Clinical trial NCT04476043
Conditions: Hidradenitis Suppurativa Acne Inversa
Sponsor: Incyte Corporation
Start date: 2020-08-25; Completion date: 2023-08-16
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).

Detailed description:

Arms: arm 1: Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. arm 2: Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. arm 3: Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks. arm 4: Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
Interventions: intervention 1: INCB054707 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral; Tablet intervention 2: Oral; Tablet

Protocol documents:
Prot_000.pdf: 
Official Title: 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-
Ranging Study of the Efficacy and Safety of INCB054707 in 
Participants With Hidradenitis Suppurativa 
NCT Number: 
NCT04476043 
Document Date: 
Clinical Study Protocol Version 2: 10-September-2021 


Incyte Corporation  
Page 1 of 93 
Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474
CONFIDENTIAL 
TITLE PAGE 
Clinical Study Protocol 
INCB 54707-204 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 
Dose-Ranging Study of the Efficacy and Safety of INCB054707 
in Participants With Hidradenitis Suppurativa 
Product: 
INCB054707 
IND Number: 
 
EudraCT Number: 
2020-001981-13 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol: 
29 APR 2020 
Amendment 1: 
10 SEP 2021 
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. 


Incyte Corporation  
Page 2 of 93 
Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
INVESTIGATOR'S AGREEMENT 
I have read the INCB 54707-204 Protocol Amendment 1 (dated 10 SEP 2021) 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) 


Incyte Corporation  
Page 3 of 93 
Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY ..........................................................................................11 
2. 
INTRODUCTION ......................................................................................................18 
2.1. 
Background .................................................................................................................18 
2.1.1. 
Study Rationale ...........................................................................................................18 
2.1.2. 
Scientific Rationale for Study Design ........................................................................18 
 
19 
 
20 
 
20 
2.2. 
Benefit/Risk Assessment ............................................................................................21 
2.2.1. 
Clinical Studies ...........................................................................................................21 
2.2.2. 
Benefit Assessment .....................................................................................................23 
2.2.3. 
Benefit-Risk Conclusion .............................................................................................23 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................24 
4. 
STUDY DESIGN .......................................................................................................31 
4.1. 
Overall Design ............................................................................................................31 
4.2. 
Overall Study Duration ...............................................................................................32 
4.3. 
Study Termination ......................................................................................................32 
5. 
STUDY POPULATION .............................................................................................33 
5.1. 
Inclusion Criteria ........................................................................................................33 
5.2. 
Exclusion Criteria .......................................................................................................34 
5.3. 
Lifestyle Considerations .............................................................................................36 
5.4. 
Screen Failures ............................................................................................................37 
5.5. 
Replacement of Participants .......................................................................................37 
5.6. 
Data Monitoring Committee .......................................................................................37 
6. 
STUDY TREATMENT ..............................................................................................37 
6.1. 
Study Treatments Administered .................................................................................37 
6.2. 
Preparation, Handling, and Accountability ................................................................40 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................40 


Incyte Corporation  
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Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
6.4. 
Study Treatment Compliance .....................................................................................41 
6.5. 
Dose Modifications .....................................................................................................41 
6.5.1. 
Criteria and Procedures for Dose Interruptions and Adjustments of Study 
Drug ............................................................................................................................41 
6.5.2. 
Criteria for Permanent Discontinuation of Study Drug ..............................................44 
6.6. 
Concomitant Medications and Procedures .................................................................45 
6.6.1. 
Permitted Medications and Procedures ......................................................................45 
6.6.1.1. 
Analgesic Therapy ......................................................................................................45 
6.6.1.2. 
Wound Care ................................................................................................................45 
6.6.2. 
Restricted Medications and Procedures ......................................................................46 
6.6.3. 
Prohibited Medications and Procedures .....................................................................47 
6.6.4. 
Rescue Interventions ...................................................................................................47 
6.6.4.1. 
Types of Rescue Intervention .....................................................................................48 
6.6.4.2. 
Number of Rescue Interventions ................................................................................48 
6.7. 
Treatment After the End of the Study .........................................................................48 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
WITHDRAWAL ........................................................................................................49 
7.1. 
Discontinuation of Study Treatment ...........................................................................49 
7.1.1. 
Reasons for Discontinuation .......................................................................................49 
7.1.2. 
Discontinuation Procedures ........................................................................................49 
7.2. 
Participant Withdrawal From the Study .....................................................................50 
7.3. 
Lost to Follow-Up.......................................................................................................50 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................51 
8.1. 
Administrative and General Procedures .....................................................................51 
8.1.1. 
Informed Consent Process ..........................................................................................51 
8.1.2. 
Screening Procedures ..................................................................................................52 
8.1.3. 
Interactive Response Technology Procedure ..............................................................52 
8.1.4. 
Distribution of Study Reminder Cards and Diaries ....................................................52 
8.1.5. 
Demography and Medical History ..............................................................................52 
8.1.5.1. 
Demographics and General Medical History .............................................................52 
8.1.5.2. 
Disease Characteristics and Treatment History ..........................................................53 
8.1.6. 
Follow-Up Phone Call ................................................................................................53 
8.2. 
Efficacy Assessments .................................................................................................53 


Incyte Corporation  
Page 5 of 93 
Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
8.2.1. 
Lesion Counts .............................................................................................................53 
8.2.1.1. 
AN and ANF Counts ..................................................................................................54 
8.2.1.2. 
Hidradenitis Suppurativa Clinical Response ..............................................................54 
8.2.1.3. 
International Hidradenitis Suppurativa Severity Score System ..................................54 
 
55 
8.2.2. 
Hurley Stages of Hidradenitis Suppurativa ................................................................55 
 
55 
 
55 
 
56 
 
56 
 
56 
 
56 
 
57 
 
58 
 
58 
 
59 
 
59 
 
59 
8.3. 
Safety Assessments .....................................................................................................60 
8.3.1. 
Adverse Events ...........................................................................................................60 
8.3.2. 
Physical Examinations ................................................................................................60 
8.3.3. 
Vital Signs ..................................................................................................................61 
8.3.4. 
Electrocardiograms .....................................................................................................61 
8.3.5. 
Chest X-Ray ................................................................................................................61 
8.3.6. 
Tuberculosis Screening ...............................................................................................61 
8.3.7. 
Laboratory Assessments .............................................................................................62 
8.3.7.1. 
Serology Testing .........................................................................................................64 
8.3.7.2. 
Pregnancy Testing ......................................................................................................64 
 
64 
 
64 
 
65 
 
65 
8.6. 
Unscheduled Visits .....................................................................................................66 


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Incyte Corporation  
Page 7 of 93 
Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
11.4. 
Financial Disclosure ...................................................................................................82 
11.5. 
Publication Policy .......................................................................................................82 
11.6. 
Study and Site Closure................................................................................................83 
12. 
REFERENCES ...........................................................................................................84 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS ...............................................................................86 
 
87 
88 
APPENDIX D. PROTOCOL AMENDMENT SUMMARY OF CHANGES ...........................91 
 
LIST OF TABLES 
Table 1: 
Primary and Key Secondary Objectives and Endpoints .............................................11 
Table 2: 
Key Study Design Elements .......................................................................................11 
Table 3: 
Schedule of Activities .................................................................................................14 
 
22 
Table 5: 
Objectives and Endpoints ...........................................................................................24 
 
38 
 
42 
Table 8: 
Definition of Hidradenitis Suppurativa Lesions .........................................................54 
Table 9: 
Hurley Stages of Hidradenitis Suppurativa ................................................................55 
Table 10: Required Laboratory Analytes ....................................................................................63 
65 
66 
Table 13: Populations for Analysis .............................................................................................75 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................12 
Figure 2: 
Control of the Overall Type I Error Rate ....................................................................76 
 


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Incyte Corporation  
Page 11 of 93 
Protocol INCB 54707-204 Am 1 
Version 2 
10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 
Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa 
Protocol Number:  INCB 54707-204 
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 efficacy of INCB054707 
• Mean change of AN count at Week 16 relative to 
baseline. 
Key Secondary 
To further evaluate the efficacy of INCB054707 
• Proportion of participants who achieve HiSCR at 
Week 16.  Hidradenitis suppurativa clinical 
response is defined as at least a 50% decrease 
from baseline in AN count with no increase in the 
number of abscesses or draining fistulas. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 
Table 2: 
Key Study Design Elements 
Study Phase 
Phase 2 
Clinical Indication 
Treatment of patients 18 years and older with hidradenitis suppurativa. 
Population 
Men or women aged 18 to 75 years who have been diagnosed with HS (Hurley 
Stage I, II, or III) for at least 3 months with a total AN count of at least 5 and 
inflammatory lesions that affect at least 2 distinct anatomical areas. 
Number of 
Participants 
Approximately 200 participants will be randomized 1:1:1:1 to 1 of 
3 INCB054707 treatment groups or the placebo group (approximately 
50 participants per group).  Participants will be enrolled globally from 
approximately 50 study sites. 
The 36-week OLE period will include all participants who successfully 
complete the initial 16-week treatment period (placebo-controlled). 
All eligible participants will be invited to continue treatment for an additional 
48-week LTE period (also open label). 


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Table 2: 
Key Study Design Elements (Continued) 
Study Design 
This is a Phase 2, multicenter, parallel group, placebo-controlled, double-blind, 
randomized study to evaluate the efficacy and safety of INCB054707 (15, 45, 
and 75 mg QD) over a 16-week treatment period.  Upon completion of the 
16-week treatment period, participants will continue for 36 weeks of 
open-label INCB054707 treatment (75 mg QD).  At the end of the OLE, all 
eligible participants will have the option to continue treatment for additional 
48 weeks in an LTE period, to collect long-term safety and efficacy data for a 
total of 104 weeks.  A safety follow-up visit will be conducted approximately 
4 weeks after the last dose of study drug. 
Estimated Duration 
of Study 
Participation 
Up to 30 days for screening, followed by continuous treatment in the 
placebo-controlled period for 16 weeks, followed by a 36-week OLE period, 
an optional 48-week LTE period, and then a 28-day safety follow-up visit.  It 
is estimated that an individual will participate for approximately 14 months 
(without the LTE period), or approximately 25 months if participating in the 
LTE period. 
DMC 
Yes (internal) 
Coordinating 
Principal 
Investigator 
Joslyn Sciacca Kirby, MD, MS, MEd 
Treatment Groups and Duration: 
The study design is shown in Figure 1.  The SoA is detailed in Table 3. 
Figure 1: 
Study Design Schema 
 
After providing informed consent, participants will be assessed for study eligibility at the 
screening visit.  Participants will undergo screening within 30 days prior to randomization.  
Participants who continue to meet eligibility criteria at baseline will undergo Day 1 (Week 0) 
assessments and be randomized to 1 of 4 treatment groups.  Participants will be stratified based 
on geographical region (North America and outside of North America) and disease severity 
(Hurley Stages I, II, and III) with no more than 25% of the total number of participants as Hurley 
Stage III. 
Approximately 200 participants will be randomized 1:1:1:1 to receive double-blinded study 
treatment of placebo or 1 of 3 doses of INCB054707 (15, 45, or 75 mg) PO QD for 16 weeks.  At 
Week 16, participants will enter the 36-week OLE period (INCB054707 75 mg QD).  At the 


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completion of the OLE period, Week 52 visit, eligible participants may enter the 48-week LTE 
period.  A safety follow-up visit will be scheduled approximately 4 weeks after the end of the 
OLE period (Week 56 visit) or the LTE period (Week 104 visit). 
Study visits will occur at screening, baseline (Day 1/Week 0), Weeks 2, 4, 6, 8, 12, 16 (EOT1), 
18, 20, 22, 24, 28, 32, 36, 40, 44, 48, 52 (EOT2), 56 (EOS, for participants not continuing into 
the LTE) and early termination if the participant discontinues before Week 16 (ET1) or during 
the OLE period and before Week 52 (ET2).  After Week 52, the study visits during the optional 
LTE period will occur at Weeks 60, 68, 76, 84, 92, 100 (EOT3), 104 (EOS), and early 
termination if the participant discontinues during the LTE period and before Week 100 (ET3).  
Each visit denoted by Week 2, Week 4, Week 6, etc represents a target visit date corresponding 
to the end of the specified week; therefore, Weeks 2, 4, and 6 respectively represent Days 14, 28, 
and 42 of the study.  Additionally, all participants will be contacted by phone 1 week before the 
baseline visit (Day 1/Week 0) to ensure that daily assessments 
 
 are being recorded. 
Visits in the LTE are named to reflect continuation from the OLE study, with the first visit of the 
LTE occurring at Week 52.  The eligibility assessment for the LTE occurs at Week 52.  
Participants who enter the safety-follow period immediately after the Week 52 visit are not 
allowed to start the LTE period.  Participants who are currently tolerating INCB054707 in the 
OLE, as assessed by the investigator, and who demonstrate willingness and ability to comply 
with the scheduled visits, will be considered eligible for the LTE period.  Furthermore, details on 
the LTE dose assignment and dose change are described in Section 2.1.5 and Section 6.5.1. 
Efficacy 
 will be assessed throughout the study at selected visits (see Table 3).  Safety 
and tolerability will be evaluated throughout the study.  Adherence to the study design 
requirements, including those specified in the SoA (see Table 3), is essential and required for 
study conduct. 


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Table 3: 
Schedule of Activities 
Visit Day/Range 
Section 
Screening 
Baseline 
(W0/Day 1) 
Treatment 
(Placebo-Controlled Period) 
Treatment 
(Open-Label Extension) 
Treatment 
(Long-Term 
Extension) 
Follow-Up 
Days 
-30 to -1 
W2 
± 3d 
W4 
± 3d 
W6 
± 3d 
W8 
± 3d 
W12 
± 3d 
W16 
± 3d; 
EOT1 
(or 
ET1) 
W18, W20, 
W22 and 
W24; 
± 3d 
W28-W48, 
visits every 
4 weeks; 
± 3d 
W52 
± 3d; 
EOT2 
(or 
ET2) 
W60-W92, 
visits 
every 
8 weeks; 
± 7d 
W100 
± 7d; 
EOT3 
(or 
ET3) 
W56 + 7d or 
W104 + 7d; or 
28 (+ 7) days 
after last dose 
of study drug 
(EOS) 
Administrative Procedures 
Informed consent 
8.1.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
5.1/5.2 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic, HS disease 
history, alcohol use, and 
medical history 
8.1.5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nicotine use 
8.1.5 
X 
 
 
 
 
 
 
X 
 
 
X 
 
X 
 
Prior/concomitant 
medications 
8.1.5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Contact IRT 
8.1.3 
X 
X 
 
X 
 
X 
X 
X 
X 
(W20, 
W24) 
X 
X 
X 
X 
 
Randomization to 
treatment group 
8.1.3 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Dispense study drug 
8.1.3 
 
X 
 
X 
 
X 
X 
X 
X 
(W20, 
W24) 
X 
X 
(LTE 
only) 
X 
 
 
Collect study drug and 
assess compliance 
6.4 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Distribute reminder card 
8.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Distribute diary 
8.1.4 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diary review and/or 
collection 
8.1.4 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Follow-up phone call 
8.1.6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Table 3: 
Schedule of Activities (Continued) 
Visit Day/Range 
Section 
Screening 
Baseline 
(W0/Day 1) 
Treatment 
(Placebo-Controlled Period) 
Treatment 
(Open-Label Extension) 
Treatment 
(Long-Term 
Extension) 
Follow-Up 
Days 
-30 to -1 
W2 
± 3d 
W4 
± 3d 
W6 
± 3d 
W8 
± 3d 
W12 
± 3d 
W16 
± 3d; 
EOT1 
(or 
ET1) 
W18, W20, 
W22 and 
W24; 
± 3d 
W28-W48, 
visits every 
4 weeks; 
± 3d 
W52 
± 3d; 
EOT2 
(or 
ET2) 
W60-W92, 
visits 
every 
8 weeks; 
± 7d 
W100 
± 7d; 
EOT3 
(or 
ET3) 
W56 + 7d or 
W104 + 7d; or 
28 (+ 7) days 
after last dose 
of study drug 
(EOS) 
Safety Assessments 
AE assessments 
8.3.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Comprehensive physical 
examination 
8.3.2 
X 
X 
 
 
 
 
 
X 
 
 
X 
 
X 
 
Targeted physical 
examination 
8.3.2 
 
 
X 
X 
 
X 
X 
 
X 
(W18, 
W20, W24) 
X 
 
X 
 
X 
Vital signs 
8.3.3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
8.3.4 
X 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
Chest x-ray 
8.3.5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Efficacy Assessments 
Lesion counts 
8.2.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hurley stage 
8.2.2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 


Incyte Corporation  
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Protocol INCB 54707-204 Am 1 
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CONFIDENTIAL 
Table 3: 
Schedule of Activities (Continued) 
Visit Day/Range 
Section 
Screening 
Baseline 
(W0/Day 1) 
Treatment 
(Placebo-Controlled Period) 
Treatment 
(Open-Label Extension) 
Treatment 
(Long-Term 
Extension) 
Follow-Up 
Days 
-30 to -1 
W2 
± 3d 
W4 
± 3d 
W6 
± 3d 
W8 
± 3d 
W12 
± 3d 
W16 
± 3d; 
EOT1 
(or 
ET1) 
W18, W20, 
W22 and 
W24; 
± 3d 
W28-W48, 
visits every 
4 weeks; 
± 3d 
W52 
± 3d; 
EOT2 
(or 
ET2) 
W60-W92, 
visits 
every 
8 weeks; 
± 7d 
W100 
± 7d; 
EOT3 
(or 
ET3) 
W56 + 7d or 
W104 + 7d; or 
28 (+ 7) days 
after last dose 
of study drug 
(EOS) 
Laboratory Assessments 
Serum FSH (WONCBP 
only) 
8.3.7.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum pregnancy test 
(WOCBP) 
8.3.7.2 
X 
 
 
 
 
 
 
X 
 
 
X 
 
X 
 
Urine pregnancy test 
(WOCBP) 
8.3.7.2 
 
X 
 
X 
 
X 
X 
 
X 
(W20, 
W24) 
X 
 
X 
 
X 
TB screening 
8.3.6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV testing 
8.3.7.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis testing 
8.3.7.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 


Incyte Corporation  
Page 17 of 93 
Protocol INCB 54707-204 Am 1 
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10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
Table 3: 
Schedule of Activities (Continued) 
Visit Day/Range 
Section 
Screening 
Baseline 
(W0/Day 1) 
Treatment 
(Placebo-Controlled Period) 
Treatment 
(Open-Label Extension) 
Treatment 
(Long-Term 
Extension) 
Follow-Up 
Days 
-30 to -1 
W2 
± 3d 
W4 
± 3d 
W6 
± 3d 
W8 
± 3d 
W12 
± 3d 
W16 
± 3d; 
EOT1 
(or 
ET1) 
W18, W20, 
W22 and 
W24; 
± 3d 
W28-W48, 
visits every 
4 weeks; 
± 3d 
W52 
± 3d; 
EOT2 
(or 
ET2) 
W60-W92, 
visits 
every 
8 weeks; 
± 7d 
W100 
± 7d; 
EOT3 
(or 
ET3) 
W56 + 7d or 
W104 + 7d; or 
28 (+ 7) days 
after last dose 
of study drug 
(EOS) 
Laboratory Assessments (Continued) 
Urinalysis 
8.3.7.1 
X 
 
 
 
 
X 
 
X 
X 
(W24) 
X 
(W32) 
X 
X 
(W76) 
X 
 
Urine nicotine metabolite 
8.3.7 
 
X 
 
 
 
 
 
X 
 
 
X 
 
X 
 
Hematology and chemistry 
assessments 
8.3.7 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Lipid panel 
8.3.7 
 
X 
 
 
 
X 
 
X 
X (W24) 
X 
(W32, 
W40) 
X 
X 
X 
X 
Inflammation markers 
8.3.7 
X 
X 
 
X 
 
X 
 
X 
X 
(W24) 
X 
(W32, 
W40) 
X 
X 
X 
X 
 


Incyte Corporation  
Page 18 of 93 
Protocol INCB 54707-204 Am 1 
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2. 
INTRODUCTION 
INCB054707 is a JAK inhibitor, with selectivity for JAK1.  Janus kinase signaling regulates 
many different proinflammatory signaling pathways and is now well-recognized as a key driver 
for numerous inflammatory skin diseases. 
 
results from a recent 
Phase 2a study with INCB054707 demonstrated proof of concept in HS. 
 
 and supports 
further investigation of oral INCB054707 in a Phase 2 dose-ranging study in participants with 
HS. 
2.1. 
Background 
2.1.1. 
Study Rationale 
Hidradenitis suppurativa is a chronic inflammatory disease characterized by painful nodules and 
abscesses, distributed to apocrine-bearing skin (sweat glands) that appears to result from a 
pathologic change in the pilosebaceous-apocrine unit (Hoffman et al 2017). 
 
 
In 2 clinical studies of participants with HS, INCB 54707-202 (15 mg only) and 
INCB 54707-203 (placebo and 30, 60, and 90 mg), INCB054707 QD was administered for up to 
8 weeks and proof-of-concept was established by demonstrating a decrease in AN count, a 
percentage of participants achieving HiSCR, and an improvement in quality of life, in addition to 
an adequate safety profile.  With the goal of informing dose selection for future Phase 3 clinical 
trials, the proposed study aims to further explore the efficacy and safety of INCB054707 in 
addition to its dose-response curve in participants with HS. 
2.1.2. 
Scientific Rationale for Study Design 
Recent literature suggests that the cytokines IL-1β, IL-17, IL-23, IL-10, and, to a lesser extent, 
 
 
 
 
 
 Adalimumab (Humira®), a TNF-α fully human monoclonal antibody administered 
via subcutaneous injection, was approved in 2015 by the FDA for the treatment of moderate to 
severe HS in patients 12 years of age and older and currently remains the only approved therapy.  
Given the modest response rates observed with adalimumab treatment (42% and 59% vs placebo 
26% and 28%, respectively in each of the Phase 3 trials) and the significant dropout rates in 
existing studies due to lack of efficacy (27% to 50%; Frew et al 2020), additional  treatments for 
HS patients are needed. 
In the proposed study, the clinical efficacy and safety of 3 doses (15, 45, and 75 mg) of 
INCB054707, a small molecule JAK1 inhibitor, will be evaluated in adult participants with HS 


Incyte Corporation  
Page 19 of 93 
Protocol INCB 54707-204 Am 1 
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CONFIDENTIAL 
and compared with placebo for 16 weeks.  Since HS is a chronic inflammatory disorder, all 
participants will enter the 36-week OLE period to evaluate the long-term safety and efficacy of 
INCB054707 in HS (up to 52 weeks in total).  Participants will receive INCB054707 75 mg QD 
in the OLE period.  To further evaluate long-term safety and efficacy of INCB054707 in HS, all 
eligible participants will have the option to continue treatment for an additional 48 weeks (LTE 
period).  Participants who are currently tolerating INCB054707 in the OLE, as assessed by the 
investigator, and who demonstrate willingness and ability to comply with the scheduled visits, 
will be considered eligible for the LTE period. 
The primary efficacy endpoint is based on the count of AN, as this appears to be a relevant 
measure of INCB054707 anti-inflammatory activity.  The AN count also serves as the basis of 
the key secondary endpoint, HiSCR, which is defined as at least a 50% decrease in AN count 
with no increase in the number of abscesses or draining fistulas, relative to baseline.  Participants 
who experience rapid abscess formation at diseased sites will receive appropriate rescue 
treatments. 
It is expected that the outcome of this study will be instrumental in the selection of a single 
treatment regimen to be evaluated in a Phase 3 study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Incyte Corporation  
Page 21 of 93 
Protocol INCB 54707-204 Am 1 
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2.2. 
Benefit/Risk Assessment 
More detailed information about the known and expected benefits and risks, and reasonably 
expected AEs of INCB054707, may be found in the IB. 
2.2.1. 
Clinical Studies 
Single doses of INCB054707 up to 405 mg and multiple doses of INCB054707 up to 120 mg 
QD for up to 10 days have been evaluated in 2 placebo-controlled studies in healthy participants.  
The most common TEAEs were mild-to-moderate headaches in 31% of participants who 
received INCB054707 in the multiple-dose study; the events resolved spontaneously following 
discontinuation of INCB054707.  Furthermore, decreases in platelet counts were observed 
among participants treated with INCB054707 at doses ≥ 60 mg QD.  The magnitude of the 
decrease was larger for participants treated at 120 mg QD compared with those who received 
60 mg QD suggesting a dose-related trend.  Of note, for the participants with a 
treatment-emergent decrease in platelets, platelet counts remained within the normal range. 
In 2 clinical studies in participants with HS, INCB 54707-202 (15 mg only) and 
INCB 54707-203 (placebo and 30, 60, and 90 mg), QD doses of study treatment were 
administered for up to 8 weeks.  Thrombocytopenia was observed in 4 of 8 participants who 
received INCB054707 90 mg QD after 4 weeks of exposure, which lead to dose interruption for 
a maximum of 2 weeks, and resolved without medical intervention.  All participants returned to 
their normal dosing schedule after dose interruption and completed the study without clinical 
sequelae or reemergence of thrombocytopenia.  Platelet count decreases have been transient and 
stabilize over time, as observed in studies with other JAK1 inhibitors for treatment of other 
dermatological indications, such as abrocitinib in atopic dermatitis (Gooderham et al 2019) and 
itacitinib in plaque psoriasis (Bissonnette et al 2016).  Thrombocytopenia TEAEs were judged as 
treatment-related.  Hemoglobin levels remained within the normal limits and mostly unchanged 
during the study, while neutrophil counts showed a mild dose-dependent decrease within the 
normal limits.  Mild-to-moderate headaches were observed in 11% (4 of 36) of the participants 
exposed to INCB054707, and in 22% (2 of 9) of participants exposed to placebo.  Across the 
2 studies, the most common TEAE was fatigue, observed in 7 out of the 45 participants; 
clinically significant fatigue, identified via FACIT-Fatigue scores, has been reported as affecting 


Incyte Corporation  
Page 22 of 93 
Protocol INCB 54707-204 Am 1 
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10 SEP 2021 
VV-CLIN-010474 
CONFIDENTIAL 
40% of patients with HS (Dufour et al 2014).  No serious or fatal TEAEs were reported in the 
studies; more details are provided in the IB. 
Based on the available nonclinical and clinical data, the potential risks to participants and the risk 
mitigations are summarized in Table 4. 


Incyte Corporation  
Page 23 of 93 
Protocol INCB 54707-204 Am 1 
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10 SEP 2021 
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2.2.2. 
Benefit Assessment 
Based on the expected mode of action of INCB054707, participants randomly assigned to 1 of 
the 3 active treatment groups may experience clinically meaningful improvements in their HS 
lesions during the placebo-controlled (16-week) period, and may continue to receive benefit 
from treatment during the OLE (36 weeks) and LTE (48 weeks) periods. 
Participants 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 patients' well-being and daily 
functioning. 
2.2.3. 
Benefit-Risk Conclusion 
Considering the safety measures initiated 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 participants. 


Incyte Corporation  
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Protocol INCB 54707-204 Am 1 
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10 SEP 2021 
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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 efficacy of INCB054707 
• Mean change of AN count at Week 16 relative 
to baseline. 
Secondary 
To further evaluate the efficacy of INCB054707 
• Key secondary endpoint:  Proportion of 
participants who achieve HiSCR at Week 16.  
Hidradenitis suppurativa clinical response is 
defined as at least a 50% decrease from baseline 
in AN count with no increase in the number of 
abscesses or draining fistulas. 
• Proportion of participants who achieve HiSCR 
at each visit from Weeks 2 to 12. 
• Proportion of participants who achieve at least a 
75% decrease from baseline in AN count with 
no increase in the number of abscesses or 
draining fistulas from Weeks 2 to 16. 
• Mean change from baseline in the severity of 
the disease, as assessed by the IHS4 score, from 
Weeks 2 to 16. 
• Proportion of participants achieving AN50, 
AN75, AN90, and AN100 (at least 50%, 75%, 
90%, and 100% reduction in AN count relative 
to baseline, respectively) from Weeks 2 to 16. 
• Mean change in AN count at Weeks 2 to 12, 
relative to baseline. 
• Proportion of participants with a total AN count 
of 0 to 2 from Weeks 2 to 16. 
• Mean change in draining fistula count from 
Weeks 2 to 16, relative to baseline. 
• Mean change in ANF count from Weeks 2 to 
16, relative to baseline. 
To evaluate the safety and tolerability of 
INCB054707 
• Frequency and severity of AEs, including the 
evaluation of clinical laboratory results, vital 
signs, ECGs, and the results of physical 
examinations. 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This is a Phase 2, multicenter, randomized, parallel group, placebo-controlled, dose-ranging 
study to evaluate the efficacy and safety of INCB054707 (15, 45, and 75 mg QD) over a 
16-week treatment period followed by a 36-week OLE period (INCB054707 75 mg QD) and an 
additional optional 48-week long-term extension period (LTE).  The study will enroll men and 
women aged 18 to 75 years with HS.  Approximately 200 participants will be enrolled globally.  
Figure 1 presents the study design schema, and Table 3 presents the SoA. 
Participants will be screened for up to 4 weeks before the first dose of study drug.  Key entry 
criteria for participants are diagnosis of HS (Hurley Stage I, II, or III) for at least 3 months and a 
total AN count of at least 5 at screening and baseline affecting at least 2 distinct anatomical 
areas.  Participants will also agree to NOT use topical antiseptics on the areas affected by HS 
lesions as well as systemic antibiotics (for HS treatment) during the placebo-controlled 
(16-week) period.  Individual lesion rescue treatment (incision and drainage or intralesional 
corticosteroid injection) will be allowed during the 16-week placebo-controlled, OLE and LTE 
periods, and is further discussed in Section 6.6.4.  Screening will include medical and medication 
history, physical examination including clinical assessments, vital sign measurements, routine 
laboratory assessments, pregnancy testing, and ECGs. 
Participants who meet all the study inclusion criteria and none of the exclusion criteria will 
return to the study site on Day 1/Week 0 of dosing and be randomized to treatment in a 
1:1:1:1 ratio to 1 of 4 treatment groups (placebo or INCB054707 15, 45, or 75 mg).  Participant 
randomization will be stratified based on geographical region (North America and outside of 
North America) and disease severity (Hurley Stages I, II, and III) with no more than 25% of the 
total number of participants as Hurley Stage III. 
Approximately 200 participants will receive blinded study treatment of placebo or 1 of 3 doses 
of INCB054707 PO QD for 16 weeks.  At Week 16, participants will enter the 36-week OLE 
period (INCB054707 75 mg QD).  At the completion of the OLE period, all eligible participants 
will have the option to continue treatment for an additional 48 weeks (LTE period).  A safety 
follow-up visit will be scheduled 4 weeks after the last dose of study drug. 
The eligibility assessment for the LTE period will occur at Week 52.  Participants who enter the 
safety-follow period immediately after the Week 52 visit are not allowed to start the LTE period.  
Participants who are currently tolerating INCB054707 in the OLE as assessed by the 
investigator, and who demonstrate willingness and ability to comply with the scheduled visits, 
will be considered eligible for the LTE period. 
Efficacy will be assessed via mean change in AN count, mean change in ANF count, proportion 
of participants achieving HiSCR, mean change in IHS4, mean change in draining fistula count, 
 
 
 
Participants will be assessed for safety and tolerability by monitoring the frequency and severity 
of AEs, performing physical examinations, ECGs, vital sign measurements, and clinical 
laboratory assessments at various timepoints during the study. 


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4.2. 
Overall Study Duration 
Participants will be on-study for a duration of up to 60 weeks (if not participating in the LTE), or 
108 weeks (if participating in the LTE), as follows:  screening, up to 30 days; placebo-controlled 
period, 16 weeks; OLE period, 36 weeks; LTE period, 48 weeks; and a 28-day (+ 7 days) safety 
follow-up. 
The study begins when the first participant (or guardian or legally authorized representative) 
signs the ICF.  The end of the study is defined as the date of the last visit of the last participant in 
the study or the last scheduled procedure shown in the SoA for the last participant in the study. 
A participant who does not continue into the LTE period is considered to have completed the 
study if he/she has completed both the placebo-controlled period and the OLE period of the 
study, including the last visit or the last scheduled procedure shown in the SoA.  A participant 
who continues into the LTE period is considered to have completed the study if he/she has 
completed the placebo-controlled; OLE and LTE periods of the study, including the last visit or 
the last scheduled procedure shown in the SoA (see Table 3). 
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 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 if, for example, required by regulatory decision.  
If the study is terminated prematurely, the sponsor will notify the investigators, the IRBs and 
IECs, and the regulatory bodies of the decision and reason for termination of the study. 


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5. 
STUDY POPULATION 
The study population will include men and women aged 18 to 75 years who have had a diagnosis 
of HS (Hurley Stage I, II, or III) for at least 3 months and who have at least a 5 AN count at 
screening and baseline with inflammatory lesions that affect at least 2 distinct anatomical areas. 
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 age 18 to 75 years inclusive at the time of signing the ICF. 
2. HS disease duration of at least 3 months before screening. 
3. Diagnosis of HS defined as: 
a. A total of at least 5 inflammatory lesions (AN) at screening AND baseline 
AND 
b. Inflammatory lesions present in at least 2 distinct anatomical areas 
4. Willingness to avoid pregnancy or fathering children based on the criteria below. 
a. Male participants with childbearing potential must agree to take appropriate 
precautions to avoid fathering children (with at least 99% certainty) from screening 
through 90 days after the last dose of study drug and must 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 participants 
and their understanding confirmed. 
b. Female participants with childbearing potential must have a negative serum 
pregnancy test at screening 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. Female participants without childbearing potential (ie, surgically sterile with a 
hysterectomy and/or bilateral oophorectomy OR postmenopausal, defined as 
amenorrhea ≥ 12 months prior to screening), confirmed by FSH levels at screening, 
are eligible. 
5. Participants agree NOT to use topical antiseptics (see Section 6.6.2) on the areas affected 
by HS lesions during the placebo-controlled 16-week treatment period. 
6. For Germany only, participants must have a history of inadequate response or intolerance 
to an adequate course of oral antibiotics for treatment of HS, as assessed by the 
investigator through study participant interview and review of medical history. 


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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Inability of the participant (or guardian or legally authorized representative) to 
comprehend the ICF or unwillingness to sign the ICF. 
2. Presence of > 20 draining fistulas at screening or baseline. 
3. Women who are pregnant (or who are considering pregnancy) or lactating. 
4. Participants with concurrent conditions or history of other diseases, as follows: 
a. Thrombocytopenia, coagulopathy, or platelet dysfunction. 
b. Any clinically significant medical condition other than HS, as determined by the 
investigator, that is not adequately controlled with appropriate treatment OR may 
interfere with the course, severity, or assessments of HS. 
c. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) 
that may interfere with the course, severity, or assessments of HS. 
d. Active systemic viral infection or any active viral infection that, based on the 
investigator's clinical assessment, makes the participant an unsuitable candidate for 
the study. 
e. Current herpes zoster infection, a history of disseminated herpes simplex, or a history 
of herpes zoster. 
f. History of malignancy, including lymphoma and leukemia within 5 years before 
baseline, other than a successfully treated nonmetastatic cutaneous squamous cell 
carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix. 
g. Albinism. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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6. Prolonged QTcF, defined as ≥ 450 milliseconds. 
Note:  Prolonged QTcF values of ≥ 450 milliseconds at screening are to be confirmed by 
performing 2 additional ECGs and averaging the results to determine if the averaged 
value meets the exclusion criterion. 
7. Have evidence of active or latent or inadequately treated infection with Mycobacterium 
tuberculosis (ie, TB) as defined by the following: 
• A positive QuantiFERON®-TB Gold In-Tube test (QFT-GIT) or positive 
Mantoux/PPD tuberculin skin test (if appropriate, per Section 8.3.6) performed at or 
within the 12 weeks prior to Day 1 is exclusionary; a negative test is required for 
eligibility.  It is recommended that participants with a history of Bacille Calmette 
Guérin vaccination be tested with the QFT-GIT, since the Mantoux/PPD tuberculin 
skin test may be positive due to vaccination.  See Section 8.3.6 for requirements for 
Mantoux/PPD tuberculin skin testing.  A QFT-GIT or Mantoux/PPD tuberculin skin 
test is not required if the participant has previously received a documented adequate 
course of therapy for either latent or active TB infection. 
• A history of either untreated or inadequately treated latent or active TB infection. 


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• If a participant has previously received an adequate course of therapy for either latent 
(9 months of isoniazid in a locale where rates of primary multidrug TB resistance are 
< 5% or an acceptable alternative regimen) or active (acceptable multidrug regimen) 
TB infection, neither a QFT-GIT nor a Mantoux/PPD tuberculin skin test is needed, 
but a chest radiograph(s), performed within 3 months of Day 1, is required.  To be 
considered eligible for the study, the radiograph(s) must be negative for active 
tuberculosis infection as determined by a qualified radiologist.  Documentation of 
adequate treatment for TB and negative chest radiograph(s) results must be obtained 
prior to Day 1. 
• A participant who is currently being treated for active TB infection is to be excluded. 
8. Participants known to be infected with HIV, hepatitis B, or hepatitis C (see Table 10). 
9. Decreased blood cell counts at screening, defined as follows: 
a. Leukocytes < 3.0 × 109/L (< 2.5 × 109/L for African-American participants). 
b. ANC < 1.5 × 109/L. 
c. Lymphocytes < 0.8 × 109/L. 
d. Hemoglobin < 9 g/dL. 
e. Platelet count < 150 × 109/L. 
10. Severely impaired liver function (Child-Pugh Class C) or ALT or AST levels ≥ 2 × ULN 
or total bilirubin ≥ 2 × ULN, unless due to Gilbert's syndrome. 
11. Impaired renal function with serum creatinine > 1.5 mg/dL. 
12. Known hypersensitivity or severe reaction to INCB054707 or excipients of INCB054707 
(refer to the IB). 
13. Known history of clinically significant drug or alcohol abuse in the last year prior to 
baseline. 
14. Inability or unlikeliness of the participant to comply with the dose schedule and study 
evaluations, in the opinion of the investigator. 
15. Any other condition that would, in the investigator's judgment, 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. 
16. The following patients are excluded in France:  vulnerable populations according to 
article L.1121-6 of the French Public Health Code and adults under legal protection or 
who are unable to express their consent per article L.1121-8 of the French Public Health 
Code. 
5.3. 
Lifestyle Considerations 
No lifestyle restrictions are required for this study; however, nicotine and alcohol use will be 
evaluated as indicated in the SoA (see Table 3).  Additional information regarding nicotine and 
alcohol use data collection is provided in the Study Manual. 


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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 (or designee) 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 (or 
designee) 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 
Participants may be replaced at any time during this study, at the discretion of the medical 
monitor or designee. 
5.6. 
Data Monitoring Committee 
An internal DMC will be established to provide independent oversight of the study.  The primary 
responsibility of the DMC will be to ensure the safety of study participants.  The specific 
responsibilities of the DMC will be detailed in a separate DMC charter. 
6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
Information regarding study drug and administration is provided in Table 6.  Participants will 
record study drug administration in a daily diary.  Further information regarding treatment 
administration is provided in Appendix B. 


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6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatments received and any discrepancies are reported and 
resolved before use of the study treatment. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply or administer study treatment.  All study treatment must be stored in a secure, 
environmentally controlled, and monitored (manual or automated) area in accordance with the 
labeled storage conditions with access limited to the investigator and authorized site staff. 
The investigator (or designee) is responsible for study treatment accountability, reconciliation, 
and record maintenance (ie, receipt, reconciliation, and final disposition records).  Inventory and 
accountability records must be maintained and readily available for inspection by the study 
monitor and are open to inspection at any time by any applicable regulatory authorities.  The 
investigator or designee must maintain records that document: 
• Delivery of study drugs to the study site. 
• Inventory of study drugs at the site. 
• Participant use of the study drugs, including pill counts from each supply dispensed. 
• Return of study drugs to the investigator or designee by participants. 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study drug.  These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
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 the investigational supply, the site should (where 
local procedures allow) maintain the investigational supply until the study monitor inspects the 
accountability records in order to evaluate compliance and accuracy of accountability by the 
investigative site.  At sites where the study drug is destroyed before monitor inspection, the 
monitors rely on documentation of destruction per the site SOP. 
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 in the double-blind period of the study will occur centrally via the 
IRT system (see Section 8.1.3).  Participant randomization will be stratified based on 
geographical region (North America and outside of North America) and disease severity (Hurley 


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Stages I, II, and III) with no more than 25% of the total number of participants as Hurley 
Stage III.  Full details for randomization will be provided in the Study Manual. 
Participants, investigators, and the sponsor will be blinded to each participant's initial treatment 
assignment for the double-blind treatment period.  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 9.5). 
During the 36-week open-label treatment period, participants will receive INCB054707 75 mg 
QD.  During the LTE period (also open label), participants will receive INCB054707 up to 
75 mg QD, with the possibility of dose change and dose decrease, as described in Section 6.5.1. 
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 study drug will be calculated by the sponsor based on the drug accountability 
(eg, tablet counts) documented by the site staff and monitored by the sponsor/designee.  
Participants will be instructed to bring all unused study drugs with them to the 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 Modifications 
6.5.1. 
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. 
No dose modifications will be allowed during the placebo-controlled period.  In some 
circumstances, it may be necessary to temporarily interrupt study treatment as a result of AEs or 
laboratory abnormalities that have an unclear relationship to the study drug (see Table 7). 
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 designee) before temporarily 
interrupting study drug.  Participants who experience a recurrence of the AEs or laboratory 
abnormalities upon restarting the study drug at the previously administered dose may have the 
study drug permanently discontinued. 
 
 
 
 
 
 
 
 
 
 


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6.5.2. 
Criteria for Permanent Discontinuation of Study Drug 
The occurrence of unacceptable severity of an AE not caused by the underlying disease will be 
presumed to be related to study drug treatment and will require that the study drug be 
permanently discontinued.  Unacceptable severity is defined as follows: 
• The occurrence of an AE that is related to study drug that, in the judgment of the 
investigator or the sponsor's medical monitor (or designee), compromises the 
participant's ability to continue study-specific procedures or is considered to not be in 
the participant's best interest. 
• Participant presents with a worsening of HS that requires treatment with a prohibited 
concomitant medication. 
Additionally, study drug will be discontinued as outlined in Section 6.5.1 and Section 6.6.4. 
See Section 7 for discontinuation procedures. 


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6.6. 
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 30 days before the first dose of study treatment and within 
35 days after the last dose of study treatment will be recorded in the eCRF.  A detailed history of 
prior medications related to HS used 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 (or designee) should be 
contacted if there are any questions regarding concomitant or prior therapy. 
6.6.1. 
Permitted Medications and Procedures 
6.6.1.1. 
Analgesic Therapy 
Analgesic (nonopioid and opioid) use is allowed during the entire study 
 
  Further information will be provided in the Study Manual.  The 
following analgesics may be used: 
• Nonsteroidal anti-inflammatory drugs, as needed, without exceeding the 
recommended dose on the label. 
− Low dose acetyl salicylic acid (aspirin, ≤ 100 mg QD) is permitted for the 
purpose of cardiovascular prophylaxis at the discretion of the investigator. 
• Acetaminophen/paracetamol, intermittently (not to exceed 1 g/day). 
• Prescribed analgesics, at the discretion of the medical monitor or designee. 
6.6.1.2. 
Wound Care 
Concomitant use of wound care dressings on HS wounds is allowed. 


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6.6.2. 
Restricted Medications and Procedures 
The following are permitted during the study under specified conditions: 
• Use of antihyperglycemic agents (eg, metformin, liraglutide, sitagliptin, saxagliptin, 
linagliptin, pioglitazone, rosiglitazone) is allowed unless if prescription is intended 
for HS treatment. 
• Use of hormonal therapies (eg, finasteride, spironolactone) is allowed unless if 
prescription is intended for HS treatment. 
• Use of systemic and topical anti-infectives (eg, antibiotics, antivirals, and 
antifungals):  
 
 
 
 
 
 
• Use of topical antiseptics such as washes, creams, soaps, ointments, gels, and liquids 
containing chlorhexidine, zinc gluconate, triclosan, benzoyl peroxide, or diluted 
bleach:  
 
 
 
 
 
 
• Use of corticosteroid inhalers and intranasal sprays are allowed for stable asthma 
participants. 


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6.6.3. 
Prohibited Medications and Procedures 
The following medications are prohibited for all participants in the study: 
• Conventional therapies with potential therapeutic impact on HS, per discretion of 
investigator or designee. 
• JAK or TYK2 inhibitors (systemic or topical) other than INCB054707 
(eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib, abrocitinib, 
brepocitinib). 
• Anticoagulants or medications known to cause thrombocytopenia (unless considered 
safe to stop and washout for the duration of the study). 
• Acetyl salicylic acid (aspirin). 
Note:  Low dose acetyl salicylic acid (≤ 100 mg QD) is permitted for the purpose of 
cardiovascular prophylaxis at the discretion of the investigator. 
• Use of biologics (eg, anti–TNF-α, anti–IL-12/23, anti–IL-17, anti–IL-23, anti–CD-40, 
anti–IL-1, anti–C5a, anti–T-cell inhibitors). 
• Adalimumab or any other investigational or experimental treatments for HS. 
• Apremilast, crisaborole, or any other systemic or topical PDE-4 inhibitor. 
 
 
 
 
 
• Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable 
corticosteroids, methotrexate, cyclosporine, dapsone, azathioprine) except as 
described in Section 6.6.4 and Section 8.2.3. 
• Systemic and topical retinoids if prescribed for HS treatment (eg, acitretin, 
isotretinoin, adapalene, tazarotene, trifarotene). 
 
 
• Strong and moderate systemic CYP3A4 inhibitors and strong systemic CYP3A4 
inducers.  Examples include but are not limited to the following medications (refer to 
Study Manual for details):  erythromycin, rifampicin/rifampin, ciprofloxacin, some 
azole antifungals (eg, ketoconazole, fluconazole), nefazodone, St. John's Wort, 
diltiazem, mibefradil, verapamil, and grapefruit/grapefruit juice. 
• Live vaccines (during the study and within 6 weeks after the last dose of study drug). 
6.6.4. 
Rescue Interventions 
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 


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(ie, nonresponder lesion) from the date of the intervention and must account for it in the source 
file and on the appropriate eCRF. 
Concomitant use of wound care dressings is allowed as described in Section 6.6.1.2.  Participants 
should continue using any oral and topical therapies during the study, consistent with the 
allowances and restrictions described in Section 6.6. 
6.6.4.1. 
Types of Rescue Intervention 
The following types of rescue interventions are permitted (further information to be included in 
the Study Manual): 
• Injection with intralesional corticosteroids. 
• Incision and drainage. 
6.6.4.2. 
Number of Rescue Interventions 
The number of rescue interventions during each study period are provided below. 
During the placebo-controlled period: 
• Total of 2 Protocol-allowed interventions. 
• An intervention can occur on maximally 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 at the same visit. 
• If a participant requires more than 2 interventions within the first 16 weeks, then they 
must be withdrawn from the study. 
During the OLE or LTE periods: 
• Maximum of 2 interventions every 4 weeks. 
• An intervention can occur on 2 different lesions at the same visit or on the same 
lesion at 2 different study visits. 
• Within each 4-week period, the same type of intervention cannot be used 2 times on 
the same lesion. 
• If a participant requires more than 2 interventions within a 4-week period or has 2 of 
the same interventions on the same lesion within that period, then they must be 
withdrawn from the study. 
6.7. 
Treatment After the End of the Study 
After completion of the double-blind, placebo-controlled, 16-week treatment period, participants 
will receive INCB054707 75 mg for 36 weeks during an OLE period.  At the completion of the 
36-week OLE period, all eligible participants will have the option to continue treatment with 
INCB054707 for an additional 48 weeks (LTE period).  Upon completion of the study, additional 
treatment will not be available. 


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7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
Participants must be discontinued from study treatment for the following reasons: 
• The participant becomes pregnant. 
• Consent is withdrawn. 
Note:  Consent withdrawn means that the participant has explicitly indicated that 
he/she does not want to be followed any longer; in this case no further data, except 
data in public domain, may be solicited from or collected on the participant.  
Participants may choose to discontinue study treatment and remain in the study to be 
followed for safety monitoring. 
• Further participation would be injurious to the participant's health or well-being, in 
the investigator's (or designee) medical judgment. 
• Any adverse event of unacceptable severity as noted in Section 6.5. 
• Participant meets discontinuation criteria as described in Section 6.6.4. 
• 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 course of 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 withdrawn from study treatment. 
• If a participant is noncompliant with study procedures or study drug/treatment 
administration in the investigator's opinion, the sponsor should be consulted for 
instruction on handling the participant. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the 
ET1/EOT1 (during the placebo-controlled period), ET2/EOT2 (during the OLE period), or 
ET3/EOT3 (during the LTE period) visit should be conducted.  Reasonable efforts should be 
made to have the participant return for a follow-up visit.  These visits are described in Table 3.  
The last date of the last dose of study drug and the reason for discontinuation of study drug 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 discontinuation must be documented in the participant's medical 
record and the primary reason for discontinuation must be included in the eCRF. 


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• The ET1/EOT1, ET2/EOT2, or ET3/EOT3 visit should be performed and date 
recorded. 
• The status of the participant should be updated to EOT1, EOT2, or EOT3 as 
applicable, in the IRT. 
• Participants must be followed for safety until the time of the follow-up visit 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.  When a participant is withdrawn from the study, the ET visit procedures 
should be performed; if possible, the safety follow-up visit should also be conducted within 
35 days of the last dose of study treatment.  This study has an ET1, applicable for the 
placebo-controlled period; an ET2, applicable for the OLE period; and an ET3, applicable for the 
LTE period.  See Table 3 for data to be collected at the ET1, ET2, or ET3 visit. 
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. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he/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 and counsel the participant on 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. 


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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 countries 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 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 
Screening is the interval between signing the ICF and the day the participant is randomly 
assigned to study drug (Day 1).  Screening assessments for determination of eligibility may be 
performed over a period lasting up to 30 days.  For participants who are randomized in the study, 
information associated with eligibility requirements must be entered into the appropriate eCRF 
pages. 
Results from the screening visit evaluations will be reviewed to confirm eligibility before 
randomization or the administration of study drug.  Tests with results that fail eligibility 
requirements may be repeated once during screening if the investigator believes the results to be 
in error.  For screening assessments that are repeated, the most recent available result before 
randomization will be used to determine eligibility. 
See Sections 5.4 and 5.5 for information regarding screen failures and replacement of 
participants, respectively. 
8.1.3. 
Interactive Response Technology 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 staff should contact the IRT to obtain the 
participant ID number during screening.  Upon determining that the participant is eligible for 
randomization, the IRT will be contacted to obtain the treatment assignment.  Additionally, the 
IRT will be contacted at predetermined visits (see Table 3) to update the study drug supply.  
Additional details are provided in the IRT Manual. 
8.1.4. 
Distribution of Study Reminder Cards and Diaries 
Participants will be provided a diary and study reminder cards as outlined in Table 3.  Reminder 
cards will indicate the schedule of the next visit
 
, they should withhold self-administration 
of the study treatment on the visits at Week 4, Week 8, Week 16, and Week 24, when dose will 
be administered at the study site (see Table 6 for further information).  The Day 1 dose will also 
be administered at the study site. 
Study participants will be instructed on the use of the diary.  
 
 
 
 
 
 
8.1.5. 
Demography and Medical History 
8.1.5.1. 
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 year of birth/age, race, ethnicity, medical and surgical 
history, and current illnesses as well as nicotine and alcohol use information.  Nicotine use 
information will also be collected at EOT1, EOT2, and EOT3 visits.  Medical history will 


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include relevant medical treatment within the last year or surgical procedures that are considered 
clinically significant by the investigator. 
8.1.5.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical, surgical, and treatment history will be collected at screening for the 
past year.  A detailed history of prior medication use related to HS in the year before screening 
will also be collected, as well as response to each treatment and reason for discontinuation.  
Surgical history beyond the past year will also be recorded if considered relevant by the 
investigator or designee. 
8.1.6. 
Follow-Up Phone Call 
All participants will be contacted by phone 1 week prior to the baseline visit (Day 1/Week 0) to 
ensure that daily assessments 
 are being recorded; study sites 
are also encouraged to contact participants 1 week after the baseline visit to ensure compliance 
with the daily assessments.  If daily assessments are not completed for at least the 7 consecutive 
days before the baseline visit, the participant may not be randomized (at the discretion of 
investigator or designee). 
 
 
8.2. 
Efficacy Assessments 
Efficacy assessments, 
 are provided in this section.  Unless an exception is 
required, the same investigator/designee should perform the efficacy assessments for a 
participant at each of the participant's efficacy evaluation visits. 
The lesion count worksheet (provided in the Study Manual) will be used for recording the 
abscess, nodule (inflammatory and noninflammatory), fistula (draining and nondraining), and 
hypertrophic scar counts, and the assessment of Hurley stage.  The lesion counts will be used for 
calculation (by Incyte or designee) of efficacy parameters, including HiSCR and IHS4.  
Additionally, the number and type of lesional interventions will be documented on this 
worksheet. 
8.2.1. 
Lesion Counts 
The definition of each HS lesion to be recorded in the lesion count worksheet is outlined in 
Table 8.  The worksheet includes assessment of anatomical regions such as left/right axilla, 
left/right sub/inframammary area, intermammary area, left/right buttock, left/right inguino-crural 
fold, perianal area, and perineal area.  The lesion counts will be used for calculation of efficacy 
parameters (see Table 5 for objectives and endpoints), as follows:  AN and ANF counts (see 
Section 8.2.1.1), HiSCR (see Section 8.2.1.2), IHS4 (see Section 8.2.1.3), 
 
 


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Table 8: 
Definition of Hidradenitis Suppurativa Lesions 
HS Lesion 
Definition 
Abscess 
A circumscribed collection of purulent exudate frequently associated with 
swelling and other signs of inflammation, such as fluctuance, tenderness, and 
pain 
Inflammatory 
nodules 
A tender, erythematous, well-defined nodule.  The lesion has no evidence of 
fluctuance.  A pyogenic granuloma-like lesion is considered an inflammatory 
nodule; a papule or pustule is not considered an inflammatory nodule. 
Noninflammatory 
nodules 
Nontender or minimally tender, nonerythematous nodules. 
Draining fistula 
(or draining tunnel) 
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. 
Sinus tracts 
(nondraining 
fistula/tunnel) 
Sinus tracts are a subtype of (nondraining) fistula in which the passageway links 
2 or more areas underneath the skin surface but does not communicate with the 
skin surface. 
Hypertrophic scar 
Enlargement or overgrowth of a scar so that it extends above the surrounding 
skin surface 
8.2.1.1. 
AN and ANF Counts 
The AN and ANF counts will be recorded at all visits.  The AN results will be used to calculate 
change in AN count relative to baseline, as well as AN50, AN75, AN90, and AN100, defined 
respectively as at least a 50%, 75%, 90%, and 100% decrease in AN count relative to baseline.  
The ANF results will be used to calculate the change in ANF count relative to baseline.  Further 
information will be provided in the Study Manual. 
8.2.1.2. 
Hidradenitis Suppurativa Clinical Response 
The HiSCR was originally developed based on the underlying Phase 2 trial of adalimumab and 
validated against meaningful changes in pain score and DLQI (Kimball et al 2016c, Sabat 
et al 2020).  The achievement of HiSCR is defined as at least 50% reduction in AN count with no 
increase in either abscess or draining fistula counts, relative to baseline.  Further information will 
be provided in the Study Manual. 
8.2.1.3. 
International Hidradenitis Suppurativa Severity Score System 
The IHS4 (Zouboulis et al 2017) is a composite, dynamic score and validated tool used to 
determine HS severity.  It employs a weighted scale using the number of inflammatory nodules, 
the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective 
weight factors of 1, 2, and 4.  Further information will be provided in the Study Manual. 


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8.3. 
Safety Assessments 
Planned timepoints for all safety assessments are provided in the SoA (see Table 3).  See 
Section 6.5 for guidelines regarding the management of relevant laboratory or other safety 
assessment abnormalities. 
8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until the end of the 
safety follow-up period.  Adverse events that begin or worsen after informed consent should be 
recorded on the Adverse Events 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, 
considered related to the study drug, or that caused the participant to discontinue the study drug.  
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 immediately, without undue 
delay and not later than within 24 hours.  The investigator will submit any updated SAE data to 
the sponsor immediately, without undue delay and not later than 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 timepoints listed in Table 3. 
A comprehensive physical examination will include height (at screening only) 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 (or designee) are to be reported as AEs. 


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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 (to be taken before blood collection for laboratory tests), include blood 
pressure, pulse, respiratory rate, and body temperature.  If vital signs cannot be taken before 
blood collection for laboratory tests, there must be a minimum of 30 minutes from the 
completion of the blood collection procedures to the beginning of the vital signs collection.  
Blood pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or 
sitting position after 5 minutes of rest.  Vital sign results identified after the first dose of study 
treatment constitute an AE if they are considered clinically significant in the judgement of the 
investigator. 
8.3.4. 
Electrocardiograms 
Single 12-lead ECGs will be obtained as outlined in the SoA (see Table 3) using an ECG 
machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF 
intervals.  All 12-lead ECGs will be performed with the participant in a recumbent or 
semirecumbent position after 5 minutes of rest.  Prolonged QTcF values of ≥ 450 milliseconds 
are to be confirmed by performing 2 additional ECGs (within the next 5 minutes) and averaging 
the results to determine the averaged value. 
Additional 12-lead ECGs may be performed at other visits as deemed clinically necessary.  
Electrocardiograms will be interpreted by the investigator at the site or designee, 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.  Refer to the Study 
Manual for additional details on ECGs. 
8.3.5. 
Chest X-Ray 
As per Section 8.3.6, at the discretion of the medical monitor (or designee), participants may be 
required to have a chest radiograph (posterior-anterior and lateral views) or other appropriate 
diagnostic image (ie, computed tomography or magnetic resonance imaging) taken at screening 
or within 12 weeks prior to Study Day 1 and read by a qualified radiologist. 
8.3.6. 
Tuberculosis Screening 
At the time of screening, all participants will undergo TB testing unless performed within 
12 weeks before Day 1.  The QFT-GIT is the preferred testing method.  If the QFT-GIT cannot 
be performed, or if the results cannot be determined by the reference laboratory to be either 
positive or negative, then participants may be screened using the PPD tuberculin skin test 
(Mantoux method) with approval of the medical monitor (or designee). 
In addition to TB testing as specified in this clinical Protocol, a chest x-ray (see Section 8.3.5) 
may be requested to aid in TB status determination. 


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The QFT-GIT is an indirect test for Mycobacterium tuberculosis infection (including disease) 
and is intended for use in conjunction with risk assessment, radiography, and other medical and 
diagnostic evaluations. 
A negative PPD test can be substituted for the QFT-GIT only if the central laboratory is unable 
to perform the QFT-GIT or cannot determine the results to be positive or negative and the 
medical monitor (or designee) approves it, on a case-by-case basis. 
Purified Protein Derivative Test 
If the QFT-GIT cannot be performed, or if the results cannot be determined to be positive or 
negative, then participants may be screened using the PPD tuberculin test (Mantoux method), 
with the approval of the medical monitor (or designee). 
Participants must have the PPD test administered and evaluated by a health care professional 
48 to 72 hours later in order to be eligible for the study, unless performed and documented within 
the last 3 months.  The test should be performed according to local standards with induration of 
< 5 mm required for inclusion. 
8.3.7. 
Laboratory Assessments 
See Table 10 for the list of clinical laboratory analytes to be performed and Table 3 for the 
laboratory assessment visit schedule.  A central laboratory will perform all clinical laboratory 
assessments for safety (ie, blood chemistries, hematology assessments, urinalysis, inflammation 
markers, and lipid panel). 
 
  Additional testing may be required by the sponsor based on emerging safety data.  All 
Protocol-required laboratory assessments must be conducted in accordance with the Laboratory 
Manual and Table 3.  Information regarding collection, processing, and shipping of samples for 
laboratory assessment is provided in the Laboratory Manual. 
Clinically significant abnormal laboratory findings are those that are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for the 
participant's condition.  All laboratory tests with values considered clinically significantly 
abnormal during participation in the study or within 4 weeks after the last dose of study drug 
should be repeated until the values return to normal or baseline or are no longer considered 
clinically significant by the investigator or medical monitor. 
If screening laboratory assessments are performed more than 30 days before Day 1, then the tests 
must be repeated and eligibility confirmed before study drug administration on Day 1.  
Laboratory sample collection on Day 1 must be performed before study drug administration. 
See Section 9.1 for information regarding laboratory abnormalities that should be recorded as an 
AE in the eCRF. 


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Table 10: 
Required Laboratory Analytes 
Chemistry 
Hematology 
Urinalysis 
Serology/Infection 
Pregnancy testing 
• Albumin 
• Alkaline phosphatase 
• ALT 
• AST 
• Bicarbonate or CO2 
• Blood urea nitrogen or 
urea 
• Calcium 
• Chloride 
• Creatine kinase 
• Creatinine 
• Glucose 
• Gamma-glutamyl 
transferase (GGT) 
• Lactate dehydrogenase 
• Phosphate 
• Potassium 
• Sodium 
• Total bilirubin 
• Direct bilirubin (if total 
bilirubin is elevated above 
ULN) 
• Total protein 
Complete blood count, 
including: 
• Hemoglobin 
• Mean corpuscular volume 
• Hematocrit 
• Platelet count 
• Mean platelet volume 
• In samples with 
abnormalities in platelet 
count or size distribution 
(as indicated by an 
automated analyzer), a 
blood film should be 
examined. 
• Red blood cell count 
• Red blood cell distribution 
width 
• White blood cell count 
• Hemoglobin A1c 
 
Differential count (% and 
absolute values), including: 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
 
Biomarkers: 
• Hepcidin 
• Ferritin 
• Color and appearance 
• pH and specific gravity 
• Bilirubin 
• Glucose 
• Ketones 
• Leukocyte esterase 
• Nitrite 
• Occult blood 
• Protein 
• Microscopic evaluation (in 
case of abnormal 
urinalysis results) 
 
• Nicotine metabolite screen 
(at specified visits in 
Table 3) 
• Hepatitis B surface antigen 
and Hepatitis B core 
antibody* 
• Hepatitis C antibody* 
• HIV 
• QFT-GIT (see 
Section 8.3.6) 
 
(*DNA & RNA only if 
serology is positive) 
Pregnancy testing will only 
be performed for female 
participants. 
 
Further instructions are 
provided in Section 8.3.7.2. 
 
• Serum FSH test:  For 
confirmation of 
nonchildbearing status; to 
be performed at screening 
only. 
• Serum pregnancy test: 
For WOCBP only; to be 
performed at screening and 
at visits indicated in 
Table 3. 
• Urine pregnancy test: For 
WOCBP only; to be 
performed at visits 
indicated in Table 3. 
 
Pregnancy tests (serum or 
urine) should be repeated if 
required by local regulations. 
Lipid Panel 
Inflammation Markers 
• Total cholesterol 
• Triglycerides 
• LDL 
• HDL 
 
Observation:  Fasting not 
required  
• High sensitivity C-reactive 
protein (hsCRP) 
Note:  Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data. 


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8.3.7.1. 
Serology Testing 
Screening laboratory tests (see Table 3 and Table 10) include serology, TB screening, pregnancy 
test (for WOCBP), serum FSH test (for confirmation of nonchildbearing status), urinalysis, 
hematology, chemistry assessments, and inflammation markers.  Refer to the Laboratory Manual 
for further screening assessment instructions. 
Hepatitis and HIV screening assessments will be performed at the screening visit to rule out 
infection; required analytes are shown in Table 10.  Generally, HIV and hepatitis tests should be 
performed early in the screening process due to the length of time needed to obtain the results.  
Additional tests may be performed if clinically indicated. 
8.3.7.2. 
Pregnancy Testing 
A serum pregnancy test will be required for all WOCBP during screening (before the first dose 
of study drug) and at the EOT visits, as applicable.  Urine pregnancy tests will be performed 
locally as outlined in Table 3, as medically indicated (eg, in case of loss of menstrual cycle, 
when pregnancy is suspected), or per country-specific requirement (note that country-required 
urine pregnancy testing will be outlined and communicated to investigational sites under separate 
cover).  If a urine pregnancy test is positive, the results should be confirmed with a serum 
pregnancy test. 
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 9.6 for reporting 
requirements. 
A serum FSH test will be required for all WONCBP during screening (before the first dose of 
study drug) for confirmation of nonchildbearing status.  Women of nonchildbearing potential are 
defined as surgically sterile with a hysterectomy and/or bilateral oophorectomy OR 
postmenopausal defined as amenorrhea ≥ 12 months prior to screening. 


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8.6. 
Unscheduled Visits 
Unscheduled visits may occur at any time at the investigator's (or designee's) discretion, and 
appropriate clinical and laboratory tests may be performed, as clinically indicated. 
If there is a potential clinically significant abnormality in hematology or chemistry assessments 
(particularly in platelet count) during the study, an unscheduled visit within the following week 
should occur to repeat laboratory assessments (further details are provided in Table 7 and 
Section 8.3.7).  See Section 6.5.1 for instructions on dose interruption and restart.  The 
investigator must inform and consult the sponsor (or designee) with any hematological 
abnormality. 
8.7. 
End of Treatment and/or Early Termination 
When the participant permanently discontinues study drug, whether the participant is terminating 
the study early (ET) or the participant has completed the study, the EOT visit should be 
conducted.  If the EOT visit coincides with a regular study visit, the EOT evaluations will 
supersede those of that scheduled visit, and the data should be entered in the EOT visit in the 
eCRF.  This study has an EOT1, applicable for the placebo-controlled period; an EOT2, 
applicable for the OLE period; and an EOT3, applicable for the LTE period.  The ET1, ET2, and 
ET3 procedures to be followed (see Table 3) are respectively the same as EOT1, EOT2, and 
EOT3.  The participant should be encouraged to return for the follow-up visit (EOS). 
8.8. 
Follow-Up 
8.8.1. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit (EOT1, EOT2, or EOT3) and 
the scheduled safety follow-up visit, which should occur 28 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 1) at least 28 days after the last dose of study drug or 2) 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.  In exceptional cases when the participant cannot return to the site for 
the safety follow-up visit, the participant should be contacted by telephone for assessment of 
AEs and SAEs and the site should properly document the contact. 


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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 laboratory test 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 they 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 an AE or SAE 
if they fulfill the definition of an AE or SAE. 
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. 
• Efficacy endpoints as outlined in Section 3 will not be reported as AE/SAEs, specifically, any event 
that is related to disease progression of the disease under study.  Unblinded aggregated efficacy 
endpoint events and safety data will be monitored to ensure the safety of the participants in the study.  
Any suspected endpoint that upon review is not progression of the disease under study will be 
forwarded to Incyte Pharmacovigilance as an SAE within 24 hours of determination that the event is 
not progression of the disease under study. 


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• Medical or surgical procedure (eg, endoscopy, appendectomy):  the condition that leads to the 
procedure is the AE if it occurred after signing informed consent.  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 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. 
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 1 of the outcomes listed in the 
above definition.  Examples of such events include new invasive or malignant cancers, 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.  


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9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
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 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 v5 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 treatment 
(including 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 Adverse Event Form and the treatment should 
be specified on the appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and Non-Drug 
Therapy). 
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5 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; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate 
activities of daily living. 


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• Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment 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 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.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
send a follow-up SAE 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 to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 
• If a participant dies during participation in the study or during a recognized follow-up period, the 
investigator will provide the sponsor with a copy of any postmortem findings including 
histopathology. 
• New or updated information will be recorded in the originally completed eCRF. 
• 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. 


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See Appendix C for the management of potential Hy's Law cases. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study drug or study procedures), all SAEs 
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) immediately, without undue delay and not later than 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) immediately, without undue delay and not later than 
within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE information after conclusion of 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) immediately, without undue delay and not later than 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 an 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 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 suspected unexpected serious adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 


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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. 
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. 
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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9.6. 
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. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.7. 
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 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. 
9.8. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 


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The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be 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. 
9.9. 
Treatment of Overdose 
For this study, any dose of study treatment greater than the assigned daily dose (depending on 
the participant's treatment assignment) within the same day will be considered an overdose.  The 
Sponsor does not recommend specific treatment for an overdose. 
In the event of an overdose, the investigator should: 
• Contact the medical monitor immediately. 
• Closely monitor the participant for any AE/SAE and laboratory abnormalities until 
INCB054707 can no longer be detected systemically (at least 3 days). 
• Obtain a plasma sample for PK analysis within 3 days from the date of the last dose 
of study treatment if requested by the medical monitor (determined on a case-by-case 
basis). 
• Document the quantity of the excess dose as well as the duration of the overdose in 
the eCRF. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 
There has been no clinical experience with overdose of INCB054707.  Treatment of overdose 
should consist of general supportive measures. 


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10. 
STATISTICS 
10.1. 
Sample Size Determination 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.2. 
Populations for Analysis 
The populations for analysis are provided in Table 13. 
Table 13: 
Populations for Analysis 
Population 
Description 
ITT 
The ITT population includes all randomized participants.  Treatment groups for this 
population will be defined according to the treatment assignment at randomization. 
PP 
The PP population includes randomized participants who are considered to be 
sufficiently compliant with the Protocol. 
Safety 
The safety population includes all participants who received at least 1 dose of study 
drug.  Treatment groups for this population will be determined according to the 
actual treatment the participant received on Day 1. 
 
 
 
 
 
10.3. 
Level of Significance 
 
 
 
 
 
 


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10.4. 
Statistical Analyses 
 
 
 


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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 approval from both Health Authorities 
and IRB/IEC 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. 
11.1.1. 
Identification of the Coordinating Principal Investigator 
A coordinating principal investigator has been appointed by the Sponsor.  As part of her 
responsibilities, the coordinating principal investigator will review the final CSR.  Agreement 
with the final CSR will be documented by the dated signature of the coordinating principal 
investigator. 
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 with 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.  Other data outside the EDC system required in the study conduct 
of the Protocol such as documents or results transmitted to the sponsor via a central laboratory or 
specialized technical vendors and, as designated by the sponsor, will have their own data flow 
management plans, study charters, 
 as applicable. 
The sponsor (or designee) will be responsible for: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
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. 
• Managing and reconciling the data generated, and/or collected including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 
The investigator will be responsible for: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, 
 
 diary data), 
or as otherwise specified in the Protocol. 
• Verifying that data entries are accurate and correct by physically or electronically 
signing the eCRF. 


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• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF, or sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− 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 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.  Current applicable medical records must be available. 
• May have responsibility for sending participants' data, either as unique samples, or 
copies, or photographs, to be evaluated centrally or analyzed centrally, or both, by a 
qualified vendor designated by the sponsor. 
• 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 protection laws 
and regulations.  The investigator and the sponsor or its designee are responsible for ensuring 
that sensitive personal information is handled in accordance with local data protection laws 
(including but not limited to HIPAA and GDPR) as applicable.  Appropriate consent for 
collection, use and disclosure and/or transfer (if applicable) of personal information must be 
obtained in accordance with local data protection laws. 
Participant names will not be supplied to the sponsor or its designee.  Only the participant 
number will be recorded in the eCRF; if the participant's name appears on any other document 


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(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 
appropriate technical and organizational measures as required by local data protection laws. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for 30 years after study completion unless local regulations require 
otherwise.  No records may be destroyed during the retention period without the written approval 
of the sponsor.  No records may be transferred to another location or party without written 
notification to the sponsor. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 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. 
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/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. 


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Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.6. 
Study and Site Closure 
The sponsor or 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 
Amir Ali A, Seng EK, Alavi A, Lowes, MA. Exploring changes in placebo treatment arms in 
hidradenitis suppurativa randomized clinical trials: A systematic review. J Am Acad Dermatol 
2020;82:45-53. 
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. 
Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective 
multiple test procedures. Stat Med 2009;28:586-604. 
 
Clinical Trials Facilitation and Coordination Group. Recommendations related to contraception 
and pregnancy testing in clinical trials. 2014. 
Dufour DN, Emtestam L, Jemec GB.  Hidradenitis suppurativa: a common and burdensome, yet 
under-recognised, inflammatory skin disease. Postgrad Med J 2014;90:216-220. 
 
Frew JW, Jiang CS, Singh N, et al. Clinical response rates, placebo response rates, and 
significantly associated covariates are dependent on choice of outcome measure in hidradenitis 
suppurativa: a post hoc analysis of PIONEER 1 and 2 individual patient data. J Am Acad 
Dermatol 2020;82:1150-1157. 
Gooderham MJ, Forman SB, Bissonnette R, et al. Efficacy and safety of oral Janus kinase 1 
inhibitor abrocitinib for patients with atopic dermatitis: A phase 2 randomized clinical trial. 
JAMA Dermatol 2019;155:1371-1379. 
 
 
Hoffman LK, Ghias MH, Lowes MA. Pathophysiology of hidradenitis suppurativa. Semin Cutan 
Med Surg 2017;36:47-54. 
INCB054707 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change 
scores: a reanalysis of two clinical trials of postoperative pain. J Pain 2003;4:407-414. 
Kelly G, Prens EP. Inflammatory mechanisms in hidradenitis suppurativa. Dermatol Clin 
2016;34:51-58. 
 
 
 
Kimball AB, Okun MM, Williams DA, et al. Two phase 3 trials of adalimumab for hidradenitis 
suppurativa. N Engl J Med 2016b;375:422-434. 


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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 2016c;30:989-994. 
 
 
Mehta CR, Patel NR.  Exact logistic regression: theory and examples. Stat Med 
1995;14:2143-2160. 
Millum J, Grady C. The ethics of placebo-controlled trials: methodological justifications. 
Contemp Clin Trials 2013;36:510-514. 
Nguyen TV, Damiani G, Orenstein LAV, Hamzavi I, Jemec GB. Hidradenitis suppurativa: an 
update on epidemiology, phenotypes, diagnosis, pathogenesis, comorbidities and quality of life. 
J Eur Acad Dermatol Venereol 2021;35:50-61. 
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and 
activity impairment instrument. PharmacoEconomics 1993;4:353-365. 
Sabat R, Jemec GBE, Matusiak L, Kimbal AB, Prens E, Wolk K. Hidradenitis suppurativa. Nat 
Rev Dis Prim 2020;6:1-20. 
Zouboulis CC, Okun MM, Prens EP, et al. Long-term adalimumab efficacy in patients with 
moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label 
extension study. J Am Acad Dermatol 2019;80:60-69. 
Zouboulis CC, Tzellos T, Kyrgidis A, et al. Development and validation of the International 
Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to 
assess HS severity. Br J Dermatol 2017;177:1401-1409. 


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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 (assessed for surgical success) qualify as having 
met the requirement for a highly effective birth control method. 
For female 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 ovulationa 
− 
 oral 
− 
 intravaginal 
− 
 transdermal 
• 
 Progestogen-only hormonal contraception associated with inhibition of ovulationa 
− 
oral 
− 
injectable 
− 
implantableb 
• 
Intrauterine deviceb 
• 
Intrauterine hormone-releasing systemb 
• 
Bilateral tubal occlusionb 
• 
Vasectomized partnerbc 
• 
Sexual abstinenced 
Unacceptable 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 spermicidee 
• 
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 unacceptable. 
Source:  Clinical Trials Facilitation and Coordination Group 2014. 


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APPENDIX D. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment 1 
10 SEP 2021 
Amendment 1 (10 SEP 2021) 
Overall Rationale for the Amendment: 
The primary purpose of the amendment is to obtain additional long-term safety and efficacy data 
through 104 weeks; and to incorporate changes from country-specific amendments for Germany 
(dated 04 DEC 2020) and Canada (dated 08 MAR 2021).  Additional changes are summarized 
below. 
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements; 
Table 3:  Schedule of Activities); Section 2.1.2, Scientific Rationale for Study 
Design; Section 2.1.3, Justification of Dose; Section 2.2.2, Benefit Assessment; 
Section 3, Objectives and Endpoints (Table 5:  Objectives and Endpoints); 
Section 4.1, Overall Design; Section 4.2, Overall Study Duration; Section 6.1, Study 
Treatments Administered (Table 6:  Study Treatment Information); Section 6.3, 
Measures to Minimize Bias:  Randomization and Blinding; Section 6.5.1, Criteria 
and Procedures for Dose Interruptions and Adjustments of Study Drug; 
Section 6.6.2, Restricted Medication and Procedures; Section 6.6.4.2, Number of 
Rescue Interventions; Section 6.7, Treatment After the End of the Study; 
Section 7.1.2, Discontinuation Procedures; Section 7.2, Participant Withdrawal 
From the Study; Section 8.7, End of Treatment and/or Early Termination 
Description of change:  At the completion of the 36-week OLE period (preceded by the 
16-week placebo-controlled period), all eligible participants will have the option to 
continue treatment for an additional 48 weeks (LTE period), followed by a 4-week safety 
follow-up period. 
Rationale for change:  To obtain additional long-term safety and efficacy data through 
104 weeks. 
 
 
 
 
 
 
 
 
 
 


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4. Section 2.1.4, Justification for Placebo 
Description of change:  Added Section 2.1.4, Justification for Placebo. 
Rationale for change:  Per request made by the Germany's Health Authority to provide a 
rationale for a placebo arm in this HS study. 
5. Section 2.1.5, Justification for Doses in the Long-term Extension 
Description of change: Added Section 2.1.5, Justification for Doses in the Long-term 
Extension. 
Rationale for change:  To provide a rationale for the long-term extension and the doses 
available in that period. 
6. Section 5.1, Inclusion Criteria 
Description of change:  Added Inclusion Criterion 6. 
Rationale for change:  Per request made by the Germany's Health Authority to 
determine that participants must have been previously exposed to at least 1 line of HS 
treatment (systemic antibiotics) before starting this study. 
7. Section 6.5.1, Criteria and Procedures for Dose Interruptions and Adjustments of 
Study Drug (Table 7:  Guidelines for Interruption, Restart, and Discontinuation of 
Study Drug) 
Description of change:  Added clarification on the guidance for study drug 
interruption/restart when AST and/or ALT > 3.0 × ULN. 
Rationale for change:  To clarify that Appendix C should be consulted and to specify 
that the study drug can only be interrupted/restarted up to 2 times. 
8. Section 6.5.1, Criteria and Procedures for Dose Interruptions and Adjustments of 
Study Drug (Table 7:  Guidelines for Interrupting, Restarting, and Discontinuing 
Study Drug) 
Description of change:  Revised sentences that explained study treatment reinitiation 
after study treatment is interrupted when a platelet count between 50 × 109/L to < 75 × 
109/L is observed. 
Rationale for chance:  Per request made by Health Canada to provide a clarification that 
study treatment in the open-label extension will be reinitiated when platelet count is 
≥ 100 × 109/L. 
9. Section 8.3.7, Laboratory Assessments (Table 10:  Required Laboratory Analytes) 
Description of change:  Creatine kinase was added to the list of analytes in the 
chemistry column. 
Rationale for change:  To align with emerging literature suggesting that JAK inhibitors 
may lead to increases in creatine kinase. 


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10. Section 8.3.7, Laboratory Assessments (Table 10:  Required Laboratory Analytes) 
Description of change:  Erythrocyte sedimentation rate (ESR) was removed from the 
Inflammation Markers subheading. 
Rationale for change:  The inflammation markers assessment will focus on the high 
sensitivity C-reactive protein results, thus not requiring ESR evaluation. 
11. Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Added clarification for timing of SAE reporting. 
Rationale for change:  Per request made by the Germany's Health Authority to clarify 
that SAE reporting must happen immediately and not later than within 24 hours. 
12. Appendix A, Information Regarding Effectiveness of Contraceptive Methods 
Description of change:  The following updates (deletions indicated by strikethroughs; 
insertions indicated by underlines) were made: 
Acceptable Unacceptable birth control methods that result in a failure rate of more than 
1% per year include: 
e  A combination of male condom with either cap, diaphragm, or sponge with spermicide 
(double barrier methods) are also considered unacceptable, but not highly effective birth 
control methods. 
Rationale for change:  To clarify the contraceptive methods that are not allowed in the 
study, and to ensure consistency between the information on contraceptive methods 
presented in Appendix A and the requirements described in Inclusion Criterion 4b. 
13. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted on the redline version of the 
amendment. 
 


Signature Page for VV-CLIN-010474 v2.0
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10-Sep-2021 17:05:30 GMT+0000
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SAP_001.pdf: 
 
Official Title: 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-
Ranging Study of the Efficacy and Safety of INCB054707 in 
Participants With Hidradenitis Suppurativa 
NCT Number: 
NCT04476043 
Document Date: 
SAP Version Original: 12-October-2021 
 
 


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Statistical Analysis Plan 
 
TITLE PAGE 
INCB 54707-204 
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 
Dose-Ranging Study of the Efficacy and Safety of INCB054707 in 
Participants With Hidradenitis Suppurativa 
 
 
IND Number: 
137,156 
EudraCT Number: 
2020-001981-13 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
United States 
Protocol Version: 
Protocol Amendment 1 dated 10 SEP 2021 
CRF Approval Date: 
27 JUL 2020 
SAP Version: 
Original 
SAP Author:  
 
 Biostatistics 
Date of Plan: 
12 OCT 2021 
 
 
This study is being conducted in compliance with Good Clinical Practice, 
including the archiving of essential documents. 
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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
TABLE OF CONTENTS .................................................................................................................2 
LIST OF ABBREVIATIONS ..........................................................................................................6 
1. 
INTRODUCTION ........................................................................................................8 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................9 
2.1. 
Protocol and Case Report Form Version ......................................................................9 
2.2. 
Study Objectives and Endpoints ...................................................................................9 
3. 
STUDY DESIGN .......................................................................................................16 
3.1. 
Randomization ............................................................................................................17 
 
17 
 
18 
3.4. 
Schedule of Assessments ............................................................................................18 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................19 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................19 
4.1.1. 
Day 1 ...........................................................................................................................19 
4.1.2. 
Study Day ...................................................................................................................19 
4.1.3. 
Baseline Value ............................................................................................................19 
4.1.4. 
Handling of Missing and Incomplete Dates ...............................................................20 
4.2. 
Variable Definitions ....................................................................................................21 
4.2.1. 
Body Mass Index ........................................................................................................21 
4.2.2. 
Prior and Concomitant Medication .............................................................................21 
5. 
STATISTICAL METHODOLOGY ...........................................................................23 
5.1. 
General Methodology .................................................................................................23 
5.2. 
Treatment Groups .......................................................................................................23 
5.3. 
Analysis Populations ..................................................................................................23 
5.3.1. 
Intent-to-Treat Population ..........................................................................................23 
5.3.2. 
Per Protocol Population ..............................................................................................24 
5.3.3. 
Safety Population ........................................................................................................24 
5.3.4. 
Open-Label Evaluable Population ..............................................................................24 
5.3.5. 
Long-Term Evaluable Population ...............................................................................24 
 
24 


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6. 
BASELINE, EXPOSURE, AND DISPOSITION ......................................................25 
6.1. 
Demographics, Baseline Characteristics, and Disease History ..................................25 
6.1.1. 
Demographics and Baseline Characteristics ...............................................................25 
6.1.2. 
Baseline Disease Characteristics and Disease History ...............................................25 
6.1.3. 
Medical History ..........................................................................................................26 
6.2. 
Disposition of Participant ...........................................................................................26 
6.3. 
Protocol Deviations ....................................................................................................27 
6.4. 
Exposure .....................................................................................................................27 
6.5. 
Study Drug Compliance .............................................................................................29 
6.6. 
Prior and Concomitant Medication .............................................................................29 
7. 
EFFICACY .................................................................................................................30 
7.1. 
General Considerations ...............................................................................................30 
7.2. 
Efficacy Parameters ....................................................................................................30 
7.2.1. 
AN and ANF Counts ..................................................................................................30 
7.2.2. 
Hidradenitis Suppurativa Clinical Response ..............................................................31 
7.2.3. 
International Hidradenitis Suppurativa Severity Score System ..................................31 
 
31 
7.2.5. 
Hurley Stages of Hidradenitis Suppurativa .................................................................31 
 
32 
 
32 
 
32 
 
32 
 
.33 
 
.34 
 
.34 
 
35 
 
36 
 
37 
7.3. 
Efficacy Hypotheses ...................................................................................................38 
7.4. 
Analysis of the Primary Efficacy Parameter ..............................................................38 
7.4.1. 
Primary Efficacy Analysis ..........................................................................................38 
7.4.2. 
Subgroup Analyses for Primary Endpoint ..................................................................38 
7.4.3. 
Sensitivity and Supportive Analyses for Primary Endpoint .......................................38 
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7.5. 
Analysis of the Secondary Efficacy Parameters .........................................................39 
7.5.1. 
Analysis of the Key Secondary Efficacy Endpoint ....................................................39 
7.5.2. 
Analysis of Other Secondary Efficacy Endpoints ......................................................39 
 
39 
7.7. 
Analysis of Additional Efficacy Parameters ...............................................................40 
 
41 
 
41 
 
41 
9. 
SAFETY AND TOLERABILITY ..............................................................................41 
9.1. 
General Considerations ...............................................................................................41 
9.2. 
Adverse Events ...........................................................................................................41 
9.2.1. 
Adverse Event Definitions ..........................................................................................41 
9.2.2. 
Adverse Event Summaries ..........................................................................................42 
9.3. 
Clinical Laboratory Tests ...........................................................................................43 
9.3.1. 
Laboratory Value Definitions .....................................................................................43 
9.3.2. 
Laboratory Value Summaries .....................................................................................43 
9.3.3. 
Potentially Clinically Important Laboratory Values ...................................................44 
9.3.4. 
Potential Drug Induced Liver Injury Events ...............................................................44 
9.4. 
Vital Signs ..................................................................................................................45 
9.5. 
Electrocardiograms .....................................................................................................45 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................47 
10.1. 
Changes to Protocol-Defined Analyses ......................................................................47 
10.2. 
Changes to the Statistical Analysis Plan .....................................................................47 
11. 
REFERENCES ...........................................................................................................48 
49 
 
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LIST OF TABLES 
Table 1: 
Objectives and Endpoints .............................................................................................9 
Table 2: 
Definition of Day 1 .....................................................................................................19 
Table 3: 
Definition of First and Last Dose Date .......................................................................28 
Table 4: 
Hurley Stages of Hidradenitis Suppurativa ................................................................31 
Table 5: 
Criteria for Potentially Clinically Important Laboratory Values ................................44 
 
45 
 
46 
Table 8: 
Statistical Analysis Plan Versions ..............................................................................47 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................16 
Figure 2: 
Control of the Overall Type I Error Rate ....................................................................18 
 


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LIST OF ABBREVIATIONS 
Abbreviations 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
AN 
abscess and inflammatory nodule 
ANF 
abscess, inflammatory nodule, and draining fistula 
AST 
aspartate aminotransferase 
 
 
 
 
 
 
CTCAE 
Common Terminology Criteria for Adverse Events 
DILI 
Drug Induced Liver Injury 
DLQI 
Dermatology Life Quality Index 
DMC 
data monitoring committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
 
 
 
 
 
 
HDL 
high-density lipoprotein 
 
 
 
 
HS 
hidradenitis suppurativa 
IHS4 
International Hidradenitis Suppurativa Severity Score System 
ITT 
intent-to-treat 
LDL 
low-density lipoprotein 
LTE 
long-term extension 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed model repeated measures 
NCI 
National Cancer Institute 
NRI 
non-responder imputation 
 
 
OLE 
open-label extension 
PC 
placebo-controlled 
 
 
 
 
PP 
per protocol 
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PT 
preferred term 
QALYs 
quality-adjusted life years 
QD 
once daily 
QTcF 
Fridericia's corrected QT interval 
SAP 
Statistical Analysis Plan  
SOC 
system organ class 
 
 
TEAE 
treatment-emergent adverse event  
 
 
ULN 
upper limit of normal 
 
a 
 
P
I
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1. 
INTRODUCTION 
This is a Phase 2, multicenter, parallel group, placebo-controlled, double-blind, randomized 
study to evaluate the efficacy and safety of INCB054707 (15, 45, and 75 mg QD) over a 
16-week PC period. Upon completion of the 16-week PC period, participants will continue for 
36 weeks of OLE period (INCB054707 75 mg QD). At the end of the OLE period, all eligible 
participants have the option to continue treatment for additional 48 weeks in an LTE period, to 
collect long-term safety and efficacy data for a total of 104 weeks. A safety follow-up visit will 
be conducted approximately 4 weeks after the last dose of study drug. 
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the Study INCB 54707-204 Protocol. 


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2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCB 054707-204 Protocol Amendment 1 dated 10 SEP 2021 and CRFs 
approved 27 JUL 2020. Unless superseded by an amendment, this SAP will be effective for all 
subsequent Protocol amendments and eCRF versions. 
2.2. 
Study Objectives and Endpoints 
Table 1 presents the objectives and endpoints. 
Table 1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To determine the efficacy of INCB054707 
• Mean change of AN count at Week 16 relative 
to baseline. 
Secondary 
To further evaluate the efficacy of INCB054707 
• Key secondary endpoint: Proportion of 
participants who achieve HiSCR at Week 16. 
Hidradenitis suppurativa clinical response is 
defined as at least a 50% decrease from baseline 
in AN count with no increase in the number of 
abscesses or draining fistulas. 
• Proportion of participants who achieve HiSCR 
at each visit from Weeks 2 to 12. 
• Proportion of participants who achieve at least a 
75% decrease from baseline in AN count with 
no increase in the number of abscesses or 
draining fistulas from Weeks 2 to 16. 
• Mean change from baseline in the severity of 
the disease, as assessed by the IHS4 score, from 
Weeks 2 to 16. 
• Proportion of participants achieving AN50, 
AN75, AN90, and AN100 (at least 50%, 75%, 
90%, and 100% reduction in AN count relative 
to baseline, respectively) from Weeks 2 to 16. 
• Mean change in AN count at Weeks 2 to 12, 
relative to baseline. 
• Proportion of participants with a total AN count 
of 0 to 2 from Weeks 2 to 16. 
• Mean change in draining fistula count from 
Weeks 2 to 16, relative to baseline. 
• Mean change in ANF count from Weeks 2 to 
16, relative to baseline. 


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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
To evaluate the safety and tolerability of 
INCB054707 
• Frequency and severity of AEs, including the 
evaluation of clinical laboratory results, vital 
signs, ECGs, and the results of physical 
examinations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3. 
STUDY DESIGN 
This is a Phase 2, multicenter, randomized, parallel group, placebo-controlled, dose-ranging 
study to evaluate the efficacy and safety of INCB054707 (15, 45, and 75 mg QD) over a 
16-week PC period followed by a 36-week OLE period (INCB054707 75 mg QD) and an 
additional optional 48-week LTE period. The study will enroll men or women aged 18 to 
75 years who have been diagnosed with HS (Hurley Stage I, II, or III) for at least 3 months with 
a total AN count of at least 5 and inflammatory lesions that affect at least 2 distinct anatomical 
areas. 
Participants will undergo screening within 30 days prior to randomization. Participants who 
continue to meet eligibility criteria at baseline will have Day 1 (Week 0) assessments and will be 
randomized to 1 of 4 treatment groups. Participants will be stratified based on geographical 
region (North America and outside of North America) and disease severity (Hurley Stages I, II, 
and III) with no more than 25% of the total number of participants as Hurley Stage III. 
Participants will receive double-blinded study treatment of placebo or 1 of 3 doses of 
INCB054707 (15, 45, or 75 mg) QD for 16 weeks. At Week 16, participants will enter the 
36-week OLE period (INCB054707 75 mg QD). At the completion of the OLE period, all 
eligible participants will have the option to continue treatment for an additional 48-week LTE 
period. A safety follow-up visit will be scheduled approximately 4 weeks after the end of OLE 
period (Week 56 visit) for participants who do not continue into the LTE period, or the LTE 
period (Week 104 visit) for participants who continue into the LTE period. 
The study schema is shown below in Figure 1. 
Figure 1: 
Study Design Schema 
 
The primary analysis will occur after the primary database lock, when all participants have 
completed or discontinued from the placebo-controlled, double-blind treatment period. 
The final analysis will occur when all participants have completed or withdrew from the study. 


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3.1. 
Randomization 
Approximately 200 participants will be randomized 1:1:1:1 to 1 of 3 INCB054707 treatment 
groups or the placebo group (approximately 50 participants per group). 
Participant randomization will be stratified based on geographical region (North America and 
outside of North America) and disease severity (Hurley Stages I, II, and III) with no more than 
25% of the total number of participants as Hurley Stage III. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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3.4. 
Schedule of Assessments 
Refer to Protocol Amendment 1 dated 10 SEP 2021 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 and Study Periods 
4.1.1. 
Day 1 
Day 1 is defined in Table 2 for each period, and combination of periods specified. Note that the 
treatment groups for each period are described in Section 5.2. 
Table 2: 
Definition of Day 1 
Treatment Period 
Treatment Groups 
Day 1 
PC period 
Placebo 
INCB054707 15 mg 
INCB054707 45 mg 
INCB054707 75 mg 
The day of the first dose of study drug (INCB054707 
or placebo) administered to the participants in the PC 
period. 
OLE period 
Placebo to INCB054707 75 mg 
INCB054707 15 mg to 75 mg 
INCB054707 45 mg to 75 mg 
INCB054707 75 mg 
The day of the first dose of study drug (INCB054707 
75 mg) administered to the participants in the OLE 
period 
Throughout study 
participation up to 
Week 52 
INCB054707 75 mg 
The day of the first dose of study drug (INCB054707 
75 mg) administered to the participants in the PC 
period 
LTE period 
INCB054707 ≤ 45 mg 
INCB054707 ≥ 60 mg 
The day of the first dose of study drug (INCB054707) 
administered to the participants in the LTE period 
For randomized participants not treated with any study drug, Day 1 is defined as the day of 
randomization. 
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 in the PC period, unless otherwise defined. 
For randomized participants not treated with any study drug, baseline is defined as the last 
nonmissing assessment before or on the day of randomization for all parameters. 


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For participants who continue in the OLE period, baseline is defined as follows: 
• For efficacy evaluation, baseline is the last nonmissing measurement obtained before 
the first administration of study drug in the PC period, unless otherwise defined. 
• For safety evaluation in the OLE period: 
− For participants who cross over from the placebo group or the INCB054707 15 or 
45 mg groups to INCB054707 75 mg, baseline is the last nonmissing 
measurement obtained before the first administration of INCB054707 75 mg in 
the OLE period. 
− For participants who take INCB054707 75 mg throughout study participation up 
to Week 52, baseline is the last nonmissing measurement obtained before the first 
administration of study drug in the PC period.  
For participants who continue in the LTE period, baseline is defined as follows: 
• For efficacy evaluation, baseline is the last nonmissing measurement obtained before 
the first administration of study drug in the PC period, unless otherwise defined.  
• For safety evaluation in the LTE period, baseline is the last nonmissing measurement 
obtained before the first administration of INCB054707 in the LTE period. 
When scheduled assessments and unscheduled assessments occur on the same day and the 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. 
Handling of Missing and Incomplete Dates 
In general, values for missing dates will not be handled unless methods for handling missing 
dates are specified in this section or relevant sections. The original reported dates collected on 
the eCRF should be used in all relevant listings. The following rules will be used for handling 
partial dates for analyses requiring dates. 
When calculating the time since diagnosis of HS, a partial HS diagnosis date will be handled as 
follows in the calculation: 
• If only the day is missing, then the first day of the month will be used. 
• If both the month and day are missing, then 01 JAN of the year will be used. 
• If the diagnosis date is completely missing, then the time since diagnosis will not be 
calculated. 


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When the date of the last dose is used in deriving variables such as duration of treatment or 
TEAE flag, a missing or partial date of the last dose will be handled as follows: 
• If only the day is missing, then the earlier date of the last day of the month or the date 
that the participant discontinued treatment will be used. 
• If both the month and day are missing, then the earlier date of 31 DEC of the year or 
the date that the participant discontinued treatment will be used. 
• Otherwise, the date that the participant discontinued treatment will be used as the date 
of the last dose. 
For response endpoints, all nonresponders, as well as all participants who are missing 
postbaseline values, will be defined as nonresponders for the NRI analysis. 
For continuous endpoints, any participant who is missing postbaseline values may have missing 
data handled using MMRM under the missing-at-random assumption. Mixed model repeated 
measures implicitly adjusts for missing data through a variance-covariance structure. 
For other endpoints, missing observations will be handled as detailed in the specific sections 
addressing each analysis. 
4.2. 
Variable Definitions 
The following variables will only be calculated if not reported on the eCRF. 
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 in the PC period. 
In the PC period, concomitant medication is defined as any nonstudy medication that is started 
accordingly: 
• Before the date of first administration of INCB054707 or placebo in the PC period 
and is ongoing throughout the study or ends on/after the date of first study drug 
administration during the PC period. 
• On/after the date of first administration of INCB054707 or placebo in the PC period 
and is ongoing or ends during the PC period. 


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In the OLE period, concomitant medication is defined as any nonstudy medication that is started 
accordingly: 
• Before the date of first administration of INCB054707 75 mg in the OLE period and 
is ongoing throughout the study or ends on/after the date of first study drug 
administration during the OLE period. 
• On/after the date of first administration of INCB054707 75 mg in the OLE period and 
is ongoing or ends during the OLE period. 
In the LTE period, concomitant medication is defined as any nonstudy medication that is started 
accordingly: 
• Before the date of first administration of INCB054707 in the LTE period and is 
ongoing throughout the study or ends on/after the date of first study drug 
administration during the LTE period. 
• On/after the date of first administration of INCB054707 in the LTE period and is 
ongoing or ends during the LTE period. 
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first dose of INCB054707 or placebo. In the listing, it will be indicated whether 
a medication is only prior, only concomitant, or both prior and concomitant. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant. 


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5. 
STATISTICAL METHODOLOGY 
5.1. 
General Methodology 
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9.1 or later) will be used 
for the generation of all tables, graphs, and statistical analyses. Descriptive summaries for 
continuous variables will include but not be limited to the number of observations, mean, 
standard deviation, median, minimum, and maximum. Descriptive summaries for categorical 
variables will include the number and percentage of participants in each category. 
5.2. 
Treatment Groups 
This is a randomized, double-blind, placebo-controlled, dose-ranging study followed by an 
open-label extension period, and an optional long-term extension period. Table summaries, 
unless otherwise indicated, will present data by treatment groups. The results will be summarized 
and presented separately for the PC period, the OLE period, and the LTE period, unless 
otherwise specified. 
For the PC period, the treatment groups will be placebo and INCB054707 15 mg, 45 mg, and 
75 mg. 
For the OLE period, the participants will be grouped into the following groups according to the 
treatment group they received during the PC period: 
• Placebo to INCB054707 75 mg 
• INCB054707 15 mg to 75 mg 
• INCB054707 45 mg to 75 mg 
• INCB054707 75 mg 
For the LTE period, the participants will be grouped into the following groups according to the 
initial INCB054707 dose group they received in the LTE period: 
• INCB054707 ≤ 45 mg 
• INCB054707 ≥ 60 mg 
5.3. 
Analysis Populations 
5.3.1. 
Intent-to-Treat Population 
All participants who were randomized to the study constitute the ITT population. Treatment 
groups for this population will be defined according to the treatment assignment at the time of 
randomization regardless of the actual study treatment the participant might apply during his/her 
participation in the PC period. 
The ITT population will be used for the summary of demographics, baseline characteristics, 
participant disposition, and analyses of all efficacy data in the PC period. 


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5.3.2. 
Per Protocol Population 
Participants in the ITT population who are considered to be sufficiently compliant with the 
Protocol compose the PP population. The determination of participants being considered for 
exclusion from the PP population by the clinical team will be prepared and signed before 
unblinding and database lock. 
The PP population will be used in the supportive sensitivity analysis for the primary efficacy 
endpoint. 
5.3.3. 
Safety Population 
The safety population will include all participants who received at least 1 dose of INCB054707 
or placebo during the PC period. Treatment groups for this population will be determined 
according to the actual treatment the participant received on Day 1 regardless of assigned study 
treatment. 
All safety analyses for the PC period will be conducted using the safety population. 
5.3.4. 
Open-Label Evaluable Population 
All analyses for the OLE period will be conducted with the open-label evaluable population, 
which includes all participants who received at least 1 dose of INCB054707 75 mg during the 
OLE period. 
5.3.5. 
Long-Term Evaluable Population 
All analyses for the LTE period will be conducted with the long-term evaluable population, 
which includes all participants who received at least 1 dose of INCB054707 during the 
LTE period. 
 
 
 
 
 
  
 
 
 
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6. 
BASELINE, EXPOSURE, AND DISPOSITION 
Appendix A provides a list of data displays. Sample data displays are included in a separate 
document. 
6.1. 
Demographics, Baseline Characteristics, and Disease History 
The demographics, baseline characteristics, and disease history will be summarized by treatment 
groups and overall. 
6.1.1. 
Demographics and Baseline Characteristics 
The following demographics will be summarized for the ITT population, the open-label 
evaluable population, and the long-term evaluable population: age, sex, race, ethnicity, weight, 
height, BMI, BMI category (< 25 kg/m2, ≥ 25 to < 30 kg/m2, ≥ 30 to < 40 kg/m2, ≥ 40 to 
< 50 kg/m2, ≥ 50 kg/m2), and geographic region (North America, Outside of North America). 
The following demographics will be summarized for the ITT population only: tobacco use (never 
used, current user, former user), cannabis use (never used, current user, former user), and alcohol 
use (yes, no). 
6.1.2. 
Baseline Disease Characteristics and Disease History 
The following baseline disease characteristics and disease history summarized for all participants 
in the ITT population include but are not limited to: 
• Disease duration (years) 
• Prior therapy or surgical intervention administered for HS 
 
 
• HS family history 
• Comorbidities 
 
• Hurley stage (Stage I, Stage II, Stage III) (See Section 7.2.5 for patient overall 
Hurley stage) 
• AN count 
• AN count category 
 
• ANF count 
• Inflammatory nodule count 
• Abscess count 
• Draining fistula count 
• Draining fistula count category 
 
• Number of anatomical areas with abscess, inflammatory nodule or draining fistula 
 


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• IHS4 score 
 
 
 
 
 
 
 
 
Note: Disease duration (years) will be calculated as follows: 
Disease duration (years) = (date of randomization – date of initial HS diagnosis + 1) / 365.25. 
6.1.3. 
Medical History 
For participants in the ITT population, medical history will be summarized by assigned treatment 
groups. This summary will include the number and percentage of participants with medical 
history for each body system/organ class as documented on the eCRF. 
6.2. 
Disposition of Participant 
The following categories will be summarized by treatment groups and overall for the ITT 
population in the PC period: 
• Number (%) of participants who were randomized 
• Number (%) of participants who were treated in the PC period 
• Number (%) of participants who completed treatment in the PC period through 
Week 16 
• Number (%) of participants who discontinued study treatment with a primary reason 
for discontinuation in the PC period 
• Number (%) of participants who withdrew from the study with a primary reason for 
withdrawal in the PC period 
The number of participants enrolled by country and/or site will also be provided by treatment 
group and overall. 
The following categories will be summarized by treatment groups and overall for the open-label 
evaluable population in the OLE period: 
• Number (%) of participants who were treated in the OLE period 
• Number (%) of participants who completed treatment in the OLE period through 
Week 52 
• Number (%) of participants who discontinued the study treatment with a primary 
reason for discontinuation in the OLE period 
• Number (%) of participants who completed the study through Week 56 
• Number (%) of participants who withdrew from the study with a primary reason for 
withdrawal in the OLE period 


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The following categories will be summarized by treatment groups and overall for the long-term 
evaluable population in the LTE period:  
• Number (%) of participants who were treated in the LTE period 
• Number (%) of participants who completed treatment in the LTE period through 
Week 100 
• Number (%) of participants who discontinued the study treatment with a primary 
reason for discontinuation in the LTE period 
• Number (%) of participants who completed the study through Week 104 
• Number (%) of participants who withdrew from the study with a primary reason for 
withdrawal in the LTE period 
6.3. 
Protocol Deviations 
Protocol deviations recorded on the eCRF will be summarized by treatment groups and overall 
for ITT population in the PC period, open-label evaluable population in the OLE period, and 
long-term evaluable population in the LTE period, and listed. 
6.4. 
Exposure 
For participants in the safety population in the PC period, the open-label evaluable population in 
the OLE period, those who take INCB054707 75 mg throughout study participation up to 
Week 52, and the long-term evaluable population in the LTE period, study drug exposure in 
terms of duration of treatment with study drug will be summarized by treatment groups 
descriptively as follows: 
• Duration of treatment with study drug (days): date of last dose of study 
drug – date of first dose of study drug + 1. 
Note that the date of first and last dose of study drug are period-specific and defined in Table 3. 


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Table 3: 
Definition of First and Last Dose Date 
Treatment Period 
Treatment Group 
First Dose Date 
Last Dose Date 
PC period 
Placebo 
INCB054707 15 mg 
INCB054707 45 mg 
INCB054707 75 mg 
Date that the first dose of 
study drug (INCB054707 or 
placebo) was administered 
to the participants in the PC 
period 
Date that the last dose of 
study drug (INCB054707 
or placebo) is administered 
to the participants in the 
PC period 
OLE period 
Placebo to INCB054707 75 mg 
INCB054707 15 mg to 75 mg 
INCB054707 45 mg to 75 mg 
INCB054707 75 mg 
Date that the first dose of 
study drug (INCB054707 
75 mg) was administered to 
the participants in the OLE 
period 
Date that the last dose of 
study drug (INCB054707 
75 mg) is administered to 
the participants in the OLE 
period 
Throughout study 
participation up to 
Week 52  
INCB054707 75 mg 
Date that the first dose of 
study drug (INCB054707 
75 mg) was administered to 
the participants in the PC 
period 
Date that the last dose of 
study drug (INCB054707 
75 mg) is administered to 
the participants throughout 
study participation up to 
Week 52 
LTE period 
INCB054707 ≤ 45 mg 
INCB054707 ≥ 60 mg 
Date that the first dose of 
study drug (INCB054707) 
was administered to the 
participants in the LTE 
period 
Date that the last dose of 
study drug (INCB054707) 
is administered to the 
participants in the LTE 
period 
In addition, for the safety population in the PC period and the open-label evaluable population in 
the OLE period, average daily dose of INCB054707 and total actual dose of INCB054707 taken 
will be summarized by treatment groups descriptively as follows: 
• Average daily dose of INCB054707 (mg/day): total actual INCB054707 dose 
taken (mg) / [duration of treatment with study drug (days) – number of interrupted 
days with study drug]. 
• Total actual dose of INCB054707 taken (mg) will be calculated as: (total number 
of tablets dispensed – total number of tablets returned) ×15 (mg/tablet) × 𝑝𝑇 
Where  𝑝𝑇 denotes the proportion of INCB054707 among the 5 tablets taken daily 
with 𝑝𝑇= 0 (0/5) for placebo group, 1/5 for INCB054707 15 mg group, 3/5 for 
INCB054707 45 mg group, and 1 (5/5) for INCB054707 75 mg group. 
Total number of tablets dispensed and returned in each period is based on information entered on 
the Drug Accountability eCRF. If there is dispensed drug that has not been returned yet, the 
actual dose taken starting from the dispense date of the unreturned drug will be imputed by the 
dose taken as reported on the Dosing eCRF. 


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6.5. 
Study Drug Compliance 
For participants in the safety population, the open-label evaluable population, and the long-term 
evaluable population, overall compliance (%) for INCB05707/placebo will be calculated for all 
participants as follows: 
compliance (%) = 100  [total dose actually taken (in the specific period)] / [total prescribed 
dose]. 
Total prescribed dose is defined as the sum of the doses prescribed by the investigator 
accounting for dose modifications. 
Total dose actually taken will be calculated as: total number of tablets dispensed – total number 
of tablets returned (see Section 6.4 for details on total number of tablets dispensed and returned). 
6.6. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary. 
The number and percentage of participants in the ITT during the PC period for each prior and 
concomitant medication will be summarized by treatment groups and overall by WHO drug class 
and WHO drug preferred term. For the open-label evaluable population in the OLE period and 
the long-term evaluable population in the LTE period, only concomitant medications will be 
summarized by treatment groups and overall by WHO drug class and WHO drug preferred term. 


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7. 
EFFICACY 
Appendix A provides a list of data displays. Sample data displays are included in a separate 
document. 
7.1. 
General Considerations 
For participants who enter the OLE period and do not continue in the LTE period, all by-visit 
analyses for open-label evaluable population will include the follow-up period if the data are 
available, unless otherwise specified. 
For participants who continue into the LTE period, all by-visit analyses for long-term evaluable 
population will include the follow-up period if the data are available, unless otherwise specified. 
Unless otherwise stated, the strata identified in the randomization process will be used in all 
efficacy analyses. 
7.2. 
Efficacy Parameters 
An example of the lesion count worksheet is provided in the Study Manual and will be used for 
assessment of AN and ANF counts, HiSCR, IHS4, 
 and Hurley Stage. It includes 
assessment of 7 anatomic regions: 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
7.2.1. 
AN and ANF Counts 
The AN count is defined as the sum of abscess and inflammatory nodule counts. The AN results 
will be used to calculate change in AN count relative to baseline, as well as AN50, AN75, AN90, 
and AN100, defined respectively as at least a 50%, 75%, 90%, and 100% decrease in AN count 
relative to baseline. 
The ANF count is defined as the sum of abscess, inflammatory nodule, and draining fistula 
counts. The ANF results will be used to calculate the change in ANF count relative to baseline. 


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7.2.2. 
Hidradenitis Suppurativa Clinical Response 
A HiSCR definition is based on the following criteria relative to the baseline at each visit: 
• at least 50% reduction in AN count, 
• no increase in abscess count, and 
• no increase in draining fistula count. 
HiSCR75 is defined as at least 75% reduction from baseline in AN count with no increase in the 
number of abscesses or draining fistulas. 
HiSCR90 is defined as at least 90% reduction from baseline in AN count with no increase in the 
number of abscesses or draining fistulas. 
7.2.3. 
International Hidradenitis Suppurativa Severity Score System 
The IHS4 (Zouboulis et al 2017) is a composite, dynamic score and validated tool used to 
determine HS severity. The total IHS4 score can be calculated as: 
IHS4 (points) = (number of inflammatory nodules × 1) + (number of abscesses × 2) + 
(number of draining tunnels [draining fistulae/sinuses] × 4) 
And the IHS4 category is defined as: 
Mild HS: ≤ 3points; Moderate HS: 4-10 points; Severe HS: ≥11 points. 
 
 
 
 
7.2.5. 
Hurley Stages of Hidradenitis Suppurativa 
The Hurley Stages are defined in Table 4. The investigator (or designee) will determine the 
Hurley Stage in each affected anatomical region at the designated study visits. If more than 
1 stage is present in the region, the worst stage in that region should be documented. The 
participant will be assigned an overall Hurley Stage corresponding to the stage of the worst 
involved anatomical region. 
Table 4: 
Hurley Stages of Hidradenitis Suppurativa 
Hurley Stage 
Description 
I 
Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring). 
II 
One or more widely separated recurrent abscesses with tract formation and cicatrization 
(scarring). 
III 
Multiple interconnected tracts and abscesses across the entire area, with diffuse or 
near diffuse involvement. 
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7.3. 
Efficacy Hypotheses 
The primary hypothesis is that INCB054707 75 mg is superior to placebo at Week 16 on mean 
change from baseline in AN in participants with HS. Assuming 𝜇𝑇 is the mean change from 
baseline at Week 16 in AN count in INCB054707 75 mg group and 𝜇𝐶 is the mean change from 
baseline at Week 16 in AN count in placebo group, the primary hypothesis of the study are as 
follows: 
• 𝐻0 (null hypothesis): 𝜇𝑇= 𝜇𝐶 
• 𝐻𝐴 (alternative hypothesis): 𝜇𝑇≠𝜇𝐶 
7.4. 
Analysis of the Primary Efficacy Parameter 
The primary efficacy endpoint is the mean change of AN count at Week 16 relative to baseline. 
7.4.1. 
Primary Efficacy Analysis 
 
 
 
 
 
 
 
  
 
 
7.4.2. 
Subgroup Analyses for Primary Endpoint 
Subgroups will be formed based on the following participant characteristics and baseline 
variables for those participants whose data are available:  
• Geographic region (North America, Outside of North America) 
• Baseline Hurley Stage (Stage I, Stage II, Stage III) 
The primary efficacy endpoint will be summarized using descriptive statistics based on the ITT 
population for the subgroups defined above. 
7.4.3. 
Sensitivity and Supportive Analyses for Primary Endpoint 
The primary endpoint will be analyzed using the PP population as a sensitivity analysis to the 
ITT. 


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7.5. 
Analysis of the Secondary Efficacy Parameters 
7.5.1. 
Analysis of the Key Secondary Efficacy Endpoint 
The key secondary efficacy endpoint is proportion of participants who achieve HiSCR at 
Week 16 will be conducted for the ITT population. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.5.2. 
Analysis of Other Secondary Efficacy Endpoints 
All other secondary efficacy endpoints are listed in Table 1 and will be summarized using 
descriptive statistics based on the ITT population. 
For categorical measurements, summary statistics will include sample size, frequency, and 
percentages. For continuous measurements, summary statistics will include sample size, mean, 
median, standard deviation, minimum, and maximum. Summary statistics for continuous 
measures will be provided for baseline, the actual measurements at each visit, and the change 
from baseline at each visit.  
 
 
 
 
 
PI


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7.7. 
Analysis of Additional Efficacy Parameters 
The following additional efficacy endpoints will be summarized descriptively based on the 
ITT population in the PC period, the open-label evaluable population in the OLE period, and the 
long-term evaluable population in the LTE period: 
• Proportion of participants in each category of Hurley Stage at each scheduled visit 
• Proportion of participants with Hurley Stage change from baseline at each scheduled 
visit 
• Mean percent change from baseline in AN count at each scheduled visit 
 
 
 
• Proportion of participants achieving HiSCR90 at each scheduled visit 


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9. 
SAFETY AND TOLERABILITY 
Appendix A provides a list of data displays. Sample data displays are included in a separate 
document. 
9.1. 
General Considerations 
The analyses in this section will be provided for the safety population in the PC period, the 
open-label evaluable population in the OLE period, and the long-term evaluable population in 
the LTE period, unless otherwise specified. 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. 
9.2. 
Adverse Events 
9.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the 
first dose of study drug until the end of the safety follow-up. 
TEAE in each period is any AE with a start time after the first dose of study drug in each period 
and until the end of the safety follow-up, or prior to the first dose in the subsequent period for 
participants who entered in to the subsequent period. 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. For purposes of analysis, all AEs will be considered TEAEs unless the 
AE can unequivocally be defined as not treatment-emergent. 
Adverse events will be tabulated by MedDRA PT and SOC. Severity of AEs will be graded 
using the NCI CTCAE v5.0. The CTCAE reporting guidelines and grading details are available 
on the Cancer Therapy Evaluation Program website. 


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The subset of AEs considered by the investigator to be related 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, the AE will be considered to be treatment-related. The incidence of AEs and 
treatment-related AEs will be tabulated. In addition, serious TEAEs will also be tabulated. 
9.2.2. 
Adverse Event Summaries 
AE will be summarized by treatment groups for the safety population in the PC period, the 
open-label evaluable population in the OLE period, participants who take INCB054707 75 mg 
throughout study participation up to Week 52, and the long-term evaluable population in the 
LTE period. 
An overall summary of AEs will include the following: 
• 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 
• Number (%) of participants who permanently discontinued study treatment because 
of TEAEs 
• Number (%) of participants who had a fatal TEAE 
The following summaries will be produced by MedDRA term (if 10 or fewer subjects appear in a 
table, a listing may be appropriate): 
• Summary of TEAEs by MedDRA SOC and PT 
• Summary of TEAEs by MedDRA PT in decreasing order of frequency 
• Summary of TEAEs by MedDRA SOC, PT, and maximum severity 
• Summary of TEAEs by MedDRA SOC, PT, and CTCAE grade category 
• Summary of Grade 3 or higher TEAEs by MedDRA SOC and PT 
• Summary of Grade 3 or higher TEAEs by MedDRA PT in decreasing order of 
frequency 
• Summary of serious TEAEs by MedDRA SOC and PT 
• Summary of serious TEAEs by MedDRA PT in decreasing order of frequency 
• Summary of treatment-related TEAEs by MedDRA SOC and PT 
• Summary of treatment-related TEAEs by MedDRA PT in decreasing order of 
frequency 
• Summary of Grade 3 or higher treatment-related TEAEs by MedDRA SOC and PT 


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• Summary of treatment-related serious TEAEs by MedDRA SOC and PT 
• Summary of TEAEs with a fatal outcome by MedDRA SOC and PT 
• Summary of TEAEs leading to dose reduction by MedDRA SOC and PT 
• Summary of TEAEs leading to dose interruption by MedDRA SOC and PT 
• Summary of TEAEs leading to discontinuation of study drug by MedDRA SOC and 
PT 
• Summary of TEAEs requiring concomitant medications by MedDRA SOC and PT 
9.3. 
Clinical Laboratory Tests 
9.3.1. 
Laboratory Value Definitions 
Laboratory values, change from baseline values, and percent change from baseline values will be 
summarized descriptively by visit, and non-numeric test values will be tabulated when necessary. 
Baseline will be determined according to Section 4.1.3. The last record before administration in 
the highest priority will be considered the baseline record. For baseline laboratory candidates 
with the same date and time in the same priority category, additional rules may be provided after 
consultation with the medical monitor to delineate which value will be defined as baseline. 
9.3.2. 
Laboratory Value Summaries 
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. 
When there are multiple laboratory nonmissing values for a participant's particular test within a 
visit window, the laboratory value with the smallest laboratory sequence number will be used in 
by-visit summaries.
 
 
For test results that will be summarized with available normal ranges, the number and percentage 
of participants with laboratory values being low (but never high), normal, high (but never low), 
and both low and high will be calculated for each test. This shift summary will be produced for 
each test. 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 study. 
Severity grades will be assigned to laboratory test values based on the numerical component of 
CTCAE v5. Shift tables will also be presented showing change in CTCAE grade from baseline to 
the worst grade postbaseline. Separate summaries for abnormally high and abnormally low 
laboratory values will be provided when the laboratory parameter has both high and low grading 
criteria. The denominator for the percentage calculation will be the number of participants in the 
baseline category. The number of participants who experienced worsening of laboratory 
abnormalities will be summarized by maximum severity. 


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9.3.3. 
Potentially Clinically Important Laboratory Values 
Criteria for potentially clinically important laboratory values are listed in Table 5 below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Note that combination of values need to be measured on the same day.  
The number and percentage of participants with postbaseline liver specific function test values 
that meet each of the above criteria will be presented at each scheduled visit by treatment groups. 
Participants with potential DILI events will also be listed. 
9.4. 
Vital Signs 
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, and body 
temperature will be summarized descriptively. 
Normal ranges for vital sign values are defined in Table 6. For participants exhibiting vital sign 
abnormalities, the abnormal values will be listed along with their assigned treatment group. Alert 
vital signs are defined as an absolute value outside the defined normal range and percentage 
change greater than 25%. Note that the definition of alert vital signs does not apply to body 
temperature. The abnormal values for participants exhibiting alert vital sign abnormalities will be 
listed. 
9.5. 
Electrocardiograms 
Twelve-lead ECGs including PR, QT, QRS and QTcF intervals will be obtained for each 
participant during the study. Values at each scheduled visit, change, and percentage change from 
baseline will be summarized for each ECG parameter. Baseline will be determined as the 
average of all nonmissing values before the first administration of INCB054707 or placebo. 


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Normal ranges for ECG values are defined in Table 7. ECG values will also be considered 
abnormal if the absolute percentage change from baseline is more than 25% (30% for QRS 
interval). Participants exhibiting ECG abnormalities will be listed with study visit and assigned 
treatment group. Abnormal values for participants with alert ECG values, defined as both the 
absolute value and the percentage change from baseline being outside normal ranges, will be 
identified and listed. Outliers of QT and QTcF values, defined as absolute values 
> 450 millisecond, > 500 millisecond, or change from baseline > 30 millisecond, will be 
summarized. 


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10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 8. 
Table 8: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
12 OCT 2021 
10.1. 
Changes to Protocol-Defined Analyses 
 
 
 
10.2. 
Changes to the Statistical Analysis Plan 
Not applicable. 


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11. 
REFERENCES 
 
 
Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective 
multiple test procedures. Stat Med 2009;28:586-604. 
Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with 
fatigue in the general United States population. Cancer 2002;94:528-538. 
 
 
 
Food and Drug Administration. Guidance for Industry. Drug-induced liver injury: Premarketing 
Clinical Evaluation. 2009. 
 
 
Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change 
scores: a reanalysis of two clinical trials of postoperative pain. J Pain 2003;4:407-414. 
 
 
 
 
 
Mehta CR, Patel NR. Exact logistic regression: theory and examples. Stat Med 
1995;14:2143-2160. 
 
 
Sabat R, Jemec GBE, Matusiak L, Kimbal AB, Prens E, Wolk K. Hidradenitis suppurativa. Nat 
Rev Dis Prim 2020;6:1-20. 
Zouboulis CC, Tzellos T, Kyrgidis A, et al. Development and validation of the International 
Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to 
assess HS severity. Br J Dermatol 2017;177:1401-1409. 


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Figures 


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Incyte Corporation 
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INCB 54707-204 Statistical Analysis Plan 
12 OCT 2021 
VV-CLIN-017355 
CONFIDENTIAL