Clinical trial NCT05556265
Conditions: Alopecia Areata
Keywords: Deucravacitinib IM011134 BMS-986165
Sponsor: Bristol-Myers Squibb
Start date: 2022-11-08; Completion date: 2024-05-16
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of deucravacitinib versus placebo at Week 24 and safety and tolerability of deucravacitinib versus placebo in adults with alopecia areata.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Deucravacitinib intervention 2: Placebo
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Placebo was administered.

Protocol documents:
Prot_SAP_000.pdf: 
Official Title of Study: 
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to 
Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants with Alopecia 
Areata 
 
NCT Number: NCT05556265 
Document Date (Date in which document was last revised): 29 August 2023 


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IND: 131,993 
Page: 1 
Protocol Number: IM011134 
Date: 13-Jan-2021 
Revised Date: 29-Aug-2023 
REGULATORY AGENCY IDENTIFIER NUMBER(S) 
EudraCT: 2020-000113-33 
UTN: U1111-1246-1767 
CLINICAL PROTOCOL IM011134 
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to 
Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants with Alopecia 
Areata 
Protocol Amendment 02 
Brief Title: Efficacy and Safety of Deucravacitinib in Adults with Alopecia Areata 
Medical Monitoring Contact Information 
 
Clinical Trial Physician - 
Medical Monitor 
Bristol-Myers Squibb Company 
Bristol-Myers Squibb Company 
3401 Princeton Pike 
Lawrenceville, NJ 08648 
86 Morris Ave 
Summit, NJ 07901 
Phone: 
Phone: 
Email: 
Email: 
 
24-hr Emergency Telephone Number 
USA: 
International: 
 
Bristol-Myers Squibb Company 
Route 206 & Province Line Road 
Lawrenceville, NJ 08543 
 
Avenue de Finlande 4 
B-1420 Braine-l’Alleud, Belgium 
 
1-2-1 Otematchi, Chiyoda-ku 
Tokyo, 163-1327 100-0004, Japan 
Clinical Scientist 


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This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company (BMS) and its global affiliates. By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS sponsored 
study. Any permitted disclosures will be made only on a confidential "need to know" basis 
within your organization or to your independent ethics committee(s). Any other use, copying, 
disclosure or dissemination of this information is strictly prohibited unless expressly 
authorized in writing by BMS. Any supplemental information (eg, amendments) that may be 
added to this document is also confidential and proprietary to BMS and must be kept in 
confidence in the same manner as the contents of this document. Any person who receives 
this document without due authorization from BMS is requested to return it to BMS or 
promptly destroy it. References to BMS in this protocol may apply to partners to which BMS 
has transferred obligations (eg, a Contract Research Organization [CRO]). 
 
© 2023 Bristol-Myers Squibb Company 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Amendment No.: 02 
Date: 29-Aug-2023 
2 


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DOCUMENT HISTORY 
 
Document 
Date of Issue 
Summary of Changes 
Protocol 
Amendment 02 
29-Aug-2023 
The primary purpose for Protocol Amendment 02 is to incorporate changes 
as well as to add clarifications based on feedback from study 
investigators. 
Language from the Japan-specific protocol amendment 01 was 
incorporated. 
Protocol 
Amendment 01 
24-Mar-2022 
The primary reason for Protocol Amendment 01 is to refine the endpoints 
based on recently available external data. Additional revisions include the 
addition of a summary of the completed Phase 3 psoriasis deucravacitinib 
trials; updates to the background section based on new compounds in 
development; update of the Protocol Summary to align with respective 
changes to the protocol; updated study contacts on the Title Page. 
Original Protocol 
13-Jan-2021 
Not applicable 


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OVERALL RATIONALE FOR PROTOCOL AMENDMENT 02: 
The primary purpose of this amendment is to incorporate changes 
as well as to add clarifications based 
on feedback from study investigators. 
Language from the Japan-specific Amendment 01, related to the interpretation of hepatitis B virus 
test results to assess eligibility and to clarify expectations for assessments and sample collections, 
has been incorporated into this global amendment. 
Other edits were incorporated throughout the protocol to correct minor errors, add clarity, and 
improve consistency. Key changes are summarized below. 
This protocol amendment applies to all participants. 
 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
Title page 
Clinical 
Scientist 
contact 
information updated. 
To reflect personnel change 
Section 2, Table 2-2 and Table 2-3: 
Schedule of Activities 
Added a line item to assess for 
adverse events (AEs) of suicidal 
ideation and behavior throughout the 
study. 
To add a reminder to document AEs 
of suicidal ideation and behavior as 
described 
Section 2, Table 2-2 and Table 2-3: 
Schedule of Activities 
Added hepatitis B virus (HBV) 
testing during the Treatment and 
Follow-up periods (Table 2-2 and 
Table 2-3). 
To 
incorporate 
Japan-specific 
amendment language into the global 
amendment. 
Section 6.2 Exclusion Criteria 
Modified Exclusion Criteria 2) f) 
Section 8.1: Discontinuation from 
Study Intervention 
Added category to clarify criteria 
related to HBV status. 
Appendix 
9: 
Interpretation 
of 
Hepatitis Serologic Test Results 
Added a new appendix. 
Appendix 
4: 
Women 
of 
Childbearing Potential Definitions 
and Methods of Contraception 
Modified language on contraceptive 
use to align with 
requirements. 
Added “Note: Intravaginal and 
transdermal 
combined 
hormonal 
contraceptives are not approved by 
the Health Authority in Japan. Also, 
progestogen-only 
hormonal 
contraceptives are not approved by 
the Health Authority in Japan.” 


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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
Table 
4-1: 
Objectives 
and 
Endpoints 
Section 6.2: Exclusion Criteria, 5e) 
Replaced 
“tacrolimus” 
with 
“topical calcineurin inhibitors 
(applied to the scalp)”. 
To clarify that the criterion referred 
to the class rather than a single 
example (tacrolimus). 
Section 7.7: Concomitant Therapy 
Added that topical corticosteroids 
cannot be applied to the eyelids and 
eyebrows. 
Added 
that 
topical 
calcineurin 
inhibitors are permitted but cannot 
be applied on the eyelids, eyebrows, 
or scalp. 
To clarify permitted concomitant 
medications. 
Section 8.1: Discontinuation from 
Study Intervention 
Added additional discontinuation 
criterium for suicidal ideation and 
behavior. with referral to a mental 
health professional 
Text added 
Section 9.1: Efficacy Assessments 
Section 9.2.6: Pregnancy 
Replaced the text “including during 
and at least for 3 days after study 
product administration” with “and 
through the end of the saftey follow- 
up period”. 
To clarify reporting of pregnancies. 
Section 10.3: Analysis Sets 
Section 
10.4.1: 
General 
Considerations 
Section 10.4.2: Primary Efficacy 
Endpoints 
Modified the population for all 
efficacy analyses from the Full 
Analysis 
Set 
(FAS) 
to 
the 
randomized population. 
updated to use intent-to-treat (ITT) 
population for efficacy analyses. 
Section 10.3: Analysis Sets 
Expanded analysis sets to include 
populations. 
Populations 
will 
be 
used 
for 
summaries, 
respectively. 
Section 
10.4.5: 
Other 
Safety 
Remove 
statement 
“An 
outlier 
analysis of ECG results will be 
conducted.” 
While 
ECG 
results 
will 
be 
summarized, no outlier test will be 
performed as data to be collected 
will be too limited to support this 
test. . 
Analyses 


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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
All 
Minor grammatical, formatting, and 
typographical corrections. 
To correct minor errors. 


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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
1 
DOCUMENT HISTORY.............................................................................................. 
3 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 02: ............................ 
4 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02................ 
4 
TABLE OF CONTENTS.............................................................................................. 
7 
1 PROTOCOL SUMMARY......................................................................................... 
10 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
15 
3 INTRODUCTION ..................................................................................................... 
24 
3.1 Study Rationale ................................................................................................. 
25 
3.2 Background ....................................................................................................... 
26 
3.3 Benefit/Risk Assessment .................................................................................. 
26 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
28 
5 STUDY DESIGN....................................................................................................... 
30 
5.1 Overall Design .................................................................................................. 
30 
5.1.1 Data Monitoring Committee and Other External Committees ................ 
31 
5.2 Number of Participants ..................................................................................... 
31 
5.3 End of Study Definition .................................................................................... 
31 
5.4 Scientific Rationale for Study Design............................................................... 
32 
32 
6 STUDY POPULATION ............................................................................................ 
33 
6.1 Inclusion Criteria .............................................................................................. 
33 
6.2 Exclusion Criteria ............................................................................................. 
35 
6.3 Lifestyle Restrictions ........................................................................................ 
38 
6.3.1 Meals and Dietary Restrictions ............................................................... 
38 
6.3.2 Caffeine, Alcohol and Tobacco................................................................ 
38 
6.3.3 Activity ..................................................................................................... 
39 
6.4 Screen Failures.................................................................................................. 
39 
6.4.1 Retesting During Screening or Lead-In Period ....................................... 
39 
7 STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ....................... 
40 
7.1 Study Interventions Administered .................................................................... 
40 
7.2 Method of Study Intervention Assignment....................................................... 
41 
7.3 Blinding............................................................................................................. 
41 
7.4 Dose Modification ............................................................................................ 
42 
7.5 Preparation/Handling/Storage/Accountability .................................................. 
42 
7.6 Treatment Compliance...................................................................................... 
43 
7.7 Concomitant Therapy........................................................................................ 
43 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
44 
7.7.2 Permitted Vaccines (Including COVID-19 Vaccine) ............................... 
44 
7.8 Continued Access to Study Intervention After the End of the Study ............... 
45 
8 DISCONTINUATION CRITERIA ........................................................................... 
45 
8.1 Discontinuation from Study Intervention ......................................................... 
45 
8.1.1 Temporary Interruption ........................................................................... 
46 
8.1.2 Post-study Intervention Study Follow-up................................................. 
46 
8.2 Discontinuation from the Study ........................................................................ 
47 


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8.2.1 Individual Discontinuation Criteria ........................................................ 
47 
8.3 Lost to Follow-up.............................................................................................. 
47 
9 STUDY ASSESSMENTS AND PROCEDURES..................................................... 
48 
9.1 Efficacy Assessments........................................................................................ 
49 
50 
9.1.2 Medical Photography............................................................................... 
51 
9.2 Adverse Events ................................................................................................. 
51 
9.2.1 Adverse Events of Interest........................................................................ 
51 
9.2.2 Time Period and Frequency for Collecting AE and SAE Information .... 
51 
9.2.3 Method of Detecting AEs and SAEs......................................................... 
52 
9.2.4 Follow-up of AEs and SAEs ..................................................................... 
52 
9.2.5 Regulatory Reporting Requirements for SAEs......................................... 
53 
9.2.6 Pregnancy ................................................................................................ 
53 
9.2.7 Laboratory Test Result Abnormalities ..................................................... 
53 
9.2.8 Potential Drug Induced Liver Injury (DILI) ............................................ 
54 
9.2.9 Other Safety Considerations .................................................................... 
54 
9.3 Overdose ........................................................................................................... 
54 
9.4 Safety ................................................................................................................ 
54 
9.4.1 Physical Examinations............................................................................. 
55 
9.4.2 Vital signs................................................................................................. 
55 
9.4.3 Electrocardiograms ................................................................................. 
55 
9.4.4 Clinical Safety Laboratory Assessments .................................................. 
55 
57 
58 
58 
62 
9.9 Other Assessments ............................................................................................ 
63 
9.10 Health Economics OR Medical Resource Utilization and Health Economics 
........................................................................................................................... 
63 
10 STATISTICAL CONSIDERATIONS .................................................................... 
63 
10.1 Statistical Hypothesis...................................................................................... 
63 
10.2 Sample Size Determination............................................................................. 
63 
10.3 Analysis Sets ................................................................................................... 
64 
10.4 Statistical Analysis.......................................................................................... 
64 
10.4.1 General Considerations ......................................................................... 
64 
10.4.2 Primary Efficacy Endpoints ................................................................... 
65 
10.4.3 Secondary Efficacy Endpoint(s)............................................................. 
65 
65 
10.4.5 Other Safety Analyses ............................................................................ 
65 
10.4.6 Other Analyses ....................................................................................... 
66 
10.5 Interim Analysis.............................................................................................. 
66 
11 REFERENCES ........................................................................................................ 
67 
12 APPENDICES ......................................................................................................... 
70 
APPENDIX 1 ABBREVIATIONS............................................................................... 
71 
APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. 
75 


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APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW UP AND REPORTING......................................................................... 
APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION..................................................................... 
APPENDIX 5 SEVERITY OF ALOPECIA TOOL (SALT) ....................................... 
 
APPENDIX 9 INTERPRETATION OF HEPATITIS SEROLOGIC TEST RESULTS 
(JAPAN SPECIFIC) ............................................................................................... 
APPENDIX 10 PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY 
................................................................................................................................. 
 
 
87 
91 
95 
96 
97 
98 
 
99 
 
103 


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1 
PROTOCOL SUMMARY 
Protocol Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, 
Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib ( BMS-986165) in 
Participants with Alopecia Areata 
Brief Title: Efficacy and Safety of Deucravacitinib in Adults with Alopecia Areata 
Rationale: 
Study IM011134 is a Phase 2, randomized, double-blind, placebo-controlled study to assess the 
efficacy and safety of deucravacitinib (BMS-986165) in participants with alopecia areata (AA). 
Deucravacitinib will be compared to placebo to evaluate the efficacy of deucravacitinib versus 
placebo for the treatment of alopecia areata. 
Alopecia areata is a chronic, relapsing, immune-mediated inflammatory disorder characterized by 
non-scarring hair loss. AA can affect nearly 2% of the general population at some point in their 
lifetime. The pathogenesis of AA is thought to involve autoimmune-mediated attack on the hair 
follicles (HF) leading to the inhibition of normal hair growth. The proximal portion of the HF 
constitutes an immune-privileged site, refractory to immune responses, similar to the anterior 
chamber of the eye. This immune privilege appears to be disrupted in AA with increased 
leukocyte trafficking into the dermis, enhanced antigen presentation, and migration of 
autoreactive T cells to be within close proximity of HFs in AA lesions. Cluster of differentiation 
(CD) 8+ and CD4+ T cells, mostly of the T1 type, comprise a significant portion of the infiltrate 
around the bulb of the HF and are considered to be the main drivers of pathology in this condition. 
Interleukin (IL)-12 made by antigen-presenting cells are thought to drive T1 responses in 
inflammation. 
Tyrosine kinase 2 (TYK2) is a non-receptor tyrosine kinase associated with receptors for the 
p40-containing cytokines interleukin (IL)-12 and IL-23, as well as the type I interferon (IFN) 
receptor, and is required for the activation of their downstream signaling pathways. TYK2 
catalyzes the phosphorylation of the intracellular receptor domains and signal transducer and 
activator of transcription (STAT) proteins, resulting in the activation of STAT-dependent 
transcription and functional responses specific for these cytokines. TYK2-dependent pathways 
and the cytokine networks they modulate have been implicated in the pathophysiology of multiple 
immune-mediated diseases. 
Deucravacitinib (BMS-986165) is a selective TYK2 inhibitor with a unique mechanism of action 
distinct from related Janus kinase (JAK) 1-3 inhibitors. Potent inhibition of IL-12/23 and Type 
I/III IFN-driven responses in mouse models of autoimmunity (psoriasis, colitis, and systemic 
lupus erythematosus [SLE]) and in healthy humans have been demonstrated with 
deucravacitinib. It has been shown to be effective in treatment of chronic plaque psoriasis 
in Phase 2 and Phase 3 studies and is currently being evaluated in psoriatic arthritis, SLE, 
lupus nephritis, Crohn’s disease, and ulcerative colitis. 


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The rationale for evaluating the efficacy and safety of deucravacitinib for the treatment of AA is: 
• A major pathway in the TYK2 signaling cascade (IL-12-mediated T1 cell induction and IFNγ 
production) has been implicated in AA disease pathogenesis, as noted above 
• Targeting the IL-12/23 pathway with biologic agents has been shown to be efficacious in case 
studies and Phase 2 studies in AA 
 
Objectives and Endpoints: 
 
Objectives 
Endpoints 
Primary: Efficacy 
To evaluate the efficacy of 
deucravacitinib versus placebo at 
Week 24 
• 
Change from baseline in SALT score at Week 24 
Primary: Safety 
To evaluate the safety and tolerability of 
deucravacitinib versus placebo 
• Incidence of AEs, SAEs, AEs leading to study discontinuation, and 
AEIs 
• Change in laboratory, ECG, physical examination, and vital sign 
parameters over time 
Secondary: Efficacy 
To evaluate the efficacy of 
deucravacitinib versus placebo on 
additional endpoints at Week 24 
• 
Proportion of participants achieving a ≥ 50% reduction in SALT 
score (SALT50 response) from baseline at Week 24 
• 
Proportion of participants achieving a SALT score ≤ 20 at Week 24 
• 
Proportion of participants achieving an AA-IGA score of 0 or 1 at 
Week 24 with at least a 2-point change from baseline 
Abbreviations: AA-IGA, Alopecia Areata Investigator Global Assessment; AE, adverse event; AEI, adverse event of 
interest; ECG, electrocardiogram; SAE, serious adverse event; SALT, Severity of Alopecia Tool. 
 
Overall Design: 
This is a randomized, placebo-controlled, double-blind, parallel group, multi-center Phase 2 
study to evaluate the efficacy and safety of 2 dosages of deucravacitinib (6 mg once daily [QD] 
and 6 mg twice daily [BID]) in participants with AA. 
The primary endpoint of the study is the change from baseline in SALT score at Week 24. 
The total duration of participation in the study will be approximately 60 weeks as follows: 
• Screening Period: up to 4 weeks 
• Placebo-controlled Treatment Period: 24 weeks (Day 1 to Week 24) 
• Active Treatment Period: 28 weeks (Weeks 24 to 52) 
• Post-treatment Follow-up Period: 4 weeks (Weeks 52 to 56) 
The study design schematic is presented in Figure 1. 


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Figure 1: 
Study Design Schematic 
 
Abbreviations: BID, twice daily; N, number; QD, once daily. 
 
Eligible participants will be randomized on Day 1 in a blinded manner to receive deucravacitinib 
6 mg QD, deucravacitinib 6 mg BID, or placebo in a 1:1:1 ratio. Randomization will be stratified 
by current duration of disease episode: < 4 years and ≥ 4 years. At the Week 24 study visit, the 
participants initially randomized to receive placebo will be re-randomized 1:1 in a blinded manner 
to receive deucravacitinib (6 mg QD or 6 mg BID) until Week 52. Participants initially randomized 
to deucravacitinib will continue on their assigned dosage in a blinded manner. 
Number of Participants: 
Approximately 90 participants will be randomized on Day 1 into 1 of 3 treatment arms in a 
1:1:1 ratio, resulting in 30 participants in each of the 2 deucravacitinib treatment arms (6 mg QD 
and 6 mg BID) and 30 participants in the placebo arm. 
Study Population: 
Men and women ≥ 18 years to ≤ 65 years must meet the following criteria for entry into the study. 
Key Inclusion Criteria: 
• Signed Written Informed Consent 
− Participant must be willing and able to participate in the study and sign the informed 
consent form (ICF) 
− Participant must be willing and able to complete all study-specific procedures and visits 
• Type of Participant and Target Disease Characteristics 
− Documented clinical diagnosis of AA for at least 6 months 
− Current episode of scalp hair loss (at Screening) must meet the following criteria: 
♦ Duration of at least 6 months 


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♦ Duration of current hair loss episode of AA affecting ≥ 50% of the scalp is not to exceed 
8 years 
♦ Scalp hair loss has been stable (ie, no significant spontaneous regrowth [> 10%] over 
the last 6 months) 
− SALT score ≥ 50 at Screening and Day 1 
Participant with complete scalp hair loss (SALT score of 100) with or without body hair 
involvement can be included 
− Participant must have an Alopecia Areata Investigator Global Assessment (AA-IGA) 
grade ≥ 3 at Screening and Day 1 
− Participant should not shave their scalp 7 days prior to the Screening visit, and agree to not 
shave their scalp 7 days prior to each study visit, to allow for SALT assessment of hair 
regrowth. If participant is using a hairpiece or wig, the participant must be willing and able 
to remove the hair prosthetic at each appointment. Participant should maintain a stable hair 
style to allow for reliable and consistent assessment of SALT throughout the study. 
− Participant with current or a history of androgenetic alopecia can be included as long as, in 
the opinion of the investigator, the participant has either of the following classifications: 
Ludwig Scale ≤ II for women; Hamilton-Norwood Scale ≤ III for men. 
Note: A male participant with Hamilton-Norwood III vertex or Hamilton-Norwood IIIa 
classification will be excluded. 
Key Exclusion Criteria: 
• Exclusionary Disease Characteristics 
− Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, 
lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc. 
− Other active skin diseases affecting the scalp that in the opinion of the investigator may 
interfere with accurate assessment of SALT score. 
− Extensive tattooing of the scalp that in the opinion of the investigator may interfere with 
the accurate assessment of SALT score. 
 
Intervention Groups and Duration: 
Participants will receive oral doses of the investigational product (IP) as tablets for 52 weeks. 
• Deucravacitinib 6 mg QD: 52 weeks 
• Deucravacitinib 6 mg BID: 52 weeks 
• Placebo: 24 weeks of placebo followed by 28 weeks of deucravacitinib (6 mg QD or 6 mg BID) 


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Study Intervention: 
 
Study Intervention for IM011134 
Medication 
Potency 
IP/Non-IP 
Deucravacitinib 
6 mg 
IP 
Placebo 
N/A 
IP 
Abbreviations: IP, investigational product; mg, milligram, N/A, not applicable. 
 
 
Statistical Methods 
The primary efficacy analysis will be conducted on the randomized population. The randomized 
population consists of all participants who were randomized using Interactive Response 
Technology (IRT). 
The analysis model for the primary efficacy endpoint will use the analysis of covariance 
(ANCOVA) to compare change from baseline of each active treatment group to placebo. The 
model will include treatment arm, the randomization stratification variable of alopecia episode 
duration (< 4 years and ≥ 4 years), and baseline SALT score. The primary methodology to impute 
the missing data will be multiple imputation with the assumption of missing at random. Additional 
sensitivity analyses will be further outlined in the statistical analysis plan (SAP). 
The appropriate statistical models to each secondary 
endpoints will be specified 
in detail in the SAP. 
Data Monitoring Committee 
A Data Monitoring Committee will be used in the study. 
Other Committee: No 
No other review committee will be used in the study. 


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2 
SCHEDULE OF ACTIVITIES 
Table 2-1: 
Screening Procedural Outline (IM011134) 
 
Procedure 
Screening 
Visit 
Notes 
Eligibility Assessments 
Informed Consent 
X 
Enroll Participant 
X 
Enroll participant only after the protocol-specific informed consent has been signed. Obtain 
number from IRT. Participant who is not eligible should be screen-failed in IRT. 
Review Inclusion/Exclusion Criteria 
X 
See full inclusion/exclusion criteria in Section 6. 
Medical History 
X 
Record medical history, include current alcohol, illicit drug, tobacco, and nicotine product use. 
See Section 6 for eligibility criteria associated with medical history and surgical history. 
AA-related History 
X 
Record age of first onset of AA and history of episodes. 
Prior Alopecia-related Medications 
X 
Record prior treatments for AA and the responses to the therapies, including topical 
treatments. 
Other (Non-Alopecia Related) Prior and 
Concomitant Medications 
X 
Record prior medications taken within 4 weeks of the first dose of study intervention on Day 1 
and current medications. 
SALT Assessment 
X 
To assess eligibility; see Section 6 and Appendix 5. 
AA-IGA 
X 
To assess eligibility; see Section 6. 
Hamilton-Norwood Scale/Ludwig Scale 
Classification 
X 
To assess eligibility; see Section 6. 
Safety Assessments 
Complete Physical Examination 
X 
See Section 9.4.1. 
Physical Measurements 
X 
Height and weight. 
Vital Signs 
X 
Body temperature, respiratory rate, seated blood pressure, and heart rate. Blood pressure and 
heart rate should be measured after the participant has been resting quietly for at least 
5 minutes; see Section 9.4.2. 
12-lead ECG 
X 
Record ECGs after the participant has been supine for at least 5 minutes; see Section 9.4.3. 


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Table 2-1: 
Screening Procedural Outline (IM011134) 
 
Procedure 
Screening 
Visit 
Notes 
Chest Imaging (eg, X-ray, PA and Lateral) 
X 
Chest imaging is required if not performed within 6 months of Screening visit; a copy of the 
radiology report must be on file and reviewed by the investigator prior to dosing. 
Monitor for Serious AEs 
X 
Record all SAEs from the date of participant’s written consent. 
Monitor for SARS CoV-2-related AEs 
X 
Record all AEs (SAEs and non-serious AEs) related to SARS-CoV-2 infection from time of 
consent. 
Laboratory/Safety Assessments 
Clinical Safety Laboratory Assessments 
X 
Hematology, coagulation panel, chemistry panel, hemoglobin A1c, urinalysis, lipid panel 
(non-fasting); see Section 9.4.4. 
TSH 
X 
If TSH is above the normal reference range, test free T4. If TSH is below normal range, test 
free T4 and T3; see Section 9.4.4. 
Serology 
X 
HCV antibody with reflex to HCV RNA if positive; HBsAg, HBsAb, HBcAb with reflex HBV 
DNA if required; and HIV antibodies; see Section 9.4.4. 
For Japan-specific HBV serology requirements, see Appendix 9. 
Tuberculosis Screening 
X 
QuantiFERON-TB Gold test; see Section 6.2. Exclusion Criterion #3. 
Pregnancy Test (Serum) 
X 
WOCBP only; see Appendix 4. 
FSH (Serum) 
X 
To confirm menopausal status; see Appendix 4. 
Abbreviations: AA, alopecia areata; AA-IGA, Alopecia Areata Investigator Global Assessment; AE, adverse event; DNA, deoxyribonucleic acid; 
ECG, electrocardiogram; FSH, follicle-stimulating hormone; HBcAb, hepatitis B core antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface 
antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IRT, Interactive Response Technology; PA, posteroanterior; 
RNA, ribonucleic acid; SAE, serious adverse event; SALT, Severity of Alopecia Tool; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; 
T3, triiodothyronine; T4, thyroxine; TB, tuberculosis; TSH, thyroid-stimulating hormone; WOCBP, women of childbearing potential. 


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Table 2-2: 
On Treatment Procedural Outline (IM011134): Week 0 through Week 24 
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Procedure 
Week 0 
(D1)a 
Week 4 
(D29 ± 3 d) 
Week 8 
(D57 ± 3 d) 
Week 12 
(D85 ± 3 d) 
Week 16 
(D113 ± 3 d) 
Week 20 
(D141 ± 3 d) 
Week 24 
(D169 ± 3 d) 
Notes 
Eligibility Assessments 
Review 
Inclusion/Exclusion 
Criteria 
X 
To confirm eligibility. 
Randomize Participantb 
X 
Safety Assessments 
Complete Physical 
Examination 
X 
X 
See Section 9.4.1. 
Targeted Physical 
Examination 
X 
X 
X 
X 
X 
As clinically indicated for reported 
AE/SAE. See Section 9.4.1. 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
See Section 9.4.2. 
Body Weight 
X 
X 
X 
12-lead ECG 
X 
X 
See Section 9.4.3. 
AE and SAE Monitoring 
X 
X 
X 
X 
X 
X 
X 
See Section 9.2. 
AEs of Suicidal Ideation 
and Behavior Monitoring 
X 
X 
X 
X 
X 
X 
X 
See Section 9.2. 
Concomitant Medication 
Use Monitoring 
X 
X 
X 
X 
X 
X 
X 
Clinical Efficacy/Health Outcomes Assessments 
SALT Assessment 
X 
X 
X 
X 
X 
X 
X 
See Appendix 5. 
AA-IGA 
X 
X 
X 
X 
X 
X 
X 
See Section 9.1. 


Clinical Protocol 
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Table 2-2: 
On Treatment Procedural Outline (IM011134): Week 0 through Week 24 
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Procedure 
Week 0 
(D1)a 
Week 4 
(D29 ± 3 d) 
Week 8 
(D57 ± 3 d) 
Week 12 
(D85 ± 3 d) 
Week 16 
(D113 ± 3 d) 
Week 20 
(D141 ± 3 d) 
Week 24 
(D169 ± 3 d) 
Notes 
Hamilton-Norwood 
Scale/Ludwig Scale 
Classification 
X 
X 
Medical Photography 
(Scalp)c 
X 
X 
See Section 9.1.2. 
Medical Photography 
(Eyelashes and 
Eyebrows)d 
X 
X 
See Section 9.1.2. 
Laboratory Tests 
Hematology 
X 
X 
X 
X 
X 
X 
X 
See Section 9.4.4. 
Chemistry Panel 
X 
X 
X 
X 
X 
X 
X 
See Section 9.4.4. 
Fasting Lipid Panel 
X 
X 
X 
After at least a 10-hour fast. See 
Section 9.4.4. 
Fasting Glucose 
X 
X 
X 
After at least a 10-hour fast. See 
Section 9.4.4. 
Urinalysis 
X 
X 
See Section 9.4.4. 
Hemoglobin A1c 
X 
X 
Pregnancy Test (Urine)e 
X 
X 
X 
X 
X 
X 
X 
For WOCBP only. See Appendix 
4. 
HBV DNA Test (Japan 
only) 
X 
X 
X 
X 
X 
X 
X 
For participants with a negative 
HBsAg, but a positive HBcAb 


Clinical Protocol 
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IM011134 
deucravacitinib 
Table 2-2: 
On Treatment Procedural Outline (IM011134): Week 0 through Week 24 
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Procedure 
Week 0 
(D1)a 
Week 4 
(D29 ± 3 d) 
Week 8 
(D57 ± 3 d) 
Week 12 
(D85 ± 3 d) 
Week 16 
(D113 ± 3 d) 
Week 20 
(D141 ± 3 d) 
Week 24 
(D169 ± 3 d) 
Notes 
and/or HBsAb result at Screening. 
See Appendix 9. 
Study Intervention 
Dispense Study 
Intervention 
X 
X 
X 
X 
X 
X 
X 
Dispense study intervention after 
all visit procedures have been 
performed. 
Assess Study 
Intervention 
Compliance/Perform 
Study Intervention 
Accountability 
X 
X 
X 
X 
X 
X 
 
Abbreviations: AA-IGA, Alopecia Areata Investigator Global Assessment; 
AE, adverse event; BID, twice daily; 
D, Day; d, days; DNA, deoxyribonucleic acid; ECG, electrocardiogram; ED, early discontinuation; 
HBcAb, hepatitis B core antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; IRT, Interactive Response 
Technology; 
QD, once daily; SAE, serious adverse 
event; SALT, Severity of Alopecia Tool; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of childbearing potential. 
a All assessments and sample collections (laboratory test, 
 ) should occur before study intervention administration. 
b Participants will be randomized on Day 1 to either deucravacitinib (6 mg QD or 6 mg BID) or placebo; participants initially assigned to the placebo arm will 
be re-randomized in a blinded manner by IRT to deucravacitinib (6 mg QD or 6 mg BID) at Week 24. 
c Photography of the scalp is required. 
d Photography of eyebrows and eyelashes is optional and will only be performed on participants who provide consent. In those who consent, if new onset of 
eyebrows and/or eyelashes involvement (that is not involved at baseline) is observed after Day 1, a photograph should be taken at the visit when first observed, in 
addition to Week 24. 


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e If the urine pregnancy test is positive, a serum pregnancy test should be performed to confirm urine test results prior to initiation of study intervention on Day 
1 and prior to discontinuing the participant. Study intervention is not to be administered until the results of the confirmatory test are known and negative. 


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Table 2-3: 
On Treatment (Week 28 through Week 52) and Post-Treatment Follow-Up (Week 56) Procedural 
Outline (IM011134) 
 
Procedure 
Week 28 
(D197 ± 3 d) 
Week 32 
(D225 ± 3 d) 
Week 40 
(D281± 7 d) 
Week 48 
(D337 ± 7 d) 
Week 52/EDa 
(D365 ± 3 d) 
Week 56/Post- 
Treatment 
Follow-Up 
(D393 ± 3 d) 
Notes 
Safety Assessments 
Complete Physical Examination 
X 
See Section 9.4.1. 
Targeted Physical Examination 
X 
X 
X 
X 
X 
As clinically indicated for 
reported AE/SAE. See 
Section 9.4.1. 
Vital Signs 
X 
X 
X 
X 
X 
X 
See Section 9.4.2. 
Body Weight 
X 
X 
12-lead ECG 
X 
See Section 9.4.3 
AE and SAE Monitoring 
X 
X 
X 
X 
X 
X 
See Section 9.2. 
AEs of Suicidal Ideation and 
Behavior Monitoring 
X 
X 
X 
X 
X 
X 
See Section 9.2. 
Concomitant Medication Use 
Monitoring 
X 
X 
X 
X 
X 
X 
See Section 7.7. 
Clinical Efficacy/Health Outcomes Assessments 
SALT Assessment 
X 
X 
X 
X 
X 
X 
See Appendix 5. 
AA-IGA 
X 
X 
X 
X 
X 
X 
See Section 9.1. 
Hamilton-Norwood Scale/Ludwig 
Scale Classification 
X 
X 
Medical Photography (Scalp)b 
X 
X 
See Section 9.1.2. 


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Table 2-3: 
On Treatment (Week 28 through Week 52) and Post-Treatment Follow-Up (Week 56) Procedural 
Outline (IM011134) 
 
Procedure 
Week 28 
(D197 ± 3 d) 
Week 32 
(D225 ± 3 d) 
Week 40 
(D281± 7 d) 
Week 48 
(D337 ± 7 d) 
Week 52/EDa 
(D365 ± 3 d) 
Week 56/Post- 
Treatment 
Follow-Up 
(D393 ± 3 d) 
Notes 
Medical Photography (Eyelashes 
and Eyebrows)c 
X 
X 
See Section 9.1.2. 
Laboratory Tests 
Hematology 
X 
X 
X 
X 
X 
X 
See Section 9.4.4. 
Chemistry Panel 
X 
X 
X 
X 
X 
X 
See Section 9.4.4. 
Urinalysis 
X 
X 
X 
See Section 9.4.4. 
Fasting Lipid Panel 
X 
X 
X 
After at least a 10-hour 
fast. See Section 9.4.4. 
Fasting Glucose 
X 
X 
X 
After at least a 10-hour 
fast. See Section 9.4.4. 
Hemoglobin A1c 
X 
X 
Pregnancy Test (Urine)d 
X 
X 
X 
X 
X 
X 
WOCBP only. See 
Appendix 4. 
HBV DNA Test (Japan only) 
X 
X 
Testing will occur every 4 or 8 weeks (frequency of testing is 
at the discretion of the investigator). 
For participants with a 
negative HBsAg, but a 
positive 
HBcAb 
and/or 
HBsAb result at Screening. 
See Appendix 9. 


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Procedure 
Week 28 
(D197 ± 3 d) 
Week 32 
(D225 ± 3 d) 
Week 40 
(D281± 7 d) 
Week 48 
(D337 ± 7 d) 
Week 52/EDa 
(D365 ± 3 d) 
Week 56/Post- 
Treatment 
Follow-Up 
(D393 ± 3 d) 
Notes 
Table 2-3: 
On Treatment (Week 28 through Week 52) and Post-Treatment Follow-Up (Week 56) Procedural 
Outline (IM011134) 
 
 
 
Assess Study Intervention 
Compliance/ Perform Study 
Intervention Reconciliation 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Abbreviations: AA-IGA, Alopecia Areata Investigator Global Assessment; 
AE, adverse event; 
D, Day; d, days; DNA, deoxyribonucleic acid; ECG, electrocardiogram; ED, early discontinuation; HBcAb, hepatitis B core 
antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; 
SAE, serious adverse event; SALT, Severity of Alopecia Tool; WOCBP, women of childbearing 
potential. 
a ED: For participants who discontinue from the study prior to Week 52, all assessments scheduled for Week 52 are to be performed. 
b Photography of the scalp is required. 
c Photography of eyebrows and eyelashes is optional and will only be performed on participants who provide consent. In those who consent, if new onset of 
eyebrows and/or eyelashes involvement (that is not involved at baseline) is observed after Week 24, a photograph should be taken at the visit when first observed, 
in addition to Weeks 40 and 52. 
d If the urine pregnancy is positive, a serum pregnancy test should be performed to confirm urine test results prior to discontinuing the participant. Study 
intervention is not to be administered until the results of the confirmatory test are known and negative. 
Study Intervention 
Dispense study 
intervention after all visit 
procedures have been 
performed. 
 
X 
 
X 
 
X 
 
X 
Dispense Study Intervention 


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3 
INTRODUCTION 
Alopecia areata (AA) is a chronic, relapsing, immune-mediated inflammatory disorder affecting 
hair follicles (HFs), causing nonscarring hair loss. AA can range from small patches of smooth, 
sharply demarcated, round patches of alopecia on any hair-bearing area to the complete loss of 
scalp hair (alopecia totalis) eyebrow, eyelash, and even complete total body hair loss 
(alopecia universalis). 
The cardinal pathophysiology of AA is the collapse of the intrinsic immune privilege of healthy 
HFs. Normal hair growth is a life-long cyclic transformation involving anagen (active growth), 
catagen (involution), and telogen (quiescence) phases. AA is a chronic inflammatory disease of 
the HF that leads to premature and accelerated progression to catagen.1,2 In healthy individuals, 
the HF is one of the immune-privileged sites of the body, similar to the anterior chamber of the 
eye, characterized by low levels of major histocompatibility complex (MHC) class I/II 
expression, suppressed natural killer (NK) cell activity, and the presence of immune-suppressant 
proteins.3 The immune privilege in AA patients is effectively collapsed by perifollicular 
inflammation directed at the anagen phase HF bulb.4 AA lesional skin is manifested by infiltration 
of mast cells, Langerhans cells, dendritic cells, cluster of differentiation (CD) 4+ and CD8+ 
T cells5,6 and a potential establishment of tissue-resident memory CD8+ T cells.7 While 
autoreactive CD8+ T cell-mediated cytotoxicity of bulb melanocytes is an important pathogenic 
mechanism of hair loss, the TH1 effector cytokine IFNγ is a principal mediator of immune privilege 
collapse and anagen HF damage.8,9 In addition to T1 cells, natural killer group 2D+ (NKG2D+) 
cells and NK-T cells are significant sources of IFNγ that also participate in AA pathogenesis.10 In 
response  to IFNγ, AA lesional HFs secrete CXC motif chemokine ligand (CXCL) 10, a 
chemokine that recruits more T1 cells (TH1 [CD4+] and Tc1 [CD8+] T cells) from the periphery 
to ongoing lesions, thus effectively amplifying the loop. Therefore, targeted blockade of the IFNγ 
signaling pathway is a therapeutic concept currently being explored with other pharmacologic 
agents. Several case studies of off-label treatment of AA participants with tofacitinib, which is 
known to inhibit IFNγ signaling, further support such a therapeutic concept. IL-12 is known to 
promote the generation of IFNγ-secreting TH1 cells as well as to stimulate NK cells for IFNγ 
secretion. Apart from the dominant TH1 signature, transcriptome analyses in lesional skin of AA 
patients have revealed that IL-23 is also upregulated.11,12,13 Targeting the IL-12/23 pathway with 
biologic agents has been shown to be efficacious in Phase 2 studies in AA; case studies on 
blockade of IL-12 and IL-23 with ustekinumab have shown varying degrees of efficacy in AA 
participants.14,15 
A variety of topical, intralesional, and systemic agents are used as treatment options, but the 
response to treatment varies widely, and none is Food and Drug Administration (FDA) 
approved.16,17 Corticosteroids, either administered as an injection intradermally into the skin or 
applied topically as a cream, ointment, or gel, are the preferred initial treatment for participants 
with limited patchy AA. Second-line treatment options include contact immunotherapies, 
calcineurin inhibitors, and hair growth-stimulating solutions. However, while treatments can 


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induce hair growth in some participants, not only are results variable but none has been shown to 
alter the long-term course of the disease.16,17 There are several compounds currently in Phase 2 
and Phase 3 development, the majority being JAK inhibitors (eg, baricitinib, ruxolitinib, and 
ritlecitinib), which have demonstrated potential benefit in the treatment of AA. Baricitinib 
(JAK1/2 inhibitor) Phase 3 studies showed positive results in the treatment of AA.18,19,20 The 
primary endpoint was met in both studies (proportion of participants achieving SALT score ≤ 20 
at Week 36) and no deaths, thromboembolic events, opportunistic infections, or gastrointestinal 
(GI) perforations occurred. 
Managing AA involves addressing the psychological needs of the patients. Many describe it as a 
chronic disease that touches multiple aspects of their daily lives and for many this can lead to 
anxiety and depression.21 Patients with AA consistently demonstrate poor health-related quality 
of life similar to that seen in other chronic skin diseases including atopic dermatitis and psoriasis.22 
The lack of long-term effective treatments and the impact of AA on quality of life represent a 
significant unmet medical need. 
3.1 
Study Rationale 
Tyrosine Kinase 2 (TYK2) is a nonreceptor tyrosine kinase associated with receptors for the 
p40-containing cytokines interleukin (IL)-12 and IL-23, as well as the Type I interferon (IFN) 
receptor, and is required for the activation of their downstream signaling pathways. TYK2 
catalyzes the phosphorylation of the intracellular receptor domains and signal transducer and 
activator of transcription (STAT) proteins, resulting in the activation of STAT-dependent 
transcription and functional responses specific for these cytokines.23,24,25 TYK2-dependent 
pathways and the cytokine networks they modulate have been implicated in the pathophysiology 
of multiple immune-mediated diseases. 
Deucravacitinib (Bristol-Myers Squibb Company [BMS]-986165) is a potent, highly selective, oral 
small molecule inhibitor of TYK2 that binds to the regulatory domain of TYK2 and stabilizes the 
inhibitory interactions between the pseudokinase and the catalytic domains of the enzyme. The 
binding mode of deucravacitinib takes advantage of unique structural features of the TYK2 
pseudokinase domain compared to other kinases and pseudokinases to provide high biochemical, 
cellular, and functional selectivity. This approach differentiates deucravacitinib from nonselective 
inhibitors of the Janus kinase (JAK) family of kinases that target the highly conserved adenosine 
triphosphate-binding site within the active site of the catalytic domain. As a result, deucravacitinib 
selectively blocks the IL-23, IL-12, and Type I IFN pathways involved in inflammatory diseases, 
without inhibiting -pathways mediated by JAK1/JAK3 (eg, IL2, IL-15, IL-7), -JAK2/JAK2 (eg, 
erythropoietin, thrombopoietin, granulocyte macrophage colony-stimulating factor), or 
JAK1/JAK2 (eg, IFNγ, IL-6). Therefore, deucravacitinib demonstrates a highly differentiated 
profile from inhibitors of closely related JAKs 1-3. Deucravacitinib could potentially interfere with 
the pathophysiology of AA. By blocking IL-12 receptor signaling, which is a critical upstream 
event of TH1 development, deucravacitinib may reduce local IFNγ production at newly 
developing lesions.26,27 In addition, deucravacitinib may minimize the spread of lesions since 
the emerging data suggest that T1 clonal expansion and maintenance of memory cell 


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population depends on IL-12 receptor signaling. In support of this, a pre-clinical animal study 
employing a xenograft model of AA demonstrated that immune-mediated hair loss was reversed 
by therapeutic treatment with BMS-986202, an analogue of deucravacitinib. Clinical data from a 
Phase 1 study in healthy volunteers  (IM011002) showed that deucravacitinib reduced 
IL-12-induced IFNγ production from whole blood cells in a dose dependent manner. Further, 
deucravacitinib has been shown to be effective in the treatment of psoriasis (see below), an 
IL-23-mediated disease. Thus, these data support the clinical development of deucravacitinib for 
the treatment of AA. 
This Phase 2 study is intended to determine whether inhibition of TYK2 is associated with clinical 
improvement of AA disease activity and modulation of related 
 as well as to assess the 
safety, and tolerability of deucravacitinib in participants with AA in order 
to determine the dosage that provides the optimal benefit/risk assessment in this population. 
3.2 
Background 
A comprehensive in vitro and in vivo characterization of deucravacitinib has been established and 
supports the development of this compound in humans. Furthermore, clinical data available from 
multiple Phase 1 studies in healthy participants, Phase 2 (IM011011) and Phase 3 (IM011046 and 
IM011047) studies in adult participants with moderate-to-severe plaque psoriasis (PsO), and a 
Phase 2 (IM011084) study in adult participants with psoriatic arthritis (PsA) helped to establish 
the safety of deucravacitinib and to characterize the PK and pharmacodynamic (PD) properties of 
deucravacitinib. 
The 2 Phase 3 studies (IM011046 and IM011047) demonstrated the efficacy and safety of 
deucravacitinib in participants with moderate-to-severe PsO. In both studies, statistical 
significance was achieved for the deucravacitinib group compared with placebo for the co-primary 
endpoints at Week 16 (Static Physicians Global Assessment [sPGA] 0/1 response, Psoriasis Area 
Severity Index [PASI] 75 response). Deucravacitinib also demonstrated an acceptable safety and 
tolerability profile compared with placebo and apremilast (a positive control). The overall 
frequency of adverse events (AEs) in the 16-week placebo-controlled period in the deucravacitinib 
group was comparable to the apremilast group and higher than the placebo group. The most 
common AEs (> 5%) in the deucravacitinib group were nasopharyngitis and upper respiratory tract 
infection. There is no evidence of an increased risk of major adverse cardiac events (MACE) or 
extended MACE associated with deucravacitinib. The overall incidence of SAEs was low and 
comparable across treatment groups. Serious or systemic opportunistic or fungal infections were 
not observed.28 
Deucravacitinib is also being developed for oral treatment of other immune-mediated diseases 
such as PsA, systemic lupus erythematosus (SLE), Crohn’s disease, and ulcerative colitis (UC). 
3.3 
Benefit/Risk Assessment 
At this early stage in the development of deucravacitinib for the treatment of participants with AA, 
assessments of benefit and risk rely on nonclinical data and the experience of participants in 
clinical trials for other indications. The dosages administered in this study are within the range 


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tested in the first-in-human (FIH) study that had been shown to be safe and well tolerated; the 6 mg 
once daily (QD) dosage has also been extensively characterized in patients with psoriasis. 
Deucravacitinib is being studied at various doses in other programs, including 6 mg QD and 12 mg 
QD in PsA; 6 mg BID and 12 mg BID in UC; and 3 mg BID, 6 mg BID, and 12 mg QD in Crohn’s 
disease and SLE. 
Findings in toxicology studies were consistent with expectations based on the pharmacology of 
deucravacitinib. Please refer to current version Investigator’s Brochure (IB). 
The risk for PK drug-drug interactions (DDIs) with deucravacitinib was assessed based on in vitro 
studies, clinical DDI studies, and relevant regulatory guidance. At the maximum concentrations 
expected in this study, the potential for DDIs involving drug- metabolizing enzymes and 
transporters is low. A thorough QT study (IM011048) indicated no effect on corrected QT and 
other relevant electrocardiographic parameters, even at a supratherapeutic dose of 36 mg. 
Nonclinical data and clinical experience, indicate an overall favorable risk/benefit assessment 
for investigating deucravacitinib at dosages of 6 mg QD and 6 mg BID in the current Phase 2 
study in AA. Detailed information about the known and expected benefits and risks and 
anticipated adverse events (AEs) of deucravacitinib is provided in the IB. 
The global coronavirus disease 2019 (COVID-19) pandemic has been identified as a potential risk 
to clinical trial participants in general, and it may particularly affect individuals who are on 
immunosuppressive therapies for underlying chronic diseases. At this time, the Sponsor is tracking 
and accumulating data on COVID-19 and its potential effects on participants taking 
deucravacitinib. The data are analyzed on a regular basis. The risk of COVID-19 for participants 
taking deucravacitinib is still unknown due to insufficient clinical data. Deucravacitinib is an 
immunomodulator; therefore, participants taking deucravacitinib may have a higher chance of 
infections. Accordingly, this study has exclusion criteria aimed at minimizing the risk for serious 
infection and a study visit schedule that allows for monitoring of participants’ safety. 
In addition, the Sponsor has developed a guidance for investigators on how to manage a participant 
with a clinical suspicion of, or a diagnosis of, COVID-19. This includes criteria for temporarily 
interrupting or permanently discontinuing the investigational product (IP; Section 8.1 and Section 
8.1.1), and criteria for reinitiating IP on resolution of a COVID-19 infection (Section 8.1.1). 
Investigators should apply clinical judgment and consider the risks and benefits of interruption 
versus continuation of deucravacitinib therapy in participants who are enrolled in this study. In 
order to facilitate reporting of COVID-19 events that occur during the study, all AEs and SAEs 
associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or 
COVID-19 must be reported, regardless of relatedness or causality (Section 9.2.2). 
COVID-19-related AEs or SAEs reported after randomization will also trigger additional data 
collection through specialized electronic Case Report Form (eCRF) pages, which will allow the 
Sponsor to further evaluate these events. Testing to exclude participants with COVID-19 infection 
prior to enrollment and to inform decisions about participant care during the study should follow 
local standard practice and requirements. 


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4 
OBJECTIVES AND ENDPOINTS 
Table 4-1: 
Objectives and Endpoints 
 
Objectives 
Endpoints 
Primary 
Efficacy 
To evaluate the efficacy of 
deucravacitinib versus placebo at 
Week 24 
• Change from baseline in SALT score at Week 24 
Safety 
To evaluate the safety and tolerability of 
deucravacitinib versus placebo 
• Incidence of SAEs, AEs, AEs leading to study discontinuation, 
and AEIs 
• Change in laboratory, ECG, physical examination, and vital sign 
parameters over time 
Secondary 
Efficacy 
To evaluate the efficacy of 
deucravacitinib versus placebo on 
additional endpoints at Week 24 
• Proportion of participants achieving a ≥ 50% reduction in SALT 
score (SALT50 response) from baseline at Week 24 
• Proportion of participants achieving a SALT score ≤ 20 at 
Week 24 
• Proportion of participants achieving an AA-IGA score of 0 or 1 at 
Week 24 with at least a 2-point change from baseline 


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Abbreviations: AA, alopecia areata; AA-IGA, Alopecia Areata Investigator Global Assessment; 
ECG, electrocardiogram; AE, adverse event; 
ECG, electrocardiogram; 
SAE, serious adverse event; SALT, Severity of Alopecia Tool; 
. 
Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
 


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5 
STUDY DESIGN 
5.1 
Overall Design 
This is a randomized, placebo-controlled, double-blind, parallel group, multi-center Phase 2 
study to evaluate the efficacy and safety of 2 dosages of deucravacitinib (6 mg QD and 6 mg BID) 
in participants with AA. 
The primary endpoint of the study is the change from baseline in Severity of Alopecia Tool 
(SALT) score at Week 24. 
The total duration of participation in the study will be approximately 60 weeks as follows: 
• Screening Period: up to 4 weeks 
• Placebo-controlled Treatment Period: 24 weeks (Day 1 to Week 24) 
• Active Treatment Period: 28 weeks (Weeks 24 to 52) 
• Post-Treatment Follow-up Period: 4 weeks (Weeks 52 to 56) 
 
The study design schematic is presented in Figure 5.1-1. 
Eligible participants will be randomized on Day 1, in a blinded manner, to receive deucravacitinib 
6 mg QD, deucravacitinib 6 mg BID, or placebo in a 1:1:1 ratio. Randomization will be stratified by 
current duration of disease episode: < 4 years and ≥ 4 years. At the Week 24 study visit, the 
participants initially randomized to receive placebo will be re-randomized 1:1 in a blinded manner 
to receive deucravacitinib (6 mg QD or 6 mg BID) until Week 52. Participants initially randomized 
to deucravacitinib will continue on their assigned dosage in a blinded manner. 
Efficacy and safety will be assessed throughout the study; samples will be collected for 
assessments and to characterize the 
 properties of deucravacitinib, as per the Schedule of 
Activities (Section 2). 
A database lock will be performed after all randomized participants have reached Week 24 or have 
discontinued prior to Week 24. 


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Figure 5.1-1: 
Study Design Schematic 
 
Abbreviations: BID, twice daily; N, number; QD, once daily. 
 
 
5.1.1 
Data Monitoring Committee and Other External Committees 
An independent external Data Monitoring Committee (DMC) will be charged with monitoring 
accumulating data from the trial, as well as general aspects of trial conduct. The committee will 
meet periodically during the study to review aggregate summaries of the efficacy and safety data 
from the trial. All members are selected with consideration for their respective expertise in the 
subject matter and/or in their experience in convening or participating in a DMC. Based on their 
overall benefit/risk evaluation, the DMC recommendations may include proceeding with the study 
per protocol, proceeding with the study with modification, or study suspension. The scope, 
conduct, membership, processes, and accountabilities of the DMC are specified in the DMC 
charter. 
5.2 
Number of Participants 
Approximately 90 participants will be randomized on Day 1 into 1 of 3 treatment arms in a 
1:1:1 ratio, resulting in 30 participants in each deucravacitinib treatment arm (6 mg QD and 
6 mg BID) and 30 participants in the placebo arm. 
Further details on sample size calculations are provided in Section 10.1. 
5.3 
End of Study Definition 
The start of the trial is defined as the first visit for first participant screened. 
End of trial is defined as the last visit or scheduled procedure shown in the Schedule of Activities 
for the last participant. 
Primary completion is defined as the final date on which data for the primary endpoint were 
or are expected to be collected, if this is not the same. 
A participant is considered to have completed the study if he/she has completed the last visit. 


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5.4 
Scientific Rationale for Study Design 
The purpose of the study is to gain a preliminary understanding of the efficacy and safety of 
deucravacitinib administered for up to 52 weeks in participants with AA. 
The primary efficacy endpoint assessment, change from baseline in SALT score, at Week 24 
accounts for the period required to demonstrate improvement in an accurate and reliable manner in 
this condition and is consistent with the design of AA clinical trials with other agents. A placebo 
control arm is included for the first 24 weeks to allow the effects of treatment to be appropriately 
attributed to study interventions received. At Week 24, participants in the placebo arm will be 
re-randomized 1:1 in a blinded manner to receive deucravacitinib (6 mg QD or 6 mg BID) for 
the remainder of the study; this will allow all study participants to receive deucravacitinib. 
Participants initially randomized to active study intervention will continue to receive their assigned 
dosage of deucravacitinib in a blinded manner for an additional 28 weeks, which will allow for 
an assessment of long- term safety and efficacy. 
Randomization on Day 1 will be stratified by the duration of the current disease episode as this 
may impact potential responsiveness to study intervention for AA. 
deucravacitinib and 
assessments will be performed to characterize the biological activity of 
properties, respectively, of the 2 dosages in participants with AA. 


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6 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
For entry into the study, the following criteria MUST be met. 
6.1 
Inclusion Criteria 
1) Signed Written Informed Consent 
a) Participant must be willing and able to participate in the study and sign the ICF 
b) Participant must be willing and able to complete all study-specific procedures and visits 
2) Type of Participant and Target Disease Characteristics 
a) Documented clinical diagnosis of AA for at least 6 months 
b) Current episode of scalp hair loss (at Screening) must meet the following criteria: 
i) Duration at least 6 months 
ii) Duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 
8 years 
iii) Scalp hair loss has been stable ( ie, no significant spontaneous regrowth [> 10%] over 
the last 6 months) 
c) SALT score ≥ 50 at Screening and Day 1 (see Appendix 5) 
Participant with complete scalp hair loss (SALT score of 100) with or without body hair 
involvement can be included. 
d) Participant must have an Alopecia Areata Investigator Global Assessment ( AA-IGA) 
grade ≥ 3 at Screening and Day 1. 
e) Participant should not shave their scalp from 7 days prior to the Screening visit and agree 
to not shave their scalp 7 days prior to each study visit, to allow for SALT assessment of 
hair regrowth. If participant is using a hairpiece or wig, the participant must be willing and 
able to remove the hair prosthetic at each appointment. Participant should maintain a stable 
hair style to allow for reliable and consistent assessment of SALT throughout the study. 
f) Participant with current or a history of androgenetic alopecia can be included as long as, 
in the opinion of the investigator, the participant has either of the following classifications: 
Ludwig Scale30 ≤ II for women; Hamilton-Norwood Scale31 ≤ III for men. 


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Note: A male participant with Hamilton-Norwood III vertex or Hamilton-Norwood IIIa 
classification will be excluded. 
3) Age of Participant 
a) Men and women aged ≥ 18 years to ≤ 65 years at the time of Screening visit. 
4) Reproductive Status 
• Investigators shall counsel women of childbearing potential (WOCBP) participants, and male 
participants who are sexually active with WOCBP, on the importance of pregnancy prevention 
and the implications of an unexpected pregnancy. 
• The investigator shall evaluate the effectiveness of the contraceptive method in relationship to 
the first dose of study intervention. 
• Local laws and regulations may require the use of alternative and/or additional contraception 
methods. 
a) Female Participants: 
i) Women who are not of childbearing potential (as defined in Appendix 4) are exempt 
from contraceptive requirements. 
ii) Woman of childbearing potential (WOCBP) must have a negative highly sensitive 
serum pregnancy test at Screening Visit, and a negative urine pregnancy test (minimum 
sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 
24 hours prior to the start of study treatment. 
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum 
pregnancy test is required. In such cases, the participant must be excluded from 
participation if the serum pregnancy result is positive. 
• Additional requirements for pregnancy testing during and after study intervention 
are located in the Schedule of Activities. 
• The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy. 
iii) WOCBP must agree to follow instructions for method(s) of contraception defined in 
Appendix 4 and as described below and included in the ICF. 
• WOCBP is permitted to use hormonal contraception methods (as described in 
Appendix 4). 
iv) A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least one of the following conditions applies: 
(1) Is not a WOCP 
OR 
(2) Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of < 1% per year), preferably with low user dependency, as described 
in Appendix 4, during the study period until the end of the study. 
b) Male participants: 
i) A male participant should maintain his usual practice with regard to contraception (if 
any); however, no specific contraceptive measures are required. 


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6.2 
Exclusion Criteria 
1) Exclusionary Disease Characteristics 
a) Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, 
lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc 
b) Other active skin diseases affecting the scalp that in the opinion of the investigator may 
interfere with accurate assessment of SALT score 
c) Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with 
the accurate assessment of SALT score 
2) Infectious/Immune-related Exclusions 
a) In the event of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 
within 4 weeks prior to Screening: 
i) Symptoms must have completely resolved and, based on investigator assessment in 
consultation with the Medical Monitor, there are no sequelae that would place the 
participant at a higher risk of receiving investigational study intervention. See 
Section 6.4.1. 
b) History or evidence of active infection and/or febrile illness within 14 days prior to Day 1 
c) History of serious bacterial, fungal, or viral infection requiring hospitalization and 
intravenous (IV) antimicrobial treatment within 60 days prior to Day 1 
d) Received live vaccines within 60 days prior to Day 1, or plans to receive a live vaccine 
during the study 
e) Presence of herpes zoster lesions at Screening or Day 1, or history of serious herpes zoster 
or serious herpes simplex infection which includes, but is not limited to, any episode of 
disseminated herpes simplex, multidermatomal herpes zoster, herpes encephalitis, 
ophthalmic herpes, or recurrent herpes zoster 
f) Evidence of, or positive test for, hepatitis C virus (HCV) or hepatitis B virus (HBV) at 
Screening. The hepatitis screen includes testing for hepatitis B surface antigen (HBsAg), 
hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) immunoglobulin 
G/M (IgG/IgM), followed by HBV deoxyribonucleic acid (DNA) testing if required, and 
antibodies to hepatitis C, confirmed by an HCV ribonucleic acid (RNA) testing if required. 
See Section 9.4.4 and Appendix 9. 
For Japan: Participants who are HBsAg positive will be excluded from the study. 
Participants who are HBsAg negative but positive for HBsAb and/or HBcAb may be 
eligible and must also be tested for quantitative HBV DNA. Participants with detectable 
levels as specified by local guidelines at Screening will be excluded; see Appendix 9. 
Participants with HBV DNA < 2.1 Log copy/mL (20 IU/mL) can be enrolled in the study 
but must undergo periodic monitoring of HBV DNA and liver enzymes, such as aspartate 
aminotransferase (AST) and alanine aminotransferase (ALT). Monitoring should be 
performed every 4 weeks, up to and including the Week 32 study visit. Starting with Week 
40, testing should occur every 4 or 8 weeks, at the discretion of the investigator, through 
the end of the study. 
g) Positive test for human immunodeficiency virus by antibody testing at Screening 
h) Any history of known or suspected congenital or acquired immunodeficiency state or 
condition that would compromise the participant’s immune status (eg, history of 


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opportunistic infections [eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or 
coccidioidomycosis], history of splenectomy, primary immunodeficiency) 
3) Any of the following tuberculosis (TB) criteria: 
a) History of active TB prior to Screening visit, regardless of completion of adequate 
intervention 
b) Signs or symptoms of active TB (eg, fever, cough, night sweats, and weight loss) during 
Screening as judged by the investigator 
c) Any imaging of the chest (eg, chest X-ray, chest computed tomography scan) obtained 
during the Screening period or anytime within 6 months prior to the Screening visit with 
documentation, showing evidence of current active or history of active pulmonary TB 
d) Latent TB infection (LTBI) defined as a positive IFN gamma release assay (IGRA), by 
QuantiFERON-TB Gold test at Screening, in the absence of clinical manifestations 
e) Participant may be eligible if there are no current signs or symptoms of active TB AND 
participant has received adequate documented treatment for LTBI within 5 years of 
Screening OR has initiated prophylactic treatment for LTBI per local guidelines. 
i) For participant that is not currently on prophylactic treatment for LTBI per local 
guidelines, including participant that has documented completed treatment for LTBI 
within 5 years of Screening, results of initial IGRA test that is indeterminate with no 
signs or symptoms of active TB must be retested for confirmation. If the second test is 
again indeterminate, the participant will be excluded from the study. If the retest is 
positive, the participant must be treated as having LTBI. If the retest is negative, the 
participant may be eligible provided no other exclusion criteria for TB are met. 
ii) For participant on prophylactic treatment for LTBI per local guidelines, and there are no 
current signs or symptoms of active TB, retesting of an initial positive or 
indeterminate result is not required and participant may be eligible provided no other 
exclusion criteria for TB are met, and participant continues to complete treatment for 
LTBI per local guidelines. 
4) Medical History and Concurrent Diseases 
a) Any major illness/condition or evidence of an unstable clinical condition (eg, renal, 
hepatic, hematologic, gastrointestinal (GI), endocrine, pulmonary, psychiatric, neurologic, 
immunologic, or local active infection/infectious illness) that, in the investigator’s 
judgment or after consultation with the Medical Monitor, will substantially increase the 
risk to the participant if he or she participates in the study. 
b) Any major surgery within 4 weeks prior to study intervention administration (Day 1). 
c) Drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day 1. 
d) Unstable coronary heart disease or other cardiovascular disease, defined as a recent clinical 
cardiovascular event (eg, cardiac arrhythmias, unstable angina, unstable ischemic heart 
disease, myocardial infarction, stroke, rapid atrial fibrillation) in the 3 months prior to 
Screening, or a cardiac hospitalization (eg, revascularization procedure, pacemaker 
implantation) within 3 months prior to Screening. 
e) Uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) 
> 160 mm Hg or diastolic BP > 100 mm Hg at Screening. 


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Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this 
limit, the BP may be repeated once after the participant has rested sitting for ≥ 10 minutes. 
If the repeat value is less than the criterion limits, the second value may be accepted. 
f) Class III or IV congestive heart failure by New York Heart Association criteria 
g) Participant has cancer or history of cancer (solid organ or hematologic including 
myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years 
(other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of 
cervix in situ that has been treated with no evidence of recurrence) 
h) Any sound medical, psychiatric, and/or social reason as determined by the investigator 
during Screening or at Day 1 
5) Previous/Concomitant Therapy 
a) Prior exposure to deucravacitinib 
b) History of lack of response to ustekinumab, in the opinion of the investigator, (or any other 
therapeutic agent targeted to IL-12, IL-17, or IL-23) after at least 3 months of therapy 
c) History of lack of response to a JAK inhibitor (eg, tofacitinib, ruxolitinib), in the opinion 
of the investigator 
d) Thyroid medication or thyroid replacement therapies, if used, must be stable for 2 months 
and be maintained as such throughout the study. 
e) Any ongoing treatment known to affect hair growth including, but not limited to, topical 
steroids (applied to the scalp), intralesional steroids, systemic steroids, anthralin, squaric 
acid, diphenylcyclopropenone, topical calcineurin inhibitors (applied to the scalp), 
cyclosporine, finasteride/minoxidil (oral or topical) or other medication that cannot be 
discontinued at least 4 weeks prior to study intervention initiation (Day 1) and throughout 
the study. 
f) Ongoing treatment with an immune system modulator or suppressant that cannot be 
discontinued at least 4 weeks or 5 times the elimination half-life prior to study intervention 
initiation (Day 1) and throughout the study. 
g) Treatment with an experimental antibody or experimental biologic therapy within 
6 months prior to Day 1, OR received any other experimental therapy or new 
investigational agent within 4 weeks or 5 half-lives (whichever is longer) prior to study 
intervention initiation (Day 1) and throughout the study, OR is currently enrolled in an 
investigational study. 
6) Physical and Laboratory Evaluations 
a) At Screening 
i) Absolute white blood cell count < 3,000/mm3 
ii) Absolute lymphocyte count < 500/mm3 
iii) Absolute neutrophil count < 1,000/mm3 
iv) Platelet count < 100,000/mm3 
v) Hemoglobin < 9 g/dL 
vi) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 × upper 
limit of normal (ULN) 


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vii) Total unconjugated and/or conjugated bilirubin >2 × ULN 
b) Electrocardiogram (ECG) abnormalities that are considered clinically significant and 
would pose an unacceptable risk to the participant if participating in the study at Screening 
and Day 1. 
c) Clinically significant abnormalities in laboratory testing including (but not limited to): 
i) Serum creatinine > 2 × ULN or renal impairment based on an estimated glomerular 
filtration rate (eGFR) < 45 mL/min/1.73 m2 (calculated using the Modification of Diet 
in Renal Disease [MDRD] equation) at Screening 
d) Inability to have venipuncture performed and/or tolerate venous access 
e) Any other significant laboratory abnormalities that, in the opinion of the investigator, might 
place the participant at unacceptable risk for participation in this study 
7) Allergies and adverse drug reactions which, in the opinion of the investigator, could affect 
the safety of the participant 
8) Hypersensitivity to any component of the study medication formulation; if there is a 
significant drug allergy or anaphylaxis consult with the Medical Monitor. 
9) Other Exclusion Criteria 
a) Prisoner or participant who is involuntarily incarcerated. (Note: Under certain specific 
circumstances, and only in countries where local regulations permit, a person who has been 
imprisoned may be included or permitted to continue as a participant. Strict conditions 
apply, and BMS approval is required.) 
b) Participant who is compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness 
c) Inability to comply with restrictions and prohibited activities/treatments as listed in the 
study protocol 
d) Site personnel or their immediate family 
e) Inability to tolerate oral medication. 
 
6.3 
Lifestyle Restrictions 
No restrictions are required. 
6.3.1 
Meals and Dietary Restrictions 
Study intervention may be taken without regard to meals. However, blood samples for laboratory 
assessments are to be collected in a fasted state at specified visits. Refer to Schedule of Activities 
(Section 2). 
6.3.2 
Caffeine, Alcohol and Tobacco 
No restrictions are required; however, excessive use of caffeine, alcohol, and tobacco or other 
nicotine-containing products should be avoided. 


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6.3.3 
Activity 
Participants are to refrain from strenuous physical activity (activity that is more strenuous than 
the participant’s usual daily activity) 1 day prior to blood draw for chemistry panel, which includes 
creatine kinase. 
6.4 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized in the study/included in the analysis population. 
A minimal set of screen failure information is required to ensure transparent reporting of screen 
failure participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) 
publishing requirements, as applicable, and to respond to queries from regulatory authorities. 
Minimal information includes date of consent, demography, screen failure details, eligibility 
criteria, and any serious (AEs). 
6.4.1 
Retesting During Screening or Lead-In Period 
Laboratory and/or clinical assessments that are included in Table 2-1, the Schedule of Activities, 
Screening Procedural Outline, may be repeated in an effort to find all possible well-qualified 
participants. Consultation with the Medical Monitor may be needed to identify whether repeat 
testing of any particular parameter is clinically relevant. 
The study permits the re-screening (after the end of the initial 4-week Screening period) of a 
participant who discontinues the study as a pretreatment failure (ie, the participant fails Screening 
and has not been treated). The participant must be re-consented and will be assigned a new 
identification number, and a full Screening visit must be performed again. A participant can only 
be rescreened once. Depending on the timing of re-screening, repetition of some assessments may 
not be required. Duration of existing treatments and required discontinuation periods shall be 
considered relative to the start of study intervention (Day 1). The most current result prior to 
randomization is the value by which study inclusion will be assessed, because it represents the 
participant’s most current clinical state. 
Testing for asymptomatic COVID-19 infection via molecular testing is not required. However, 
some participants may develop suspected or confirmed symptomatic COVID-19 infection, or be 
discovered to have asymptomatic COVID-19 infection during the Screening period. In such cases, 
participants may be considered eligible for the study after meeting all inclusion/exclusion criteria 
related to active infection, and after meeting the following criteria: 
• At least 10 days (20 days for severe/critical illness) have passed since symptoms first appeared 
or positive test result, and 
• At least 24 hours have passed since last fever without the use of fever-reducing medications, 
and 
• Symptoms (eg, cough, shortness of breath) have resolved, and 
• In the opinion of the investigator, there are no COVID-19 sequelae that may place the 
participant at a higher risk of receiving investigational study intervention, and 


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• Negative follow-up molecular test for COVID-19 based on institutional, local or regional 
guidelines 
 
7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, 
procedure(s) or medical device intended to be administered to a study participant according to 
the study protocol. 
Study intervention includes both Investigational ( Medicinal) Product (IP/IMP) and 
Non-investigational/Auxiliary (Medicinal) Product (Non-IP/Non-IMP/AxMP) as indicated in 
Table 7.1-1. 
An IP, also known as IMP in some regions, is defined a pharmaceutical form of an active 
substance or placebo being tested or used as a reference in a clinical study, including products 
already with a marketing authorization but used or assembled (formulated or packaged) differently 
from the authorized form, or used for an unauthorized indication, or when used to gain further 
information about the authorized form. 
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered 
Non⎯IPs/AxMPs. 
Table 7.1-1 shows the study interventions for this study. 
7.1 
Study Interventions Administered 
Study intervention will be administered BID as tablets for 52 weeks. Study intervention will be 
supplied in blister cards. The tablets will be arranged into sets with 1 tablet to be taken in the 
morning and 1 tablet to be taken in the evening, approximately 12 hours apart. Study intervention 
may be taken with or without food. If the participant forgets a dose but remembers within 
4 hours of the planned dose time, the dose should be taken. If the missed dose is remembered 
more than 4 hours after it should have been taken, that dose should not be taken and the next 
scheduled dose should be taken at the usual time. 
On Day 1 and at study visits when pre-dose 
 samples will be collected, 
study intervention should be administered at the site. 
The selection and timing of dose for each participant is as follows: 
Table 7.1-1: 
Study Interventions 
 
Intervention Name 
Deucravacitinib 
(BMS⎯986165) QD 
Deucravacitinib 
(BMS⎯986165) BID 
Placebo (BID) 
Type 
drug 
drug 
N/A 
Dose Formulation 
tablet 
tablet 
tablet 
Unit Dose Strength 
6 mg 
6 mg 
N/A 


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Table 7.1-1: 
Study Interventions 
 
Intervention Name 
Deucravacitinib 
(BMS⎯986165) QD 
Deucravacitinib 
(BMS⎯986165) BID 
Placebo (BID) 
Dosage Level and 
Frequency 
6 mg QD (1 active tablet in 
morning and 1 placebo 
tablet in evening) 
6 mg BID (1 active tablet in 
morning and 1 active tablet 
in evening) 
BID (1 placebo tablet in 
morning and 1 placebo 
tablet in evening) 
Route of 
Administration 
oral 
oral 
oral 
Use 
experimental 
experimental 
placebo 
IMP and Non- 
IMP/AxMP 
IMP 
IMP 
IMP 
Sourcing 
Provided centrally by the 
Sponsor 
Provided centrally by the 
Sponsor 
Provided centrally by the 
Sponsor 
Packaging and 
Labeling 
Study intervention will be 
provided in blister cards. 
Each blister card will be 
labeled as required per 
country requirement 
Study intervention will be 
provided in blister cards. 
Each blister card will be 
labeled as required per 
country requirement 
Study intervention will be 
provided in blister cards. 
Each blister card will be 
labeled as required per 
country requirement 
Abbreviations: AxMP, Auxiliary Medicinal Product; BID, twice daily; IMP, Investigational Medicinal Product; 
mg, milligram; N/A, not applicable; PO, per os; QD, once daily. 
 
7.2 
Method of Study Intervention Assignment 
At the time of the Screening visit, immediately after informed consent is obtained and before any 
study-related procedures are performed, the investigative site will access the enrollment option 
utilizing Interactive Response Technology (IRT) for assignment of a participant number (including 
a participant not subsequently randomized or treated). This number will be unique across all sites. 
Enrolled participants, including those not dosed, will be assigned sequential participant numbers. 
The participant number may not be used for any other participant. If a potential participant is 
rescreened, they will be given a new identification number. 
Eligible participants will be centrally randomized on Day 1/Week 0, using IRT, to receive oral 
treatment with deucravacitinib (6 mg QD or 6 mg BID) or placebo BID in accordance with the 
stratification criteria. Randomization numbers will be assigned prior to dosing. At the Week 24 
study visit, the participants initially randomized to receive placebo will be automatically 
re-randomized by the IRT to receive deucravacitinib (6 mg QD or 6 mg BID) in a blinded manner 
until Week 52; participants initially randomized to receive deucravacitinib (6 mg QD or 6 mg BID) 
will remain on their assigned study intervention, in a blinded manner, until Week 52. 
7.3 
Blinding 
Study intervention will be blinded to study personnel and participants prior to final database 
lock. BMS personnel will also be blinded to study intervention during the first 24 weeks of 
placebo-controlled intervention. However, following the Week 24 database lock, designated BMS 
personnel may have access to the unblinded data. The study team members who are responsible 


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for managing the study and are site-facing, will remain blinded to treatment assignment and the 
results of this analysis. Additionally, a bioanalytical scientist (or a designee in the external 
central bioanalytical laboratory) may be unblinded (obtain the randomization codes) prior to 
database lock to facilitate the bioanalytical analysis of 
 samples in order to minimize 
unnecessary bioanalytical analysis of samples. Of note, for operational considerations, the 
managers of drug supply and IRT will be unblinded to study intervention throughout the study. 
Blinding of study treatment assignment is critical to the integrity of this clinical study. However, 
in the event of a medical emergency or pregnancy in an individual participant in which knowledge 
of the IP is critical to the participant's management, the blind for that participant may be broken 
by the investigator. The participant’s safety takes priority over any other considerations in 
determining if a treatment assignment should be unblinded. 
Before breaking the blind of an individual participant's treatment, the investigator should 
determine that the unblinded information is necessary (ie, that it will alter the participant’s 
immediate management). In many cases, particularly when the emergency is clearly not related to 
the IP, the problem may be properly managed by assuming that the participant is receiving the 
IP. 
It is highly desirable that the decision to unblind treatment assignment be discussed with the 
Medical Monitor, but the investigator always has ultimate authority for the decision to unblind. 
The actual task of unblinding can be delegated by the investigator to a designee assigned the 
task on the Delegation of Authority. The Principal Investigator or appointed designee should only 
perform the emergency unblinding after the decision to unblind the participant has been 
documented. 
For this study, the method of unblinding for emergency purposes is through the IRT system. For 
information on how to unblind in an emergency, consult the IRT manual. 
In cases of accidental unblinding, contact the Medical Monitor and ensure every attempt is made 
to minimize additional disclosure and the impact of unblinding. 
Any request to unblind a participant for nonemergency purposes should be discussed with the 
Medical Monitor. 
In case of an emergency, the investigator(s) has unrestricted access to randomization information 
via the IRT and is capable of breaking the blind through the IRT system without prior approval 
from the Sponsor. Following the unblinding, the investigator shall notify the Medical Monitor or 
designee that the unblinding took place. 
7.4 
Dose Modification 
Dose modification is not allowed. 
7.5 
Preparation/Handling/Storage/Accountability 
The IP/AxMP must be stored in a secure area according to local regulations. It is the 
responsibility of the investigator, or designee where permitted, to ensure that IP/AxMP is only 


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dispensed to study participants. The IP/AxMP must be dispensed only from official study sites 
by authorized personnel according to local regulations. 
The product storage manager should ensure that the study intervention is stored in accordance 
with the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention 
should not be dispensed, and BMS should be contacted immediately. 
Study intervention not supplied by BMS will be stored in accordance with the package insert. 
IP/AxMP documentation (whether supplied by BMS or not) must be maintained that includes all 
processes required to ensure the drug is accurately administered. This includes documentation of 
drug storage, administration and, as applicable, storage temperatures, reconstitution, and use of 
required processes (eg, required diluents, administration sets). 
IP for this study should be stored at 15°C to 25°C and protected from light. Store in original 
container. 
• The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before use of the study intervention. 
• The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records). 
• Further guidance and information for final disposition of unused study interventions are 
provided in Appendix 2. 
 
7.6 
Treatment Compliance 
Study intervention compliance will be monitored as indicated in the Schedule of Activities using 
standard study intervention accountability procedures (comparing the number of tablets returned 
to number dispensed, considering the expected regimen, and reported missed doses). Study 
intervention accountability will be reviewed by the investigative site staff at each visit to assess 
treatment compliance. Site staff will discuss any discrepancies with the participant and remind the 
participant of the importance of compliance with the assigned regimen. 
7.7 
Concomitant Therapy 
All prior treatments for AA should be recorded on the electronic Case Report Form (eCRF). 
All medications taken within 4 weeks of the first dose of study intervention on Day 1 through the 
Post-Treatment Follow-up visit should be recorded on the eCRF. 
Concomitant medications (prescription, over the counter, or herbal) should be administered during 
the study only if they are to be used for treatment of specific medical reasons. 
A non-live vaccine may be administered during the study, but the effect on immune responses 
with study intervention is unknown and could be blunted (see Section 7.7.2). 


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Use of systemic corticosteroid medications (< 7 days in duration) to treat non-AA medical 
conditions is allowed but should be discussed with the Medical Monitor to determine if the 
intercurrent condition affects the safety of the participant, or if the corticosteroid treatment is likely 
to confound efficacy assessments. 
Note: Topical corticosteroids and topical calcineurin inhibitors are permitted but cannot be applied 
on the eyelids, eyebrows, or scalp. Otic, ophthalmic, nasal, and inhaled corticosteroids within 
recommended doses and with no systemic effects are permitted. 
7.7.1 
Prohibited and/or Restricted Treatments 
Prohibited and/or restricted medications during the study are described below. Refer to Section 6.2 
Exclusion Criteria-Previous/Concomitant Therapy for medical restrictions affecting eligibility. 
• Use of any medications/therapy that would affect hair regrowth 
• Any use of biologic medications (eg, adalimumab, etanercept, infliximab, ustekinumab) 
• Any use of JAK inhibitors (eg, tofacitinib, baricitinib, ritlecitinib). 
• Live vaccination (including, but not limited to, any live attenuated COVID-19 vaccines) should 
not be used during the study, including the safety follow-up period of 30 days following last 
dose of IP (see Section 7.7.2 for permitted vaccines). 
• Exposure to any investigational drug, investigational vaccine, or placebo outside of the current 
study. Specifically, participants currently in other interventional trials for COVID-19, 
including investigational COVID-19 vaccination trials that are not authorized or approved by 
relevant health authorities, should not participate in BMS clinical trials. 
7.7.2 
Permitted Vaccines (Including COVID-19 Vaccine) 
Administration of a non-live vaccine is allowed during the study. However, the efficacy and 
safety of non-live vaccines (including non-live COVID-19 vaccines) in participants receiving 
deucravacitinib is unknown. The following are examples of non-live vaccines: inactivated 
vaccines (eg, heat-killed and formalin-killed vaccines); subunit vaccines (eg, influenza and 
pneumococcal vaccines); toxoid vaccines; nucleic acid vaccines that do not encode potentially 
infectious virus: messenger mRNA vaccines (eg, Comirnaty, Pfizer/BioNTech; Spikevax, 
Moderna COVID-19 vaccines), and replication-incompetent recombinant adenovirus vector DNA 
vaccines (eg, Vaxzevria, AstraZeneca/University of Oxford COVID-19 vaccine). 
For COVID-19 vaccines, the full series per local guidance should be completed prior to enrollment 
when feasible and when a delay in enrollment would not put the study participant at risk. Ideally, 
AEs attributable to a vaccine should have resolved prior to enrollment. 
If a participant has received a specific COVID-19 vaccination, details such as type and date of 
vaccine received should be recorded on the COVID-19 Vaccination Form. 
Please contact the Medical Monitor with any questions related to COVID-19 vaccines. 


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7.8 
Continued Access to Study Intervention After the End of the Study 
At the end of the study, BMS will not continue to provide BMS-supplied study intervention 
to participants/investigators unless BMS chooses to extend the study. The investigator should 
ensure that participants continue to receive appropriate standard of care to treat AA. 
BMS reserves the right to terminate access to BMS-supplied study intervention if for example but 
not limited to the following: a) the study is terminated due to safety concerns; b) the development 
of deucravacitinib for AA is terminated for other reasons, including but not limited to, lack of 
efficacy and/or not meeting the study objectives; c) the participant can obtain medication from a 
government-sponsored or private health program. In all cases, BMS will follow local regulations. 
8 
DISCONTINUATION CRITERIA 
8.1 
Discontinuation from Study Intervention 
Participants MUST discontinue IP (and Non-IP/AxMP at the discretion of the investigator) for any 
of the following reasons: 
• Participant’s request to stop study intervention. Participants who request to discontinue study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by the participant 
to provide this information 
• Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of 
the investigator, indicates that continued participation in the study is not in the best interest of 
the participant 
• Termination of the study by BMS 
• Loss of ability to freely provide consent through imprisonment or involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness. (Note: Under 
specific circumstances and only in countries where local regulations permit, a participant who 
has been imprisoned may be permitted to continue as a participant. Strict conditions apply, and 
BMS approval is required) 
• Participant reports suicidal ideation, suicidal behavior, or suicide attempts at any time after 
randomization. The participant should then be immediately referred to a mental health 
professional for evaluation of suicide risk 
• Abnormal liver tests suggestive of drug-induced liver injury (DILI), or if the investigator 
believes that it is in the best interest of the participant 
• Malignancy; however, a participant who develops non-melanoma skin cancer may continue in 
the study at the discretion of the investigator 
• Pregnancy, positive pregnancy test, or participant expresses an interest in becoming pregnant 
• Participant develops active TB during the study or prematurely discontinues treatment for 
LTBI, or participant is noncompliant with LTBI therapy 
• Japan only: Participant with positive HBsAb at Screening or positive HBcAb with negative or 
undetectable HBV DNA (< 1.3 Log IU/mL [20 IU/mL]) at Screening, for whom quantitative 


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HBV DNA becomes detectable (≥ 1.3 Log IU/mL ([20 IU/mL]) at any time during treatment 
with the IP 
• Inability or failure to comply with protocol requirements, in the opinion of the investigator 
• Unblinding of a participant’s study intervention assignment, to investigator or participant, for 
any reason (emergency or nonemergency) 
 
Refer to the Schedule of Activities for data to be collected at the time of treatment discontinuation 
and follow-up and for any further evaluations that can be completed. 
All participants who discontinue study intervention should comply with protocol-specified 
follow-up procedures as outlined in Section 2 (Table 2-3). The only exceptions to this requirement 
is when a participant withdraws consent for all study procedures, including post-treatment study 
follow-up, or loses the ability to consent freely (eg, is imprisoned or involuntarily incarcerated for 
the treatment of either a psychiatric or physical illness). 
If study intervention is discontinued prior to the participant’s completion of the study, the reason 
for the discontinuation must be documented in the participant’s medical records per local 
regulatory requirements in each region/country and entered on the appropriate Case Report Form 
(CRF) page. 
8.1.1 
Temporary Interruption 
Temporary study intervention interruption is only allowed if the participant develops an AE that, 
in the opinion of the investigator, indicates that it is in the participant’s best interest that the study 
intervention be interrupted. 
Study intervention in this situation should be stopped until the AE has resolved per investigator 
judgment. 
Temporary interruption of study intervention should be implemented in the context of clinical 
suspicion for SARS-CoV-2 infection or a positive diagnostic test for SARS-CoV-2. When study 
intervention is interrupted in a confirmed case of SARS-CoV-2 infection, the investigator should 
determine whether the resolution of symptoms alone (ie, without repeat diagnostic testing for 
SARS-CoV-2) is sufficient to resume study intervention. The investigator may consult with the 
Medical Monitor. 
Temporary interruption of study intervention may be considered in the event of SARS-CoV-2 
vaccination according to local guidelines. 
Any temporary study intervention interruption, as well as restart, must be documented on the 
appropriate CRF page. 
8.1.2 
Post-study Intervention Study Follow-up 
Participants who discontinue study intervention may continue to be followed. 
Participants who discontinue study intervention should complete all assessments indicated for the 
Week 52/Early Discontinuation (ED) visit and the Post-treatment Follow-up visit as outlined in the 
Schedule of Activities (Table 2-3). 


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8.2 
Discontinuation from the Study 
Participants who request to discontinue study intervention should remain in the study and 
may continue to be followed for protocol-specified follow-up procedures. The only exception to 
this is when a participant specifically withdraws consent for any further contact with him/her 
or persons previously authorized by participant to provide this information. 
• Participants should notify the investigator of the decision to withdraw consent from future 
follow-up. 
• The withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is from further treatment with study intervention only 
or also from study procedures and/or post-treatment study follow-up, and entered on the 
appropriate CRF page. 
• In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law. 
• 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. 
 
8.2.1 
Individual Discontinuation Criteria 
• A participant may withdraw completely from the study at any time at his/her own request, or 
may be withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. This is expected to be uncommon. Stopping study 
intervention is not considered withdrawal from the study. 
• At the time of discontinuing from the study, if possible, an early termination visit should be 
conducted, as shown in the Schedule of Activities. See the Schedule of Activities for data to 
be collected at the time of study discontinuation and follow-up and for any further evaluations 
that need to be completed. 
• The participant will be permanently discontinued both from the study intervention and from 
the study at that time. 
• 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. 
 
8.3 
Lost to Follow-up 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• All reasonable efforts must be made to locate participants to determine and report their 
ongoing status. This includes follow-up with persons authorized by the participant. 
• Lost to follow-up is defined by the inability to reach the participant after a minimum of 
three (3) documented phone calls, faxes, or emails, as well as lack of response by participant 
to one (1) registered mail letter. All attempts should be documented in the participant’s 
medical records. 


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• If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death. 
• If the investigator’s use of a third-party representative to assist in the follow-up portion of the 
study has been included in the participant’s informed consent, then the investigator may 
use a Sponsor-retained third-party representative to assist site staff with obtaining the 
participant’s contact information or other public vital status data necessary to complete the 
follow-up portion of the study. 
• The site staff and representative will consult publicly available sources, such as public 
health registries and databases, in order to obtain updated contact information. 
• If, after all attempts, the participant remains lost to follow-up, then the last known alive date 
as determined by the investigator should be reported and documented in the participant’s 
medical records. 
 
9 
STUDY ASSESSMENTS AND PROCEDURES 
All Screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria before randomization. The investigator will maintain a Screening Log 
to record details of all participants screened and to confirm eligibility or record reasons for 
Screening failure, as applicable. 
Procedures conducted as part of the participant’s routine clinical management (eg, blood count) 
performed before signing the informed consent may be utilized for screening purposes, provided 
the procedure meets the protocol-defined criteria and has been performed within the timeframe 
defined in Section 6. 
Below is the suggested order in which to perform the evaluations at each applicable visit: 
 
• Concomitant medications 
• Adverse event monitoring 
• 12-lead ECG 
• Vital signs 
• Body weight and height 
• Physical examination and efficacy assessments. Assessments should be completed in the 
following order: 
− Hamilton-Norwood/Ludwig Classification 
− SALT Assessment 
 
− AA-IGA 
− Medical photography of scalp and eyebrows/eyelashes (if consent obtained) 


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− 
 (if consent obtained) 
• Urine pregnancy test (WOCBP) and urinalysis 
• Blood sampling for 
 laboratory assessments. Please refer to 
regarding requirement for pre-and post-dose sample collection times 
• Study intervention accountability and study intervention compliance 
• Dispensing of study intervention 
 
9.1 
Efficacy Assessments 
The efficacy assessments listed below are commonly used tools to characterize disease severity in 
patients with AA and are established endpoints in clinical practice for assessing treatment efficacy 
in AA 
All investigator-administered assessments should be performed by a dermatologist or 
appropriately trained licensed health care provider who is experienced in the assessment of patients 
with AA. All efficacy evaluators must receive and document protocol-specific efficacy assessment 
training prior to performing the evaluations. 
To ensure consistency and reduce variability, the same evaluator must assess all dermatological 
clinical evaluations for any individual participant throughout the study whenever possible; a 
back-up experienced, qualified, and protocol-trained evaluator will only be allowed on rare 
occurrences, when the designated evaluator is unable to perform the evaluation. 
• SALT Assessment (Appendix 532,33) This is a quantitative rating scale for measuring the 
severity of terminal hair loss in each of the 4 quadrants of the scalp: posterior (back), vertex 
(top), left, and right profile. To obtain a SALT score, the degree of scalp hair loss is assessed as 
a percentage of each scalp region affected and is multiplied by its respective weighting factor 
(the scalp surface area) for each of the 4 sections in order to provide a subtotal for each region. 
The SALT score is the sum of these subtotals. SALT scores can range from 0 (no hair loss) to 
100 (total scalp hair loss). 
SALT50 indicates at least a 50% improvement from baseline in the SALT score at a particular 
time point, indicating 50% hair regrowth. 
The proportion of 
participants achieving  these  responses  will be  assessed  at all visits. 
 
 
• AA-IGA: The AA-IGA utilizes a 5-point scale, in which the investigator assesses scalp hair 
loss based on the SALT assessment. The AA-IGA measures AA severity at a single point in 
time (without taking into account the baseline disease condition). The participant’s scalp hair 
loss, as it looks at the time of evaluation, is scored as none (0) (0% scalp hair loss), limited (1) 
(1%-20% scalp hair loss), moderate (2) (21%-49% scalp hair loss), severe (3) (50%-94% scalp 
hair loss), or very severe (4) (95%-100% scalp hair loss). 


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9.1.2 
Medical Photography 
Medical photography of the scalp is required at the visits indicated in the Schedule of Activities. 
A separate consent will be required to allow for photography of a participant’s face for eyelash 
and eyebrow evaluation at Day 1, Week 24, Week 40, and Week 52. In participants who provide 
optional consent, if new onset involvement of eyelashes and/or eyebrows (not present at baseline) 
is observed after Day 1, a photograph of the eyelashes and or eyebrows should be taken at the visit 
first observed, in addition to Weeks 24, 40, and 52. 
An external reviewer will assess for regrowth of eyebrows and eyelashes. 
Sites will be equipped with clinical photography supplies. Any photographs may be used as 
supplemental documentation for publications and to increase understanding of effect of study 
intervention on hair regrowth. 
Detailed instructions on the collection and transmission of digital images will be provided to the 
investigator in a separate manual at or before the time of study initiation. 
9.2 
Adverse Events 
The definitions of an AE or SAE can be found in Appendix 3. 
AEs will be reported by the participant (or, when appropriate, by a caregiver, a surrogate, or the 
participant’s legally acceptable representative). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE and remain responsible for following up 
AEs that are serious, considered related to the study intervention or the study, or that caused the 
participant to discontinue before completing the study. 
Refer to Appendix 3 for SAE reporting. 
9.2.1 
Adverse Events of Interest 
Adverse events of interest (AEIs) are AEs for a particular product or class of products that a 
Sponsor may wish to monitor more carefully. AEIs may be serious or nonserious and may require 
further investigation to better characterize and understand them. In the deucravacitinib clinical 
development program, select infections (opportunistic, TB, herpes zoster) and malignancies have 
been identified as AEIs based on the mechanism of action of deucravacitinib. Therefore, in order to 
better characterize and understand these AEIs, information may be collected on supplemental CRFs. 
Additionally, information on potential AEIs based on the disease or population under study may be 
collected on supplemental CRFs. 
9.2.2 
Time Period and Frequency for Collecting AE and SAE Information 
All SAEs must be collected from the time of signing the consent, including those thought to be 
associated with protocol-specified procedures, and within 30 days following discontinuation of 
dosing. 


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The investigator must report any SAE that occurs after these time periods and that is believed to be 
related to study intervention or protocol-specified procedure (eg, a follow-up skin biopsy, 
). 
• Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the appropriate section of the CRF module. 
• All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as 
indicated in Appendix 3. 
• The investigator will submit any updated SAE data to the sponsor or designee within 24 hours 
of updated information being available. 
 
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
However, if the investigator learns of any SAE, including a death, at any time after a participant 
has been discontinued from the study, and he/she considers the event reasonably related to the study 
intervention or study participation, the investigator must promptly notify the Sponsor. 
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in Appendix 3. 
In order to facilitate enhanced reporting of COVID-19 events that occur during the study, all AEs 
and SAEs reported after the time of consent that are related to SARS-CoV-2 or COVID-19 
infection must be reported (Section 9.2). 
9.2.3 
Method of Detecting AEs and SAEs 
AEs can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. Care should be taken not to introduce bias when collecting AE and/or 
SAEs. Inquiry about specific AEs, should be guided by clinical judgment in the context of known 
AEs, when appropriate for the program or protocol. 
9.2.4 
Follow-up of AEs and SAEs 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if 
they become serious (see Appendix 3). 
• Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate. 
• All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for 
AEs and/or laboratory abnormalities that are reported/identified during the course of the 
study. 
 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, and nonserious AEs of special interest (as defined in 
Section 9.2.1) will be followed until resolution, until the condition stabilizes, until the event is 
otherwise explained, or until the participant is lost to follow-up (as defined in Section 8.3). 


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Further information on follow-up procedures is given in Appendix 3. 
9.2.5 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met. 
• An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the Investigator’s Brochure and will notify the IRB/ IEC, if appropriate according to local 
requirements. 
 
The Sponsor or designee must report AEs to regulatory authorities and ethics committees according 
to local applicable laws and regulations. A SUSAR (suspected, unexpected serious adverse 
reaction) is a subset of SAEs and must be reported to the appropriate regulatory authorities and 
investigators in accordance with local and global guidelines and requirements. 
9.2.6 
Pregnancy 
If, following initiation of the study intervention, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure and through the end of the safety 
follow-up period the investigator must immediately notify the BMS Medical Monitor/designee of 
this event and complete and forward a Pregnancy Surveillance Form to the BMS designee within 
24 hours of awareness of the event and in accordance with SAE reporting procedures described in 
Appendix 3. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form. Protocol-required procedures for study discontinuation and follow-up must be 
performed on the participant. 
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
the Sponsor or designee. In order for the Sponsor or designee to collect any pregnancy surveillance 
information from the female partner, the female partner must sign an ICF for disclosure of this 
information. Information on this pregnancy will be collected on the Pregnancy Surveillance Form. 
9.2.7 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page or SAE eCRF, as appropriate. Paper forms are only intended as a back-up option when the 
electronic system is not functioning. 
• Any laboratory test result that is clinically significant or meets the definition of an SAE 
• Any laboratory test result abnormality that required the participant to have study intervention 
discontinued or interrupted 
• Any laboratory test result abnormality that required the participant to receive specific 
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It is expected that, wherever possible, the clinical rather than laboratory term would be used by the 
reporting investigator (eg, anemia vs low hemoglobin value). 
9.2.8 
Potential Drug Induced Liver Injury (DILI) 
All occurrences of potential DILIs, meeting the defined criteria, must be reported as SAEs (see 
Section 9.2.5 and Appendix 3 for reporting details). 
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILIs meeting 
the defined criteria must be reported as SAEs (see Section 9.2 and Appendix 3 for reporting details). 
Potential DILI is defined as: 
• AT (ALT or AST) elevation > 3 times upper limit of normal (ULN) 
AND 
• Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum 
alkaline phosphatase) 
AND 
• No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic. 
 
9.2.9 
Other Safety Considerations 
Any significant worsening of conditions noted during interim or final physical examinations, ECG, 
x-ray filming, or any other potential safety assessment required or not required by the protocol 
should also be recorded as a nonserious AE or SAE, as appropriate, and reported accordingly. 
9.3 
Overdose 
For this study, any dose of deucravacitinib greater than 2 days’ worth of study intervention within 
a 24-hour time period will be considered an overdose. Overdoses that meet the regulatory 
definition of SAE will be reported as an SAE (see Appendix 3). 
The investigator should do the following in the event of an overdose: 
1) Contact the Medical Monitor immediately. 
2) Closely monitor the participant for AEs/SAEs and laboratory abnormalities until deucravacitinib 
can no longer be detected systemically (at least 3 days). 
3) Document the quantity of the excess dose as well as the duration of the overdosing in the eCRF. 
 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Medical Monitor based on the clinical evaluation of the participant. 
9.4 
Safety 
Planned time points for all safety assessments are listed in the Schedule of Activities. 


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All urgent safety concerns must be discussed with the Sponsor immediately upon occurrence or 
awareness to determine if the participant should continue or discontinue study intervention. 
Safety evaluations that will be performed in addition to AE monitoring are physical 
examinations, vital signs, ECGs, concomitant medication use, and laboratory tests. 
9.4.1 
Physical Examinations 
A complete physical examination will include general appearance, head, eyes, ears, nose, 
mouth, throat, neck, extremities, cardiovascular, respiratory, GI/abdomen, lymphatic, 
musculoskeletal, skin, and psychiatric and neurologic examinations. A targeted physical 
examination will include any organ system associated with an AE or a laboratory abnormality. 
9.4.2 
Vital signs 
Vital sign assessments include body temperature, respiratory rate, seated blood pressure, and heart 
rate. Blood pressure and heart rate should be measured after the participant has been resting quietly 
for at least 5 minutes. 
9.4.3 
Electrocardiograms 
A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes 
prior to the ECG; blood samples for laboratory, 
 assessments should be collected after 
the tracing so that the ECG results remain as accurate as possible. The ECG results will be read by 
the principal study investigator or a qualified and delegated designee as per local requirements. 
9.4.4 
Clinical Safety Laboratory Assessments 
• Investigators must document their review of each laboratory safety report. 
• The assessments to be performed at specified visits are indicated below. 
 
Hematology 
Hemoglobin 
Hematocrit 
White Blood Count, including differential 
Platelet count 
Coagulation Panelc 
International Normalized Ratio 
Prothrombin Time 
Partial Thromboplastin Time or Activated Thromboplastin Time 
Chemistry Panel 
Aspartate aminotransferase (AST) 
Total Protein 
Alanine aminotransferase (ALT) 
Albumin 
Total bilirubin 
Sodium 
Direct bilirubin (if total bilirubin > ULN) 
Potassium 


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Alkaline phosphatase 
Lactate dehydrogenase 
Creatinine 
Blood Urea Nitrogen (BUN) 
Uric acid 
Glucose (fastingb), at specified visits 
Hemoglobin A1c, at specified visits 
Chloride 
Calcium 
Phosphorus 
Creatine Kinasea 
Estimated Glomerular Filtration Rate 
Urinalysis 
Protein 
Glucose 
Blood 
Leukocyte Esterase 
Specific Gravity 
pH 
Microscopic examination (reflex if abnormal) 
Lipid Panelb 
Cholesterol (total) 
High Density Lipoprotein 
Low Density Lipoprotein 
Triglycerides 
Infectious Serologyc 
Hepatitis C Antibody confirmed by HCV-RNA testing if required 
Hepatitis B Surface Antigen 
Hepatitis B Surface Antibody 
Hepatitis B Core Antibody 
Hepatitis B DNA as required with confirmed HBV infection; see Appendix 9 (Japan only). 
Human Immunodeficiency Virus -1 and -2 Antibody 
Other Analyses 
Pregnancy test (WOCBP only: serum HCG test at Screening, urine HCG test all other visits) 
Follicle-stimulating Hormone (to confirm menopausal status)c 
Thyroid-stimulating Hormonec,d 
Abbreviations: CK, creatine kinase; DNA, deoxyribonucleic acid; HBV, hepatitis B virus; HCV, hepatitis C virus; 
RNA, ribonucleic acid; TSH, thyroid-stimulating hormone; ULN, upper limit of normal; WOCBP, women of 
childbearing potential. 
a If CK > 2.5 × ULN, then reflex testing (ie, CK-MB, Troponin I) will be required. 
b Samples will be collected after the participant has fasted for ≥ 10 hours; fasting not required for samples collected 
at the Screening visit. 


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c Performed at Screening. 
d If TSH is above the normal reference range, test free T4; if TSH is below the normal range, test free T4 and T3. 


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It may also be used to support health authority requests 
for further analysis (refer to 
 
 
 
 
 
 
 
 
 
 
 
 
9.9 
Other Assessments 
 
9.10 
Health Economics OR Medical Resource Utilization and Health 
Economics 
Health Economics/Medical Resource Utilization and Health Economics parameters will not be 
evaluated in this study. 
10 
STATISTICAL CONSIDERATIONS 
10.1 
Statistical Hypothesis 
Let μ1 and μ2 be the population means of change from baseline at Week 24 in SALT for 6 mg QD 
and 6 mg BID dosages of deucravacitinib, respectively, and μ0 be the population mean of change 
from baseline at Week 24 in SALT for placebo; the 2 primary hypotheses for this study are: 
1) H01: μ1 = μ0 versus H11: μ1 ≠ μ0 
2) H02: μ2 = μ0 versus H12: μ2 ≠ μ0 
 
10.2 
Sample Size Determination 
Approximately 90 participants will be randomized on Day 1 in a 1:1:1 ratio, resulting in 
30 participants in each deucravacitinib dose arm (6 mg QD and 6 mg BID) and 30 participants in 
the placebo arm. 
Assuming a 39-point difference in change in SALT score from baseline to Week 24 between both 
deucravacitinib doses and placebo, and a common standard deviation (SD) of 43 points, the 
following table presents 2 scenarios on sample size and overall power of the study. 
 
Type I error 
Sample Size 
Overall Power 
0.10 
25 
93% 
0.05 
25 
88% 


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Assuming a 15% drop out rate and an overall type I error of 0.10 level: 
1) Without multiplicity adjustment for 2 doses to be compared with the placebo, the study overall 
power with a sample size of 30 in each arm is 93% 
2) With Bonferroni adjustment for 2 doses to be compared with the placebo, the study overall 
power with a sample size of 30 in each arm is 88% 
 
The expected difference (39 points) between deucravacitinib dose and placebo and common SD 
(43 points) in the change from baseline in the SALT score are based on an average of recently 
reported data from clinical trials with oral compounds in participants with moderate to severe AA 
treated with an oral TYK2/JAK1 inhibitor, PF-06700841 (placebo-adjusted mean 49.5 points, 95% 
confidence interval [CI] [37.1, 61.8]), and with an oral JAK 3 inhibitor, PF-06651600 
(placebo-adjusted mean 33.6 points, 95% CI [21.4, 45.7]) compared to placebo.18 
10.3 
Analysis Sets 
For the purposes of analyses, the following populations are defined: 
 
Population 
Description 
Enrolled 
All participants who signed the informed consent. 
Randomized 
All participants who were in the enrolled population and were randomized 
using IRT. 
Safety 
All participants who were in the randomized population and received at least 1 
dose of study intervention. 
Abbreviations: IRT, Interactive Response Technology. 
 
10.4 
Statistical Analysis 
10.4.1 
General Considerations 
All efficacy analyses will be carried out on the randomized population and will be analyzed 
according to the treatment assigned at randomization. 
All safety analyses will be carried out on the safety population and will be analyzed by the actual 
treatment received. 
The statistical analysis plan (SAP) will be developed and finalized before database lock and will 
describe the selection of participants to be included in the analyses and procedures for accounting 
for missing, unused, and spurious data. Below is a summary of planned statistical analyses of the 
primary and secondary endpoints. 


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The SAP will include a more technical and detailed description of the statistical analyses described 
in this section. This section is a summary of the planned statistical analyses of the most important 
endpoints. 
A description of the participant population will be included in the clinical study report, including 
subgroups of age, gender, race, and other study specific populations and demographic 
characteristics. A description of participant disposition will also be included in the clinical study 
report. 
A database lock will occur once all randomized participants have completed the Week 24 
assessments or have discontinued prior to Week 24. Analyses of the collected efficacy and safety 
results during the 24-week placebo-controlled period will be performed in order to aid in planning 
for subsequent clinical development. Details of these analyses will be described in the SAP. 
10.4.2 
Primary Efficacy Endpoints 
The 2 primary hypotheses, as specified in Section 10.1, will be tested on the overall significance 
level of 10%. To strongly control the overall type I error at 10% level, the Bonferroni adjustment 
will be used to adjust multiplicity due to 2 deucravacitinib dose arms to be compared with the 
placebo arm. 
The primary efficacy endpoint (change in SALT score from baseline to Week 24 [Day 169]) will 
be analyzed on the randomized population using an analysis of covariance (ANCOVA). The 
ANCOVA model will include treatment arm, the randomization stratification variable of alopecia 
episode duration (< 4 years and ≥ 4 years), as factors, and baseline SALT score as a covariate. 
The primary methodology to impute the missing data will be multiple imputation with the 
assumption of missing at random. 
Additional sensitivity analyses will be further outlined in the SAP. 
10.4.3 
Secondary Efficacy Endpoint(s) 
The analyses and summary statistics for all secondary efficacy endpoints, as specified in Table 4- 
1, will be presented in appropriate tables. The 90% confidence intervals and p values will be 
provided, as needed, by applying appropriate statistical models to each endpoint that will be 
specified in detail in the SAP. 
 
 
 
 
10.4.5 
Other Safety Analyses 
All safety analyses will be carried out on the safety population. 
Adverse events will be monitored during the trial and the data analyzed with respect to incidence 
within each treatment arm as well as severity and potential relationship of the AEs to study 
intervention. Adverse events will be summarized for the safety population by System Organ Class 


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and Preferred Term and presented in descending order of frequency within each System Organ 
Class. Serious AEs and AEs leading to discontinuation will be summarized similarly. 
Associated laboratory parameters such as hepatic profile, renal function, and hematology values 
will be grouped and presented together. Changes from baseline to each visit for each laboratory 
parameter will also be summarized. 
The change from baseline to each visit for each of the vital sign variables will be summarized. 
Abnormal vital sign values will be flagged and listed. 
The change from baseline to each visit for each of the ECG parameters will be summarized. 
10.4.6 
Other Analyses 
Not applicable. 
10.5 
Interim Analysis 
Not applicable. 


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11 
REFERENCES 
 
 
 
1 
Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med 2012;366:1515-25. 
2  Pratt CH, King Jr LE, Messenger AG, Christiano A, Sundberg JP. Alopecia areata. Nat Rev 
Dis Primers 2017;3:17011. 
3  Paus R, Ito N, Takigawa M, Ito T. The hair follicle and immune privilege. J Investig Dermatol 
Symp Proc 2003;8:188-94. 
4 
Paus R, Nickoloff BJ, Ito T. A ‘hairy’ privilege. Trends Immunol 2005;26:32-40. 
5 Bertolini M, Zilio F, Rossi A, et al. Abnormal interactions between perifollicular mast cells 
and CD8+ T-cells may contribute to the pathogenesis of alopecia areata. PLoS One 
2014;9:e94260. 
6  Zhang X, Zhao Y, Ye Y, et al. Lesional infiltration of mast cells, Langerhans cells, T cells and 
local cytokine profiles in alopecia areata. Arch Dermatol Res 2015;307:319-31. 
7 Xing L, Dai Z, Jabbari A, et al. Alopecia areata is driven by cytotoxic T lymphocytes and is 
reversed by JAK inhibition. Nat Med 2014;20:1043-9. 
8  Ito T, Ito N, Saathoff M, et al. Interferon-gamma is a potent inducer of catagen-like changes 
in cultured human anagen hair follicles. Br J Dermatol 2005;152:623-31. 
9 Rückert R, Hofmann U, van der Veen C, Bulfone-Paus S, Paus R. MHC class I expression in 
murine skin: developmentally controlled and strikingly restricted intraepithelial expression 
during hair follicle morphogenesis and cycling, and response to cytokine treatment in vivo. J 
Invest Dermatol 1998;111:25-30. 
10 Uchida Y, Bertolini M, Alam M, et al. 051 γδ T cells as novel players in alopecia areata 
pathobiology: Vδ1+ T lymphocytes may recognize “stressed” hair follicle keratinocytes, 
leading to IFNγ-dependent hair follicle dystrophy and immune privilege collapse. J Investig 
Dermatol 2016;136:S9. 
11 Suarez-Farinas, M. Ungar B, Noda S, et al. Alopecia areata profiling shows TH1, TH2, and 
IL-23 cytokine activation without parallel TH17/TH22 skewing. J Allergy Clin Immunol 
2015;136:1277-87. 
12 Song T, Pavel AB, Wen H-C, et al. An integrated model of alopecia areata biomarkers 
highlights both TH1 and TH2 upregulation. J Allergy Clin Immunol 2018;142:1631-34.e13. 
13 Guttman-Yassky E, Ungar B, Noda S, et al. Extensive alopecia areata is reversed by IL-12/IL- 
23p40 cytokine antagonism. J Allergy Clin Immunol 2016;137:301-4. 
14 Aleisa A, Lim Y, Gordon S, et al. Response to ustekinumab in three pediatric participants with 
alopecia areata. Pediatr Dermatol 2019;36:e44-e45. 


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15 Burke JR, Cheng L, Gillooly KM, et al. Autoimmune pathways in mice and humans are 
blocked by pharmacological stabilization of the TYK2 pseudokinase domain. Sci Transl Med 
2019;11:eaaw1736. 
16 Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of 
Dermatologists’ guidelines for the management of alopecia areata 2012. Br J Dermatol 
2012;166:916-26. 
17 Rossi A, Muscianese M, Piraccini BM, et al. Italian Guidelines in diagnosis and treatment of 
alopecia areata. G Ital Dermatol Venereol 2019;154:609-23. 
18 King B, Ko J, Forman S, et al. Efficacy and safety of the oral Janus kinase inhibitor baricitinib 
in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled 
study. J Am Acad Dermatol 2021;85:847-53. 
19 EADV 2021: Abstract N°: 605 Title: Efficacy and safety of baricitinib in adults with alopecia 
areata: Phase 3 results from two randomized controlled trials (BRAVE-AA1 and BRAVE- 
AA2). 
20 Baricitinib improved hair regrowth for alopecia areata patients in second Phase 3 study. Eli 
Lilly and Company and Incyte. 
21 (FDA’s), T.U.S.F.a.D.A.s., The Voice of the Participants: Alopecia Areata in Participants- 
Focused Drug Development Initiative 2017. 
22 Liu LY, King BA, Craiglow BG. Health-related quality of life (HRQoL) among participants 
with alopecia areata (AA): a systematic review. J Am Acad Dermatol 2016;75:806-812.e3. 
23 Shaw MH, Boyartchuk V, Wong S, et al. A natural mutation in the Tyk2 pseudokinase domain 
underlies altered susceptibility of B10.Q/J mice to infection and autoimmunity. Proc Natl Acad 
Sci U S A 2003;100:11594-9. 
24 Tokarski JS, Zupa-Fernandez A, Tredup JA, et al. Tyrosine kinase 2-mediated signal 
transduction in T lymphocytes is blocked by pharmacological stabilization of its pseudokinase 
domain. J Biol Chem 2015;290:11061-74. 
25 Watford WT, Hissong BD, Bream JH, et al. Signaling by IL-12 and IL-23 and the 
immunoregulatory roles of STAT4. Immunol Rev 2004;202:139-56. 
26 Trinchieri G. Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nat 
Rev Immunol 2003;3:133-46. 
27 Yano S, Nakamura K, Okochi H, et al. Analysis of the expression of cutaneous lymphocyte- 
associated antigen on the peripheral blood and cutaneous lymphocytes of alopecia areata 
patients. Acta Derm Venereol 2002;82:82-5. 
28  BMS-986165: Investigator’s Brochure Version 08, Section 1.6. 


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30 Ludwig E. Classification of the types of androgenetic alopecia (common baldness) occurring 
in the female sex. Br J Dermatol 1977;97:247-54. 
31 Hamilton JB. Patterned loss of hair in man; types and incidence. Ann N Y Acad Sci 
1951;53:708-28. 
32 Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment 
guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol 2004;51:440- 
7. 
33 Olsen EA, Roberts J, Sperling L, et al. Objective outcome measures: collecting meaningful 
data on alopecia areata. J Am Acad Dermatol 2018;79:470-8.e3. 


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12 
APPENDICES 


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APPENDIX 1 
ABBREVIATIONS 
 
Term 
Definition 
AA 
alopecia areata 
AA-IGA 
Alopecia Areata Investigator Global Assessment 
AE 
adverse event 
AEI 
adverse event of interest 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
APTT 
activated partial thromboplastin time 
AT 
aminotransaminase 
AST 
aspartate aminotransferase 
AxMP 
auxiliary medicinal product 
BID 
twice daily 
BMS 
Bristol-Myers Squibb Company 
BP 
blood pressure 
BUN 
blood urea nitrogen 
Cavg 
average concentration 
CBC 
complete blood count 
CD 
cluster of differentiation 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CK 
creatine kinase 
Cmin 
minimum observed concentration 
COVID-19 
coronavirus disease 2019 
CRF 
Case Report Form, paper or electronic 
CRO 
Contract Research Organization 
CXCL 
CXC motif chemokine ligand 
D 
Day 
d 
days 
DDI 
drug-drug interaction 
DILI 
drug-induced liver injury 


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Term 
Definition 
DMC 
Data Monitoring Committee 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
eCRF 
electronic Case Report Form 
ED 
early discontinuation 
eGFR 
estimated glomerular filtration rate 
E-R 
exposure-response 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FIH 
first-in-human 
FSH 
follicle stimulating hormone 
GI 
gastrointestinal 
HbA1c 
hemoglobin A1c 
HBcAb 
hepatitis B core antibody 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCG 
human chorionic gonadotropin 
Hct 
hematocrit 
HCV 
hepatitis C virus 
HDL 
high density lipoprotein 
HF 
hair follicle 
Hgb 
hemoglobin 
HIV 
human immunodeficiency virus 
hr 
hour 
hs-CRP 
high-sensitivity C-reactive protein 
IB 
Investigator Brochure 
ICF 
informed consent form 
IFN 
interferon 


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Term 
Definition 
Ig 
immunoglobulin 
IGRA 
IFN gamma release assay 
IL 
interleukin 
IMP 
Investigational Medicinal Product 
INR 
international normalized ratio 
IP 
investigational product 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IU 
international unit 
IV 
intravenous 
JAK 
Janus kinase 
LDH 
lactate dehydrogenase 
LDL 
low density lipoprotein 
LTBI 
latent TB infection 
MACE 
major adverse cardiovascular events 
MHC 
major histocompatibility complex 
min 
minute 
N/A 
not applicable 
NA 
nucleoside/nucleotide analogues 
NK 
natural killer 
NKG2D+ 
natural killer group 2D+ 
PA 
posteroanterior 
PASI 
psoriasis area severity index 
PD 
pharmacodynamics 
PE 
physical examination 
PK 
pharmacokinetics 
PO 
per os 


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Term 
Definition 
PsA 
psoriatic arthritis 
PsO 
plaque psoriasis 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
QD 
once daily 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SALT 
Severity of Alopecia Tool 
SAP 
statistical analysis plan 
SARS-CoV-2 severe acute respiratory syndrome coronavirus 2 
SD 
standard deviation 
SLE 
systemic lupus erythematosus 
SOA 
Schedule of Activities 
STAT 
signal transducer and activator of transcription 
T3 
triiodothyronine 
T4 
thyroxine 
TB 
tuberculosis 
TE 
target engagement 
TSH 
thyroid-stimulating hormone 
TYK2 
tyrosine kinase 2 
UC 
ulcerative colitis 
ULN 
upper limit of normal 
WOCBP 
women of childbearing potential 


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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
The terms “participant” and “subject” refer to a person who has consented to participate in the 
clinical research study. Typically, the term “participant” is used in the protocol and the term 
“subject” is used in the Case Report Form (CRF). 
REGULATORY AND ETHICAL CONSIDERATIONS 
This study will be conducted in accordance with: 
• Consensus ethical principles derived from international guidelines, including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical Guidelines 
• Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) 
Guidelines 
• Applicable laws, regulations, and requirements 
 
The study will be conducted in compliance with the protocol. The protocol, any 
revisions/amendments, and the participant informed consent form (ICF) will receive 
approval/favorable  opinion  by  Institutional  Review  Board/Independent  Ethics 
Committee (IRB/IEC), and regulatory authorities according to applicable regulations prior to 
initiation of the study. 
All potential serious breaches must be reported to the Sponsor or designee immediately. A 
potential serious breach is defined as a Quality Issue (eg, protocol deviation) that is likely to affect, 
to a significant degree, one or more of the following: (1) the rights, physical safety or mental 
integrity of one or more participants; (2) the scientific value of the clinical trial (eg, reliability and 
robustness of generated data). Items (1) or (2) can be associated with either GCP regulation(s) or 
trial protocol(s). 
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks. 
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE 
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, Investigator’s Brochure, product labeling information, ICF, 
participant recruitment materials (eg, advertisements), and any other written information to be 
provided to participants. 
The investigator, Sponsor, or designee should provide the IRB/IEC with reports, updates, and other 
information (eg, expedited safety reports, amendments, administrative letters) annually, or more 
frequently, in accordance with regulatory requirements or institution procedures. 


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The investigator is responsible for providing oversight of the conduct of the study at the site and 
adherence to requirements of the following where applicable: 
• ICH guidelines, 
• United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 
• European Union Directive 2001/20/EC; or 
• European Regulation 536/2014 for clinical studies (if applicable), 
• European Medical Device Regulation 2017/745 for clinical device research (if applicable), 
• the IRB/IEC 
• and all other applicable local regulations. 
 
COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS 
The investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and, if 
applicable, also by the local Health Authority), except where necessary to eliminate an immediate 
hazard(s) to study participants. 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s), the deviation or change will be submitted as soon 
as possible to: 
• IRB/IEC 
• Regulatory authority(ies), if applicable by local regulations (per national requirements) 
 
Documentation of approval/favorable opinion signed by the chairperson or designee of the 
IRB(s)/IEC(s) and, if applicable, also by the local Health Authority, must be sent to Bristol-Myers 
Squibb (BMS). 
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the ICF must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from participants 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new participants prior to enrollment. 
FINANCIAL DISCLOSURE 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information, in accordance with regulations, to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate Health Authorities. Investigators 
are responsible for providing information on financial interests during the course of the study and 
for 1 year after completion of the study. 


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INFORMED CONSENT PROCESS 
Investigators must ensure that participants are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which they volunteer to 
participate. 
The Sponsor or designee will provide the investigator with an appropriate sample ICF, which will 
include all elements required by the ICH GCP, and applicable regulatory requirements. The sample 
ICF will adhere to the ethical principles that have their origin in the Declaration of Helsinki. 
The investigator or his/her representative must: 
• Obtain IRB/IEC written approval/favorable opinion of the written ICF and any other 
information to be provided to the participant prior to the beginning of the study and after any 
revisions are completed for new information. 
• Provide a copy of the ICF and written information about the study in the language in which 
the participant is proficient prior to clinical study participation. The language must be 
nontechnical and easily understood. 
• Explain the nature of the study to the participant or his/her legally acceptable representative 
and answer all questions regarding the study. 
• Inform participant that his/her participation is voluntary. Participant or his/her legally 
acceptable representative will be required to sign a statement of informed consent that meets 
the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability 
and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study 
center. 
• Allow time necessary for participant or his/her legally acceptable representative to inquire 
about the details of the study. 
 
Obtain an ICF signed and personally dated by participant or his/her legally acceptable 
representative and by the person who conducted the informed consent discussion. 
• Include a statement in participant’s medical record that written informed consent was obtained 
before 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. 
• Re-consent participant to the most current version of the ICF(s) during his/her participation in 
the study, as applicable. 
 
Revise the ICF whenever important new information becomes available that is relevant to the 
participant’s consent. The investigator, or a person designated by the investigator, should fully 
inform the participant or his/her legally acceptable representative of all pertinent aspects of the 
study and of any new information relevant to the participant’s willingness to continue participation 
in the study. This communication should be documented. 


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The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the participant’s signed 
ICF, and, in the US, the participant’s signed HIPAA Authorization. 
The ICF must also include a statement that BMS and local and foreign regulatory authorities have 
direct access to participant records. 
In situations where consent cannot be given by participants, their legally acceptable representatives 
(as per country regulation) are clearly and fully informed about the purpose, potential risks, and 
other critical issues regarding clinical studies in which the participant volunteers to participate. 
If informed consent is initially given by a participant’s legally acceptable representative or legal 
guardian and the participant subsequently becomes capable of making and communicating his or 
her informed consent during the study, consent must additionally be obtained from the participant. 
Participant unable to give their written informed consent (eg, stroke or participants with severe 
dementia) may only be enrolled in the study with the consent of a legally acceptable representative. 
The participant must also be informed about the nature of the study to the extent compatible with 
his or her understanding, and should this participant become capable, he or she should personally 
sign and date the ICF as soon as possible. The explicit wish of a participant who is unable to give 
his or her written consent, but who is capable of forming an opinion and assessing information to 
refuse participation in, or to be withdrawn from, the clinical study at any time, should be 
considered by the investigator. 
The rights, safety, and well-being of the study participants are the most important considerations 
and should prevail over interests of science and society. 
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS 
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes. 
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical trial becomes more reflective of the real-world population and the people impacted by 
the diseases studied. 
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY 
BMS collects and processes personal data of study participants, patients, health care providers, 
and researchers for biopharmaceutical research and development to advance innovative, high- 
quality medicines that address the medical needs of patients. BMS ensures the privacy, protection, 
and confidentiality of such personal data to comply with applicable laws. To achieve these goals, 
BMS has internal policies that indicate measures and controls for processing personal data. BMS 
adheres to these standards to ensure that collection and processing of personal data are limited and 
proportionate to the purpose for which BMS collects such personal data. This purpose is clearly 
and unambiguously notified to the individual at the time of collection of personal data. In the true 


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spirit of science, BMS is dedicated to sharing clinical trial information and data with participants, 
medical/research communities, the media, policy makers, and the general public. This is done in a 
manner that safeguards participant privacy and informed consent while respecting the integrity of 
national regulatory systems. Clinical trial data, health-related research, and pharmacovigilance 
activities on key-coded health data transferred by BMS across national borders is done in 
compliance with the relevant data protection laws in the country and GCP requirements. 
BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of 
its processing. 
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data. 
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 
adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information: 
1) Responsibilities of IT Personnel 
2) Securing the BMS Digital Infrastructure 
3) Identity and Access Management 
4) External Partner Connections 
5) Cyber Threat Detection and Response 
6) Internal Cyber Incident Investigation 
 
SOURCE DOCUMENTS 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site. 
Data reported on the CRF or entered in the electronic CRF (eCRF) that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be explained. 
• The investigator may need to request previous medical records or transfer records, depending 
on the study. Also, current medical records must be available. 
• Definitions of what constitutes source data can be found in systems that may include, but are 
not limited to, electronic medical/health records (EMRs/EHRs), adverse event 
tracking/reporting, protocol required assessments, and/or drug accountability records). 


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The investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original, and attributable, whether the data are handwritten on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical records/electronic health 
records, adverse event (AE) tracking/reporting, protocol-required assessments, and/or drug 
accountability records. 
When paper records from such systems are used in place of an electronic format to perform 
regulated activities, such paper records should be certified copies. A certified copy consists of a 
copy of original information that has been verified, as indicated by a dated signature, as an exact 
copy having all of the same attributes and information as the original. 
STUDY INTERVENTION RECORDS 
Records for study intervention (whether supplied by BMS, its vendors, or the site) must 
substantiate study intervention integrity and traceability from receipt, preparation, administration, 
and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority. 


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If 
Then 
Supplied by BMS (or its vendors): 
Records or logs must comply with applicable 
regulations and guidelines and should include: 
• amount received and placed in storage area 
• amount currently in storage area 
• label identification number or batch number 
• amount dispensed to and returned by each 
participant, including unique participant 
identifiers 
• amount transferred to another area/site for 
dispensing or storage 
• nonstudy disposition (eg, lost, wasted) 
• amount destroyed at study site, if applicable 
• amount returned to BMS 
• retain samples for 
bioavailability/bioequivalence/biocomparability, 
if applicable 
• dates and initials of person responsible for 
Investigational Product 
dispensing/accountability, as per the Delegation 
of Authority Form 
Sourced by site and not supplied by BMS 
or its vendors (examples include IP 
sourced from 
the 
sites stock 
or 
commercial supply or a specialty 
pharmacy) 
The investigator or designee accepts responsibility 
for documenting traceability and study treatment 
integrity in accordance with requirements applicable 
under 
law 
and 
the 
standard 
operating 
procedures/standards of the sourcing pharmacy 
BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements. 
CASE REPORT FORMS 
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents, or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study. 
For sites using the Sponsor or designee electronic data capture (EDC) tool, eCRFs will be prepared 
for all data collection fields except for fields specific to SAEs and pregnancy, which will be 
reported on the electronic SAE form and Pregnancy Surveillance Form, respectively. If the 


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electronic SAE form is not available, a paper SAE form can be used. Spaces may be left blank 
only in those circumstances permitted by study-specific CRF completion guidelines provided by 
the Sponsor or designee. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF and SAE/pregnancy CRFs must be promptly reviewed, signed, and dated by 
the investigator or qualified physician who is a sub-investigator and who is delegated this task on 
the Delegation of Authority Form. Sub-investigators in Japan may not be delegated the CRF 
approval task. For eCRFs, review and approval/signature is completed electronically through the 
BMS EDC tool. The investigator must retain a copy of the CRFs, including records of the changes 
and corrections. 
Each individual electronically signing eCRFs must meet Sponsor or designee training 
requirements and must only access the BMS EDC tool using the unique user account provided by 
the Sponsor or designee. User accounts are not to be shared or reassigned to other individuals. 
MONITORING 
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan. 
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. 
Certain CRF pages and/or electronic files may serve as the source documents. 
In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to CRFs, source documents, other study files, 
and study facilities. BMS audit reports will be kept confidential. 
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee. 
RECORDS RETENTION 
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or its designee, whichever is longer. 
The investigator (or head of the study site in Japan) must contact BMS prior to destroying any 
records associated with the study. 


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BMS or its designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed. 
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed-upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or its designee. 
RETURN OF STUDY TREATMENT 
For this study, study treatments (those supplied by BMS or a vendor or sourced by the 
investigator), such as partially used study treatment containers, vials, and syringes, may be 
destroyed on site. 
 
If 
Then 
Study treatments supplied by BMS (including 
its vendors) 
Any unused study interventions supplied by 
BMS can only be destroyed after being 
inspected and reconciled by the responsible 
Study Monitor, unless study treatments 
containers must be immediately destroyed as 
required for safety, or to meet local regulations 
(eg, cytotoxics or biologics). 
Partially used study interventions and/or 
empty containers may be destroyed after 
proper reconciliation and documentation. But 
unused IMP must be reconciled by site 
monitor/Clinical Research Associate prior to 
destruction. 
If study treatments will be returned, the return 
will be arranged by the responsible Study 
Monitor. 
Study treatments sourced by site, not supplied 
by BMS (or its vendors; eg, study treatments 
sourced from the site’s stock or commercial 
supply or a specialty pharmacy) 
It 
is 
the 
investigator’s 
or 
designee’s 
responsibility to dispose of all containers 
according to the institutional guidelines and 
procedures. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met: 
• On-site disposal practices must not expose humans to risks from the drug. 
• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 


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• Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s standard operating procedures and a copy provided to BMS upon request. 
• Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal (eg, incinerator, licensed sanitary landfill, or licensed waste-disposal 
vendor) must be documented. 
• Accountability and disposal records are complete, up-to-date, and available for the Study 
Monitor to review throughout the clinical trial period. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers. 
If conditions for destruction cannot be met, the responsible Study Monitor will make arrangements 
for return of study treatments provided by BMS (or its vendors). Destruction of non-study 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee. 
STUDY AND SITE START AND CLOSURE 
The Sponsor/designee reserves the right to close the study site or to 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 intervention development 
 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
DISSEMINATION OF CLINICAL STUDY DATA 
In order to benefit potential study participants, patients, healthcare providers and researchers, and 
to help BMS honor its commitments to study participants, BMS will make information about 
clinical research studies and a summary of their results available to the public as per regulatory 
and BMS requirements. BMS will post study information on local, national or regional databases 


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in compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases. 
CLINICAL STUDY REPORT 
A Signatory Investigator must be selected to sign the Clinical Study Report (CSR). 
For each CSR related to this protocol, the following criteria will be used to select the Signatory 
Investigator: 
• External Principal Investigator designated at protocol development 
• National Coordinating Investigator 
• Study Steering Committee chair or their designee 
• Participant recruitment (eg, among the top quartile of enrollers) 
• Involvement in trial design 
• Regionalrepresentation (eg, among top quartile of enrollers from a specified region or country) 
 
SCIENTIFIC PUBLICATIONS 
The data collected during this study are confidential and proprietary to the Sponsor or designee. 
Any publications or abstracts arising from this study must adhere to the publication requirements 
set forth in the Clinical Trial Agreement (CTAg) governing [study site or investigator] 
participation in the study. These requirements include, but are not limited to, submitting proposed 
publications to the Sponsor or designee at the earliest practicable time prior to submission or 
presentation and otherwise within the time period set forth in the CTAg. 
Scientific publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors. No public presentation or publication of any interim results may be made by any 
Principal Investigator, sub-investigator, or any other member of the study staff without the prior 
written consent of the Sponsor. 
Authorship of publications at BMS is aligned with the criteria of the International Committee of 
Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon significant 
contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE criteria for 
authorship: 
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the 
work (eg, problem solving, advice, evaluation, insights and conclusion); AND 
2) Drafting the work or revising it critically for important intellectual content; AND 
3) Final approval of the version to be published; AND 
4) Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 


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Those who make the most significant contributions, as defined above, will be considered by BMS 
for authorship of the primary publication. Sub-investigators will generally not be considered for 
authorship in the primary publication. Geographic representation will also be considered. 
Authors will be listed by order of significant contributions (highest to lowest), with the exception 
of the last author. Authors in first and last position have provided the most significant contributions 
to the work. 
For secondary analyses and related publications, author list and author order may vary from 
primary to reflect additional contributions. 


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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW UP AND REPORTING 
ADVERSE EVENTS 
 
Adverse Event Definition: 
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a 
pre-existing medical condition in a clinical investigation participant administered study 
treatment that does not necessarily have a causal relationship with this treatment. 
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of study treatment, whether or 
not considered related to the study treatment. 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, electrocardiograms, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal lab tests or 
other safety assessments should only be reported as AEs if the final diagnosis is not 
available. Once the final diagnosis is known, the reported term should be updated to be the 
diagnosis. 
• Exacerbation of a chronic or intermittent pre-existing condition, including either an increase 
in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration, even though 
it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator), 
should not be reported as an AE/serious adverse event (SAE) unless it is an intentional 
overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae and should specify “intentional overdose” as the verbatim 
term. 
Events NOT Meeting the AE Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy); the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE, even if serious conditions 
are met. 


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SERIOUS ADVERSE EVENTS 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any 
dose: 
Results in death. 
Is life-threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe). 
Requires inpatient hospitalization or causes prolongation of existing hospitalization (see NOTE 
below). 
NOTE: 
The following hospitalizations are not considered SAEs in Bristol-Myers Squibb (BMS) clinical 
studies: 
• A visit to the emergency room or other hospital department < 24 hours that does not result 
in admission (unless considered an important medical or life-threatening event). 
• Elective surgery, planned prior to signing consent. 
• Admissions as per protocol for a planned medical/surgical procedure. 
• Routine health assessment requiring admission for baseline/trending of health 
status (eg, routine colonoscopy). 
• Medical/surgical admission other than to remedy ill health and planned prior to entry into 
the study. Appropriate documentation is required in these cases. 
• Admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason). 
• Admission for administration of anticancer therapy in the absence of any other 
SAEs (applies to oncology protocols). 
Results in persistent or significant disability/incapacity. 
Is a congenital anomaly/birth defect. 
Is an important medical event (defined as a medical event[s] that may not be immediately 
life-threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or at 
home for allergic bronchospasm and blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.7 for the definition of potential DILI.) 


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Pregnancy and DILI must follow the same transmission timing and processes to BMS as used for 
SAEs. (See Section 9.2.5 for reporting pregnancies.) 
EVALUATING AES AND SAES 
 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE. 
• A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration, 
will be considered and investigated. 
• The investigator will also consult the Investigator’s Brochure and/or product information for 
marketed products in his/her assessment. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to the Sponsor. 
• The investigator may change his/her opinion of causality in light of follow-up information 
and send an SAE follow-up report with the updated causality assessment. 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
Assessment of Intensity 
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: 
• Mild: An event that is easily tolerated by the participant, causing minimal discomfort and 
not interfering with everyday activities. 
• Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with an SAE. Severe is a category utilized for rating the intensity of 
an event, and both AEs and SAEs can be assessed as severe. 
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as described 
in the definition of an SAE, NOT when it is rated as severe. 


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Follow-up of AEs and SAEs 
If only limited information is initially available, follow-up reports are required. 
(Note: Follow-up SAE reports must include the same investigator term[s] initially reported.) 
If an ongoing SAE changes in its intensity or relationship to study treatment or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or designee) using the same procedure used for transmitting the initial SAE report. 
All SAEs must be followed to resolution or stabilization. 
 
REPORTING OF SAES TO SPONSOR OR DESIGNEE 
 
• SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event. 
• SAEs must be recorded on the SAE Report Form. 
The required method for SAE data reporting is through the electronic case report 
form (eCRF). 
The paper SAE Report Form is intended only as a back-up option when the electronic data 
capture system is unavailable/not functioning for transmission of the eCRF to BMS (or 
designee). 
In this case, the paper form is transmitted via email or confirmed facsimile 
transmission. 
When paper forms are used, the original paper forms are to remain on site. 
• Pregnancies must be recorded on paper Pregnancy Surveillance Forms and transmitted via 
email or confirmed facsimile transmission. 
SAE Email Address: 
SAE Facsimile Number: Will be provided by local site monitor. 
SAE Telephone Contact (required for SAE and pregnancy reporting): Will be provided by local 
site monitor. 


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APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION 
Appendix 4 provides general information and definitions related to Woman of Childbearing 
Potential and methods of contraception that can be applied to most clinical trials. For information 
specific to this study regarding acceptable contraception requirements for female and male 
participants, refer to Section 6.1 of the protocol. Only the contraception methods as described in 
Section 6.1 are acceptable for this study. 
DEFINITIONS 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal female with 1 of the following: 
Documented hysterectomy 
Documented bilateral salpingectomy 
Documented bilateral oophorectomy 
 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
• Postmenopausal female 
A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 45 years 
in the absence of other biological or physiological causes. In addition, females under the 
age of 55 years must have a serum follicle-stimulating hormone (FSH) level > 40 mIU/mL 
to confirm menopause. 
 
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used. Suggested 
guidelines for the duration of the washout periods for HRT types are presented below. Investigators 
should use their judgement in checking serum FSH levels. 
• 1-week minimum for vaginal hormonal products (rings, creams, gels) 
• 4-week minimum for transdermal products 
• 8-week minimum for oral products 


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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the woman can be considered 
postmenopausal. 
End of Relevant Systemic Exposure 
End of relevant systemic exposure is the timepoint where the Investigational Medicinal Product 
(IMP) or any active major metabolites have decreased to a concentration that is no longer 
considered to be relevant for human teratogenicity or fetotoxicity. This should be evaluated in 
context of safety margins from the no-observed-adverse-effect level or the time required for 5 half- 
lives of the IMP to pass. 
METHODS OF CONTRACEPTION 
Note: Intravaginal and transdermal combined hormonal contraceptives are not approved by the 
Health Authority in Japan. Also, progestogen-only hormonal contraceptives are not approved by 
the Health Authority in Japan. 
Local laws and regulations may require use of alternative and/or additional contraception methods. 
 
Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of < 1% per year when used consistently and correctly.a 
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation and/or implantation. (This method of contraception can only be used 
by WOCBP participants in studies where hormonal contraception is permitted by the study 
protocol.)b 
Oral (birth control pills) 
Intravaginal (rings) 
Transdermal 
• Combined (estrogen-and progestogen-containing) hormonal contraception must begin at 
least 30 days prior to initiation of study therapy. 
• 
Progestogen-only hormonal contraception associated with inhibition of ovulation. (This 
method of contraception can only be used by WOCBP participants in studies where 
hormonal contraception is permitted by the study protocol.)b 
Oral 
Injectable 
• Progestogen-only hormonal contraception must begin at least 30 days prior to initiation of 
study therapy. 
Highly Effective Methods That Are User Independent 
• Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation and/or implantation. (This method of contraception can only be used by WOCBP 
participants in studies where hormonal contraception is permitted by the study protocol.)b 


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• Intrauterine device. 
• Intrauterine hormone-releasing system (IUS). (This method of contraception can only be 
used by WOCBP participants in studies where hormonal contraception is permitted by the 
study protocol.)b,c 
• Bilateral tubal occlusion. 
• Vasectomized partner 
Having a vasectomized partner is a highly effective contraception method provided that the 
partner is the sole male sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be used. 
A vasectomy is a highly effective contraception method provided that the participant is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used. 
• Sexual abstinence. 
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 treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant. 
• Continuous abstinence must begin at least 30 days prior to initiation of study therapy. 
• It is not necessary to use any other method of contraception when complete abstinence is 
elected. 
• WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2. 
• Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence. 
• Periodic abstinence (including, but not limited to, calendar, symptothermal, postovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea 
method (LAM) are not acceptable methods of contraception for this study. 
NOTES: 
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the IMP and other study medications will not alter hormonal exposures such that contraception 
would be ineffective or result in increased exposures that could be potentially hazardous. In this case, alternative 
methods of contraception should be utilized. For information specific to this study regarding permissibility of 
hormonal contraception, refer to .Sections 6.1 INCLUSION CRITERIA and 7.7.1 PROHIBITED AND/OR 
RESTRICTED TREATMENTS of the protocol. 
c IUSs are acceptable methods of contraception in the absence of definitive drug interaction studies when hormone 
exposures from intrauterine devices do not alter contraception effectiveness. For information specific to this 


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study regarding permissibility of hormonal contraception, refer to. Sections 6.1 INCLUSION CRITERIA and 
7.7.1 PROHIBITED AND/OR RESTRICTED TREATMENTS of the protocol. 
 
Less Than Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of > 1% per year when used consistently and correctly. 
• Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously. 
• Diaphragm with spermicide. 
• Cervical cap with spermicide. 
• Vaginal sponge with spermicide. 
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action. (This method of contraception cannot be used by WOCBP 
participants in studies where hormonal contraception is prohibited.) 
Unacceptable Methods of Contraception 
• Periodic abstinence (calendar, symptothermal, postovulation methods). 
• Withdrawal (coitus interruptus). 
• Spermicide only. 
• LAM. 
 
COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of pregnancy information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.5 and Appendix 3. 


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APPENDIX 5 
SEVERITY OF ALOPECIA TOOL (SALT) 
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the 
severity of AA based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; 
back region, top region, left and right regions of the scalp (see Figure 1). To calculate a SALT 
score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. 
Each region is multiplied by its respective weighting factor (percentage surface area of the scalp 
in that area), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp 
hair loss in each area (sum of the subtotals). 
Percentage surface area of the scalp for each of the four regions.1 
 
 
1 J Am Acad Dermatol Sep 2004 Olsen et al 


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APPENDIX 9 
INTERPRETATION OF HEPATITIS SEROLOGIC TEST RESULTS 
(JAPAN SPECIFIC) 
Hepatitis C Virus 
Testing for hepatitis C virus (HCV) is a 2-step process: (i) anti-HCV antibody and (ii) HCV 
ribonucleic acid (RNA). 
Participants with a negative result for anti-HCV antibody may be eligible for the study. 
Participants with a positive or indeterminate result for anti-HCV antibody require additional HCV 
RNA testing to determine eligibility. Participants with negative or undetectable HCV RNA may 
be eligible for the study. Participants with positive or detectable HCV RNA have HCV infection, 
will be excluded from the study, and should be referred for appropriate assessment and 
consideration for treatment. 
Participants who were previously treated with an approved treatment regimen for HCV infection 
may be eligible to participate in the study provided they achieve a Week 24 sustained virologic 
response (undetectable HCV RNA 24 weeks after completion of a full course of an approved 
treatment regimen for HCV infection). 
Hepatitis B Serologic Test Results 
As study treatment in this study is expected to demonstrate immunosuppressive effects, it is 
imperative to carefully evaluate and exclude participants with potentially active hepatitis B virus 
(HBV) infection. For this reason, in order to fully evaluate a participant’s eligibility for enrollment, 
the exclusion criterion 2) f) (see Section 6.2) requires interpretation of data from 3 standard tests 
for HBV (ie, measurement of hepatitis B surface antigen [HBsAg], hepatitis B core antibody 
[HBcAb], and hepatitis B surface antibody [HBsAb]). 
Eligibility for enrollment should be assessed as follows: 
• HBsAg positive participant is to be excluded from the study (acute or chronic infection). 
• In a participant that is HBsAg negative and HBcAb positive and/or HBsAb positive (HBV 
DNA is required) 
o If HBV DNA is ≥20 IU/ml, participant is to be excluded from the study 
o If HBV DNA is <20 IU/ml, participant may be eligible; see below 
 
Please refer to the below “Interpretation of Hepatitis B Serologic Test Results1 provided by the 
Department of Health and Human Services, Centers for Disease Control and Prevention. 


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For Japan 
Participants who are HBsAg positive will be excluded from the study. Participants who are HBsAg 
negative but positive for HBsAb and/or HBcAb will perform the quantitative HBV 
deoxyribonucleic acid (DNA) test to determine their eligibility to participate. Participants with 
detectable HBV DNA levels at screening, as defined per the local guidelines, are to be excluded. 
Participants with a negative HBsAg, but a positive HBcAb and/or HBsAb may be randomized if 
HBV DNA levels are undetectable during Screening (see chart below2). These participants will be 
followed with HBV DNA testing and review of liver chemistries throughout their participation in 
the study. 
During the treatment and follow-up periods, participants in this subgroup will have HBV DNA 
tested every 4 weeks, up to and including the Week 32 study visit. Starting with Week 40, Testing 
should occur every 4 or 8 weeks, at the discretion of the investigator, through the end of the study. 
If participants in this subgroup have detectable HBV DNA levels, which are defined per the local 
guidelines, at any time, they must permanently discontinue study treatment; the investigator should 
consider referring them for appropriate specialty care and follow-up. Participants should continue 
in the study as described in Section 8.1. 
 
Adapted from Japan Society of Hepatology Guidelines for the Management of Hepatitis B Virus Infection: 2019 
update. 
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; DNA, deoxyribonucleic acid; 
HBcAb, hepatitis B core antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HBV, 
hepatitis B virus; NA, nucleoside/nucleotide analogues. 
 
REFERENCES: 
1. Interpretation of hepatitis B serologic test results. Centers for Disease Control and Prevention. Accessed 21-Jul- 
2022. https://www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf. 


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2.  Drafting Committee for Hepatitis Management Guidelines, the Japan Society of Hepatology. Japan Society of 
Hepatology Guidelines for the Management of Hepatitis B Virus Infection: 2019 update. Hepatol Res 2020;50:892- 
923. 


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APPENDIX 10  PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY 
Overall Rationale for the Protocol Amendment 01, 24-Mar-2022 
The primary reason for Protocol Amendment 01 is to refine the endpoints based on recently 
available external data. 
Additional revisions include the addition of a summary of the completed Phase 3 psoriasis 
deucravacitinib trials; updates to the background section based on new compounds in 
development; update of the Protocol Summary to align with respective changes to the protocol; 
updated study contacts on the Title Page. 
Minor formatting and typographical corrections as well as updates to align with the current BMS 
guidance have been made and have not been summarized. 
 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Global 
Changed BMS-986165 to 
deucravacitinib. 
To update the protocol with the 
approved generic name. 
Table 2-1: Screening Procedural 
Outline (IM011134) 
Updated text in the Notes column. 
To provide clarity and further 
guidance on screening procedures. 
Table 2-1: Screening Procedural 
Outline (IM011134) 
 
 
Table 2-2: On Treatment 
Procedural Outline (IM011134): 
Week 0 through Week 24 
Table 2-3: On Treatment (Week 28 
through Week 52) and Post- 
Treatment Follow-Up (Week 56) 
Procedural Outline (IM011134) 
Table 4-1: Objectives and 
Endpoints 
Section 9: Study Assessments and 
Procedures 
Section 9.1: Efficacy Assessments 


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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
• Added note to Dispense Study 
Intervention row to dispense 
after all visit procedures have 
been performed. 
• To ensure that participants do 
not take study intervention 
prior to completion of 
assessments. 
Table 2-2: On Treatment 
Procedural Outline (IM011134): 
Week 0 through Week 24 
Table 2-3: On Treatment (Week 28 
through Week 52) and Post- 
Treatment Follow-Up (Week 56) 
Procedural Outline (IM011134) 
Section 9: Study Assessments and 
Procedures 
• Added footnote “a” to Week 0 
stating that all assessments and 
sample collections should 
occur before study 
intervention administration. 
• Removed Body Weight 
assessments from Week 28 
and Week 56 and removed 
Urinalysis from Week 56. 
• To ensure baseline samples are 
collected and assessments are 
performed prior to dosing. 
• To reduce burden on site and 
participant. 
Section 3: Introduction 
Added information on compounds 
currently in development which 
have demonstrated potential benefit 
in the treatment of alopecia areata. 
To include information not 
available at the time of the final 
protocol. 
Section 3.1: Study Rationale 
Updated text with pre-clinical 
animal study of a deucravacitinib 
analogue, and most recent efficacy 
and safety data from Phase 3 
studies. 
To further support development of 
deucravacitinib for this indication. 
Section 3.2: Background 
Added efficacy and safety 
information from 2 Phase 3 trials of 
deucravacitinib in participants with 
moderate-to-severe plaque psoriasis. 
At time of final protocol, the 2 
Phase 3 studies were ongoing and 
data were not yet available. 
Section 3.3: Benefit/Risk 
Assessment 
• Added dosing information from 
first-in-human study for safety 
and tolerability of 
deucravacitinib daily dose of 6 
mg. 
• Updated text to include 
coronavirus disease 2019 
(COVID-19) as a potential risk 
and information related to 
guidance for investigators in 
relation to COVID-19. 
• To support the benefit/risk 
assessment. 
• To provide a summary of 
benefit/risk information in the 
context of the COVID-19 
pandemic. 


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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Table 4-1: Objectives and 
Endpoints 
• Updated wording of objectives 
from assess to evaluate. 
• Moved assessment of safety 
from a secondary objective to 
a primary objective. 
• To refine primary and 
secondary endpoints. 
• Safety is a key assessment for 
this new deucravacitinib 
indication. 
 
 
• To align language with other 
deucravacitinib protocols. 
 
 
Section 5.1: Overall Design 
Section 10.4.2 Primary Efficacy 
Analyses 
Updated the stratification for 
randomization of current disease 
duration from ≤ 3.5 years and > 3.5 
years to < 4 years to ≥ 4 years. 
To align with competitor trials on 
disease duration for stratification. 
Section 6.1: Inclusion Criteria 
Added requirement of a negative 
highly sensitive serum pregnancy 
test at Screening Visit to criterion 
4) a). 
To clarify criterion for pregnancy 
testing at Screening. 
Section 6.2: Exclusion Criteria 
• Added note to criterion 5) e) 
that low-potency topical 
corticosteroids are permitted 
but cannot be applied to the 
scalp. 
• Added criterion 9) e) regarding 
inability to tolerate oral 
medication. 
• To clarify guidance for topical 
steroid application. 
• To ensure participant is able to 
tolerate oral medication before 
participating in the study. 
Section 6.3.3: Activity 
Added that strenuous physical 
activity is activity that is more 
strenuous than the participant’s 
usual daily activity. 
To further clarify the restriction of 
strenuous physical activity. 
Section 7.2: Method of Study 
Intervention Assignment 
Added statement that participants 
initially randomized to receive 
deucravacitinib will remain on their 
assigned study intervention, in a 
blinded manner, until Week 52. 
To clarify guidance on study 
intervention assignment and 
blinding until Week 52. 
Section 7.3: Blinding 
Modified text regarding blinding of 
study intervention, result of Week 
To clarify when the unblinded 
analysis will occur and who will 
remain blinded. 


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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
24 database lock analysis, and 
unblinding. 
Section 7.7: Concomitant Therapy 
Moved text from Section 7.7.1: 
Prohibited and/or Restricted 
Treatments related to systemic 
corticosteroid medication use when 
and discussions with the Medical 
Monitor should occur. 
To clarify guidance on the use of 
systemic corticosteroid medications 
in the concomitant therapy section. 
Section 7.7.1: Prohibited and/or 
Restricted Treatments 
Added Janus kinase (JAK) 
inhibitors. 
To clarify that any use of JAK 
inhibitors is prohibited. 
Section 7.7.2: Permitted Vaccines 
(Including COVID-19 Vaccine) 
Added information on COVID-19 
vaccines and investigational 
vaccines. 
To provide information for 
permitted vaccines on the study. 
Section 8.1.1: Temporary 
Interruption 
Added confirmed or suspected cases 
of severe acute respiratory 
syndrome coronavirus 2 
(SARS-CoV-2). 
To provide guidance for temporary 
discontinuation of study 
intervention in the context of the 
COVID-19 pandemic. 
Section 9.1: Efficacy Assessments 
Added training requirement for 
evaluators. 
To ensure consistency and reduce 
variability of assessments. 
Section 9.1: Efficacy Assessments 
Section 9.2.1: Adverse Events of 
Interest 
Added information on adverse 
events of interest (AEIs). 
To better characterize and 
understand AEIs related to 
deucravacitinib. 
Section 9.2.2: Time Period and 
Frequency for Collecting AE and 
SAE Information 
Added statement regarding 
reporting of adverse events (AEs) 
and serious adverse events (SAEs) 
related to SARS-CoV-2 or 
COVID-19 infection. 
To align with current guidance 
regarding reporting of AEs, SAEs, 
and those related to SARS-CoV-2 
infection. 


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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 
Section Number & Title 
Description of Change 
Brief Rationale 
 
 
 
 
Section 10.1: Statistical 
Hypothesis 
Added section. 
To articulate the primary study 
hypotheses to reflect there are 2 
dosages to be compared with 
placebo. 
Section 10.2: Sample Size 
Determination 
• 
Updated text for sample size 
and overall power of the study. 
• 
Updated text for TYK2/JAK 1 
and JAK 3 inhibitors. 
• 
To restate power calculations to 
address multiplicity by 
Bonferroni procedure. 
• 
For clarification on JAK 
inhibitor analysis. 
Section 10.3: Analysis Sets 
• 
Updated description text for 
full analysis set and 
randomized populations. 
• 
Removed as treated population. 
• 
Added safety population. 
For alignment across the protocol. 
Section 10.4: Statistical Analysis 
Updated section with information 
on general considerations, primary 
efficacy endpoints, secondary 
efficacy endpoints, 
and other safety analyses. 
To clarify statistical analyses for all 
efficacy endpoints (primary, 
secondary, 
).