Clinical trial NCT05247489
Conditions: Vitiligo
Keywords: Non-segmental Vitiligo hypopigmentation Pigment Disorders Skin Diseases JAK inhibitor
Sponsor: Incyte Corporation
Start date: 2022-05-05; Completion date: 2023-12-19
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Detailed description:

Arms: arm 1: Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have \< 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study. arm 2: Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.
Interventions: intervention 1: Ruxolitinib 1.5% cream intervention 2: NB-UVB phototherapy
Intervention descriptions: intervention 1: Ruxolitinib cream 1.5% applied twice a day (BID). intervention 2: NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit

Protocol documents:
Prot_000.pdf: 
Official Title: 
A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-
Band Ultraviolet B Phototherapy in Participants With Vitiligo 
NCT Number: 
NCT05247489 
Document 
Date:
Clinical Study Protocol Original Version: 30 September 2021


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Clinical Study Protocol 
TITLE PAGE 
INCB 18424-217 
A Safety and Efficacy Study of Ruxolitinib Cream Combined With 
Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo 
Product: 
Ruxolitinib Cream 
IND Number: 
77,101 
Phase of Study: 
2 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, Delaware, USA 19803 
Original Protocol: 
30 SEP 2021 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted. 
The information in this document is confidential. No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 


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INVESTIGATOR'S AGREEMENT 
I have read the INCB 18424-217 Protocol (dated 30 SEP 2021) and agree to conduct the study as 
outlined. I agree to maintain the confidentiality of all information received or developed in 
connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 


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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY ..........................................................................................10 
2. 
INTRODUCTION ......................................................................................................18 
2.1. 
Ruxolitinib Cream ......................................................................................................18 
2.2. 
Background .................................................................................................................18 
2.3. 
Clinical Efficacy and Safety Data With Ruxolitinib Cream .......................................19 
2.4. 
Study Rationale ...........................................................................................................20 
2.5. 
Justification for Strength of Ruxolitinib Cream .........................................................21 
2.6. 
Justification for Dose of Narrow-Band Ultraviolet B Phototherapy ..........................21 
2.7. 
Benefit/Risk Assessment ............................................................................................22 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................23 
4. 
STUDY DESIGN .......................................................................................................25 
4.1. 
Overall Design ............................................................................................................25 
4.2. 
Overall Study Duration ...............................................................................................25 
4.3. 
Study Termination ......................................................................................................25 
5. 
STUDY POPULATION .............................................................................................26 
5.1. 
Inclusion Criteria ........................................................................................................26 
5.2. 
Exclusion Criteria .......................................................................................................26 
5.3. 
Lifestyle Considerations .............................................................................................29 
5.4. 
Screen Failures ............................................................................................................29 
5.5. 
Replacement of Participants .......................................................................................29 
6. 
STUDY TREATMENT ..............................................................................................29 
6.1. 
Study Treatments Administered .................................................................................29 
6.2. 
Preparation, Handling, and Accountability ................................................................31 
6.3. 
Measures to Minimize Bias: Randomization and Blinding ........................................32 
6.4. 
Study Treatment Compliance .....................................................................................32 
6.5. 
Dose Modifications .....................................................................................................32 
6.5.1. 
Criteria and Procedures for Application Interruptions of Study Cream .....................32 


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6.5.2. 
Criteria for Permanent Discontinuation of Study Cream Due to an Adverse 
Event ...........................................................................................................................33 
6.5.3. 
Dose Modification for NB-UVB ................................................................................33 
6.6. 
Concomitant Medications and Procedures .................................................................34 
6.6.1. 
Permitted Medications and Procedures ......................................................................35 
6.6.2. 
Restricted Medications and Measures ........................................................................35 
6.7. 
Prohibited Medications and Procedures .....................................................................36 
6.8. 
Treatment After the End of the Study .........................................................................36 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
WITHDRAWAL ........................................................................................................36 
7.1. 
Discontinuation of Study Treatment ...........................................................................36 
7.1.1. 
Reasons for Discontinuation .......................................................................................36 
7.1.2. 
Discontinuation Procedures ........................................................................................37 
7.2. 
Participant Withdrawal From the Study .....................................................................37 
7.3. 
Lost to Follow-Up.......................................................................................................38 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................39 
8.1. 
Administrative and General Procedures .....................................................................39 
8.1.1. 
Informed Consent Process ..........................................................................................39 
8.1.2. 
Screening Procedures ..................................................................................................40 
8.1.3. 
Interactive Response Technology Procedure ..............................................................40 
8.1.4. 
Distribution of Study Reminder Cards and Diaries ....................................................40 
8.1.5. 
Demography and Medical History ..............................................................................41 
8.1.5.1. 
Demographics and General Medical History .............................................................41 
8.1.5.2. 
Disease Characteristics and Treatment History ..........................................................41 
8.2. 
Efficacy Assessments .................................................................................................41 
8.2.1. 
Body Surface Area ......................................................................................................41 
8.2.2. 
Vitiligo Area Scoring Index ........................................................................................41 
 
42 
 
43 
8.2.5. 
Photography ................................................................................................................43 
 
43 
 
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.44 
 
.45 
 
45 
 
45 
 
45 
 
46 
8.3. 
Safety Assessments .....................................................................................................46 
8.3.1. 
Adverse Events ...........................................................................................................46 
8.3.2. 
Physical Examinations ................................................................................................46 
8.3.3. 
Vital Signs ..................................................................................................................47 
8.3.4. 
Electrocardiograms .....................................................................................................47 
8.3.5. 
Laboratory Assessments .............................................................................................47 
8.3.5.1. 
Pregnancy Testing ......................................................................................................49 
8.3.5.2. 
Serology ......................................................................................................................49 
8.4. 
Pharmacokinetic Assessments ....................................................................................49 
 
49 
8.6. 
Unscheduled Visits .....................................................................................................50 
8.7. 
End of Treatment and/or Early Termination ..............................................................50 
8.8. 
Safety Follow-Up ........................................................................................................50 
9. 
ADVERSE EVENTS: DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................51 
9.1. 
Definition of Adverse Event .......................................................................................51 
9.2. 
Definition of Serious Adverse Event ..........................................................................51 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........52 
9.4. 
Reporting of Serious Adverse Events .........................................................................55 
9.5. 
Events of Clinical Interest ..........................................................................................56 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................56 
9.7. 
Pregnancy ...................................................................................................................57 
9.8. 
Warnings and Precautions ..........................................................................................57 
9.9. 
Product Complaints ....................................................................................................57 
9.10. 
Treatment of Overdose ...............................................................................................58 
10. 
STATISTICS ..............................................................................................................59 
10.1. 
Sample Size Determination ........................................................................................59 


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10.2. 
Populations for Analysis .............................................................................................59 
10.3. 
Level of Significance ..................................................................................................59 
10.4. 
Statistical Analyses .....................................................................................................59 
10.4.1. 
Efficacy Analysis ........................................................................................................60 
10.4.1.1. 
Analysis of Primary Efficacy Analysis .......................................................................60 
10.4.1.2. 
Analysis of Secondary Efficacy Endpoints ................................................................60 
10.4.2. 
Safety Analysis ...........................................................................................................60 
10.4.3. 
Other Analyses ............................................................................................................61 
10.5. 
Interim Analysis ..........................................................................................................61 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................62 
11.1. 
Investigator Responsibilities .......................................................................................62 
11.1.1. 
Identification of the Coordinating Principal Investigator ...........................................63 
11.2. 
Data Management .......................................................................................................63 
11.3. 
Data Privacy and Confidentiality of Study Records ...................................................65 
11.4. 
Financial Disclosure ...................................................................................................65 
11.5. 
Publication Policy .......................................................................................................66 
11.6. 
Study and Site Closure................................................................................................66 
12. 
REFERENCES ...........................................................................................................67 
APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND DEFINITIONS ............................................68 
APPENDIX B. INSTRUCTION TO PARTICIPANTS FOR HANDLING 
RUXOLITINIB CREAM ...........................................................................................70 
APPENDIX C. COVID-19 PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS .......................................................................................................71 
APPENDIX D. WHO CLASSIFICATION OF TOPICAL CORTICOSTEROIDS...................73 
APPENDIX E. PROTOCOL AMENDMENT SUMMARY OF CHANGES ............................74 
 
LIST OF TABLES 
Table 1: 
Primary Objective and Endpoint ................................................................................10 
Table 2: 
Key Study Design Elements .......................................................................................10 
Table 3: 
Schedule of Assessments for Screening Through Week 12 .......................................12 
Table 4: 
Schedule of Assessments Week 16 Through End of Study ........................................15 
Table 5: 
Objectives and Endpoints ...........................................................................................23 


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Table 6: 
Study Treatment Information (Ruxolitinib Cream) ....................................................30 
Table 7: 
Study Treatment Information (NB-UVB) ..................................................................30 
Table 8: 
Guidelines for Interruption and Restarting of Study Cream .......................................33 
Table 9: 
NB-UVB Dose Adjustments Based on the Skin Assessments ...................................34 
Table 10: NB-UVB Dose Adjustments for Missed Treatments .................................................34 
 
42 
 
.43 
Table 13: Required Laboratory Analytes ....................................................................................48 
Table 14: Populations for Analysis .............................................................................................59 
Table 15: Safety Analyses ..........................................................................................................61 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................11 
 


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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
AA 
alopecia areata 
AD 
atopic dermatitis 
AE 
adverse event 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BID 
twice daily 
BMI 
body mass index 
BSA 
body surface area 
CFR 
Code of Federal Regulations 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMB 
Data Safety Monitoring Board 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
EOS 
end of study 
EOT 
end of treatment 
F-BSA 
facial body surface area 
 
 
 
 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
F-VASI 
Face Vitiligo Area Scoring Index 
F-VASI25/50/75/90 
≥ 25%/ 50%/ 75%/ 90% improvement from baseline in Face Vitiligo Area 
Scoring Index score 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IB 
Investigator's Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
ID 
identification 
IEC 
independent ethics committee 
IRB 
institutional review board 


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Abbreviations and 
Special Terms 
Definition 
IRT 
interactive response technology 
JAK 
Janus kinase 
MedDRA 
Medical Dictionary for Regulatory Activities 
NB-UVB 
narrow-band ultraviolet B 
 
 
 
 
 
 
PK 
pharmacokinetic 
PUVA 
psoralen and ultraviolet A 
QD 
once daily 
RSI 
reference safety information 
SAE 
serious adverse event 
SD 
standard deviation 
SoA 
schedule of assessments 
SOP 
standard operating procedure 
SPF 
sun protection factor 
SUSAR 
suspected unexpected adverse reaction 
T-BSA 
total body surface area 
TEAE 
treatment-emergent adverse event 
 
 
T-PaGVA 
total body assessment of Patient's Global Vitiligo Assessment 
 
 
TSH 
thyroid-stimulating hormone 
T-VASI 
total body Vitiligo Area Scoring Index 
T-VASI25/50/75/90 
≥ 25%/ 50%/ 75%/ 90% improvement in total body Vitiligo Area Scoring Index 
TYK 
tyrosine kinase 
ULN 
upper limit of normal 
UV 
ultraviolet 
VASI 
Vitiligo Area Scoring Index 
 
 
 
 
WHO 
World Health Organization 
 
 
WOCBP 
women of childbearing potential 


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1. 
PROTOCOL SUMMARY 
Protocol Title: 
A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B 
Phototherapy in Participants With Vitiligo 
Protocol Number: INCB 18424-217 
Objectives and Endpoints: 
Table 1 presents the primary objective and endpoint. 
Table 1: 
Primary Objective and Endpoint 
Objective 
Endpoint 
Primary 
To evaluate the efficacy of ruxolitinib cream in 
combination with NB-UVB in participants with 
vitiligo. 
Change from baseline in T-VASI at Week 48. 
Overall Design: 
Table 2 presents the key study design elements. Further study details are presented after the 
table. 
Table 2: 
Key Study Design Elements 
Study Phase 
Phase 2 
Clinical Indication 
Patients with nonsegmental vitiligo 
Population 
Males and female participants, aged ≥ 12 years, who have vitiligo with 
≥ 0.5 F-VASI, ≥ 3.0 T-VASI (body areas not including the face), and total 
body vitiligo area (facial and nonfacial) not exceeding 10% BSA. 
Number of 
Participants 
Approximately 50 participants will receive ruxolitinib 1.5% cream BID 
Study Design 
Open-label 
Estimated Duration 
of Study 
Participation 
Screening: Up to 30 days 
Treatment period: 48 weeks 
Safety follow-up: 30 days after last application of study drug or last study visit 
Total: Up to approximately 56 weeks 
DSMB/DMC 
No 
Coordinating 
Principal 
Investigator 
 


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Treatment Groups and Duration: 
This is an open-label study in which participants will apply ruxolitinib 1.5% cream BID to all 
depigmented areas up to 10% BSA for up to 48 weeks. Participants should continue to treat 
depigmented areas identified for treatment at baseline regardless of whether the area begins to 
improve or fully repigment. 
On Day 1, all participants will apply ruxolitinib 1.5% cream BID as monotherapy. At Week 12, 
participants will apply ruxolitinib 1.5% cream alone or in combination with NB-UVB based on 
improvement in T-VASI score. Participants who have < T-VASI25 will have NB-UVB 
phototherapy added to their ruxolitinib 1.5% cream BID regimen (Group A). NB-UVB will be 
given 3 times per week through Week 48 (36 weeks). Participants who have ≥ T-VASI25 at 
Week 12 will continue on ruxolitinib 1.5% cream BID alone (Group B). For participants who 
receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use 
during the study. 
Figure 1 presents the study design schema. Table 3 presents the schedule of activities for the 
monotherapy portion of the study (screening through Week 12). Table 4 presents the schedule of 
activities for Week 16 through the end of the study. 
Figure 1: 
Study Design Schema 
 
 


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Table 3: 
Schedule of Assessments for Screening Through Week 12 
Procedure 
Screening 
Treatment Run-In 
 
Days 
−30 to −1 
Day 1 
Week 4 
(± 3 d) 
Week 8 
(± 3 d) 
Week 12 
(± 3 d) 
Notes 
Administrative procedures 
 
Informed consent 
X 
 
 
 
 
Section 8.1.1  
Contact IRT 
X 
X 
X 
X 
X 
Section 8.1.3  
Inclusion and exclusion criteria 
X 
X 
 
 
 
Section 5  
Demography 
X 
 
 
 
 
Section 8.1.5.1  
General and vitiligo medical history 
X 
 
 
 
 
Section 8.1.5.2  
Prior/concomitant medications  
X 
X 
X 
X 
X 
Section 6.6  
Apply study cream 
 
X 
X 
X 
X 
Should be applied by the participant under direct 
supervision of the site staff. Study cream should be 
applied after PK or translational blood draws on 
applicable days. 
Dispense (D) and return (R) study cream 
and reminder/diary cards 
 
D 
R/D 
R/D 
R/D 
All tubes of study drug to be weighed before dispensing 
and when returned. Tubes may not be redispensed. 
Collect study cream tubes and 
collect/review study cream diary cards 
 
 
X 
X 
X 
 
Assess compliance of study cream 
 
 
X 
X 
X 
Compliance is based on the number of applications. 
Section 6.4. 
Safety assessments 
 
AE assessment* 
X 
X 
X 
X 
X 
*If an AE is noted, relevant body systems should be 
physically examined in a targeted physical exam. 
Section 8.3.2 
Ad hoc photography of skin-related AEs should occur as 
applicable. Section 8.2.5 
Comprehensive physical examination 
X 
 
 
 
X 
Section 8.3.2  
Vital signs 
X 
X 
X 
X 
X 
Section 8.3.3  
12-lead ECG 
X 
 
 
 
 
12-lead ECG performed within 2 months before baseline 
is acceptable. Section 8.3.4 


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Table 3: 
Schedule of Assessments for Screening Through Week 12 (Continued) 
Procedure 
Screening 
Treatment Run-In 
 
Days 
−30 to −1 
Day 1 
Week 4 
(± 3 d) 
Week 8 
(± 3 d) 
Week 12 
(± 3 d) 
Notes 
Efficacy assessments 
 
F-BSA 
X 
X 
X 
X 
X 
Section 8.2.1  
T-BSA 
X 
X 
X 
X 
X 
Includes facial and nonfacial areas. Section 8.2.1  
F-VASI 
X 
X 
X 
X 
X 
Section 8.2.2  
T-VASI 
X 
X 
X 
X 
X 
Includes facial and nonfacial areas. Section 8.2.2  
Photography of face 
X 
X* 
 
 
X 
*If photo quality at screening is not adequate, the 
photography may be repeated on Day 1. Section 8.2.5  
Photography of nonfacial target area 
X 
X* 
 
 
X 
Laboratory assessments 
 
Hematology and chemistry assessments 
X 
X 
 
 
X 
Section 8.3.5  
Serology and thyroid testing 
X 
 
 
 
 
Section 8.3.5.2  
Urinalysis 
X 
 
 
 
 
Section 8.3.5  
FSH 
X 
 
 
 
 
 
Pregnancy testing (serum) 
X 
 
 
 
 
Section 8.3.5.1  
Pregnancy testing (urine) 
 
X 
X 
X 
X 
Section 8.3.5.1 


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Table 3: 
Schedule of Assessments for Screening Through Week 12 (Continued) 
Procedure 
Screening 
Treatment Run-In 
 
Days 
−30 to −1 
Day 1 
Week 4 
(± 3 d) 
Week 8 
(± 3 d) 
Week 12 
(± 3 d) 
Notes 
PK and translational assessments 
 
PK blood draw 
 
 
X 
 
X 
Blood samples must not be drawn from the area that has 
been treated with study cream. 
Samples will be drawn at preapplication. Section 8.4  
Vitamin D assessment 
X 
X 
 
 
X 
 
Note: Unscheduled visits may occur at any time at the investigator's discretion, and appropriate clinical and laboratory tests may be performed, as clinically indicated. 


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Table 4: 
Schedule of Assessments Week 16 Through End of Study 
Procedure 
 
Safety 
Follow-Up 
Notes 
Week 16 
(± 3 d) 
Week 24 
(± 7 d) 
Week 32 
(± 7 d) 
Week 40 
(± 7 d) 
Week 48 
(EOT) 
(± 7 d) 
30 days 
(EOT*+7 d) 
(EOS) 
*After last application of study cream or last visit. 
Administrative procedures 
 
Contact IRT 
X 
X 
X 
X 
X 
X 
Section 8.1.3  
Prior/concomitant medications  
X 
X 
X 
X 
X 
X 
Section 6.6  
Apply study cream 
X 
X 
X 
X 
 
 
Should be applied by the participant under direct 
supervision of the site staff. Study cream should be applied 
after PK or translational blood draws on applicable days. 
Dispense (D) and return (R) study 
cream and reminder/diary cards 
R/D 
R/D 
R/D 
R/D 
R 
 
All tubes of study drug to be weighed before dispensing and 
when returned. Tubes may not be redispensed. 
Collect study cream tubes and 
collect/review study cream diary 
cards 
X 
X 
X 
X 
X 
 
 
Assess compliance of study 
cream 
X 
X 
X 
X 
X 
 
Compliance is based on the number of applications. 
Section 6.4  
Assess compliance with NB-UVB 
X 
X 
X 
X 
X 
 
Compliance is based on the number of sessions recorded by 
the NB-UVB machine. Section 6.4  
Safety assessments 
 
AE assessment* 
X 
X 
X 
X 
X 
X 
*If an AE is noted, relevant body systems should be 
physically examined in a targeted physical exam. 
Section 8.3.2 
Ad hoc photography of skin-related AEs may occur as 
applicable. Section 8.2.5  
Comprehensive physical 
examination 
 
X 
 
 
X 
 
Section 8.3.2  
Vital signs 
X 
X 
X 
X 
X 
X 
Section 8.3.3  


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Table 4: 
Schedule of Assessments Week 16 Through End of Study (Continued) 
Procedure 
 
Safety 
Follow-Up 
Notes 
Week 16 
(± 3 d) 
Week 24 
(± 7 d) 
Week 32 
(± 7 d) 
Week 40 
(± 7 d) 
Week 48 
(EOT) 
(± 7 d) 
30 days 
(EOT*+7 d) 
(EOS) 
*After last application of study cream or last visit. 
Efficacy assessments 
 
F-BSA 
X 
X 
X 
X 
X 
X 
Section 8.2.1  
T-BSA 
X 
X 
X 
X 
X 
X 
Includes facial and nonfacial areas. Section 8.2.1  
F-VASI 
X 
X 
X 
X 
X 
X 
Section 8.2.2  
T-VASI 
X 
X 
X 
X 
X 
X 
Includes facial and nonfacial areas. Section 8.2.2  
Photography of face 
 
X 
 
X 
X 
 
Section 8.2.5  
Photography of nonfacial target 
area 
 
X 
 
X 
X 
 
Laboratory assessments 
 
 
Hematology and chemistry 
assessments 
 
X 
 
X 
X 
 
Section 8.3.5  
Pregnancy testing (serum) 
 
 
 
 
 
X 
Section 8.3.5.1 
Pregnancy testing (urine) 
X 
X 
X 
X 
X 
 
Section 8.3.5.1 


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Table 4: 
Schedule of Assessments Week 16 Through End of Study (Continued) 
Procedure 
 
Safety 
Follow-Up 
Notes 
Week 16 
(± 3 d) 
Week 24 
(± 7 d) 
Week 32 
(± 7 d) 
Week 40 
(± 7 d) 
Week 48 
(EOT) 
(± 7 d) 
30 days 
(EOT*+7 d) 
(EOS) 
*After last application of study cream or last visit. 
PK and translational assessments 
 
PK blood draw 
X* 
 
 
 
 
 
Blood samples must not be drawn from an area that has been 
treated with study cream. 
Samples will be drawn at preapplication. Section 8.4 
*Only participants starting combination at Week 12. 
Vitamin D assessment 
 
X 
 
X 
X 
X 
 
Note: Unscheduled visits may occur at any time at the investigator's discretion, and appropriate clinical and laboratory tests may be performed, as clinically indicated. 


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2. 
INTRODUCTION 
2.1. 
Ruxolitinib Cream 
Ruxolitinib cream is in Phase 3 development for the treatment of vitiligo and is a topical 
formulation of ruxolitinib phosphate, an inhibitor of the JAK family of protein TYKs. Janus 
kinases are intracellular signaling enzymes that act downstream of key proinflammatory 
cytokines implicated in vitiligo pathogenesis. Ruxolitinib is a novel, potent, and selective 
inhibitor of the JAKs, specifically JAK1 and JAK2 with modest to marked selectivity against 
TYK2 and JAK3. Ruxolitinib potently (IC50 < 5 nM) inhibits JAKs, yet it does not significantly 
inhibit (< 30% inhibition) a broad panel of 26 kinases when tested at 200 nM (approximately 
100 times the average IC50 value for JAK enzyme inhibition). Ruxolitinib-mediated inhibition of 
JAK signaling may be an effective strategy for vitiligo treatment. 
2.2. 
Background 
Vitiligo is an autoimmune pigmentary disease that is estimated to affect 0.5% to 2% of the 
population worldwide (Krüger and Schallreuter 2012) and is characterized by depigmented 
patches of skin with a selective loss of melanocytes. The natural course of the disease is 
generally unpredictable, but it is often progressive. Some degree of spontaneous repigmentation 
may occur in 10% to 20% of patients; however, it is typically not cosmetically acceptable 
(Castanet and Ortonne 1997). 
Vitiligo is considered a serious disease owing to its substantial psychological burden on patients 
and its progressive course if left untreated. Involvement of exposed skin (eg, face and hands) can 
have a major negative impact on self-esteem and quality of life (Silverberg and Silverberg 2013). 
Currently, there is no approved drug  treatment for repigmentation in vitiligo. The management 
of vitiligo is empirical and based on the most recent consensus guidelines (American Academy 
of Dermatology, Gawkrodger et al 2008, Taieb et al 2013, Vitiligo Research Foundation). In 
general, first-line treatments consist of topical steroids and calcineurin inhibitors, which may be 
most useful for treating disease that is localized. However, this use is off-label, there are 
inconclusive (or insufficient) data supporting their efficacy, many have restrictions on duration 
of chronic use, and AEs can limit their tolerability. Second-line treatments consist of 
phototherapy (NB-UVB and PUVA) and systemic steroid treatment. However, phototherapy 
regimens typically require 2 to 3 treatments per week, and 12 to 24 months of continuous 
phototherapy may be necessary to acquire maximal repigmentation (Taieb et al 2013); relapses 
are common. Third-line treatments consist of surgical grafting techniques and depigmenting 
treatments. Surgery is best indicated for stable and localized forms of vitiligo, and only a small 
number of patients with vitiligo are considered suitable candidates. All of these treatments can 
have adverse effects that limit their use. 
No available product or therapy is able to modify the course of vitiligo disease and produce a 
long-lasting effect. Given the lack of approved therapies, safety concerns, and modest 
effectiveness of current off-label drug treatments, there is a need to identify a safe and effective 
new treatment for vitiligo. 


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2.3. 
Clinical Efficacy and Safety Data With Ruxolitinib Cream 
The clinical efficacy and safety of ruxolitinib cream in vitiligo has been evaluated in over 
800 participants in 3 randomized, vehicle-controlled studies, 1 Phase 2 (157 participants) and 
2 Phase 3 studies (674 participants). 
Study INCB 18424-211 evaluated 4 regimens of ruxolitinib cream (1.5% BID, 1.5% QD, 
0.5% QD, 0.15% QD) versus vehicle BID for 24 weeks in adults. In INCB 18424-211, all 
participants initially randomized to vehicle BID and participants initially randomized to 
0.15% QD who did not achieve ≥ 25% improvement from baseline in F-VASI25 were 
rerandomized to 1 of the 3 higher strength groups for an additional 28 weeks. All other 
participants maintained in the same treatment until Week 52. After Week 52, participants could 
receive open-label 1.5% BID for an additional 104 weeks. The primary endpoint was the 
proportion of participants who achieved a ≥ 50% improvement from baseline in F-VASI50 at 
Week 24. 
In Study INCB 18424-211, all ruxolitinib treatment groups demonstrated clinically meaningful 
efficacy and superiority over vehicle. The proportion of participants who achieved an F-VASI50 
at Week 24 was statistically significantly greater for ruxolitinib cream versus vehicle with 
response rates of 32.3%, 25.8%, 50.0%, and 45.5% for ruxolitinib cream 0.15% QD, 0.5% QD, 
1.5% QD, and 1.5% BID, respectively, and 3.1% for vehicle. The proportion of participants who 
achieved an F-VASI75 at Week 24 was also statistically significantly greater for ruxolitinib 
cream versus vehicle with response rates of 9.7%, 16.1%, 16.7%, and 30.3% for ruxolitinib 
cream 0.15% QD, 0.5% QD, 1.5% QD, and 1.5% BID, respectively, and 0% for vehicle. 
In Study INCB 18424-211, improvements in T-VASI were observed at both Weeks 24 and 52. 
The proportion of participants who achieved a T-VASI50 at Week 24 was also statistically 
significantly greater for ruxolitinib cream 0.15% QD, 0.5% QD, 1.5% QD, and 1.5% BID 
compared with vehicle with response rates of 16.1%, 6.5%%, 23.3%, and 12.1%, respectively, 
compared with 0% in vehicle treated participants. Continued improvement in participants treated 
with 0.5% QD, 1.5% QD, and 1.5% BID through Week 52 was observed with response rates in 
T-VASI50 of 25.8%, 30.0%, and 36.4%, respectively. 
In participants with vitiligo in Study 18424-211, the incidence and severity of TEAEs among 
participants who applied ruxolitinib cream were generally similar to those in participants who 
applied vehicle cream during the vehicle-controlled period; 67.2% and 62.5% of participants on 
active treatment and vehicle, respectively, had at least 1 TEAE; 0.8% and 0% of participants on 
active treatment and vehicle, respectively, had at least 1 Grade 3 or higher TEAE. The most 
frequently reported TEAEs in the active treatment groups during the vehicle-controlled period 
were acne (12.0%), application site pruritus (10.4%), pruritus (8.8%), and viral upper respiratory 
tract infection (6.4%). The most common events by preferred term occurred at a comparable 
incidence for participants on vehicle cream with the exception of acne, which was more common 
in participants on active treatment. With continued exposure for the 3 highest application 
strength groups, acne (14.9%), pruritus (12.8%), application site pruritus (7.4%), and viral upper 
respiratory tract infection (10.6%) remained among the most common TEAEs. No serious TEAE 
had a fatal outcome nor were they considered related to the study cream by the investigator. 
There were no clinically meaningful changes in chemistry or hematology parameters, and no 
clinically meaningful changes were noted for vital signs. 


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In Study INCB 18424-211, after Week 52, a subset of participants were offered optional 
concomitant NB-UVB phototherapy while continuing open-label treatment with ruxolitinib 1.5% 
cream BID. Participants could start phototherapy at any time during the open-label period. 
Nineteen participants received add-on NB-UVB for ≥ 12 weeks (Pandya et al 2021), with 3 times 
per week being the most common phototherapy regimen. Among these 19 participants, 
15 participants (78.9%) had further improvement in F-VASI and 18 participants (94.7%) had 
further improvement in T-VASI after the addition of NB-UVB to the ruxolitinib cream regimen. 
Only 4 participants (21%) who received concomitant NB-UVB therapy had AEs, all of which 
were Grade 1 or 2 in severity and none were related to treatment. 
Studies INCB 18424-306 and -307 are identically-designed, randomized, vehicle-controlled, 
Phase 3 studies in adolescent and adult participants (≥ 12 years old, ~10% of whom were 
adolescents) with vitiligo. Participants received blinded study treatment for 24 weeks and were 
then offered the opportunity to receive an additional 28 weeks of treatment with ruxolitinib 
cream 1.5% BID. NB-UVB therapy was not allowed in the Phase 3 studies. 
Both ongoing Phase 3 studies (INCB 18424-306 and -307) studies met the primary endpoint 
(p < 0.0001 for both studies), demonstrating that significantly more participants treated with 
ruxolitinib cream 1.5% twice daily (BID) achieved a ≥ 75% improvement from baseline in the 
facial vitiligo area scoring index (F-VASI75) compared to participants treated with a vehicle 
control at Week 24. Safety and tolerability in the Phase 3 studies were similar to Study 
INCB 18424-211 in that the rate of Grade 3 TEAEs, SAEs, and TEAEs leading to 
discontinuation was low. Further, there were no significant TEAEs or application site events and 
no clinically relevant hematological changes. 
2.4. 
Study Rationale 
NB-UVB phototherapy is thought to stimulate the proliferation of melanocytes and 
melanogenesis, thereby acting in coordination with JAK inhibition, which creates a more 
favorable immune environment for melanocyte survival by inhibiting the autoimmune response. 
In Study INCB 18424-211, the addition of phototherapy to ruxolitinib cream in participants with 
vitiligo was well tolerated; the frequency of adverse events was low, and none were related to 
treatment (Pandya et al 2021). The addition of NB-UVB phototherapy to ruxolitinib cream 
resulted in further substantial improvement in repigmentation, including in participants who did 
not achieve F-VASI50 at Week 24. The current study will investigate these findings in a larger 
study. 
This study is a 2-part, open-label study examining the addition of NB-UVB to ruxolitinib 1.5% 
cream BID. Approximately 50 participants will receive ruxolitinib 1.5% cream BID for 
12 weeks. At Week 12, participants will be assigned to ruxolitinib 1.5% cream alone or in 
combination with NB-UVB (3 times per week through Week 48) based on the improvement in 
T-VASI (see Figure 1). Participants who have < T-VASI25 will receive the combination of 
NB-UVB phototherapy and ruxolitinib 1.5% cream BID (Group A). Participants who have 
≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone (Group B). 


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In Study INCB 18424-211, 21.2% of participant who applied ruxolitinib 1.5% cream BID 
achieved a T-VASI25 at Week 12. T-VASI25 at Week 12 represents a reasonable outcome 
showing that the participant is having a response to ruxolitinib cream and will potentially benefit 
from ruxolitinib cream alone. In participants that do not achieve a T-VASI25 at Week 12, 
NB-UVB will be added to possibly increase the response rate. 
NB-UVB phototherapy administered 3 times per week has been chosen as the regimen for this 
study as this regimen has been shown to induce repigmentation (Mohammad et al 2017). This 
combination regimen should provide adequate stimulation to the melanocytes to augment the 
repigmentation provided by ruxolitinib cream alone. 
The primary purpose of this study is to evaluate mean percentage change from baseline of 
T-VASI at Week 48. Additionally, a secondary endpoint is the safety and tolerability of 
combination therapy (ruxolitinib cream plus NB-UVB) in participants with vitiligo. 
2.5. 
Justification for Strength of Ruxolitinib Cream 
Results from Study INCB 18424-211 showed that ruxolitinib 1.5% cream BID had the highest 
repigmentation rate on both F-VASI and T-VASI, particularly at Week 48. All ruxolitinib 
treatment strengths were generally safe and well tolerated with no significant TEAEs or 
application site events and no clinically relevant hematological changes. Also, the available data 
for phototherapy combination was with ruxolitinib 1.5% cream BID. Further, in the 2 Phase 3 
studies, ruxolitinib 1.5% BID showed statistically significant and clinically meaningful 
improvements for F-VASI and T-VASI compared with vehicle, and the safety profile was similar 
to that seen in the Phase 2 study. 
2.6. 
Justification for Dose of Narrow-Band Ultraviolet B Phototherapy 
NB-UVB phototherapy is an established treatment modality for vitiligo. Recent research 
suggests that in addition to an immunosuppression effect, NB-UVB stimulates growth and 
migration of remaining perilesional and follicular melanocytes. A combination of NB-UVB and 
ruxolitinib cream may lead to an accelerated rate of repigmentation, and potentially a more 
durable response to treatment. 
NB-UVB phototherapy administered 3 times per week (see Table 7) has been chosen as the 
regimen for this study as this regimen has been shown to induce repigmentation 
(Mohammad et al 2017); therefore, starting at Week 12 participants who have < T-VASI25 will 
receive combination therapy of ruxolitinib cream 1.5% BID in combination with NB-UVB 
phototherapy 3 times per week through Week 48. Participants who have ≥ T-VASI25 at Week 12 
will continue to receive ruxolitinib cream monotherapy. This combination regimen should 
provide adequate stimulation to the melanocytes to augment the repigmentation provided by 
ruxolitinib cream alone. 


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2.7. 
Benefit/Risk Assessment 
Results from dermal safety studies to evaluate local tolerability in healthy participants 
demonstrate that ruxolitinib 1.5% cream did not cause sensitization and was only slightly 
irritating under exaggerated testing conditions (occlusive application). In addition, ruxolitinib 
1.5% cream was not phototoxic and did not induce photosensitization. This was further 
confirmed by the available safety data in the Phase 2 and Phase 3 studies where ruxolitinib cream 
was well tolerated at the application sites with infrequently reported application site reactions. 
In participants with vitiligo, all ruxolitinib treatment strengths were generally safe and well 
tolerated with no significant TEAEs or application site events. The TEAE rate overall was low 
and similar between active treatment and vehicle. Application site acne was noted as an adverse 
drug reaction in the IB. The rate of TEAEs leading to discontinuation from treatment was low. 
No serious TEAE had a fatal outcome nor were they considered related to the study cream by the 
investigator. There were no clinically meaningful changes in chemistry or hematology 
parameters, and no clinically meaningful changes were noted for vital signs. 
A comprehensive analysis of potential safety concerns associated with oral ruxolitinib and other 
oral JAK inhibitors was performed. As expected given the low bioavailability and the low 
plasma concentrations of ruxolitinib observed following topical application, ruxolitinib cream 
was not associated with these safety concerns. 
Narrow-band UVB is generally safe and there were no safety issues with the combination in the 
small subset of participants in Study INCB 18424-211. There are no substantial safety issues 
expected. 
Ruxolitinib cream showed statistically significant and clinically meaningful improvement in 
participants with vitiligo compared with vehicle. Also, among the 19 participants who received 
combination therapy with ruxolitinib 1.5% cream and NB-UVB in Study INCB 18424-211, 
F-VASI and T-VASI improvements after add-on phototherapy increased for all response 
parameters. 
As ruxolitinib 1.5% cream is generally safe and well tolerated and showed clear benefit in the 
Phase 2 and Phase 3 studies, the benefit risk profile is expected to be positive. 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of ruxolitinib cream may be found in the IB. 


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3. 
OBJECTIVES AND ENDPOINTS 
Table 5 presents the objectives and endpoints. 
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To evaluate the efficacy of 
ruxolitinib cream in combination 
with NB-UVB in participants with 
vitiligo. 
• Change from baseline in T-VASI at Week 48. 
Secondary 
To evaluate the safety and 
tolerability of ruxolitinib cream in 
combination with NB-UVB. 
• Occurrence of AEs and evaluation of vital signs and 
laboratory data. 
To further evaluate the efficacy of 
ruxolitinib cream in combination 
with NB-UVB in participants with 
vitiligo. 
• Proportion of participants achieving F-VASI50/75/90 at each 
postbaseline visit. 
• Proportion of participants achieving T-VASI50/75/90 at each 
postbaseline visit. 
• Change and percentage change from baseline in 
F-VASI/T-VASI at each postbaseline visit. 
• Change and percentage change from baseline in 
F-BSA/T-BSA at each postbaseline visit. 
To evaluate the ruxolitinib PK in 
plasma after treatment with 
ruxolitinib cream in combination 
with NB-UVB. 
• Population-based (trough) plasma concentrations of 
ruxolitinib at Weeks 4, 12, and 16. 


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Table 5: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 


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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This is an open-label study in which participants will apply ruxolitinib 1.5% cream BID to all 
depigmented areas up to 10% BSA for up to 48 weeks. Participants should continue to treat 
depigmented areas identified for treatment at baseline regardless of whether the area begins to 
improve or fully repigment. 
On Day 1, all participants will apply ruxolitinib 1.5% cream BID as monotherapy (see Figure 1). 
At Week 12, participants will apply ruxolitinib 1.5% cream alone or in combination with 
NB-UVB based on improvement in T-VASI score. Participants who have < T-VASI25 will have 
NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen (Group A). NB-UVB 
will be given 3 times per week through Week 48 (36 weeks). Participants who have ≥ T-VASI25 
at Week 12 will continue on ruxolitinib 1.5% cream BID alone (Group B). For participants who 
receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use 
during the study. 
At any time during the study, if vitiligo areas become significantly more extensive than from the 
previous visit, the participant should contact the study site to discuss with the investigator 
whether additional evaluation at the clinic is required. Participants who have expansion of areas 
of vitiligo identified at baseline or new areas of vitiligo during the course of the treatment period 
should not treat the additional areas of vitiligo with ruxolitinib cream. 
Participants who permanently discontinue NB-UVB will be allowed to remain in the study and 
continue to apply ruxolitinib 1.5% cream BID alone. Participants who permanently discontinue 
ruxolitinib 1.5% cream BID will be allowed to remain in the study and continue NB-UVB 
phototherapy alone. 
4.2. 
Overall Study Duration 
The study begins when the first participant signs the study ICF. It is estimated that an individual 
will participate for approximately 14 months (up to 30 days for screening, up to 48 weeks of 
treatment, and 30 days for safety follow-up). 
A participant is considered to have completed the study if they have completed the 48-week 
treatment period and the safety-follow-up period. A study is considered completed when the last 
participant last visit has occurred. 
4.3. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract. The investigator is to notify the IRB/IEC of the study's 
completion or early termination in writing, send a copy of the notification to the sponsor or 
sponsor's designee, and retain 1 copy for the site study regulatory file. 
The sponsor may terminate the study electively if required by regulatory decision. If the study is 
terminated prematurely, the sponsor will notify the investigators, the IRBs and IECs, and the 
regulatory bodies of the decision and reason for termination of the study. 


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5. 
STUDY POPULATION 
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. Ability to comprehend and willingness to sign a written ICF for the study (or by parent or 
legally authorized representative). 
2. Age ≥ 12 years at the time of signing the ICF. 
3. A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the 
following: 
a. ≥ 0.5 F-VASI on the face 
b. ≥ 3.0 T-VASI (body areas not including the face) 
c. Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA. 
4. Agree to discontinue all agents used to treat vitiligo from screening through the final 
safety follow-up visit. Over-the-counter preparations deemed acceptable by the 
investigator and camouflage makeups are permitted. 
5. Willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a 
child for the duration of study participation with the exception of the following: 
a. Female participants of nonchildbearing potential (ie, or surgically sterile with a 
hysterectomy and/or bilateral oophorectomy OR postmenopausal [≥ 12 months of 
amenorrhea without an alternative medical cause]). 
Note: Permitted methods in preventing pregnancy (see Appendix A) should be 
communicated to the participants and their understanding confirmed. 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. No pigmented hair within any of the vitiligo areas on the face. 
2. Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other 
skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory 
hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical 
leukoderma, and tinea versicolor). 
3. Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other 
pigmented areas. 
Note: Prior use of hydroquinone is not prohibited. 


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4. Previous pruritic, urticarial, morbilliform reaction to NB-UVB phototherapy that caused 
discontinuation of therapy. 
5. Received at least 36 phototherapy sessions for vitiligo within 6 months and shown little 
or no repigmentation in response to previous phototherapy, including NB-UVB and 
excimer laser. 
6. History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, 
ischemic stroke, myocardial infarction). 
7. Concurrent conditions and history of other diseases: 
a. Any other skin disease that, in the opinion of the investigator, would interfere with 
the study cream application or study assessments. 
b. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes 
zoster, chicken pox) within 1 week before baseline. 
c. Conditions at baseline that would interfere with evaluation of vitiligo. 
d. Any serious illness or medical, physical, or psychiatric condition(s) that, in the 
investigator's opinion, would interfere with full participation in the study, including 
application of study cream and attending required study visits; pose a significant risk 
to the participant; or interfere with interpretation of study data. 
Examples include but are not limited to the following: 
− Clinically significant or uncontrolled cardiac disease, including unstable angina, 
acute myocardial infarction within 6 months from Day 1 of study cream 
application, New York Heart Association Class III or IV congestive heart failure, 
and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure 
> 150/90 mmHg) unless approved by the medical monitor/sponsor. 
− Concurrent malignant disease or a history of that in the 5 years preceding the 
baseline visit except for adequately treated nonmetastatic malignancies. 
− Current and/or history of liver disease, including known hepatitis B or C, with 
hepatic or biliary abnormalities. 
− History of tuberculosis. 
− History of alcohol use disorder or drug addiction within 1 year before screening 
or current alcohol or drug use that, in the opinion of the investigator, will interfere 
with the participant's ability to comply with the application schedule and study 
assessments. 
− Committed to an institution by virtue of an order issued by either the judicial or 
the administrative authorities. 
8. Use of any topical drugs on the vitiligo areas (eg, corticosteroids, calcineurin, and 
phosphodiesterase type 4 inhibitors or retinoids) within 1 week before baseline. 
9. Use of any of the following treatments within 4 weeks before baseline: 
a. Melanocyte-stimulating agents (eg, afamelanotide). 
b. Immunomodulating systemic medications (eg, corticosteroids, methotrexate, 
cyclosporine). 


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c. Any other systemic therapies that could increase the skin sensitivity to UV/visible 
light or impact skin pigmentation, for example, tetracyclines, metoxypsoralens. 
d. Received live attenuated vaccine. 
10. Use of laser or any kind of phototherapy (including tanning bed or intentional UV 
exposure) within 12 weeks before baseline. 
11. Use of any of the following treatments within 5 half-lives or 12 weeks (whichever is 
longer) before baseline: 
a. Biologic agents for the treatment of vitiligo. 
b. Investigational or experimental therapy or procedures for vitiligo. 
Note: Investigational biologics should be discussed with the sponsor to determine 
whether a longer period of discontinuation is required. 
12. Previously received JAK inhibitors, systemic or topical. 
13. Any of the following clinical laboratory values at screening: 
a. Hemoglobin (< 10 g/dL). 
b. Liver function tests: 
− AST or ALT ≥ 2 × ULN. 
− Alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin 
> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%). 
c. Severe renal disease (with creatinine clearance < 30 mL/min) or renal disease 
requiring dialysis. 
d. Clinically significant abnormal TSH or free T4 at screening as determined by the 
investigator. 
e. Positive serology test results at screening for HIV antibody. 
14. Appropriate BMI: 
a. Adults: < 17 or > 40 kg/m2. 
b. Adolescents (age  12 to < 18 years): BMI-for-age in the < 5th percentile or ≥ 85th 
percentile range according to the CDC BMI Percentile Calculator for Child and Teen 
(CDC). 
15. Pregnant or lactating, or those considering pregnancy during the period of their study 
participation. 
16. In the opinion of the investigator are unable or unlikely to comply with the application 
schedule and study evaluations. 
17. Known allergy or reaction to any component of the ruxolitinib formulation. 
18. No venous access outside of the areas to be treated. 
19. Live with anyone participating in any current Incyte-sponsored ruxolitinib cream study. 
20. Employees of the sponsor or investigator or are otherwise dependents of them. 


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5.3. 
Lifestyle Considerations 
If sunscreen, makeup, or other cosmetics have been applied to the areas to be treated, participants 
should follow the application guidance (see Section 6.6.1). 
Participants should not take baths or showers within 2 hours after study cream application. 
It is recommended that swimming should not take place within 2 hours before and after the study 
cream application. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently enrolled in the study.  
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes that the participant would be eligible if retested. Additionally, a participant 
who fails screening may repeat the screening process 1 time if the investigator believes that there 
has been a change in eligibility status or any laboratory abnormality is inconsistent with the 
participant’s medical history. Participants who rescreen must reconsent and be assigned a new 
screening number. 
5.5. 
Replacement of Participants 
Participants will not be replaced during the study. 
6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
Table 6 and Table 7 present the study treatment information. Participants should apply study 
cream only to depigmented vitiligo areas identified by the investigator at baseline up to a T-BSA 
(facial and nonfacial) of ≤ 10% BSA. Participants should continue to treat all depigmented 
vitiligo areas identified for treatment at baseline regardless of whether the area begins to improve 
or fully repigment. 
On visit days, study cream will be applied in the clinic during the visit. Participants should 
remove study cream from the tube in fingertip units until all of the areas to be treated are covered 
by a thin film; the tube will be weighed before and after application to determine the 
participant’s dosage. On the day of a visit, the participant should not apply the study cream at 
home and will apply study cream from a new kit in the clinic during the visit under direct 
supervision of the site staff. Participants will be instructed to document the treated areas and be 
advised to limit use to no more than 1 tube (60 g) per week. Application instructions will be 
provided by the site study staff, and the participants will record their daily applications via a 
diary card given to the participants during each study visit. Refer to the Study Pharmacy Manual 
for participant instructions for handling of study cream. 
On days where there are PK or translational assessments, study cream should be applied after 
these procedures have occurred. 


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For participants who receive combination therapy, ruxolitinib cream should be applied at least 
2 hours before NB-UVB phototherapy. 
See Appendix B for application instructions. 
At any time, if vitiligo areas become significantly more extensive than from the previous visit, 
the participant should contact the study site to discuss with the investigator whether additional 
evaluation at the clinic is required. Participants may not treat the expanded or newly identified 
areas with study cream. If any other skin products that are permitted under the study Protocol are 
used, participants should continue these unchanged during the study. 
See Appendix C for COVID-19-related guidance. 
Table 6: 
Study Treatment Information (Ruxolitinib Cream) 
Study treatment name: 
Ruxolitinib 
Dosage formulation: 
Cream 
Mechanism of action: 
JAK inhibitor 
Unit strength: 
1.5% 
Route of administration: 
Topical 
Application instructions: 
A thin film is applied BID to depigmented vitiligo areas. 
Packaging and labeling: 
Ruxolitinib cream will be provided in 60 g tubes. Each tube will be 
labeled as required per country requirement. 
Storage: 
Ambient (15°C-30°C/59°F-86°F) 
Status of treatment in 
participating countries: 
Investigational 
Table 7: 
Study Treatment Information (NB-UVB) 
Study treatment name: 
NB-UVB (311-312 nm) 
Dosage formulation: 
Cleared medical device 
Dosage levels: 
Starting dose = 200 mJ/cm2 
Increase dose by 10% at each visit until mild erythema lasting 
< 24 hours as reported by the participant. 
Hold dose at 1500 mJ/cm2 – this may vary or be increased over the 
course of treatment. Dose information will be collected in the 
database. 
Administration 
instructions: 
Three times a week; not on consecutive days. 
Status of treatment in 
participating countries: 
Standard of care 


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6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm and document that appropriate temperature conditions 
(ruxolitinib cream is to be stored between 15°C and 30°C [59°F-86°F]) have been maintained 
during transit for all study treatments received and any discrepancies are reported and resolved 
before use of the study cream. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply study cream. Immediately after application of ruxolitinib cream, participants are 
to wash their hands thoroughly with soap and warm water (unless the area to be treated includes 
the hands). Refer to the Study Pharmacy Manual for participant instructions for handling of 
study cream. 
All study cream must be stored in a secure, environmentally controlled, and monitored (manual 
or automated) area in accordance with the labeled storage conditions with access limited to the 
investigator and authorized site staff. Participants should store study cream at ambient 
temperature conditions. 
The investigator (or designee) is responsible for study cream 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 cream to the study site. 
• Inventory of study cream at the site. 
• Participant use of the study cream, including tube counts from each supply dispensed. 
• Return of study cream to the investigator or designee by participants. 
The investigational product must be used only in accordance with the Protocol. The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study cream. These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
Completed accountability records will be archived by the site. The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study cream 
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 cream 
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 cream 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 cream are provided in 
the study materials provided to sites. 


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6.3. 
Measures to Minimize Bias: Randomization and Blinding 
Not applicable as this is an open-label study. 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments must be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study. 
Compliance with ruxolitinib cream will be evaluated by participants' adherence to the application 
regimen and drug accountability documented by the site staff and monitored by the 
sponsor/designee. 
In general, the application compliance will be determined by the number of actual versus 
anticipated number of applications, which should be within 70% to 130% of the prescribed 
number of applications. Participants will be instructed to bring all tubes of study cream with 
them to the study visits in order for site personnel to conduct tube counts to assess study cream 
accountability. The drug accountability documentation will be used by the sponsor to calculate 
treatment compliance. 
Compliance with NB-UVB will be determined by the number of sessions as recorded by the 
NB-UVB machine. Participants will be instructed to bring the session recording device with 
them to the study visits in order for site personnel to conduct the compliance assessment. Site 
staff must provide source documentation of all treatment dates and details. 
6.5. 
Dose Modifications 
6.5.1. 
Criteria and Procedures for Application Interruptions of Study Cream 
Safety concerns should be discussed with the sponsor immediately upon occurrence or awareness 
to determine whether the participant should continue or discontinue application of study cream. 
In some circumstances, it may be necessary to temporarily interrupt application of ruxolitinib 
cream. Except in cases of emergency, it is recommended that any findings of concern (eg, AE) 
be confirmed and that the investigator consult with the sponsor medical monitor (or other 
representative of the sponsor) before interrupting study cream. Additionally, the investigator 
must obtain approval from the sponsor before restarting study cream. Participants who have a 
recurrence of the initial AEs upon restarting the study cream and the AE is confirmed related to 
the study cream may need the study cream to be permanently discontinued. 
If a participant has an AE at an application site, application of ruxolitinib cream to that site can 
be temporarily interrupted without interrupting application of study cream elsewhere. 
Instructions for application interruptions for ruxolitinib cream are outlined in Table 8. Individual 
decisions regarding interruptions should be made using clinical judgment in consultation with the 
medical monitor (whenever possible), taking into account relatedness of the AE to the study 
cream and the participant's underlying condition. 
If it is unclear whether a skin reaction is related to ruxolitinib cream or the NB-UVB, the 
investigator should consider interrupting both. 


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Table 8: 
Guidelines for Interruption and Restarting of Study Cream 
Adverse Event 
Action Taken 
Chemistry 
ALT (> 3 × ULN) or AST (> 3 × ULN)  • Laboratory abnormalities should be confirmed with repeat 
testing within 48 hours whenever possible and immediate 
delivery of the laboratory results requested. 
• Study cream applications must be interrupted. At the 
discretion of the investigator, after consultation with the 
sponsor, study cream application may be restored once 
these have resolved. 
Other laboratory abnormalities 
Any other Grade 3 or higher laboratory 
abnormality 
• Laboratory abnormalities should be confirmed with repeat 
testing within 48 hours whenever possible and immediate 
delivery of the laboratory results requested. 
• Study cream applications must be interrupted. At the 
discretion of the investigator, after consultation with the 
sponsor, study cream application may be restored once 
these have resolved. 
Any Grade 4 laboratory abnormality or 
AST or ALT (> 5 × ULN)  
• Laboratory abnormalities should be confirmed with repeat 
testing within 48 hours whenever possible and immediate 
delivery of the laboratory results requested. 
• Discontinue study cream if lab abnormalities are 
confirmed. 
6.5.2. 
Criteria for Permanent Discontinuation of Study Cream Due to an Adverse 
Event 
The occurrence of unacceptable severity of an AE that is related to study cream application will 
require that the study cream be permanently discontinued. Unacceptable severity is defined as 
follows: 
• Occurrence of an AE that is related to treatment with the study cream that, in the 
judgment of the investigator or the sponsor's medical monitor, compromises the 
participant's ability to continue study-specific procedures or continuing treatment is 
considered not to be in the participant's best interest. 
• Worsening of vitiligo that requires treatment with a prohibited concomitant 
medication. 
See Section 7 for discontinuation procedures. 
6.5.3. 
Dose Modification for NB-UVB 
On subsequent treatments, the NB-UVB machine will record participant responses about 
pinkness/tenderness of the skin during the previous days. Table 9 shows the dose modifications 
that should occur based on skin reaction. These dose modifications will be programmed into the 
machine. If there is severe pinkness/redness or there is pain, the participant may need to have an 
unscheduled visit for the investigator to evaluate the participant. The participant is not to 


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undergo any further light treatments until it resolves, and treatment can restart at a 15% 
decreased dose. Once the ordered holding dose is reached, hold at that dose until evaluated by 
the investigator. The holding dose may be increased at that time. 
If it is unclear whether a skin reaction is related to ruxolitinib cream or the NB-UVB, the 
investigator should consider interrupting both. 
If the participant has missed NB-UVB treatments, dose adjustments for missed treatments are 
listed in Table 10. 
Table 9: 
NB-UVB Dose Adjustments Based on the Skin Assessments 
Responses to NB-UVB 
Machine Questiona 
Skin Assessment 
Dose Adjustment 
No, or < 24 hours 
No erythema reported after last treatment Increase by 10% 
24 – 48 hours 
Mild erythema but not painful 
Hold dose constant 
> 48 hours 
Moderate erythema or painful 
Decrease by 10% 
Still red/pain 
Severe, painful erythema 
Wait until resolution, decrease 
dose by 15% 
a The NB-UVB machine will provide the following question to the participant, "Were you in pain or red after your 
last treatment?". The participant's response will result in a hold or change to the dose as noted in the dose 
adjustment column. 
Table 10: 
NB-UVB Dose Adjustments for Missed Treatments 
Length of Time Since Previous Dose 
Dose Adjustment 
Up to 1 week 
Maintain dose 
1-2 weeks 
Decrease by 25% to a minimum of 200 mJ/cm2 
2-3 weeks 
Decrease by 50% to a minimum of 200 mJ/cm2 
3-4 weeks 
Decrease by 75% to a minimum of 200 mJ/cm2 
> 4 weeks 
Restart at 200 mJ/cm2 
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 
medication or procedure received up to 12 weeks before baseline through 30 days after the last 
application of study cream will be recorded in the eCRF. Any addition, deletion, or change in the 
dose of these medications will also be recorded. 
Other relevant medications or procedures received more than 12 weeks before the first 
application of study cream may be recorded in the eCRF at the discretion of the investigator or at 
the request of the sponsor based on emerging events during the study. 
If a participant has an SAE, concomitant medications administered more than 30 days after the 
last application of study cream for treatment of the SAE should be reported until the SAE is no 
longer being followed (see Section 9.3). 


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6.6.1. 
Permitted Medications and Procedures 
The following are permitted during the study with application guidance. Investigators and site 
staff are expected to use their best clinical judgment with these recommendations and adhere to 
the guidelines as closely as possible. Please consult the sponsor if there are specific questions. 
• Participants may use bland emollients or camouflage makeups. 
Note: Emollients or camouflage makeups should not be used within 2 hours after 
study cream application. The study cream should be applied before sunscreens and 
camouflage makeup. It is also recommended these be removed from the skin before 
application of the study cream. Any makeup remover must then be washed off and 
the skin dried before application of the study cream. 
• If sunscreen is needed, a mineral-based sunscreen (such as zinc oxide– or titanium 
oxide–based) with SPF of at least 30 is recommended 2 hours after study cream 
application and/or NB-UVB phototherapy. 
Note: Sunscreen must be removed from the skin before study cream application if it 
has been applied to the areas to be treated. 
• Participants who receive combination therapy should apply ruxolitinib cream at least 
2 hours before NB-UVB phototherapy. 
• Concomitant oral vitamins and other skin products should be approved by the 
investigator and ideally should remain stable during the study. 
6.6.2. 
Restricted Medications and Measures 
The following are restricted during the study under specified conditions: 
• Use of any over-the-counter, nonprescription preparations (including vitamins, 
minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days 
before the baseline visit through the safety follow-up visit, unless deemed acceptable 
by the investigator. 
• Use of any prescription medication (including immunizations, phytotherapeutic, 
herbal, or plant-derived preparations) within 7 days before the baseline visit through 
the safety follow-up visit, unless deemed acceptable by the investigator. 
• Baths or showers within 2 hours after study cream application. 
• Treatment for dermatologic disease besides vitiligo (eg, AD or psoriasis) is allowed 
for areas not being treated for vitiligo, if: 
− It involves < 10% of the BSA outside of the areas treated for vitiligo. 
− Topical tacrolimus, pimecrolimus, or corticosteroids Class 6 or 7 (or low potency 
per WHO classification; see Appendix C) are at a stable dose. 
− Topical corticosteroids Class 1 through 5 (see Appendix C) are used for no longer 
than 7 sequential days and no more than 14 days in total. 


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• Use of oral corticosteroids for no longer than 7 days if deemed acceptable by the 
investigator and the sponsor for nondermatologic conditions (eg, asthma 
exacerbation, bronchitis). 
6.7. 
Prohibited Medications and Procedures 
Participants should not use any other treatments for vitiligo at any time during the study. The 
following medications are not permitted during the study: 
• Any investigational medication other than the study cream 
• Treatment known to affect the course of vitiligo, such as skin bleaching treatments 
(eg, hydroquinone) or depigmenting agents (eg, monobenzone) 
Note: Skin bleaching (eg, hydroquinone) use is prohibited during the study but is 
allowed as prior therapy. 
• Other topical agents (except those in Section 6.6.1) or treatments for vitiligo 
(including corticosteroids [topical, systemic, or oral], vitamin D derivatives, 
calcineurin inhibitors, laser or surgical treatments, phototherapy, or other procedures). 
• Biological therapies or other immunosuppressant agents 
• Any phototherapy other than that prescribed as part of the study 
• Use of a tanning bed 
• Receipt of a live vaccine during the course of the study and within 4 weeks after the 
EOT visit 
6.8. 
Treatment After the End of the Study 
Upon completion of the 48 weeks of treatment, participants will not be provided additional 
treatment within this study. 
7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
Participants must be discontinued from study treatment for the following reasons: 
• The participant becomes pregnant. 
• Consent is withdrawn.  
Note: Consent withdrawn means that the participant has explicitly indicated that they 
do not want to be followed any longer; in this case, no further data (except data in 
public domain) may be solicited from or collected regarding the participant. 
Participants may choose to discontinue application of study cream and remain in the 
study to be followed for safety. 


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• Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• Any AE of unacceptable severity as noted in Section 6.5.2. 
• 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: 
• A participant is found not to have met eligibility criteria (any exclusion criterion or 
any inclusion criteria related to participant safety) or if legal requirements have been 
violated. 
• If, at 2 consecutive study visits, a participant's study cream usage exceeds 1 tube 
(60 g) per week. 
• If a participant is noncompliant with study procedures or study cream application in 
the investigator's opinion, the medical monitor should be consulted for instruction on 
handling the participant. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the application of study cream, 
an EOT visit should be conducted. Reasonable efforts should be made to have the participant 
return for a safety follow-up visit. The last date of the last application of study cream and the 
reason for discontinuation of study cream will be recorded in the eCRF. 
If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for withdrawal must be documented in the participant's medical record 
and the primary reason for withdrawal must be included in the eCRF. 
• The EOT visit should be performed. 
• The date of the EOT visit should be recorded in the eCRF. 
• Participants must be followed for safety until the time of the safety follow-up visit or 
until study cream/treatment–related AEs resolve, return to baseline, or are deemed 
irreversible, whichever is longest. 
If the participant discontinues application of study cream 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 safety follow-up period. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at their own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 


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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, they may request destruction of any samples taken and 
not tested, and the investigator must document this in the site study records. 
See Table 3 and Table 4 for data to be collected at the time of study withdrawal and follow-up 
and for any further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible. The participant will be counseled regarding the importance of 
maintaining the assigned visit schedule and ascertain whether or not the participant 
wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant's last known mailing address 
or local equivalent methods). These contact attempts should be documented in the 
participant's medical record. 
• Should the participant continue to be unreachable, they will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 


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8. 
STUDY ASSESSMENTS AND PROCEDURES 
See Appendix C for COVID-19-related guidance. 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or their representative will explain the nature of the study to the 
participant or their 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. 
Note: Adolescent participants who become legal adults during the study will be 
asked for their signed consent to continue the study, and in the event of lack 
thereof, will be discontinued from further participation. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant. A template will be 
provided by the sponsor or its designee. The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template. The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary. Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the countries in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that their 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 their medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained. The authorized person obtaining the informed consent must 
also sign the ICF. 
• Participants must provide consent to the most current version of the ICF during their 
participation in the study. 


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• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
8.1.2. 
Screening Procedures 
Screening is the interval between signing the ICF and the day that the participant is assigned to 
the study cream (Day 1). Screening assessments for determination of eligibility may be 
performed over a period lasting up to 30 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 30 days before Day 1. All information associated with eligibility requirements, 
including demography and medical history, must be entered into the appropriate eCRF pages. 
Results from the screening assessments will be reviewed by the investigators to confirm 
eligibility before Day 1 and application of study cream. Tests results that fail eligibility 
requirements may be repeated once during screening if the investigator believes that the 
participant would be eligible if retested. For screening assessments that are repeated, the most 
recent available result before application of study cream will be used to determine eligibility. 
See Sections 5.4 and 5.5 for information regarding screen failures and replacement of 
participants, respectively. 
8.1.3. 
Interactive Response Technology Procedure 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the 2-letter alpha ISO country code, 3-digit site ID, and 3-digit participant 
number. Site personnel should contact the IRT system to obtain the participant ID number during 
screening. Upon determining that the participant is eligible for study entry, the IRT system will 
be contacted to obtain the study treatment kit assignment. Additionally, the IRT system will be 
contacted at each regular study visit to update the study cream supply. Additional details are 
provided in the IRT Manual. 
8.1.4. 
Distribution of Study Reminder Cards and Diaries 
Starting at the Day 1 visit and each visit thereafter, a study cream–specific diary will be given to 
each participant in order to record use of the study cream. The completed diary will be collected 
during each of the participant's visits. 
Qualified clinical site staff will review the participants' entries for compliance. Participants who 
are noncompliant with their study cream schedule (defined as < 70% or > 130% of the expected 
number of applications between study visits) will have their application instructions reinforced 
by the investigator or a qualified designee. Participants will be considered compliant with the 
treatment regimen if they apply at least 70% but no more than 130% of the expected applications 
during participation in the treatment period of the study. 
Participants will be provided with a reminder card starting on Day 1 and at all visits (through 
Week 48). The reminder card will indicate the date/time of the next visit and will also remind the 
participant that they should have their application at the clinic during the visit under site 
supervision after their blood draws for PK and safety evaluations have been completed. 


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8.1.5. 
Demography and Medical History 
8.1.5.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include year of birth/age, race, ethnicity, medical and surgical 
history, and current illnesses. Medical history will include relevant medical or surgical treatment 
within the last 2 years that are considered to be clinically significant by the investigator. 
8.1.5.2. 
Disease Characteristics and Treatment History 
Vitiligo medical and treatment history, including date of diagnosis, relevant disease 
characteristics, and prior treatments, including systemic treatments, phototherapy, and surgical 
procedures, will be recorded. Medical history of other conditions related to vitiligo will also be 
collected at screening. 
8.2. 
Efficacy Assessments 
8.2.1. 
Body Surface Area 
Total BSA (includes facial and nonfacial areas) depigmented by vitiligo will be estimated at each 
visit. Body surface area assessment will be performed by the Palmar Method. The BSA should 
be estimated to the nearest 0.1%. The approximate size of the participant’s entire palmar surface 
(ie, the palm plus 5 digits) should be considered as 1% BSA, and the approximate size of the 
participant’s thumb should be considered as 0.1% BSA. 
Facial BSA (F-BSA) takes into account the facial depigmented areas as a percentage of the total 
body area. 
Total BSA (T-BSA) takes into account the depigmented areas for each of the following body 
regions: head/neck (including scalp), upper extremities (including axillae), hands, trunk 
(including genitalia), lower extremities (including buttocks), and feet. 
F-BSA and T-BSA will be assessed at visits listed in Table 3 and Table 4. 
8.2.2. 
Vitiligo Area Scoring Index 
Areas affected by depigmentation due to vitiligo will be assessed using the VASI 
(Hamzavi et al 2004). It is based on a composite estimate of the overall area of vitiligo patches at 
baseline and the degree of macular repigmentation within these patches over time. Facial VASI 
is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation. 
The %BSA (hand unit) vitiligo involvement is estimated by the investigator using the Palmar 
Method (see Section 8.2.1). Hand unit is based on participant’s hand size. The investigator uses 
their hand to mimic the participant’s hand size to evaluate %BSA vitiligo involvement. The 
degree of depigmentation for each vitiligo involvement site is determined and estimated to the 
nearest of the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. At 100% 
depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the 
depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented area are 
equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of 
depigmentation are present. The F-VASI is then derived by multiplying the values assessed for 


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the vitiligo involvement by the percentage of affected skin for each site on the face and summing 
the values of all sites together (possible range 0-3). 
The area "face" is defined as including the area on the forehead to the original hairline, on the 
cheek to the jawline vertically, and laterally from the corner of the mouth to the tragus. The area 
"face" will not include surface area of the lips, scalp, ears, or neck but will include the nose and 
eyelids. 
Total body VASI is calculated using a formula that includes contributions from all body regions 
(possible range, 0-100) as follows: 
 
The body is divided into the following 6 separate and mutually exclusive sites: (1) head/neck, 
(2) hands, (3) upper extremities (excluding hands), (4) trunk, (5) lower extremities (excluding 
feet), and (6) feet. The percentage of vitiligo involvement is estimated in hand units (%BSA) by 
the same investigator during the entire course of the study. Hand unit is based on participant’s 
hand size. The investigator uses their hand to mimic the participant’s hand size to evaluate 
%BSA vitiligo involvement. The degree of depigmentation for each body site is determined and 
estimated to the nearest of the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. 
The T-VASI is then derived by multiplying the values assessed for the vitiligo involvement by 
the percentage of affected skin for each body site and summing the values of all body sites 
together. 
F-VASI and T-VASI will be assessed at visits listed in Table 3 and Table 4. Full details on the 
conduct of these assessments will be provided in the Study Manual. 
 
 
 
 
 
 
 
 


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.
 
 
8.2.5. 
Photography 
Photography of the face and/or body areas affected with vitiligo will be obtained at visits listed 
in Table 3 and Table 4. 
All sites will use 2-dimensional photography to photograph areas of the participant’s face 
affected with vitiligo and 2 target nonfacial depigmented areas. 
Target nonfacial vitiligo depigmented area definition: At the screening visit, depigmented 
nonfacial areas that are representative of the participant's overall disease will be selected as 
targeted nonfacial vitiligo depigmented areas. These areas will be assessed, measured, and 
documented in the participant's medical record at each subsequent visit during the study (see 
Table 3 and Table 4). A note should be made in their medical record, and the baseline 
photographs can be marked with the location of the target-depigmented area. The genitalia area 
should not be photographed. 
If photo quality at screening is not adequate, the photography may be repeated on Day 1. The 
baseline photos are defined as the adequate ones either taken at screening or Day 1. 
Ad hoc photography of skin-related AEs is recommended. 
Photographic procedures will be standardized, and a full description of the methodology will be 
provided in a photography manual to be provided to the sites. 
 
 
 
 
 
 
 
 


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8.3. 
Safety Assessments 
Planned timepoints for all safety assessments are provided in Table 3 and Table 4. 
See Section 6.5 for guidelines regarding the management of relevant laboratory or other safety 
assessment abnormalities. 
8.3.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until at least 
30 days after the last application of study cream. Adverse events for enrolled participants 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 cream. Conditions that 
were already present at the time of informed consent should be recorded on the Medical History 
Form in the eCRF. Adverse events (including laboratory abnormalities that constitute AEs) 
should be described using a diagnosis whenever possible rather than by individual underlying 
signs and symptoms. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative). The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following up on AEs that are serious, 
considered related to the study cream/procedures, or that caused the participant to discontinue the 
study cream or NB-UVB. 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 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 timepoints listed in Table 3 and Table 4. 
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 
neurologic examination will also be performed. 


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A targeted physical examination should only 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, a physician's assistant, or an advanced registered nurse practitioner, as local law 
permits. 
8.3.3. 
Vital Signs 
Vital sign measurements will be conducted at the timepoints listed in Table 3 and Table 4. 
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 
Electrocardiograms will be performed at screening or if deemed clinically necessary. 
A single 12-lead ECG will be obtained at screening (12-lead ECG performed within 2 months 
before baseline is acceptable) using an ECG machine that automatically calculates the heart rate 
and measures PR, QRS, QT, and QTc intervals. All 12-lead ECGs will be performed with the 
participant in a recumbent or semirecumbent position after 5 minutes of rest. 
The decision to include or exclude a participant or withdraw a participant from the study 
treatment based on an ECG flagged as "Abnormal, Clinically Significant" is the responsibility of 
the investigator, in consultation with the sponsor's medical monitor, as appropriate. Clinically 
notable abnormalities that are considered clinically significant in the judgment of the investigator 
are to be reported as AEs. 
8.3.5. 
Laboratory Assessments 
Required laboratory tests are listed in Table 13. See Table 3 and Table 4 for timing of 
assessments. Clinical laboratory tests will be performed at a central laboratory (refer to the 
Laboratory Manual for sample handling and shipping instructions). 
Clinically significant abnormal laboratory findings are those that induce clinical signs or 
symptoms, require concomitant therapy, or require changes in study cream or NB-UVB. All 
laboratory tests with values considered clinically significantly abnormal during participation in 
the study, or within 30 days after the last application of study cream, should be repeated until the 
values return to normal or baseline or are no longer considered clinically significant by the 
investigator or medical monitor. 
See Section 9.1 for information regarding laboratory abnormalities that should be recorded as an 
AE in the eCRF. 


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Table 13: 
Required Laboratory Analytes 
Serum Chemistriesa 
Hematology 
Urinalysis 
Serology 
Other 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Bicarbonate 
Blood urea nitrogen 
Calcium 
Chloride 
Creatine kinase 
Creatinine 
Glucose 
Lactate dehydrogenase 
Phosphate 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if total 
bilirubin is elevated 
above ULN) 
Total protein 
Complete blood count, 
including: 
• Hemoglobin 
• Hematocrit 
• Mean corpuscular 
volume (MCV) 
• Platelet count 
• Mean platelet volume 
• Red blood cell count 
• Reticulocyte count 
• White blood cell count 
 
Differential count, 
including: 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
Color and 
appearance 
pH and specific 
gravity 
Bilirubin 
Glucose 
Ketones 
Leukocytes 
Nitrite 
Occult blood 
Protein 
Note: Abnormal 
results should be 
microscopically 
examined. 
HIV antibody 
FSHb 
Free T4 
TSH 
Vitamin D2 and 
D3 
Pregnancy Testing 
Female participants of childbearing potential will 
undergo a serum test at the screening and safety 
follow-up visits. A urine test will be conducted at all 
other visits. A positive urine test will be confirmed by a 
serum test. 
Note: Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data or to rule out a 
diagnosis. 
a All serum chemistries will be performed on samples collected without respect to food intake (ie, nonfasting). 
b FSH is only measured for postmenopausal women (defined by amenorrhea for ≥ 12 months without an alternative medical 
cause before screening); FSH should be in the postmenopausal range to consider the participant of nonchildbearing potential. 


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8.3.5.1. 
Pregnancy Testing 
A serum pregnancy test will be required for all women of childbearing potential during screening 
and at the safety follow-up visit (30 [+ 7] days after EOT). Urine pregnancy tests will be 
conducted as outlined in Table 3 and Table 4, as medically indicated, or per country-specific 
requirement. Urine pregnancy tests will be performed locally. If a urine pregnancy test is 
positive, the result should be confirmed with a serum pregnancy test, which may be performed 
locally. 
If the serum pregnancy test is negative after a urine test was positive, the investigator will assess 
the potential benefit/risk to the participant and determine whether it is in the participant's best 
interest to resume study cream and continue participation in the study. 
If a pregnancy is confirmed by a serum pregnancy test, see Section 9.7 for reporting 
requirements. 
8.3.5.2. 
Serology 
An HIV antibody assessment will be performed at the screening visit to rule out infection 
(see Table 3). Serology tests should be performed early in the screening process due to the length 
of time needed to obtain the results. Additional tests may be performed if clinically indicated. 
8.4. 
Pharmacokinetic Assessments 
Venous blood samples will be collected as indicated in Table 3 and Table 4 to assess the PK of 
ruxolitinib cream in this study population. 
The exact date and time of the PK blood draws and the date and time of the last application of 
study cream before the blood draw (if applicable) will be recorded in the eCRF. 
Instructions for sample preparation and shipping will be provided in the Laboratory Manual. 
Participants will receive reminder cards in advance of the study visit providing instruction to 
hold the application of study cream on the day of the visit and a place to record the time of the 
prior application of study cream. 
Pharmacokinetic blood samples can be collected before application of study cream during study 
visits noted in the Table 3 and Table 4. Blood samples must not be drawn from the area that has 
been treated with study cream. If it is not possible to access an area that is not treated with study 
cream, the site must adequately document this in the eCRF and not take the PK blood sample for 
that visit. After the PK sample is drawn, participants will apply ruxolitinib cream 1.5% at the 
site. 
All analyses will be conducted by Incyte Corporation (Wilmington, DE) or Incyte's designee. 
 
 
 
 
 
 
 


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8.6. 
Unscheduled Visits 
Unscheduled visits may occur at any time at the investigator's discretion, and appropriate clinical 
and laboratory tests may be performed, as clinically indicated. 
8.7. 
End of Treatment and/or Early Termination 
If a decision is made that the participant will permanently discontinue application of study 
cream, the EOT visit should be conducted. If the EOT visit coincides with a regular study visit, 
then the EOT evaluations will supersede those of that scheduled visit, and the data should be 
entered in the EOT page in the eCRF. If this decision does not coincide with a regular visit, 
reasonable efforts should be made to have the participant return to the site to have the EOT 
procedures completed. 
8.8. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit and the scheduled safety 
follow-up visit, which should occur 30 (+ 7) days after the EOT visit (or after the last application 
of study cream if an EOT visit was not performed). 
Adverse events and SAEs must be reported up until at least 30 days after the last application of 
study cream/treatment. Adverse events and SAEs must be followed until toxicities resolve, return 
to baseline, or are deemed irreversible. Reasonable efforts should be made to have the participant 
return for the safety follow-up visit and report any AEs that may occur during this period. 


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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 it is considered drug-related. 
• An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
cream. 
Additional Guidance for 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) are to be reported as an AE. 
• Abnormal laboratory test results are to be reported as an AE if they are considered clinically 
meaningful, induce clinical signs or symptoms, require concomitant therapy, or require changes in 
study cream. Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded in 
the eCRF rather than the abnormal laboratory test result (eg, low hemoglobin, platelet count 
decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition/disease, including either an increase 
in the frequency and/or intensity of the condition, is to be reported as an AE. 
• New conditions detected or diagnosed after the start of study cream application are to be reported as 
an AE. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction are to be reported as 
an AE. 
• Signs and/or symptoms from application errors of a study cream (eg, overdose) or a concomitant 
medication are to be reported as an AE. 
• "Lack of efficacy," "disease progression," or "failure of expected pharmacological action" will not be 
reported as an AE or SAE. Such instances will be captured in the efficacy assessments. 
• A condition that leads to a medical or surgical procedure (eg, endoscopy, appendectomy) will be 
reported as an AE if it occurs after obtaining informed consent. The procedure should also be 
reported in the eCRF. If the condition was present before entering the study, then it should be 
captured as medical history. 
• Pre-existing diseases or conditions with expected fluctuations in signs or symptoms should be 
reported as an AE only if the investigator judges the fluctuation to have worsened more than 
expected during study participation. 
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). 


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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 occurs. 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 (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 or planned surgery (eg, stent replacement, hip surgery) is not 
considered an SAE. 
Hospitalization for medical interventions in which no unfavorable medical occurrence occurred 
(ie, elective procedures or routine medical visits) are not considered SAEs. 
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. Is an important medical event 
An important medical event is 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 new invasive or 
malignant cancers, intensive treatment in an emergency department or at home for allergic 
bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse. Secondary malignancies should always be considered SAEs. 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF. AEs/SAEs should be reported for enrolled participants, but only 
SAEs need to be reported for screen failure participants. For enrolled participants, conditions that 
were present at the time informed consent was given should be recorded on the Medical History 
Form in the eCRF. For detailed information, refer to the eCRF guidelines. 


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• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostic reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records 
in lieu of completing the Adverse Event Form in the eCRF. 
• There may be rare 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 by the 
site staff on the copies of the medical records before submission. These records can be submitted to 
Incyte Pharmacovigilance by email/fax per the contact information listed in the Study Reference 
Manual or as per SAE completing guidelines. 
• 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 following: 
• The severity grade (CTCAE v5.0 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 cream: suspected 
(yes) or not suspected (no). See below for further instructions on the assessment of causality. 
• The start and end dates, unless unresolved at the final safety follow-up visit. 
• The action taken with regard to study cream 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 v5.0 Grades 1 through 5. If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate the 
grade of severity. 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2: Moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate 
activities of daily living. 
• Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4: Life-threatening consequences; urgent treatment indicated. 
• Grade 5: Fatal. 


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Assessment of Causality 
• The investigator is obligated to assess the relationship between study cream and each occurrence of 
each AE/SAE. 
• A "reasonable possibility" of a relationship conveys that there are medical 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 possibility of a relationship. 
• The investigator will also consult the RSI in the IB or Product Information for ruxolitinib cream, or 
marketed products, respectively, in making their assessment. 
• Alternative causes, such as underlying or concurrent disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study cream application, will be 
considered and investigated. 
• For each AE/SAE, the investigator must document in the medical notes that they has reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report. However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements. Therefore, it is very important that 
the investigator always make an assessment of causality based on the available information 
for every event before the initial transmission of the SAE. 
− The investigator may change their opinion of causality in light of follow-up information and 
submit the updated causality assessment. 


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Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible. This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 
• Once an AE is detected, it should be followed in the AE eCRFs 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 cream, 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. 
• If a participant dies during participation in the study or during a recognized follow-up period, the 
investigator will provide the sponsor with a copy of any postmortem findings, including 
histopathology. 
• Updated SAE information will be recorded in the originally completed eCRF and reported to Incyte 
Pharmacovigilance (via the AE and SAE eCRFs in the EDC) until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up. 
• Any updated SAE data (including SAEs being downgraded to nonserious) will be submitted to the 
sponsor (or designee) within 24 hours of receipt of the information. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study cream, study procedures), all SAEs 
occurring after the participant has signed the ICF through the last safety visit or at least 30 days 
after the last application of study cream must be reported to the sponsor (or designee) 
immediately, without undue delay, but not later than within 24 hours of obtaining knowledge of 
its occurrence unless otherwise specified by the Protocol. The investigator will submit any 
updated SAE data to the sponsor (or designee) immediately, without undue delay, but not later 
than within 24 hours of it being available. 
Investigators are not obligated to actively seek SAE information after the safety follow-up visit 
or 30 days after the last application of study cream. If the investigator learns of any SAE, 
including death, at any time during this period, and the event is considered to be reasonably 
related to the study cream 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 regarding an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a study 
cream under clinical investigation are met. 
If the SAE is not documented in the RSI of the IB for the study cream (new occurrence) and is 
thought to be related to the study cream, the sponsor or its designee may urgently require further 
information from the investigator for expedited reporting to health authorities. The sponsor or its 


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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 cream under clinical investigation. The sponsor 
will comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must report within 24 hours of learning of its occurrence any SAE via the EDC 
system (primary method) or by completing the Serious Adverse Event Report Form in English (only 
if the EDC system is not available). The contact information for Incyte Pharmacovigilance by 
email/fax is listed in the Study Reference Manual or as per the Incyte Reference Guide for 
Completing the Serious Adverse Event Report Form. 
• In circumstances where the EDC system is not accessible for reporting SAE information (initial 
and/or follow-up SAE information) to the sponsor within 24 hours, refer to the Incyte Reference 
Guide for Completing the Serious Adverse Report Form. Once the EDC system is functional, the 
SAE report should be retrospectively added to the EDC system and follow-up should be completed 
through the EDC. The original copy of the Serious Adverse Event Report Form and the email or 
facsimile confirmation sheet must be kept at the study site (refer to the Incyte Reference Guide for 
Completing the Serious Adverse Event Report Form or Study Reference Manual for details and for 
the email address or fax number). 
• Follow-up information is also recorded in the eCRF and transmitted to Incyte Pharmacovigilance via 
the EDC system. The follow-up report should include information that was not provided previously, 
such as the outcome of the event, treatment provided, action taken with study cream because of the 
SAE (eg, application amount 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. 
9.5. 
Events of Clinical Interest 
Not applicable. 
9.6. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 


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9.7. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that the study 
cream may have interfered with the effectiveness of a contraceptive medication or method. When 
a pregnancy has been confirmed in a participant during maternal or paternal exposure to study 
cream, the following procedures should be followed in order to ensure safety: 
• The study cream must be discontinued immediately (female participants only). 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation. 
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit. Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee. Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study cream 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 or Study Reference Manual. 
Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or its designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4 . If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.8. 
Warnings and Precautions 
Special warnings or precautions for the study cream, 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. 
9.9. 
Product Complaints 
The sponsor collects product complaints on study cream and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor. All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 


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The investigator or their 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, they will return a copy of the 
product complaint communication with the product. 
9.10. 
Treatment of Overdose 
There has been no clinical experience with overdose of ruxolitinib cream. Treatment of overdose 
should consist of general supportive measures. 
NB-UVB can result in skin burning similar to sunlight. If the participant experiences skin 
burning from the NB-UVB device, they should apply emollients and contact the study site for 
instructions on how to treat the skin reaction. 


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10. 
STATISTICS 
10.1. 
Sample Size Determination 
Due to the exploratory nature of the study, there will be no statistical hypothesis test between the 
2 treatment groups, and the sample size is not based on statistical power calculations. The sample 
size is considered to be sufficient to obtain adequate efficacy, safety, tolerability, and PK data to 
achieve the objectives of the study. 
10.2. 
Populations for Analysis 
Table 14 presents the populations for analysis. 
Table 14: 
Populations for Analysis 
Population 
Description 
FAS 
The FAS includes all participants enrolled in the study who applied study cream 
at least once. The FAS will be used for the summary of demographics, baseline 
characteristics, participant disposition, and analyses of all efficacy and safety 
data.  
PK evaluable 
The PK evaluable population includes participants who applied study cream at 
least once and provided at least 1 postapplication blood sample for PK. The study 
pharmacokineticist will review data listings of participant application and sample 
records to identify participants to be excluded from the analysis. 
Pharmacodynamic 
evaluable 
The pharmacodynamic evaluable population includes participants who applied 
study cream at least once and provided at least 1 postapplication blood sample for 
translational assessment. The study translational scientist will review data listings 
of participant application and sample records to identify participants to be 
excluded from the analysis. 
10.3. 
Level of Significance 
This is an exploratory study, and no formal statistical tests will be performed. All confidence 
intervals will be 95%. 
10.4. 
Statistical Analyses 
The Statistical Analysis Plan will be developed and finalized before database lock and will 
describe the details of the statistical analyses and procedures for accounting for missing data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints. 


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10.4.1. 
Efficacy Analysis 
All efficacy assessments will be summarized using descriptive statistics at each visit for FAS. 
10.4.1.1. Analysis of Primary Efficacy Analysis 
The primary efficacy endpoint is the change from baseline in T-VASI at Week 48. For the 
primary endpoint, summary statistics will include sample size, mean, median, standard deviation, 
minimum, maximum, and the 95% confidence interval. 
10.4.1.2. Analysis of Secondary Efficacy Endpoints 
10.4.1.2.1. Continuous Efficacy Endpoints 
By-visit summary statistics for the following continuous measurements, including actual 
measurement, change from baseline, and percentage change from baseline, will be presented: 
• F-VASI/T-VASI 
• F-BSA/T-BSA 
Summary statistics, including sample size, mean, median, standard deviation, minimum, 
maximum, first quartile, third quartile, and 95% CI, will be presented by visits. 
10.4.1.2.2. Categorical Efficacy Endpoints 
For the following categorical parameters, summary statistics will include sample size, frequency, 
percentages and standard error of percentage, and the 95% confidence interval at each visit. 
• Proportion of participants achieving F-VASI50/75/90 
• Proportion of participants achieving T-VASI50/75/90 
10.4.2. 
Safety Analysis 
Safety is being evaluated as a secondary objective in this study. Safety analyses will be 
conducted using the safety population and are summarized in Table 15. 


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Table 15: 
Safety Analyses 
Endpoint 
Statistical Analysis Methods 
Secondary 
Adverse Events 
A TEAE is any AE either reported for the first time or worsening of a pre-existing 
event after first application of study cream. Analysis of AEs will be limited to 
TEAEs, but data listings will include all AEs regardless of their timing to study 
cream application. Adverse events will be coded using MedDRA and tabulated by 
preferred term and system organ class. Severity of AEs will be based on the 
CTCAE v5.0 using Grades 1 through 5. 
The subset of AEs considered by the investigator to have a relationship to study 
cream will be considered to be treatment-related AEs. If the investigator does not 
specify the relationship of the AE to study cream, then the AE will be considered 
treatment-related. The incidence of AEs and treatment-related AEs will be tabulated. 
Clinical Laboratory Tests 
Actual values and changes from baseline in clinical laboratory test results will be 
summarized using descriptive statistics. Laboratory test values outside the normal 
range will be assessed for severity based on the normal ranges for the clinical 
reference laboratory. The incidence of abnormal laboratory values will be tabulated. 
Laboratory data will be classified into Grades 1 through 5 using CTCAE v5.0. 
Shift tables from baseline to the worst postbaseline value using CTCAE grade will be 
tabulated. 
Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital 
signs (blood pressure, pulse, respiratory rate, and body temperature) at each 
assessment time. 
10.4.3. 
Other Analyses 
Pharmacokinetic endpoints are listed in Section 8.4. Pharmacokinetic analyses will be performed 
using the PK evaluable population. The INCB018424 plasma concentration data will be analyzed 
by descriptive summary analysis. 
Translational endpoints are listed in Section 8.5. Details of translational analyses will be 
provided in the Statistical Analysis Plan. 
10.5. 
Interim Analysis 
No formal interim analysis is planned in this study. 


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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC and Health Authorities, before the study is 
initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require approval from both Health Authorities 
and IRB/IEC before implementation of changes made to the study design, except for 
changes necessary to eliminate an immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC. Each investigator is responsible for enrolling participants who have met the 
specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study without 
receiving approval from the sponsor. The investigator must notify the sponsor or 
its designee in the event of accidental loss or destruction of any study records. If 
the investigator leaves the institution where the study was conducted, the sponsor 
or its designee must be contacted to arrange alternative record storage options. 


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− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations. 
The sponsor will retain the original eCRF data and audit trail. 
11.1.1. 
Identification of the Coordinating Principal Investigator 
A coordinating principal investigator will be appointed by the sponsor before the end of the 
study. As part of his or her responsibilities, the coordinating principal investigator will review 
the final CSR. Agreement with the final CSR will be documented by the dated signature of the 
coordinating principal investigator. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system. The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided with eCRF completion guidelines for instructions on data entry in the 
eCRF. The study monitor will reference the Monitoring Plan in order to ensure that each issue 
identified is appropriately documented, reported, and resolved in a timely manner in accordance 
with the plan's requirements. Other data outside the EDC system required in the study conduct of 
the Protocol such as documents or results transmitted to the sponsor via a central laboratory or 
specialized technical vendors and, as designated by the sponsor, will have their own data flow 
management plans, study charters, or 
, as applicable. 
The sponsor (or designee) will be responsible for: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved Protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Managing and reconciling the data generated, and/or collected including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 
The investigator will be responsible for: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, 
, photographs, diary data), 
or as otherwise specified in the Protocol. 
• Maintaining adequate and accurate source documents and trial records that include all 
pertinent observations on each of the site's trial participants. Source data should be 


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attributable, legible, contemporaneous, original, accurate, and complete. Changes to 
source data should be traceable, should not obscure the original entry, and should be 
explained if necessary (eg, via an audit trail). Source data are in general all 
information in original records and certified copies of original records of clinical 
findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial. Source data are contained in source 
documents (original records or certified copies). 
• 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, or sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed and 
available at the investigator's site. Examples of source documents are original 
documents, data, and records (eg, hospital records, electronic hospital records, 
clinical and office charts, laboratory notes, memoranda, participants' diaries or 
evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, copies or transcriptions certified after verification as being 
accurate copies, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, participants' files, and e-records/records kept at the pharmacy, at 
the laboratories and at medico-technical departments involved in the clinical 
trial). 
− Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, 
depending on the study. Current applicable medical records must be available. 
• Sending participants' data, either as unique samples, or copies, or photographs, to be 
evaluated centrally or analyzed centrally, or both, by a qualified vendor designated by 
the sponsor. 
• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring: Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan. The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 
− Auditing: Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct. The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 


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− Regulatory inspection: Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product. The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents. The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data protection laws 
and regulations. The investigator and the sponsor or its designee are responsible for ensuring that 
sensitive personal information is handled in accordance with local data protection laws 
(including but not limited to HIPAA and GDPR) as applicable. Appropriate consent for 
collection, use and disclosure and/or transfer (if applicable) of personal information must be 
obtained in accordance with local data protection laws. 
Participant names will not be supplied to the sponsor or its designee. Only the participant number 
will be recorded in the eCRF; if the participant's name appears on any other document (eg, 
laboratory report), it must be obliterated on the copy of the document to be supplied to the 
sponsor or its designee. Study findings stored on a computer will be stored in accordance with 
appropriate technical and organizational measures as required by local data protection laws. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for 10 years after study completion unless local regulations require 
otherwise. No records may be destroyed during the retention period without the written approval 
of the sponsor. No records may be transferred to another location or party without written 
notification to the sponsor. 
11.4. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure form that 
sufficiently details any financial interests and arrangements that apply. For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator. These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Investigator Financial Disclosure Form. During a covered clinical study, any 
changes to the financial information previously reported by a clinical investigator must be 
reported to the sponsor or its designee. At the conclusion of the covered clinical study, the 
clinical investigators will be reminded of their obligations. In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 


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11.5. 
Publication Policy 
By signing the study Protocol, the investigator and their 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 or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the Protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study treatment development. 


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12. 
REFERENCES 
American Academy of Dermatology. Vitiligo: diagnosis and treatment. 
https://www.aad.org/public/diseases/a-z/vitiligo-treatment. 
 
 
 
Castanet J, Ortonne JP. Pathophysiology of vitiligo. Clin Dermatol 1997;15:845-851. 
Centers for Disease Control and Prevention. BMI percentile calculator for child and teen. 
https://www.cdc.gov/healthyweight/bmi/calculator.html. 
Gawkrodger DJ, Ormerod AD, Shaw L, et al. Guideline for the diagnosis and management of 
vitiligo. Br J Dermatol 2008;159:1051-1076. 
Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband 
UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. 
Arch Dermatol 2004;140:677-683. 
Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in 
children/adolescents and adults. Int J Dermatol 2012;51:1206-1212. 
 
 
Mohammad TF, Al-Jamal M, Hamzavi IH, et al. The vitiligo working group recommendations 
for narrowband ultraviolet B light phototherapy treatment of vitiligo. J Am Acad Dermatol 
2017;76:879-888. 
Pandya AG, Harris JE, Lebwohl M, et al. Addition of narrow-band ultraviolet light B 
phototherapy to ruxolitinib cream in patients with vitiligo. Poster presented at the American 
Academy of Dermatology Virtual Meeting Experience, April 23–25, 2021, Poster 27636. 
Ruxolitinib Cream Investigator's Brochure, Wilmington, DE: Incyte Corporation. 
Silverberg JI, Silverberg NB. Association between vitiligo extent and distribution and 
quality-of-life impairment. JAMA Dermatol 2013;149:159-164. 
Taieb A, Alomar A, Böhm M, et al. Guidelines for the management of vitiligo: the European 
Dermatology Forum consensus. Br J Dermatol 2013;168:5-19. 
 
 
Vitiligo Research Foundation. Treatment Guidelines. 
https://vrfoundation.org/treatment_guidelines. 
 
 
World Health Organization. WHO Model Prescribing Information: Drugs Used in Skin Diseases. 
Geneva, Switzerland: World Health Organization 1997. 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS AND DEFINITIONS 
Definitions 
WOCBP: A woman who is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below) 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal with 1 of the following:a 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
• Postmenopausal 
− A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 
o A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in 
women not using hormonal contraception or HRT. However, in the absence of 12 months of 
amenorrhea, confirmation with 2 FSH measurements in the postmenopausal range is required. 
− Females on HRT and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, 
highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, 
they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. 
For male participants of reproductive potentialb 
The following methods during the Protocol-defined timeframe in Section 5.1 are highly effective: 
• Use of a male condom plus partner use of an additional contraceptive method when having penile-vaginal 
intercourse with a woman of childbearing potential who is not currently pregnant. 
• Vasectomy with medical assessment of the surgical success (verified by site personnel's review of the 
participant's medical records) 
• Sexual abstinencec 
−  Abstinence from penile-vaginal intercourse 
The following are not acceptable methods of contraception: 
• Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhoea method. 
• Male condom with cap, diaphragm, or sponge with spermicide. 
• Male and female condom used together. 
Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal 
intercourse or use a male condom during each episode of penile penetration.  


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For female participants who are WOCBP 
The following methods during the Protocol-defined timeframe in Section 5.1 that can achieve a failure rate of less 
than 1% per year when used consistently and correctly are considered as highly effective birth control methods: 
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of 
ovulation.d 
− oral 
− intravaginal 
− transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulationd 
− oral 
− injectable 
− implantablee 
• Intrauterine devicee 
• Intrauterine hormone-releasing systeme 
• Bilateral tubal occlusione 
• Vasectomized partnere,f 
• Sexual abstinencec 
a Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical 
history interview. 
b If the male participant has a partner with childbearing potential the partner should also use contraceptives. 
c In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the 
participant. 
d Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may reduce the 
efficacy of the contraception method. 
e Contraception methods that in the context of this guidance are considered to have low user dependency. 
f Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual partner of the 
WOCBP study participant and that the vasectomized partner has received medical assessment of the surgical success. 
Source: Clinical Trials Facilitation and Coordination Group (2020). 


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APPENDIX B. INSTRUCTION TO PARTICIPANTS FOR HANDLING 
RUXOLITINIB CREAM 
The participant must be instructed in the handling of study cream as follows: 
• Store study cream at room temperature. 
• Make every effort to apply study cream on schedule. 
• Report any missed applications. 
• Keep study cream in a safe place and out of reach of children. 
• Bring all used and unused study cream tubes to the site at each visit. 
• Remove study cream from the tube in fingertip units until all of the areas to be treated 
are covered by a thin film. 
• Do not apply study cream on visit days as it will be applied at the site under 
supervision of the site staff. 
• Do not use more than 1 tube (60 g) per week. 
• Emollients, sunscreen, or camouflage makeups should not be used within 2 hours 
after study cream application. 
• Do not apply study cream over sunscreen or camouflage makeup. These must be 
removed from the skin before application of the study cream. Any makeup remover 
must then be washed off and the skin dried before application of the study cream. 
• Participants should not take baths or showers within 2 hours after study cream 
application. 


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APPENDIX C. COVID-19 PANDEMIC MITIGATION STRATEGIES AND 
INSTRUCTIONS 
The COVID-19 global pandemic presents numerous challenges to the ongoing conduct of 
clinical trials. In line with the European Medicines Agency Guidelines on the Management of 
Clinical Trials During the COVID-19 (Coronavirus) Pandemic (2020), the sponsor has issued the 
following Protocol considerations to ensure participant safety is maintained and adequate 
benefit/risk analyses are applied relative to the completion of study procedures and maintaining 
the investigational product supply chain. 
Recognizing the flexibility required to manage the impact of the pandemic on this clinical trial, 
additional details will be added to respective study manuals and project plan documents and 
communicated to the investigative sites as needed. 
Study Site Visits 
If local travel restrictions, isolation requirements, or the investigator's benefit/risk assessment 
determines it to be unsafe for participants to attend study visits at the investigational site, the site 
staff may elect to pursue the following: 
• In order to minimize participant risk, study visits (except Day 1, Week 4, Week 12, 
and Week 16 visits) may be conducted via telemedicine modalities (phone or video). 
At a minimum, a review of AEs, concomitant medications, and study drug 
compliance must be completed. Periodic on-site visits should be conducted whenever 
feasible. The physician efficacy assessments must not be conducted by phone or 
video. 
• Day 1, Week 4, and Week 16 visits must be conducted in person in their entirety 
because translational samples and physician efficacy assessments must be conducted 
in person. Also, the Week 12 visit must be conducted in person, as this is the 
assessment for possible addition of NB-UVB phototherapy. These visits cannot be 
missed or conducted remotely. The investigator should document visit-window 
deviations in the eCRF if necessary. If an out-of-window deviation is significant 
(ie, > 4 weeks out-of-window), the investigator should contact the sponsor for 
discussion and further instructions. 
Investigational Medicinal Product Dispensing and Distribution 
In order to ensure the continuity of providing their participants' clinical supplies within the 
constraints imparted by the pandemic, the site staff can decide to supply study drug to 
participants. Adequate supplies of study drug as determined by the investigator can be shipped to 
the participants by the investigator or appropriately delegated staff (eg, the study pharmacy staff) 
using a third-party service if duly authorized by the participant. The study site may use their own 
preferred courier, provided the courier adheres to certain standards (eg, use of personal 
protection equipment, maintenance of temperature-controlled transit environment), or one 
centrally contracted by the sponsor. 
Clinical Trial Monitoring 
Study monitoring visits may be postponed; however, the site monitor will continue to employ 
off-site monitoring practices such as routine communication methods (eg, phone calls, emails, 


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video visits) with the sites to get information on trial progress, participant status, and information 
on issue resolution. The study monitor may remotely review data entered into the EDC for 
accuracy and completeness. Remote source data verification may be implemented with 
agreement of the principal investigator and institution, as applicable. 
If the study-site monitor cannot be on-site to perform the final drug accountability for 
reconciliation purposes, and the operation cannot be postponed, it may be performed by a 
pharmacist from the hospital pharmacy or by the study coordinator/data manager with suitable 
training. The study drug can be returned to the sponsor by the hospital pharmacy directly, or it 
can be destroyed in accordance with local practices, if applicable, and with sponsor approval. 


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APPENDIX D. WHO CLASSIFICATION OF TOPICAL 
CORTICOSTEROIDS 
Hydrocortisone and betamethasone are examples of low- and high-potency topical 
corticosteroids. Topical corticosteroids have been ranked in terms of potency into 4 groups 
consisting of 7 classes. Class I topical corticosteroids are the most potent, and Class VII are the 
least potent. Efficacy and side effects are greatest with the Class I ultra-high–potency 
preparations, which should only be used for limited time periods (2-3 weeks). Representative 
preparations by group are listed in the table below. These groups may vary depending on the 
formulation and concentration and should be considered approximate. In general, ointments are 
more potent than creams or lotions. Potency is also increased when topical corticosteroids are 
used under occlusive dressings or in intertriginous areas. 
Potency 
Class 
Topical Corticosteroid 
Formulation 
Ultra high 
I 
Clobetasol propionate 
Cream, 0.05% 
Diflorasone diacetate 
Ointment, 0.05% 
High 
II 
Amcinonide 
Ointment, 0.1% 
Betamethasone dipropionate 
Ointment, 0.05% 
Desoximetasone 
Cream or ointment, 0.025% 
Fluocinonide 
Cream, ointment or gel, 0.05% 
Halcinonide 
Cream, 0.1% 
III 
Betamethasone dipropionate 
Cream, 0.05% 
Betamethasone valerate 
Ointment, 0.1% 
Diflorasone diacetate 
Cream, 0.05% 
Triamcinolone acetonide 
Ointment, 0.1% 
Moderate 
IV 
Desoximetasone 
Cream, 0.05% 
Fluocinolone acetonide 
Ointment, 0.025% 
Fludroxycortide 
Ointment, 0.05% 
Hydrocortisone valerate 
Ointment, 0.2% 
Triamcinolone acetonide 
Cream, 0.1% 
V 
Betamethasone dipropionate 
Lotion, 0.02% 
Betamethasone valerate 
Cream, 0.1% 
Fluocinolone acetonide 
Cream, 0.025% 
Fludroxycortide 
Cream, 0.05% 
Hydrocortisone butyrate 
Cream, 0.1% 
Hydrocortisone valerate 
Cream, 0.2% 
Triamcinolone acetonide 
Lotion, 0.1% 
Low 
VI 
Betamethasone valerate 
Lotion, 0.05% 
Desonide 
Cream, 0.05% 
Fluocinolone acetonide 
Solution, 0.01% 
VII 
Dexamethasone sodium phosphate 
Cream, 0.1% 
Hydrocortisone acetate 
Cream, 1% 
Methylprednisolone acetate 
Cream, 0.25% 
Source: WHO 1997. 


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APPENDIX E. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Not applicable. 


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SAP_001.pdf: 
Official Title: 
 A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band 
Ultraviolet B Phototherapy in Participants With Vitiligo 
NCT Number: 
NCT05247489 
Document 
Date:  
Statistical Analysis Plan Original Version: 10 May 2023


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Statistical Analysis Plan 
TITLE PAGE 
 
INCB 18424-217 
A Safety and Efficacy Study of Ruxolitinib Cream Combined With 
Narrow-Band Ultraviolet B Phototherapy in Participants With 
Vitiligo 
IND Number: 
77,101 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
United States 
Protocol Version: 
Protocol dated 30 SEP 2021 
CRF Approval Date: 
18 FEB 2022 
SAP Version: 
Original 
SAP Author: 
 
 Biostatistics  
Date of Plan: 
10 MAY 2023 
 
 
 
 
 
 
 
 
This study is being conducted in compliance with Good Clinical Practice,  
including the archiving of essential documents. 


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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
TABLE OF CONTENTS .................................................................................................................2 
LIST OF ABBREVIATIONS ..........................................................................................................6 
1. 
INTRODUCTION ........................................................................................................8 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................8 
2.1. 
Protocol and Case Report Form Version ......................................................................8 
2.2. 
Objectives and Endpoints .............................................................................................8 
3. 
STUDY DESIGN .......................................................................................................10 
3.1. 
Randomization ............................................................................................................10 
3.2. 
Control of Type I Error ...............................................................................................10 
3.3. 
Sample Size Considerations .......................................................................................10 
3.4. 
Schedule of Assessments ............................................................................................11 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................12 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................12 
4.1.1. 
Day 1 ...........................................................................................................................12 
4.1.2. 
Study Day ...................................................................................................................12 
4.1.3. 
Baseline Value ............................................................................................................12 
4.1.4. 
Handling of Missing and Incomplete Data .................................................................12 
4.2. 
Variable Definitions ....................................................................................................12 
4.2.1. 
Body Mass Index ........................................................................................................12 
4.2.2. 
Prior and Concomitant Medication .............................................................................13 
5. 
STATISTICAL METHODOLOGY ...........................................................................14 
5.1. 
General Methodology .................................................................................................14 
5.2. 
Treatment Groups .......................................................................................................14 
5.3. 
Analysis Populations ..................................................................................................14 
5.3.1. 
All-Screened Population .............................................................................................14 
5.3.2. 
Full Analysis Set .........................................................................................................14 
5.3.3. 
Pharmacokinetic-Evaluable Population ......................................................................14 
5.3.4. 
Pharmacodynamic-Evaluable Population ...................................................................14 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................15 
6.1. 
Demographics, Baseline Characteristics, and Disease History ..................................15 


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6.1.1. 
Demographics and Baseline Characteristics ...............................................................15 
6.1.2. 
Baseline Disease Characteristics and Disease History ...............................................15 
6.1.3. 
Prior Medication for Vitiligo ......................................................................................15 
6.1.4. 
Medical History ..........................................................................................................16 
6.2. 
Disposition of Participants ..........................................................................................16 
6.3. 
Protocol Deviations ....................................................................................................16 
6.4. 
Exposure .....................................................................................................................16 
6.5. 
Study Drug Compliance .............................................................................................16 
6.6. 
NB-UVB Machine Compliance ..................................................................................16 
6.7. 
Prior and Concomitant Medication .............................................................................16 
7. 
EFFICACY .................................................................................................................17 
7.1. 
General Considerations ...............................................................................................17 
7.2. 
Efficacy Measures ......................................................................................................17 
7.2.1. 
Body Surface Area ......................................................................................................17 
7.2.2. 
Vitiligo Area Scoring Index ........................................................................................17 
 
18 
 
18 
 
19 
 
19 
 
20 
 
20 
 
20 
 
20 
 
21 
 
21 
7.3. 
Efficacy Analysis ........................................................................................................21 
7.3.1. 
Primary Efficacy Analysis ..........................................................................................21 
7.3.2. 
Secondary and 
 Efficacy Analysis ...........................................................21 
7.3.2.1. 
Continuous Efficacy Endpoints ..................................................................................21 
7.3.2.2. 
Categorical Efficacy Endpoints ..................................................................................22 
8. 
PHARMACOKINETICSAND PHARMACODYNAMICS ......................................23 
8.1. 
Pharmacokinetic Analyses ..........................................................................................23 
 
23 


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8.3. 
Pharmacokinetic/Pharmacodynamic Analyses ...........................................................23 
9. 
SAFETY AND TOLERABILITY ..............................................................................23 
9.1. 
General Considerations ...............................................................................................23 
9.2. 
Adverse Events ...........................................................................................................23 
9.2.1. 
Adverse Event Definitions ..........................................................................................23 
9.2.2. 
Adverse Event Summaries ..........................................................................................24 
9.3. 
Clinical Laboratory Tests ...........................................................................................25 
9.3.1. 
Laboratory Value Definitions .....................................................................................25 
9.3.2. 
Laboratory Value Summaries .....................................................................................25 
9.4. 
Vital Signs ..................................................................................................................25 
10. 
INTERIM ANALYSES ..............................................................................................26 
11. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................26 
11.1. 
Changes to Protocol-Defined Analyses ......................................................................26 
11.2. 
Changes to the Statistical Analysis Plan .....................................................................26 
12. 
REFERENCES ...........................................................................................................27 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ........................................28 
 


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LIST OF TABLES 
Table 1: 
Objectives and Endpoints .............................................................................................8 
Table 2: 
Facial Physician's Global Vitiligo Assessment Scale .................................................18 
Table 3: 
Total Body Physician's Global Vitiligo Assessment Scale ........................................19 
Table 4: 
Criteria for Clinically Notable Vital Sign Abnormalities for ≥ 18 Years Old ............26 
Table 5: 
Statistical Analysis Plan Versions ..............................................................................26 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schema .................................................................................................10 
 


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LIST OF ABBREVIATIONS 
Abbreviation 
Term 
AE 
adverse event 
ASR 
application site reaction 
BID 
twice daily 
BMI 
body mass index 
BSA 
body surface area 
CI 
confidence interval 
CRF 
case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
eCRF 
electronic case report form 
FAS 
full analysis set 
F-BSA 
facial body surface area 
 
 
 
 
F-VASI 
Face Vitiligo Area Scoring Index 
F-VASI50/75/90 
≥ 50%/75%/90% improvement from baseline in Face Vitiligo Area Scoring 
Index score 
MedDRA 
Medical Dictionary for Regulatory Activities 
NB-UVB 
narrow-band ultraviolet B 
NCI 
National Cancer Institute 
 
 
PD 
pharmacodynamics(s)  
  
 
PK 
pharmacokinetic(s) 
PT 
preferred term 
SAP 
Statistical Analysis Plan 
SOC 
system organ class 
T-BSA 
total body surface area 
TEAE 
treatment-emergent adverse event 
 
 
 
 
T-VASI 
total body Vitiligo Area Scoring Index 
T-
VASI25/50/75/90 
≥ 25%/50%/75%/90% improvement from baseline in total body Vitiligo Area 
Scoring Index score 
VASI 
Vitiligo Area Scoring Index 
 
 


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Abbreviation 
Term 
 
 
WHO 
World Health Organization 
 
 


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1. 
INTRODUCTION 
This is an open-label study in which participants will apply ruxolitinib 1.5% cream BID to all 
depigmented areas (ie, up to 10% BSA) for up to 48 weeks. Participants will continue to treat 
depigmented areas identified for treatment at baseline regardless of whether the area begins to 
improve or fully repigment. 
On Day 1, all participants will apply ruxolitinib 1.5% cream BID as monotherapy. At Week 12, 
participants will apply ruxolitinib 1.5% cream alone or in combination with NB-UVB, the latter 
of which is based on improvement in T-VASI score. Participants who have < T-VASI25 will 
have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen (Group A); this 
team will be given NB-UVB phototherapy 3 times per week through Week 48 (ie, 36 weeks). 
Participants who have ≥ T-VASI25 at Week 12 will continue on-treatment with ruxolitinib 1.5% 
cream BID alone (Group B). 
Following the last application of ruxolitinib 1.5% cream alone or in combination with NB-UVB 
at Week 48, there will be a 30-day safety follow-up period. 
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the INCB 18424-217 Protocol. The scope of this plan will be executed by the Department of 
Biostatistics or designee, and the analyses of PK and PD will be executed by the Department of 
Clinical Pharmacokinetics or designee in this SAP. 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCB 18424-217 Protocol dated 30 SEP 2021 and CRF approved 
18 FEB 2022. Unless superseded by an amendment, this SAP will be effective for all subsequent 
Protocol Amendments and CRF versions. 
2.2. 
Objectives and Endpoints 
Table 1 presents the objectives and endpoints. 
Table 1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To evaluate the efficacy of ruxolitinib cream in 
combination with NB-UVB in participants with 
vitiligo. 
• Change from baseline in T-VASI at Week 48. 
Secondary 
To evaluate the safety and tolerability of 
ruxolitinib cream in combination with NB-UVB. 
• Occurrence of AEs and evaluation of vital signs and 
laboratory data. 


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Table 1: 
Objectives and Endpoints (Continued) 
Objectives 
Endpoints 
To further evaluate the efficacy of ruxolitinib 
cream in combination with NB-UVB in 
participants with vitiligo. 
• Proportion of participants achieving F-VASI50/75/90 at 
each postbaseline visit. 
• Proportion of participants achieving T-VASI50/75/90 at 
each postbaseline visit. 
• Change and percentage change from baseline in 
F-VASI/T-VASI at each postbaseline visit. 
• Change and percentage change from baseline in 
F-BSA/T-BSA at each postbaseline visit. 
To evaluate the ruxolitinib PK in plasma after 
treatment with ruxolitinib cream in combination 
with NB-UVB. 
• Population-based (trough) plasma concentrations of 
ruxolitinib at Weeks 4, 12, and 16. 


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3. 
STUDY DESIGN 
This is an open-label study in which participants will apply ruxolitinib 1.5% cream BID to all 
depigmented areas (up to 10% BSA) for up to 48 weeks. Participants will continue to treat 
depigmented areas identified for treatment at baseline regardless of whether the area begins to 
improve or fully repigment. 
On Day 1, all participants will apply ruxolitinib 1.5% cream BID as monotherapy (see Figure 1). 
At Week 12, participants will apply ruxolitinib 1.5% cream BID alone or in combination with 
NB-UVB based on their T-VASI score. Participants who have < T-VASI25 will have NB-UVB 
phototherapy added to their ruxolitinib 1.5% cream BID regimen (Group A). The NB-UVB 
phototherapy will be given 3 times per week through Week 48 (ie, 36 weeks). Participants who 
have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone (Group B). 
The study schema is shown below in Figure 1. All participants will have follow-up assessments 
30 (+7) days after the last application of study drug. 
Figure 1: 
Study Design Schema 
 
3.1. 
Randomization 
Not applicable. 
3.2. 
Control of Type I Error 
All statistical analyses for efficacy endpoints are exploratory in nature. No alpha control will be 
implemented. Unless otherwise specified, all CIs provided will be at the 95% confidence level. 
3.3. 
Sample Size Considerations 
Due to the exploratory nature of the study, the sample size is not based on calculation of 
statistical power. The sample size is considered to be sufficient to obtain adequate efficacy, 
safety, tolerability, and PK data to achieve the objectives of the study. 
Approximately 50 participants will receive ruxolitinib 1.5% cream BID for 12 weeks. At 
Week 12, participants will be assigned to ruxolitinib cream 1.5% BID alone or in combination 
with NB-UVB phototherapy based on their T-VASI score. 


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3.4. 
Schedule of Assessments 
Refer to the Protocol dated 30 SEP 2021 for a full description of all study procedures and 
assessment schedules for this study. 


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4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Day 1 
Day 1 is the date that the first application of ruxolitinib cream is administered to participants in 
the specific period. 
4.1.2. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as follows: 
Day # = (visit/reporting date – Day 1 date + 1). 
If the visit/reporting date is before Day 1, then the study day at the visit/reporting date will be 
calculated as follows: 
Day # = (visit/reporting date – Day 1 date). 
A study day of −1 indicates 1 day before Day 1. 
4.1.3. 
Baseline Value 
Baseline is the last nonmissing measurement obtained before (or on) the day of first application 
of ruxolitinib cream. 
4.1.4. 
Handling of Missing and Incomplete Data 
In general, values for missing data will not be imputed unless methods for handling missing data 
are specified in this section or relevant sections. The original reported dates collected on the 
eCRF should be used in all relevant listings. The following rules will be used for handling partial 
dates for analyses requiring dates. 
4.2. 
Variable Definitions 
4.2.1. 
Body Mass Index 
Body mass index will be calculated as follows: 
BMI (kg/m2) = [weight (kg)] / [height (m)]2. 


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4.2.2. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before the first application of 
ruxolitinib cream 1.5%. 
Concomitant medication is defined as any nonstudy medication that is started accordingly: 
• Before the date of first application of ruxolitinib cream 1.5% and is ongoing 
throughout the study or ends on/after the date of first application of study treatment. 
• On/after the date of first application of ruxolitinib cream 1.5% and is ongoing or ends 
during the course of study treatment. 
A prior medication could also be classified as "both prior and concomitant medication," if the end 
date is on or after the first application of ruxolitinib cream 1.5%. In the listing, it will be indicated 
whether a medication is prior-only, concomitant-only, or both prior and concomitant. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant. 


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5. 
STATISTICAL METHODOLOGY 
5.1. 
General Methodology 
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9.1 or later) will be used 
for the generation of all tables, graphs, and statistical analyses. Descriptive summaries for 
continuous variables will include, but not be limited to, the number of observations, mean, 
standard deviation, median, minimum, maximum, first quartile, third quartile, and 95% CI. 
Descriptive summaries for categorical variables will include the number and percentage of 
participants in each category. 
5.2. 
Treatment Groups 
This is an open-label study composed of a 48-week treatment period, including a 12-week 
treatment run-in. During the 12-week run-in, all participants will apply ruxolitinib 1.5% cream 
BID. Following these 12 weeks, participants will receive either ruxolitinib 1.5% cream BID 
alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks. Participant 
groups were determined based on their T-VASI score at Week 12. Data will be summarized 
based on the treatments that the participant received. 
5.3. 
Analysis Populations 
5.3.1. 
All-Screened Population 
The all-screened population will include all participants who signed the informed consent form. 
5.3.2. 
Full Analysis Set 
The FAS will include all participants who applied at least one dose of ruxolitinib cream. 
The FAS will be used for the summary of demographics, baseline characteristics, participant 
disposition, and analyses of all efficacy and safety data. 
5.3.3. 
Pharmacokinetic-Evaluable Population 
The PK-evaluable population includes participants who applied at least 1 dose of ruxolitinib 
cream and provided at least 1 postdose blood sample. The study pharmacokineticist will review 
data listings of participant administration and sample records to identify participants to be 
excluded from the analyses.  
5.3.4. 
Pharmacodynamic-Evaluable Population 
The PD-evaluable population will include all participants who applied at least 1 dose of 
ruxolitinib cream and provided at least 1 PD measurement that complies with the instructions in 
the Protocol. The study research investigator will review data listings of PD data and sample 
records to identify participants to be excluded from analyses of PD data. 


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6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES 
Appendix A provides a list of planned tables, figures, and listings. Sample data displays are 
included in a separate document. 
6.1. 
Demographics, Baseline Characteristics, and Disease History 
6.1.1. 
Demographics and Baseline Characteristics 
The following demographics will be summarized for the FAS population: age, age group, sex, 
race, ethnicity, region, weight, height, and BMI. 
6.1.2. 
Baseline Disease Characteristics and Disease History 
The following baseline disease characteristics will be summarized for the FAS population and 
will include, but will not be limited to the following: 
• Time since initial diagnosis of vitiligo 
• Vitiligo diagnosed in childhood (no/yes [age]: 0-5 years, 6-11 years, 12-17 years) 
• Disease status (stable/progressive) 
• Skin type (Fitzpatrick scale Type I/II/III/IV/V/VI) 
• Other autoimmune disorders 
• Prior therapy given for vitiligo (predefined systemic treatments, phototherapy, and 
surgical procedures) 
• History of acne vulgaris (no/yes) 
• Currently have acne vulgaris on the face (no/yes) 
• Itching associated with the vitiligo lesions (no/yes) 
• Vitiligo in genital area (no/yes) 
• Baseline F-VASI 
• Baseline T-VASI 
• Baseline F-BSA involvement (% of the total body) 
• Baseline T-BSA involvement (% of the total body) 
6.1.3. 
Prior Medication for Vitiligo 
Prior medication information for vitiligo will be used to identify other nonpredefined medication 
received by participants before enrollment into the study. Prior medication for vitiligo will be 
summarized by treatment group. 


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6.1.4. 
Medical History 
For participants in the FAS, medical history will be summarized by treatment group. This 
summary will include the number and percentage of participants with medical history for each 
body SOC/PT as documented in the eCRF. 
6.2. 
Disposition of Participants 
The number and percentage of participants who were enrolled, who were treated, and who 
completed the study for each period will be summarized for the ITT population. 
6.3. 
Protocol Deviations 
Protocol deviations recorded on the eCRF will be summarized and listed. 
6.4. 
Exposure 
For participants in the FAS population during the treatment period, exposure will be summarized 
descriptively for duration of treatment, average daily dose, and total dose.  
6.5. 
Study Drug Compliance 
For the participants in the FAS population, overall compliance (%) for the application of 
ruxolitinib cream during the treatment period will be calculated for all participants as follows: 
Compliance (%) of ruxolitinib cream = 100  [total number of applied applications] / [total 
number of prescribed applications]. 
The total number of intended applications is the number of planned applications minus the 
number of interrupted applications. 
6.6. 
NB-UVB Machine Compliance 
Overall compliance (%) for the NB-UVB machine will be calculated by the number of sessions 
recorded by the NB-UVB machine. 
Compliance (%) of NB-UVB = 100  [total number of days using NB-UVB] / [total number 
of days intended to use NB-UVB] 
The total number of days intended to use is the number of days prescribed based on the 
frequency of 3 days per week. Compliance will be summarized and listed for participants in 
Group A. 
6.7. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary. 
The number and percentage of participants in the safety population for each prior and 
concomitant medication will be summarized by WHO drug class and WHO drug preferred term. 
Prior and concomitant medications will also be summarized (and listed) by treatment group. 


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7. 
EFFICACY 
Appendix A provides a list of data displays. Sample data displays are included in a separate 
document.  
7.1. 
General Considerations 
For all continuous variables, the actual value and change and/or percentage from baseline (if 
available) will be analyzed. 
For continuous measurements, summary statistics will include sample size, mean, median, 
standard deviation, standard error of the mean, minimum, and maximum. 
For categorical measurements, summary statistics will include sample size, frequency, and 
percentages. All by-visit analyses will include the follow-up period, if the data are available. 
7.2. 
Efficacy Measures 
7.2.1. 
Body Surface Area 
Total % BSA (includes facial and nonfacial areas) depigmented by vitiligo will be estimated at 
each visit. Body surface area assessment will be performed by the Palmar Method. Body surface 
area should be estimated to the nearest 0.1%. The approximate size of the participant's entire 
palmar surface (ie, the palm plus 5 digits) should be considered as 1% BSA; the approximate 
size of the participant's thumb should be considered as 0.1% BSA. 
7.2.2. 
Vitiligo Area Scoring Index  
Areas affected by depigmentation due to vitiligo will be assessed using the VASI. It is based on a 
composite estimate of the overall area of vitiligo patches at baseline and the degree of macular 
repigmentation within these patches over time. 
Facial VASI is measured by percentage of vitiligo involvement (% BSA) and the degree of 
depigmentation. The percentage of BSA (hand unit) vitiligo involvement is estimated by the 
investigator using the Palmar Method. The hand unit is based on participant's hand size. The 
investigator uses his/her hand to mimic the participant's hand size to evaluate percentage BSA 
vitiligo involvement. The degree of depigmentation for each vitiligo involvement site is 
determined and estimated to the nearest of the following percentages: 0%, 10%, 25%, 50%, 75%, 
90%, or 100%. At 100% depigmentation, no pigment is present; at 90%, specks of pigment are 
present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and 
pigmented area are equal; at 25%, the pigmented area exceeds the depigmented area; and at 10%, 
only specks of depigmentation are present. The F-VASI is then derived by multiplying the values 
assessed for the vitiligo involvement by the percentage of affected skin for each site on the face, 
summing the values of all sites together (possible range, 0-3). 
The area "Face" is defined as including the area on the forehead to the original hairline, on the 
cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the 
tragus. The area "Face" will not include surface area of the lips, scalp, ears, or neck, but will 
include the nose and eyelids. 


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Total body VASI is calculated using a formula that includes contributions from all body regions 
(possible range, 0-100). 
The body is divided into the following 6 separate and mutually exclusive sites: 1) head/neck, 
2) hands, 3) upper extremities (excluding hands), 4) trunk, 5) lower extremities (excluding feet), 
and 6) feet. The percentage of vitiligo involvement is estimated in hand units (% BSA) by the 
same investigator during the entire course of the study. Hand unit is based on participant's hand 
size. The investigator uses their hand to mimic the participant's hand size to evaluate % BSA 
vitiligo involvement. The degree of depigmentation for each body site is determined and 
estimated to the nearest of the following percentages: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. 
The T-VASI is then derived by multiplying the values assessed for the vitiligo involvement by 
the percentage of affected skin for each body site, summing the values of all body sites together 
(Hamzavi et al 2004). 
 
 
 
 
 
 
 
 


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7.3. 
Efficacy Analysis 
7.3.1. 
Primary Efficacy Analysis 
The primary efficacy endpoint is the change from baseline in T-VASI at Week 48. For the 
primary endpoint, summary statistics will include sample size, mean, median, standard deviation, 
minimum, maximum, and the 95% CI. 
7.3.2. 
Secondary and 
 Efficacy Analysis 
7.3.2.1. 
Continuous Efficacy Endpoints 
By-visit summary statistics for the following continuous measurements, including actual 
measurement, change from baseline, and percentage change from baseline, will be presented: 
• F-VASI/T-VASI 
• F-BSA/
/T-BSA 
 
 
 
 
 
 
Summary statistics, including sample size, mean, median, standard deviation, minimum, 
maximum, first quartile, third quartile, and 95% CI, will be presented by visit. In addition, line 
graphs and mean and standard error plots will be provided. 


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7.3.2.2. 
Categorical Efficacy Endpoints 
For the following categorical parameters, summary statistics will include sample size, frequency, 
percentages and standard error of percentage, and the 95% CI at each visit. In addition, box plots 
will be provided. 
• Proportion of participants achieving F-VASI50/75/90 
• Proportion of participants achieving T-VASI25/50/75/90 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8. 
PHARMACOKINETICSAND PHARMACODYNAMICS 
8.1. 
Pharmacokinetic Analyses 
Trough plasma ruxolitinib concentrations at applicable study visits will be summarized using 
descriptive statistics by treatment group. 
 
 
 
8.3. 
Pharmacokinetic/Pharmacodynamic Analyses 
Pharmacokinetic analyses will be performed using the PK-evaluable population. 
9. 
SAFETY AND TOLERABILITY 
Appendix A  provides a list of data displays. Sample data displays are included in a separate 
document. 
9.1. 
General Considerations 
The analyses in this section will be provided for the safety population. 
Summary tables may be replaced with listings when appropriate. For instance, an AE frequency 
table may be replaced with a listing if it only contains a few unique PTs reported on relatively 
few participants. 
9.2. 
Adverse Events 
9.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after 
first application of study drug and within 30 days of the last application of study drug. For 
participants who have NB-UVB phototherapy added, the first application date is period-specific, 
and the end date is 30 days after the last application date in this period, or the day before the first 
application date in the next period, whichever comes first. Analysis of AEs (as discussed below) 
will be limited to TEAEs, but data listings will include all AEs regardless of their timing in 
relation to study drug application. 
Adverse events will be tabulated by MedDRA PT and SOC. Severity of AEs will be graded 
using the NCI CTCAE v5. The CTCAE reporting guidelines and grading details are available on 
the Cancer Therapy Evaluation Program website. 
The subset of AEs considered by the investigator to be related to study drug will be considered to 
be treatment-related AEs. If the investigator does not specify the relationship of the AE to study 
drug, the AE will be considered to be treatment-related. The incidence of AEs and 
treatment-related AEs will be tabulated. Serious AEs will also be tabulated. 


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Any missing onset date, causality, or severity must be queried for resolution. Unresolved missing 
causality and severity will be handled according to the following rules: 
• An unresolved missing causality will be considered treatment-related. 
• An unresolved missing severity will be identified as an unknown severity. 
For purposes of analysis, all AEs will be considered TEAEs unless the AE can unequivocally be 
defined as not treatment-emergent. 
Application site reactions are AEs that occur at the site of drug application. A summary of ASRs 
will be provided.  
9.2.2. 
Adverse Event Summaries 
An overall summary of AEs by treatment group will include the following: 
• Number (%) of participants reporting any TEAEs 
• Number (%) of participants reporting any serious TEAEs 
• Number (%) of participants reporting any Grade 3 or higher TEAEs 
• Number (%) of participants reporting any treatment-related TEAEs 
• Number (%) of participants who temporarily interrupted study drug because of 
TEAEs 
• Number (%) of participants who permanently discontinued study drug because of 
TEAEs 
• Number (%) of participants who had a fatal TEAE 
The following summaries will be produced by MedDRA term (if 5 or fewer participants appear 
in a table, a listing may be appropriate): 
• Summary of TEAEs by SOC, PT, and maximum severity 
• Summary of TEAEs by SOC and PT 
• Summary of TEAEs by PT in decreasing order of frequency 
• Summary of Grade 3 or higher AEs by SOC and PT 
• Summary of Grade 3 or higher AEs by PT in decreasing order of frequency 
• Summary of serious TEAEs by SOC and PT 
• Summary of serious TEAEs by PT in decreasing order of frequency 
• Summary of ASRs by SOC and PT 
•  Summary of ASRs by PT in decreasing order of frequency 
• Summary of treatment-related TEAEs by SOC and PT 
• Summary of treatment-related TEAEs by PT in decreasing order of frequency 
• Summary of Grade 3 or higher treatment-related TEAEs by SOC and PT 


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• Summary of treatment-related serious TEAEs by SOC and PT 
• Summary of TEAEs with a fatal outcome by SOC and PT 
• Summary of TEAEs leading to dose interruption of study drug by SOC and PT 
• Summary of TEAEs leading to discontinuation of study drug by SOC and PT 
9.3. 
Clinical Laboratory Tests 
9.3.1. 
Laboratory Value Definitions 
All laboratory assessments will be performed using a central laboratory, except for urine 
pregnancy tests (when applicable). Laboratory values and change from baseline values will be 
summarized descriptively by visit; non-numeric test values will be tabulated when necessary. 
The baseline value will be determined using the last nonmissing value collected before the first 
application, prioritizing scheduled assessments for baseline identification over unscheduled 
visits. The last record before application in the highest priority will be considered the baseline 
record. For baseline laboratory candidates with the same date and time in the same priority 
category, additional rules may be provided after consultation with the medical monitor to 
delineate which value will be defined as baseline. 
9.3.2. 
Laboratory Value Summaries 
Actual values and changes from baseline in clinical laboratory test results will be summarized 
using descriptive statistics. Laboratory test values outside the normal range will be assessed for 
severity based on the normal ranges for the clinical reference laboratory. The incidence of 
abnormal laboratory values will be tabulated. 
Laboratory data will be classified into Grades 1 through 5 using CTCAE v5.0. The following 
summaries will be produced for the laboratory data: 
• Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of baseline value). (Note: Each participant will be counted only for their 
worst grade observed postbaseline.) 
• Shift tables from baseline to the worst postbaseline value using CTCAE grade. 
In addition, box plots will be provided for hemoglobin, platelet counts, neutrophils, leukocytes, 
lymphocytes, erythrocytes, and reticulocytes. 
9.4. 
Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital signs (blood 
pressure, pulse, respiratory rate, and body temperature) at each assessment time. 
Criteria for clinically notable vital sign abnormalities are defined in Table 4. The abnormal 
values for participants exhibiting clinically notable vital sign abnormalities will be listed along 
with their assigned treatment group. Alert vital signs are defined as an absolute value outside the 
defined range and percentage change > 25%. The abnormal values for participants exhibiting 
alert vital sign abnormalities will be listed. 


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Table 4: 
Criteria for Clinically Notable Vital Sign Abnormalities for ≥ 18 Years Old 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
> 155 mmHg 
< 85 mmHg 
Diastolic blood pressure 
> 100 mmHg 
< 40 mmHg 
Pulse 
> 100 bpm 
< 45 bpm 
Temperature 
> 38ºC 
< 35.5ºC 
Respiratory rate 
> 20 breaths/min 
< 8 breaths/min 
 
10. 
INTERIM ANALYSES 
No formal interim analysis is planned in this study. 
11. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 5. 
Table 5: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
10 MAY 2023 
11.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
11.2. 
Changes to the Statistical Analysis Plan 
Not applicable. 


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12. 
REFERENCES 
 
 
Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband 
UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. 
Arch Dermatol 2004;140:677-683. 
 
 
World Health Organization. Wellbeing measures in primary health care/the Depcare Project: 
report on a WHO meeting: Stockholm, Sweden. WHO Regional Office for Europe, Copenhagen: 
12-13 February 1998. 


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APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS 
This appendix provides a list of the planned tables, figures, and listings for the Clinical Study 
Report. Shells are provided in a separate document for tables that are not in the most current 
Standard Safety Tables. 
The list of tables, figures, and listings are to be used as guidelines. Modifications of the lists that 
do not otherwise affect the nature of the analysis will not warrant an amendment to the SAP. 
Tables 
Table No. 
Title 
Population 
Standard 
1.1.1 
Analysis Populations 
All 
X 
1.1.2.1 
Summary of Participant Disposition  
FAS 
X 
1.1.3 
Summary of Number of Participants Enrolled by Country and Site 
FAS 
X 
1.1.4.1 
Summary of Protocol Deviations 
FAS 
X 
1.2.1 
Summary of Demographics and Baseline Characteristics 
FAS 
X 
1.3 
Summary of Baseline Disease Characteristics 
FAS 
X 
1.4.1 
Summary of Prior Medications for Vitiligo 
FAS 
X 
1.4.2 
Summary of Prior Medications 
FAS 
X 
1.4.3.1 
Summary of Concomitant Medications 
FAS 
X 
1.5 
Summary of General Medical History 
FAS 
X 
1.6 
Summary of Participants With Assessments Not Done Due to 
COVID-19 Pandemic 
FAS 
X 
Efficacy 
F-VASI/T-VASI 
2.1.1 
Summary and Analysis of T-VASI During the Treatment Period 
FAS 
 
2.1.2 
Summary and Analysis of Participants Achieving T-VASI25 During the 
Treatment Period 
FAS 
 
2.1.3 
Summary and Analysis of Participants Achieving T-VASI50 During the 
Treatment Period 
FAS  
 
2.1.4 
Summary and Analysis of Participants Achieving T-VASI75 During the 
Treatment Period 
FAS 
 
2.1.5 
Summary and Analysis of Participants Achieving T-VASI90 During the 
Treatment Period 
FAS 
 
2.2.1 
Summary and Analysis of F-VASI During the Treatment Period 
FAS 
 
2.2.2 
Summary and Analysis of Participants Achieving F-VASI50 During the 
Treatment Period 
FAS 
 
2.2.3 
Summary and Analysis of Participants Achieving F-VASI75 During the 
Treatment Period 
FAS 
 
2.2.4 
Summary and Analysis of Participants Achieving F-VASI90 During the 
Treatment Period 
FAS 
 
F-BSA/BSA 
2.4.1 
Summary and Analysis of F-BSA During the Treatment Period 
FAS 
 
2.4.2 
FAS 
 
2.4.3 
Summary and Analysis of T-BSA During the Treatment Period 
FAS 
 


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Table No. 
Title 
Population 
Standard 
Exposure and Compliance 
3.1.1 
Summary of Exposure in During Treatment Period 
FAS 
X 
3.1.2 
Summary of Study Drug Compliance in During Treatment Period 
FAS 
X 
3.1.3 
Summary of NB-UVB Compliance in During Treatment Period 
FAS 
X 
Adverse Events 
3.2.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
FAS 
X 
3.2.2.1 
Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class and Preferred Term 
FAS 
X 
3.2.3.1 
Summary of Treatment-Emergent Adverse Events by MedDRA System 
Organ Class, Preferred Term, and Maximum Severity 
FAS 
X 
3.2.4.1 
Summary of Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
FAS 
X 


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Table No. 
Title 
Population 
Standard 
3.2.5.1.1 
Summary of Application Site Reactions by MedDRA System Organ 
Class and Preferred Term 
FAS 
X 
3.2.5.1.2 
Summary of Application Site Reactions by MedDRA Preferred Term in 
Decreasing Order of Frequency 
FAS 
X 
3.2.6.1 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA System Organ Class and Preferred Term  
FAS 
X 
3.2.6.2 
Summary of Grade 3 or Higher Treatment-Emergent Adverse Events by 
MedDRA Preferred Term in Decreasing Order of Frequency 
FAS 
X 
3.2.7.1 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
System Organ Class and Preferred Term 
FAS 
X 
3.2.7.2 
Summary of Serious Treatment-Emergent Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
FAS 
X 
3.2.8.1 
Summary of Treatment-Related Treatment-Emergent Adverse Events 
by MedDRA System Organ Class and Preferred Term 
FAS 
X 
3.2.8.2 
Summary of Treatment-Related Treatment-Emergent Adverse Events 
by MedDRA Preferred Term in Decreasing Order of Frequency 
FAS 
X 
3.2.8.3 
Summary of Treatment-Related Treatment-Emergent Adverse Events in 
Cohort A by MedDRA Preferred Term in Decreasing Order of 
Frequency 
FAS 
X 
3.2.9.1 
Summary of Grade 3 or Higher Treatment-Related Treatment-Emergent 
Adverse Events by MedDRA System Organ Class and Preferred Term 
FAS 
X 
3.2.10.1 
Summary of Treatment-Related Serious Treatment-Emergent Adverse 
Events by MedDRA System Organ Class and Preferred Term 
FAS 
X 
3.2.11.1 
Summary of Treatment-Emergent Adverse Events With a Fatal 
Outcome by MedDRA System Organ Class and Preferred Term 
FAS 
X 
3.2.12.1 
Summary of Treatment-Emergent Adverse Events Leading to Dose 
Interruption by MedDRA System Organ Class and Preferred Term 
FAS 
X 
3.2.13.1 
Summary of Treatment-Emergent Adverse Events Leading to 
Discontinuation of Study Drug by MedDRA System Organ Class and 
Preferred Term 
FAS 
X 
Laboratory Values and Vital Signs 
3.3.1 
Summary of Laboratory Values - Hematology 
FAS 
X 
3.3.3 
Shift Summary of Hematology Laboratory Values in CTC Grade - to 
the Worst Abnormal Value 
FAS 
X 
3.3.4 
Summary of Laboratory Values - Chemistry 
FAS 
X 
3.3.6 
Shift Summary of Chemistry Laboratory Values in CTC Grade - to the 
Worst Abnormal Value 
FAS 
X 
3.4.1 
Summary of Systolic Blood Pressure 
FAS 
X 
3.4.2 
Summary of Diastolic Blood Pressure 
FAS 
X 
3.4.3 
Summary of Pulse 
FAS 
X 
3.4.4 
Summary of Respiration Rate 
FAS 
X 
3.4.5 
Summary of Body Temperature 
FAS 
X 
Note: Cohort A includes all participants reported TEAEs related to either 1.5% BID or NB-NVB.  


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Figures 
Figure No. 
Title 
Population 
4.1.1 
Proportion of Participants Achieving F-VASI25 During Treatment Period 
FAS 
4.1.2 
Proportion of Participants Achieving F-VASI50 During Treatment Period 
FAS 
4.1.3 
Proportion of Participants Achieving F-VASI75 During Treatment Period 
FAS 
4.1.4 
Proportion of Participants Achieving F-VASI90 During Treatment Period 
FAS 
4.1.6 
Mean and Standard Error Plot of F-VASI During Treatment Period 
FAS 
4.1.7 
Mean and Standard Error Plot of Change From Baseline in F-VASI During 
Treatment Period 
FAS 
4.1.8 
Mean and Standard Error Plot of Percent Change From Baseline in F-VASI During 
Treatment Period 
FAS 
4.2.1 
Proportion of Participants Achieving T-VASI25 During Treatment Period 
FAS 
4.2.2 
Proportion of Participants Achieving T-VASI50 During Treatment Period 
FAS 
4.2.3 
Proportion of Participants Achieving T-VASI75 During Treatment Period 
FAS 
4.2.4 
Proportion of Participants Achieving T-VASI90 During Treatment Period 
FAS 
4.2.6 
Mean and Standard Error Plot of T-VASI During Treatment Period 
FAS 
4.2.7 
Mean and Standard Error Plot of Change From Baseline in T-VASI During 
Treatment Period 
FAS 
4.2.8 
Mean and Standard Error Plot of Percent Change From Baseline in T-VASI During 
Treatment Period 
FAS 
4.3.1 
Mean and Standard Error Plot of F-BSA During Treatment Period 
FAS 
4.3.2 
Mean and Standard Error Plot of Change From Baseline in F-BSA During 
Treatment Period 
FAS 
4.3.3 
Mean and Standard Error Plot of Percent Change From Baseline in F-BSA During 
Treatment Period 
FAS 
4.4.1 
Mean and Standard Error Plot of T-BSA During Treatment Period 
FAS 
4.4.2 
Mean and Standard Error Plot of Change From Baseline in T-BSA During 
Treatment Period 
FAS 
4.4.3 
Mean and Standard Error Plot of Percent Change From Baseline in T-BSA During 
Treatment Period 
FAS 


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Figure No. 
Title 
Population 
5.1.1 
Box Plot of Hemoglobin (g/L) by Visit 
FAS 
5.1.2 
Box Plot of Change From Baseline in Hemoglobin (g/L) by Visit 
FAS 
5.1.3 
Box Plot of Percentage Change From Baseline in Hemoglobin (g/L) by Visit 
FAS 
5.2.1 
Box Plot of Platelets (109/L) by Visit 
FAS 
5.2.2 
Box Plot of Change From Baseline in Platelets (109/L) by Visit  
FAS 
5.2.3 
Box Plot of Percentage Change From Baseline in Platelets (109/L) by Visit 
FAS 
5.3.1 
Box Plot of Neutrophils (109/L) by Visit 
FAS 
5.3.2 
Box Plot of Change From Baseline in Neutrophils (109/L) by Visit  
FAS 
5.3.3 
Box Plot of Percentage Change From Baseline in Neutrophils (109/L) by Visit 
FAS 
5.4.1 
Box Plot of Leukocytes (109/L) by Visit 
FAS 
5.4.2 
Box Plot of Change From Baseline in Leukocytes (109/L) by Visit  
FAS 
5.4.3 
Box Plot of Percentage Change From Baseline in Leukocytes (109/L) by Visit 
FAS 
5.5.1 
Box Plot of Lymphocytes (109/L) by Visit 
FAS 
5.5.2 
Box Plot of Change From Baseline in Lymphocytes (109/L) by Visit 
FAS 
5.5.3 
Box Plot of Percentage Change From Baseline in Lymphocytes (109/L) by Visit 
FAS 
5.6.1 
Box Plot of Erythrocytes (1012/L) by Visit  
FAS 
5.6.2 
Box Plot of Change From Baseline in Erythrocytes (1012/L) by Visit  
FAS 
5.6.3 
Box Plot of Percentage Change From Baseline in Erythrocytes (1012/L) by Visit 
FAS 
5.7.1 
Box Plot of Reticulocytes (109/L) by Visit  
FAS 
5.7.2 
Box Plot of Change From Baseline in Reticulocytes (109/L) by Visit 
FAS 
5.7.3 
Box Plot of Percentage Change From Baseline in Reticulocytes (109/L) by Visit 
FAS 
Listings 
Listing No. 
Title 
Demographic and Baseline Characteristics 
2.1.1 
Participant Enrollment and Disposition Status 
2.1.2 
Participant Inclusion and Exclusion Criteria Violations 
2.1.3 
Participants Who Discontinued Treatment or Discontinued From Study Due to COVID-19 
2.1.4 
Participants With Assessments Not Done Due to COVID-19 Pandemic 
2.2.1 
Protocol Deviations and Violations 


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Listing No. 
Title 
2.3 
Analysis Populations 
2.4.1 
Demographic Characteristics 
2.4.2 
Baseline Disease Characteristics 
2.4.3 
Medical History 
2.4.4 
Prior and Concomitant Medications 
2.4.5 
Prior Medications for Vitiligo 
2.4.6 
Study Drug Exposure and Compliance 
2.4.7 
NB-UVB Compliance 
Efficacy 
2.6.1 
F-VASI Score 
2.6.2 
T-VASI Score 
2.6.3 
F-BSA 
 
  
2.6.5 
T-BSA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.6.15 
Participants With F-VASI Assessments Not Done Due to COVID-19 Pandemic 
Adverse Events  
2.7.1 
Adverse Events 
2.7.2 
Adverse Events Leading to Study Drug Discontinuation 
2.7.3 
Serious Adverse Events 
2.7.4 
Treatment-Related Adverse Events 
2.7.5 
Adverse Events With a Fatal Outcome 
2.7.6 
Adverse Events Leading to Interruption of Study Drug 
2.7.8 
Grade 3 or Higher Adverse Events 
2.7.9 
Application Site Reactions 
Laboratory Data 
2.8.1.1 
Clinical Laboratory Values - Hematology 
2.8.1.2 
Clinical Laboratory Values - Chemistry 
2.8.1.3 
Abnormal Clinical Laboratory Values - Hematology 
2.8.1.4 
Abnormal Clinical Laboratory Values - Chemistry 
Vital Signs 
2.8.2.1 
Vital Signs 
2.8.2.2 
Abnormal Vital Sign Values 
2.8.2.3 
Alert Vital Sign Values