Clinical trial NCT03607487
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa Janus kinase (JAK) inhibitor skin disease
Sponsor: Incyte Corporation
Start date: 2018-10-15; Completion date: 2019-08-13
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.

Detailed description:

Arms: arm 1: INCB054707 at the Cohort 1 dose or placebo. arm 2: INCB054707 at the Cohort 2 dose or placebo. arm 3: INCB054707 at the Cohort 3 dose or placebo.
Interventions: intervention 1: INCB054707 intervention 2: Placebo
Intervention descriptions: intervention 1: INCB054707 tablet administered orally once daily at the protocol-defined dose. intervention 2: Placebo tablet administered orally once daily.

Protocol documents:
Prot_000.pdf: 
Incyte Corporation 
Page 1 of 67 
Protocol INCB 54707-203 Am 1 
Version 1 
09 AUG 2018 
CONFIDENTIAL 
 
Clinical Study Protocol 
 
INCB 54707-203 
A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety 
of INCB054707 in Participants With Hidradenitis Suppurativa 
 
 
 
Product: 
INCB054707 
EudraCT Number: 
2018-000827-15 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol (Version 0): 
15 MAR 2018 
Amendment (Version) 1: 
09 AUG 2018 
 
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, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted. 
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 prior 
written consent. 


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Protocol INCB 54707-203 Am 1 
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09 AUG 2018 
CONFIDENTIAL 
INVESTIGATOR'S AGREEMENT 
I have read the INCB 54707-203 Protocol Amendment 1 (Version 1 dated 09 AUG 2018) 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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CONFIDENTIAL 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY ..........................................................................................11 
2. 
INTRODUCTION ......................................................................................................15 
2.1. 
Background .................................................................................................................15 
2.1.1. 
Hidradenitis Suppurativa ............................................................................................15 
2.1.2. 
Current Treatment and Unmet Need in Hidradenitis Suppurativa .............................15 
2.1.3. 
JAK-STAT Signaling in Inflammatory Skin Disease ................................................16 
 
 
2.2. 
Study Rationale ...........................................................................................................17 
2.2.1. 
Scientific Rationale for Study Design ........................................................................17 
2.2.2. 
Justification of Dose ...................................................................................................18 
 
 
 
 
2.3.2. 
Clinical Studies ...........................................................................................................19 
2.3.3. 
Benefit Assessment .....................................................................................................21 
2.3.4. 
Benefit-Risk Conclusion .............................................................................................21 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................22 
4. 
STUDY DESIGN .......................................................................................................23 
4.1. 
Overall Design ............................................................................................................23 
4.2. 
Overall Study Duration ...............................................................................................23 
4.3. 
Study Termination ......................................................................................................24 
5. 
STUDY POPULATION .............................................................................................24 
5.1. 
Inclusion Criteria ........................................................................................................24 
5.2. 
Exclusion Criteria .......................................................................................................25 
5.3. 
Lifestyle Considerations .............................................................................................27 
5.4. 
Screen Failures ............................................................................................................27 
5.5. 
Replacement of Participants .......................................................................................27 
6. 
STUDY TREATMENT ..............................................................................................28 
6.1. 
Study Treatment Administered ...................................................................................28 
6.2. 
Preparation, Handling, and Accountability ................................................................28 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................29 


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6.4. 
Study Treatment Compliance .....................................................................................29 
6.5. 
Dose-Limiting Toxicity and Determination of Maximum Tolerated Dose 
and/or Pharmacologically Active Dose ......................................................................29 
6.5.1. 
Definition of a Dose-Limiting Toxicity ......................................................................29 
6.5.2. 
Procedures for Cohort Review and Dose Escalation ..................................................30 
6.6. 
Dose Modifications .....................................................................................................31 
6.6.1. 
Management of Dose-Limiting Toxicities or Other Urgent Situations ......................31 
6.6.2. 
Follow-Up of Dose-Limiting Toxicities .....................................................................31 
6.6.3. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study 
Drug ............................................................................................................................31 
6.7. 
Concomitant Medications and Procedures .................................................................33 
6.7.1. 
Permitted Medications and Procedures ......................................................................33 
6.7.1.1. 
Antibiotic Therapy ......................................................................................................33 
6.7.1.2. 
Analgesic Therapy ......................................................................................................33 
6.7.1.3. 
Antiseptic Therapy ......................................................................................................33 
6.7.1.4. 
Wound Care ................................................................................................................33 
6.7.2. 
Prohibited Medications and Procedures .....................................................................34 
6.7.3. 
Rescue Lesional Treatments .......................................................................................34 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................35 
7.1. 
Discontinuation of Study Treatment ...........................................................................35 
7.1.1. 
Reasons for Discontinuation .......................................................................................35 
7.1.2. 
Discontinuation Procedures ........................................................................................35 
7.2. 
Participant Withdrawal From the Study .....................................................................36 
7.3. 
Lost to Follow-Up.......................................................................................................36 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................37 
8.1. 
Administrative and General Procedures .....................................................................37 
8.1.1. 
Informed Consent Process ..........................................................................................37 
8.1.2. 
Screening Procedures ..................................................................................................38 
8.1.3. 
Interactive Web Response System Procedure ............................................................38 
8.1.4. 
Distribution of Reminder Cards ..................................................................................38 
8.1.5. 
Electronic Diary ..........................................................................................................38 
8.1.6. 
Demography and Medical History ..............................................................................39 


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8.1.6.1. 
Demographics and General Medical History .............................................................39 
8.1.6.2. 
Disease Characteristics and Treatment History ..........................................................39 
8.2. 
Efficacy Assessments .................................................................................................39 
8.2.1. 
Hurley Stages of Hidradenitis Suppurativa ................................................................39 
8.2.2. 
Hidradenitis Suppurativa Clinical Response (Abscess and Inflammatory 
Nodule Count) ............................................................................................................39 
8.2.3. 
Modified Sartorius Scale ............................................................................................40 
8.2.4. 
Need for Rescue Lesional Treatment .........................................................................40 
8.2.5. 
Hidradenitis Suppurativa Pain Numeric Rating Scale ................................................40 
8.2.6. 
Analgesic Use .............................................................................................................41 
8.2.7. 
Hidradenitis Suppurativa Patient Global Impression of Change ................................41 
8.2.8. 
Dermatology Life Quality Index ................................................................................41 
8.2.9. 
Photography of Target Lesions ...................................................................................41 
8.3. 
Safety Assessments .....................................................................................................41 
8.3.1. 
Adverse Events ...........................................................................................................41 
8.3.2. 
Physical Examinations ................................................................................................42 
8.3.3. 
Vital Signs ..................................................................................................................42 
8.3.4. 
Electrocardiograms .....................................................................................................42 
8.3.5. 
Laboratory Assessments .............................................................................................43 
8.3.5.1. 
Safety Assessments .....................................................................................................43 
8.3.5.2. 
Screening Assessments ...............................................................................................43 
8.3.5.3. 
Pregnancy Testing ......................................................................................................44 
 
 
 
 
 
 
 
 
 
 
 
 
8.6. 
Unscheduled Visits .....................................................................................................47 
8.7. 
End of Treatment and/or Early Termination ..............................................................47 
8.8. 
Safety Follow-Up ........................................................................................................48 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................48 


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9.1. 
Definition of Adverse Event .......................................................................................48 
9.2. 
Definition of Serious Adverse Event ..........................................................................49 
9.3. 
Recording an Adverse Event and/or Serious Adverse Event .....................................50 
9.4. 
Reporting of Serious Adverse Events .........................................................................52 
9.5. 
Adverse Events of Special Interest .............................................................................53 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................53 
9.7. 
Pregnancy ...................................................................................................................54 
9.8. 
Warnings and Precautions ..........................................................................................54 
9.9. 
Product Complaints ....................................................................................................54 
9.10. 
Treatment of Overdose ...............................................................................................55 
10. 
STATISTICS ..............................................................................................................55 
10.1. 
Sample Size Determination ........................................................................................55 
10.2. 
Populations for Analysis .............................................................................................55 
10.3. 
Level of Significance ..................................................................................................56 
10.4. 
Statistical Analyses .....................................................................................................56 
10.4.1. 
Safety Analyses ..........................................................................................................56 
10.4.2. 
Efficacy Analyses .......................................................................................................57 
10.4.3. 
Other Analyses ............................................................................................................57 
10.5. 
Interim Analysis ..........................................................................................................57 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................58 
11.1. 
Investigator Responsibilities .......................................................................................58 
11.2. 
Data Management .......................................................................................................59 
11.3. 
Data Privacy and Confidentiality of Study Records ...................................................60 
11.4. 
Financial Disclosure ...................................................................................................60 
11.5. 
Publication Policy .......................................................................................................61 
11.6. 
Study and Site Closure................................................................................................61 
12. 
REFERENCES ...........................................................................................................62 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS ...............................................................................64 
APPENDIX B. PROTOCOL AMENDMENT SUMMARY OF CHANGES ............................65 
 




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LIST OF ABBREVIATIONS 
The following abbreviations and special terms are used in this clinical study Protocol. 
Abbreviations and 
Special Terms 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
AN 
abscess and inflammatory nodule 
ANC 
absolute neutrophil count 
AST 
aspartate aminotransferase 
BALT 
bronchial-associated lymphoid tissue 
CFR 
Code of Federal Regulations 
Cl/F 
apparent oral dose clearance 
CRF 
case report form 
CRP 
C-reactive protein 
CTCAE 
Common Terminology Criteria for Adverse Events 
CYP 
cytochrome P450 
DLQI 
Dermatology Life Quality Index 
DLT 
Dose-Limiting Toxicity 
eCRF 
electronic case report form 
ECG 
electrocardiogram 
EDC 
electronic data capture 
EOT 
end of treatment 
EOS 
end of study 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
FU 
follow-up 
GGT 
Gamma-glutamyl transferase 
GCP 
Good Clinical Practice 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HiSCR 
Hidradenitis Suppurativa Clinical Response is defined as at least 50% reduction in 
AN count with no increase in abscess count and no increase in draining fistula 
count relative to baseline at each visit 
 
 
HIV 
human immunodeficiency virus 


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Abbreviations and 
Special Terms 
Definition 
HS 
hidradenitis suppurativa 
HS Pain NRS 
Hidradenitis Suppurativa Pain Numeric Rating Scale  
HS-PGIC 
Hidradenitis Suppurative Patient Global Impression of Change 
IB 
Investigator's Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
ID 
identification 
IEC 
independent ethics committee 
 
 
IL 
interleukin 
IPL 
intense pulsed light 
IRB 
institutional review board 
IWRS 
Interactive Web Response System 
ITT 
Intent to treat 
JAK 
Janus kinase 
MedDRA 
Medical Dictionary for Regulatory Affairs 
Nd:YAG 
Neodymium-doped yttrium aluminum garnet; Nd:Y3Al5O12 
NRS 
numeric rating scale 
PGIC 
Patient Global Impression of Change 
P-gp 
P-glycoprotein 
 
 
PK 
pharmacokinetic 
QD 
once daily 
QTcF 
QT interval corrected for heart rate using Fridericia's formula 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SOP 
standard operating procedure 
SRC 
Safety review committee 
STAT 
signal transducer and activator of transcription 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
Th 
T helper cell 
TNF-α 
tumor necrosis factor alpha 
TYK 
tyrosine kinase 


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Abbreviations and 
Special Terms 
Definition 
ULN 
upper limit of normal 
Vd/F 
apparent volume of distribution after non-intravenous administration 
WBC 
white blood cell 


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Protocol INCB 54707-203 Am 1 
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1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of 
INCB054707 in Participants With Hidradenitis Suppurativa  
Protocol Number:  INCB 54707-203 
Objectives and Endpoints: 
Table 1 presents the primary and key secondary objectives and endpoints. 
Table 1: 
Primary and Key Secondary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the safety and tolerability of 
INCB054707. 
 Frequency, duration, and severity of AEs, clinical 
laboratory test results, vital signs results, ECGs, 
and physical examination findings. 
Key Secondary 
To determine the systemic exposure to 
INCB054707. 
 Population PK parameters of INCB054707. 
To determine the efficacy of INCB054707. 
 Proportion of participants achieving a HiSCR at 
each visit. 
 Proportion of participants achieving an AN count 
of 0 to 2 at each visit. 
 Mean change from baseline in the HS Pain NRS 
scores, worst and average pain, at each visit. 
 Mean change from baseline to Week 8 in the 
modified Sartorius scale score. 
 Mean change from baseline in the number of 
draining fistulas count at each visit. 
 Proportion of participants at each category of 
Hurley Stage at baseline and Week 8. 
 Proportion of participants with change from 
baseline in Hurley Stage at Week 8. 
 Proportions of participants in each HS-PGIC 
category during the treatment period.  
 Actual measurements in HS-PGIC at each visit. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 




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Table 3: 
Schedule of Assessments 
Evaluation 
Section 
Screening 
Treatment 
Safety 
Follow-Up 
Day -28 to 
-1 
Day 1
a 
Week 1 
± 1 day 
Week 2
b 
± 3 days 
Week 4a 
± 3 days 
Week 6b 
± 3 days 
Week 8a 
± 3 days 
(EOT) 
30 days 
+ 5 days (EOS) 
Administrative/screening procedures 
Informed consent 
8.1.1 
X 
 
 
 
 
 
 
 
Demography/medical history 
8.1.6 
X 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
5 
X 
X 
 
 
 
 
 
 
Prior/concomitant medications 
6.7 
X 
X 
X 
X 
X 
X 
X 
X 
Serology 
8.3.5.2 
X 
 
 
 
 
 
 
 
Urinalysis 
8.3.5.2 
X 
 
 
 
 
 
X 
 
TB screening 
8.3.5.2 
X 
 
 
 
 
 
 
 
FSH
c 
8.3.5.2 
X 
 
 
 
 
 
 
 
Pregnancy testing
d 
8.3.5.3 
X 
X 
X 
X 
X 
X 
X 
X 
Contact IWRS 
8.1.3 
X 
X 
X 
X 
X 
X 
X 
 
Randomization to treatment arm 
8.1.3 
 
X 
 
 
 
 
 
 
Dispense study drug 
6.1 
 
X 
 
 
X 
 
 
 
Collect study drug and assess 
compliance 
6.4 
 
 
X 
X 
X 
X 
X 
 
Distribute reminder cards 
8.1.4 
X 
X 
X 
X 
X 
X 
X 
 
Electronic diary verification 
8.1.5 
 
X 
X 
X 
X 
X 
X 
X 
Safety procedures/assessments 
Comprehensive physical examination
e 
8.3.2 
X 
 
 
 
 
 
X 
 
Targeted physical examination 
8.3.2 
 
X 
X 
X 
X 
X 
 
X 
Vital signs 
8.3.3 
X 
X 
X 
X 
X 
X 
X 
X 
Hematology and chemistry assessments
f 
8.3.5.1, 8.6 
X 
X 
X 
Xf 
Xf 
Xf 
X 
X 
Lipid panel 
8.3.5.1 
 
X 
 
 
 
 
X 
 
CRP 
8.3.5.1 
 
X 
 
 
 
 
X 
 
12-lead ECG (screening)
g 
8.3.4 
X 
 
 
 
 
 
 
 
12-lead ECG (predose and postdose)g 
8.3.4 
 
X 
 
 
X 
 
 
 
12-lead ECG (predose only)g 
8.3.4 
 
 
 
 
 
 
X 
 
Assess AEs 
8.3.1, 9 
X 
X 
X 
X 
X 
X 
X 
X 


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Table 3: 
Schedule of Assessments (Continued) 
Evaluation 
Section 
Screening 
Treatment 
Safety 
Follow-Up 
Day -28 to 
-1 
Day 1a 
Week 1 
± 1 day 
Week 2b 
± 3 days 
Week 4a 
± 3 days 
Week 6b 
± 3 days 
Week 8a 
± 3 days 
(EOT) 
30 days 
+ 5 days (EOS) 
Efficacy assessments 
Hurley Stage 
8.2.1 
X 
 
 
 
 
 
X 
X 
AN count (HiSCR) 
8.2.2 
X 
X 
X 
X 
X 
X 
X 
X 
Modified Sartorius score 
8.2.3 
 
X 
 
 
 
 
X 
X 
Record rescue lesional treatment 
8.2.4 
 
 
X 
X 
X 
X 
X 
X 
HS Pain NRS
h 
8.2.5 
 
X 
X 
X 
X 
X 
X 
X 
Evaluate daily analgesic use 
8.2.6 
 
X 
X 
X 
X 
X 
X 
X 
HS-PGIC 
8.2.7 
 
 
X 
X 
X 
X 
X 
X 
DLQI 
8.2.8 
 
X 
X 
X 
X 
X 
X 
X 
Optional photography (target area) 
8.2.9 
 
X 
 
 
X 
 
X 
 
a An overnight (at least 8-hour) fast will be required at these visits.  Participant will take study drug at the study sites. 
b Participants will take study drug before the study visit.  
c For confirmation of nonchildbearing status for women who are postmenopausal, defined as amenorrhea at least 12 months before screening. 
d For women of childbearing potential only.  Serum test will be conducted at screening and urine test will be conducted at all other visits. 
e A brief neurological examination will also be performed. 
f If there is a potential clinically significant abnormality in chemistry or hematology assessments (particularly in platelet count) at Week 2, 4, or 6, then an unscheduled visit the 
following week (Weeks 3, 5, 7) to repeat the assessment is required. 
g See Table 10. 
h The HS Pain NRS includes worst pain and average pain in the last 24 hours. 
 
 
 
 
 
 
 














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2.3.3. 
Benefit Assessment 
Participants may experience clinically meaningful improvements in their HS lesions during the 
study and may additionally benefit from the comprehensive safety assessments conducted as part 
of the study (eg, clinical laboratory tests, physical examinations, ECGs). 
They will also contribute to the process of developing a novel anti-inflammatory agent for HS, a 
disease with high unmet need that is severely debilitating to participants' well-being and daily 
functioning. 
2.3.4. 
Benefit-Risk Conclusion 
Taking into account the safety measures taken to minimize risk to participants in this study, the 
potential risks identified in association with INCB054707 are justifiable and appropriately 
balanced by the anticipated efficacy benefits expected to be afforded to this specific group of 
participants and, more broadly, to the general population of patients with HS.  More detailed 
information about the known and expected benefits and risks and reasonably expected adverse 
events of INCB054707 may be found in the INCB054707 IB. 


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3. 
OBJECTIVES AND ENDPOINTS 
Table 5 presents the objectives and endpoints. 
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the safety and tolerability of 
INCB054707. 
 Frequency, duration, and severity of AEs, clinical 
laboratory test results, vital signs results, ECGs, 
and physical examination findings. 
Secondary 
To determine the systemic exposure to 
INCB054707. 
 Population PK parameters of INCB054707. 
To determine the efficacy of INCB054707. 
 Proportion of participants achieving a HiSCR at 
each visit. 
 Proportion of participants achieving an AN count 
of 0 to 2 at each visit. 
 Mean change from baseline in the HS Pain NRS 
scores, worst and average pain, at each visit. 
 Mean change from baseline to Week 8 in the 
modified Sartorius scale score. 
 Mean change from baseline in the number of 
draining fistulas count at each visit. 
 Proportion of participants at each category of 
Hurley Stage at baseline and Week 8. 
 Proportion of participants with change from 
baseline in Hurley Stage at Week 8. 
 Proportions of participants in each HS-PGIC 
category during the treatment period.  
 Actual measurements in HS-PGIC at each visit. 
To assess the need for rescue lesional treatment. 
 Proportion of participants requiring rescue 
lesional treatment. 
 Number of interventions with rescue lesional 
treatment. 
To assess patient-reported quality-of-life burden. 
 Proportion of participants at each scoring 
category of DLQI at each visit.  
 Mean change from baseline in DLQI total scores 
at each visit. 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
4. 
STUDY DESIGN 
4.1. 
Overall Design 
This is a Phase 2, multicenter, randomized, placebo controlled, dose escalation study to evaluate 
the safety of INCB054707 
 over an 8-week treatment period in men and 
women aged 18 to 75 years with moderate to severe HS with a targeted enrollment of 
approximately 36 participants (see Figure 1). 
The study includes 3 cohorts, and approximately 36 participants will be enrolled.  In each cohort, 
approximately 12 participants will be randomized to receive either INCB054707 (n = 9) or 
placebo (n = 3; randomization 3:1).  The total duration of therapy for all enrolled participants is 
8 weeks followed by a 30-day safety follow-up period.  After all participants in each cohort have 
completed the Week 4 study visit and assessments, a SRC will review safety data.  See 
Section 6.5.2 for detail procedures for cohort review and dose escalation. 
4.2. 
Overall Study Duration 
The study will consist of a screening period of up to 28 days, an 8-week treatment period, and a 
30-day safety follow-up period.  The estimated total duration of study participation is 
approximately 16 weeks for each participant. 


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4.3. 
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/IEC in writing of the 
study's completion or early termination, 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 or upon 
advice of the SRC.  If the study is terminated prematurely, the sponsor or designee will notify the 
investigators, the IRBs/IECs, and regulatory bodies of the decision and reason for termination of 
the study.  The SRC will recommend termination of the study if warranted, as described in 
Section 6.5.2.  
5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Men and women aged 18 to 75 years at the time of consent. 
2. Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 
6 months before screening. 
3. Stable course of HS for at least 90 days before screening, as determined by the 
investigator. 
4. HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley 
Stage II (ie, recurrent abscessed with tract formation and cicatrization; single or multiple, 
widely separated lesions) or Hurley Stage III (ie, diffuse or near diffuse involvement, or 
multiple interconnected tracts and abscesses across the entire area) at screening. 
5. Total AN count of at least 3 at screening and baseline. 
6. Willingness to avoid pregnancy or fathering children based on the criteria below:  
a. Male participants must agree to take appropriate precautions to avoid pregnancy (with 
at least 99% certainty) from screening through 90 days after the last dose of study 
drug.  Male participants must also refrain from donating sperm during this period.  
Permitted methods that are at least 99% effective in preventing pregnancy (see 
Appendix A) should be communicated to the participant and his understanding 
confirmed. 


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b. Women of childbearing potential must have a negative serum pregnancy test at 
screening and a negative urine pregnancy test before the first dose on Day 1 and must 
agree 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 
participants and their understanding confirmed. 
c. Women of nonchildbearing potential (ie, surgically sterile [hysterectomy, bilateral 
oophorectomy, or bilateral salpingectomy] OR postmenopausal, defined as 
≥ 12 months of amenorrhea before screening without an alternative medical cause, 
confirmed by FSH levels at screening) are eligible. 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Women who are currently pregnant or lactating. 
2. Presence of > 20 draining fistulas at screening and baseline. 
3. Participants with concurrent conditions or history of other diseases, as follows: 
a. Any clinically significant medical condition other than HS, as determined by the 
investigator, that is not adequately controlled with appropriate treatment. 
b. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) 
that may interfere with the course, severity, or assessments of HS. 
c. Active systemic viral infection or any active viral infection that, based on the 
investigator's clinical assessment, make the participant an unsuitable candidate for the 
study. 
d. Current herpes zoster infection, a history of recurrent herpes zoster, a history of 
disseminated herpes simplex, or a history of herpes zoster. 
e. History of or ongoing serious illness or medical, physical or psychiatric condition(s) 
that – in the investigator's opinion – would interfere with full participation in the 
study, including administration of study drug and attending required study visits; pose 
a significant risk to the participant; or interfere with interpretation of study data. 
f. Albinism. 
4. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined 
as ≥ 450 msec. 
Note:  Prolonged QTcF values of ≥ 450 msec at screening are to be confirmed by 
performing 2 additional ECGs and averaging the results to determine whether the 
averaged value meets the exclusion criterion. 
5. Positive test result for TB from the QuantiFERON-TB Gold test, or T-SPOT.TB test at 
screening (or, if two indeterminate tests, then as evaluated by a purified protein derivative 
test with a result of < 5 mm of induration within 3 months of screening). 


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6. A history of active TB (treated or untreated) or a history of untreated latent TB. 
Note:  If the participant has possible evidence of a latent TB infection, the participant 
must have documented completion of an adequate course of therapy for latent TB and 
provide recent (within 3 months) posteroanterior and lateral view chest X-rays without 
changes suggestive of active or latent TB, before baseline. 
7. Positive serology test results for HIV, HBsAg, HBV core antibody, or HCV 
(HCV-antibody with positive HCV-RNA) at screening. 
8. Decreased blood cell counts at screening, defined as follows: 
a. Leukocytes < 3.0 × 109/L (< 2.5 × 109/L for participants who are African-American). 
b. ANC < 1.5 × 109/L. 
c. Lymphocytes < 0.8 × 109/L. 
d. Hemoglobin < 10 g/dL. 
e. Platelets < 150 × 109/L. 
9. Severely impaired liver function (Child-Pugh Class C) or ALT or AST levels 
≥ 1.5 × ULN at screening. 
10. Impaired renal function with serum creatinine > 1.5 mg/dL at screening.  
11. Use of the following medications: 
a. Previous use of JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, 
baricitinib, filgotinib, lestaurtinib, and pacritinib). 
b. Previous use of adalimumab or any other TNF-α treatment within 12 weeks or 
5 half-lives (whichever is longer) before baseline. 
c. Use of any investigational or experimental treatments within 12 weeks or 5 half-lives 
(whichever is longer) before baseline. 
d. Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable 
corticosteroids, methotrexate, cyclosporine, and azathioprine) within 4 weeks or 
5 half-lives (whichever is longer) before baseline. 
e. Other systemic therapies for HS (eg, retinoids and antiandrogens) with potential 
therapeutic impact for HS within 4 weeks or 5 half-lives (whichever is longer) before 
baseline. 
f. Surgical, laser, or IPL intervention in area with HS lesion within 4 weeks before 
baseline. 
g. Systemic anti-infectives (eg, antibiotics, antivirals, antifungals) within 4 weeks, 
except as described in Section 6.7.1.1 for antibiotic therapy, or topical anti-infectives 
on HS lesions (eg, antibiotics, antivirals, antifungals) within 2 weeks before baseline. 
h. Received live vaccine within 6 weeks before baseline or planning to receive live 
vaccine during the course of the study or within 6 weeks after EOT. 


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i. Topical antiseptic washes, creams, soaps, ointments, gels, and liquids containing 
antibacterial agents to treat HS, except those listed in Sections 6.7.1.3 and 6.7.1.4, 
within 2 weeks before baseline. 
j. Potent systemic CYP3A4 inhibitors and inducers (see Study Manual) or fluconazole 
within 2 weeks or 5 half-lives (whichever is longer) before baseline. 
Note:  Topical agents with limited systemic availability are permitted. 
12. Known or suspected allergy to INCB054707 or any component of the study drug. 
13. Known history of clinically significant drug or alcohol abuse in the last year before 
baseline. 
14. For participants consenting to biopsies only: 
a. Participant has a history of an allergic reaction or significant sensitivity to lidocaine 
or other local anesthetics. 
b. Participant has a history of hypertrophic scarring or keloid formation in scars or 
suture sites. 
c. Participant is taking anticoagulant medication, such as heparin, low molecular 
weight–heparin, warfarin, and antiplatelets (nonsteroidal anti-inflammatory drugs and 
low-dose aspirin will be allowed), or has a contraindication to skin biopsies. 
15. Inability or unlikeliness of the participant to comply with the dose schedule and study 
evaluations, in the opinion of the investigator. 
16. Inability of the participant (or parent, guardian, or legally authorized representative) to 
comprehend or unwilling to sign the ICF. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.4. 
Screen Failures  
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently randomly assigned to study treatment. 
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes that the participant would be eligible if retested.  Additionally, a participant 
who fails screening may repeat the screening process 1 time if the investigator believes that there 
has been a change in eligibility status.  Participants who are rescreened must reconsent and be 
assigned a new participant number. 
5.5. 
Replacement of Participants 
No participants will be replaced at any time during this study. 




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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 SOPs.  
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. 
Further guidance and information for the final disposition of unused study treatments are 
provided in the Study Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Randomization to treatment will occur centrally by IWRS (see Section 8.1.3).  Full details will 
be provided in the IWRS Manual. 
Participants, investigators, and the sponsor will be blinded to each participant's initial treatment 
assignment.  Emergency unblinding will occur if an AE requires the investigator to be made 
aware of the participant's treatment assignment (see emergency unblinding procedures in 
Section 9.6). 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study.  
Compliance with INCB054707 will be calculated by the sponsor based on the drug 
accountability documented by site personnel and monitored by the sponsor/designee using tablet 
counts.  Participants will be instructed to bring all study drug with them to all study visits in 
order for site personnel to conduct tablet counts to assess study drug accountability.  The drug 
accountability documentation will be used by the sponsor to calculate treatment compliance. 
6.5. 
Dose-Limiting Toxicity and Determination of Maximum Tolerated 
Dose and/or Pharmacologically Active Dose 
6.5.1. 
Definition of a Dose-Limiting Toxicity 
Dose-limiting toxicity will be defined as the occurrence of any of the evens listed in Table 7 
occurring up to Week 8 (EOT), except those with a clear alternative explanation not related to 
study drug.  All DLTs will be assessed for severity by the investigator using CTCAE v4.03 
criteria.  Participants who receive at least 1 dose of study drug at the level assigned or have a 
DLT will be considered evaluable for determining tolerability of the dose.  


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Table 7: 
Definition of Dose-Limiting Toxicity 
Toxicity 
Definition 
Nonhematologic 
 Any liver function abnormalities that meet the definition of Hy's law.
a 
 Any ≥ Grade 3 nonhematologic toxicity EXCEPT: 
 Transient (≤ 72 hours) abnormal laboratory values without associated clinically 
significant signs or symptoms. 
 Nausea, vomiting, and diarrhea adequately controlled with medical therapy within 
48 hours. 
 An event clearly associated with the underlying disease, disease progression, a 
concomitant medication, or comorbidity. 
 Asymptomatic changes in lipid profiles. 
Hematologic 
 Grade 2 neutropenia (neutrophils:  1 to < 1.5 × 109/L) with ≥ Grade 3 infection. 
 ≥ Grade 3 neutropenia (neutrophils:  < 1 × 109/L). 
 ≥ Grade 2 thrombocytopenia (platelets:  < 75 × 109/L). 
 Grade 4 anemia (hemoglobin:  < 6.5 g/dL). 
Events of special 
interest 
 Serious infections due to bacterial, mycobacterial, invasive fungal, viral, or other 
opportunistic pathogens; viral reactivation; malignancy. 
a Hy's law is defined as 1) ALT or AST elevation > 3 × ULN, 2) total bilirubin > 2 × ULN without initial findings of 
cholestasis (elevated serum alkaline phosphatase), AND 3) no other apparent possible causes of aminotransferase 
elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver 
disease, or the administration of other drug(s) known to be hepatotoxic. 
6.5.2. 
Procedures for Cohort Review and Dose Escalation 
After all participants in each cohort have completed the Week 4 visit and assessments, a SRC 
will review safety data on a blinded basis from that cohort.  If blinded data are determined to 
support the safety and tolerability of the dose for that cohort, the next higher dose cohort may 
open to enrollment.  If necessary, the SRC may request to further review unblinded safety data 
from that cohort at Week 4.  In the case that the unblinded data at Week 4 is not enough to 
support dose escalation, the SRC can also choose to wait until all participants complete Week 8 
assessment and then make the decision.  The SRC could also make a recommendation to expand 
a cohort to obtain additional safety data.  
A participant's randomization will be unblinded for the SRC if the participant experiences any of 
the DLTs listed in Table 7 and the DLT is attributed to study drug.  If ≥ 3 participants in any 
cohort treated with INCB054707 have DLTs or the study drug is considered not tolerable, then 
the escalation will be terminated. 
After the completion of a cohort, the sponsor may also be unblinded to safety and efficacy data 
from that cohort. 
Telephone conferences will also be scheduled by the sponsor with active study investigators in 
order to review cohort-specific data and overall safety data, agree on dose escalation, adjudicate 
individual high-grade AEs as potentially dose-limiting, and guide other major study decisions. 


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6.6. 
Dose Modifications 
6.6.1. 
Management of Dose-Limiting Toxicities or Other Urgent Situations 
Investigators may employ any measures or concomitant medications necessary to optimally treat 
the participant after discussion with the sponsor (whenever possible). 
6.6.2. 
Follow-Up of Dose-Limiting Toxicities 
Any DLT should be monitored until it resolves to baseline or appears to have stabilized for a 
minimum of 2 weeks.  During follow-up, participants should be seen as often as medically 
indicated to assure safety, in consultation with the medical monitor.  
6.6.3. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study Drug 
Safety concerns should be discussed with the sponsor immediately upon occurrence or awareness 
to determine if the participant should continue or discontinue study treatment. 
There are no dose modifications in this study.  In some circumstances, it may be necessary to 
temporarily interrupt treatment with INCB054707 as a result of AEs or laboratory abnormalities 
that have an unclear relationship to the study drug (see Table 8).  Except in cases of emergency, 
it is recommended that any laboratory findings be confirmed and that the investigator consult 
with the sponsor medical monitor (or other representative of the sponsor) before temporarily 
interrupting study drug.  Participants who experience a recurrence of the AEs or laboratory 
abnormalities upon restarting the study drug may have the study drug permanently discontinued.  


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Table 8: 
Guidelines for Interrupting, Restarting, and Discontinuing Study Drug 
ADVERSE EVENT 
ACTION TAKEN 
Chemistry 
AST and/or ALT > 3.0 × ULN 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to ≤ 3.0 × ULN. 
Step 2:  Restart study drug, and monitor as described 
specifically in Section 9.3. 
AST and/or ALT > 5.0 × ULN 
Discontinue study drug administration, and monitor as 
described specifically in Section 9.3. 
Hematology 
Platelet counts 50 to < 100 × 109/L or 
≥ 50% decrease from baseline 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to ≥ 100 × 109/L. 
Step 2:  Restart study drug, and monitor as described in 
Section 9.3. 
ANC 0.5 to < 1.0 × 109/L 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to ≥ 1 × 109/L or the 
baseline value. 
Step 2:  Restart study drug, and monitor as described 
specifically in Section 9.3. 
Hemoglobin 8 to < 10 g/dL or > 2 g/dL 
decrease from baseline 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved ≥ 10 g/dL or 
≤ 2 g/dL decrease from baseline. 
Step 2:  Restart study drug, and monitor as described 
specifically in Section 9.3. 
 Platelet count < 50 × 109/L 
 ANC < 0.5 × 109/L 
 ANC < 1.0 × 109/L with an oral 
temperature of at least 38.5°C OR with 
≥ Grade 3 infection 
 Hemoglobin < 8 g/dL 
Discontinue study drug administration, and monitor as 
described specifically in Section 9.3. 
Other toxicities 
Any Grade 1 or Grade 2 toxicity 
Continue study drug and treat the toxicity; monitor as 
described specifically in Section 9.3. 
Any Grade 3 toxicity except those defined 
in Table 7 (exception for any ≥ Grade 3 
nonhematologic toxicity)  
Step 1:  Interrupt study drug up to 2 weeks (14 days), until 
toxicity resolves to ≤ Grade 1. 
Step 2:  Restart study drug and monitor as described 
specifically in Section 9.3. 
Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up as 
described in specifically Section 8.8. 


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6.7. 
Concomitant Medications and Procedures 
All concomitant medications and treatments (including over-the-counter or prescription 
medicines, vitamins, vaccines, and/or herbal supplements) must be recorded in the eCRF.  Any 
prior medication received up to 28 days before the first dose of study treatment and 30 days after 
the last dose of study treatment will be recorded in the eCRF.  A detailed history of prior 
medications use related to HS in the year before screening will be also be collected, as well as 
response to each treatment and reason for discontinuation. 
Any addition, deletion, or change in the dose of these medications will also be recorded.  
Concomitant treatments/procedures that are required to manage a participant's medical condition 
during the study will also be recorded in the eCRF.  The medical monitor should be contacted if 
there are any questions regarding concomitant or prior therapy. 
6.7.1. 
Permitted Medications and Procedures 
6.7.1.1. 
Antibiotic Therapy 
After Week 4, if a participant experiences signs or symptoms indicative of an infection at an HS 
site (eg, fever and local/regional lymphadenopathy), the following antibiotic therapy may be 
initiated without interruption of study drug administration: 
 Amoxicillin 500 mg/clavulanic acid 125 mg, 2 tablets, 3 times daily for 3 days 
In participants for whom amoxicillin is contraindicated, the investigators should consult with the 
sponsor or designee to discuss alternative treatment options. 
6.7.1.2. 
Analgesic Therapy 
If a participant experiences significant pain after baseline, one of the following analgesic 
regimens may be initiated at any time: 
 Ibuprofen (at a dose of up to 800 mg orally every 6 hours) not to exceed 
3200 mg/24 hours. 
 Acetaminophen not to exceed 4 g/24 hours. 
If pain is not sufficiently controlled with one of the above regiments, a revised analgesic 
regiment can be considered in consultation with the sponsor or designee. 
Dose modifications in these analgesics on an as needed basis up to the maximum permitted dose 
and frequency are allowed during the study. 
Analgesic usage (yes/no) will be recorded daily (see Study Manual). 
6.7.1.3. 
Antiseptic Therapy 
Permitted antiseptic washes are limited to one of the following:  chlorhexidine gluconate, 
triclosan, benzoyl peroxide, or diluted bleach in bathwater. 
6.7.1.4. 
Wound Care 
Concomitant use of wound care dressings on HS wounds is allowed.  Options are limited to 
alginates, hydrocolloids, and hydrogels. 


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6.7.2. 
Prohibited Medications and Procedures 
The following medications are prohibited for all participants in the study: 
 JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, 
lestaurtinib, and pacritinib). 
 Adalimumab or any other TNF-α treatment or any investigational or experimental 
treatments. 
 Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable 
corticosteroids, methotrexate, cyclosporine, and azathioprine) except as described in 
Sections 6.7.3 and 8.2.4. 
 Systemic therapies for HS (eg, retinoids and antiandrogens) with potential therapeutic 
impact for HS. 
 Surgical, laser, or IPL intervention in area with HS lesion, except as specified in 
Section 8.2.4 for rescue lesional treatment. 
 Systemic anti-infectives (eg, antibiotics, antivirals, and antifungals), except as 
described in Section 6.7.1.1 for antibiotic therapy, or topical anti-infectives on HS 
lesions. 
 Conventional therapies with potential therapeutic impact for HS. 
 Topical antiseptic washes, creams, soaps, ointments, gels, and liquids containing 
antibacterial agents to treat HS, except those listed in Sections 6.7.1.3 and 6.7.1.4. 
 Potent systemic CYP3A4 inhibitors or inducers (see Study Manual) or fluconazole. 
Note:  Topical agents with limited systemic availability are permitted. 
 Concomitant uses of P-gp inhibitors and inducers (refer to the Study Manual) need to 
be consulted with the medical monitor. 
 Live vaccines (during the study and within 6 weeks after EOT). 
6.7.3. 
Rescue Lesional Treatments 
Rescue lesional treatments are described in Section 8.2.4, as the need for rescue lesional 
treatment is considered an efficacy assessment. 


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7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
Participants must be withdrawn from study treatment for the following reasons: 
 The participant becomes pregnant. 
 Consent is withdrawn. 
Note:  Consent withdrawn means that the participant can no longer be followed.  
Participants who choose to discontinue study treatment will be encouraged to remain 
in the study for safety monitoring. 
 Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
 The study is terminated by the sponsor. 
 The study is terminated by the local health authority, IRB, or IEC. 
A participant may be discontinued from study treatment as follows: 
 If, during the study, a participant is found not to have met eligibility criteria, the 
medical monitor, in collaboration with the investigator, will determine whether the 
participant should be discontinued from the study treatment. 
 If a participant is noncompliant with study procedures or study drug administration in 
the investigator's opinion, the sponsor should be consulted for discussion regarding 
the participant's continued participation. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the EOT 
visit should be conducted.  Reasonable efforts should be made to have the participant return for 
an EOT visit.  These visits are described in Table 3 and Section 8.7.  The last date of the last 
dose of study drug and the reason for discontinuation of study treatment will be recorded in the 
eCRF. 
If a participant is discontinued from study treatment: 
 The study monitor or sponsor must be notified. 
 The reason(s) for withdrawal must be documented in the participant's medical record 
and the primary reason for withdrawal must be included in the eCRF. 
 The EOT visit should be performed. 


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 The date of the EOT visit should be recorded in the eCRF. 
 Participants must be followed for safety until the time of the follow-up visit 
(discontinue date + 30 days) or until study drug–related toxicities resolve, return to 
baseline, or are deemed irreversible, whichever is longest.    
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 
should occur; however, participants will have the option of withdrawing consent for study 
treatment but continuing in the follow-up period of the study for safety/efficacy assessments. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
See Table 3 for data to be collected at the time of study discontinuation and follow-up and for 
any further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
 The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible.  The participant will be counseled regarding the importance of 
maintaining the assigned visit schedule and ascertain whether or not the participant 
wishes to and/or should continue in the study. 
 Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant's last known mailing address 
or local equivalent methods).  These contact attempts should be documented in the 
participant's medical record. 
 Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 


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8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
 The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
 Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
 Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  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 participant records. 
 The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
 Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the country in 
which the study is being conducted as well as the IRB/IEC or study center. 
 The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 
 The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
 The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 
 Participants must provide consent to the most current version of the ICF(s) during 
their participation in the study. 
 A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
 Participants who are rescreened are required to sign a new ICF. 


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8.1.2. 
Screening Procedures 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number. 
Screening is the interval between signing the informed consent and the day that the participant is 
randomly assigned to the study drug (Day 1).  Screening assessments for determination of 
eligibility may be performed over a period lasting up to 28 days. 
Procedures conducted as part of the participant's routine clinical management (eg, clinical 
laboratory tests) and collected before informed consent is obtained may be used for screening or 
baseline purposes, provided the procedure meets the Protocol-defined criteria and has been 
performed within 28 days before Day 1.  All information associated with eligibility 
requirements, including demography and medical history, must be entered into the appropriate 
eCRF pages. 
Results from the screening assessments will be reviewed by the investigators to confirm 
eligibility before randomization and administration of study drug.  Tests results that do not meet 
eligibility requirements may be repeated once during screening if the investigator believes there 
is a reasonable possibility that the participant would be eligible if retested.  For screening 
assessments that are repeated, the most recent available result before administration of study 
drug will be used to determine eligibility.  See Section 5.4 regarding screen failures. 
8.1.3. 
Interactive Web Response System Procedure 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number.  Site personnel should use the IWRS to obtain 
the participant ID number during screening.  Upon determining that the participant is eligible for 
randomization, the IWRS will be contacted to obtain the treatment assignment.  Additionally, the 
IWRS will be contacted to update the study drug supply (see Table 3).  Additional details are 
provided in the IWRS manual. 
8.1.4. 
Distribution of Reminder Cards 
Participants will be provided with a reminder card at the visits indicated at Table 3.  The 
reminder card will indicate the date/time of the next visit and will also remind the participant that 
they should not take study drug on Day 1, Week 4, and Week 8 as they will take it after blood 
draws for safety evaluation have been completed. 
8.1.5. 
Electronic Diary 
The date and time of the last dose of study drug and the time of their last meal preceding each 
PK sample collection visit (see Table 12) will be recorded in the eCRF.  Daily study drug 
administration HS pain NRS (see Section 8.2.5) and daily analgesic use (see Section 8.2.6) will 
be recorded in the electronic diary, which will be completed through the web or by phone. 


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8.1.6. 
Demography and Medical History 
8.1.6.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include date of birth, race, ethnicity, medical and surgical history, 
and current illnesses.  Medical history will include relevant medical or surgical treatment within 
the last year that are considered to be clinically significant by the investigator. 
8.1.6.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  A detailed 
history of prior medications use related to HS in the year before screening will be also be 
collected, as well as response to each treatment and reason for discontinuation. 
8.2. 
Efficacy Assessments 
An example of the lesion count worksheet is provided in the Study Manual and will be used for 
assessment of Hurley Stage, HiSCR, modified Sartorius scale, 
  It 
includes assessment of 12 anatomic regions:  left/right axilla, left/right sub/inframammary area, 
intermammary area, left/right buttock, left/right inguino-crural fold, perianal area, perineal area, 
and other areas.  Additionally, the need for rescue lesional treatment, including number of 
interventions, will be documented in this worksheet. 
8.2.1. 
Hurley Stages of Hidradenitis Suppurativa 
Hurley Stages of HS are defined in Table 9.  The investigator will determine the Hurley Stage in 
each affected anatomical region at the designated study visits listed in Table 3.  If more than 
1 stage is present in a region, the worst stage in each region should be documented.  The 
participant is assigned Hurley Stage corresponding to the Hurley Stage of his or her worst 
involved anatomic region.  The Hurley Stages of HS in screening visit is considered as baseline 
value. 
Table 9: 
Hurley Stages of Hidradenitis Suppurativa 
Stage 
Description 
I 
Abscess formation (single or multiple) without sinus tracts and cicatrization. 
II 
Recurrent abscesses with tract formation and cicatrization; single or multiple, widely 
separated lesions. 
III 
Diffuse or near-diffuse involvement or multiple interconnected tracts and abscesses across 
the entire area. 
8.2.2. 
Hidradenitis Suppurativa Clinical Response (Abscess and Inflammatory Nodule 
Count) 
An HiSCR is defined as at least 50% reduction in AN count with no increase in abscess count 
and no increase in draining fistula (see definition below) count relative to baseline at each visit 
(refer to the Study Manual; Kimball et al 2016). 


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A fistula is a pathologic passageway connecting to the skin surface from dermis or subcutaneous 
tissue.  Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or 
by gentle palpation. 
8.2.3. 
Modified Sartorius Scale 
The modified Sartorius scale is a measure of the severity of HS (refer to the Study Manual; 
Sartorius et al 2003). 
Points are given as follows for each body area:  2 points for each nodule (both inflammatory and 
noninflammatory); 4 points for each abscess; 4 points for each fistula (both draining and 
nondraining); 1 point for each scar; 2 to 6 points for the longest distance between 2 lesions or 
0 points if no lesions; and 6 points if lesions are not separated by normal skin or 0 points if 
lesions are separated by normal skin.  The "other area" only with the highest modified Sartorius 
scale at baseline will be calculated, and the same area should be evaluated throughout the study.  
The total modified Sartorius scale score is the sum of the 12 anatomic region scores. 
8.2.4. 
Need for Rescue Lesional Treatment 
The need for lesional rescue treatment will be recorded as a measure of efficacy. 
In the event of an acutely painful lesion that requires immediate intervention, investigators will 
have the option to perform Protocol-allowed interventions.  Two types of interventions are 
permitted:  injection with intralesional triamcinolone acetonide suspension (up to 30 mg in total 
at the same visit) and/or incision and drainage.  If incision and drainage is performed, 
participants should continue using the same over-the-counter antiseptic as previously.  New 
systemic and topical therapies following incision and drainage, including antibiotics, are 
prohibited.  Concomitant use of wound care dressings is allowed as described in Section 6.7.1.4.  
Participants should continue using any oral and topical therapies during the study, consistent 
with the allowances and restrictions described in Section 6.7.1. 
From Day 1 through Week 8 (EOT), an intervention can occur on a maximum of 2 different 
lesions at the same visit or on the same lesion at 2 different study visits.  The same lesion cannot 
be treated 2 times during the same visit.  If participants require more than 2 interventions before 
Week 8 (EOT), then the study drug will be discontinued for those participants. 
Study procedures must be performed before any interventions.  Any lesion undergoing an 
intervention will be documented in the lesion count worksheet (refer to the Study Manual).  The 
site will be required to count any lesion that undergoes an intervention as permanently present 
from the date of the intervention, and must account for it in the source and on the appropriate 
eCRF. 
8.2.5. 
Hidradenitis Suppurativa Pain Numeric Rating Scale  
The HS Pain NRS (refer to the Study Manual) will be completed in a daily diary by participants 
from Day1 through the follow-up visit (EOS).  An 11-point scale will be used to assess the worst 
skin pain and the average skin pain due to HS.  Ratings for the 2 items range from 0 ("no skin 
pain") to 10 ("skin pain as bad as you can imagine").  Assessments will be recorded before 
bedtime (participants who go to bed after midnight should complete the assessment before 
midnight) and will be based on a recall period of the last 24 hours. 


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8.2.6. 
Analgesic Use 
From Day1 through the follow-up visit (EOS), participants will complete a daily electronic diary 
of their analgesic use (yes/no; refer to the Study Manual).  All analgesics and dose modifications 
will be captured in the source and on the appropriate eCRF. 
8.2.7. 
Hidradenitis Suppurativa Patient Global Impression of Change 
Participants will complete the HS-PGIC questionnaire at the designated study visits listed in 
Table 3.  The HS-PGIC consists of 1 self-administered item that assesses change in the severity 
of skin in the HS area.  Participants are asked to indicate their impression of change compared 
with their previous visit.  The participant will answer the following:  "Since your last visit, your 
HS is:  (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, 
(5) minimally worse, (6) much worse, or (7) very much worse."  The participant should complete 
the questionnaire before site personnel perform any efficacy assessments. 
8.2.8. 
Dermatology Life Quality Index 
Participants will complete a DLQI questionnaire (refer to the Study Manual) from Day1 through 
the follow-up visit (EOS).  The DLQI will be used to assess the symptoms and the impact of skin 
problems on quality of life (Hongbo et al 2005).  The DLQI can be used to evaluate the impact of 
HS on daily activities, based on 6 areas:  symptoms and feelings, daily activities, leisure, work 
and school, personal relationships, and treatment.  Participants will be asked to respond to the 
10 items of the DLQI based on a recall period of "the last week."  Decreased scores indicate 
improved health-related quality of life.  The participant should complete the questionnaire before 
site personnel perform any efficacy assessments. 
8.2.9. 
Photography of Target Lesions 
For participants who consent to photography, a target area for each participant will be identified 
at screening and the same area should be photographed at visits specified in Table 3 for purposes 
of documentation.  The lesion should be located in an area with inflammatory nodules and/or 
abscesses that are a good representation of the disease severity.  
8.3. 
Safety Assessments 
8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF up until the end of 
the safety follow-up period.  Adverse events that begin or worsen after informed consent should 
be recorded on the Adverse Event Form in the eCRF regardless of the assumption of a causal 
relationship with the study drug.  Conditions that were already present at the time of informed 
consent should be recorded on the Medical History Form in the eCRF.  Adverse events 
(including laboratory abnormalities that constitute AEs) should be described using a diagnosis 
whenever possible rather than by individual underlying signs and symptoms. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following-up on AEs that are serious, 


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considered related to the study treatment, or that caused the participant to discontinue the study 
treatment.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?" is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant during the screening process or between 
visits, or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be recorded and reported to the sponsor or designee within 24 hours.  The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
8.3.2. 
Physical Examinations 
Physical examinations will be conducted at the time points listed in Table 3. 
A comprehensive physical examination will include height and body weight and assessment of 
the following organ or body systems:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; 
cardiovascular system; abdomen (liver, spleen); extremities; and lymph nodes.  A brief 
neurological examination will also be performed. 
A targeted physical examination should be conducted as indicated by symptoms reported by the 
participant, AEs, or other findings.  Abnormalities that are considered clinically significant in the 
judgment of the investigator are to be reported as AEs. 
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. 
8.3.3. 
Vital Signs 
Vital sign measurements include blood pressure, pulse, respiratory rate, and body temperature.  
Blood pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or 
sitting position after 5 minutes of rest.  Any abnormalities that are considered clinically 
significant in the judgment of the investigator are to be reported as AEs. 
8.3.4. 
Electrocardiograms 
All 12-lead ECGs will be performed with the participant in a recumbent or semirecumbent 
position after at least 5 minutes of rest.  Electrocardiograms should be performed as indicated in 
Table 3 and Table 10.  Additional 12-lead ECGs may be performed at other visits as deemed 
clinically necessary. 




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8.3.5.3. 
Pregnancy Testing 
A serum pregnancy test will be required for all women of childbearing potential during 
screening.  Urine pregnancy tests will be conducted as outlined in Table 3, as medically 
indicated, or per country-specific requirement.  Urine pregnancy tests will be performed locally.  
If a urine pregnancy test is positive, the results should be confirmed with a serum pregnancy test, 
which may be performed locally. 
If the serum pregnancy test is negative after a urine test was positive, the investigator will assess 
the potential benefit/risk to the participant and determine whether it is in the participant's best 
interest to resume study drug and continue participation in the study. 
If a pregnancy is confirmed by a serum pregnancy test, see Section 9.7 for reporting 
requirements. 








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8.8. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit and the scheduled safety 
follow-up visit, which should occur 30 to 35 days after the EOT visit (or after the last dose of 
study drug if the EOT visit was not performed).  Adverse events and SAEs must be reported up 
until the end of the safety follow-up period, 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 participant return for the follow-up visit and report any AEs that may 
occur during this period. 
For purposes of analysis, participants who complete through Week 8 will be considered to have 
completed the study. 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
 An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not 
considered drug-related. 
 An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
treatment. 
Events Meeting the Adverse Event Definition 
 Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator (ie, 
not related to progression of underlying disease). 
 Abnormal laboratory test results constitute an AE if they are considered clinically meaningful, induce 
clinical signs or symptoms, require concomitant therapy, or require changes in study drug.  Whenever 
possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded in the eCRF rather than the 
abnormal lab result (eg, low hemoglobin, platelet count decreased). 
 Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
 New conditions detected or diagnosed after study treatment administration even though it may have 
been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a 
concomitant medication.  Overdose per se will not be reported as an AE/SAE unless it is an intentional 
overdose taken with possible suicidal/self-harming intent.  Such overdoses should be reported 
regardless of sequelae. 
 "Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an AE 
or SAE.  Such instances will be captured in the efficacy assessments.  However, the signs, symptoms, 
and/or clinical sequelae resulting from lack of efficacy will be reported as AE or SAE if they fulfill the 
definition of an AE or SAE.   


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Events NOT Meeting the Adverse Event Definition 
 Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are 
associated with the underlying disease, unless judged by the investigator to be more severe than 
expected for the participant's condition. 
 The disease/disorder being studied or expected progression, signs, or symptoms of the disease/disorder 
being studied, unless more severe than expected for the participant's condition or considered to be 
treatment-related by the investigator. 
 Medical or surgical procedure (eg, endoscopy, appendectomy):  the condition that leads to the 
procedure is the AE if it occurred after signing the ICF.  If present before entering the study, the 
condition should be captured as medical history. 
 Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
 Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the 
start of the study that do not worsen. 
9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due 
to progression of disease). 
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term "life-threatening" in the definition of "serious" refers to an adverse drug experience that places 
the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurred.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether "hospitalization" occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not 
considered an AE. 
d. Results in persistent or significant disability/incapacity 
 The term disability means a substantial disruption of a person's ability to conduct normal life functions. 
 This definition is not intended to include experiences of relatively minor medical significance, such as 
uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (eg, sprained 
ankle), that may interfere with or prevent everyday life functions but do not constitute a substantial 
disruption. 


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e. Is a congenital anomaly/birth defect 
f. Other situations (Important Medical Event) 
An event that may not result in death, be immediately life-threatening, or require hospitalization, but may 
be considered serious when, based on appropriate medical judgment, the event may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in the 
above definition.  Examples of such events include invasive or malignant cancers (excluding the 
disease[s] under study in oncology protocols), intensive treatment in an emergency department or at home 
for allergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
9.3. 
Recording an Adverse Event and/or Serious Adverse Event 
Adverse Event and Serious Adverse Event Recording 
 An AE/SAE that begins or worsens after informed consent is signed should be recorded on the Adverse 
Event Form in the eCRF.  Conditions that were present at the time informed consent was given should 
be recorded on the Medical History Form in the eCRF. 
 When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
 The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
 It is not acceptable for the investigator to send photocopies of the participant's medical records to 
sponsor or designee in lieu of completing the AE eCRF page. 
 There may be instances when copies of medical records for certain cases are requested.  In this case, all 
participant identifiers, with the exception of the participant number, will be redacted on the copies of 
the medical records before submission. 
 The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) will 
be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or symptom 
should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine: 
 The severity grade (CTCAE Grade 1 to 5).  See below for further instructions on the assessment of 
intensity. 
 Whether there is at least a reasonable possibility that the AE is related to the study drug:  suspected 
(yes) or not suspected (no).  See below for further instructions on the assessment of causality. 
 The start and end dates, unless unresolved at final follow-up. 
 The action taken with regard to study drug as a result of the AE/SAE(s). 
 The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
 The seriousness, as per the SAE definition provided in Section 9.2. 
 The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication or 
nondrug therapy, this action should be recorded on the Adverse Event Form, and the treatment should 
be specified on the appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and Non-Drug 
Therapy). 


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Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v4.03 Grades 1 through 5.  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. 
The investigator will make an assessment of intensity for each AE and SAE reported during the study and 
assign it to 1 of the following categories:  
 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 medical 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. 
 Grade 5:  Fatal. 
Assessment of Causality 
 The investigator is obligated to assess the relationship between study treatment and each occurrence of 
each AE/SAE. 
 A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments to 
suggest a causal relationship, rather than that a relationship cannot be ruled out. 
 The investigator will use clinical judgment to determine the relationship. 
 The investigator will also consult the RSI in the INCB054707 IB and/or Product Information, for 
marketed products, in his/her assessment. 
 Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well as 
the temporal relationship of the event to study treatment administration, will be considered and 
investigated. 
 For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the 
AE/SAE and has provided an assessment of causality. 
 With regard to assessing causality of SAEs: 
 There may be situations in which an SAE has occurred and the investigator has minimal information 
to include in the initial report to the sponsor or designee.  However, it is very important that the 
investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to sponsor or designee. 
 The investigator may change his/her opinion of causality in light of follow-up information and send a 
SAE follow-up report with the updated causality assessment. 
Follow-Up of Adverse Events and Serious Adverse Events 
 The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor or designee to elucidate the 
nature and/or causality of the AE/SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other healthcare professionals. 
 If a participant dies during participation in the study or during a recognized follow-up period, the 
investigator will provide the sponsor or designee with a copy of any postmortem findings, including 
histopathology. 
 New or updated information will be recorded in the originally completed eCRF. 


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 Any updated SAE data will be submitted to the sponsor or designee within 24 hours of receipt of the 
information. 
 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 the event, 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. 
9.4. 
Reporting of Serious Adverse Events 
All SAEs, regardless of suspected causality (eg, relationship to study drug or study 
procedure[s]), occurring after the participant has signed the ICF through the last study visit 
(or up until the end of the safety follow-up period, whichever occurs later) must be reported to 
the sponsor (or designee) within 24 hours of learning of its occurrence, unless otherwise 
specified by the Protocol.  The investigator will submit any updated SAE data to the sponsor (or 
designee) within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE information after conclusion of the 
study participation.  However, if the investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study treatment or study participation, the investigator must notify the 
sponsor (or designee) within 24 hours of becoming aware of the event. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the INCB054707 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 to inform all investigators involved in 
any study with the same drug that this SAE has been reported.  Suspected Unexpected Serious 
Adverse Reactions 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. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation.  The 
sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 


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An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the Investigator's Brochure and will notify the IRB/IEC, if appropriate according to 
local requirements. 
Serious Adverse Event Reporting 
 Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
 The investigator must also complete the Incyte Serious Adverse Event Report Form, in English.  Refer 
to the Incyte Reference Guide for Completing the Serious Adverse Event Report Form. 
 Facsimile or email transmission of the Serious Adverse Event Report Form is the preferred method to 
transmit this information to the PhV/designee.  The contact information of the sponsor's study-specific 
representatives is listed in the Study Manual provided to each site.  The original copy of the Serious 
Adverse Event Report Form and the confirmation sheet must be kept at the study site. 
 Follow-up information is recorded on an amended or new Serious Adverse Event 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 Serious Adverse 
Event 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 
participant 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. 
 In rare circumstances and in the absence of facsimile or computer equipment, notification by telephone 
is acceptable with a copy of the Incyte Serious Adverse Event Report Form sent by overnight mail or 
courier service.  Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Serious Adverse Event Report Form within the designated reporting time 
frames. 
 Contacts for SAE reporting can be found in the Study Manual. 
9.5. 
Adverse Events of Special Interest 
AEs of special interest are defined as decreases in platelets, ANC below the LLN, or the 
occurrence of serious infections.  
9.6. 
Emergency Unblinding of Treatment Assignment 
In a medical emergency, if knowledge of the treatment assignment is necessary to determine 
optimal medical management of the participant, the procedure for emergency unblinding is 
provided in the Study Manual.  This option may be used only if the participant's well-being 
requires the investigator to be aware of the participant's treatment assignment.  If a participant's 
treatment assignment is unblinded, the sponsor or its designee must be notified immediately by 
telephone and follow up by email. 
If an investigator, site personnel performing assessments, or participant is unblinded, the 
participant must be withdrawn from the study treatment, unless there are ethical reasons to have 
the participant remain on the study treatment.  In these cases, the investigator must obtain 
specific approval from the sponsor's (or its designee's) medical monitor for the participant to 
continue in the study. 


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9.7. 
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 participant during maternal or paternal exposure to study 
drug, the following procedures should be followed in order to ensure safety: 
 The study drug must be discontinued immediately (female participants 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 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 of a study participant must be recorded on the Serious 
Adverse Event Report Form and submitted to the sponsor or designee. 
9.8. 
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 INCB054707 IB.  Additional safety information 
collected between IB updates will be communicated in the form of Investigator Notifications.  
Any important new safety information should be discussed with the participant during the study, 
as necessary.  If new significant risks are identified, they will be added to the ICF. 
9.9. 
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. 
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 recorded as described in Section 9.3. 
If the investigator is asked to return the product for investigation, he/she will return a copy of the 
product complaint communication with the product. 




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10.3. 
Level of Significance 
This is a safety study.  No formal efficacy hypotheses will be tested. 
10.4. 
Statistical Analyses 
10.4.1. 
Safety Analyses 
Safety endpoints are listed in Section 3.  Safety analyses will be conducted using the FAS 
population and are summarized in Table 14. 
Table 14: 
Safety Analyses 
Endpoint 
Statistical Analysis Methods 
Primary 
Adverse Events 
A TEAE is any AE either reported for the first time or worsening of a pre-existing 
event after first dose of study drug.  Analysis of AEs will be limited to TEAEs, but data 
listings will include all AEs regardless of their timing to study drug administration.  
Adverse events will be coded using MedDRA and tabulated by preferred term and 
system organ class.  Severity of AEs will be based on the CTCAE v4.03 using Grades 
1 through 5. 
The subset of AEs considered by the investigator to have a relationship to study drug 
will be considered to be treatment-related AEs.  If the investigator does not specify the 
relationship of the AE to study drug, then the AE will be considered treatment-related.  
The incidence of AEs and treatment-related AEs will be tabulated. 
Clinical Laboratory Tests 
Actual values and changes from baseline in clinical laboratory test results will be 
summarized using descriptive statistics.  Laboratory test values outside the normal 
range will be assessed for severity based on the normal ranges for the clinical reference 
laboratory.  The incidence of abnormal laboratory values will be tabulated. 
Laboratory data will be classified into Grades 1 through 4 using CTCAE v4.03.  The 
following summaries will be produced for the laboratory data: 
Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of baseline value) will be summarized.  Each participant will be counted 
only for the worst grade observed postbaseline. 
Shift tables from baseline to the worst postbaseline value using CTCAE grade. 
For laboratory parameters where CTCAE grades are not defined, shift tables to the 
worst postbaseline value using the low/normal/high classifications based on laboratory 
reference ranges will be provided. 
Vital Signs 
Descriptive statistics and mean change from baseline will be summarized for vital signs 
(blood pressure, pulse, respiratory rate, and body temperature) at each assessment time. 
Electrocardiograms 
Twelve-lead ECGs will be obtained for each participant during the study.  
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.  Participants 
exhibiting clinically notable ECG abnormalities will be listed. 


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10.4.2. 
Efficacy Analyses 
Efficacy analyses will be conducted using the FAS.  Efficacy assessments will be summarized 
using descriptive statistics at each visit.  The baseline value for a variable will be defined as the 
last nonmissing value for this variable before or on Day 1, unless otherwise specified. 
Categorical variables, including proportions of participants achieving HiSCR, achieving an AN 
count of 0 to 2, requiring rescue lesional treatment, at each category of Hurley Stage, with a 
change in Hurley Stage, in each HS-PGIC category, and at each scoring category of DLQI, will 
be summarized using descriptive statistics, including sample size, frequency, and percentages.  
Actual measurements of HS-PGIC, mean, change from baseline, and percentage change from 
baseline in DLQI, HS pain NRS, modified Sartorius scale, and in the number of draining fistulas 
will be summarized using descriptive statistics, including sample size, mean, median, standard 
deviation, standard error of the mean, minimum, and maximum.  A logistic regression model will 
be fit for assessment of the dose-response relationship on HiSCR at Week 8. 
10.4.3. 
Other Analyses 
Pharmacokinetic endpoints are listed in Section 3.  Pharmacokinetic analyses will be performed 
using the PK population.  The INCB054707 plasma concentration data will be analyzed by a 
population PK modeling approach.  Such data may be combined with data from other studies in 
the clinical development program to develop or refine population PK models.  This model may 
be used to evaluate the effects of intrinsic and extrinsic covariates on the PK of INCB054707 and 
to determine measures of individual exposure (such as steady-state peak, trough, and/or time 
averaged concentrations).  A data analysis plan and results of population PK will be reported 
separately. 
Translational endpoints are listed in Section 3.  Details of translational analyses will be provided 
in the Statistical Analysis Plan. 
10.5. 
Interim Analysis 
No formal interim analysis is planned in this study. 


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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
 The Protocol, Protocol amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated. 
 The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
 Any amendments to the Protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study participants. 
 The investigator will be responsible for the following: 
 Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
 Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
 Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
 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 participants 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. 


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 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. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided eCRF completion guidelines for instructions on data entry in 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. 
The sponsor (or designee) will be responsible for: 
 The data management of this study including quality checking of the data. 
 Ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
The investigator will be responsible for: 
 Ensuring participant data relating to the study is recorded in the eCRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data) or as 
otherwise specified in the Protocol.  The investigator is responsible for verifying that 
data entries are accurate and correct by physically or electronically signing the eCRF. 
 Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF. 
 Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed at the 
investigator's site. 
 Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies 
must be explained.  The investigator may need to request previous medical 
records or transfer records, depending on the study.  Also, current medical records 
must be available. 


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 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 
participant 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 participants. 
 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. 
11.3. 
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. 
Participant names will not be supplied to the sponsor or its designee.  Only the participant 
number and the participant's initials (participant's initials will only be recorded if allowable by 
local regulations) will be recorded in the eCRF, where permitted; if the participant'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. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to 
21 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 participants, 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. 


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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. 
11.5. 
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. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.6. 
Study and Site Closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
 Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
 Inadequate recruitment of participants by the investigator. 
 Discontinuation of further study treatment development. 


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12. 
REFERENCES 
Bissonnette R, Luchi M, Fidelus-Gort R, et al. A randomized, double-blind, placebo-controlled, 
dose-escalation study of the safety and efficacy of INCB039110, an oral janus kinase 1 inhibitor, 
in patients with stable, chronic plaque psoriasis. J Dermatolog Treat 2016;27:332-338. 
Clinical Trial Facilitation Group. Recommendations related to contraception and pregnancy 
testing in clinical trials. 2014. http://www.hma.eu/fileadmin/dateien/ 
Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_ 
Contraception.pdf. Accessed October 2, 2017. 
Gulliver W, Zouboulis CC, Prense E, Jemec GB, Tzellos T. Evidence-based approach to the 
treatment of hidradenitis suppurativa/acne inversa, based on European guidelines for hidradenitis 
suppurativa. Rev Endocr Metab Disord 2016;17:343-351. 
Hamzavi IH, Sundaram M, Nicholson C, et al. Uncovering burden disparity: a comparative 
analysis of the impact of moderate-to-severe psoriasis and hidradenitis suppurativa. J Am Acad 
Dermatol 2017:1-9. 
Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality 
of life into practice: what do dermatology life quality index scores mean? J Invest Dermatol 
2005;125:659-664. 
INCB054707 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med 2012;366:158-164. 
Jemec GB, Heidenheim M, Nielsen NH. The prevalence of hidradenitis suppurativa and its 
potential precursor lesions. J Am Acad Dermatol 1996;35:191-194. 
Kelly G, Hughes R, McGarry T, et al. Dysregulated cytokine expression in lesional and 
nonlesional skin in hidradenitis suppurativa. Br J Dermatol 2015;173:1431-1439. 
Kelly G, Prens EP. Inflammatory mechanisms in hidradenitis suppurativa. Dermatol Clin 
2016;34:51-58. 
Kimball AB, Sobell JM, Zouboulis CC, et al. HiSCR (Hidradenitis Suppurativa Clinical 
Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with 
hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. 
J Eur Acad Dermatol Venereol 2016;30:989-994. 
Mehta CR, Patel NR. Exact logistic regression: theory and examples. Stat Med 
1995;14:2143-2160. 
Miller IM, Ellervik C, Vinding GR, et al. Association of metabolic syndrome and hidradenitis 
suppurativa. JAMA Dermatol 2014;150:1273-1280. 
Moran B, Sweeney CM, Hughes R, et al. Hidradenitis suppurativa is characterized by 
dysregulation of the Th17:Treg cell axis, which is corrected by anti-TNF therapy. J Invest 
Dermatol 2017;137:2389-2395. 
Punwani N, Burn T, Scherle P, et al. Downmodulation of key inflammatory cell markers with a 
topical Janus kinase 1/2 inhibitor. Br J Dermatol 2015;173:989-997. 


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Rambhatla PV, Lim HW, Hamzavi I. A systematic review of treatments for hidradenitis 
suppurativa. Arch Dermatol 2012;148:439-446. 
Rawlings JS, Rosler KM, Harrison DA. The JAK/STAT signaling pathway. J Cell Sci 
2004;117:1281-1283. 
Revuz JE. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009;23:985-998. 
Revuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with 
hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 
2008;59:596-601. 
Sartorius K, Lapins J, Emtestam L, Jemec GB. Suggestions for uniform outcome variables when 
reporting treatment effects in hidradenitis suppurativa. Br J Dermatol 2003;149:211-213. 
Schlapbach C, Hänni T, Yalwalker N, Hunger RE. Expression of the IL-23/Th17 pathway in 
lesions of hidradenitis suppurativa. J Am Acad Dermatol 2011;65:790-798. 
van der Zee HH, de Ruiter L, van den Broecke DG, Dik WA, Laman JD, Prens EP. Elevated 
levels of tumour necrosis factor (TNF)-α, interleukin (IL)-1β and IL-10 in hidradenitis 
suppurativa skin: a rationale for targeting TNF-α and IL-1β. Br J Dermatol 2011;164:1292-1298. 
van der Zee HH, Laman JD, de Ruiter L, Dik WA, Prens EP. Adalimumab (antitumour necrosis 
factor-α) treatment of hidradenitis suppurativa ameliorates skin inflammation: an in situ and 
ex vivo study. Br J Dermatol 2012;166:298-305. 
Zouboulis CC, Desai N, Emtestam L, et al. European S1 guideline for the treatment of 
hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol 2015;29:619-644. 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For male participants in the study: 
Male participants should use a condom from screening through 90 days after the end of systemic 
exposure.  If the male participant has a partner that is of child-bearing potential, the partner should also 
use contraception through 90 days after the end of relevant systemic exposure.  In addition, male 
participants must refrain from donating sperm from screening through 90 days after the end of relevant 
systemic exposure.  Males who have had a vasectomy qualify as having met the requirement for a highly 
effective birth control method. 
For female participants and female partners of male participants 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: 
 Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition 
of ovulation
a 
 oral 
 intravaginal 
 transdermal 
 Progestogen-only hormonal contraception associated with inhibition of ovulationa 
 oral 
 injectable 
 implantable
b 
 Intrauterine deviceb 
 Intrauterine hormone-releasing systemb 
 Bilateral tubal occlusionb 
 Vasectomized partnerbc 
 Sexual abstinence
d 
Acceptable birth control methods that result in a failure rate of more than 1% per year include: 
 Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode 
of action 
 Male or female condom with or without spermicide
e 
 Cap, diaphragm, or sponge with spermicidee 
 Tubal ligation 
a Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method. 
b Contraception methods that in the context of this guidance are considered to have low user dependency. 
c Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the woman of childbearing potential study participant and that the vasectomized partner has received 
medical assessment of the surgical success. 
d 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 study and the 
preferred and usual lifestyle of the participant. 
e A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) 
are also considered acceptable, but not highly effective, birth control methods. 
Source:  Clinical Trial Facilitation Group 2014. 


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APPENDIX B. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment (Version) 1: 
09 AUG 2018 
Amendment 1 (09 AUG 2018) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to remove the exclusion of women of childbearing 
potential. 
1. Section 1, Protocol Summary (Table 3:  Schedule of Assessments); Section 2.3.2, 
Clinical Studies (Table 4:  Potential Risks Associated With INCB054707); 
Section 5.1, Inclusion Criteria; Section 5.2, Exclusion Criteria; Section 8.3.5, 
Laboratory Assessments (Table 10:  Required Laboratory Analytes); 
Section 8.3.5.2, Screening Assessments; Section 8.3.5.3, Pregnancy Testing; 
Appendix A, Information Regarding Effectiveness of Contraceptive Methods 
Description of change:  Removed exclusion of women of childbearing potential.  Added 
pregnancy tests at every study visit. 
Rationale for change:  Results of reproductive toxicology studies allow for enrollment 
of women of childbearing potential in this study. 
2. Section 1, Protocol Summary (Table 3:  Schedule of Assessments); Section 8.1.4, 
Distribution of Reminder Cards 
Description of change:  Removed the fasting requirement at Week 1. 
Rationale for change:  No fast is needed at Week 1, because neither lipid panel 
sampling nor serum sampling for biomarkers occurs at this visit. 
3. Section 1, Protocol Summary (Table 3:  Schedule of Assessments); Section 8.2.9, 
Photography of Target Lesions 
Description of change:  Added "Optional" photography and removed "for each 
participant." 
Rationale for change:  The photography of target lesions will be optional. 


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4. Section 6.1, Study Treatment Administered (Table 6:  Study Treatment 
Information); Section 8.1.5, Electronic Diary; Section 8.4, Pharmacokinetic 
Assessments 
Description of change:  Table 6 was updated to indicate that study drug and matching 
placebo are to be taken orally, once daily, and preferably in the morning.  Daily study 
drug administration will be recorded in an electronic diary, which will be completed 
through the web or by phone.  References to a separate device were removed.  The date 
and time of the last dose of study drug and the time of the last meal preceding each PK 
sample collection visit will be recorded in the electronic case report form only. 
Rationale for change:  To clarify study drug administration and documentation. 
5. Section 6.7, Concomitant Medications and Procedures 
Description of change:  Removed the sentence "Concomitant medications administered 
after 30 days after the last dose of study treatment should be recorded for SAEs as 
defined in Section 9.3." 
Rationale for change:  Concomitant medication administration 30 days after the last 
dose of treatment should not be recorded for SAEs. 
6. Section 8.2, Efficacy Assessments 
Description of change:  Removed "the number and size of ulcerated HS lesions." 
Rationale for change:  Ulcerated HS lesion count and size are not evaluated in this 
study. 
7. Section 8.2.2, Hidradenitis Suppurativa Clinical Response (Abscess and 
Inflammatory Nodule Count) 
Description of change:  Removed sinus tract description. 
Rationale for change:  Sinus is considered as a draining fistula. 
8. Section 8.2.7, Hidradenitis Suppurativa Patient Global Impression of Change; 
Section 8.2.8, Dermatology Life Quality Index;
 
Description of change:  Revised text such that the HS-PGIC, DLQI, and 
should 
be assessed before all efficacy assessments. 
Rationale for change:  To clarify the timing of patient-reported outcome assessments. 
9. Section 8.3.4, Electrocardiograms (Table 10:  Electrocardiogram Schedule) 
Description of changes:  Added that predose and postdose ECGs should be performed 
5 to 10 minutes before the predose and postdose 
, respectively. 
Rationale for change:  To clarify the timing for ECG and PK sample collections. 



SAP_001.pdf: 


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INCB 54707-203 Statistical Analysis Plan 
01 MAR 2019 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................5 
1. 
INTRODUCTION ........................................................................................................6 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS .................................6 
2.1. 
Protocol and Case Report Form Version ......................................................................6 
2.2. 
Objectives and Endpoints .............................................................................................6 
3. 
STUDY DESIGN .........................................................................................................8 
3.1. 
Randomization ..............................................................................................................8 
3.2. 
Control of Type I Error .................................................................................................8 
3.3. 
Sample Size Considerations .........................................................................................8 
3.4. 
Schedule of Assessments ..............................................................................................8 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ....................................9 
4.1. 
Scheduled Study Evaluations .......................................................................................9 
4.1.1. 
Day 1 .............................................................................................................................9 
4.1.2. 
Study Day .....................................................................................................................9 
4.1.3. 
Baseline Value ..............................................................................................................9 
4.1.4. 
Last Available Value ....................................................................................................9 
4.1.5. 
Handling of Missing and Incomplete Data ...................................................................9 
4.2. 
Variable Definitions ....................................................................................................10 
4.2.1. 
Body Mass Index ........................................................................................................10 
4.2.2. 
Prior and Concomitant Medication .............................................................................10 
5. 
STATISTICAL METHODOLOGY ...........................................................................11 
5.1. 
General Methodology .................................................................................................11 
5.2. 
Treatment Groups .......................................................................................................11 
5.3. 
Analysis Populations ..................................................................................................11 
5.3.1. 
Full Analysis Set .........................................................................................................11 
 
 .......................................11 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................12 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............12 
6.1.1. 
Demographics .............................................................................................................12 
6.1.2. 
Baseline Disease Characteristics ................................................................................12 
6.1.3. 
Prior Therapy ..............................................................................................................12 
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6.1.4. 
General Medical History .............................................................................................12 
6.2. 
Disposition of Participants ..........................................................................................12 
6.3. 
Protocol Deviations ....................................................................................................12 
6.4. 
Exposure .....................................................................................................................13 
6.5. 
Study Drug Compliance .............................................................................................13 
6.6. 
Prior and Concomitant Medication .............................................................................13 
7. 
EFFICACY .................................................................................................................14 
7.1. 
Efficacy Parameters ....................................................................................................14 
7.1.1. 
Hurley Stages of Hidradenitis Suppurativa ................................................................14 
7.1.2. 
Hidradenitis Suppurativa Clinical Response (Abscess and Inflammatory 
Nodule Count) ............................................................................................................15 
7.1.3. 
Modified Sartorius Scale ............................................................................................15 
7.1.4. 
Need for Rescue Lesional Treatment .........................................................................15 
7.1.5. 
Hidradenitis Suppurativa Pain Numeric Rating Scale ................................................15 
7.1.6. 
Analgesic Use .............................................................................................................16 
7.1.7. 
Hidradenitis Suppurativa Patient Global Impression of Change ................................16 
7.1.8. 
Dermatology Life Quality Index ................................................................................16 
 
 
 
 
7.2. 
Analysis of Efficacy Endpoints ..................................................................................17 
 
 
 
 
8. 
SAFETY AND TOLERABILITY ..............................................................................19 
8.1. 
General Considerations ...............................................................................................19 
8.2. 
Adverse Events ...........................................................................................................19 
8.2.1. 
Adverse Event Definitions ..........................................................................................19 
8.2.2. 
Adverse Event Summaries ..........................................................................................19 
8.3. 
Clinical Laboratory Tests ...........................................................................................20 
8.3.1. 
Laboratory Value Definitions .....................................................................................20 
8.3.2. 
Laboratory Value Summaries .....................................................................................21 
8.4. 
Vital Signs ..................................................................................................................22 
8.5. 
Electrocardiograms .....................................................................................................22 
9. 
INTERIM ANALYSES ..............................................................................................23 
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10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................23 
10.1. 
Changes to Protocol-Defined Analyses ......................................................................23 
10.2. 
Changes to the Statistical Analysis Plan .....................................................................23 
11. 
REFERENCES ...........................................................................................................24 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ........................................25 
 
LIST OF TABLES 
Table 1: 
Objectives and Endpoints .............................................................................................7 
Table 2: 
Hurley Stages of Hidradenitis Suppurativa ................................................................14 
Table 3: 
Sartorius Score ............................................................................................................15 
Table 4: 
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................22 
Table 5: 
Electrocardiogram Schedule .......................................................................................23 
Table 6: 
Statistical Analysis Plan Versions ..............................................................................23 
 
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LIST OF ABBREVIATIONS 
Abbreviation 
Term 
AE 
adverse event 
AN 
abscess and inflammatory nodule 
BMI 
body mass index 
CRF 
case report form 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLQI 
Dermatology Quality of Life Index 
eCRF 
electronic case report form  
ECG 
electrocardiogram  
EOS 
end of study  
FAS 
full analysis set 
HiSCR 
Hidradenitis Suppurativa Clinical Response 
 
 
HS 
hidradenitis suppurativa 
IBD 
inflammatory bowel disease 
 
 
MedDRA 
Medical Dictionary for Regulatory Affairs  
NCI 
National Cancer Institute 
NRS 
numeric rating scale  
PCOS 
polycystic ovarian syndrome 
 
  
PGIC 
Patient Global Impression of Change 
 
  
PT 
preferred term 
QD 
once daily 
QTcF 
QT interval corrected for heart rate using Fridericia's formula 
SAP 
statistical analysis plan 
SOC 
system organ class 
SRC 
safety review committee 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
WHO 
World Health Organization 
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1. 
INTRODUCTION 
This is a Phase 2, multicenter, randomized, placebo controlled, dose escalation study to evaluate 
the safety of INCB054707 
 over an 8-week treatment period in men and 
women aged 18 to 75 years with moderate to severe HS. 
The study includes 3 cohorts, and approximately 36 participants will be enrolled.  In each cohort, 
approximately 12 participants will be randomized in a 3:1 ratio to receive either INCB054707 
(n = 9) or placebo (n = 3).  The total duration of therapy for all enrolled participants is 8 weeks 
followed by a 30-day safety follow-up period.  After all participants in each cohort have 
completed the Week 4 study visit and assessments, a SRC will review safety data. 
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the Study INCB 54707-203 Protocol. 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCB 54707-203 Protocol Amendment 1 dated 09 AUG 2018 and CRFs 
approved 28 AUG 2018.  Unless superseded by an amendment, this SAP will be effective for all 
subsequent Protocol amendments and CRF versions. 
2.2. 
Objectives and Endpoints 
Table 1 presents the objectives and endpoints. 
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Table 1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the safety and tolerability of 
INCB054707. 
• 
Frequency, duration, and severity of AEs, clinical 
laboratory test results, vital signs results, ECGs, and 
physical examination findings. 
Secondary 
To determine the systemic exposure to 
INCB054707. 
• 
Population PK parameters of INCB054707. 
To determine the efficacy of INCB054707. 
• 
Proportion of participants achieving a HiSCR at each visit. 
• 
Proportion of participants achieving an AN count of 0 to 
2 at each visit. 
• 
Mean change from baseline in the HS Pain NRS scores, 
worst and average pain, at each visit. 
• 
Mean change from baseline to Week 8 in the modified 
Sartorius scale score. 
• 
Mean change from baseline in the number of draining 
fistulas count at each visit. 
• 
Proportion of participants at each category of Hurley Stage 
at baseline and Week 8. 
• 
Proportion of participants with change from baseline in 
Hurley Stage at Week 8. 
• 
Proportions of participants in each HS-PGIC category 
during the treatment period. 
• 
Actual measurements in HS-PGIC at each visit. 
To assess the need for rescue lesional treatment. 
• 
Proportion of participants requiring rescue lesional 
treatment. 
• 
Number of interventions with rescue lesional treatment. 
To assess patient-reported quality-of-life burden. 
• 
Proportion of participants at each scoring category of DLQI 
at each visit.  
• 
Mean change from baseline in DLQI total scores at each 
visit. 
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3. 
STUDY DESIGN 
This is a Phase 2, multicenter, randomized, placebo controlled, dose escalation study to evaluate 
the safety of INCB054707 
 over an 8-week treatment period in men and 
women aged 18 to 75 years with moderate to severe HS with a targeted enrollment of 
approximately 36 participants. 
The study includes 3 cohorts, and approximately 36 participants will be enrolled.  In each cohort, 
approximately 12 participants will be randomized to receive either INCB054707 (n = 9) or 
placebo (n = 3; randomization 3:1).  The total duration of therapy for all enrolled participants is 
8 weeks followed by a 30-day safety follow-up period.  After all participants in each cohort have 
completed the Week 4 study visit and assessments, a SRC will review safety data. 
3.1. 
Randomization 
The study includes 3 cohorts, and approximately 36 participants will be enrolled.  In each cohort, 
approximately 12 participants will be randomized in a 3:1 ratio to receive either INCB054707 
(n = 9) or placebo (n = 3). 
3.2. 
Control of Type I Error 
All statistical analyses are exploratory in nature.  No alpha control will be implemented.  Unless 
otherwise specified, all confidence intervals provided will be at the 95% confidence level. 
3.3. 
Sample Size Considerations 
The study is a standard dose-escalation design, and the sample size depends on the occurrence of 
safety findings.  Approximately 9 participants will be randomized in each dose level, which will 
provide > 85% chance of detecting at least 1 AE of interest (eg, platelets, hemoglobin, absolute 
neutrophil count, liver functions, and infections) if the underlying rate is 20%. 
3.4. 
Schedule of Assessments 
See Protocol Amendment 1 dated 09 AUG 2018 for a full description of all study procedures and 
assessment schedules for this study. 
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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations 
4.1.1. 
Day 1 
Day 1 is the date that the first dose of study drug (INCB054707) or placebo is administered to 
the participants. 
4.1.2. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (Visit/Reporting Date – Day 1 date + 1). 
If the visit/reporting date is before Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (Visit/Reporting Date – Day 1 date). 
A study day of –1 indicates 1 day before Day 1. 
4.1.3. 
Baseline Value 
Baseline is the last nonmissing measurement obtained before the first administration of 
INCB054707 or placebo. 
When scheduled assessments and unscheduled assessments occur on the same day and time of 
the assessment or time of 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. 
4.1.4. 
Last Available Value 
The last available value is the last nonmissing measurement obtained after starting INCB054707 
or placebo and within 30 days after the last dose of INCB054707 or placebo. 
4.1.5. 
Handling of Missing and Incomplete Data  
In general, values for missing data will not be imputed unless methods for handling missing data 
are specified in relevant sections. 
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4.2. 
Variable Definitions 
4.2.1. 
Body Mass Index 
Body mass index will be calculated as follows: 
BMI (kg/m2) = [weight (kg)] / [height (m)]2 
4.2.2. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before the first dose of 
INCB054707 or placebo. 
Concomitant medication is defined as any nonstudy medication that is started accordingly: 
• Before the date of first administration of INCB054707 and is ongoing throughout the 
study or ends on/after the date of first study drug administration. 
• On/after the date of first administration of INCB054707 and is ongoing or ends 
during the course of study drug administration. 
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first administration of INCB054707.  In the listing, it will be indicated whether 
a medication is prior-only, concomitant-only, or both prior and concomitant. 
The start/stop dates recorded in the eCRF 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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6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease 
History 
6.1.1. 
Demographics 
The following demographics will be summarized for the FAS:  age, sex, race, ethnicity, weight, 
height, and BMI. 
6.1.2. 
Baseline Disease Characteristics 
The following baseline disease characteristics will be summarized for the FAS: 
• Days since first onset of HS; 
• Stable disease at least 90 days before screening (Yes/No); 
• Other autoimmune disorders (Hyperlipidemia/Hypertension/Diabetes/Abdominal 
obesity/Arthritis/IBD:  Crohn disease/IBD:  Ulcerative 
colitis/Psoriasis/Spondylarthropathy/PCOS/Other/None). 
6.1.3. 
Prior Therapy 
Prior medication information for HS will be used to identify medication received by participants 
before enrollment into the study.  Prior medications for HS will be summarized. 
6.1.4. 
General Medical History 
For participants in the FAS, general medical history will be summarized by assigned treatment 
group.  This summation will include the number and percentage of participants with significant 
medical history for each body system/organ class as documented on the eCRF. 
6.2. 
Disposition of Participants 
The number and percentage of participants who were enrolled, randomized, treated, completed 
the study, discontinued study treatment with a primary reason for discontinuation, and 
discontinued from the study with a primary reason for withdrawal will be summarized for the 
FAS.  The number of participants randomized/enrolled by site will also be provided by treatment 
group. 
6.3. 
Protocol Deviations 
Protocol deviations recorded on the eCRF will be presented in the participant data listings and 
tables. 
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6.4. 
Exposure 
For participants in the FAS, descriptive statistics will be provided by treatment group for 
duration of treatment, average daily dose, and total dose.  Duration of treatment with 
INCB054707 is defined as the number of days from Day 1 to the date of last record of 
INCB054707 administration. 
6.5. 
Study Drug Compliance 
For participants in the FAS, overall compliance (%) for INCB054707 will be calculated for all 
participants as 
Compliance (%) = 100 × [total number of tablets dispensed – total number of tablets 
returned] / [total intended number of tablets]. 
• The total intended number of tablets will be based on the earliest study day of 
permanent discontinuation of the study drug or last study drug record in the database. 
6.6. 
Prior and Concomitant Medication 
For participants in the FAS, prior medications and concomitant medications will be coded using 
the WHO Drug Dictionary and summarized by WHO drug class and WHO drug term.  Results 
will be summarized as number and percentage of participants with prior and concomitant 
medications by preferred term and WHO drug class. 
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7. 
EFFICACY 
All efficacy analyses are exploratory.  Hence, no p-values will be provided and multiple 
adjustment will not be made. 
Appendix A provides a list of planned tables, figures, and listings. 
7.1. 
Efficacy Parameters 
An example of the lesion count worksheet is provided in the Study Manual and will be used for 
assessment of Hurley Stage, HiSCR, modified Sartorius scale, 
  It includes assessment 
of 12 anatomic regions: 
• left/right axilla, 
• left/right sub/inframammary area, 
• intermammary area, 
• left/right buttock, 
• left/right inguino-crural fold, 
• perianal area, perineal area, 
• and other areas. 
Additionally, the need for rescue lesional treatment, including number of interventions, will be 
documented in this worksheet. 
7.1.1. 
Hurley Stages of Hidradenitis Suppurativa 
Hurley Stages of HS are defined in Table 2.  The investigator will determine the Hurley Stage in 
each affected anatomical region at the designated study visits.  If more than 1 stage is present in 
a region, the worst stage in each region should be documented.  The participant is assigned 
Hurley Stage corresponding to the Hurley Stage of his or her worst involved anatomic region. 
Table 2: 
Hurley Stages of Hidradenitis Suppurativa 
Stage 
Description 
I 
Abscess formation (single or multiple) without sinus tracts and cicatrization 
II 
Recurrent abscesses with tract formation and cicatrization; single or multiple, widely 
separated lesions 
III 
Diffuse or near-diffuse involvement or multiple interconnected tracts and abscesses 
across the entire area 
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7.1.2. 
Hidradenitis Suppurativa Clinical Response (Abscess and Inflammatory Nodule 
Count) 
A HiSCR definition is based on the following criteria relative to the baseline at each visit:  
• at least 50% reduction in total of counts of the abscess and inflammatory nodule, and 
• no increase in abscess count, and  
• no increase in draining fistula count (refer to the Study Manual; Kimball et al 2016).  
7.1.3. 
Modified Sartorius Scale 
The modified Sartorius scale is a measure of the severity of HS (refer to the Study Manual; 
Sartorius et al 2003).  A larger score denotes a more severe disease status.  The total Sartorius score 
is the sum of 12 anatomic region Sartorius scores.  The regional Sartorius score can be calculated 
as follows, using the parameters in Table 3: 
Regional Sartorius Score = Region + (2 × Number of Inflammatory Nodules) + (2 × Number 
of Non-Inflammatory Nodules) + (4 × Number of Abscesses) + (4 × Number of Draining 
Fistulas) + (4 × Number of Non-Draining Fistulas) + (1 × Number of Hypertrophic Scars) + 
Distance + Separate. 
Table 3: 
Sartorius Score 
Region 
0 
Otherwise 
3 
If any lesion count in this anatomic region > 0 
Distance 
0 
If no active lesion 
2 
If longest distance between two relevant lesions or size < 50 mm 
4 
If longest distance between two relevant lesions or size ≥ 50 mm and < 100 mm 
6 
If longest distance between two relevant lesions or size ≥ 100 mm 
Separate 
0 
If all lesions clearly separated by normal appearing skin 
6 
Otherwise 
7.1.4. 
Need for Rescue Lesional Treatment 
Study procedures must be performed before any interventions.  Any lesion undergoing an 
intervention will be documented in the lesion count worksheet (refer to the Study Manual).  The 
site will be required to count any lesion that undergoes an intervention as permanently present 
from the date of the intervention, and must account for it in the source and on the appropriate 
eCRF. 
7.1.5. 
Hidradenitis Suppurativa Pain Numeric Rating Scale 
The HS Pain NRS will be completed in a daily diary by participants from screening through the 
follow-up visit (EOS).  An 11-point scale will be used to assess the worst skin pain and the 
average skin pain due to HS based on a recall period of the last 24 hours.  Ratings for the 2 items 
range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). 
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8. 
SAFETY AND TOLERABILITY 
Appendix A provides a list of planned tables, figures, and listings. 
8.1. 
General Considerations 
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 participants. 
Unless otherwise stated, table summaries will be limited to AEs occurring within 30 days of the 
last administration of study drug. 
8.2. 
Adverse Events 
8.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after 
first administration of study drug.  Analysis of AEs (as discussed below) will be limited to 
TEAEs, but data listings will include all AEs regardless of their timing in relation to study drug 
administration. 
Adverse events will be tabulated by MedDRA PT and SOC.  Severity of AEs will be graded 
using the NCI CTCAE.  The CTCAE v4.03 is used for this study.  The CTCAE reporting 
guidelines and grading details are available on the Cancer Therapy Evaluation Program website. 
The subset of AEs considered by the investigator to be related to study drug will be considered to 
be treatment-related AEs.  The incidence of AEs and treatment-related AEs will be tabulated.  
Serious TEAEs will also be tabulated. 
Any missing onset date, causality, or severity must be queried for resolution.  Unresolved 
missing causality and severity 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. 
8.2.2. 
Adverse Event Summaries 
An overall summary of AEs will include: 
• Number (%) of participants reporting any TEAEs 
• Number (%) of participants reporting any serious TEAEs 
• Number (%) of participants reporting any Grade 3 or higher TEAEs 
• Number (%) of participants reporting any treatment-related TEAEs 
• Number (%) of participants who temporarily interrupted study treatment because of 
TEAEs 
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• Number (%) of participants who permanently discontinued study treatment because 
of TEAEs 
• Number (%) of participants who had a TEAE leading to death 
The following summaries will be produced by MedDRA term (if 2 or fewer participants appear 
in a table, a listing may be appropriate): 
• Summary of TEAEs by SOC and PT 
• Summary of TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs by SOC, PT, and maximum severity 
• Summary of treatment-related TEAEs by SOC and PT 
• Summary of treatment-related TEAEs by PT in decreasing order of frequency 
• Summary of treatment-related TEAEs by SOC, PT, and maximum severity 
• Summary of Grade 3 or higher TEAEs by SOC and PT 
• Summary of Grade 3 or higher treatment-related TEAEs by PT 
• Summary of Grade 3 or higher TEAE by PT in decreasing order of frequency 
• Summary of TEAEs leading to death by SOC and PT 
• Summary of serious TEAEs by SOC and PT 
• Summary of serious TEAEs by PT in descending order of frequency 
• Summary of serious treatment-related TEAEs by SOC and PT 
• Summary of TEAEs leading to dose interruption by SOC and PT 
• Summary of TEAEs leading to discontinuation of treatment by SOC and PT 
• Summary of nonserious TEAEs by SOC and PT 
8.3. 
Clinical Laboratory Tests 
8.3.1. 
Laboratory Value Definitions 
All laboratory assessments (refer to Protocol Table 11) will be performed using a central 
laboratory except for urine pregnancy tests (as applicable) or tests that are deemed necessary by 
the investigator for participant management (refer to Protocol Section 8.3.5).  Laboratory values, 
change from baseline values, and percent change from baseline values will be summarized 
descriptively by visit.  Baseline values will be determined using the nonmissing values collected 
before the first administration, prioritizing scheduled assessments over unscheduled visits.  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. 
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8.3.2. 
Laboratory Value Summaries 
Clinical laboratory tests, including hematology, serum chemistry, urinalysis, lipid panel, 
serology, C-reactive protein, follicle-stimulating hormone, serum pregnancy test, urine 
pregnancy test, and QuantiFERON-TB Gold test (refer to Protocol Table 11), will be performed 
for each participant during the study in accordance with study schedule of assessments (refer to 
Protocol Table 3).  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 participant's particular test within a 
visit window, the smallest laboratory sequence number will be used to identify the record for 
postbaseline visits. 
Laboratory parameters identified in Protocol Table 11 will be summarized.  Shift tables based on 
worst postbaseline value recorded will use all postbaseline values occurring within 30 days of 
stopping study treatment.  Other laboratory parameters collected will only be listed in an 
appendix to the CSR in their original units without SI conversions. 
Actual values and changes from baseline in clinical laboratory test results will be summarized 
using descriptive statistics.  Laboratory test values outside the normal range will be assessed for 
severity based on the normal ranges for the clinical reference laboratory.  The incidence of 
abnormal laboratory values will be tabulated. 
Laboratory data will be classified into Grades 1 through 5 using CTCAE v4.03.  The following 
summaries will be produced for the laboratory data:  
• Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of baseline value).  Each participant will be counted only for the worst 
grade observed postbaseline.  
• Shift tables from baseline to the worst postbaseline value using CTCAE grade.  The 
denominator for the percentage calculation will use the number of participants in the 
baseline category (ie, low, high, normal, missing) as the denominator for the 
percentage in each of the categories during the treatment period. 
• For laboratory parameters where CTCAE grades are not defined, shift tables to the 
worst postbaseline value using the low/normal/high classifications based on 
laboratory reference ranges. 
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8.4. 
Vital Signs 
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including systolic blood pressure, diastolic blood pressure, pulse, body temperature, and 
respiratory rate will be summarized descriptively. 
Criteria for clinically notable vital sign abnormalities are defined in Table 4.  The abnormal 
values for participants exhibiting clinically notable vital sign abnormalities will be listed.  Alert 
vital signs are defined as an absolute value outside the defined range and percentage change 
greater than 25%.  The abnormal values for participants exhibiting alert vital sign abnormalities 
will be listed. 
Table 4: 
Criteria for Clinically Notable Vital Sign Abnormalities 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
> 155 mmHg 
< 85 mmHg 
Diastolic blood pressure 
> 100 mmHg 
< 40 mmHg 
Pulse 
> 100 bpm 
< 45 bpm 
Temperature 
> 38°C 
< 35.5°C 
Respiratory rate 
> 24 breaths/min 
< 8 breaths/min 
8.5. 
Electrocardiograms 
All 12-lead ECGs will be performed as indicated in Table 5 with the participant in a recumbent 
or semirecumbent position after at least 5 minutes of rest.  Additional 12-lead ECGs may be 
performed at other visits as deemed clinically necessary.  Electrocardiograms will be interpreted 
by the investigator at the site, and the results will be used for immediate management of the 
participant's care.  The decision to include or exclude a participant or withdraw a participant 
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.  Any abnormalities that are considered clinically significant in the judgment of the 
investigator are to be reported as AEs. 
Descriptive statistics and mean change from baseline will be determined for each ECG parameter 
at each assessment time.  Change and percentage change from baseline will be calculated.  Triple 
ECGs will be measured at baseline and postbaseline visits if necessary.  Electrocardiogram 
abnormalities, both at baseline and postbaseline visits, will be tabulated.  Incidences of 
abnormalities will be listed with study visit, and a description of the abnormality. 
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INCB 54707-203 Statistical Analysis Plan 
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Table 5: 
Electrocardiogram Schedule 
Study Visit 
Timing of Electrocardiogram Relative to Administration of Study Drug 
Not Applicable 
Predose (Trough) ECG
a
 
Postdose (Postdose 2) ECG
b
 
Screening
c
 
Single  Triple
d
 
 
 
Day 1 
 
Triple
e 
Single  Tripled 
Week 4 
 
Single  Tripled 
Single  Tripled 
Week 8 
 
Single  Tripled 
 
a Predose ECG should be performed 5 to 10 minutes before the predose 
. 
b Postdose ECGs will be performed after participants complete all of the study assessments but before the collection of the 
second postdose (postdose 2) 
.  Postdose ECG will be measured 5 to 10 minutes before the postdose (postdose 2) 
 collection. 
c Prolonged QTcF values of ≥ 450 ms at screening are to be confirmed by performing 2 additional ECGs and averaging the 
results to determine whether the averaged value meets the exclusion criterion. 
d Single  Triple:  Single ECG will be performed first.  If prolonged QT interval (corrected for heart rate using Fridericia's 
formula [QTcF], defined as ≥ 450 ms) are observed, an additional 2 ECGs will be measured within the next 5 minutes.  
e Day 1 predose ECG will be performed in triplicate, and values will be averaged to calculate the baseline values. 
9. 
INTERIM ANALYSES 
No formal interim analysis is planned in this study. 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 6. 
Table 6: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
01 MAR 2019 
10.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
10.2. 
Changes to the Statistical Analysis Plan 
Not applicable. 
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INCB 54707-203 Statistical Analysis Plan 
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11. 
REFERENCES 
Kimball AB, Sobell JM, Zouboulis CC, et al. HiSCR (Hidradenitis Suppurativa Clinical 
Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with 
hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. 
J Eur Acad Dermatol Venereol 2016;30:989-994. 
Sartorius K, Lapins J, Emtestam L, Jemec GB. Suggestions for uniform outcome variables when 
reporting treatment effects in hidradenitis suppurativa. Br J Dermatol 2003;149:211-213. 
Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality 
of life into practice: what do dermatology life quality index scores mean? J Invest Dermatol 
2005;125:659-664. 
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INCB 54707-203 Statistical Analysis Plan 
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APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS 
This appendix provides a list of the planned tables, figures, and listings for the CSR.  Shells are 
provided for nonstandard tables in a separate document.  In-text tables are identical in structure 
and content as appendix tables, but follow a Rich Text Format. 
The lists of tables, figures, and listings are to be used as guidelines.  Modifications of the lists 
that do not otherwise affect the nature of the analysis will not warrant an amendment to the SAP. 
Tables 
Table No. 
Title 
Population 
Baseline and Demographic Characteristics 
1.1  Disposition 
1.1.1 
Analysis Populations 
FAS 
1.1.2 
Summary of Participant Disposition 
FAS 
1.1.3 
Summary of Number of Participants Enrolled By Site 
FAS 
1.2  Demography 
1.2.1 
Summary of Demographics 
FAS 
1.3  Baseline Characteristics 
1.3.1 
Summary of Baseline Disease Characteristics 
FAS 
1.4  Prior Medication and Concomitant Medication 
1.4.1 
Summary of Prior Medications 
FAS 
1.4.2 
Summary of Prior Medications for Hidradenitis Suppurativa 
FAS 
1.4.3 
Summary of Concomitant Medications 
FAS 
1.5  Others 
1.5.1 
Summary of General Medical History 
FAS 
1.5.2 
Summary of Protocol Deviations 
FAS 
Efficacy 
2.1.1 
Summary of Participants With a HiSCR by Visit 
FAS 
2.1.2 
Summary of Participants Achieving an AN Count of 0 to 2 by Visit 
FAS 
2.1.3.1 
Summary of HS Pain NRS Score From Baseline to End of Study (Worst Pain) 
FAS 
2.1.3.2 
Summary of HS Pain NRS Score From Baseline to End of Study (Average Pain) 
FAS 
2.1.4 
Summary of Modified Sartorius Scale Score From Baseline to Week 8 
FAS 
2.1.5 
Summary of Draining Fistulas Count From Baseline to End of Study 
FAS 
2.1.6.1 
Summary of Hurley Stage at Baseline and Week 8 
FAS 
2.1.6.2 
Summary of Hurley Stage Change From Baseline to Week 8 
FAS 
2.1.7 
Summary of HS-PGIC Category by Visit 
FAS 
2.1.7.1 
Summary of HS-PGIC by Visit 
FAS 
2.1.8 
Summary of Participants Requiring Rescue Lesional Treatment by Visit 
FAS 
2.1.9 
Summary of Interventions With Rescue Lesional Treatment by Visit 
FAS 
2.1.10.1 
Summary of DLQI Category by Visit 
FAS 
2.1.10.2 
Summary of DLQI Score From Baseline to End of Study 
FAS 
 
 
 
 
 
 
 
2.1.13 
Summary of Daily Analgesic Usage 
FAS 
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INCB 54707-203 Statistical Analysis Plan 
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Table No. 
Title 
Population 
Safety 
3.1  Study Drug Exposure 
3.1.1 
Summary of Drug Compliance  
FAS 
3.1.2 
Summary of Study Drug Exposure  
FAS 
3.2  Adverse Events 
3.2.1 
Overall Summary of Treatment-Emergent Adverse Events 
FAS 
3.2.2 
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term 
FAS 
3.2.3 
Summary of Treatment-Emergent Adverse Events by MedDRA Preferred Term in 
Decreasing Order of Frequency 
FAS 
3.2.4 
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class, Preferred Term, and Maximum Severity 
FAS 
3.2.5 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
FAS 
3.2.6 
Summary of Treatment-Related Adverse Events by MedDRA System Organ Class 
and Preferred Term 
FAS 
3.2.7 
Summary of Treatment-Related Adverse Events by MedDRA Preferred Term in 
Decreasing Order of Frequency 
FAS 
3.2.8 
Summary of Treatment-Related Adverse Events by MedDRA System Organ Class, 
Preferred Term, and Maximum Severity 
FAS 
3.2.9 
Summary of Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse 
Events by MedDRA Preferred Term 
FAS 
3.2.9.1 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by Preferred 
Term in Decreasing Order of Frequency 
FAS 
3.2.10 
Summary of Treatment-Emergent Adverse Events Leading to Death by MedDRA 
System Organ Class and Preferred Term 
FAS 
3.2.11 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term 
FAS 
3.2.12 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA Preferred 
Term in Decreasing Order of Frequency 
FAS 
3.2.13 
Summary of Treatment-Related Serious Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term 
FAS 
3.2.14 
Summary of Treatment-Emergent Adverse Events Leading to Dose Interruption by 
MedDRA System Organ Class and Preferred Term 
FAS 
3.2.15 
Summary of Treatment-Emergent Adverse Events Leading to Discontinuation of 
Treatment by MedDRA System Organ Class and Preferred Term 
FAS 
3.2.16 
Summary of Nonserious Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term
a 
FAS 
3.3  Laboratory 
3.3.1 
Summary of Laboratory Values - Hematology 
FAS 
3.3.2 
Shift Summary of Hematology Values - To the Worst Abnormal Value 
FAS 
3.3.3  
Shift Summary of Hematology Laboratory Values in CTC Grade - To the Worst 
Abnormal Value  
FAS 
3.3.4 
Summary of Laboratory Values - Chemistry 
FAS 
3.3.5 
Shift Summary of Chemistry Values - To the Worst Abnormal Value 
FAS 
3.3.6 
Shift Summary of Chemistry Laboratory Values in CTC Grade - To the Worst 
Abnormal Value 
FAS 
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INCB 54707-203 Statistical Analysis Plan 
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Table No. 
Title 
Population 
3.4  Vital Signs 
3.4.1 
Summary of Systolic Blood Pressure 
FAS 
3.4.2 
Summary of Diastolic Blood Pressure 
FAS 
3.4.3 
Summary of Pulse 
FAS 
3.4.4 
Summary of Respiratory Rate 
FAS 
3.4.5 
Summary of Body Temperature 
FAS 
3.5  ECG 
3.5.1 
Summary of PR Interval (ms) From 12-Lead ECG 
FAS 
3.5.2 
Summary of RR Interval (ms) From 12-Lead ECG 
FAS 
3.5.3 
Summary of QT Interval (ms) From 12-Lead ECG 
FAS 
3.5.4 
Summary of QRS Interval (ms) From 12-Lead ECG 
FAS 
3.5.5 
Summary of QTcB Interval (ms) From 12-Lead ECG 
FAS 
3.5.6 
Summary of QTcF Interval (ms) From 12-Lead ECG 
FAS 
3.5.7 
Summary of Treatment Emergent, Clinically Significant ECG Abnormality From 
Baseline 
FAS 
a Nonserious adverse event table will be generated for the study for the express purpose of clinical trial results posting. 
Listings 
Listing No. 
Title 
Demographic and Baseline Characteristics  
1.1.1 
Participant Enrollment and Disposition Status 
1.1.2 
Participant Inclusion and Exclusion Criteria Violations 
1.1.3 
Protocol Deviations 
1.2.1 
Demographic  
1.2.2 
Baseline Disease Characteristics  
1.3 
General Medical History  
1.4.1 
Prior and Concomitant Medications  
1.4.2 
Prior Medications for Hidradenitis Suppurativa 
1.5 
Study Drug Compliance  
Efficacy 
2.1 
HiSCR Response 
2.2 
AN Count 
2.3 
Draining Fistula Count 
2.4 
HS Pain NRS Score 
2.5 
Modified Sartorius Scale 
2.6 
Hurley Stage 
2.7 
HS-PGIC Category 
2.8 
Rescue Lesional Treatment 
2.9 
DLQI 
 
 
 
 
 
 
Adverse Events and Exposure 
3.1 
Study Drug Administration 
3.2.1 
Adverse Events 
3.2.2 
Serious Treatment-Emergent Adverse Events 
3.2.3 
Adverse Events Leading to Death 
3.2.4 
Treatment-Related Adverse Events 
3.2.5 
Adverse Events Leading to Dose Interruption 
3.2.6 
Adverse Events Leading to Discontinuation 
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Listing No. 
Title 
Laboratory Data 
3.3.1 
Clinical Laboratory Values – Hematology  
3.3.2 
Clinical Laboratory Values – Serum Chemistry  
3.3.3 
Abnormal Clinical Laboratory Values – Hematology  
3.3.4 
Abnormal Clinical Laboratory Values – Serum Chemistry  
 
  
3.3.6 
Central Laboratory Collection Times  
Vital Signs 
3.4.1 
Vital Signs 
3.4.2 
Abnormal Vital Sign Values 
3.4.3 
Alert Vital Sign Values 
ECG 
3.5.1 
12-Lead ECG Values 
3.5.2 
Abnormal 12-Lead ECG Values 
3.5.3 
Alert 12-Lead ECG Values 
 
CONFIDENTIAL