subject during the study in accordance with Table 1.  
Electrocardiogram abnormalities, both at baseline and postbaseline visits, will be tabulated by 
treatment group.  Incidences of abnormalities will be listed with study visit, assigned treatment 
group, and a description of the abnormality. 


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9. 
INTERIM ANALYSES 
9.1. 
Overview of Interim Analyses 
Two formal interim analyses and a third, potential interim analysis are planned for this study.  
The 2 formal analyses in Part A and Part B are futility analyses to determine whether to enroll 
the last 34 randomized subjects in Part B.  If there is insufficient evidence of terminal hair 
growth demonstrated in the first 2 interim analyses and any Part B stratum contains ≤ 10 subjects 
at the second interim analysis, enrollment in said stratum will be reopened, and a third interim 
analysis in Part B will be conducted.  Overall, Part B will complete randomization if sufficient 
evidence of terminal hair growth is demonstrated either at the interim analysis in Part A or at 1 of 
the 2 interim analyses in Part B. 
9.1.1. 
Part A 
In Part A, the decision to enroll more than 34 subjects in Part B will be mainly driven by the 
number of SALT50 responders observed or by the number of subjects with evidence on other 
endpoints for hair regrowth throughout the treatment period. 
For subjects with 25% to < 50% and 50% to 100% scalp involvement, the response rate is 
assumed to be 61% for active versus 25% for placebo and 35% for active versus 5% for placebo, 
respectively.  Because of the different response rates between the 2 strata, the overall response 
rates will be different depending on the proportion of subjects enrolled in the 2 strata; therefore, 
the number of responders who are considered to have sufficient efficacy to complete enrollment 
of Part B will also be different.  A likelihood-based approach applying a binomial distribution 
and assuming the null hypothesis rates of response in the 2 strata are used to test for futility in 
Part A.  Assuming the number of responders among the 10 subjects in Part A follows binomial 
distribution with the overall response rates, the futility rule is that the cumulative probability of 
observing the exact number of responders (x) must be greater than 20%; that said, the probability 
of observing more than x responders among the 10 subjects in Part A must be less than 80%. 
Table 10 presents the number of responders required to complete enrollment of Part B, given the 
overall responses in different combinations of the subjects in the 2 stratums. 


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Table 10: 
Part A Interim Analysis 
Number of 
Subjects in 
25%-< 50% 
Stratum 
Number of 
Subjects in 
50%-100% 
Stratum 
Overall 
Response 
Rate for 
Active Agent 
(%) 
Number of 
Responders 
Required to 
Complete Part B 
(%) 
Probability to 
Go to Complete 
Part B for 
Active Agent 
(%) 
Overall  
Response Rate 
for Inactive 
Agent 
(%) 
Probability to 
Go to Complete 
Part B for 
Inactive Agent 
(%) 
10 
0 
61 
5 
65.9 
25 
2 
9 
1 
58.4 
5 
59.2 
23 
1.4 
8 
2 
55.8 
4 
75.5 
21 
4 
7 
3 
53.2 
4 
69.8 
19 
2.7 
6 
4 
50.6 
4 
63.7 
17 
1.7 
5 
5 
48 
3 
79.5 
15 
5 
4 
6 
45.4 
3 
74.3 
13 
3.2 
3 
7 
42.8 
3 
68.6 
11 
1.8 
2 
8 
40.2 
3 
62.3 
9 
1 
1 
9 
37.6 
2 
79.1 
7 
2.9 
0 
10 
35 
2 
73.9 
5 
1.1 
For example, if all subjects are enrolled in the > 25% to 50% stratum, the probability of 
observing ≥ 5 responses in the 10 subjects is 66%, then 5 responders will be sufficient to 
complete enrollment of Part B.  If all subjects are in > 50% to 100% stratum, the probability of 
observing 2 or more responses is 74%, then 2 responders will be sufficient to complete 
enrollment of Part B. 
Other evidence on hair regrowth will be also considered in Part A, in addition to the numbers of 
SALT50 responders, for any decision to enroll more than 34 subjects in Part B.   
9.1.2. 
Part B 
An interim analysis will be performed when 34 subjects, randomized in Part B, have Week 12 
data available and a test for futility will be performed based upon conditional power.  The 
conditional power is the probability to reach significance at the end of the study given the data at 
the interim.  The conditional power will be approximated using the empirical estimates of the 
treatment effect under the observed trend for a 2-sided alpha of 0.05. 
If the conditional power is ≤ 30% and there are more than 10 subjects in each defined stratum, 
then the study will be stopped for futility.  If conditional power is ≤ 30% but there is a stratum 
with ≤ 10 subjects, then enrollment of Part B will be continued for that stratum until a total of 
20 subjects in that stratum have been randomized in Part B.  The additional futility analysis in 
Part B will be conducted using the observed difference in SALT50 response rates between the 
2 treatment groups in the expanded stratum.  If the difference between the 2 observed 
percentages for the expanded stratum is ≥ 20 percentage points, then randomization will be 
reopened to that expanded stratum until 68 subjects are randomized in Part B. 


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CONFIDENTIAL 
Sites will remain blinded to study drug, but some personnel at Incyte without direct contact with 
sites will be unblinded.  An internal committee at Incyte will be charged with evaluating the 
unblinded interim results based on the futility rule above, as well as considering interim safety 
results.  If the study is stopped for futility, investigators and subjects will be unblinded, and the 
decision to continue study drug will be left to the discretion of the investigator, based on an 
individual assessment of clinical benefit.  As there are no plans for stopping early for efficacy, no 
adjustments of alpha or final p-values for repeated testing are necessary. 
9.2. 
Data Cut-Off for Interim Analysis 
In Part A, data will be monitored on a regular and ongoing basis during the study.  
In Part B, for analysis of the primary endpoint, a cutoff for clinical data used in the second 
interim analysis will be based on the earliest date that the first 34 subjects in Part B of the study 
completed the Week 12 visit or discontinued the study.  Data will include all visits occurring on 
or before this date for these 34 subjects.  This cutoff will ensure that the statistical properties of 
the conditional power calculations are as intended.  The cutoff for the third interim analysis (if 
needed) will be defined in a similar fashion. 
9.3. 
Derivations and Calculations for Interim Analyses 
The conditional power is the conditional probability of a statistically significant benefit at the 
end of the study, given the interim data. 
The test statistic, 
1
Z , given the data at the interim analysis could be calculated as follows: 
t
t
t
c
c
c
t
c
n
q
p
n
q
p
p
p
Z
1
1
1
1
1
1
1
1
1
+
−
=
, 
where 
c
p1  and 
t
p1 are the observed response rates at the interim analysis. 
c
c
c
n
Y
p
1
1
1 =
and 
t
t
t
n
Y
p
1
1
1 =
 
c
Y1  and 
t
Y1 are numbers of SALT50 responders at the interim for placebo group and active 
treatment group, and 
c
n1 =
t
n1 = 17 subjects per treatment arm at the interim. 
Using the conditional power formula provided by Lan and Wittes (1988), the conditional power 
under the observed trend for a 2-sided test is 






−
−
Θ
+
+
Φ
Φ
=
Θ
−
t
t
t
Z
t
CP
1
)
1(
)
2
/
(
)
;
(
1
1 α
, 


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CONFIDENTIAL 
where Φ-1 and Φ are inverse cumulative and cumulative distribution functions for a standard 
normal distribution, 
5.0
=
t
, and 
t
Z /
1
=
Θ
. 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
Dates for the SAP, including any amendments, are included in Table 11. 
Table 11: 
Dates for the SAP 
SAP Version 
Date 
Original 
27 OCT 2015 
10.1. 
Changes to Protocol Defined Analyses 
Not applicable. 
10.2. 
Changes to the SAP 
Not applicable. 


Incyte Corporation 
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CONFIDENTIAL 
11. 
REFERENCES 
Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment 
guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol 
2004;51:440-447. 
Mehta CR, Patel NR. Exact logistic regression: theory and examples. Stat Med 
1995;14:2143-2160. 
Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics 1988;44:579-585. 


Incyte Corporation 
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CONFIDENTIAL 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS 
This appendix provides a list of the planned tables, figures, and listings for the CSR.  Standard 
tables will follow the conventions in the Standard Safety Tables initial version.  Sample shells 
are provided for nonstandard, in-text CSR tables.  Modifications of the list or shells that do not 
otherwise affect the nature of the analysis will not warrant an amendment to the SAP. 
Tables 
Table No. 
Title 
Population 
Baseline Demographic and Characteristics 
1.1.1.1 
Analysis Populations 
 
1.1.1.2 
Analysis Populations 
 
1.1.2.1 
Summary of Subject Disposition 
Part A Evaluable Treatment  
1.1.2.2 
Summary of Subject Disposition 
Part B Intent-to-Treat 
1.1.2.4 
Summary of Subject Disposition 
Part B Evaluable Extension 
1.1.3.1 
Summary of Number of Subjects Enrolled by Site 
Part A Evaluable Treatment  
1.1.3.2 
Summary of Number of Subjects Enrolled by Site 
Part B Intent-to-Treat 
1.2.1.1 
Summary of Demographics 
Part A Evaluable Treatment  
1.2.1.2 
Summary of Demographics 
Part B Intent-to-Treat 
1.3.1.1 
Summary of Baseline Characteristics 
Part A Evaluable Treatment  
1.3.1.2 
Summary of Baseline Characteristics 
Part B Intent-to-Treat 
1.3.2.1 
Summary of Medical History 
Part A Evaluable Treatment  
1.3.2.2 
Summary of Medical History 
Part B Intent-to-Treat 
1.4.1.1 
Summary of Prior Medications 
Part A Evaluable Treatment  
1.4.1.2 
Summary of Prior Medications 
Part B Intent-to-Treat 
1.4.2.1 
Summary of Concomitant Medications 
Part A Evaluable Treatment  
1.4.2.2 
Summary of Concomitant Medications 
Part B Intent-to-Treat 
1.4.2.3 
Summary of Concomitant Medications 
Part A Evaluable Extension 
1.4.2.4 
Summary of Concomitant Medications 
Part B Evaluable Extension 
1.4.3.1 
Summary of Prior Medications for Alopecia Areata 
Part A Evaluable Treatment  
1.4.3.2 
Summary of Prior Medications for Alopecia Areata 
Part B Intent-to-Treat 
1.5.1.1 
Summary of Study Drug Compliance 
Part A Evaluable Treatment 
1.5.1.2 
Summary of Study Drug Compliance 
Part B Intent-to-Treat 
1.5.1.3 
Summary of Study Drug Compliance 
Part A Evaluable Extension 
1.5.1.4 
Summary of Study Drug Compliance 
Part B Evaluable Extension 
Efficacy 
2.1.1.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 
Part A Evaluable Treatment 
2.1.1.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 
Part B Intent-to-Treat 
2.1.1.3 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score by Visit 
Part A Evaluable Extension 
2.1.1.4 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score by Visit 
Part B Evaluable Extension 


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Table No. 
Title 
Population 
2.1.1.5 
Summary of Subjects Achieving >= 50% Reduction From 
Baseline in SALT Score at Week 24 
Part B Intent-to-Treat 
2.1.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 
Part B Per-Protocol 
2.1.3.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
from Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement 
Part A Evaluable Treatment 
2.1.3.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement 
Part B Intent-to-Treat 
2.1.3.3 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score by Visit by Baseline Scalp 
Involvement 
Part A Evaluable Extension 
2.1.3.4 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score by Visit by Baseline Scalp 
Involvement 
Part B Evaluable Extension 
2.1.4 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement 
Part B Per-Protocol 
2.1.5.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 by Duration of Current 
Episode 
Part A Evaluable Treatment 
2.1.5.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 by Duration of Current 
Episode 
Part B Intent-to-Treat 
2.1.6.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 by Pattern of Hair Loss 
Part A Evaluable Treatment 
2.1.6.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction 
From Baseline in SALT Score to Week 24 by Pattern of Hair Loss 
Part B Intent-to-Treat 
2.2.1.1 
Summary and Analysis of SALT Score From Baseline to Week 24 
Part A Evaluable Treatment 
2.2.1.2 
Summary and Analysis of SALT Score From Baseline to Week 24 
Part B Intent-to-Treat 
2.2.1.3 
Summary of Analysis of SALT Score From Baseline to Week 24 
Part A Evaluable Extension 
2.2.1.4 
Summary of Analysis of SALT Score From Baseline to Week 24 
Part B Evaluable Extension 
2.2.2.1 
Summary and Analysis of SALT Score From Baseline to Week 24 
by Baseline Scalp Involvement 
Part A Evaluable Treatment 
2.2.2.2 
Summary and Analysis of SALT Score From Baseline to Week 24 
by Baseline Scalp Involvement 
Part B Intent-to-Treat 
2.2.2.3 
Summary and Analysis of SALT Score by Visit and Baseline 
Scalp Involvement 
Part A Evaluable Extension 
2.2.2.4 
Summary and Analysis of SALT Score by Visit and Baseline 
Scalp Involvement 
Part B Evaluable Extension 
2.2.3 
Summary and Analysis of SALT Score From Baseline to Week 24 
Part B Per-Protocol 
2.2.4 
Summary and Analysis of SALT Score From Baseline to Week 24 
by Baseline Scalp Involvement 
Part B Per-Protocol 
2.3.1.1 
Summary of Subjects Achieving Complete Clinical Response in 
SALT Score From Baseline to Week 24 
Part A Evaluable Treatment 
2.3.1.2 
Summary of Subjects Achieving Complete Clinical Response in 
SALT Score From Baseline to Week 24 
Part B Intent-to-Treat 


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Table No. 
Title 
Population 
2.3.3.1 
Summary of Subjects Achieving Complete Clinical Response in 
SALT Score From Baseline to Week 24 by Baseline Scalp 
Involvement 
Part A Evaluable Treatment  
2.3.3.2 
Summary of Subjects Achieving Complete Clinical Response in 
SALT Score From Baseline to Week 24 by Baseline Scalp 
Involvement 
Part B Intent-to-Treat 
Exposure 
3.1.1 
Summary of Exposure and Duration of Exposure 
Part A Evaluable Treatment 
3.1.2 
Summary of Exposure and Duration of Exposure 
Part B Safety Treatment 
3.1.3 
Summary of Exposure and Duration of Exposure 
Part A Evaluable Extension 
3.1.4 
Summary of Exposure and Duration of Exposure 
Part B Evaluable Extension 
Adverse Events 
3.2.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
Part A Evaluable Treatment 
3.2.1.2 
Overall Summary of Treatment-Emergent Adverse Events 
Part B Safety 
3.2.1.3 
Overall Summary of Treatment-Emergent Adverse Events 
Part A Evaluable Extension 
3.2.1.4 
Overall Summary of Treatment-Emergent Adverse Events 
Part B Evaluable Extension 
3.2.2.1 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.2.2 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part B Safety 
3.2.2.3 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.2.4 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part B Evaluable Extension 
3.2.3.1 
Summary of Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part A Evaluable Treatment 
3.2.3.2 
Summary of Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part B Safety 
3.2.3.3 
Summary of Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part A Evaluable Extension 
3.2.3.4 
Summary of Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part B Evaluable Extension 
3.2.4.1 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part A Evaluable Treatment 
3.2.4.2 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part B Safety 
3.2.4.3 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part A Evaluable Extension 
3.2.4.4 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part B Evaluable Extension 
3.2.5.1 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part A Evaluable Treatment 
3.2.5.2 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part B Safety 
3.2.5.3 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part A Evaluable Extension 
3.2.5.4 
Summary of Treatment-Emergent Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part B Evaluable Extension 


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Table No. 
Title 
Population 
3.2.6.1 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.6.2 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part B Safety 
3.2.6.3 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.6.4 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Part B Evaluable Extension 
3.2.7.1 
Summary of Treatment-Related Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part A Evaluable Treatment 
3.2.7.2 
Summary of Treatment-Related Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part B Safety 
3.2.7.3 
Summary of Treatment-Related Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part A Evaluable Extension 
3.2.7.4 
Summary of Treatment-Related Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Part B Evaluable Extension 
3.2.8.1 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part A Evaluable Treatment 
3.2.8.2 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part B Safety 
3.2.8.3 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part A Evaluable Extension 
3.2.8.4 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and Maximum Severity 
Part B Evaluable Extension 
3.2.9.1 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part A Evaluable Treatment 
3.2.9.2 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part B Safety 
3.2.9.3 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part A Evaluable Extension 
3.2.9.4 
Summary of Treatment-Related Adverse Events by MedDRA 
System Organ Class, Preferred Term, and CTCAE Grade Group 
Part B Evaluable Extension 
3.2.10.1 
Summary of Treatment-Emergent Adverse Events Leading to 
Death by MedDRA System Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.10.2 
Summary of Treatment-Emergent Adverse Events Leading to 
Death by MedDRA System Organ Class and Preferred Term 
Part B Safety 
3.2.10.3 
Summary of Treatment-Emergent Adverse Events Leading to 
Death by MedDRA System Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.10.4 
Summary of Treatment-Emergent Adverse Events Leading to 
Death by MedDRA System Organ Class and Preferred Term 
Part B Evaluable Extension 
3.2.11.1 
Summary of Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.11.2 
Summary of Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part B Safety 
3.2.11.3 
Summary of Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.11.4 
Summary of Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part B Evaluable Extension 


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Table No. 
Title 
Population 
3.2.12.1 
Summary of Non-Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.12.2 
Summary of Non-Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part B Safety 
3.2.12.3 
Summary of Non-Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.12.4 
Summary of Non-Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part B Evaluable Extension 
3.2.13.1 
Summary of Treatment-Related Serious Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.13.2 
Summary of Treatment-Related Serious Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part B Safety 
3.2.13.3 
Summary of Treatment-Related Serious Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.13.4 
Summary of Treatment-Related Serious Adverse Events by 
MedDRA System Organ Class and Preferred Term 
Part B Evaluable Extension 
3.2.14.1 
Summary of Treatment-Emergent Adverse Events Leading to 
Permanent Discontinuation of Study Drug by MedDRA System 
Organ Class and Preferred Term 
Part A Evaluable Treatment 
3.2.14.2 
Summary of Treatment-Emergent Adverse Events Leading to 
Permanent Discontinuation of Study Drug by MedDRA System 
Organ Class and Preferred Term 
Part B Safety 
3.2.14.3 
Summary of Treatment-Emergent Adverse Events Leading to 
Permanent Discontinuation of Study Drug by MedDRA System 
Organ Class and Preferred Term 
Part A Evaluable Extension 
3.2.14.4 
Summary of Treatment-Emergent Adverse Events Leading to 
Permanent Discontinuation of Study Drug by MedDRA System 
Organ Class and Preferred Term 
Part B Evaluable Extension 
3.2.15.1 
Summary of Treatment-Emergent Adverse Events Leading to 
Interruption of Drug by MedDRA System Organ Class and 
Preferred Term 
Part A Evaluable Treatment 
3.2.15.2 
Summary of Treatment-Emergent Adverse Events Leading to 
Interruption of Drug by MedDRA System Organ Class and 
Preferred Term 
Part B Safety 
3.2.15.3 
Summary of Treatment-Emergent Adverse Events Leading to 
Interruption of Drug by MedDRA System Organ Class and 
Preferred Term 
Part A Evaluable Extension 
3.2.15.4 
Summary of Treatment-Emergent Adverse Events Leading to 
Interruption of Drug by MedDRA System Organ Class and 
Preferred Term 
Part B Evaluable Extension 
3.2.16.1 
Summary of Treatment-Emergent Adverse Events Requiring 
Concomitant Medications by MedDRA System Organ Class and 
Preferred Term 
Part A Evaluable Treatment 
3.2.16.2 
Summary of Treatment-Emergent Adverse Events Requiring 
Concomitant Medications by MedDRA System Organ Class and 
Preferred Term 
Part B Safety 
3.2.16.3 
Summary of Treatment-Emergent Adverse Events Requiring 
Concomitant Medications by MedDRA System Organ Class and 
Preferred Term 
Part A Evaluable Extension 


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Table No. 
Title 
Population 
3.2.16.4 
Summary of Treatment-Emergent Adverse Events Requiring 
Concomitant Medications by MedDRA System Organ Class and 
Preferred Term 
Part B Evaluable Extension 
Laboratory 
3.3.1.1 
Summary of Laboratory Values - Hematology 
Part A Evaluable Treatment 
3.3.1.2 
Summary of Laboratory Values - Hematology 
Part B Safety 
3.3.1.3 
Summary of Laboratory Values - Hematology 
Part A Evaluable Extension 
3.3.1.4 
Summary of Laboratory Values - Hematology 
Part B Evaluable Extension 
3.3.1.5 
Summary of Laboratory Values - Free T4 and TSH 
Part A Evaluable Treatment 
3.3.1.6 
Summary of Laboratory Values - Free T4 and TSH 
Part B Safety 
3.3.2.1 
Shift Summary of Hematology Laboratory Values - to the Worst 
Abnormal Value 
Part A Evaluable Treatment 
3.3.2.2 
Shift Summary of Hematology Values - to the Worst Abnormal 
Value 
Part B Safety 
3.3.2.3 
Shift Summary of Hematology Values - to the Worst Abnormal 
Value 
Part A Evaluable Extension 
3.3.2.4 
Shift Summary of Hematology Values - to the Worst Abnormal 
Value 
Part B Evaluable Extension 
3.3.3.1 
Summary of Laboratory Values - Chemistry 
Part A Evaluable Treatment 
3.3.3.2 
Summary of Laboratory Values - Chemistry 
Part B Safety 
3.3.3.3 
Summary of Laboratory Values - Chemistry 
Part A Evaluable Extension 
3.3.3.4 
Summary of Laboratory Values - Chemistry 
Part B Evaluable Extension 
3.3.4.1 
Shift Summary of Chemistry Values - to the Worst Abnormal 
Value 
Part A Evaluable Treatment 
3.3.4.2 
Shift Summary of Chemistry Values - to the Worst Abnormal 
Value 
Part B Safety 
3.3.4.3 
Shift Summary of Chemistry Values - to the Worst Abnormal 
Value 
Part A Evaluable Extension 
3.3.4.4 
Shift Summary of Chemistry Values - to the Worst Abnormal 
Value 
Part B Evaluable Extension 
3.3.5.1 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (One Directional CTC Grade) 
Part A Evaluable Treatment 
3.3.5.2 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (One Directional CTC Grade) 
Part B Safety 
3.3.5.3 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (One Directional CTC Grade) 
Part A Evaluable Extension 
3.3.5.4 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (One Directional CTC Grade) 
Part B Evaluable Extension 
3.3.6.1 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (One Directional CTC Grade) 
Part A Evaluable Treatment 
3.3.6.2 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (One Directional CTC Grade) 
Part B Safety 
3.3.6.3 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (One Directional CTC Grade) 
Part A Evaluable Extension 
3.3.6.4 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (One Directional CTC Grade) 
Part B Evaluable Extension 
3.3.7.1 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (Two Directional CTC Grade) 
Part A Evaluable Treatment 


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Table No. 
Title 
Population 
3.3.7.2 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (Two Directional CTC Grade) 
Part B Safety 
3.3.7.3 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (Two Directional CTC Grade) 
Part A Evaluable Extension 
3.3.7.4 
Shift Summary of Hematology Values in CTC Grade - to the 
Worst Abnormal Value (Two Directional CTC Grade) 
Part B Evaluable Extension 
3.3.8.1 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (Two Directional CTC Grade) 
Part A Evaluable Treatment 
3.3.8.2 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (Two Directional CTC Grade) 
Part B Safety 
3.3.8.3 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (Two Directional CTC Grade) 
Part A Evaluable Extension 
3.3.8.4 
Shift Summary of Chemistry Values in CTC Grade - to the Worst 
Abnormal Value (Two Directional CTC Grade) 
Part B Evaluable Extension 
3.3.9.1 
Summary of Laboratory Values - Urinalysis 
Part A Evaluable Treatment 
3.3.9.2 
Summary of Laboratory Values - Urinalysis 
Part B Safety 
3.3.9.3 
Summary of Laboratory Values - Urinalysis 
Part A Evaluable Extension 
3.3.9.4 
Summary of Laboratory Values - Urinalysis 
Part B Evaluable Extension 
Vital Signs 
3.4.1.1 
Summary of Systolic Blood Pressure 
Part A Evaluable Treatment 
3.4.1.2 
Summary of Systolic Blood Pressure 
Part B Safety 
3.4.1.3 
Summary of Systolic Blood Pressure 
Part A Evaluable Extension 
3.4.1.4 
Summary of Systolic Blood Pressure 
Part B Evaluable Extension 
3.4.2.1 
Summary of Diastolic Blood Pressure 
Part A Evaluable Treatment 
3.4.2.2 
Summary of Diastolic Blood Pressure 
Part B Safety 
3.4.2.3 
Summary of Diastolic Blood Pressure 
Part A Evaluable Extension 
3.4.2.4 
Summary of Diastolic Blood Pressure 
Part B Evaluable Extension 
3.4.3.1 
Summary of Pulse 
Part A Evaluable Treatment 
3.4.3.2 
Summary of Pulse 
Part B Safety 
3.4.3.3 
Summary of Pulse 
Part A Evaluable Extension 
3.4.3.4 
Summary of Pulse 
Part B Evaluable Extension 
3.4.4.1 
Summary of Body Temperature 
Part A Evaluable Treatment 
3.4.4.2 
Summary of Body Temperature 
Part B Safety 
3.4.4.3 
Summary of Body Temperature 
Part A Evaluable Extension 
3.4.4.4 
Summary of Body Temperature 
Part B Evaluable Extension 
3.4.5.1 
Summary of Respiration Rate 
Part A Evaluable Treatment 
3.4.5.2 
Summary of Respiration Rate 
Part B Safety 
3.4.5.3 
Summary of Respiration Rate 
Part A Evaluable Extension 
3.4.5.4 
Summary of Respiration Rate 
Part B Evaluable Extension 
ECG 
3.5.1.1 
Summary of 12-Lead ECG:  PR Interval Values 
Part A Evaluable Treatment 
3.5.1.2 
Summary of 12-Lead ECG:  PR Interval Values 
Part B Safety 
3.5.1.3 
Summary of 12-Lead ECG:  PR Interval Values 
Part A Evaluable Extension 
3.5.1.4 
Summary of 12-Lead ECG:  PR Interval Values 
Part B Evaluable Extension 
3.5.2.1 
Summary of 12-Lead ECG:  QRS Interval Values 
Part A Evaluable Treatment 


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Table No. 
Title 
Population 
3.5.2.2 
Summary of 12-Lead ECG:  QRS Interval Values 
Part B Safety 
3.5.2.3 
Summary of 12-Lead ECG:  QRS Interval Values 
Part A Evaluable Extension 
3.5.2.4 
Summary of 12-Lead ECG:  QRS Interval Values 
Part B Evaluable Extension 
3.5.3.1 
Summary of 12-Lead ECG:  QT Interval Values 
Part A Evaluable Treatment 
3.5.3.2 
Summary of 12-Lead ECG:  QT Interval Values 
Part B Safety 
3.5.3.3 
Summary of 12-Lead ECG:  QT Interval Values 
Part A Evaluable Extension 
3.5.3.4 
Summary of 12-Lead ECG:  QT Interval Values 
Part B Evaluable Extension 
3.5.4.1 
Summary of 12-Lead ECG:  QTcB Interval Values 
Part A Evaluable Treatment 
3.5.4.2 
Summary of 12-Lead ECG:  QTcB Interval Values 
Part B Safety 
3.5.4.3 
Summary of 12-Lead ECG:  QTcB Interval Values 
Part A Evaluable Extension 
3.5.4.4 
Summary of 12-Lead ECG:  QTcB Interval Values 
Part B Evaluable Extension 
3.5.5.1 
Summary of 12-Lead ECG:  QTcF Interval Values 
Part A Evaluable Treatment 
3.5.5.2 
Summary of 12-Lead ECG:  QTcF Interval Values 
Part B Safety 
3.5.5.3 
Summary of 12-Lead ECG:  QTcF Interval Values 
Part A Evaluable Extension 
3.5.5.4 
Summary of 12-Lead ECG:  QTcF Interval Values 
Part B Evaluable Extension 
3.5.6.1 
Summary of 12-Lead ECG:  RR Interval Values 
Part A Evaluable Treatment 
3.5.6.2 
Summary of 12-Lead ECG:  RR Interval Values 
Part B Safety 
3.5.6.3 
Summary of 12-Lead ECG:  RR Interval Values 
Part A Evaluable Extension 
3.5.6.4 
Summary of 12-Lead ECG:  RR Interval Values 
Part B Evaluable Extension 
3.5.7.1 
Summary of Treatment Emergent, Clinically Significant ECG 
Abnormality From Baseline 
Part A Evaluable Treatment 
3.5.7.2 
Summary of Treatment Emergent, Clinically Significant ECG 
Abnormality From Baseline 
Part B Safety 
3.5.7.3 
Summary of Treatment Emergent, Clinically Significant ECG 
Abnormality From Baseline 
Part A Evaluable Extension 
3.5.7.4 
Summary of Treatment Emergent, Clinically Significant ECG 
Abnormality From Baseline 
Part B Evaluable Extension 
Listings 
Listing No. 
Title 
2.1  Discontinued Subjects (Subject Disposition) 
2.1.1 
Subject Enrollment and Disposition Status 
2.1.3 
Subject Inclusion and Exclusion Criteria 
2.1.5.1 
Medical History 
2.2 
Protocol Deviations 
2.4.1 
Demographic and Baseline Characteristics 
2.4.2 
Prior and Concomitant Drug Treatments 
2.4.3 
Prior and Concomitant Drug Treatments for Alopecia Areata  
2.1.4 
Primary Reason of Study Discontinuation   
2.5  Drug Compliance 
2.5 
Study Drug Compliance 
2.6  Efficacy 
 
2.6.1 
SALT Scores 
2.6.2 
Subjects With Complete Clinical Response    
 
    


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Listing No. 
Title 
2.7  Adverse Events (and Exposure) 
2.7.1 
Study Drug Administration 
2.7.2 
Adverse Events  
2.7.4 
Adverse Events Leading to Discontinuation of Study Drug 
2.7.5 
Serious Adverse Events 
2.7.6 
Fatal Adverse Events 
2.8  Laboratory Data 
2.8.1.1 
Clinical Laboratory Values – Hematology 
2.8.1.2 
Clinical Laboratory Values – Serum Chemistry 
2.8.1.3 
Clinical Laboratory Values – Urinalysis 
2.8.2 
Abnormal Clinical Laboratory Values 
 
 
 
 
2.8.6    
Central Laboratory Collection Times  
2.9  Vital Signs 
2.9.1 
Vital Signs 
2.9.2 
Abnormal Vital Sign Values 
2.9.3 
Alert Vital Sign Values 
2.10  ECG 
2.10.1 
12-Lead ECG Values 
2.10.2 
Abnormal 12-Lead ECG Values 
2.10.3 
Alert 12-Lead ECG Values 
Figures 
Figure No.a 
Title 
Part B 
Population 
Part A 
Evaluable 
Population 
Part A/B 
Evaluable 
Population 
in Extension 
Period 
4.1.1.x 
Proportion of Subjects with a >=50% Reduction in 
SALT Score by Visit and Treatment Group 
ITT 
X 
X 
4.1.2 
Proportion of Subjects with a >=50% Reduction in 
SALT Score by Visit and Treatment Group (Per-
Protocol Population) 
Per-
Protocol  
 
 
4.1.2.1.x 
Proportion of Subjects with a >=90% Reduction in 
SALT Score by Visit and Treatment Group 
ITT 
X 
X 
4.1.2.2 
Proportion of Subjects with a >=90% Reduction in 
SALT Score by Visit and Treatment Group (Per-
Protocol Population) 
Per-
Protocol  
 
 
4.1.3.1.xb 
Mean and LS Mean Plot with Standard Errors for 
Percent Change in SALT Score by Visit and Treatment 
Group 
ITT 
X 
X 
4.1.3.2 
Mean and LS Mean Plot with Standard Errors for 
Percent Change in SALT Score by Visit and Treatment 
Group (Per-Protocol Population) 
Per-
Protocol  
 
 


Incyte Corporation 
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CONFIDENTIAL 
Figure No.a 
Title 
Part B 
Population 
Part A 
Evaluable 
Population 
Part A/B 
Evaluable 
Population 
in Extension 
Period 
4.1.4 
Kaplan –Meier Plot for Time to First Worsening of 
Disease during  Extension Period 
(Subjects with dose suspended  due to clinical responses 
at the end of treatment periods who continue to 
extension period ) 
 
 
X 
4.1.5 
Kaplan –Meier Plot for Time to First Worsening of 
Disease  
(Subjects with clinical responses at any time of the 
study)   
X 
X 
X 
4.4.1.x 
Line Graph of Selected Laboratory Values by Visit for 
Subjects Discontinued the Study Drug or Drug 
Interruption 
Safety 
X 
X 
4.4.2.x 
Box-and-Whisker Plot of Selected Laboratory Values 
by Study Visit 
Safety 
X 
X 
a Figure No of #.#.#..x where x = 1 for Part A treatment period, x = 2 for Part B treatment period,  x = 3 for Part A Extension 
Period, and x = 4 for Part B extension period. 
b Mean and LS Mean plots will be set in different pages; LS Mean will only be available for Part B treatment period. 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.1.1.1 
  
                                             Analysis Populations Part A 
 
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
______________________________________________________________________________________________________________________ 
                 Number (%) of Subjects Enrolled in Part A                                ## (###.#) 
  
                 Number (%) of Subjects in Part A Open Label Treatment Period             ## (###.#) 
  
                 Number (%) of Subjects in Part A Open Label Extension Period             ## (###.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_APOPA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                          Table 1.1.1.2 
                                                 Analysis Populations Part B 
  
                            
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
    Variable                                                                 INCB018424   Placebo      Total 
______________________________________________________________________________________________________________________ 
    Number (%) of Subjects Enrolled in Part B Treatment Period               ## (###.#)   ## (###.#)   ## (###.#) 
  
    Number (%) of Intent-to-Treat Subjects in Part B Treatment Period        ## (###.#)   ## (###.#)   ## (###.#) 
  
    Number (%) of Safety Subjects in Part B Treatment Period        
    ## (###.#)   ## (###.#)   ## (###.#) 
  
    Number (%) of Per-Protocol Subjects in Part B Treatment Period           ## (###.#)   ## (###.#)   ## (###.#) 
  
    Number (%) of 
 Subjects                                              ## (###.#)   ## (###.#)   ## (###.#) 
     
    Number (%) of Evaluable Subjects in Part B Extension Period              ## (###.#)   ## (###.#)   ## (###.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_APOPB.LST                                               DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.1.2.1 
                                            Summary of Subject Disposition 
  
                                      (Population: Part A Evaluable Subjects) 
______________________________________________________________________________________________________________________ 
                                                                                              INCB018424 
                                                                                              ____________ 
                                                                                              Total 
             Variable                                                                         (N=##) 
______________________________________________________________________________________________________________________ 
             Number (%) of Subjects Treated in Part A: Treatment Period                      ## (###.#) 
  
             Number (%) of Subjects Treated in Part A: Extension Period                      ## (###.#) 
  
             Number (%) of Subjects who Completed Study through Week 24                      ## (###.#) 
  
             Number (%) of Subjects who Completed Study through Week 48                      ## (###.#) 
 
             Number (%) of Subjects who entered Follow-up Phase                              ## (###.#) 
  
             Number (%) of Subjects Discontinued from Study: Part A Treatment Period         ## (###.#) 
               Adverse Event                                                                  ## (##.#) 
               Lost to Follow-up                                                              ## (##.#) 
               Physician Decision                                                             ## (##.#) 
               Consent Withdrawn                                                              ## (##.#) 
               Xxxxxxxx                                                                       ## (##.#)  
             Number (%) of Subjects Discontinued from Study: Part A Extension Period          ## (###.#) 
  
               Adverse Event                                                                  ## (##.#) 
               Lost to Follow-up                                                              ## (##.#) 
               Physician Decision                                                             ## (##.#) 
               Consent Withdrawn                                                              ## (##.#) 
               Xxxxxxxx                                                                       ## (##.#) 
__________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DISPA.LST                                                DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.1.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.1.2.2 
                                            Summary of Subject Disposition 
  
                          (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Number (%) of Subjects Randomized                                     ## (###.#)   ## (###.#)   ## (###.#) 
  
    Number (%) of Subjects Treated                                        ## (###.#)   ## (###.#)   ## (###.#) 
  
    Number (%) of Subjects who Completed Study through Week 24            ## (###.#)   ## (###.#)   ## (###.#) 
     
Number (%) of Subjects who entered Follow-up Phase                    ## (###.#)   ## (###.#)   ## (###.#)           
 
    Number (%) of Subjects Discontinued from Study:                        ## (###.#)   ## (###.#)   ## (###.#) 
  
      Adverse Event                                                          ## (##.#)    ## (##.#)    ## (##.#) 
      Lost to Follow-up                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      Physician Decision                                                     ## (##.#)    ## (##.#)    ## (##.#) 
      Consent Withdrawn                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      Xxxxxxxx                                                               ## (##.#)    ## (##.#)    ## (##.#) 
      .                                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      .                                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      .                                                                      ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DISPBITT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.1.2.4 
  
                                            Summary of Subject Disposition 
                         (Population: Part B Evaluable Subjects: Extension Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                                          Placebo to  
                                                                             INCB018424   INCB018424   Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Number (%) of Subjects Treated                                           ## (###.#)   ## (###.#)   ## (###.#) 
      
Number (%) of Subjects who Completed Study through Week 48               ## (###.#)   ## (###.#)   ## (###.#) 
 
Number (%) of Subjects who entered Follow-up Phase                       ## (###.#)   ## (###.#)   ## (###.#)           
  
    Number (%) of Subjects Discontinued from Study:                          ## (###.#)   ## (###.#)   ## (###.#) 
  
      Adverse Event                                                          ## (##.#)    ## (##.#)    ## (##.#) 
      Lost to Follow-up                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      Physician Decision                                                     ## (##.#)    ## (##.#)    ## (##.#) 
      Consent Withdrawn                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      Xxxxxxxx                                                               ## (##.#)    ## (##.#)    ## (##.#) 
      .                                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      .                                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      .                                                                      ## (##.#)    ## (##.#)    ## (##.#) 
  
      
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DISPBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.1 


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CONFIDENTIAL 
PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.1.3.1 
                                    Summary of Number of Subjects Enrolled By Site 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                                                                                          All Subjects 
                 Variable                                                                 (N=##) 
______________________________________________________________________________________________________________________ 
                   Site 1                                                                 ## (###.#) 
                   Site 2                                                                 ## (###.#) 
                   Site 3                                                                 ## (###.#) 
                   ...                                                                    ## (###.#) 
                   ...                                                                    ## (###.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ENRLA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.1.3.2 
                                    Summary of Number of Subjects Enrolled By Site 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
      Site 1                                                                 ## (###.#)   ## (###.#)   ## (###.#) 
      Site 2                                                                 ## (###.#)   ## (###.#)   ## (###.#) 
      Site 3                                                                 ## (###.#)   ## (###.#)   ## (###.#) 
      ...                                                                    ## (###.#)   ## (###.#)   ## (###.#) 
      ...                                                                    ## (###.#)   ## (###.#)   ## (###.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ENRLBITT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.1 


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PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.2.1.1 
                                               Summary of Demographics 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                                                                                         ____________ 
                  Variable                                                               All Subjects 
                                                                                         (N=##) 
______________________________________________________________________________________________________________________ 
                  Age (years) 
                    N                                                                    ## 
                    Mean                                                                 ##.# 
                    STD                                                                  ##.## 
                    Min                                                                  ## 
                    Median                                                               ##.# 
                    Max                                                                  ## 
                   Sex  n(%) 
                    Male                                                                 ## (##.#) 
                    Female                                                               ## (##.#) 
  
                  Ethnicity  n(%) 
                    Hispanic or Latino                                                   ## (##.#) 
                    Not Hispanic or Latino                                               ## (##.#) 
                    Other                                                                ## (##.#) 
  
                  Race  n(%) 
                    White                                                                ## (##.#) 
                    Black or African American                                            ## (##.#) 
                    Asian                                                                ## (##.#) 
                    Native Hawaiian or Other Pacific Islander                            ## (##.#) 
                    American Indian or Alaska Native                                     ## (##.#) 
                    Other                                                                ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMOA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.2.1.1 
                                               Summary of Demographics 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                                                                                         ____________ 
                  Variable                                                               All Subjects 
_________________________________________________________________________________________(N=##)________________________ 
                  Height (cm) 
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.# 
  
                  Weight (kg) 
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.# 
  
                  Body Mass Index (kg/m|2) 
                    N                                                                    ## 
                    Mean                                                                 ##.### 
                    STD                                                                  ##.#### 
                    Min                                                                  ##.## 
                    Median                                                               ##.### 
                    Max                                                                  ##.## 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMOA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.2.1.2 
                                               Summary of Demographics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                 Treatment Group 
                                                                            _________________________ 
                                                                            INCB018424   Placebo      Total 
     Variable                                                               (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
     Age (years) 
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.#         ##.#         ##.# 
       STD                                                                  ##.##        ##.##        ##.## 
       Min                                                                  ##           ##           ## 
       Median                                                               ##.#         ##.#         ##.# 
       Max                                                                  ##           ##           ##  
     Sex  n(%) 
       Male                                                                 ## (##.#)    ## (##.#)    ## (##.#) 
       Female                                                               ## (##.#)    ## (##.#)    ## (##.#) 
     Ethnicity  n(%) 
       Hispanic or Latino                                                   ## (##.#)    ## (##.#)    ## (##.#) 
       Not Hispanic or Latino                                               ## (##.#)    ## (##.#)    ## (##.#) 
       Other                                                                ## (##.#)    ## (##.#)    ## (##.#) 
 
     Race  n(%) 
       White                                                                ## (##.#)    ## (##.#)    ## (##.#) 
       Black or African American                                            ## (##.#)    ## (##.#)    ## (##.#) 
       Asian                                                                ## (##.#)    ## (##.#)    ## (##.#) 
       Native Hawaiian or Other Pacific Islander                            ## (##.#)    ## (##.#)    ## (##.#) 
       American Indian or Alaska Native                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Other                                                                ## (##.#)    ## (##.#)    ## (##.#) 
___________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMOBITT.LST                                             DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.4.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.2.1.2 
                                               Summary of Demographics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                 Treatment Group 
                                                                            _________________________ 
                                                                            INCB018424   Placebo      Total 
     Variable                                                               (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
     Height (cm) 
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.##        ##.##        ##.## 
       STD                                                                  ##.###       ##.###       ##.### 
       Min                                                                  ##.#         ##.#         ##.# 
       Median                                                               ##.##        ##.##        ##.## 
       Max                                                                  ##.#         ##.#         ##.# 
     Weight (kg) 
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.##        ##.##        ##.## 
       STD                                                                  ##.###       ##.###       ##.### 
       Min                                                                  ##.#         ##.#         ##.# 
       Median                                                               ##.##        ##.##        ##.## 
       Max                                                                  ##.#         ##.#         ##.# 
  
     Body Mass Index (kg/m|2) 
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.###       ##.###       ##.### 
       STD                                                                  ##.####      ##.####      ##.#### 
       Min                                                                  ##.##        ##.##        ##.## 
       Median                                                               ##.###       ##.###       ##.### 
       Max                                                                  ##.##        ##.##        ##.# 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMOBITT.LST                                             DATE(TIME): 18AUG15(13:51)  
Reference: Listing 2.4.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.1 
                                         Summary of Baseline Characteristics 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.3.1.2 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2A.LST                                               DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
Page 60 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
____________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Numeric Baseline SALT Score 
      N                                                                      ##           ##           ## 
      Mean                                                                   ##.##        ##.##        ##.## 
      STD                                                                    ##.###       ##.###       ##.### 
      Min                                                                    ##.#         ##.#         ##.# 
      Median                                                                 ##.##        ##.##        ##.## 
      Max                                                                    ##.#         ##.#         ##.# 
 
    Categorical Baseline SALT Score n(%) 
      25 - <50%                                                               ## (##.#)    ## (##.#)    ## (##.#) 
      50 - 100%                                                               ## (##.#)    ## (##.#)    ## (##.#) 
  
    Predominant Hair Color n(%) 
      Black                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
      Brown                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
      Red                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      Blonde                                                                 ## (##.#)    ## (##.#)    ## (##.#) 
      Gray                                                                   ## (##.#)    ## (##.#)    ## (##.#) 
      White                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
      Other                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
 ____________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 
 
 
     
 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 


Incyte Corporation 
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TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
 
____________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
   
    Days since first onset of Alopecia Areata 
      N                                                                      ##           ##           ## 
      Mean                                                                   ##.##        ##.##        ##.## 
      STD                                                                    ##.###       ##.###       ##.### 
      Min                                                                    ##.#         ##.#         ##.# 
      Median                                                                 ##.##        ##.##        ##.## 
      Max                                                                    ##.#         ##.#         ##.# 
    Number of Prior episodes of Alopecia Areata 
      N                                                                      ##           ##           ## 
      Mean                                                                   ##.##        ##.##        ##.## 
      STD                                                                    ##.###       ##.###       ##.### 
      Min                                                                    ##.#         ##.#         ##.# 
      Median                                                                 ##.##        ##.##        ##.## 
      Max                                                                    ##.#         ##.#         ##.# 
    Estimated maximum extent of hair loss for current episode (%) 
      N                                                                      ##           ##           ## 
      Mean                                                                   ##.##        ##.##        ##.## 
      STD                                                                    ##.###       ##.###       ##.### 
      Min                                                                    ##.#         ##.#         ##.# 
      Median                                                                 ##.##        ##.##        ##.## 
      Max                                                                    ##.#         ##.#         ##.# 
 ____________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
 Reference: Listing 2.4.1 


Incyte Corporation 
Page 62 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period)  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________  
    History of Alopecia Totalis at any time n(%) 
      Yes                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
          <= 2 years                                                         ## (##.#)    ## (##.#)    ## (##.#) 
           > 2 years                                                         ## (##.#)    ## (##.#)    ## (##.#) 
      No                                                                     ## (##.#)    ## (##.#)    ## (##.#) 
  
    History of Alopecia Universalis at any time n(%) 
      Yes                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
          <= 2 years                                                         ## (##.#)    ## (##.#)    ## (##.#) 
           > 2 years                                                         ## (##.#)    ## (##.#)    ## (##.#) 
      No                                                                     ## (##.#)    ## (##.#)    ## (##.#) 
  
    History of Male/Female Pattern Baldness n(%) 
     No                                                                      ## (##.#)    ## (##.#)    ## (##.#)      
     Yes                                                                     ## (##.#)    ## (##.#)    ## (##.#) 
      Anterior Scalp                                                         ## (##.#)    ## (##.#)    ## (##.#) 
      Mid Scalp                                                              ## (##.#)    ## (##.#)    ## (##.#) 
      Temporal Scalp                                                         ## (##.#)    ## (##.#)    ## (##.#) 
      Vertex of Scalp                                                        ## (##.#)    ## (##.#)    ## (##.#) 
      Other                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
  
    Prior Therapy for Alopecia Areata n(%) 
      Yes                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      No                                                                     ## (##.#)    ## (##.#)    ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
 Reference: Listing 2.4.1 


Incyte Corporation 
Page 63 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
  
   Days since first onset of Current Alopecia Areata 
      N                                                                      ##           ##           ## 
      Mean                                                                   ##.##        ##.##        ##.## 
      STD                                                                    ##.###       ##.###       ##.### 
      Min                                                                    ##.#         ##.#         ##.# 
      Median                                                                 ##.##        ##.##        ##.## 
      Max                                                                    ##.#         ##.#         ##.# 
  
    Duration of Current Episode n(%) 
      <6     months                                                           ## (##.#)    ## (##.#)    ## (##.#) 
      6-<12  months                                                           ## (##.#)    ## (##.#)    ## (##.#) 
      12-<24 months                                                           ## (##.#)    ## (##.#)    ## (##.#) 
      2-5    years                                                            ## (##.#)    ## (##.#)    ## (##.#) 
      >5     years                                                            ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
Page 64 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
 
Type of Hair remaining 
 
      Terminal n(%)                                                          ## (##.#)    ## (##.#)    ## (##.#) 
         Percent Pigmented Hair 
                N                                                            ##           ##           ## 
                Mean                                                         ##.##        ##.##        ##.## 
                STD                                                          ##.###       ##.###       ##.### 
                Min                                                          ##.#         ##.#         ##.# 
                Median                                                       ##.##        ##.##        ##.## 
                Max                                                          ##.#         ##.#         ##.# 
         Percent Non-pigmented Hair  
                N                                                            ##           ##           ##             
                Mean                                                         ##.##        ##.##        ##.## 
                STD                                                          ##.###       ##.###       ##.### 
                Min                                                          ##.#         ##.#         ##.# 
                Median                                                       ##.##        ##.##        ##.## 
                Max                                                          ##.#         ##.#         ##.#                  
                                                             
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
Page 65 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
 
Type of Hair remaining 
 
      Vellus/Indeterminant n(%)                                              ## (##.#)    ## (##.#)    ## (##.#) 
        Percent Vellus/Indeterminant  
 
                N                                                            ##           ##           ## 
                Mean                                                         ##.##        ##.##        ##.## 
                STD                                                          ##.###       ##.###       ##.### 
                Min                                                          ##.#         ##.#         ##.# 
                Median                                                       ##.##        ##.##        ##.## 
                Max                                                          ##.#         ##.#         ##.# 
                                                             
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
Page 66 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.1.2 
                                         Summary of Baseline Characteristics 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Pattern of scalp hair loss n(%) 
      Patchy                                                                 ## (##.#)    ## (##.#)    ## (##.#) 
      Totalis                                                                ## (##.#)    ## (##.#)    ## (##.#) 
      Ophiasis                                                               ## (##.#)    ## (##.#)    ## (##.#) 
  
    Body Hair Loss (Excluding scalp) n(%) 
      No body hair loss                                                      ## (##.#)    ## (##.#)    ## (##.#) 
      Some body hair loss                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      100% body hair loss                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
    Nail Involvement n(%) 
      No nail involvement                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      Some nail involvement                                                  ## (##.#)    ## (##.#)    ## (##.#) 
      Twenty nail dystrophy/Trachyonychia                                    ## (##.#)    ## (##.#)    ## (##.#) 
 
                                                             
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DEMO2BITT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.1 


Incyte Corporation 
Page 67 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.2.1 
                                              Summary of Medical History 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                 MedDRA System Organ Class/                                               ____________ 
                   MedDRA Preferred Term                                                  All Subjects 
                                                                                             (N=##) 
______________________________________________________________________________________________________________________ 
                 Number (%) of Subjects with Medical History                              ## (##.#) 
  
                 System Organ Class 1 
                   Preferred Term 1                                                       ## (##.#) 
                   Preferred Term 2                                                       ## (##.#) 
                   Preferred Term 3                                                       ## (##.#) 
                   ...                                                                    ## (##.#) 
                   ...                                                                    ## (##.#) 
  
                 System Organ Class 2 
                   Preferred Term 1                                                       ## (##.#) 
                   Preferred Term 2                                                       ## (##.#) 
                   Preferred Term 3                                                       ## (##.#) 
                   ...                                                                    ## (##.#) 
                   ...                                                                    ## (##.#) 
  
                 System Organ Class ... 
                   Preferred Term 1                                                       ## (##.#) 
                   Preferred Term 2                                                       ## (##.#) 
                   Preferred Term 3                                                       ## (##.#) 
                   ...                                                                    ## (##.#) 
                   ...                                                                    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_MEDHA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.1.5.1 


Incyte Corporation 
Page 68 of 277 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.3.2.2 
                                              Summary of Medical History 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
    MedDRA System Organ Class/                                               INCB018424   Placebo      Total 
      MedDRA Preferred Term                                                  (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Number (%) of Subjects with Medical History                              ## (##.#)    ## (##.#)    ## (##.#) 
  
    System Organ Class 1 
      Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
    System Organ Class 2 
      Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
    System Organ Class ... 
      Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_MEDHBITT.LST                                             DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.1.5.1 


Incyte Corporation 
Page 69 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.1.1 
                                             Summary of Prior Medications 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                 ATC Class/                                                          ____________ 
                   WHO Preferred Term                                                     All Subjects 
___________________________________________________________________________________________(N=##)_____________________ 
 
                 Number (%) of Subjects with Prior Medications                            ## (##.#) 
  
                 Drug Class 1 
                   Preferred Term 1                                                       ## (##.#) 
                   Preferred Term 2                                                       ## (##.#) 
                   Preferred Term 3                                                       ## (##.#) 
                   ...                                                                    ## (##.#) 
                   ...                                                                    ## (##.#) 
  
                 Drug Class 2 
                   Preferred Term 1                                                       ## (##.#) 
                   Preferred Term 2                                                       ## (##.#) 
                   Preferred Term 3                                                       ## (##.#) 
                   ...                                                                    ## (##.#) 
                   ...                                                                    ## (##.#) 
  
                 Drug Class ... 
                   Preferred Term 1                                                       ## (##.#) 
                   Preferred Term 2                                                       ## (##.#) 
                   Preferred Term 3                                                       ## (##.#) 
                   ...                                                                    ## (##.#) 
                   ...                                                                    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PRMEDA.LST                                               DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.4.2 


Incyte Corporation 
Page 70 of 277 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.1.2 
                                             Summary of Prior Medications 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
    ATC Class/                                                             INCB018424   Placebo      Total 
      WHO Preferred Term                                                    (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Number (%) of Subjects with Medical History                              ## (##.#)    ## (##.#)    ## (##.#) 
  
    System Organ Class 1 
      Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
    System Organ Class 2 
      Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
    System Organ Class ... 
      Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
      ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PRMEDBITT.LST                                            DATE(TIME): 18AUG15(13:51) 
 Reference: Listing 2.4.2 


Incyte Corporation 
Page 71 of 277 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.2.1 
                                          Summary of Concomitant Medications 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                  ATC Class/                                                        ___________________ 
                    WHO Preferred Term                                                   All Subjects 
                                                                                         (N=##) 
______________________________________________________________________________________________________________________ 
                  Number (%) of Subjects with Concomitant Medications                    ## (##.#) 
  
                  Drug Class 1 
                    Preferred Term 1                                                     ## (##.#) 
                    Preferred Term 2                                                     ## (##.#) 
                    Preferred Term 3                                                     ## (##.#) 
                    ...                                                                  ## (##.#) 
                    ...                                                                  ## (##.#) 
  
                  Drug Class 2 
                    Preferred Term 1                                                     ## (##.#) 
                    Preferred Term 2                                                     ## (##.#) 
                    Preferred Term 3                                                     ## (##.#) 
                    ...                                                                  ## (##.#) 
                    ...                                                                  ## (##.#) 
  
                  Drug Class ... 
                    Preferred Term 1                                                     ## (##.#) 
                    Preferred Term 2                                                     ## (##.#) 
                    Preferred Term 3                                                     ## (##.#) 
                    ...                                                                  ## (##.#) 
                    ...                                                                  ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CONMEDA.LST                                              DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.4.2 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.2.2 
                                          Summary of Concomitant Medications 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.4.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CONMEDBITT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.2 
 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.2.3 
                                          Summary of Concomitant Medications 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.4.2.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CONMEDAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.2 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.2.4 
                                          Summary of Concomitant Medications 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.4.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CONMEDBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.2 
 


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PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.3.1 
                                   Summary of Prior Medications for Alopecia Areata 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.4.1.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PRMEDAAA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.3 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.4.3.2 
                                   Summary of Prior Medications for Alopecia Areata 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.4.1.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PRMEDAABITT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.3 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 1.5.1.1 
Summary of Drug Compliance 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                                                                                         ____________ 
                  Variable                                                               All Subjects 
                                                                                         (N=##) 
______________________________________________________________________________________________________________________ 
                  Duration of Treatment (days)  
 
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.# 
  
                 Dose Compliance (%) 
 
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.# 
 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DCMPLNCA.LST                                          DATE(TIME): 18AUG15(13:51) 
Note: Dose Compliance (100%) = 100 × [total dose taken]/[intended dose]. 
 
Reference: Listing 2.5.1 
 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.5.1.2 
  Summary of Drug Compliance 
 
  
                      
 
 (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.5.1.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ DCMPLNCBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.3 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.5.1.3 
  Summary of Drug Compliance 
 
  
                      
 
 (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.5.1.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ DCMPLNCAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.3 


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PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 1.5.1.4 
  Summary of Drug Compliance 
 
  
                      
 
 (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 1.5.1.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ DCMPLNCBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.4.3 
 


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PROTOCOL: INCB 018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.1.1 
           Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                      INCB018424 
                                                                                      ____________________ 
             Variable                                                                 All Subjects 
                                                                                         (N=xx)       
______________________________________________________________________________________________________________________ 
             Number (%) of Evaluable Subjects [1]                                     ## (###.#) 
  
             Week 4 
  
             Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
                  Yes                                                                 ## (##.#) 
                  No                                                                  ## (##.#) 
  
             Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
                  Yes                                                                 ## (##.#) 
                  No                                                                  ## (##.#) 
  
             Week XX 
  
             Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
                  Yes                                                                 ## (##.#) 
                  No                                                                  ## (##.#) 
  
             Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
                  Yes                                                                 ## (##.#) 
                  No                                                                  ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTA.LST                                                DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Number of subjects who have ever achieved SALT50 or SALT90 at any visit in the Part A Treatment Period. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.1.2 
           Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                            _________________________________________ 
   Variable                                                                 INCB018424           Placebo 
________________________________________________________________________________N=##              (N=##)_____________        
   Number (%) of Evaluable Subjects [1]                                     ## (###.#)           ## (###.#) 
  
   Week 4 
  
   Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
        Yes                                                                 ## (##.#)            ## (##.#) 
        No                                                                  ## (##.#)            ## (##.#) 
        INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)       
        P-value                                                             0.##                  
  
   Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
        Yes                                                                 ## (##.#)            ## (##.#) 
        No                                                                  ## (##.#)            ## (##.#) 
        INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)       
        P-value                                                             0.##                  
  
   Reason for Subjects not achieving >=50% OR >= 90% Reduction  N (%) 
        Less than 50% Reduction at the visit                                ## (##.#)            ## (##.#) 
        Less than 90% Reduction at the visit                                ## (##.#)            ## (##.#) 
        Missing Values at the Visit                                         ## (##.#)            ## (##.#) 
 ______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBITT.LST                                             DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study before the assessed visit for any reason are considered as not having 
achieved the >= 50% or >= 90% reduction in SALT score. 
[3] Logistic Regression model including treatment, stratification factor(baseline scalp, 25%-<50% vs 50% to 100%), 
and baseline SALT score. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.1.2 
           Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                            _________________________________________ 
   Variable                                                                 INCB018424           Placebo 
_______________________________________________________________________________N=##              (N=##)_______ 
   Week xx  
  
   Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
        Yes                                                                 ## (##.#)            ## (##.#) 
        No                                                                  ## (##.#)            ## (##.#) 
        INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)       
        P-value                                                             0.##                  
  
   Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
        Yes                                                                 ## (##.#)            ## (##.#) 
        No                                                                  ## (##.#)            ## (##.#) 
        INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)       
        P-value                                                             0.##                  
  
   Reason for Subjects not achieving >=50% OR >= 90% Reduction  N (%) 
        Less than 50% Reduction at the visit                                ## (##.#)            ## (##.#) 
        Less than 90% Reduction at the visit                                ## (##.#)            ## (##.#) 
        Missing Values at the Visit                                         ## (##.#)            ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBITT.LST                                             DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study before the assessed visit for any reason are considered as not having 
achieved the >= 50% or >= 90% reduction in SALT score. 
[3] Logistic Regression model including treatment, stratification factor(baseline scalp, 25%-<50% vs 50% to 100%), 
and baseline SALT score. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.1.3 
            Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score by Visit 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.3.1 with appropriate treatment groups without sub-groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.1.4 
            Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score by Visit 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.3.1 with appropriate treatment groups without sub-groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 2.1.1.5 
          
  Summary of Subjects Achieving >= 50% Reduction from Baseline in SALT Score at Week 24 
  
                                 (Population: Part B Intent to Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
______________________________________________________________________________________________________________________ 
       Number (%) of Evaluable Subjects [1] 
 
 
 
 
 
## (###.#)       ## (###.#) 
 
 
 
Week 24 (Primary Endpoint) 
  
       Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
            Yes                                                                 ## (##.#)        ## (##.#) 
            No                                                                  ## (##.#)        ## (##.#) 
            INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)   
            P-value                                                             0.##              
  
       Reason for Subjects not achieving >=50% Reduction  N (%) 
            Less than 50% Reduction at the visit                                ## (##.#)        ## (##.#) 
            Discontinued prior to the visit                                     ## (##.#)        ## (##.#) 
            Missing Values at the Visit                                         ## (##.#)        ## (##.#)  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBPP.LST                                              DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study for any reason are considered as not having achieved the >= 50% reduction    
    in SALT score. 
[3] Logistic Regression model including treatment, stratification factor(baseline scalp, 25%-<50% vs 50% to 100%), 
    and baseline SALT score. 
Reference: Listing 2.6.1 
Programming Note: For interim analysis when some subjects are still ongoing and week 24 data is not available, use the 
footnote below in place of foot note 1. 
[1] A subject was not evaluable if the subject had a missing score at baseline or is ongoing without reaching Week 24. 
In this case a, patients with missing week 24 SALT and missing discontinuation status will be excluded from evaluable 
subjects. 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 2.1.2 
           Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 
  
                                 (Population: Part B Per-Protocol Subjects) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
________________________________________________________________________________N=##              (N=##)_______ 
       Number (%) of Evaluable Subjects [1]                                     ## (###.#)       ## (###.#) 
  
       Week 4 
  
       Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
            Yes                                                                 ## (##.#)        ## (##.#) 
            No                                                                  ## (##.#)        ## (##.#) 
            INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)   
            P-value                                                             0.##              
  
       Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
            Yes                                                                 ## (##.#)        ## (##.#) 
            No                                                                  ## (##.#)        ## (##.#) 
            INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)   
            P-value                                                             0.##               
       Reason for Subjects not achieving >=50% OR >= 90% Reduction  N (%) 
            Less than 50% Reduction at the visit                                ## (##.#)        ## (##.#) 
            Less than 90% Reduction at the visit                                ## (##.#)        ## (##.#) 
            Missing Values at the Visit                                         ## (##.#)        ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBPP.LST                                              DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study before the assessed visit for any reason are considered as not having 
achieved the >= 50% or >= 90% reduction in SALT score . 
[3] Logistic Regression model including treatment, stratification factor(baseline scalp, 25%-<50% vs 50% to 100%), 
and baseline SALT score. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 2.1.2 
           Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 
  
                                 (Population: Part B Per-Protocol Subjects) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
______________________________________________________________________________________________________________________ 
       Week XX 
  
       Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
            Yes                                                                 ## (##.#)        ## (##.#) 
            No                                                                  ## (##.#)        ## (##.#) 
            INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)   
            P-value                                                             0.##              
  
       Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
            Yes                                                                 ## (##.#)        ## (##.#) 
            No                                                                  ## (##.#)        ## (##.#) 
            INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #.##)  
            P-value                                                             0.##             
  
       Reason for Subjects not achieving >=50% OR >= 90% Reduction  N (%) 
            Less than 50% Reduction at the visit                                ## (##.#)        ## (##.#) 
            Less than 90% Reduction at the visit                                ## (##.#)        ## (##.#) 
            Missing Values at the Visit                                         ## (##.#)        ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBPP.LST                                              DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study for any reason are considered as not having achieved the >= 50% or >= 90% 
    reduction in SALT score. 
[3] Logistic Regression model including treatment, stratification factor(baseline scalp, 25%-<50% vs 50% to 100%), 
    and baseline SALT score. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.3.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ---------------------------------------- Baseline Scalp Involvement 25% to <50% -------------------------------------- 
  
                 _____________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
                 _____________________________________________________________________________________ 
                 Number (%) of Evaluable Subjects [1]                                     ## (###.#) 
                 Week 4 
  
                 Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
  
                 Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
  
                 Week XX 
  
                 Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
  
                 Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLPA.LST                                           DATE(TIME): 18AUG15(13:51) 
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Number of subjects who have ever achieved SALT50 or SALT90 at any visit in the Part A Treatment Period. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.3.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 --------------------------------------- Baseline Scalp Involvement 50% to 100% --------------------------------------- 
 ______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
 ______________________________________________________________________________________________________________________ 
                 Number (%) of Evaluable Subjects [1]                                     ## (###.#) 
  
                 Week 4 
  
                 Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
  
                 Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
  
                 Week XX 
  
                 Subjects Achieving >=  50% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
  
                 Subjects Achieving >=  90% Reduction from Baseline  N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
 ______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLPA.LST                                           DATE(TIME): 18AUG15(13:51)  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Number of subjects who have ever achieved SALT50 or SALT90 at any visit in the Part A Treatment Period. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.3.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.2 with appropriate treatment groups for each baseline scalp 
 involvement sub-group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLPBITT.LST                                        DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study for any reason are considered as not having achieved the >= 50% or >= 90% 
    reduction in SALT score . 
[3] Logistic Regression model including treatment and baseline SALT score. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.3.3 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score by Visit by Baseline Scalp 
Involvement 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.3.1 with appropriate treatment groups for each baseline scalp 
 involvement sub-group for all visits 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLPAEXT.LST                                        DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.3.4 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score by Visit by Baseline Scalp 
Involvement 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.3.1 with appropriate treatment groups for each baseline 
 scalp involvement sub-group for all visits 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLPBEXT.LST                                        DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
Reference: Listing 2.6.1 
 
 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 2.1.4 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Baseline Scalp 
Involvement 
  
                                 (Population: Part B Per-Protocol Subjects) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.2 with appropriate treatment groups for each baseline scalp 
 involvement sub-group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLPBPP.LST                                         DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study for any reason are considered as not having achieved the >= 50% or >= 90% 
    reduction in SALT score . 
[3] Logistic Regression model including treatment and baseline SALT score. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.1 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
_____________________________________________________________________________________________(N=xxx)___________________ 
                 Measured SALT Score at Baseline 
                     N[1]                                                                 # 
                     Mean(STD)                                                            xx.x(xx.xx) 
                     Median                                                               xx.x 
                     (Q1,Q3)                                                             (xx.x, xx.x) 
                     (Min,Max)                                                           (xx.x, xx.x) 
  
                 Measured SALT Score at week XX 
                      N                                                                   # 
                      Mean(STD)                                                           xx.x(xx.xx) 
                      Median                                                              xx.x 
                      (Q1,Q3)                                                             (xx.x, xx.x) 
                      (Min,Max)                                                           (xx.x, xx.x) 
  
                 Change in SALT Score from Baseline at week XX 
                      N                                                                   # 
                      Mean(STD)                                                           xx.x(xx.xx) 
                      Median                                                              xx.x 
                      (Q1,Q3)                                                             (xx.x, xx.x) 
                      (Min,Max)                                                           (xx.x, xx.x) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSA.LST                                              DATE(TIME): 18AUG15(13:51)  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
    Abbreviations: Q1 =; Q2 =; STD = Standard deviation; SE = Standard error; Max = Maximum; Min = Minimum. 
Reference: Listing 2.6.1 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 


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                                                   Table 2.2.1.1 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
_____________________________________________________________________________________________(N=xxx)___________________               
               Percentage change in SALT Score from Baseline at week XX 
                      N                                                                   # 
                      Mean(STD)                                                           xx.x(xx.xx) 
                      Median                                                              xx.x 
                      (Q1,Q3)                                                             (xx.x, xx.x) 
                      (Min,Max)                                                           (xx.x, xx.x) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSA.LST                                              DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
    Abbreviations: Q1 =; Q2 =; STD = Standard deviation; SE = Standard error; Max = Maximum; Min = Minimum. 
Reference: Listing 2.6.1 
 
 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.2 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                      (Population: Part B Intent-to-Treat Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
________________________________________________________________________________(N=xx)__________(N=xx)_________________ 
       Measured SALT Score at Baseline 
       N                                                                        #                # 
       Mean(STD)                                                                xx.x(xx.xx)      xx.x(xx.xx) 
       Median                                                                   xx.x             xx.x 
       (Q1,Q3)                                                                  (xx.x, xx.x)     (xx.x, xx.x) 
       (Min,Max)                                                                (xx.x, xx.x)     (xx.x, xx.x) 
  
 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBITT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Stratification factor 
    (baseline scalp involvement, 25-<50% vs 50-100%) + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
 
 
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 


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TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.2 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
(N=xx)
(N=xx)
 
       Measured SALT Score at week XX 
           N                                                                    #                # 
           Mean(STD)                                                            xx.x(xx.xx)      xx.x(xx.xx) 
           Median                                                               xx.x             xx.x 
          (Q1,Q3)                                                               (xx.x, xx.x)     (xx.x, xx.x) 
          (Min,Max)                                                             xx.x, xx.x)     (xx.x, xx.x) 
 
       Results from MMRM [1] 
            LS Mean(SE)                                                         x.xx(x.xxx)      x.xx(x.xxx) 
            95% CI of the LS Mean                                               (x.xxx, x.xx)    (x.xxx, x.xx) 
            Within-group P-value                                                0.xxx            0.xxx 
  
       INCB018424 - Placebo 
            LS Mean Difference(SE)                                              x.xx(x.xxx)      
            95% CI of the LS Mean Difference                                   (x.xxx, x.xx)     
            Between-group P-value                                               0.xxx            
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBITT.LST                                           DATE(TIME): 18AUG15(13:51)  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Stratification factor (baseline 
scalp involvement, 25-<50% vs 50-100%) + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.2 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
______________________________________________________________________________________________________________________ 
       Change in SALT Score from Baseline at week XX 
           N                                                                    #                # 
           Mean(STD)                                                            xx.x(xx.xx)      xx.x(xx.xx) 
           Median                                                               xx.x             xx.x 
          (Q1,Q3)                                                               (xx.x, xx.x)     (xx.x, xx.x) 
          (Min,Max)                                                             (xx.x, xx.x)     (xx.x, xx.x) 
 
 
       Results from MMRM [1] 
            LS Mean(SE)                                                         x.xx(x.xxx)      x.xx(x.xxx) 
            95% CI of the LS Mean                                               (x.xxx, x.xx)    (x.xxx, x.xx) 
            Within-group P-value                                                0.xxx            0.xxx 
  
       INCB018424 - Placebo 
            LS Mean Difference(SE)                                              x.xx(x.xxx)      
            95% CI of the LS Mean Difference                                   (x.xxx, x.xx)     
            Between-group P-value                                               0.xxx            
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBITT.LST                                           DATE(TIME): 18AUG15(13:51)  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Stratification factor 
    (baseline scalp involvement, 25-<50% vs 50-100%) + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.2 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         Treatment Group 
                                                                                _________________________________ 
       Variable                                                                 INCB018424       Placebo 
______________________________________________________________________________________________________________________ 
       Percentage change in SALT Score from Baseline at week XX 
  
           N                                                                    #                # 
           Mean(STD)                                                            xx.x(xx.xx)      xx.x(xx.xx) 
           Median                                                               xx.x             xx.x 
          (Q1,Q3)                                                               xx.x, xx.x)     (xx.x, xx.x) 
          (Min,Max)                                                             xx.x, xx.x)     (xx.x, xx.x) 
 
 
       Results from MMRM [1] 
            LS Mean(SE)                                                         x.xx(x.xxx)      x.xx(x.xxx) 
            95% CI of the LS Mean                                               (x.xxx, x.xx)    (x.xxx, x.xx) 
            Within-group P-value                                                0.xxx            0.xxx 
  
       INCB018424 - Placebo 
            LS Mean Difference(SE)                                              x.xx(x.xxx)      
            95% CI of the LS Mean Difference                                   (x.xxx, x.xx)     
            Between-group P-value                                               0.xxx            
 _____________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBITT.LST                                           DATE(TIME): 18AUG15(13:51)  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Stratification factor 
    (baseline scalp involvement, 25-<50% vs 50-100%) + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.3 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                            (Population: Part A Evaluable Subjects: Extension Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                     Treatment Group 
                                                                                _________________________________ 
       Variable                                                                         INCB018424        
________________________________________________________________________________    ____(N=xx)_______________________ 
Measured SALT Score at Baseline 
       N                                                                                #                 
       Mean(STD)                                                                 
 xx.x(xx.xx)       
       Median                                                                    
 xx.x              
      (Q1,Q3)                                                                          (xx.x, xx.x)      
      (Min,Max)                                                                        (xx.x, xx.x)      
 
 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum;  
 
Reference: Listing 2.6.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.3 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                            (Population: Part A Evaluable Subjects: Extension Period) 
______________________________________________________________________________________________________________________ 
                                                                                     Treatment Group 
                                                                                _________________________________ 
       Variable                                                                         INCB018424        
    
(N=xx)
 
Measured SALT Score at Week xx 
       N                                                                                #                 
       Mean(STD)                                                                 
 xx.x(xx.xx)       
       Median                                                                    
 xx.x              
      (Q1,Q3)                                                                          (xx.x, xx.x)      
      (Min,Max)                                                                        (xx.x, xx.x)      
 
Change in SALT Score from Baseline at week XX 
       N                                                                                #                 
       Mean(STD)                                                                 
 xx.x(xx.xx)       
       Median                                                                    
 xx.x              
      (Q1,Q3)                                                                          (xx.x, xx.x)      
      (Min,Max)                                                                        (xx.x, xx.x) 
 
Percentage change in SALT Score from Baseline at week XX 
       N                                                                                #                 
       Mean(STD)                                                                 
 xx.x(xx.xx)       
       Median                                                                    
 xx.x              
      (Q1,Q3)                                                                          (xx.x, xx.x)      
      (Min,Max)                                                                        (xx.x, xx.x) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSAEXT.LST                                           DATE(TIME): 18AUG15(13:51)  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.4 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                            (Population: Part B Evaluable Subjects: Extension Period) 
 ______________________________________________________________________________________________________________________ 
                                                                                      Treatment Group 
                                                                             ________________________________ 
                                                                                        Placebo to  
                                                                           INCB018424   INCB018424     Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
Measured SALT Score at Baseline 
       N                                                                  #             #            # 
       Mean(STD)                                                          xx.x(xx.xx)   xx.x(xx.xx)  xx.x(xx.xx) 
       Median                                                             xx.x          xx.x  
 xx.x    
      (Q1,Q3)                                                            (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x) 
      (Min,Max)                                                          (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x)    
  
____________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum;  
 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.1.4 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                            (Population: Part B Evaluable Subjects: Extension Period) 
 ______________________________________________________________________________________________________________________ 
                                                                                      Treatment Group 
                                                                             ________________________________ 
                                                                                        Placebo to  
                                                                           INCB018424   INCB018424     Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
Measured SALT Score at Week xx 
       N                                                                  #             #            # 
       Mean(STD)                                                          xx.x(xx.xx)   xx.x(xx.xx)  xx.x(xx.xx) 
       Median                                                             xx.x          xx.x  
 xx.x    
      (Q1,Q3)                                                            (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x) 
      (Min,Max)                                                          (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x)    
  
Change in SALT Score from Baseline at week XX 
       N                                                                  #             #            # 
       Mean(STD)                                                          xx.x(xx.xx)   xx.x(xx.xx)  xx.x(xx.xx) 
       Median                                                             xx.x          xx.x  
 xx.x    
      (Q1,Q3)                                                            (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x) 
      (Min,Max)                                                          (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x)    
 
Percentage change in SALT Score from Baseline at week XX 
      
       N                                                                  #             #            # 
       Mean(STD)                                                          xx.x(xx.xx)   xx.x(xx.xx)  xx.x(xx.xx) 
       Median                                                             xx.x          xx.x  
 xx.x    
      (Q1,Q3)                                                            (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x) 
      (Min,Max)                                                          (xx.x, xx.x)  (xx.x, xx.x) (xx.x, xx.x)    
 ...____________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum;  
Reference: Listing 2.6.1 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 


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                                                   Table 2.2.2.1 
              Summary and Analysis of SALT Score from Baseline to Week 24 by Baseline Scalp Involvement 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.2.1.1 with appropriate treatment groups for each baseline scalp 
 involvement sub-group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLP2A.LST                                          DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
Abbreviations: Q1 =; Q2 =; STD = Standard deviation; SE = Standard error; Max = Maximum; Min = Minimum. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.2.2 
              Summary and Analysis of SALT Score from Baseline to Week 24 by Baseline Scalp Involvement 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.2.1.2 with appropriate treatment groups for each baseline scalp 
 involvement sub-group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLP2BITT.LST                                       DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.2.3 
                      Summary and Analysis of SALT Score by Visit and Baseline Scalp Involvement 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.2.1.1 with appropriate treatment groups for each baseline scalp 
 involvement group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLP2AEXT.LST                                       DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
Abbreviations: Q1 =; Q2 =; STD = Standard deviation; SE = Standard error; Max = Maximum; Min = Minimum. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.2.2.4 
                      Summary and Analysis of SALT Score by Visit and Baseline Scalp Involvement 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.2.1.1 with appropriate treatment groups for each baseline scalp 
 involvement group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLP2BEXT.LST                                       DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 2.2.3 
                             Summary and Analysis of SALT Score from Baseline to Week 24 
  
                                 (Population: Part B Per-Protocol Subjects) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.2.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTVSBPP.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
               Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Stratification facto 
    (baseline scalp involvement, 25-<50% vs 50-100%) + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 2.2.4 
              Summary and Analysis of SALT Score from Baseline to Week 24 by Baseline Scalp Involvement 
  
                                 (Population: Part B Per-Protocol Subjects) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.2.1.2 with appropriate treatment groups for each baseline scalp 
 involvement sub-group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTBSCLP2BPP.LST                                        DATE(TIME): 18AUG15(13:51) 
  
Abbreviations: CI = confidence interval; LSMean = least squares mean; STD = standard deviation; SE = standard error; 
Max = maximum; Min = minimum; MMRM = Mixed-Model with Repeated Measures 
[1] MMRM model for post-baseline measures: [Response Variable = Baseline + Treatment + Visit + Treatment*Visit]. 
Note: Only Subjects with non-missing baseline value and at least one non-missing post-baseline value of the response 
      variable were included in summary and analysis. 
Reference: Listing 2.6.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.3.1.1 
           Summary of Subjects Achieving Complete Clinical Response in SALT Score from Baseline to Week 24 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
______________________________________________________________________________________________________________________ 
                 Number (%) of Evaluable Subjects [1]                                     ## (###.#) 
  
                 Week 8 
  
                 Subjects Achieving Complete Clinical Response N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
 
                 Week XX 
  
                 Subjects Achieving Complete Clinical Response N (%)[2] 
                      Yes                                                                 ## (##.#) 
                      No                                                                  ## (##.#) 
 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CCRESPA.LST                                              DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Complete Clinical Response is defined as 100% terminal hair regrowth and no evidence of active hair loss at 
    2 consecutive visits 
 
Reference: Listing 2.6.2 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.3.1.2 
           Summary of Subjects Achieving Complete Clinical Response in SALT Score from Baseline to Week 24 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                                           
    Variable                                                                 INCB018424   Placebo     Total 
______________________________________________________________________________________________________________________ 
    Number (%) of Evaluable Subjects [1]                                     ## (###.#)   ## (###.#)   ## (###.#) 
  
    Week 8 
  
    Subjects Achieving Complete Clinical Response N (%)[2] 
         Yes                                                                 ## (##.#)    ## (##.#)    ## (##.#) 
         No                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
         INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #. #.#) 
         P-value                                                             0.##         
  
    Week XX 
  
    Subjects Achieving Complete Clinical Response N (%)[2] 
         Yes                                                                 ## (##.#)    ## (##.#)    ## (##.#) 
         No                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
         INCB018424/Placebo Odds Ratio (95% CI) [3]                          #.#(#.##, #. #.#) 
         P-value                                                             0.##          
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CCRESPBITT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Complete Clinical Response is defined as 100% terminal hair regrowth and no evidence of active hair loss at 
    2 consecutive visits 
[3] Logistic regression model including treatment, stratification factor (baseline scalp involvement, 25-<50% 
    vs 50-100%), and baseline SALT score. 
Reference: Listing 2.6.2 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.3.2.1 
Summary of Subjects Achieving Complete Clinical Response in SALT Score from Baseline to Week 24 by Baseline Scalp 
Involvement 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ---------------------------------------- Baseline Scalp Involvement 25% to <50% --------------------------------------- 
  
                _______________________________________________________________________________________ 
                                                                                       INCB018424 
                                                                                       ________________ 
                Variable                                                               All Subjects 
                _______________________________________________________________________________________ 
                Number (%) of Evaluable Subjects [1]                                   ## (###.#) 
  
                Week 4 
  
                Subjects Achieving Complete Clinical Response N (%)[2] 
                     Yes                                                               ## (##.#) 
                     No                                                                ## (##.#) 
 
                Week XX 
  
                Subjects Achieving Complete Clinical Response N (%)[2] 
                     Yes                                                               ## (##.#) 
                     No                                                                ## (##.#) 
 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CCRESPBSA.LST                                            DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Complete Clinical Response is defined as 100% terminal hair regrowth and no evidence of active hair loss at 
    2 consecutive visits 
 
Reference: Listing 2.6.2 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.3.2.1 
Summary of Subjects Achieving Complete Clinical Response in SALT Score from Baseline to Week 24 by Baseline Scalp 
Involvement 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 --------------------------------------- Baseline Scalp Involvement 50% to 100% ---------------------------------------- 
 ______________________________________________________________________________________________________________________ 
                                                                                       INCB018424 
                                                                                       ________________ 
                Variable                                                               All Subjects 
 ______________________________________________________________________________________________________________________ 
                Number (%) of Evaluable Subjects [1]                                   ## (###.#) 
  
                Week 4 
  
                Subjects Achieving Complete Clinical Response N (%)[2] 
                     Yes                                                               ## (##.#) 
                     No                                                                ## (##.#) 
 
                Week XX 
  
                Subjects Achieving Complete Clinical Response N (%)[2] 
                     Yes                                                               ## (##.#) 
                     No                                                                ## (##.#) 
 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CCRESPBSA.LST                                            DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Complete Clinical Response is defined as 100% terminal hair regrowth and no evidence of active hair loss at 
    2 consecutive visits 
Reference: Listing 2.6.2 
 
 
 
 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
 


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                                                   Table 2.3.2.2 
Summary of Subjects Achieving Complete Clinical Response in SALT Score from Baseline to Week 24 by Baseline Scalp 
Involvement 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.3.3.1/2.1.1.2(without reasons) with appropriate treatment 
 groups for each baseline scalp Involvement group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_CCRESPBSBITT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Complete Clinical Response is defined as 100% terminal hair regrowth and no evidence of active hair loss at 
    2 consecutive visits 
[3] Logistic regression model including treatment, stratification factor (baseline scalp involvement, 25-<50% 
    vs 50-100%), and baseline SALT score. 
Reference: Listing 2.6.2 
 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.5.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Duration of Current 
Episode 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.1.1 for each Duration of Current Episode Group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTDURA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Number of subjects who have ever achieved SALT50 or SALT90 at any visit in the Part A Treatment Period. 
Reference: Listing 2.6.1 
  


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.5.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Duration of Current 
Episode 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.1.2 for each Duration of Current Episode Group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTDURBITT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study before the assessed visit for any reason are considered as not having 
achieved the >= 50% or >= 90% reduction in SALT score. 
[3] Logistic regression model including treatment, stratification factor (baseline scalp involvement, 25-<50% vs 
    50-100%), and baseline SALT score. 
Reference: Listing 2.6.1 
  


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.6.1 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Pattern of Hair Loss 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.1.1 for each Pattern of Scalp Hair Loss 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTHRLSA.LST                                            DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Number of subjects who have ever achieved SALT50 or SALT90 at any visit in the Part A Treatment Period. 
Reference: Listing 2.6.1 
  


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 2.1.6.2 
Summary of Subjects Achieving >= 50% and >= 90% Reduction from Baseline in SALT Score to Week 24 by Pattern of Hair Loss 
  
                      (Population: Part B Intent-to-Treat Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 2.1.1.2 for each Pattern of Scalp Hair Loss 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SALTHRLSBITT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
[1] A subject was not evaluable if the subject had a missing score at baseline. 
[2] Subjects who discontinued from the study before the assessed visit for any reason are considered as not having 
achieved the >= 50% or >= 90% reduction in SALT score. 
[3] Logistic regression model including treatment, stratification factor (baseline scalp involvement, 25-<50% vs 
50-100%), and baseline SALT score. 
 
 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 3.1.1 
                                     Summary of Exposure and Duration of Exposure 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                                                                                         ____________ 
                  Variable                                                               All Subjects 
                                                                                         (N=##) 
______________________________________________________________________________________________________________________ 
                  Duration of Treatment (days)  
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.# 
  
                  Average Daily Dose (g/day)  
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.# 
  
                  Total Dose of INCB018424 
                    N                                                                    ## 
                    Mean                                                                 ##.## 
                    STD                                                                  ##.### 
                    Min                                                                  ##.# 
                    Median                                                               ##.## 
                    Max                                                                  ##.#  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EXPA.LST                                                 DATE(TIME): 18AUG15(13:51)  
Reference: Listing 2.7.1 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 3.1.2 
                                     Summary of Exposure and Duration of Exposure 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                 Treatment Group 
                                                                            _________________________ 
                                                                            INCB018424   Placebo      Total 
     Variable                                                               (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
     Duration of Treatment (days)  
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.##        ##.##        ##.## 
       STD                                                                  ##.###       ##.###       ##.### 
       Min                                                                  ##.#         ##.#         ##.# 
       Median                                                               ##.##        ##.##        ##.## 
       Max                                                                  ##.#         ##.#         ##.# 
  
     Average Daily Dose (g/day)  
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.##        ##.##        ##.## 
       STD                                                                  ##.###       ##.###       ##.### 
       Min                                                                  ##.#         ##.#         ##.# 
       Median                                                               ##.##        ##.##        ##.## 
       Max                                                                  ##.#         ##.#         ##.# 
  
     Total Dose  
       N                                                                    ##           ##           ## 
       Mean                                                                 ##.##        ##.##        ##.## 
       STD                                                                  ##.###       ##.###       ##.### 
       Min                                                                  ##.#         ##.#         ##.# 
       Median                                                               ##.##        ##.##        ##.## 
       Max                                                                  ##.#         ##.#         ##.#  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EXPBSAF.LST                                              DATE(TIME): 18AUG15(13:51) 
 Reference: Listing 2.7.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 3.1.3 
                                     Summary of Exposure and Duration of Exposure 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.1.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EXPAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.1 


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PROTOCOL: INCB 018424-204                                                                              (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 3.1.4 
                                     Summary of Exposure and Duration of Exposure 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for 3.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EXPBEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.1 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.1.1 
                                 Overall Summary of Treatment-Emergent Adverse Events 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                          INCB018424 
                                                                                          ____________ 
                 Variable                                                                 All Subjects 
______________________________________________________________________________________________________________________ 
                 Treatment-Emergent Adverse Events Reported                               #### 
  
                 Subjects Who Had any Treatment-Emergent Adverse Event                    ## (##.#) 
                 Subjects Who Had any Treatment-Related TEAEs                             ## (##.#) 
                 Subjects Who Had any Serious Adverse Event                               ## (##.#) 
                 Subjects Who Had Adverse Events of Grade 3 or 4 TEAE                     ## (##.#) 
                 Subjects Who Had any Severe TEAEs                                        ## (##.#) 
                 Subjects Who Had a Fatal Adverse Event                                   ## (##.#) 
                 Subjects Who Had TEAEs Leading to Discontinuation of Study Drug          ## (##.#) 
                 
                 Additional Customized Category 1                                         ## (##.#) 
                 Additional Customized Category 2                                         ## (##.#) 
                 ..........                                                               ## (##.#) 
                 ..........                                                               ## (##.#) 
  
______________________________________________________________________________________________________________________ 
 
Abbreviation: TEAE = Treatment-Emergent Adverse Event. 
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESUMA.LST                                               DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.7.2 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.1.2 
                                 Overall Summary of Treatment-Emergent Adverse Events 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                  Treatment Group 
                                                                             _________________________ 
                                                                             INCB018424   Placebo      Total 
    Variable                                                                 (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
    Treatment-Emergent Adverse Events Reported                              ####         ####         #### 
  
    Subjects Who Had any Treatment-Emergent Adverse Event                   ## (##.#)    ## (##.#)    ## (##.#) 
    Subjects Who Had any Treatment-Related TEAEs                            ## (##.#)    ## (##.#)    ## (##.#) 
    Subjects Who Had any Serious Adverse Event                              ## (##.#)    ## (##.#)    ## (##.#) 
    Subjects Who Had Adverse Events of Grade 3 or 4 TEAE                    ## (##.#)    ## (##.#)    ## (##.#) 
    Subjects Who Had any Severe TEAEs                                       ## (##.#)    ## (##.#)    ## (##.#) 
    Subjects Who Had a Fatal Adverse Event                                  ## (##.#)    ## (##.#)    ## (##.#) 
    Subjects Who Had TEAEs Leading to Discontinuation of Study Drug         ## (##.#)    ## (##.#)    ## (##.#)     
    
    Additional Customized Category 1                                      
    Additional Customized Category 2                                        ## (##.#)    ## (##.#)    ## (##.#) 
    ..........                                                              ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESUMBSAF.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.1.3 
                                 Overall Summary of Treatment-Emergent Adverse Events 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.1.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESUMAEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.1.4 
                                 Overall Summary of Treatment-Emergent Adverse Events 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESUMBEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.2.1 
             Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                  MedDRA System Organ Class/                                             ____________ 
                    MedDRA Preferred Term                                                All Subjects 
______________________________________________________________________________________________________________________ 
                  Number (%) of Subjects With Any Adverse Events                         ## (##.#) 
  
                  System Organ Class 1 
                    Preferred Term 1                                                     ## (##.#) 
                    Preferred Term 2                                                     ## (##.#) 
                    Preferred Term 3                                                     ## (##.#) 
                    ...                                                                  ## (##.#) 
                    ...                                                                  ## (##.#) 
  
                  System Organ Class 2 
                    Preferred Term 1                                                     ## (##.#) 
                    Preferred Term 2                                                     ## (##.#) 
                    Preferred Term 3                                                     ## (##.#) 
                    ...                                                                  ## (##.#) 
                    ...                                                                  ## (##.#) 
  
                  System Organ Class ... 
                    Preferred Term 1                                                     ## (##.#) 
                    Preferred Term 2                                                     ## (##.#) 
                    Preferred Term 3                                                     ## (##.#) 
                    ...                                                                  ## (##.#) 
                    ...                                                                  ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESOCPTA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.2.2 
             Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                 Treatment Group 
                                                                            _________________________ 
     MedDRA System Organ Class/                                             INCB018424   Placebo      Total 
       MedDRA Preferred Term                                                (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
     Number (%) of Subjects With Any Adverse Events                         ## (##.#)    ## (##.#)    ## (##.#) 
  
     System Organ Class 1 
       Preferred Term 1                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Preferred Term 2                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Preferred Term 3                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       ...                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
       ...                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
  
     System Organ Class 2 
       Preferred Term 1                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Preferred Term 2                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Preferred Term 3                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       ...                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
       ...                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
  
     System Organ Class ... 
       Preferred Term 1                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Preferred Term 2                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       Preferred Term 3                                                     ## (##.#)    ## (##.#)    ## (##.#) 
       ...                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
       ...                                                                  ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESOCPTBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.2.3 
             Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.2.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESOCPTAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.2.4 
             Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.2.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESOCPTBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.3.1 
        Summary of Treatment-Emergent Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                         INCB018424 
                                                                                         ____________ 
                  MedDRA Preferred Term                                                  All Subjects 
______________________________________________________________________________________________________________________ 
                  Number (%) of Subjects With Any Adverse Events                         ## (##.#) 
  
                  Preferred Term 1                                                       ## (##.#) 
                  Preferred Term 2                                                       ## (##.#) 
                  Preferred Term 3                                                       ## (##.#) 
                  ...                                                                    ## (##.#) 
                  ...                                                                    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEPTDA.LST                                               DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.3.2 
        Summary of Treatment-Emergent Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                 Treatment Group 
                                                                            _________________________ 
                                                                            INCB018424   Placebo      Total 
     MedDRA Preferred Term                                                  (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________ 
     Number (%) of Subjects With Any Adverse Events                         ## (##.#)    ## (##.#)    ## (##.#) 
  
     Preferred Term 1                                                       ## (##.#)    ## (##.#)    ## (##.#) 
     Preferred Term 2                                                       ## (##.#)    ## (##.#)    ## (##.#) 
     Preferred Term 3                                                       ## (##.#)    ## (##.#)    ## (##.#) 
     ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
     ...                                                                    ## (##.#)    ## (##.#)    ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEPTDBSAF.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.3.3 
        Summary of Treatment-Emergent Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table Table 3.2.3.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEPTDAEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.3.4 
        Summary of Treatment-Emergent Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.3.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEPTDBEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.4.1 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                INCB018424 
                                                                                  (N=##) 
       MedDRA System Organ Class/                         ______________________________________________________ 
         MedDRA Preferred Term                            Grade 1    Grade 2    Grade 3    Grade 4    Any 
______________________________________________________________________________________________________________________ 
       Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 1 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 2 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class ... 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  
______________________________________________________________________________________________________________________ 
Note: Maximum Severity was determined from the first dose of INCB018424 cream.  
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEMXSVA.LST                                              DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.4.2 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 --------------------------------------------- Treatment Group=INCB018424 --------------------------------------------- 
  
       _________________________________________________________________________________________________________ 
                                                                              Toxicity Grade 
       MedDRA System Organ Class/                         ______________________________________________________ 
         MedDRA Preferred Term                            Grade 1    Grade 2    Grade 3    Grade 4    Any 
       _________________________________________________________________________________________________________ 
       Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 1 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 2 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class ... 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
________________________________________________________________________________________________________________ 
Note: Maximum Severity was determined from the first dose of INCB018424 cream or Placebo in Treatment Period.  
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEMXSVBSAF.LST                                           DATE(TIME): 18AUG15(13:51) 
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.4.2 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ---------------------------------------------- Treatment Group=Placebo ----------------------------------------------- 
 ______________________________________________________________________________________________________________________ 
                                                                              Toxicity Grade 
       MedDRA System Organ Class/                         ______________________________________________________ 
         MedDRA Preferred Term                            Grade 1    Grade 2    Grade 3    Grade 4    Any 
 ______________________________________________________________________________________________________________________ 
       Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 1 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 2 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class ... 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
______________________________________________________________________________________________________________________ 
Note: Maximum Severity was determined from the first dose of INCB018424 cream or Placebo in Treatment Period.  
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEMXSVBSAF.LST                                           DATE(TIME): 18AUG15(13:51)  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.4.2 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ----------------------------------------------- Treatment Group=Total ------------------------------------------------ 
 ______________________________________________________________________________________________________________________ 
                                                                              Toxicity Grade 
       MedDRA System Organ Class/                         ______________________________________________________ 
         MedDRA Preferred Term                            Grade 1    Grade 2    Grade 3    Grade 4    Any 
 ______________________________________________________________________________________________________________________ 
       Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 1 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class 2 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
  
       System Organ Class ... 
         Preferred Term 1                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 2                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         Preferred Term 3                                 ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
         ...                                              ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#)  ## (##.#) 
______________________________________________________________________________________________________________________ 
Note: Maximum Severity was determined from the first dose of INCB018424 cream or Placebo in Treatment Period.  
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEMXSVBSAF.LST                                           DATE(TIME): 18AUG15(13:51)  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.4.3 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
Note: Maximum Severity was determined from the first dose of INCB018424 cream in Treatment Period.  
 
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEMXSVAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 141 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.4.4 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
Note: Maximum Severity was determined from the first dose of INCB018424 cream in Treatment Period, or in Extension 
Period for subjects who cross over to INCB018424.  
 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEMXSVBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 142 of 277 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.5.1 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
______________________________________________________________________________________________________________________ 
                                                                                INCB018424 
                                                                                  (N=##) 
                        MedDRA System Organ Class/                         _____________________ 
                          MedDRA Preferred Term                            Grades 1-2 Grade 3-4 
______________________________________________________________________________________________________________________ 
                        Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#) 
  
                        System Organ Class 1 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class 2 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class ... 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGPA.LST                                             DATE(TIME): 18AUG15(13:51) 
 Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.5.2 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 --------------------------------------------- Treatment Group=INCB018424 --------------------------------------------- 
  
                        ________________________________________________________________________ 
                                                                              Toxicity Grade 
                        MedDRA System Organ Class/                         _____________________ 
                          MedDRA Preferred Term                            Grades 1-2 Grades 3-4 
                        ________________________________________________________________________ 
                        Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#) 
  
                        System Organ Class 1 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class 2 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class ... 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGPBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
 Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.5.2 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ---------------------------------------------- Treatment Group=Placebo ----------------------------------------------- 
 ______________________________________________________________________________________________________________________ 
                                                                              Toxicity Grade 
                        MedDRA System Organ Class/                         _____________________ 
                          MedDRA Preferred Term                            Grades 1-2 Grades 3-4 
 ______________________________________________________________________________________________________________________ 
                        Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#) 
  
                        System Organ Class 1 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class 2 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class ... 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGPBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.5.2 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ----------------------------------------------- Treatment Group=Total ------------------------------------------------ 
 ______________________________________________________________________________________________________________________ 
                                                                              Toxicity Grade 
                        MedDRA System Organ Class/                         _____________________ 
                          MedDRA Preferred Term                            Grades 1-2 Grades 3-4 
 ______________________________________________________________________________________________________________________ 
                        Number (%) of Subjects With Any Adverse Events     ## (##.#)  ## (##.#) 
  
                        System Organ Class 1 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class 2 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
  
                        System Organ Class ... 
                          Preferred Term 1                                 ## (##.#)  ## (##.#) 
                          Preferred Term 2                                 ## (##.#)  ## (##.#) 
                          Preferred Term 3                                 ## (##.#)  ## (##.#) 
                          ...                                              ## (##.#)  ## (##.#) 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGPBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.5.3 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.5.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGPAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.2.5.4 
   Summary of Treatment-Emergent Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.5.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGPBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.6.1 
             Summary of Treatment-Related Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.2.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.6.2 
             Summary of Treatment-Related Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                           (Population: Part B Safety Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.2.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.6.3 
             Summary of Treatment-Related Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.2.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.6.4 
             Summary of Treatment-Related Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.2.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.7.1 
        Summary of Treatment-Related Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.3.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLPTDA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.7.2 
        Summary of Treatment-Related Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.3.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLPTDBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
Page 154 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.7.3 
        Summary of Treatment-Related Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.3.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLPTDAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 155 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.7.4 
        Summary of Treatment-Related Adverse Events By MedDRA Preferred Term in Decreasing Order of Frequency 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.3.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLPTDBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 156 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.8.1 
    Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLMXSVA.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 157 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.8.2 
    Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLMXSVBSAF.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
Page 158 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.8.3 
    Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLMXSVAEXT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 159 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.8.4 
    Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and Maximum Severity 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERLMXSVBEXT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.9.1 
   Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.5.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGDA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 161 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.9.2 
   Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.5.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGDBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
Page 162 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.9.3 
   Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.5.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGDAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
Page 163 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.9.4 
   Summary of Treatment-Related Adverse Events By MedDRA System Organ Class, Preferred Term, and CTCAE Grade Group 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.5.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECTCGDBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
Page 164 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.10.1 
    Summary of Treatment-Emergent Adverse Events Leading to Death By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEFATALA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.6 


Incyte Corporation 
Page 165 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.10.2 
    Summary of Treatment-Emergent Adverse Events Leading to Death By MedDRA System Organ Class and Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEFATALBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.6 
 


Incyte Corporation 
Page 166 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.10.3 
    Summary of Treatment-Emergent Adverse Events Leading to Death By MedDRA System Organ Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEFATALAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.6


Incyte Corporation 
Page 167 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.10.4 
    Summary of Treatment-Emergent Adverse Events Leading to Death By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEFATALBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.6 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.11.1 
         Summary of Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESERA.LST                                               DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.11.2 
         Summary of Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESERBSAF.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.11.3 
         Summary of Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESERAEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.11.4 
         Summary of Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AESERBEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.12.1 
       Summary of Non-Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AENSERA.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.12.2 
       Summary of Non-Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AENSERBSAF.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.12.3 
       Summary of Non-Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AENSERAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.12.4 
       Summary of Non-Serious Treatment-Emergent Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AENSERBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.13.1 
         Summary of Treatment-Related Serious Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERSERA.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.13.2 
         Summary of Treatment-Related Serious Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERSERBSAF.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.13.3 
         Summary of Treatment-Related Serious Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERSERAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.13.4 
         Summary of Treatment-Related Serious Adverse Events By MedDRA System Organ Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AERSERBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.5 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.14.1 
Summary of Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Drug By MedDRA System Organ 
Class and Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEWDRWLA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.4 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.14.2 
Summary of Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Drug By MedDRA System Organ 
Class and Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEWDRWLBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.4 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.14.3 
Summary of Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Drug By MedDRA System Organ 
Class and Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEWDRWLAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.4


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.14.4 
Summary of Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Drug By MedDRA System Organ 
Class and Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEWDRWLBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.4 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.15.1 
Summary of Treatment-Emergent Adverse Events Leading to Interruption of Drug By MedDRA System Organ Class and Preferred 
Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEDSINTA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.15.2 
Summary of Treatment-Emergent Adverse Events Leading to Interruption of Drug By MedDRA System Organ Class and Preferred 
Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEDSINTBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.15.3 
Summary of Treatment-Emergent Adverse Events Leading to Interruption of Drug By MedDRA System Organ Class and Preferred 
Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEDSINTAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.15.4 
Summary of Treatment-Emergent Adverse Events Leading to Interruption of Drug By MedDRA System Organ Class and Preferred 
Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AEDSINTBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.16.1 
Summary of Treatment-Emergent Adverse Events Requiring Concomitant Medications By MedDRA System Organ Class and 
Preferred Term 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECNMEDA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.16.2 
Summary of Treatment-Emergent Adverse Events Requiring Concomitant Medications By MedDRA System Organ Class and 
Preferred Term 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECNMEDBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.16.3 
Summary of Treatment-Emergent Adverse Events Requiring Concomitant Medications By MedDRA System Organ Class and 
Preferred Term 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.1 with appropriate treatment group 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECNMEDAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                  Table 3.2.16.4 
Summary of Treatment-Emergent Adverse Events Requiring Concomitant Medications By MedDRA System Organ Class and 
Preferred Term 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.2.4.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_AECNMEDBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.7.2 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.1.1 
                                      Summary of Laboratory Values - Hematology 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 Laboratory Test (unit) : Test Name (unit) 
  
   __________________________________________________________________________________________________________________ 
                                                        Descriptive Summary                 N (%) of Subjects 
   Treatment    Study                           ____________________________________ ________________________________ 
   Group      Visit                             N     Mean  STD   Min   Median Max   Low        Normal     High 
   __________________________________________________________________________________________________________________ 
   INCB018424   Baseline          Baseline      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
  
                Week 4 Day...     Measured      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
                                  Change        ##    ##.#  #.##  ##    ##.#   ## 
                                  % Change      ##    ##.#  #.##  ##    ##.#   ## 
  
                Week... Day...    Measured      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
                                  Change        ##    ##.#  #.##  ##    ##.#   ## 
                                  % Change      ##    ##.#  #.##  ##    ##.#   ## 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHA.LST                                                 DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
Page 193 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.1.2 
                                      Summary of Laboratory Values - Hematology 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 Laboratory Test (unit) : Test Name (unit) 
  
   __________________________________________________________________________________________________________________ 
                                                        Descriptive Summary                 N (%) of Subjects 
   Treatment    Study                           ____________________________________ ________________________________ 
   Group      Visit                             N     Mean  STD   Min   Median Max   Low        Normal     High 
   __________________________________________________________________________________________________________________ 
   INCB018424   Baseline          Baseline      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
  
                Week 4 Day...     Measured      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
                                  Change        ##    ##.#  #.##  ##    ##.#   ## 
                                  % Change      ##    ##.#  #.##  ##    ##.#   ## 
  
                Week... Day...    Measured      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
                                  Change        ##    ##.#  #.##  ##    ##.#   ## 
                                  % Change      ##    ##.#  #.##  ##    ##.#   ## 
   Placebo      Baseline          Baseline      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
  
                Week 4 Day...     Measured      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
                                  Change        ##    ##.#  #.##  ##    ##.#   ## 
                                  % Change      ##    ##.#  #.##  ##    ##.#   ## 
  
                Week... Day...    Measured      ##    ##.#  #.##  ##    ##.#   ##    ## (##.#)  ## (##.#)  ## (##.#) 
                                  Change        ##    ##.#  #.##  ##    ##.#   ## 
                                  % Change      ##    ##.#  #.##  ##    ##.#   ## 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHBSAF.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
Page 194 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.1.3 
                                      Summary of Laboratory Values - Hematology 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
Page 195 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.1.4 
                                      Summary of Laboratory Values - Hematology 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHBEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.1.5 
                                      Summary of Laboratory Values – Free T4 and TSH 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.1.6 
                                      Summary of Laboratory Values – Free T4 and TSH 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.2.1 
                           Shift Summary of Hematology Values - To the Worst Abnormal Value 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 Laboratory Test (unit): test name (unit) 
                          ___________________________________________________________________________________________ 
                              Baseline [1]                         During the Treatment Period [2] 
                          _____________________  ____________________________________________________________________ 
   Treatment              Value    n (%)         Low           Normal        High          Low & High    Missing 
  ___________________________________________________________________________________________________________________ 
  INCB018424 cream (N=#)  Low        # (##.#)    # (##.#)      # (##.#)      # (##.#)      # (##.#)       # (##.#) 
                          Normal     # (##.#)    # (##.#)      # (##.#)      # (##.#)      # (##.#)       # (##.#) 
                          High       # (##.#)    # (##.#)      # (##.#)      # (##.#)      # (##.#)       # (##.#) 
                          Missing    # (##.#)    # (##.#)      # (##.#)      # (##.#)      # (##.#)       # (##.#) 
                          Total      # (##.#)    # (##.#)      # (##.#)      # (##.#)      # (##.#)       # (##.#) 
 
 [1] The baseline total was used as the denominator 
 [2] For each row, the number of subjects with given abnormality category at baseline was used as the denominator; 
     - Low        = subjects with >=1 low value but not any high values 
     - High       = subjects with >=1 high value but not any low values 
     - Normal     = subjects without any low or high values 
     - Low & High = subjects with both low and high values 
 
 ______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: T_LBSHIFT.SAS\T_LAB8.LST                                                   DATE(TIME): 15SEP15(14:29) 
 
 
Notes 1: Baseline = Last non-missing value before first dose 
      2: This table does not include data from unscheduled visits after first dose. 
      3: When there are multiple values per test*subject*visit combination, the last value was selected. 
 
Reference: Listing 2.8.2 
 
 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.2.2 
                           Shift Summary of Hematology Values - To the Worst Abnormal Value 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHSHFTBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.2.3 
                           Shift Summary of Hematology Values - To the Worst Abnormal Value 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHSHFTAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.2.4 
                           Shift Summary of Hematology Values - To the Worst Abnormal Value 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBHSHFTBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.3.1 
                                       Summary of Laboratory Values - Chemistry 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCA.LST                                                 DATE(TIME): 18AUG15(13:51) 
  
  
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.3.2 
                                       Summary of Laboratory Values - Chemistry 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCBSAF.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.3.3 
                                       Summary of Laboratory Values - Chemistry 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.3.4 
                                       Summary of Laboratory Values - Chemistry 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCBEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.9.1 
                                       Summary of Laboratory Values - Urinalysis 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCA.LST                                                 DATE(TIME): 18AUG15(13:51) 
  
  
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.9.2 
                                       Summary of Laboratory Values - Urinalysis 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCBSAF.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.3.3 
                                       Summary of Laboratory Values - Urinalysis 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.9.4 
                                       Summary of Laboratory Values - Urinalysis 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCBEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.4.1 
                           Shift Summary of Chemistry Values - To the Worst Abnormal Value 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCSHFTA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.4.2 
                           Shift Summary of Chemistry Values - To the Worst Abnormal Value 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCSHFTBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.4.3 
                           Shift Summary of Chemistry Values - To the Worst Abnormal Value 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCSHFTAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.4.4 
                           Shift Summary of Chemistry Values - To the Worst Abnormal Value 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_LBCSHFTBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.2 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.5.1 
 Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 
   _________________________________________________________________________________________________________________ 
                               Baseline[1]                          Extreme Post-Baseline Value[2] 
   Treatment            __________________________ _________________________________________________________________ 
   Group                Grade           N (%)      Grade 0    Grade 1    Grade 2    Grade 3    Grade 4    Missing 
   _________________________________________________________________________________________________________________ 
   INCB018424           Grade 0         ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
                        Grade 1         ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
                        Grade 2         ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
                        Grade 3         ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
                        Grade 4         ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
                        Missing         ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
                        Total           ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#%   ## ##.#% 
  
  
  
 
 
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH1DA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
Page 215 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.5.2 
      Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH1DBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
Page 216 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.5.3 
 Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH1DAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
Page 217 of 277 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.5.4 
 Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH1DBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.6.1 
  Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC1DA.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.6.2 
       Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC1DBSAF.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.6.3 
  Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC1DAEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.6.4 
  Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (One Directional CTC Grade) 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC1DBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
Page 222 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.7.1 
Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH2DLA.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
Page 223 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.7.2 
Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH2DLBSAF.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
Page 224 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.7.3 
Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                              (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTH2DLAEXT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.7.4 
Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFT2DLBEXT.LST                                          DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.8.1 
Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC2DHA.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.8.2 
Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC2DHBSAF.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                    Table 3.3.8.3 
         Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC2DHAEXT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.3.8.4 
Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value (Two Directional CTC Grade) 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.3.2.1 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\LBSHFTC2DHBEXT.LST                                         DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.8.1


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.1.1 
                                          Summary of Systolic Blood Pressure 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 Treatment: INCB018424 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Visit (Time Point)     Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week 4 Day ...         Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week... Day ...        Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SBPA.LST                                                 DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.1.2 
                                          Summary of Systolic Blood Pressure 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 Treatment: INCB018424 cream  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Visit (Time Point)     Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week 4 Day ...         Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week... Day ...        Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SBPBSAF.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.1.3 
                                          Summary of Systolic Blood Pressure 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SBPAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.1.4 
                                          Summary of Systolic Blood Pressure 
  
                         (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_SBPBEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.2.1 
                                         Summary of Diastolic Blood Pressure 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DBPA.LST                                                 DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.2.2 
                                         Summary of Diastolic Blood Pressure 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DBPBSAF.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.2.3 
                                         Summary of Diastolic Blood Pressure 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DBPAEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 237 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.2.4 
                                         Summary of Diastolic Blood Pressure 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_DBPBEXT.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
Page 238 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.3.1 
                                                   Summary of Pulse 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PULSA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 239 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.3.2 
                                                   Summary of Pulse 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PULSBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
Page 240 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.3.3 
                                                   Summary of Pulse 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PULSAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 241 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.3.4 
                                                   Summary of Pulse 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_PULSBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.4.1 
                                             Summary of Body Temperature 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_TEMPA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 243 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.4.2 
                                             Summary of Body Temperature 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_TEMPBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
Page 244 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.4.3 
                                             Summary of Body Temperature 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_TEMPAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 245 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.4.4 
                                             Summary of Body Temperature 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_TEMPBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
Page 246 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.5.1 
                                             Summary of Respiration Rate 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_RESPA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 247 of 277 
INCB 18424-204 Statistical Analysis Plan 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.5.2 
                                             Summary of Respiration Rate 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_RESPBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 
 


Incyte Corporation 
Page 248 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.5.3 
                                             Summary of Respiration Rate 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_RESPAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 249 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.4.5.4 
                                             Summary of Respiration Rate 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.4.1.2 with appropriate treatment groups 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_RESPBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.9.1 


Incyte Corporation 
Page 250 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.1.1 
                                     Summary of 12-Lead ECG:  PR Interval Values 
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 Treatment: INCB018424 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Visit (Time Point)     Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week 4 Day ...         Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week ... Day ...       Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGPRA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
Page 251 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.1.2 
                                      Summary of 12-Lead ECG: PR Interval Values 
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 Treatment: INCB018424/Placebo 
  
    ________________________________________________________________________________________________________________ 
                                                Descriptive Summary             Low     Normal     High      Alert 
                                        ____________________________________ _________ _________ _________ _________ 
    Visit (Time Point)     Variable     N     Mean  STD   Min   Median Max    N   %     N   %     N   %     N   % 
    ________________________________________________________________________________________________________________ 
    Baseline               Baseline     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week 4 Day ...         Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
    Week ... Day ...       Measured     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           Change       ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
                           % Change     ##    ##.#  #.##  ##    ##.#   ##    ##  ##.#  ##  ##.#  ##  ##.#  ##  ##.# 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGPRBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.1.3 
                                     Summary of 12-Lead ECG:  PR Interval Values 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGPRAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
 
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.1.4 
                                      Summary of 12-Lead ECG: PR Interval Values 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGPRBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 
  


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.2.1 
                                     Summary of 12-Lead ECG:  QRS Interval Values 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQRSA.LST                                               DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.2.2 
                                     Summary of 12-Lead ECG: QRS Interval Values 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQRSBSAF.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.2.3 
                                     Summary of 12-Lead ECG:  QRS Interval Values 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQRSAEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.2.4 
                                     Summary of 12-Lead ECG: QRS Interval Values 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQRSBEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.3.1 
                                     Summary of 12-Lead ECG:  QT Interval Values 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.3.2 
                                      Summary of 12-Lead ECG: QT Interval Values 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.3.3 
                                     Summary of 12-Lead ECG:  QT Interval Values 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.3.4 
                                      Summary of 12-Lead ECG: QT Interval Values 
  
                              (Population: Part B Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.4.1 
                                     Summary of 12-Lead ECG: QTcB Interval Values 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCBA.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.4.2 
                                     Summary of 12-Lead ECG: QTcB Interval Values 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCBBSAF.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.4.3 
                                    Summary of 12-Lead ECG:  QTcB Interval Values 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCBAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.4.4 
                                    Summary of 12-Lead ECG:  QTcB Interval Values 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCBBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.5.1 
                                     Summary of 12-Lead ECG: QTcF Interval Values 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCFA.LST                                              DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.5.2 
                                     Summary of 12-Lead ECG: QTcF Interval Values 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCFBSAF.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
Page 268 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.5.3 
                                     Summary of 12-Lead ECG: QTcF Interval Values 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCFAEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.5.4 
                                     Summary of 12-Lead ECG: QTcF Interval Values 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGQTCFBEXT.LST                                           DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.6.1 
                                     Summary of 12-Lead ECG:  RR Interval Values 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGRRA.LST                                                DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
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PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.6.2 
                                     Summary of 12-Lead ECG:  RR Interval Values 
  
                           (Population: Part B Safety Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGRRBSAF.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
Page 272 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.6.3 
                                     Summary of 12-Lead ECG:  RR Interval Values 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.1 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGRRAEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 


Incyte Corporation 
Page 273 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.6.4 
                                     Summary of 12-Lead ECG:  RR Interval Values 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.1.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_EGRRBEXT.LST                                             DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.1 
 


Incyte Corporation 
Page 274 of 277 
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PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.7.1 
                 Summary of Treatment Emergent, Clinically Significant ECG Abnormality from Baseline 
  
                              (Population: Part A Evaluable Subjects: Treatment Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.7.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ECGCSA.LST                                               DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.2 


Incyte Corporation 
Page 275 of 277 
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CONFIDENTIAL 
PROTOCOL: INCB018424-204                                                                               (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.7.2 
                 Summary of Treatment Emergent, Clinically Significant ECG Abnormality  
  
                           (Population: Part B Safety Subjects: Treatment Period) 
   
______________________________________________________________________________________________________________________ 
                                                                                 Treatment Group 
                                                                            _________________________ 
                                                                            INCB018424   Placebo      Total 
     MedDRA Preferred Term                                                  (N=##)       (N=##)       (N=##) 
______________________________________________________________________________________________________________________      
Number (%) of Subjects With a Post-Baseline ECG Evaluation                  # (##.#)     # (##.#)      # (##.#) 
  
Number (%) of Subjects With a Clin Sig Post-Baseline Abnormality            # (##.#)     # (##.#)      # (##.#) 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: T_ECGEVAL.SAS\T_ECG8.LST                                                   DATE(TIME): 27AUG15(22:45) 
 
Abbreviation: Clin Sig = Clinically Significant. 
  
Reference: Listing 2.10.2 
  
 
 
 


Incyte Corporation 
Page 276 of 277 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.7.3 
                 Summary of Treatment Emergent, Clinically Significant ECG Abnormality from Baseline 
  
                         (Population: Part A Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.7.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ECGCSAEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.2 


Incyte Corporation 
Page 277 of 277 
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CONFIDENTIAL 
 
PROTOCOL: INCB 018424-204                                                                                (Page n of N) 
DRUG/INDICATION: INCB018424 cream/Alopecia Areata                                             DATABASE VERSION: Draft 
TLF VERSION: Draft                                                                                        TASK: Draft 
                                                   Table 3.5.7.4 
                 Summary of Treatment Emergent, Clinically Significant ECG Abnormality from Baseline 
  
                              (Population: Part B Evaluable Subjects: Extension Period) 
  
 ______________________________________________________________________________________________________________________ 
  
 This table follows same shell as that for Table 3.5.7.2 
  
______________________________________________________________________________________________________________________ 
PROGRAM\OUTPUT: _MAKESHELLS.SAS\T_ECGCSBEXT.LST                                            DATE(TIME): 18AUG15(13:51) 
  
Reference: Listing 2.10.2