A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Sponsor: Incyte Corporation

Incyte Corporation 
 
Page 1 of 78 
Protocol INCB 54707-202 Am 1 
Version 1 
19 JUL 2018 
 
Clinical Study Protocol 
 
INCB 54707-202 
A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 
in Participants With Hidradenitis Suppurativa 
 
 
Product: 
INCB054707 
IND Number: 
137,156 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol (Version 0): 
07 DEC 2017 
Amendment (Version) 1 
19 JUL 2018 
 
 
 
 
 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, Good Clinical Practices as defined in Title 21 of the 
US Code of Federal Regulations Parts 11, 50, 54, 56, and 312, as well as ICH GCP consolidated guidelines (E6) and 
applicable regulatory requirements. 
 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without the prior 
written consent of Incyte Corporation. 
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Page 2 of 78 
Protocol INCB 54707-202 Am 1 
Version 1 
19 JUL 2018 
INVESTIGATOR'S AGREEMENT 
I have read the INCB 54707-202 Protocol Amendment 1 (Version 1 dated 19 JUL 2018) and 
agree to conduct the study as outlined.  I agree to maintain the confidentiality of all information 
received or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 
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Page 3 of 78 
Protocol INCB 54707-202 Am 1 
Version 1 
19 JUL 2018 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY ..........................................................................................10 
2. 
INTRODUCTION ......................................................................................................14 
2.1. 
Background .................................................................................................................14 
2.1.1. 
Hidradenitis Suppurativa ............................................................................................14 
2.1.2. 
Current Treatment and Unmet Need in Hidradenitis Suppurativa .............................14 
2.1.3. 
JAK-STAT Signaling in Inflammatory Skin Disease ................................................15 
 
 
2.2. 
Study Rationale ...........................................................................................................16 
2.2.1. 
Scientific Rationale for Study Design ........................................................................16 
2.2.2. 
Justification of Dose ...................................................................................................17 
 
 
 
 
2.3.2. 
Clinical Studies ...........................................................................................................18 
2.3.3. 
Benefit Assessment .....................................................................................................20 
2.3.4. 
Benefit-Risk Conclusion .............................................................................................20 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................21 
4. 
STUDY DESIGN .......................................................................................................22 
4.1. 
Overall Design ............................................................................................................22 
4.2. 
Overall Study Duration ...............................................................................................22 
4.3. 
Study Termination ......................................................................................................22 
5. 
STUDY POPULATION .............................................................................................23 
5.1. 
Inclusion Criteria ........................................................................................................23 
5.2. 
Exclusion Criteria .......................................................................................................24 
5.3. 
Lifestyle Considerations .............................................................................................26 
5.4. 
Screen Failures ............................................................................................................26 
5.5. 
Replacement of Participants .......................................................................................26 
6. 
STUDY TREATMENT ..............................................................................................26 
6.1. 
Study Treatment Administered ...................................................................................26 
6.2. 
Preparation, Handling, and Accountability ................................................................27 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................27 
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6.4. 
Study Treatment Compliance .....................................................................................27 
6.5. 
Dose Modifications .....................................................................................................28 
6.6. 
Concomitant Medications and Procedures .................................................................29 
6.6.1. 
Prior Medications and Therapies ................................................................................29 
6.6.2. 
Permitted Medications and Procedures ......................................................................29 
6.6.2.1. 
Antibiotic Therapy ......................................................................................................29 
6.6.2.2. 
Analgesic Therapy ......................................................................................................30 
6.6.2.3. 
Antiseptic Therapy ......................................................................................................30 
6.6.2.4. 
Wound Care ................................................................................................................30 
6.6.3. 
Prohibited Medications and Procedures .....................................................................30 
6.6.4. 
Rescue Lesional Treatments .......................................................................................31 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................31 
7.1. 
Discontinuation of Study Treatment ...........................................................................31 
7.1.1. 
Reasons for Discontinuation .......................................................................................31 
7.1.2. 
Discontinuation Procedures ........................................................................................31 
7.2. 
Participant Withdrawal From the Study .....................................................................32 
7.3. 
Lost to Follow-Up.......................................................................................................32 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................33 
8.1. 
Administrative and General Procedures .....................................................................33 
8.1.1. 
Informed Consent Process ..........................................................................................33 
8.1.2. 
Screening Procedures ..................................................................................................34 
8.1.3. 
Distribution of Reminder Cards and Diaries ..............................................................34 
8.1.4. 
Demography and Medical History ..............................................................................35 
8.1.4.1. 
Demographics and General Medical History .............................................................35 
8.1.4.2. 
Disease Characteristics and Treatment History ..........................................................35 
8.2. 
Efficacy Assessments .................................................................................................35 
8.2.1. 
Hurley Stages of Hidradenitis Suppurativa ................................................................35 
8.2.2. 
Hidradenitis Suppurativa Clinical Response (Abscess and Inflammatory 
Nodule Count) ............................................................................................................35 
8.2.3. 
Modified Sartorius Scale ............................................................................................36 
8.2.4. 
Need for Rescue Lesional Treatment .........................................................................36 
8.2.5. 
Hidradenitis Suppurativa Pain Numeric Rating Scale ................................................36 
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Protocol INCB 54707-202 Am 1 
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8.2.6. 
Analgesic Use .............................................................................................................37 
8.2.7. 
Hidradenitis Suppurativa Patient Global Impression of Change ................................37 
8.2.8. 
Dermatology Life Quality Index ................................................................................37 
8.2.9. 
Photography of Target Lesions ...................................................................................37 
8.3. 
Safety Assessments .....................................................................................................37 
8.3.1. 
Adverse Events ...........................................................................................................37 
8.3.2. 
Physical Examinations ................................................................................................38 
8.3.3. 
Vital Signs ..................................................................................................................38 
8.3.4. 
Electrocardiograms .....................................................................................................38 
8.3.5. 
Laboratory Assessments .............................................................................................39 
8.3.5.1. 
Safety Assessments .....................................................................................................39 
8.3.5.2. 
Screening Assessments ...............................................................................................39 
8.3.5.3. 
Pregnancy Test ............................................................................................................39 
 
 
 
 
 
 
 
 
 
 
 
 
8.6. 
Unscheduled Visits .....................................................................................................43 
8.7. 
End of Treatment and/or Early Termination ..............................................................43 
8.8. 
Follow-Up ...................................................................................................................43 
8.8.1. 
Safety Follow-Up ........................................................................................................43 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................44 
9.1. 
Definition of Adverse Event .......................................................................................44 
9.2. 
Definition of Serious Adverse Event ..........................................................................45 
9.3. 
Recording an Adverse Event and/or Serious Adverse Event .....................................46 
9.4. 
Reporting of Serious Adverse Events .........................................................................48 
9.5. 
Emergency Unblinding of Treatment Assignment .....................................................49 
9.6. 
Pregnancy ...................................................................................................................49 
9.7. 
Warnings and Precautions ..........................................................................................50 
9.8. 
Product Complaints ....................................................................................................50 
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Protocol INCB 54707-202 Am 1 
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19 JUL 2018 
LIST OF ABBREVIATIONS 
The following abbreviations and special terms are used in this clinical study Protocol. 
Abbreviation 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
AN 
abscess and inflammatory nodule 
ANC 
absolute neutrophil count 
AST 
aspartate aminotransferase 
BALT 
bronchial-associated lymphoid tissue 
CFR 
Code of Federal Regulations 
Cl/F 
apparent oral dose clearance 
CRF 
case report form 
CRP 
C-reactive protein 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTFG 
Clinical Trial Facilitation Group 
CYP 
cytochrome P450 
DLQI 
Dermatology Quality of Life Index 
eCRF 
electronic case report form 
ECG 
electrocardiogram 
EDC 
electronic data capture 
EOT 
end of treatment 
EOS 
end of study 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
FU 
follow-up 
GCP 
Good Clinical Practice 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HiSCR 
Hidradenitis Suppurativa Clinical Response 
 
 
HIV 
human immunodeficiency virus 
HS 
hidradenitis suppurativa 
IB 
Investigator's Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
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Abbreviation 
Definition 
ID 
identification 
IEC 
independent ethics committee 
 
 
IL 
interleukin 
IPL 
intense pulsed light 
IRB 
institutional review board 
ITT 
intent to treat 
JAK 
Janus kinase 
MedDRA 
Medical Dictionary for Regulatory Affairs 
Nd:YAG 
Neodymium-doped yttrium aluminium garnet; Nd:Y3Al5O12 
NRS 
numeric rating scale 
PGIC 
Patient Global Impression of Change 
P-gp 
P-glycoprotein 
 
 
PK 
pharmacokinetic 
QD 
once daily 
QTcF 
QT interval corrected for heart rate using Fridericia's formula 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SOP 
standard operating procedure 
STAT 
signal transducer and activator of transcription 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
Th 
T helper cell 
TNF-α 
tumor necrosis factor alpha 
TYK 
tyrosine kinase 
ULN 
upper limit of normal 
Vd/F 
apparent volume of distribution after non-intravenous administration 
WBC 
white blood cell 
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Protocol INCB 54707-202 Am 1 
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1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in 
Participants With Hidradenitis Suppurativa 
Protocol Number:  INCB 54707-202 
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 evaluate the safety and tolerability of 
INCB054707. 
• Frequency, duration, and severity of AEs, 
clinical laboratory test results, vital signs results, 
ECGs, and physical examination findings. 
Key Secondary 
To evaluate the systemic exposure to 
INCB054707. 
• Population PK parameters of INCB054707. 
To evaluate the efficacy of INCB054707. 
• Proportion of participants with a HiSCR at each 
visit. 
• Proportion of participants achieving an AN 
count of 0 to 2 at each visit. 
• Mean change from baseline in the HS Pain NRS 
scores, worst and average pain, at each visit. 
• Mean change from baseline to Week 8 in the 
modified Sartorius scale score. 
• Mean change from baseline in the number of 
draining fistulas count at each visit. 
• Proportion of participants at each category of 
Hurley Stage at baseline and Week 8. 
• Proportion of participants with change from 
baseline in Hurley Stage at Week 8. 
• Proportions of participants in each HS-PGIC 
category during the treatment period. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 
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Table 3: 
Schedule of Assessments 
Evaluation 
Section 
Screening 
Treatment 
Follow-Up 
Day -28 to -1 
Day 1
a 
Wk 1 
± 1 day 
Wk 2 
± 3 days 
Wk 4a 
± 3 days 
Wk 6 
± 3 days 
Wk 8a 
± 3 days 
(EOT) 
Wk 12 
+ 7 days 
(EOS) 
Administrative/screening procedures 
Informed consent 
8.1.1 
X 
 
 
 
 
 
 
 
Demography/medical history 
8.1.4 
X 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
5 
X 
X 
 
 
 
 
 
 
Prior/concomitant medications 
6.6 
X 
X 
X 
X 
X 
X 
X 
X 
Serology 
8.3.5.2 
X 
 
 
 
 
 
 
 
Urinalysis 
8.3.5.2 
X 
 
 
 
 
 
 
 
TB screening 
8.3.5.2 
X 
 
 
 
 
 
 
 
FSH
b 
8.3.5.2 
X 
 
 
 
 
 
 
 
Pregnancy test
c 
8.3.5.3 
X 
X 
X 
X 
X 
X 
X 
X 
Dispense study drug 
6.1 
 
X 
 
 
X 
 
 
 
Distribute reminder cards 
8.1.3 
X 
X 
X 
X 
X 
X 
X 
 
Distribute diary 
8.1.3 
X 
X 
X 
X 
X 
X 
X 
 
Collect study drug and assess compliance 
6.4 
 
 
X 
X 
X 
X 
X 
 
Safety procedures/assessments 
Comprehensive physical examination 
8.3.2 
X 
 
 
 
 
 
X 
 
Targeted physical examination 
8.3.2 
 
X 
X 
X 
X 
X 
 
X 
Vital signs 
8.3.3 
X 
X 
X 
X 
X 
X 
X 
X 
Hematology and chemistry assessments 
8.3.5.1, 8.6 
X 
X 
X 
X 
X 
X 
X 
X 
Lipid panel 
8.3.5.1 
 
X 
 
 
 
 
X 
 
CRP 
8.3.5.1 
 
X 
 
 
 
 
X 
 
12-lead ECG (screening)
d 
8.3.4  
X 
 
 
 
 
 
 
 
12-lead ECG (predose and postdose)d 
8.3.4 
 
X 
 
 
 
 
 
 
12-lead ECG (postdose only)d 
8.3.4  
 
 
 
X 
 
X 
 
 
12-lead ECG (predose only)d 
8.3.4  
 
 
 
 
 
 
X 
 
Assess AEs 
8.3.1, 9 
X 
X 
X 
X 
X 
X 
X 
X 
Efficacy assessments 
Hurley Stage 
8.2.1 
X 
X 
 
 
 
 
X 
X 
AN count (HiSCR) 
8.2.2 
X 
X 
X 
X 
X 
X 
X 
X 
Modified Sartorius score 
8.2.3 
 
X 
 
 
 
 
X 
X 
Record rescue lesional treatment 
8.2.4  
 
 
X 
X 
X 
X 
X 
X 
HS Pain NRS
e 
8.2.5 
X 
X 
X 
X 
X 
X 
X 
X 
Analgesic use 
8.2.6 
X 
X 
X 
X 
X 
X 
X 
X 
HS-PGIC 
8.2.7  
 
 
X 
X 
X 
X 
X 
X 
DLQI 
8.2.8 
X 
X 
X 
X 
X 
X 
X 
X 
Optional photography (target area) 
8.2.9 
 
X 
 
 
X 
 
X 
 
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Protocol INCB 54707-202 Am 1 
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Table 3: 
Schedule of Assessments (Continued) 
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Protocol INCB 54707-202 Am 1 
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2.3.3. 
Benefit Assessment 
Participants may experience clinically meaningful improvements in their HS lesions during the 
study and may additionally benefit from the comprehensive safety assessments conducted as part 
of the study (eg, clinical laboratory tests, physical examinations, ECGs). 
They will also contribute to the process of developing a novel anti-inflammatory agent for HS, a 
disease with high unmet need that is severely debilitating to participants' well-being and daily 
functioning. 
2.3.4. 
Benefit-Risk Conclusion 
Taking into account the safety measures taken to minimize risk to participants in this study, the 
potential risks identified in association with INCB054707 are justifiable and appropriately 
balanced by the anticipated efficacy benefits expected to be afforded to this specific group of 
participants and, more broadly, to the general population of patients with HS.  More detailed 
information about the known and expected benefits and risks and reasonably expected adverse 
events of INCB054707 may be found in the IB. 
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Protocol INCB 54707-202 Am 1 
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3. 
OBJECTIVES AND ENDPOINTS 
Table 5 presents the objectives and endpoints. 
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To evaluate the safety and tolerability of 
INCB054707. 
• Frequency, duration, and severity of AEs, 
clinical laboratory test results, vital signs results, 
ECGs, and physical examination findings 
Secondary 
To evaluate the systemic exposure to 
INCB054707. 
• Population PK parameters of INCB054707. 
To evaluate the efficacy of INCB054707. 
• Proportion of participants with a HiSCR at each 
visit. 
• Proportion of participants achieving an AN 
count of 0 to 2 at each visit. 
• Mean change from baseline in the HS Pain NRS 
scores, worst and average pain, at each visit. 
• Mean change from baseline to Week 8 in the 
modified Sartorius scale score. 
• Mean change from baseline in the number of 
draining fistulas count at each visit. 
• Proportion of participants at each category of 
Hurley Stage at baseline and Week 8. 
• Proportion of participants with change from 
baseline in Hurley Stage at Week 8 
• Proportions of participants in each HS-PGIC 
category during the treatment period. 
To assess the need for rescue lesional treatment. 
• Proportion of participants requiring rescue 
lesional treatment. 
• Number of interventions with rescue lesional 
treatment. 
To assess patient-reported quality of life burden. 
• Proportion of participants at each scoring 
category of DLQI at each visit. 
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5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Men and women aged 18 to 75 years at the time of consent. 
2. Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 
6 months before screening. 
3. Stable course of HS for at least 90 days before screening, as determined by the 
investigator. 
4. HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley 
Stage II (ie, recurrent abscessed with tract formation and cicatrization; single or multiple, 
widely separated lesions) or Hurley Stage III (ie, diffuse, or near diffuse involvement or 
multiple interconnected tracts and abscesses across the entire area) at screening and 
baseline. 
5. Total AN count of at least 3 at screening and baseline. 
6. Willingness to avoid pregnancy or fathering children based on the criteria below:  
a. Male participants must agree to take appropriate precautions to avoid pregnancy (with 
at least 99% certainty) from screening through 90 days after the last dose of study 
drug.  Male participants must also refrain from donating sperm during this period.  
Permitted methods that are at least 99% effective in preventing pregnancy (see 
Appendix A) should be communicated to the participant and his understanding 
confirmed. 
b. Women of childbearing potential must have a negative serum pregnancy test at 
screening and a negative urine pregnancy test before the first dose on Day 1 and must 
agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) 
from screening through safety follow-up.  Permitted methods that are at least 
99% effective in preventing pregnancy (see Appendix A) should be communicated to 
the participants and their understanding confirmed. 
c. Women of nonchildbearing potential (ie, surgically sterile [hysterectomy, bilateral 
oophorectomy, or bilateral salpingectomy] OR postmenopausal, defined as 
≥ 12 months of amenorrhea before screening without an alternative medical cause, 
confirmed by FSH levels at screening) are eligible. 
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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Women who are currently pregnant or lactating. 
2. Presence of > 20 draining fistulas at screening and baseline. 
3. Participants with concurrent conditions or history of other diseases, as follows: 
a. Any clinically significant medical condition other than HS, as determined by the 
investigator, that is not adequately controlled with appropriate treatment. 
b. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) 
that may interfere with the course, severity, or assessments of HS. 
c. Active systemic viral infection or any active viral infection that, based on the 
investigator's clinical assessment, make the participant an unsuitable candidate for the 
study. 
d. Current herpes zoster infection, a history of recurrent herpes zoster, a history of 
disseminated herpes simplex, or a history of herpes zoster. 
e. History of 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. 
f. Albinism. 
4. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined 
as ≥ 450 msec. 
Note:  Prolonged QTcF values of ≥ 450 msec at screening are to be confirmed by 
performing 2 additional ECGs and averaging the results to determine if the averaged 
value meets the exclusion criterion. 
5. Positive test result for TB from the QuantiFERON-TB Gold test, or equivalent, at 
screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified 
protein derivative test with a result of < 5 mm of induration within 3 months of 
screening) or a history of active TB. 
Note:  If the participant has possible evidence of a latent TB infection, the participant 
must have documented completion of an adequate course of therapy for latent TB and 
provide recent (within 3 months) posteroanterior and lateral views chest x-ray without 
changes suggestive of active or latent TB, prior to baseline. 
6. Positive serology test results for HIV, HBsAg, HBV core antibody, or HCV 
(HCV-antibody with positive HCV-RNA) at screening. 
7. Decreased blood cell counts at screening, defined as follows: 
a. Leukocytes < 3.0 × 109/L (< 2.5 × 109/L for participants who are African-American). 
b. ANC < 1.5× 109/L. 
c. Lymphocytes < 0.8 × 109/L. 
d. Hemoglobin < 10 g/dL. 
e. Platelets < 150 × 109/L. 
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15. Any 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. Inability of the participant (or parent, guardian, or legally authorized representative) to 
comprehend or unwilling to sign the ICF. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently entered into the study. 
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes the result to be in error.  Additionally, a participant who fails screening may 
repeat the screening process 1 time if the investigator believes that there has been a change in 
eligibility status.  Participants who rescreen must reconsent and be assigned a new participant 
number. 
5.5. 
Replacement of Participants 
No participants will be replaced at any time during this study. 
6. 
STUDY TREATMENT 
6.1. 
Study Treatment Administered 
Information regarding study drug and administration is provided in Table 6.  Participants will 
record study drug administration in a daily diary.  Participants will take the study drug once 
daily, preferably in the morning. 
Table 6: 
Study Treatment Information 
Study treatment name: 
INCB054707 
Dosage formulation: 
Tablet 
Unit dose strength/dosage level: 
INCB054707 15 mg QD 
Route of administration: 
Oral 
Administration instructions: 
INCB054707 will be taken orally with water without regard to 
food. 
Packaging and labeling: 
INCB054707 will be provided as 15 mg tablets and labeled as 
required per country requirement. 
Storage: 
Ambient (15°C-30°C/59°F-86°F) 
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6.2. 
Preparation, Handling, and Accountability 
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 drug to the study site. 
• Inventory of study drug at the site. 
• Participant use of the study drug including tablet counts from each supply dispensed. 
• Return of study drug 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 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 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 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 Reference Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Not applicable.  This is an open-label study. 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study.  
Compliance with INCB054707 will be calculated by the sponsor based on the drug 
accountability documented by site personnel and monitored by the sponsor/designee using tablet 
counts.  Participants will be instructed to bring all study drug with them to 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. 
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6.5. 
Dose Modifications 
In some circumstances, it may be necessary to temporarily interrupt treatment with INCB054707 
as a result of AEs or laboratory abnormalities that have an unclear relationship to the study drug 
(see Table 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 other 
representative of the sponsor) before temporarily interrupting study drug. 
Table 7: 
Guidelines for Interrupting, Restarting, and Discontinuing Study Drug 
ADVERSE EVENT 
ACTION TAKEN 
Chemistry 
AST and/or ALT > 3.0 × ULN 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to ≤ 3.0 × ULN. 
Step 2:  Restart study drug, and monitor as clinically 
indicated. 
 AST and/or ALT > 5.0 × ULN 
Discontinue study drug administration, and monitor as 
described in Section 9.3. 
Hematology 
Platelet counts 50 to ≤ 100 × 109/L or 
≥ 50% decrease from baseline 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to > 100 × 109/L. 
Step 2:  Restart study drug, and monitor as described in 
Section 9.3. 
ANC ≤ 1.0 × 109/L 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to > 1 × 109/L or 
the baseline value. 
Step 2:  Restart study drug, and monitor as clinically 
indicated. 
Hemoglobin 8 to ≤ 10 g/dL 
Step 1:  Interrupt study drug administration up to 2 weeks 
(14 days) until the toxicity has resolved to > 10 g/dL. 
Step 2:  Restart study drug, and monitor as clinically 
indicated. 
• Platelet count < 50 × 109/L 
• ANC < 0.5 × 109/L 
• ANC ≤ 1.0 × 109/L with an oral 
temperature of at least 38.5°C OR with 
≥ Grade 3 infection 
• Hemoglobin < 8 g/dL 
Discontinue study drug administration, and monitor as 
described in Section 9.3. 
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Table 7: 
Guidelines for Interrupting, Restarting, and Discontinuing Study Drug 
(Continued) 
ADVERSE EVENT 
ACTION TAKEN 
Other toxicities 
Any Grade 1 or Grade 2 toxicity 
Continue study drug and treat the toxicity; monitor as 
clinically indicated. 
Any Grade 3 toxicity except those that 
are clearly and incontrovertibly due to 
underlying disease or extraneous causes 
Step 1:  Interrupt study drug up to 2 weeks (14 days), until 
toxicity resolves to ≤ Grade 1. 
Step 2:  Restart study drug and monitor as clinically 
indicated. 
Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up as 
described in Section 8.7. 
Note:  The investigator will make an assessment of intensity for each AE and SAE reported during the study and 
assess severity as described in Section 9.3. 
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 28 days before the first dose of study treatment and 28 days after 
the last dose of study treatment will be recorded in the eCRF. 
Any addition, deletion, or change in the dose of these medications will also be recorded.  
Concomitant treatments/procedures that are required to manage a participant's medical condition 
during the study will also be recorded in the eCRF.  The medical monitor should be contacted if 
there are any questions regarding concomitant or prior therapy. 
6.6.1. 
Prior Medications and Therapies 
Prior and current medications and procedures will be reviewed to determine eligibility.  All 
medications taken within 28 days before the first dose of study treatment will be recorded in the 
eCRF.  A detailed history of prior medications use related to HS in the year before screening will 
be also be collected, as well as response to each treatment and reason for discontinuation. 
6.6.2. 
Permitted Medications and Procedures 
6.6.2.1. 
Antibiotic Therapy 
After Week 4, if a participant experiences signs or symptoms indicative of an infection at an HS 
site (eg, fever and local/regional lymphadenopathy), the following antibiotic therapy may be 
initiated without interruption of study drug administration: 
• Amoxicillin 500 mg/clavulanic acid 125 mg, 2 tablets, 3 times daily for 3 days 
In participants for whom amoxicillin is contraindicated, the investigators should consult with the 
sponsor or designee to discuss alternative treatment options. 
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6.6.2.2. 
Analgesic Therapy 
If a participant experiences significant pain after baseline, one of the following analgesic 
regimens may be initiated at any time: 
• Ibuprofen (at a dose of up to 800 mg orally every 6 hours) not to exceed 
3200 mg/24 hours. 
• Acetaminophen not to exceed 4 g/24 hours. 
If pain is not sufficiently controlled with one of the above regiments, a revised analgesic 
regiment can be considered in consultation with the sponsor or designee. 
Dose adjustments in these analgesics on an as needed basis up to the maximum permitted dose 
and frequency are allowed during the study. 
Analgesic usage (yes/no) will be recorded daily (see Appendix F). 
6.6.2.3. 
Antiseptic Therapy 
It is recommended that participants can use a daily antiseptic wash on their HS lesions.  
Permitted antiseptic washes are limited to one of the following:  chlorhexidine gluconate, 
triclosan, benzoyl peroxide, or diluted bleach in bathwater. 
6.6.2.4. 
Wound Care 
Concomitant use of wound care dressings on HS wounds is allowed.  Options are limited to 
alginates, hydrocolloids, and hydrogels. 
6.6.3. 
Prohibited Medications and Procedures 
The following medications are prohibited for all participants in the study: 
• JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, 
lestaurtinib, and pacritinib). 
• Adalimumab or any other TNF-α treatment or any experimental treatments. 
• Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable 
corticosteroids, methotrexate, cyclosporine, and azathioprine). 
• Systemic and/or biologic therapies with potential therapeutic impact for HS. 
• Surgical, laser, or IPL intervention in area with HS lesion, except as specified in 
Section 8.2.4 for rescue lesional treatment. 
• Systemic anti-infectives (eg, antibiotics, antivirals, and antifungals), except as 
described in Section 6.6.2.1 for antibiotic therapy, or topical anti-infectives on HS 
lesions. 
• Conventional therapies with potential therapeutic impact for HS. 
• Topical antiseptic washes, creams, soaps, ointments, gels, and liquids containing 
antibacterial agents to treat HS, except those listed in Sections 6.6.2.3 and 6.6.2.4. 
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• Potent systemic CYP3A4 inhibitors or inducers or fluconazole. 
Note:  Topical agents with limited systemic availability are permitted. 
• Concomitant uses of P-gp inhibitors and inducers (see Appendix C) need to be 
consulted with the medical monitor. 
• Live vaccines (during the study and within 6 weeks after EOT). 
6.6.4. 
Rescue Lesional Treatments 
Rescue lesional treatments are described in Section 8.2.4, as the need for rescue lesional 
treatment is considered an efficacy assessment. 
7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
Participants must be withdrawn from study treatment for the following reasons: 
• Consent is withdrawn. 
Note:  Consent withdrawn means that the participant can no longer be followed.  
Participants who choose to discontinue study treatment will be encouraged to remain 
in the study for safety monitoring. 
• Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 
A participant may be discontinued from study treatment as follows: 
• If, during the study, a participant is found not to have met eligibility criteria, the 
medical monitor, in collaboration with the investigator, will determine whether the 
participant should be discontinued from the study treatment. 
• If a participant is noncompliant with study procedures or study drug administration in 
the investigator's opinion, the sponsor should be consulted for discussion regarding 
the participant's continued participation. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the EOT 
visit should be conducted.  Reasonable efforts should be made to have the participant return for a 
follow-up visit.  These visits are described in Table 3 and Section 8.7.  The last date of the last 
dose of study drug and the reason for discontinuation of study treatment will be recorded in the 
eCRF. 
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If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for withdrawal must be documented in the participant's medical record 
and the primary reason for withdrawal must be included in the eCRF. 
• The EOT visit should be performed. 
• The date of the EOT visit should be recorded in the eCRF. 
• Participants must be followed for safety until the time of the follow-up visit or until 
study drug–related toxicities resolve, return to baseline, or are deemed irreversible, 
whichever is longest. 
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 
should occur; however, participants will have the option of withdrawing consent for study 
treatment but continuing in the follow-up period of the study for safety/efficacy assessments. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
See Table 3 for data to be collected at the time of study discontinuation and follow-up and for 
any further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible.  The participant will be counseled regarding the importance of 
maintaining the assigned visit schedule and ascertain whether or not the participant 
wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant's last known mailing address 
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or local equivalent methods).  These contact attempts should be documented in the 
participant's medical record. 
• Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the country in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 
• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 
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• Participants must provide consent to the most current version of the ICF(s) during 
their participation in the study. 
• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
• Participants who are rescreened are required to sign a new ICF. 
8.1.2. 
Screening Procedures 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number.   
Screening is the interval between obtaining informed consent and the day of the first 
administration of study drug (Day 1).  Screening assessments for determination of eligibility may 
be performed over a period lasting up to 28 days. 
Procedures conducted as part of the participant's routine clinical management (eg, clinical 
laboratory tests) and collected before informed consent is obtained may be used for screening or 
baseline purposes, provided the procedure meets the protocol-defined criteria and has been 
performed within 28 days before Day 1.  All information associated with eligibility 
requirements, including demography and medical history, must be entered into the appropriate 
eCRF pages. 
Results from the screening assessments will be reviewed to confirm eligibility before 
administration of study drug.  Tests results that do not meet eligibility requirements may be 
repeated once during screening if the investigator believes there is a reasonable possibility that 
the participant would be eligible if retested.  For screening assessments that are repeated, the 
most recent available result before administration of study drug will be used to determine 
eligibility.  See Section 5.4 regarding screen failures. 
8.1.3. 
Distribution of Reminder Cards and Diaries 
Participants will be provided with a reminder card at the visits indicated at Table 3.  The 
reminder card will indicate the date/time of the next visit and will also remind the participant that 
they should not take study drug on Day 1, Week 4, and Week 8 visits, as they will take it after 
blood draws for safety evaluation have been completed.  The reminder cards will have an area on 
which the date and time of the last dose taken (from the previous evening) for Week 4 and 
Week 8 visits and the time of their last meal before the visit for Day 1, Week 2, Week 4, Week 6, 
and Week 8 will be recorded. 
Diaries will be provided to participants at the visits indicated at Table 3 to record HS pain NRS 
(see Section 8.2.5) and analgesic use (see Section 8.2.6). 
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8.1.4. 
Demography and Medical History 
8.1.4.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include date of birth, race, ethnicity, medical and surgical history, 
and current illnesses.  Medical history will include relevant medical or surgical treatment within 
the last year that are considered to be clinically significant by the investigator. 
8.1.4.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  A detailed 
history of prior medications use related to HS in the year before screening will be also be 
collected, as well as response to each treatment and reason for discontinuation. 
8.2. 
Efficacy Assessments 
An example of the lesion count worksheet is provided in Appendix D and will be used for 
assessment of Hurley Stage, HiSCR, modified Sartorius scale, and 
 (see Section 8.5.3).  It 
includes assessment of 12 anatomic regions:  left/right axilla, left/right sub/inframammary area, 
intermammary area, left/right buttock, left/right inguino-crural fold, perianal area, perineal area, 
and other areas.  Additionally, the need for rescue lesional treatment, including number of 
interventions, will be documented in this worksheet. 
8.2.1. 
Hurley Stages of Hidradenitis Suppurativa 
Hurley Stages of HS are defined in Table 8.  The investigator will determine the Hurley Stage in 
each affected anatomical region at the designated study visits listed in Table 3.  If more than 
1 stage is present in a region, the worst stage in each region should be documented.  The 
participant is assigned Hurley Stage corresponding to the Hurley Stage of his or her worst 
involved anatomic region. 
Table 8: 
Hurley Stages of Hidradenitis Suppurativa 
Stage 
Description 
I 
abscess formation (single or multiple) without sinus tracts and cicatrization 
II 
recurrent abscesses with tract formation and cicatrization; single or multiple, widely 
separated lesions 
III 
diffuse or near-diffuse involvement or multiple interconnected tracts and abscesses 
across the entire area 
8.2.2. 
Hidradenitis Suppurativa Clinical Response (Abscess and Inflammatory Nodule 
Count) 
An HiSCR is defined as at least 50% reduction in AN count with no increase in abscess count 
and no increase in draining fistula (see definition below) count relative to baseline at each visit 
(see Appendix D; Kimball et al 2016). 
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A fistula is a pathologic passageway connecting to the skin surface from dermis or subcutaneous 
tissue.  Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or 
by gentle palpation. 
8.2.3. 
Modified Sartorius Scale 
The modified Sartorius scale is a measure of the severity of HS (see Appendix D and 
Appendix E; Sartorius et al 2003). 
Points are given as follows for each body area:  2 points for each nodule (both inflammatory and 
non-inflammatory); 4 points for each abscess; 4 points for each fistula (both draining and 
non-draining); 1 point for each scar; 2 to 6 points for the longest distance between 2 lesions or 
0 points if no lesions; and 6 points if lesions are not separated by normal skin or 0 points if 
lesions are separated by normal skin.  The "other area" only with the highest modified Sartorius 
scale at baseline will be calculated, and the same area should be evaluated throughout the study.  
The total modified Sartorius scale score is the sum of the 12 anatomic region scores. 
8.2.4. 
Need for Rescue Lesional Treatment 
The need for lesional rescue treatment will be recorded as a measure of efficacy. 
In the event of an acutely painful lesion that requires immediate intervention, investigators will 
have the option to perform protocol-allowed interventions.  Two types of interventions are 
permitted:  injection with intralesional triamcinolone acetonide suspension (up to 30 mg in total 
at the same visit) and/or incision and drainage.  If incision and drainage is performed, 
participants should continue using the same over-the-counter antiseptic as previously.  New 
systemic and topical therapies following incision and drainage, including antibiotics, are 
prohibited.  Concomitant use of wound care dressings is allowed as described in Section 6.6.2.4.  
Participants should continue using any oral and topical therapies during the study, consistent 
with the allowances and restrictions described in Section 6.6.2. 
From Day 1 through Week 8, an intervention can occur on a maximum of 2 different lesions at 
the same visit or on the same lesion at 2 different study visits.  The same lesion cannot be treated 
2 times during the same visit.  If participants require more than 2 interventions before Week 8, 
then study drug will be discontinued for those participants. 
Study procedures must be performed before any interventions.  Any lesion undergoing an 
intervention will be documented in the lesion count worksheet (see Appendix D).  The site will 
be required to count any lesion that undergoes an intervention as permanently present from the 
date of the intervention, and must account for it in the source and on the appropriate eCRF. 
8.2.5. 
Hidradenitis Suppurativa Pain Numeric Rating Scale 
The HS Pain NRS (see Appendix F) will be completed in a daily diary by participants from 
screening through EOS.  An 11-point scale will be used to assess the worst skin pain and the 
average skin pain due to HS.  Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain 
as bad as you can imagine).  Assessments will be recorded before bedtime or midnight 
(whichever comes first) and will be based on a recall period of the last 24 hours. 
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8.2.6. 
Analgesic Use 
From screening through EOS, participants will complete a daily diary of their analgesic use 
(yes/no; see Appendix F).  All analgesics and dose adjustments will be captured in the source 
and on the appropriate eCRF. 
8.2.7. 
Hidradenitis Suppurativa Patient Global Impression of Change 
Participants will complete the HS-PGIC questionnaire at the designated study visits listed in 
Table 3.  The HS-PGIC consists of 1 self-administered item that assesses change in the severity 
of skin in the HS area.  Participants are asked to indicate their impression of change compared 
with their last visit.  The participant will answer the following:  Since your last visit, your HS 
is:  (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, 
(5) minimally worse, (6) much worse, or (7) very much worse. 
The participant should complete the questionnaire before site personnel perform any efficacy 
assessments. 
8.2.8. 
Dermatology Life Quality Index 
Participants will complete a DLQI questionnaire (see Appendix G) from screening through EOS.  
The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life 
(Hongbo et al 2005).  The DLQI can be used to evaluate 6 areas:  symptoms and feelings, daily 
activities, leisure, work and school, personal relationships, and treatment.  Participants will be 
asked to respond to the 10 items of the DLQI based on a recall period of "the last week."  
Decreased scores indicate improved health-related quality of life.  The participant should 
complete the questionnaire before site personnel perform any efficacy assessments. 
8.2.9. 
Photography of Target Lesions 
For participants who consent to photography, a target area will be identified at screening and 
photographed for purposes of documentation.  The lesion should be located in an area with 
inflammatory nodules and/or abscesses that are a good representation of the disease severity.  
8.3. 
Safety Assessments 
8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until at least 
28 days after the last dose of study treatment.  Adverse events that begin or worsen after 
informed consent should be recorded on the Adverse Event Form in the eCRF regardless of the 
assumption of a causal relationship with the study drug.  Conditions that were already present at 
the time of informed consent should be recorded on the Medical History Form in the eCRF.  
Adverse events (including laboratory abnormalities that constitute AEs) should be described 
using a diagnosis whenever possible rather than by individual underlying signs and symptoms. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following-up on AEs that are serious, 
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considered related to the study treatment, or that caused the participant to discontinue the study 
treatment.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?" is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant during the screening process or between 
visits, or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be recorded and reported to the sponsor or designee within 24 hours.  The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
8.3.2. 
Physical Examinations 
Physical examinations will be conducted at the time points listed in Table 3. 
A comprehensive physical examination will include height and body weight, and assessment of 
the following organ or body systems:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; 
cardiovascular system; abdomen (liver, spleen); extremities; and lymph nodes.  A brief 
neurological examination will also be performed. 
A targeted physical examination should be conducted as indicated by symptoms reported by the 
participant, AEs, or other findings.  Abnormalities that are considered clinically significant in the 
judgment of the investigator are to be reported as AEs. 
Physical examinations must be performed by a medically qualified individual such as a licensed 
physician, physician's assistant, or an advanced registered nurse practitioner, as local law 
permits. 
8.3.3. 
Vital Signs 
Vital sign measurements include blood pressure, pulse, respiratory rate, and body temperature.  
Blood pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or 
sitting position after 5 minutes of rest.  Any abnormalities that are considered clinically 
significant in the judgment of the investigator are to be reported as AEs. 
8.3.4. 
Electrocardiograms 
All 12-lead ECGs will be performed with the participant in a recumbent or semirecumbent 
position after at least 5 minutes of rest. 
Electrocardiograms should be performed as indicated in Table 3.  Additional 12-lead ECGs may 
be performed at other visits as deemed clinically necessary.  Electrocardiograms will be 
interpreted by the investigator at the site, and the results will be used for immediate management 
of the participant's care.  The decision to include or exclude a participant or withdraw a 
participant from the study based on an ECG flagged as "Abnormal, Clinically Significant" is the 
responsibility of the investigator, in consultation with the sponsor's medical monitor, as 
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appropriate.  Any abnormalities that are considered clinically significant in the judgment of the 
investigator are to be reported as AEs. 
Table 9: 
Electrocardiogram Schedule 
Study Visit 
Timing of ECG Relative to Administration of Study Drug 
Not Applicable 
Predose (trough) ECG
a 
Postdose ECG
b 
Screening 
Single  Triple 
 
 
Day 1 
 
Triple
c 
Single  Triple 
Week 2 
 
 
Single  Triple 
Week 6 
 
 
Single  Triple 
Week 8 (EOT) 
 
Single  Triple 
 
a Predose ECG should be performed 5 to 10 minutes before the predose PK assessment. 
b Postdose ECGs will be performed when participants arrive at the study sites 
 
  If abnormality ECG results are observed, an additional 2 ECGs will be measured within the next 5 minutes.  Postdose 
ECG will be measured 
. 
c Day 1 predose 12-lead ECGs will be performed in triplicate, and values will be averaged to calculate the baseline values. 
Note:  Single  Triple:  Single ECG will be performed first.  If abnormal ECG results are observed, an additional 2 ECGs will 
be measured within the next 5 minutes.  
8.3.5. 
Laboratory Assessments 
8.3.5.1. 
Safety Assessments 
Required laboratory tests are listed in Table 10.  Safety laboratory tests include hematology, 
chemistry, CRP, and lipid panel (see Table 3).  Participants may have a light snack before this 
visit, but should allow for an overnight fast (at least 8 hours) before sample collection for the 
lipid panel. 
If there is any abnormality in hematology assessment (particular for platelet counts) at Week 2, 
an unscheduled visit at Week 3 (see Section 8.6) to repeat hematology assessments will be 
required. 
Clinical laboratory tests will be performed at a central laboratory (see the Laboratory Manual for 
sample handling and shipping instructions). 
8.3.5.2. 
Screening Assessments 
Screening laboratory tests include urinalysis, serology, TB screening, pregnancy test, and an 
FSH test for confirmation of nonchildbearing status in women who are postmenopausal, defined 
as amenorrhea at least 12 months before screening.  See the Laboratory Manual for screening 
assessment instructions. 
8.3.5.3. 
Pregnancy Test 
A serum pregnancy test will be required for all women of childbearing potential during 
screening.  Urine pregnancy tests will be conducted as outlined in Table 3, as medically 
indicated, or per country-specific requirement.  Urine pregnancy tests will be performed locally.  
If a urine pregnancy test is positive, the results should be confirmed with a serum pregnancy test, 
which may be performed locally. 
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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. 
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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 lab result (eg, low hemoglobin, platelet count decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study treatment administration even though it may have 
been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a 
concomitant medication.  Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent.  Such overdoses should be 
reported regardless of sequelae. 
• "Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an 
AE or SAE.  Such instances will be captured in the efficacy assessments.  However, the signs, 
symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as AE or SAE if 
they fulfil 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. 
• Medical or surgical procedure (eg, endoscopy, appendectomy):  the condition that leads to the 
procedure is the AE if it occurred after signing the ICF.  If present before entering the study, the 
condition should be captured as medical history. 
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• Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at 
the start of the study that do not worsen. 
9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due 
to progression of disease). 
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term "life-threatening" in the definition of "serious" refers to an adverse drug experience that 
places the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurred.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether "hospitalization" occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is 
not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person's ability to conduct normal life 
functions. 
• This definition is not intended to include experiences of relatively minor medical significance, such 
as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma 
(eg, sprained ankle), that may interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Other situations (Important Medical Event): 
An event that may not result in death, be immediately life-threatening, or require hospitalization, but 
may be considered serious when, based on appropriate medical judgment, the event may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
the above definition.  Examples of such events include invasive or malignant cancers, 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 an Adverse Event and/or Serious Adverse Event 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  Conditions that were present at the time informed consent was 
given should be recorded on the Medical History Form in the eCRF. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records to 
sponsor or designee in lieu of completion of the AE eCRF page. 
• There may be instances when copies of medical records for certain cases are requested.  In this case, 
all participant identifiers, with the exception of the participant number, will be redacted on the copies 
of the medical records before submission. 
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine: 
• The severity grade (CTCAE Grade 1 to 5).  See below for further instructions on the assessment of 
intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study drug:  suspected 
(yes) or not suspected (no).  See below for further instructions on the assessment of causality. 
• The start and end dates, unless unresolved at final follow-up. 
• The action taken with regard to study drug as a result of the AE/SAE(s). 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication 
or nondrug therapy, this action should be recorded on the Adverse Event Form, and the treatment 
should be specified on the appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and 
Non-Drug Therapy). 
Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v4.03 Grades 1 through 5.  If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate 
the grade of severity. 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories:  
• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive intervention indicated; limiting age appropriate 
activities of daily living. 
• Grade 3:  Severe or medical significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
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• Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE. 
• A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments 
to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• The investigator will also consult the RSI in the IB and/or Product Information, for marketed 
products, in his/her assessment. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well 
as the temporal relationship of the event to study treatment administration will be considered and 
investigated. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the sponsor or designee.  However, it is very 
important that the investigator always make an assessment of causality for every event 
before the initial transmission of the SAE data to sponsor or designee. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
send a SAE follow-up report with the updated causality assessment. 
Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor or designee to elucidate the 
nature and/or causality of the AE/SAE as fully as possible.  This may include additional laboratory 
tests or investigations, histopathological examinations, or consultation with other healthcare 
professionals. 
• If a participant dies during participation in the study or during a recognized follow-up period, the 
investigator will provide the sponsor or designee with a copy of any postmortem findings, including 
histopathology. 
• New or updated information will be recorded in the originally completed eCRF. 
• Any updated SAE data 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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9.4. 
Reporting of Serious Adverse Events 
All SAEs, regardless of suspected causality (eg, relationship to study drug or study 
procedure[s]), occurring after the participant has signed the ICF through the last study visit 
(or 28 days after the last dose of study treatment, whichever occurs later) must be reported to the 
sponsor (or designee) within 24 hours of learning of its occurrence, unless otherwise specified 
by the Protocol.  The investigator will submit any updated SAE data to the sponsor (or designee) 
within 24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE information after conclusion of the 
study participation.  However, if the investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study treatment or study participation, the investigator must notify the 
sponsor (or designee) within 24 hours of becoming aware of the event. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the IB for the study drug (new occurrence) and is thought to be 
related to the sponsor's study drug, the sponsor or its designee may urgently require further 
information from the investigator for reporting to health authorities.  The sponsor or its designee 
may need to issue an Investigator Notification to inform all investigators involved in any study 
with the same drug that this SAE has been reported.  Suspected Unexpected Serious Adverse 
Reactions will be collected and reported to the competent authorities and relevant ethics 
committees in accordance with Directive 2001/20/EC, or as per national regulatory requirements 
in participating countries. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation.  The 
sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the Investigator's Brochure and will notify the IRB/IEC, if appropriate according to 
local requirements. 
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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 investigator 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 
Not applicable. 
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's partner during paternal exposure to study drug, 
the following procedures should be followed in order to ensure safety: 
• 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 outcomes 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. 
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If abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are reported in a study participant's partner, the events 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. 
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 INCB054707 greater than 15 mg within a 24-hour time period will be 
considered an overdose.  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. 
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10. 
STATISTICS 
10.1. 
Sample Size Determination 
The sample size was based on the precedent of other safety and PK studies and was not based on 
statistical power calculations. 
10.2.1. 
Level of Significance 
This is a safety study.  No formal efficacy hypotheses will be tested. 
10.3. 
Statistical Analyses 
10.3.1. 
Safety Analyses 
Safety endpoints are listed in Section 3.  Safety analyses will be conducted using the safety 
evaluable population and are summarized in Table 13. 
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• Retaining records in accordance with all local, national, and regulatory laws, but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study without 
receiving approval from the sponsor.  The investigator must notify the sponsor or 
its designee in the event of accidental loss or destruction of any study records.  If 
the investigator leaves the institution where the study was conducted, the sponsor 
or its designee must be contacted to arrange alternative record storage options. 
− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided eCRF completion guidelines for instructions on data entry in the eCRF.  
The study monitor will reference the Monitoring Plan in order to ensure that each issue identified 
is appropriately documented, reported, and resolved in a timely manner in accordance with the 
plan's requirements. 
The sponsor (or designee) will be responsible for: 
• The data management of this study including quality checking of the data. 
• Ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
The investigator will be responsible for: 
• Ensuring participant data relating to the study is recorded in the eCRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data) or as 
otherwise specified in the Protocol.  The investigator is responsible for verifying that 
data entries are accurate and correct by physically or electronically signing the eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed at the 
investigator's site. 
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− Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies 
must be explained.  The investigator may need to request previous medical 
records or transfer records, depending on the study.  Also, current medical records 
must be available. 
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data privacy laws and 
regulations.  The investigator and the sponsor or its designee are responsible for ensuring that 
sensitive information is handled in accordance with local requirements (eg, HIPAA).  
Appropriate consent and authorizations for use and disclosure and/or transfer (if applicable) of 
protected information must be obtained. 
Participant names will not be supplied to the sponsor or its designee.  Only the participant 
number and the participant's initials (participant's initials will only be recorded if allowable by 
local regulations) will be recorded in the eCRF, where permitted; if the participant's name 
appears on any other document (eg, laboratory report), it must be obliterated on the copy of the 
document to be supplied to the sponsor or its designee.  Study findings stored on a computer will 
be stored in accordance with local data protection laws. 
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11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to 
21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered studies") are 
required to submit a completed Clinical Investigator Financial Disclosure Form that sufficiently 
details any financial interests and arrangements that apply.  For the purpose of this regulation, 
"clinical investigator" is defined as any investigator or subinvestigator who is directly involved 
in the treatment or evaluation of research participants, including the spouse and each dependent 
child of the clinical investigator or subinvestigator.  These requirements apply to both US and 
foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Investigator Financial Disclosure Form.  During a covered clinical study, 
any changes to the financial information previously reported by a clinical investigator must be 
reported to the sponsor or its designee.  At the conclusion of the covered clinical study, the 
clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
11.5. 
Publication Policy 
By signing the study protocol, the investigator and his or her institution agree that the results of 
the study may be used by the sponsor, Incyte Corporation (Incyte), for the purposes of national 
and international registration, publication, and information for medical and pharmaceutical 
professionals.  Study results will be published in accordance with applicable local and national 
regulations.  If necessary, the authorities will be notified of the investigator's name, address, 
qualifications, and extent of involvement.  The terms regarding the publication of study results 
are contained in the agreement signed with the sponsor or its designee.  A signed agreement will 
be retained by the sponsor or its designee. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.6. 
Study and Site Closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
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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. 
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Clinical Trial Facilitation Group (CTFG). Recommendations related to contraception and 
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Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_ 
Contraception.pdf. Accessed October 2, 2017. 
Gulliver W, Zouboulis CC, Prense E, Jemec GB, Tzellos T. Evidence-based approach to the 
treatment of hidradenitis suppurativa/acne inversa, based on European guidelines for hidradenitis 
suppurativa. Rev Endocr Metab Disord 2016;17:343-351. 
Hamzavi IH, Sundaram M, Nicholson C, et al. Uncovering burden disparity: a comparative 
analysis of the impact of moderate-to-severe psoriasis and hidradenitis suppurativa. J Am Acad 
Dermatol 2017:1-9. 
Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of quality 
of life into practice: what do dermatology life quality index scores mean? J Invest Dermatol 
2005;125:659-664. 
INCB054707 Investigator's Brochure (IB). Wilmington, DE: Incyte Corporation. 
Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med 2012;366:158-164. 
Jemec GB, Heidenheim M, Nielsen NH. The prevalence of hidradenitis suppurativa and its 
potential precursor lesions. J Am Acad Dermatol 1996;35:191-194. 
Kelly G, Hughes R, McGarry T, et al. Dysregulated cytokine expression in lesional and 
nonlesional skin in hidradenitis suppurativa. Br J Dermatol 2015;173:1431-1439. 
Kelly G, Prens EP. Inflammatory mechanisms in hidradenitis suppurativa. Dermatol Clin 
2016;34:51-58. 
Kimball AB, Sobell JM, Zouboulis CC, et al. HiSCR (Hidradenitis Suppurativa Clinical 
Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with 
hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. 
J Eur Acad Dermatol Venereol 2016;30:989-994. 
Mehta CR, Patel NR. Exact logistic regression: theory and examples. Stat Med 1995;14:2143-
2160. 
Miller IM, Ellervik C, Vinding GR, et al. Association of metabolic syndrome and hidradenitis 
suppurativa. JAMA Dermatol 2014;150:1273-1280. 
Moran B, Sweeney CM, Hughes R, et al. Hidradenitis suppurativa is characterized by 
dysregulation of the Th17:Treg cell axis, which is corrected by anti-TNF therapy. J Invest 
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Punwani N, Burn T, Scherle P, et al. Downmodulation of key inflammatory cell markers with a 
topical Janus kinase 1/2 inhibitor. Br J Dermatol 2015;173:989-997. 
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Rambhatla PV, Lim HW, Hamzavi I. A systematic review of treatments for hidradenitis 
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Rawlings JS, Rosler KM, Harrison DA. The JAK/STAT signaling pathway. J Cell Sci 
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Revuz JE. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009;23:985-998. 
Revuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with 
hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 
2008;59:596-601. 
Sartorius K, Lapins J, Emtestam L, Jemec GB. Suggestions for uniform outcome variables when 
reporting treatment effects in hidradenitis suppurativa. Br J Dermatol 2003;149:211-213. 
Schlapbach C, Hänni T, Yalwalker N, Hunger RE. Expression of the IL-23/Th17 pathway in 
lesions of hidradenitis suppurativa. J Am Acad Dermatol 2011;65:790-798. 
van der Zee HH, de Ruiter L, van den Broecke DG, Dik WA, Laman JD, Prens EP. Elevated 
levels of tumour necrosis factor (TNF)-α, interleukin (IL)-1β and IL-10 in hidradenitis 
suppurativa skin: a rationale for targeting TNF-α and IL-1β. Br J Dermatol 2011;164:1292-1298. 
van der Zee HH, Laman JD, de Ruiter L, Dik WA, Prens EP. Adalimumab (antitumour necrosis 
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Zouboulis CC, Desai N, Emtestam L, et al. European S1 guideline for the treatment of 
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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For male participants in the study: 
Male participants should use a condom during treatment and through 90 days after the end of 
systemic exposure.  If the male participant has a partner that is of childbearing 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 during the study 
through 90 days after the end of relevant systemic exposure.  Males who have had a vasectomy 
qualify as having met the requirement for a highly effective birth control method. 
For female participants and for female partners of male participants in the study: 
The following methods that can achieve a failure rate of less than 1% per year when used 
consistently and correctly are considered as highly effective birth control methods. 
Such methods include: 
• Combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation 
− oral 
− intravaginal 
− transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulation 
− oral 
− injectable 
− implantable1 
• Intrauterine device (IUD)1 
• Intrauterine hormone-releasing system (IUS)1 
• Bilateral tubal occlusion1 
• Vasectomised partner1,2 
• Sexual abstinence3 
Acceptable birth control methods that result in a failure rate of more than 1% per year include: 
• progestogen-only oral hormonal contraception, where inhibition of ovulation is not 
the primary mode of action 
• male or female condom with or without spermicide4 
• cap, diaphragm or sponge with spermicide4 
• tubal ligation 
1  Contraception methods that in the context of this guidance are considered to have low user dependency. 
2  Vasectomised partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the woman and that the vasectomised partner has received medical assessment of the surgical success. 
3  In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.  The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the participant. 
4  A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) 
are also considered acceptable, but not highly effective, birth control methods. 
Source:  CTFG 2014. 
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APPENDIX B. CYTOCHROME P450 3A4 INHIBITORS AND INDUCERS 
Highlighted rows indicate recent additions to the lists at the time the database search was 
performed.  The sponsor should be contacted with any questions regarding concomitant 
medications that might be considered potent CYP3A4 inhibitors and inducers but are not on this 
list. 
University of Washington School of Pharmaceutics: Drug Interaction Database Program. 2002. 
http://www.druginteractioninfo.org. Accessed May 2015. 
Information also can be found at: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti
onsLabeling/ucm093664.htm. 
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APPENDIX C. IN VIVO P-GLYCOPROTEIN INHIBITORS AND 
INDUCERS  
Highlighted rows indicate recent additions to the lists at the time the database search was 
performed.  The sponsor should be contacted with any questions regarding concomitant 
medications that might be considered potent P-gp inhibitors and inducers but are not on this list. 
University of Washington School of Pharmaceutics: Drug Interaction Database Program. 2002. 
http://www.druginteractioninfo.org. Accessed May 2015.   
Information also can be found at: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti
onsLabeling/ucm093664.htm. 
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