A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)
Phase: PHASE4
Conditions: Palmoplantar Psoriasis, Genital Psoriasis
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy 
and Safety of Deucravacitinib in Participants with Non-Pustular Palmoplantar and Genital Psoriasis 
(Psoriatyk Special Sites) 
 
NCT Number: NCT06042920 
Document Date (Date in which document was last revised): 08-May-2023 
 
 
 

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Compound: Deucravacitinib 
Brief Title: 
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Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
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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 
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BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
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DOCUMENT HISTORY 
Document 
Date of Issue 
Summary of Changes 
Original Protocol 
08-May-2023 
Not applicable. 
 
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IM0111112 
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Date: 08-May-2023 
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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
DOCUMENT HISTORY .................................................................................................................3 
TABLE OF CONTENTS .................................................................................................................4 
1 
PROTOCOL SUMMARY ............................................................................................7 
2 
SCHEDULE OF ACTIVITIES ..................................................................................14 
3 
INTRODUCTION ......................................................................................................52 
3.1 
Study Rationale ...........................................................................................................53 
3.2 
Background .................................................................................................................54 
3.2.1 
Clinical Development .................................................................................................55 
3.3 
Benefit/Risk Assessment ............................................................................................55 
3.3.1 
Risk Assessment ..........................................................................................................56 
3.3.2 
SARS-CoV-2 Pandemic-related Risk Assessment .......................................................57 
3.3.3 
Benefit Assessment ......................................................................................................58 
3.3.4 
Overall Benefit/Risk Conclusion .................................................................................58 
4 
OBJECTIVES AND ENDPOINTS ............................................................................59 
5 
STUDY DESIGN .......................................................................................................62 
5.1 
Overall Design ............................................................................................................62 
5.1.1 
Screening period .........................................................................................................62 
5.1.2 
Intervention period .....................................................................................................62 
5.1.3 
Week 16 .......................................................................................................................63 
5.1.4 
Week 20 .......................................................................................................................63 
5.1.5 
Week 52 and Safety Follow-up Period .......................................................................63 
5.1.6 
Data Monitoring Committee and Other Committees ..................................................65 
5.1.6.1 
Study Steering Committee ...........................................................................................65 
 
 ...............................................................................................65 
5.3 
End of Study Definition ..............................................................................................65 
5.4 
Scientific Rationale for Study Design ........................................................................65 
5.5 
Justification for Dose ..................................................................................................66 
66 
5.7 
Rationale for Optional Future Research .....................................................................66 
6 
STUDY POPULATION .............................................................................................67 
6.1 
Inclusion Criteria ........................................................................................................67 
6.2 
Exclusion Criteria .......................................................................................................69 
6.3 
Lifestyle Restrictions ..................................................................................................73 
6.3.1 
Meals and Dietary Restrictions ..................................................................................73 
6.3.2 
Caffeine, Alcohol, and Tobacco ..................................................................................73 
6.3.3 
Activity ........................................................................................................................74 
6.4 
Screen Failures ............................................................................................................74 
6.4.1 
Re-testing During Screening or Re-screening ............................................................74 
7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ........................74 
7.1 
Study Interventions Administered ..............................................................................75 
7.2 
Assignment to Study Intervention ..............................................................................75 
7.3 
Blinding ......................................................................................................................76 
7.3.1 
Maintaining the Blind .................................................................................................76 
7.3.2 
Circumstances for Unblinding ....................................................................................77 
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7.4 
Dosage Modification ..................................................................................................77 
7.5 
Preparation/Handling/Storage/Accountability ............................................................78 
7.6 
Study Intervention Compliance ..................................................................................78 
7.7 
Concomitant Therapy .................................................................................................79 
79 
7.7.2 
Permitted Concomitant Medication ............................................................................80 
 
 ....................................................................................................80 
7.7.4 
Permitted Vaccines (including COVID-19 Vaccine) ..................................................80 
7.7.5 
Other Restrictions and Precautions ............................................................................81 
7.8 
Continued Access to Study Intervention After the End of the Study .........................81 
8 
DISCONTINUATION CRITERIA ............................................................................81 
8.1 
Discontinuation of Study Intervention ........................................................................81 
8.1.1 
Temporary Discontinuation From Study Intervention ...............................................82 
8.1.2 
Post-study Intervention Study Follow-up ...................................................................83 
8.2 
Discontinuation From the Study .................................................................................83 
8.2.1 
Individual Discontinuation Criteria ...........................................................................83 
8.3 
Lost to Follow-up .......................................................................................................83 
9 
STUDY ASSESSMENTS AND PROCEDURES ......................................................84 
9.1 
Efficacy Assessments .................................................................................................85 
9.1.1 
Assessments used in both sub-protocols .....................................................................85 
9.1.1.1 
Investigator-administered Assessments ......................................................................85 
 
 ..............................................................................86 
9.1.2 
Palmoplantar Sub-protocol Specific Assessments ......................................................87 
9.1.2.1 
Investigator-administered Assessments ......................................................................87 
 
 ..............................................................................87 
9.1.3 
Genital Psoriasis Sub-protocol Specific Assessments ................................................88 
9.1.3.1 
Investigator-administered Assessments ......................................................................88 
 
 ..............................................................................89 
9.1.4 
Additional Assessments ...............................................................................................90 
.90 
9.2 
Adverse Events ...........................................................................................................91 
9.2.1 
Period and Frequency for Collecting AE and SAE Information ................................91 
9.2.2 
Method of Detecting AEs and SAEs ............................................................................91 
9.2.3 
Follow-up of AEs and SAEs ........................................................................................92 
9.2.4 
Regulatory Reporting Requirements for SAEs ...........................................................92 
9.2.5 
Pregnancy ...................................................................................................................92 
9.2.6 
Laboratory Test Result Abnormalities ........................................................................93 
9.2.7 
Potential Drug-induced Liver Injury ..........................................................................93 
9.2.8 
Other Safety Considerations .......................................................................................93 
.93 
9.3 
Overdose .....................................................................................................................94 
9.4 
Safety ..........................................................................................................................94 
9.4.1 
Physical Examinations ................................................................................................94 
9.4.2 
Vital Signs ...................................................................................................................94 
9.4.3 
Electrocardiograms ....................................................................................................95 
 
 ...............................................................95 
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 .....................................................................95 
9.5 
Pharmacokinetics ........................................................................................................96 
9.6 
Immunogenicity Assessments ....................................................................................96 
.96 
.97 
.97 
9.8 
Optional Future Research ...........................................................................................97 
9.9 
Health Economics OR Medical Resource Utilization and Health Economics ...........97 
10 
STATISTICAL CONSIDERATIONS .......................................................................97 
10.1 
Statistical Hypotheses .................................................................................................97 
 
 ........................................................................................98 
10.3 
Analysis Sets .............................................................................................................102 
10.4 
Statistical Analyses ...................................................................................................103 
10.4.1 
General Considerations ............................................................................................104 
10.4.2 
Primary Endpoint(s) .................................................................................................107 
10.4.3 
Secondary Endpoint(s) ..............................................................................................108 
.109 
10.4.5 
Safety Analyses .........................................................................................................109 
10.4.6 
Other Analyses ..........................................................................................................109 
10.5 
Interim Analyses .......................................................................................................110 
11 
REFERENCES .........................................................................................................111 
12 
APPENDICES ..........................................................................................................115 
APPENDIX 1 
ABBREVIATIONS ..........................................................................................116 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS .............................................120 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING .....................................131 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION ...............................................................135 
.139 
APPENDIX 6 
HEPATITIS B VIRUS (HBV) SCREENING ..................................................142 
 
 
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1 
PROTOCOL SUMMARY 
Protocol Title: 
A 
PHASE 
4, 
MULTICENTER, 
RANDOMIZED, 
DOUBLE-BLIND, 
PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 
DEUCRAVACITINIB IN PARTICIPANTS WITH NON-PUSTULAR PALMOPLANTAR 
AND GENITAL PSORIASIS (PSORIATYK SPECIAL SITES) 
Brief Title: 
Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 
deucravacitinib in palmoplantar and genital psoriasis 
Rationale: 
SOTYKTU™ (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 
(TYK2) inhibitor is approved in multiple countries for the treatment of adults with 
moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 
This approval was based on the results of completed 52-week, randomized, Phase 3, 
placebo-controlled studies (POETYK PSO-1 and PSO-2) of deucravacitinib 6 mg daily versus 
placebo and apremilast 30 mg twice daily.  
In these 2 trials, in addition to the co-primary endpoints of Psoriasis Area and Severity 
Index (PASI)-75 and static Physician’s Global Assessment (s-PGA)0/1 at Week 16, palmoplantar 
(PP) psoriasis was assessed using the palmoplantar physician global assessment (pp-PGA) 0/1 and 
palmoplantar Psoriasis Area and Severity Index (pp-PASI)-75 change from baseline in participants 
with a pp-PGA score ≥ 3 (moderate-to-severe PP psoriasis) at baseline. Although 16% of the 
subjects had a history of PP psoriasis, only 7% of subjects in the Phase 3 studies met the baseline 
pp-PGA ≥ 3 criterion. The individual Phase 3 studies were not sized to specifically assess PP 
psoriasis. Due to the small number of subjects with pre-existing PP psoriasis in each study, the 
pooled data from PSO-1 and PSO-2 allowed for a more meaningful evaluation. In this analysis of 
the pooled PSO-1 and PSO-2 population, significantly more participants receiving deucravacitinib 
(n = 57) versus placebo (n = 25) achieved pp-PGA 0/1 at Week 16 (49.1% versus 16%, 
p = 0.0052). In the pooled PSO-1 and PSO-2 population, the mean change from baseline in 
pp-PASI, adjusted for study, body weight, prior biologic use, and the baseline value as a covariate 
was -13.3 (95% confidence interval [CI]: -16.3, -10.2) and -4.2 (95% CI: -8.4, -0.0) for 
deucravacitinib and placebo, respectively. In PSO-1, pp-PGA 0/1 responses at Week 16 were 
maintained through Week 52 with continuous deucravacitinib treatment (55.6% [95% CI: 32.6, 
78.5]). 1 Genital psoriasis (GenPs) has not yet been assessed in the deucravacitinib psoriasis 
clinical program.  
Remaining key data gaps include the efficacy of deucravacitinib in improving moderate-to-severe 
GenPs, PP psoriasis, and health-related Quality of Life measures specifically associated with these 
difficult-to-treat sites.  
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Objectives and Endpoints: 
Non-pustular Palmoplantar Psoriasis Sub-protocol Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
 
• 
To compare the efficacy, as measured by 
pp-PASI-75, of deucravacitinib versus placebo at 
Week 16 in participants with PP plaque psoriasis 
• 
pp-PASI-75, defined as a 75% improvement in 
pp-PASI score from baseline at Week 16 
Secondary 
 
• 
To compare the efficacy, as measured by pp-PGA 
0/1, of deucravacitinib versus placebo at Week 16 
in participants with PP plaque psoriasis 
• 
Proportion of participants who achieve a pp-PGA 
score of 0 (clear) or 1 (almost clear) with at least a 
2-point reduction from baseline at Week 16 
Other Secondary 
• 
To assess the safety of deucravacitinib versus 
placebo in participants with PP plaque psoriasis 
between Week 0 and Week 16  
• 
AEs, SAEs, laboratory parameters, and VS between 
Week 0 and Week 16 
 
Abbreviations: AE, adverse event; PP, palmoplantar; pp-PASI, palmoplantar Psoriasis Area and Severity Index; 
pp-PGA, palmoplantar physician global assessment; SAE, serious adverse event; VS, vital signs. 
 
Genital Psoriasis Sub-protocol Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
• 
To compare the efficacy, as measured by s-PGA-G 
0/1, of deucravacitinib versus placebo at Week 16 
in participants with GenPs 
• 
s-PGA-G 0/1, defined as proportion of participants 
achieving s-PGA-G score of 0 (clear) or 1 (almost 
clear) with at least a 2-point reduction from baseline 
at Week 16 
Key Secondary 
• 
To compare the efficacy, as measured by change 
from 
baseline 
in 
GenPs 
Itch 
NRS, 
of 
deucravacitinib versus placebo at Week 16 in 
participants with GenPs  
• 
Change from baseline in GenPs itch NRS score at 
Week 16.  
• 
To compare the efficacy, as measured by s-PGA 
0/1, of deucravacitinib versus placebo at Week 16 
in participants with GenPs 
• 
s-PGA 0/1, defined as proportion of participants 
achieving s-PGA score of 0 (clear) or 1 (almost 
clear) with at least a 2-point reduction from 
baseline at Week 16 
Other Secondary 
 
• 
To assess the safety of deucravacitinib versus 
placebo in participants with GenPs between Week 
0 and Week 16 
• 
AEs, SAEs, laboratory parameters, and VS between 
Week 0 and Week 16 
Abbreviations: AE, adverse event; GenPs, genital psoriasis; NRS, Numeric Rating Scale; PP, palmoplantar; SAE, 
serious adverse event; s-PGA, static Physician’s Global Assessment; s-PGA-G, static Physician’s Global Assessment 
of Genitalia; VS, vital signs.
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Overall Design: 
This master protocol (IM0111112) with 2 sub-protocols is a Phase 4, double-blind, 
placebo-controlled multicenter study to assess the efficacy and safety of deucravacitinib in 
participants with moderate-to-severe non-pustular PP or GenPs versus placebo. Enrollment in each 
sub-protocol will be concurrent. Participants with involvement of both sites during screening 
(genital and PP) can only be randomized to 1 of the sub-protocols as per investigator’s discretion. 
In both sub-protocols, a placebo control is included to allow the assessment of effects of the 
intervention. The placebo control will also provide a basis for comparison of safety assessments. 
For each sub-protocol participants will undergo screening evaluations within 28 days prior to the 
administration of study intervention to determine eligibility.  
For the PP psoriasis sub-protocol following the screening process, participants will be randomized 
in a 2:1 ratio to either deucravacitinib 6 mg once daily (QD) or placebo, respectively. 
 For the purpose of this 
study, even the participants with the presence of very few isolated pustules and only limited to the 
PP plaques (See Section 6.1) are still considered to have non-pustular PP psoriasis. This will allow 
enrollment of these participants into this study. However, to limit the number of participants who 
may potentially have few isolated pustules, participants with the presence of pustules (See 
Section 6.1) would be limited to a maximum of 10% of all randomized participants. Participants 
with a significant number of pustules (> 5) and/or predominant pustular component would be 
categorized as PP pustular psoriasis and would not be eligible for the study.  
For the GenPs sub-protocol, following the screening process, participants will be randomized in a 
2:1 ratio to either deucravacitinib 6 mg QD or placebo, respectively. 
 
 Given the paucity 
of data on GenPs in women in the literature, the genital sub-protocol will aim to enroll at least 
40% of female participants into the study as an attempt to address this data gap.  
For both sub-protocols the duration of study participation is approximately 60 weeks and will be 
divided into the following periods: screening (up to 4 weeks), treatment (52 weeks), and 
follow-up (4 weeks).  
At Week 16, all participants regardless of their blinded intervention, will be switched to open-label 
deucravacitinib 6 mg QD bottles through Week 52. Participants randomized to deucravacitinib 
6 mg QD will continue their current dose through Week 52.   
Participants will be followed up for safety for 4 additional weeks, from Weeks 52 through 56. 
Participants who discontinue study intervention early/withdraw prematurely must complete the 
end-of-treatment (EOT) visit. The participant will be asked to return to the clinic to complete the 
28-day safety follow-up visit and encouraged to report any serious adverse events (SAEs) or 
adverse events (AEs) experienced during this time.  
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BMS-986165 
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Study Population: 
Male and female participants ≥ 18 years of age must meet the following criteria for entry into the 
study. 
Non-pustular Palmoplantar Psoriasis Sub-protocol 
Key Inclusion Criteria: 
Type of Participant and Target Disease Characteristics 
a) Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)
and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology
changes or significant flares of disease activity in the opinion of the investigator.
b) Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at
both screening visit and Day 1.
c) Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-point
scale and pp-PASI ≥ 8 at both screening visit and Day 1.
i)
A total maximum of 5 sterile pustules across both palms and soles limited only to
psoriatic plaques will be allowed.
d) Evidence of typical plaque psoriasis outside palms and soles at both screening visit and
Day 1.
e) Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
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f) Failed to respond to, or intolerant of ≥ 1 topical therapy. 
 
Genital Psoriasis Sub-protocol 
Key Inclusion Criteria: 
Type of Participant and Target Disease Characteristics  
a) Men and women diagnosed with stable plaque psoriasis with involvement of the genital 
area for at least 6 months or more. Stable psoriasis is defined as no morphology changes 
or significant flares of disease activity in the opinion of the investigator.  
b) Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at 
both screening visit and Day 1. 
c) Moderate-to-severe GenPs, defined as static Physician’s Global Assessment of 
Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day 1. 
d) Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1. 
e) Deemed by the investigator to be a candidate for phototherapy or systemic therapy.  
f) Failed to respond to, or intolerant of ≥ 1 topical therapy.  
 
Intervention Groups and Duration: 
Participants in both sub-protocols will take oral doses of one of the Investigational [Medicinal] 
Product (IP) either deucravacitinib or placebo QD, for 16 weeks. At Week 16, all participants 
regardless of their blinded intervention, will be switched to open label deucravacitinib 6 mg QD 
bottles through Week 52. Participants randomized to deucravacitinib 6 mg QD will continue their 
current dose through Week 52. 
Study Intervention: 
 
Study Intervention for IM0111112 
Medication 
Potency 
IP/Non-IP 
Deucravacitinib (BMS-986165) 
6 mg 
IP 
Placebo 
N/A 
IP 
Abbreviation: IP, investigational product. 
 
Statistical Methods: 
For the non-pustular PP psoriasis sub-protocol, the primary hypothesis is that the odds of achieving 
pp-PASI-75 at Week 16 in participants receiving deucravacitinib 6 mg QD are improved compared 
to participants receiving placebo.  
The null hypothesis to be tested for the primary endpoint is the following: 
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BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
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• The odds of achieving pp-PASI-75 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
The null hypothesis corresponding to the key secondary endpoint is: 
• The odds of achieving pp-PGA 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo. 
 
For the GenPs sub-protocol, the primary hypothesis is that the odds of achieving s-PGA-G 0/1 at 
Week 16 in participants receiving deucravacitinib 6 mg QD are improved compared to participants 
receiving placebo. 
The null hypothesis to be tested for the primary endpoint is the following: 
• The odds of achieving s-PGA-G 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
The null hypothesis corresponding to the key secondary endpoint is: 
• The mean change from baseline in GenPs Itch NRS score at Week 16 in participants receiving 
deucravacitinib 6 mg QD is not different from participants receiving placebo. 
 
The null hypothesis corresponding to the second key secondary endpoint is: 
• The odds of achieving s-PGA 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
The statistical comparisons will be carried out in a hierarchical order for each sub-protocol. The 
hierarchical testing will preserve the overall Type I error at 0.05 for each sub-protocol. 
If statistical significance is not met for the primary endpoint, then subsequent p-values will be 
considered descriptive for that sub-protocol. 
Data Monitoring Committee: No 
A Data Monitoring Committee will not be used in the study. 
Other Committee: Yes 
This study will use an external Study Steering Committee. 
Brief Summary: 
The purpose of this study is to compare the efficacy of deucravacitinib to placebo for the treatment 
of participants with non-pustular palmoplantar or genital psoriasis.  
The primary hypothesis for the non-pustular palmoplantar psoriasis sub-protocol is that the odds 
of achieving pp-PASI-75 at Week 16 in participants receiving deucravacitinib 6 mg QD are 
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IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
13 
improved compared to participants receiving placebo. The primary hypothesis for the genital 
psoriasis sub-protocol is that the odds of achieving s-PGA-G 0/1 at Week 16 in participants 
receiving deucravacitinib 6 mg QD are improved compared to participants receiving placebo.  
The duration of study participation for both sub-protocols is approximately 60 weeks and will be 
divided into the following periods: screening (up to 4 weeks/28 days), treatment (52 weeks), and 
follow-up (4 weeks). Following the initial screening study visit, subsequent visits will occur at 
Day 1, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, 
Week 32, Week 40, Week 52, and Week 56.  
Participants who have completed the screening procedures and have met the inclusion/exclusion 
criteria for 1 of the sub-protocols will be randomized on Day 1 in a 2:1 ratio to either 
deucravacitinib 6 mg once a day or placebo, respectively, for the first 16 weeks. Participants with 
involvement of both sites during screening (genital and palmoplantar) can only be randomized to 
1 of the sub-protocols as per investigator’s discretion. At Week 16, all participants, regardless of 
their blinded intervention, will be switched to open-label deucravacitinib 6 mg QD bottles through 
Week 52. Participants and investigators will remain blinded to the double-blind study intervention 
from Day 1 to Week 16 until the end of the study.  
Statement of expanded access: Not applicable 
 
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IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
14 
2 
SCHEDULE OF ACTIVITIES 
Non-pustular Palmoplantar Sub-protocol 
The schedules of activities and procedures for the palmoplantar (PP) psoriasis sub-protocol are 
documented in Table 2-1 for screening, Table 2-2 for Week 0 (baseline) through Week 20, and 
Table 2-3 for Week 24 through Week 56.  
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IM0111112 
BMS-986165 
Deucravacitinib 
Date: 08-May-2023 
15 
Table 2-1: 
Non-pustular Palmoplantar Psoriasis Sub-protocol Screening Procedural Outline (IM0111112)
Procedure 
Screening Visit 
(Day -28 to  Day -1) 
Notes 
Eligibility Assessments 
Informed Consent 
X 
A participant is considered enrolled only when a 
protocol-specific informed consent is signed. Must be 
obtained prior to performing any screening procedures.  
Enroll participant 
X 
Obtain number from IRT. 
Inclusion/Exclusion Criteria 
X 
Includes duration of plaque psoriasis, PP psoriasis 
involvement, and documentation of evidence of typical 
plaque psoriasis outside palms and soles by the 
investigator. 
Demographics and Participant Characteristics 
X 
Some data may be collected via electronic device. Note: 
SOGIIS data will be collected for US participants only. 
History of Tobacco Use 
X 
Include description of current tobacco use. 
Psoriasis-related History 
X 
All psoriasis history including disease duration, scalp 
psoriasis, PP psoriasis, nail psoriasis, genital psoriasis, and 
PsA duration, or history of other forms of psoriasis. 
Psoriasis-related Systemic Treatment 
X 
Includes nonbiologic conventional systemic (eg, 
methotrexate), biologic agents, and/or phototherapy. For 
each therapy, include a length of time on treatment and 
reason(s) for discontinuation (eg, lack of efficacy, 
intolerance, side effects, loss of access to treatment), if 
applicable. 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
16 
Table 2-1: 
Non-pustular Palmoplantar Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit 
(Day -28 to  Day -1) 
Notes 
Psoriasis-related Topical 
Treatment 
X 
Includes topical treatments and shampoos for psoriasis. 
Other Prior and Concomitant Treatments 
X 
All medications for other/non-psoriasis conditions. 
Safety Assessments 
Physical Examination 
X 
Complete PE. 
Physical Measurements 
X 
Includes height, weight, and BMI. 
Vital Signs 
X 
Includes (ear or oral) 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. 
12-lead ECG 
X 
12-lead ECGs should be recorded after the participant has 
been supine for at least 5 minutes. A single ECG should be 
collected. See Section 9.4.3. 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
17 
Table 2-1: 
Non-pustular Palmoplantar Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit 
(Day -28 to  Day -1) 
Notes 
Adverse Event Reporting 
Monitor for AE and SAE Assessment 
X 
All AEs and SAEs must be collected from the date of 
participant’s written consent until 30 days post 
discontinuation of dosing or participant’s participation in 
the study if the last scheduled visit occurs at a later time. 
Clinical Efficacy 
 
pp-PGA 
X 
Non-pustular PP plaque psoriasis. Participants with PP 
pustulosis or PP pustular psoriasis are not eligible for 
enrollment. Refer to Section 6 for detailed eligibility 
criteria. 
pp-PASI 
X 
Refer to Section 6 for detailed eligibility criteria. 
Number of Pustules Present  
X 
Participants with a total maximum of 5 sterile pustules 
across both palms and soles and limited only to psoriatic 
plaques will be eligible for enrollment. The total number 
and location of pustules must be documented if present. 
s-PGA  
X 
Refer to Section 6 for detailed eligibility criteria. 
Evidence of Typical Plaque Psoriasis Outside Palms and 
Soles 
X 
Refer to Section 6 for detailed eligibility criteria. 
Dispense E-diary 
 
 
X 
All consented participants will be given a diary device at 
the screening visit and will begin recording PP psoriasis 
symptoms on a daily basis in the diary device. Participants 
who are not randomized will stop recording and return 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
18 
Table 2-1: 
Non-pustular Palmoplantar Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit 
(Day -28 to  Day -1) 
Notes 
their diary device to the site. Participants who are 
randomized will continue recording their psoriasis 
symptoms on a daily basis in the diary device through 
Week 16 and for 7 days prior to each subsequent visit 
through Week 52. 
Abbreviations: AE, adverse event; BMI, body mass index; 
; ECG, electrocardiogram; 
 
; 
IRT, interactive response technology; 
; PE, physical examination; 
; PI, principal 
investigator; PP, palmoplantar; pp-PGA, palmoplantar physician global assessment; PsA, psoriatic arthritis; pp-PASI, palmoplantar Psoriasis Area and Severity 
Index; SAE, serious adverse event; 
; SOGIIS, sexual orientation, gender identity and intersex status; 
s-PGA, static physician global assessment; 
; US, United States; 
. 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
19 
Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
Eligibility Assessments 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Safety Assessments 
Targeted PE 
X 
X 
X 
X 
X 
X 
X 
X 
Key aspects 
should evaluate 
important body 
systems as 
clinically 
indicated. 
Body Weight 
X 
 
 
 
 
 
X 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication Use  
X 
X 
X 
X 
X 
X 
X 
X 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
20 
Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
Adverse Event Reporting 
Monitor for AE and 
SAE Assessment  
X 
X 
X 
X 
X 
X 
X 
X 
All AEs and 
SAEs must be 
collected from 
the date of 
participant’s 
written consent 
until 30 days 
post 
discontinuation 
of dosing or 
participant’s 
participation in 
the study if the 
last scheduled 
visit occurs at a 
later time. 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
21 
Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
Clinical Efficacy Assessments 
PASI 
X 
X 
X 
X 
X 
X 
X 
X 
 
s-PGA 
X 
X 
X 
X 
X 
X 
X 
X 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
22 
Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
Evidence of Typical 
Plaque Psoriasis 
Outside Palms and 
Soles 
X 
 
 
 
 
 
 
 
 
pp-PGA 
X 
X 
X 
X 
X 
X 
X 
X 
 
Presence of pustulesa 
X 
 
 
 
 
 
X 
 
Participants 
with a total 
maximum of 5 
sterile pustules 
across both 
palms and soles 
and limited 
only to 
psoriatic 
plaques will be 
eligible for 
enrollment. The 
presence of 
pustules 
(yes/no), total 
number, and 
location of 
pustules must 
be documented 
if present. 
1.0
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Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
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P
Approved
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
24 
Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
25 
Table 2-2: 
On-treatment Procedural Outline Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 0 (Baseline) through Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12 
D85 
(±3 d) 
Visit 6 
Week 16 
D113 
(±3 d) 
Visit 7 
Week 20 
D141 
(±3 d) 
Visit 8 
Notes 
Study Intervention 
Randomization via IRT 
X 
 
 
 
 
 
 
 
 
Dispense Study 
Intervention 
X 
 
X 
X 
X 
X 
X 
X 
 
Study Intervention 
Compliance 
 
X 
X 
X 
X 
X 
X 
X 
 
Abbreviations: AE, adverse event; 
 D/d, Day; 
 
; IRT, interactive response technology; 
; PASI, Psoriasis 
Area and Severity Index; PE, physical examination; PP, palmoplantar; pp-PASI, palmoplantar Psoriasis Area and Severity Index; pp-PGA, palmoplantar physician 
global assessment; 
 
; 
; SAE, serious adverse event; s-PGA, static 
Physician Global Assessment;
; 
.  
a Only in participants with the presence of pustules at screening and/or baseline visits the investigator will record the presence (yes/no) of pustules, total number, 
and location of pustules on the electronic clinical outcome assessment (eCOA) tablet. 
When multiple assessments are conducted at a single visit, the following is the order in which they should be done as applicable: 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
26 
1) Patient-reported outcome assessments 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests 
 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
27 
Table 2-3: 
On-treatment Procedural Outline, Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 24 through Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 
(EOT or 
ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
Safety Assessments 
Complete PE 
 
 
 
 
X 
 
 
Targeted PE 
X 
X 
X 
X 
 
X 
 
Body Weight 
 
 
 
 
X 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
 
Concomitant Medication Use  
X 
X 
X 
X 
X 
X 
 
Adverse Event Reporting 
Monitor for AE and SAE 
Assessment  
X 
X 
X 
X 
X 
X 
All AEs and SAEs must be 
collected from the date of 
participant’s written consent until 
30 days post discontinuation of 
dosing or participant’s 
participation in the study if the 
last scheduled visit occurs at a 
later time. 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
28 
Table 2-3: 
On-treatment Procedural Outline, Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 24 through Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 
(EOT or 
ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
Clinical Efficacy Assessments 
PASI 
X 
X 
X 
X 
X 
 
 
s-PGA 
X 
X 
X 
X 
X 
 
 
pp-PGA 
X 
X 
X 
X 
X 
 
 
Presence of pustulesb 
 
 
 
 
X 
 
Participants with a total maximum 
of 5 sterile pustules across both 
palms and soles and limited only 
to psoriatic plaques will be 
eligible for enrollment. The 
presence of pustules (yes/no), 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
29 
Table 2-3: 
On-treatment Procedural Outline, Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 24 through Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 
(EOT or 
ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
total number, and location of 
pustules must be documented if 
present. 
pp-PASI 
X 
X 
X 
X 
X 
 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
30 
Table 2-3: 
On-treatment Procedural Outline, Non-pustular Palmoplantar Psoriasis Sub-Protocol (IM0111112), 
Week 24 through Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 
(EOT or 
ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
Study Intervention 
Dispense Study Intervention 
X 
X 
X 
X 
 
 
 
Study Intervention Compliance 
X 
X 
X 
X 
X 
 
 
Collect eDiary 
 
 
 
 
X 
 
 
Abbreviations: AE, adverse event; 
 D/d, Day; 
 
; EOT, end of treatment; ET, early termination; 
; PASI, 
Psoriasis Area and Severity Index; PE, physical examination; PP, palmoplantar; pp-PGA, palmoplantar physician global assessment; pp-PASI, palmoplantar 
Psoriasis Area and Severity Index; 
; PSO, psoriasis; SAE, serious adverse event; 
s-PGA, static Physician Global Assessment; 
. 
a EOT/ET visit for participants who discontinue treatment any time prior to completing Week 52 of active treatment period. Safety follow-up visit occurs 28±3 days 
after the last dose of study treatment. 
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BMS-986165 
 
Deucravacitinib 
 
 
Date: 08-May-2023 
 
31 
b Only in participants with the presence of pustules at screening and/or baseline visits the investigator will record the presence (yes/no) of pustules, total number, 
and location of pustules on the electronic clinical outcome assessment (eCOA) tablet. 
When multiple assessments are conducted at a single visit, the following is the order in which they should be done as applicable: 
1) Patient-reported outcome assessments 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests 
  
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Date: 08-May-2023 
32 
Genital Psoriasis Sub-protocol 
The schedules of activities and procedures for the genital psoriasis (GenPs) sub-protocol are 
documented in Table 2-4 for screening, Table 2-5 for Week 0 (baseline) through Week 20, and 
Table 2-6 for Week 24 through Week 56. 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
33 
Table 2-4: 
Genital Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit Day  
-28 to Day -1  
Notes 
Eligibility Assessments 
Informed Consent 
X 
A participant is considered enrolled only when a 
protocol-specific informed consent is signed. Must 
be obtained prior to performing any screening 
procedures.  
Enroll Participant 
X 
Obtain number from IRT. 
Inclusion/Exclusion Criteria 
X 
Includes duration of plaque psoriasis, genital 
involvement, and documentation of evidence of 
typical plaque psoriasis outside genital involvement 
by the investigator. 
Demographics and Participant Characteristics 
X 
Some data may be collected via electronic device. 
Note: SOGIIS data will be collected for US 
participants only. 
History of Tobacco Use 
X 
Include description of current tobacco use. 
Psoriasis-related History 
X 
All psoriasis history including disease duration, 
scalp psoriasis, palmoplantar psoriasis, nail 
psoriasis, genital psoriasis, and PsA duration, or 
history of other forms of psoriasis. 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
34 
Table 2-4: 
Genital Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit Day  
-28 to Day -1  
Notes 
Psoriasis-related Systemic Treatment 
X 
Includes nonbiologic conventional systemic (eg, 
methotrexate), biologic agents, and/or phototherapy. 
For each therapy, include a length of time on 
treatment and reason(s) for discontinuation (eg, lack 
of efficacy, intolerance, side effects, loss of access to 
treatment), if applicable. 
Psoriasis-related Topical 
Treatment 
X 
Includes topical treatments and shampoos for 
psoriasis. 
Other Prior and Concomitant Treatments 
X 
All medications for other/non-psoriasis conditions. 
Safety Assessments 
Physical Examination 
X 
Complete PE. 
Physical Measurements  
X 
Includes height, weight, and BMI. 
Vital Signs 
X 
Includes (ear or oral) 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. 
12-lead ECG 
X 
12-lead ECGs should be recorded after the 
participant has been supine for at least 5 minutes. A 
single ECG should be collected. See Section 9.4.3. 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
35 
Table 2-4: 
Genital Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit Day  
-28 to Day -1  
Notes 
Adverse Event Reporting  
Monitor for AE and SAE Assessment 
X 
All AEs and SAEs must be collected from the date 
of participant’s written consent until 30 days post 
discontinuation of dosing or participant’s 
participation in the study if the last scheduled visit 
occurs at a later time. 
 
 
 
Efficacy Assessments 
s-PGA-Ga 
X 
Refer to Section 6 for detailed eligibility criteria. 
s-PGA  
X 
Refer to Section 6 for detailed eligibility criteria. 
Evidence of Typical Plaque Psoriasis in Non-genital 
Area 
X 
Evidence of typical plaque psoriasis in a non-genital 
area is 1 of the required key inclusion criteria. 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
36 
Table 2-4: 
Genital Psoriasis Sub-protocol Screening Procedural Outline (IM0111112) 
Procedure 
Screening Visit Day  
-28 to Day -1  
Notes 
Dispense eDiary 
 
 
X 
All consented participants will be given a diary 
device at the screening visit and will begin recording 
 on a daily basis in the diary device. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
.  
Abbreviations: AE, adverse event; BMI, body mass index;
; ECG, electrocardiogram; 
 
 
 
 
; IRT, interactive response technology; PE, physical examination; PI, principal investigator; 
PsA, psoriatic arthritis; SAE, serious adverse event; 
; SOGIIS, sexual orientation, gender identity, 
and intersex status; s-PGA-G, static Physician’s Global Assessment of Genitalia; 
; US, United States; 
 
a In addition to s-PGA-G, the investigator will record on the electronic clinical outcome assessment (eCOA) tablet (yes/no) which exact genital regions are affected 
by psoriasis (labia minora, labia majora, and/or perineum in women and penis (glans and/or shaft), scrotum, and/or perineum in men; and for men the status of 
circumcision would be documented). 
 
 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
37 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
Eligibility Assessments 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Safety Assessments 
Targeted PE 
X 
X 
X 
X 
X 
X 
X 
X 
Key aspects 
should evaluate 
important body 
systems as 
clinically 
indicated. 
Body Weight 
X 
 
 
 
 
 
X 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
Medication Use  
X 
X 
X 
X 
X 
X 
X 
X 
 
Adverse Event Reporting  
Monitor for AE and 
SAE Assessment  
X 
X 
X 
X 
X 
X 
X 
X 
 All AEs and 
SAEs must be 
collected from 
the date of 
participant’s 
written consent 
until 30 days 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
38 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
post 
discontinuation 
of dosing or 
participant’s 
participation in 
the study if the 
last scheduled 
visit occurs at a 
later time. 
Clinical Efficacy Assessments 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
39 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
PASI 
X 
X 
X 
X 
X 
X 
X 
X 
 
s-PGA 
X 
X 
X 
X 
X 
X 
X 
X 
 
Evidence of Typical 
Plaque Psoriasis in 
Non-genital Area 
X 
 
 
 
 
 
 
 
 
s-PGA-Ga 
X 
X 
X 
X 
X 
X 
X 
X 
 
CAPP Objective 
(Genital Subindex) 
X 
 
 
 
 
 
X 
 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
40 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
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Approved
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
41 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
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Approved
930205993
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Approved
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
42 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
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Approved
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Approved
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
43 
Table 2-5: 
On-treatment Procedural Outline Genital Psoriasis Sub-Protocol (IM0111112), Week 0 through 
Week 20 
Procedure 
Week 0 
Baseline 
D1 
Visit 1 
Week 1 
D8  
(±3 d) 
Visit 2 
Week 2 
D15  
(±3 d) 
Visit 3 
Week 4 
D29  
(±3 d) 
Visit 4 
Week 8  
D57  
(±3 d)  
Visit 5 
Week 12  
D85  
(±3 d)  
Visit 6 
Week 16 
D113  
(±3 d)  
Visit 7 
Week 20 
D141  
(±3 d)  
Visit 8 
Notes 
Study Intervention 
Randomization via 
IRT 
X 
 
 
 
 
 
 
 
 
Dispense Study 
Intervention 
X 
 
X 
X 
X 
X 
X 
X 
 
Study Intervention 
Compliance 
 
X 
X 
X 
X 
X 
X 
X 
 
Abbreviations: AE, adverse event; 
; CAPP, Comprehensive Assessment of the Psoriasis Patient; D/d, Day; 
 
; eCOA, electronic clinical outcomes assessments; 
 
 IRT, interactive response technology; 
 
 
; PASI, Psoriasis Area and Severity 
Index; PE, physical examination; 
; SAE, serious adverse event; s-PGA, static Physician Global Assessment; s-PGA-G, static 
Physician’s Global Assessment of Genitalia; 
. 
a In addition to s-PGA-G, the investigator will record on the electronic clinical outcome assessment (eCOA) tablet (yes/no) which exact genital regions are affected 
by psoriasis (labia minora, labia majora, and/or perineum in women and penis (glans and/or shaft), scrotum, and/or perineum in men; and for men the status of 
circumcision would be documented). 
1) Patient-reported outcome assessments 
2) Safety assessments (eg, vitals, AEs) 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
44 
3) Clinical efficacy assessments 
4)  Laboratory tests 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
45 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
Safety Assessments 
Complete PE 
 
 
 
 
X 
 
 
Targeted PE 
X 
X 
X 
X 
 
X 
 
Body Weight 
 
 
 
 
X 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication Use  
X 
X 
X 
X 
X 
X 
 
Adverse Event Reporting 
Monitor for AE 
and SAE 
Assessment  
X 
X 
X 
X 
X 
X 
All AEs and 
SAEs must be 
collected from 
the date of 
participant’s 
written consent 
until 30 days 
post 
discontinuation 
of dosing or 
participant’s 
participation in 
the study if the 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
46 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
last scheduled 
visit occurs at a 
later time.
Clinical Efficacy Assessments 
PASI 
X 
X 
X 
X 
X 
 
 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
47 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
s-PGA 
X 
X 
X 
X 
X 
 
 
s-PGA-Gb 
X 
X 
X 
X 
X 
 
 
CAPP objective 
(Genital 
Subindex) 
X 
 
 
 
X 
 
 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
48 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
49 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
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Clinical Protocol 
 
IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
50 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
Study Intervention 
Dispense Study 
Intervention 
X 
X 
X 
X 
 
 
 
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IM0111112 
BMS-986165 
 
Deucravacitinib 
 
Date: 08-May-2023 
 
51 
Table 2-6: 
On-treatment Procedural Outline, Genital Psoriasis Sub-Protocol (IM0111112), Week 24 through 
Week 56 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 9 
Week 28 
D197 
(±3 d) 
Visit 10 
Week 32 
D225 
(±3 d) 
Visit 11 
Week 40 
D281 
(±3 d) 
Visit 12 
Week 52 (EOT 
or ETa) 
D365 
(±3 d) 
Visit 13 
Safety Follow-
up 
(Week 56 or 
Post-treatment 
Follow-upa) 
D393 
(±3 d) 
Visit 14 
Notes 
Study 
Intervention 
Compliance 
X 
X 
X 
X 
X 
 
 
Collect eDiary 
 
 
 
 
X 
 
 
Abbreviations: AE, adverse event; 
 CAPP, Comprehensive Assessment of the Psoriasis Patient; D/d, Day; 
 
 eCOA, electronic clinical outcomes assessments; EOT, end of treatment; ET, early termination; 
 
 
 
; PASI, Psoriasis Area and Severity 
Index; PE, physical examination; 
; SAE, serious adverse event; s-PGA, static Physician Global Assessment; s-PGA-G, static 
Physician’s Global Assessment of Genitalia. 
a EOT/ET visit for participants who discontinue treatment any time prior to completing Week 52 of active treatment period. Safety follow-up visit occurs 28±3 days 
after the last dose of study treatment. 
b In addition to s-PGA-G, the investigator will record on the eCOA tablet (yes/no) which exact genital regions are affected by psoriasis (labia minora, labia majora, 
and/or perineum in women and penis (glans and/or shaft), scrotum, and/or perineum in men; and for men the status of circumcision would be documented). 
When multiple assessments are conducted at a single visit, the following is the order in which they should be done as applicable: 
1) Patient-reported outcome assessments 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests 
 
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52 
3 
INTRODUCTION 
Non-pustular Palmoplantar and Genital Plaque Psoriasis  
Psoriasis is a chronic inflammatory skin disorder, characterized primarily by erythematous scaly 
plaques, that affects up to 3% of the general population. Men and women are equally affected and 
it can present at any age.2,3 Several studies have observed a bimodal distribution of psoriasis onset 
with the first peak ranging from 15 to 22 years of age, and the second peak ranging from 
55 to 60 years of age.4,5,6 The most common form of psoriasis (58% to 97%) is plaque psoriasis 
(psoriasis vulgaris), with less common forms being guttate, pustular, inverse (flexural), and 
erythrodermic psoriasis. The disease can have a fluctuating relapsing course, with flares that may 
be induced by factors such as infections, trauma, smoking, and stress.4 Psoriasis can involve skin 
in any part of the body; particularly disabling is the involvement of specific anatomic regions, such 
as hands and feet (PP), face, scalp, nails, and the genital region. PP psoriasis occurs in 12% to 16% 
of patients with psoriasis. Despite affecting less than 5% of total body surface area (BSA), PP 
psoriasis may be associated with greater physical limitations, such as opening a jar and reduced 
work productivity, as compared to patients with psoriasis in other areas.7  
GenPs is found in about 30% to 40% of patients with psoriasis and is more common in men. 
Additionally, 63% of patients with psoriasis report ever having experienced GenPs.7 Greater than 
two-thirds of patients with GenPs have never applied treatment to their genital lesions. Moreover, 
45% of patients who discussed genital lesions with their physician reported not receiving 
treatment.7 It is often overlooked and undiagnosed due to inadequate assessment for genital 
involvement and unwillingness of patients and medical professionals to discuss GenPs.8  
Despite often a low total BSA involvement, the National Psoriasis Foundation (NPF) considers PP 
psoriasis to represent a severe form of psoriasis, because of its significant impact on Quality of 
Life (QoL).9 Similarly, according to the Joint American Academy of Dermatology (AAD)-NPF 
Guidelines, psoriasis can be severe irrespective of BSA, when it has serious emotional 
consequences or when it occurs in genital area.10 Despite a limited total BSA, patients with PP 
psoriasis report greater disability, burning, soreness, and QoL impairment than patients with other 
forms of psoriasis, with 34%, 48%, and only 18% of patients being severely, moderately, and 
mildly affected, respectively.7 The QoL of participants with psoriasis affecting these 
difficult-to-treat areas may be disproportionately impacted relative to the affected area.7 For 
example, the presence of lesions in highly visible areas can affect a participant’s self-esteem, 
whereas involvement of the palms can make activities of daily living challenging. GenPs has a 
significant negative effect on QoL and sexual health.7 
Treatments for psoriasis include topical preparations, eg, corticosteroids, vitamin D analogues, 
calcineurin inhibitors, salicylic acid, urea, and coal tar; phototherapy modalities, including 
broad-band and narrow band ultraviolet B (UVB); and systemic therapies. In moderate-to-severe 
disease, systemic treatments are usually needed and may include oral agents (retinoids, 
methotrexate, cyclosporine, and apremilast) or injectables (eg, biologics such as tumor necrosis 
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53 
factor [TNF] inhibitors etanercept, infliximab, and adalimumab) anti-interleukins (IL)-12/23p40 
antibody (ustekinumab), IL-17 antagonists (secukinumab, ixekizumab, and brodalumab), and 
anti-IL-23p19 antibody (guselkumab, tildrakizumab, and risankizumab). Many of these treatments 
are associated with an increased risk of adverse events (AEs) such as hepatotoxicity and 
neutropenia 
(methotrexate);
11
 nephrotoxicity 
(cyclosporine);
12
 depression 
and 
gastrointestinal (GI) 
effects 
(diarrhea; 
apremilast);
13
 serious 
infections 
(cytokine 
inhibitors)14,15,16,17 candidiasis; and Crohn’s disease (IL-17 antagonists).17,18,19 PP psoriasis is 
considered to be recalcitrant to therapy and is one of the difficult-to-treat sites. While biologic 
agents typically have better efficacy than other treatment alternatives, their efficacy in this 
anatomic region is lower as compared to responses of psoriasis in other parts of the body.9 In cases 
of GenPs, topical agents or ultraviolet therapy are poorly tolerated or contraindicated in this region, 
which limits therapeutic options. Patients with genital involvement may be considered candidates 
for systemic therapy regardless of the total BSA involvement, but there is limited available data 
from clinical trials specifically designed for GenPs.8  
Although effective therapeutic options are available, under-treatment or nontreatment of psoriasis 
has been reported in up to half of surveyed participants (based on absence of treatment and/or 
dissatisfaction with treatment).20 Many participants with moderate-to-severe disease are still being 
managed with only topicals,5,21 and many participants consider their psoriasis treatment to be 
inadequate. There remains a significant unmet need for more effective oral options to address 
difficult-to-treat sites such as PP and GenPs and their impact on symptoms and QoL. 
3.1 
Study Rationale 
SOTYKTU™ 
(deucravacitinib), 
a 
first-in-class, 
oral, 
selective, 
allosteric 
tyrosine 
kinase 2 (TYK2) inhibitor is approved in multiple countries for the treatment of adults with 
moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This 
approval was based on the results of completed 52-week, randomized, Phase 3, placebo-controlled 
studies of deucravacitinib 6 mg daily versus placebo and apremilast 30 mg twice daily (POETYK 
PSO-1 and PSO-2).  
In these 2 trials, in addition to the co-primary endpoints of Psoriasis Area and Severity 
Index (PASI)-75 and static Physician Global Assessment (s-PGA) 0/1 at Week 16, PP psoriasis 
was assessed using the palmoplantar physician global assessment (pp-PGA) 0/1 and palmoplantar 
Psoriasis Area and Severity Index (pp-PASI)-75 change from baseline in participants with a 
pp-PGA score ≥ 3 (moderate-to-severe PP psoriasis) at baseline. Although 16% of the subjects had 
a history of PP psoriasis, only 7% of subjects in the Phase 3 studies met the baseline pp-PGA 
≥ 3 criterion. The individual Phase 3 studies were not sized to specifically assess PP psoriasis. Due 
to the small numbers of subjects with pre-existing PP psoriasis in each study, the pooled data from 
PSO-1 and PSO-2 allowed for a more meaningful evaluation. In this analysis of the pooled PSO-1 
and PSO-2 population, significantly more participants receiving deucravacitinib (n = 57) versus 
placebo (n = 25) achieved pp-PGA 0/1 at Week 16 (49.1% versus 16%, p = 0.0052). In the pooled 
PSO-1 and PSO-2 population, the mean change from baseline in pp-PASI, adjusted for study, body 
weight, prior biologic use, and the baseline value as a covariate was -13.3 (95% confidence interval 
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Clinical Protocol 
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BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
54 
[CI]: -16.3, -10.2) and -4.2 (95% CI: -8.4, -0.0) for deucravacitinib and placebo, respectively. In 
PSO-1, pp-PGA 0/1 responses at Week 16 were maintained through Week 52 with continuous 
deucravacitinib treatment (55.6% [95% CI: 32.6, 78.5]).1 GenPs has not yet been assessed in the 
deucravacitinib psoriasis clinical program.  
Remaining key data gaps include the efficacy of deucravacitinib in improving moderate-to-severe 
GenPs, PP psoriasis, and health-related Quality of Life measures specifically associated with these 
difficult-to-treat sites. 
The QoL of patients with psoriasis involving difficult-to-treat sites may be disproportionally 
impacted relative to the affected area. Involvement of these sites is often associated with a 
disproportionate level of physical impairment and emotional distress. Additionally, PP disease 
may be associated with increased financial burden due to its interference with the ability to work.7 
Given the relative paucity of data for systemic interventions specifically designed for 
difficult-to-treat sites, this study aims to evaluate the efficacy of deucravacitinib in improving 
moderate-to-severe GenPs, PP psoriasis, and health-related Quality of Life measures specifically 
associated with these difficult-to-treat sites.   
This clinical study will use a 2-sub-protocol study design under a master protocol to evaluate the 
efficacy of deucravacitinib in these 2 difficult-to-treat sites (moderate-to-severe non-pustular PP 
and GenPs). The choice of a master protocol design to evaluate the safety and efficacy of 
deucravacitinib in these 2 anatomic regions is based primarily on the overlap and presence of 
multiple difficult-to-treat sites in psoriasis patients. Participants with involvement of both sites 
during screening (genital and PP) can only be randomized to 1 of the sub-protocols as per 
investigator’s discretion. In addition, because the experience and available study populations in 
dermatology clinics commonly cover both of these sites, the master protocol design is likely to 
facilitate clinical site readiness, recruitment efficiency, and accuracy in investigator assessments. 
It is further expected that these logistical benefits will require fewer overall sites to complete the 
study.   
3.2 
Background 
TYK2 is a nonreceptor tyrosine kinase associated with receptors for the p40-containing cytokines 
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.22,23,24 Because TYK2-dependent cytokines (eg, Type I IFNs, IL-12, IL-23) are distinct 
from those dependent on closely related Janus kinase (JAK) family members JAK1/JAK3 (eg, 
IL-2, IL-15, IL-7) or JAK2 (eg, erythropoietin, thrombopoietin, GM-CSF), a TYK2 inhibitor 
would be expected to have a highly differentiated profile from inhibitors of other JAK family 
kinases. TYK2-dependent pathways and the cytokine networks they modulate (eg, IL-23/IL-17, 
IFNα) have been implicated in the pathophysiology of multiple immune-mediated diseases, 
including psoriasis, lupus, spondylarthritis, and Crohn’s disease.  
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3.2.1 
Clinical Development 
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3.3 
Benefit/Risk Assessment 
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BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
56 
3.3.1 
Risk Assessment 
Table 3.3.1-1: 
Risk Assessment for Deucravacitinib 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for 
Risk 
Mitigation Strategy 
Infection 
Deucravacitinib may increase the 
risk of infections based on its 
mechanism of action of selective 
TYK2 inhibition. In clinical studies, 
deucravacitinib has been associated 
with an increased incidence of 
infections, most commonly upper 
respiratory infections. Although 
serious infections have been 
reported in patients treated with 
deucravacitinib, available 
cumulative information does not 
suggest an increased risk. Upper 
respiratory infections, herpes 
simplex infections, and herpes 
zoster are considered to be adverse 
reactions for deucravacitinib. See 
the deucravacitinib IB (Summary of 
Data and Guidance for Investigator) 
for further information on the risk 
of infection. 
Specific exclusion criteria are 
included in this protocol to mitigate 
the risk of infection. Investigators, 
clinical personnel, and participants 
should be aware that this product 
may decrease resistance to 
infection. Participants will be 
followed closely for any signs of 
infection and will be instructed to 
immediately report signs or 
symptoms of infection. 
 
Malignancy 
As with any modulator of the 
immune system, there is a 
theoretical risk of increased 
malignancy with deucravacitinib. 
Mechanistic studies to evaluate the 
role of TYK2 in malignancies are 
inconclusive. Malignancies 
including lymphomas have been 
observed in clinical trials with 
deucravacitinib; however, based on 
the available clinical data and the 
relevant epidemiology for 
malignancy, and specifically 
lymphoma, there does not appear to 
be a clear association with 
deucravacitinib exposure. See the 
deucravacitinib IB (Summary of 
Data and Guidance for Investigator) 
for details. The potential role of 
deucravacitinib in the development 
of malignancies is currently 
unknown and will continue to be 
monitored.  
Eligibility criteria are aimed to 
minimize the risk that a participant 
with an active or recent history of 
malignancy will be enrolled. 
Furthermore, participants will be 
monitored closely for any 
symptoms or signs of malignancy 
throughout the study. 
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Deucravacitinib 
 
Date: 08-May-2023 
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Table 3.3.1-1: 
Risk Assessment for Deucravacitinib 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for 
Risk 
Mitigation Strategy 
Study Procedures 
Risk from blood sampling 
Blood sampling-associated risk of 
discomfort, syncope, dizziness, 
and/or infection at the site after or 
during venipuncture 
Blood samples will be obtained by 
a trained professional and medical 
assistance will be available. 
The potential risk of feeling faint, 
or experiencing mild local pain, 
bruising, irritation, or redness at the 
site where blood was taken, is 
mentioned in the ICF. The amount 
of blood to be taken for sampling 
will not be harmful to the 
participant’s health. 
Abbreviations: IB, Investigator’s Brochure; ICF, informed consent form; TYK2, tyrosine kinase 2. 
 
3.3.2 
SARS-CoV-2 Pandemic-related Risk Assessment 
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 with underlying 
chronic diseases who are on immunosuppressive therapies. At this time, Bristol-Myers Squibb 
(BMS) 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 on 
participants taking deucravacitinib is still unknown due to insufficient clinical data. As described 
in the Investigator Brochure and the informed consent form (ICF), deucravacitinib is an 
immunomodulator with potential immunosuppressive effects and participants taking 
deucravacitinib may have a higher chance of infections. Accordingly, the studies have exclusion 
criteria aimed at minimizing the risk for serious infection and with study visits that allow for 
monitoring of participants’ safety. Investigators should ensure that they are able to perform 
adequate safety assessments. The individual benefit/risk considerations remain the responsibility 
of the investigator using clinical judgment.  
In addition, the Sponsor has also developed 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 investigational product (IP; Section 8.1 and 
Section 8.2), and criteria for reinitiating IP on resolution of a COVID-19 infection (Section 8.2.1). 
In order to facilitate reporting of COVID-19 events that occur during the study, all AEs and serious 
adverse 
events 
(SAEs) 
associated 
with 
severe 
acute 
respiratory 
syndrome 
coronavirus 2 (SARS-CoV-2) or COVID-19 must be reported, regardless of relatedness or 
causality (Section 9.2.2). Such 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 COVID-19 infection 
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prior to enrollment and to inform decisions about participant care during the study should follow 
local standard practice and requirements.  
3.3.3 
Benefit Assessment 
The dose selection of deucravacitinib for this study is based on the dose (6 mg QD) used in the 
adult Phase 3 studies in moderate-to-severe plaque psoriasis. The dose of 6 mg QD is also approved 
by the FDA and Health Authorities in multiple other countries.  
The selection of a 6-mg QD dose in the adult Phase 3 studies was based on the results observed 
from the Phase 2 dose-ranging study in psoriasis (IM011011). There was a significant relationship 
between exposure and the PASI-75 responder rates at Week 12, with doses of deucravacitinib 3 mg 
QD, 3 mg BID, 6 mg BID, and 12 mg QD achieving significantly higher PASI-75 responses 
compared with placebo. Overall, deucravacitinib was safe and well tolerated in all intervention 
groups in IM011011.  
Efficacy and safety were evaluated in 2 pivotal, double-blind, placebo- and active-controlled 
52-week, Phase 3 studies (PSO-1 and PSO-2) in adult participants with moderate-to-severe 
psoriasis. In both studies, statistical significance was achieved for the deucravacitinib group 
compared with placebo for the co-primary endpoints at Week 16 (s-PGA 0/1 response, PASI-75 
response) and for all but the last key secondary endpoint in the statistical hierarchies versus placebo 
and apremilast. In the subset analysis in the pooled PSO-1 and PSO-2 population, significantly 
more participants receiving deucravacitinib versus placebo achieved pp-PGA 0/1 at Week 16 
(49.1% versus 16%, p = 0.0052). Additionally, in these pivotal Phase 3 studies, deucravacitinib 
demonstrated an acceptable safety and tolerability profile compared with placebo and apremilast. 
With additional exposure up to 52 weeks, there was no evidence of increased incidence or pattern 
of AEs, SAEs, or AEs leading to intervention discontinuation.  
Based on the totality of in vitro data and clinical data, deucravacitinib doses at clinically-evaluated 
doses are not anticipated to cause clinically meaningful exposure changes of co-administered 
agents that are substrates of carboxylesterase 2 (CES2), UDP‑glucuronosyltransferase (UGT) 
enzymes, cytochrome P450s (CYPs), or drug transporters. Details are described in the IB.  
Study IM011039 was an open-label, 2-cycle, multiple-dose, single-sequence, crossover study to 
assess the effect of deucravacitinib 12 mg BID on the PK of norethindrone (NET) and ethinyl 
estradiol (EE). There were no differences in NET or EE geometric mean maximum 
concentration (Cmax) following the coadministration of NET/EE and deucravacitinib compared to 
NET/EE administration alone. Minimal increases in NET and EE geometric mean AUC(TAU) of 
approximately 10% and 4%, respectively, were observed following the coadministration of 
NET/EE and deucravacitinib compared to NET/EE administration alone. Deucravacitinib can be 
co-administered with oral contraceptives since it has a minor impact on the PK of NET and EE. 
3.3.4 
Overall Benefit/Risk Conclusion 
Taken together, the nonclinical data and clinical data in healthy participants and in those with 
psoriasis indicate an overall risk/benefit assessment that is appropriate for the investigation of 
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Date: 08-May-2023 
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deucravacitinib as an oral intervention for adult participants with moderate-to-severe non-pustular 
PP and GenPs.  
4 
OBJECTIVES AND ENDPOINTS 
Objectives and endpoints for non-pustular PP psoriasis sub-protocol are presented in Table 4-1; 
those for GenPs sub-protocol are presented in Table 4-2.  
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Table 4-1: 
Objectives and Endpoints for Non-pustular Palmoplantar Psoriasis 
Sub-protocol 
Objectives 
Endpoints 
Primary 
• 
To compare the efficacy, as measured by 
pp-PASI-75, of deucravacitinib versus placebo 
at Week 16 in participants with PP plaque 
psoriasis 
• 
pp-PASI-75, defined as a 75% improvement in pp-PASI 
score from baseline at Week 16 
Key Secondary 
• 
To compare the efficacy, as measured by 
pp-PGA 0/1, of deucravacitinib versus placebo 
at Week 16 in participants with PP plaque 
psoriasis 
• 
Proportion of participants who achieve a pp-PGA score 
of 0 (clear) or 1 (almost clear) with at least a 2-point 
reduction from baseline at Week 16 
Other Secondary 
• 
To assess the safety of deucravacitinib versus 
placebo in participants with PP plaque psoriasis 
between Week 0 and Week 16  
• 
AEs, SAEs, laboratory parameters, and VS between 
Week 0 and Week 16  
Abbreviations: AE, adverse event; 
 
 
; 
 PP, palmoplantar; pp-PASI, 
palmoplantar Psoriasis Area and Severity Index; pp-PGA, palmoplantar physician global assessment; 
 
 SAE, serious adverse event; VS, vital signs. 
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Table 4-2: 
Objectives and Endpoints for Genital Psoriasis Sub-protocol 
Objectives 
Endpoints 
Primary 
• 
To compare the efficacy, as measured by 
s-PGA-G 0/1, of deucravacitinib versus 
placebo at Week 16 in participants with GenPs 
• 
s-PGA-G 0/1, defined as proportion of participants 
achieving s-PGA-G score of 0 (clear) or 1 (almost clear) 
with at least a 2-point reduction from baseline at 
Week 16 
Key Secondary 
• 
To compare the efficacy, as measured by 
change from baseline in GenPs Itch NRS, of 
deucravacitinib versus placebo at Week 16 in 
participants with GenPs  
• 
Change from baseline in GenPs itch NRS score at Week 
16  
• 
To compare the efficacy, as measured by 
s-PGA 0/1, of deucravacitinib versus placebo at 
Week 16 in participants with GenPs 
• 
s-PGA 0/1, defined as proportion of participants 
achieving s-PGA score of 0 (clear) or 1 (almost clear) 
with at least a 2-point reduction from baseline at 
Week 16 
Other Secondary 
 
• 
To assess the safety of deucravacitinib versus 
placebo in participants with GenPs between 
Week 0 and Week 16  
• 
AEs, SAEs, laboratory parameters, and VS between 
Week 0 and Week 16  
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Date: 08-May-2023 
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Abbreviations: AE, adverse event; 
 
; 
 
 GenPs, genital psoriasis; 
 
 
 NRS, numerical rating scale; 
; 
 SAE, 
serious adverse event; s-PGA, static Physician Global Assessment; s-PGA-G,  static Physician’s Global Assessment 
of Genitalia; VS, vital signs. 
 
5 
STUDY DESIGN 
5.1 
Overall Design 
This master protocol (IM0111112) with 2 sub-protocols is a Phase 4 double-blind, 
placebo-controlled, multicenter study to compare the efficacy and safety of deucravacitinib in 
participants with moderate-to-severe non-pustular PP and GenPs versus placebo. Enrollment in 
each sub-protocol will be concurrent. In both sub-protocols, a placebo control is included to allow 
the assessment of effects of the intervention. The placebo control will also provide a basis for 
comparison of safety assessments.  
Physical exams, 12-lead electrocardiograms (ECGs; screening only), and clinical laboratory 
evaluations will be done at selected visits during the study. Participants in this study will be 
monitored for AEs. 
5.1.1 
Screening period 
For each sub-protocol participants will undergo screening evaluations within 28 days prior to the 
administration of study intervention to determine eligibility. A detailed medical history will be 
done at this time, as well as a complete physical examination (PE). Psoriasis-related history, which 
will include length of diagnosis, GenPs symptoms, PP psoriasis symptoms, scalp symptoms, nail 
involvement, psoriatic arthritis (PsA)/joint pain, history of other forms of psoriasis, and history of 
systemic intervention will be assessed here. 
 
 
.  
5.1.2 
Intervention period 
Participants who have completed the screening procedures and have met the inclusion/exclusion 
for PP psoriasis sub-protocol will be randomized in a 2:1 ratio to either deucravacitinib 6 mg QD 
or placebo, respectively. 
. 
Participants with the presence of pustules (see Section 6.1) would be limited to maximum of 10% 
of all randomized participants.   
Participants who have completed the screening procedures and have met the inclusion/exclusion 
for the GenPs sub-protocol will be randomized in a 2:1 ratio to either deucravacitinib 6 mg QD or 
placebo, respectively. 
 
 In addition, the genital sub-protocol will aim to enroll at least 40% of 
female participants into the study.  
1.0
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5.1.3 
Week 16 
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Week 20 
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5.1.5 
Week 52 and Safety Follow-up Period 
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
PPD
PPD
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
64 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
65 
 
5.1.6 
Data Monitoring Committee and Other Committees 
A Data Monitoring Committee will not be used in the study.  
Other Committee Charters will describe the procedures related to the committee operations in greater 
detail.  
5.1.6.1 
Study Steering Committee 
The Study Steering Committee (SSC) is a committee composed of external experts who assist with 
the study strategy, protocol development, site identification and patient recruitment strategies. The 
SSC responsibilities, authorities, and procedures will be documented and followed according to 
the SSC Charter.  
5.3 
End of Study Definition 
For this master protocol, because each sub-protocol will enroll participants independently of each 
other, each sub-protocol will have its separate, independent start, primary completion date, and the 
study end. The start of the study is defined as the first participant’s first visit in any of the 
2 sub-protocols.  
The primary completion date for each sub-protocol is defined as the date on which the last data 
point is collected for that sub-protocol’s primary endpoint. If the sub-protocol has multiple primary 
endpoints, the primary completion date is the date on which the last data point is collected for the 
last primary endpoint. 
End of study is defined as the last participant’s last visit in a remaining sub-protocol.  
A participant is considered to have completed each sub-protocol if he/she has completed the last visit 
or the last procedure shown in the Schedule of Activities (Section 2). 
5.4 
Scientific Rationale for Study Design 
Both Phase 4 studies as part of the master protocol will be conducted in a population of participants 
with stable moderate-to-severe non-pustular PP and genital plaque psoriasis who are candidates 
for systemic psoriasis therapy. The PP psoriasis sub-protocol is designed to compare the efficacy 
and safety of deucravacitinib to placebo in achieving pp-PASI-75 at Week 16. pp-PASI-75 is a 
standard measure in clinical trials of demonstrating efficacy of systemic psoriasis treatments on 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

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Justification for Dose 
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5.7 
Rationale for Optional Future Research 
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
PPD
PPD
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
67 
6 
STUDY POPULATION 
Eligibility criteria for this study have been carefully considered to ensure: 1) selection of 
appropriate participants with PP and GenPs, 2) safety of the study participants. It is imperative that 
participants fully meet all eligibility criteria. 
All screening and randomization evaluations must be completed and reviewed to confirm that 
potential participants meet all eligibility criteria. 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. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
6.1 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply:  
1) Signed Written Informed Consent 
a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent 
Ethics Committee (IEC)-approved written ICF in accordance with regulatory, local, and 
institutional guidelines. This must be obtained before the performance of any 
protocol-related procedures that are not part of normal patient care. 
2) Type of Participant and Target Disease Characteristics  
Non-pustular Palmoplantar Psoriasis Sub-protocol 
a) Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s) 
and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology 
changes or significant flares of disease activity in the opinion of the investigator.  
b) Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at 
both screening visit and Day 1. 
c) Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥3 on a 5-point 
scale and pp-PASI ≥ 8 at both screening visit and Day 1.  
i) A total maximum of 5 sterile pustules across both palms and soles limited only to 
psoriatic plaques will be allowed. 
d) Evidence of typical plaque psoriasis outside palms and soles at both screening visit and 
Day 1. 
e) Deemed by the investigator to be a candidate for phototherapy or systemic therapy.  
f) Failed to respond to, or intolerant of ≥ 1 topical therapy. 
Genital Psoriasis Sub-Protocol 
a) Men and women diagnosed with stable plaque psoriasis with involvement of the genital 
area for at least 6 months or more. Stable psoriasis is defined as no morphology changes 
or significant flares of disease activity in the opinion of the investigator.   
b) Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 at both screening visit 
and Day 1.  
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
68 
c) Moderate-to-severe GenPs, defined as s-PGA-G score of ≥ 3 on a 6-point scale at both 
screening visit and Day 1.  
d) Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day 1 
e) Deemed by the investigator to be a candidate for phototherapy or systemic therapy.  
f) Failed to respond to, or intolerant of ≥ 1 topical therapy.   
3) Age of Participant  
a) Participant must be ≥ 18 years of age inclusive at the time of signing the ICF. 
4) Reproductive Status 
Investigators shall counsel women of childbearing potential (WOCBP; as defined in 
Appendix 4) 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 relation 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) To be considered not of childbearing potential, female participants must have 
documented proof that they are not of childbearing potential.  
(1) Women who are not of childbearing potential (as defined in Appendix 4) are 
exempt from contraceptive requirements.  
ii) WOCBP must have a negative highly sensitive serum pregnancy test at the 
screening visit, and a negative highly sensitive 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 intervention. 
• 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 in the Schedule of Activities (Section 2). 
• The investigator is responsible for review of medical history, menstrual history, 
and recent sexual activity to potentially decrease the risk for inclusion of a 
woman with an undetected pregnancy. 
iii) WOCBP must agree to follow instructions for method(s) of contraception as 
described below and included in the ICF. 
• WOCBP are 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 1 of the following conditions applies: 
(1) Is not a WOCBP  
OR 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
69 
(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) Male participants should maintain their usual practice regarding contraception (if 
any); no specific or additional contraceptive measures are required. 
 
6.2 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1) Target Disease Exceptions 
a) Has non-plaque psoriasis (ie, PP pustulosis, PP pustular psoriasis, isolated pustules on 
palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, 
erythrodermic, and drug-induced psoriasis) at screening or Day 1. 
2) Reproductive Status 
a) Pregnancy, lactation, breastfeeding, or planning pregnancy during the study period. 
3) Infectious/Immune-related Exclusions 
a) History or evidence of outpatient active infection and/or febrile illness within 7 days prior 
to Day 1. 
b) History of serious bacterial, fungal, or viral infection requiring hospitalization and/or 
intravenous (IV) antimicrobial treatment within 60 days prior to Day 1. 
c) Any untreated bacterial infection within 60 days prior to Day 1. 
d) Any ongoing evidence of chronic, bacterial infection (eg, chronic pyelonephritis, chronic 
osteomyelitis, chronic bronchiectasis). 
e) Any history of proven infection of a joint prosthesis in which the prosthesis was not 
removed or replaced, or received antibiotics for suspected infection of a joint prosthesis in 
which the prosthesis was not removed or replaced. 
f) Received live vaccines within 60 days prior to Day 1, or plans to receive a live vaccine 
during the study, or within 60 days after completing study treatment. 
g) Received any non-live vaccine within 30 days prior to Day 1 including any COVID-19 
vaccine (first, second, or booster dose). 
h) Presence of herpes zoster lesions at screening or Day 1. 
i) 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 (recurrent is defined as 
2 episodes within 2 years). 
j) Evidence of, or test positive for, hepatitis B virus (HBV) at screening. Positive hepatitis B 
lab testing is defined as (please see Appendix 6 for details):  
i) Positive hepatitis B surface antigen (HBsAg+)  
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
70 
OR 
ii) Positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface 
antibody (HBcAb+ and HBsAb-). 
k) Evidence of, or test positive for, hepatitis C virus (HCV) at screening. A positive test for 
HCV is defined as:   
i) Positive for anti-hepatitis C antibody (anti-HCVAb)  
AND  
ii) Positive via a confirmatory test for HCV (eg, HCV polymerase chain reaction). 
l) Positive for human immunodeficiency virus by antibody testing (HIV1 and 2 Ab) at 
screening. 
m) Any history of known or suspected congenital or acquired immunodeficiency state or 
condition that would compromise the participant’s immune status (eg, history of 
opportunistic infections [eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or 
coccidioidomycosis], history of splenectomy, primary immunodeficiency). 
n) Severe SARS-CoV-2 infection within 4 weeks prior to screening. Additionally, in the case 
of prior SARS-CoV-2 infection, symptoms must have completely resolved and based on 
investigator assessment in consultation with the clinical study physician, there are no 
sequelae that would place the participant at a higher risk of receiving investigational 
treatment. 
4) Any of the following TB criteria:  
a) Participant has a history of active TB prior to screening visit, regardless of completion of 
adequate treatment.  
b) Participant has signs or symptoms of active TB (eg, fever, cough, night sweats, and weight 
loss) during screening as judged by the investigator.  
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
71 
5) Medical History and Concurrent Diseases 
a) Any major surgery within 8 weeks prior to Day 1, or any major planned surgery for the 
first 52 weeks of the study. 
b) Drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day 1. 
c) Medical marijuana or prescription marijuana taken for medicinal reasons. 
d) Any major medical or neuropsychiatric illness/condition or evidence of an unstable clinical 
condition (eg, systemic inflammatory or immune-mediated disease, renal, hepatic, 
hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, or neurologic) that, in the 
investigator’s judgment or after consultation with the BMS Medical Monitor, will 
substantially increase the risk to the participant if he or she participates in the study. 
e) Unstable cardiovascular disease, defined as a recent clinical cardiovascular event (eg, 
unstable angina, myocardial infarction, stroke, rapid atrial fibrillation) in the last 3 months 
prior to screening, or a cardiac hospitalization (eg, revascularization procedure, pacemaker 
implantation) within 3 months prior to screening. 
f) Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) 
> 160 mmHg or diastolic BP > 100 mmHg. 
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. 
g) Class III or IV congestive heart failure by New York Heart Association Criteria. 
h) 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 the cervix in situ that has 
been treated with no evidence of recurrence). 
j)  If the participant has received biologics previously, the following exclusion criteria for 
washout will apply: 
1.0
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930205993
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v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
72 
i) Antibodies to IL-12/23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, 
tildrakizumab, ixekizumab, guselkumab, tildrakizumab, and risankizumab) within 
6 months of Day 1. 
ii) TNF inhibitor(s) (eg, etanercept, adalimumab, infliximab, certolizumab) within 
2 months of Day 1. 
iii) Agents that modulate integrin pathways to impact lymphocyte trafficking (eg, 
natalizumab), or agents that modulate B cells or T cells (eg, alemtuzumab, abatacept, 
or visilizumab) within 3 months of Day 1. 
iv) Rituximab within 6 months of Day 1. 
k) Has received systemic nonbiologic psoriasis medications and/or any systemic 
immunosuppressants (including, but not limited to, methotrexate, azathioprine, 
cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate mofetil, 
hydroxyurea, tacrolimus, oral or injectable corticosteroids, retinoids, psoralens, 
sulfasalazine, or fumaric acid derivatives and apremilast) within 4 weeks prior to Day 1. 
l) Has used leflunomide within 6 months prior to Day 1. 
m) Has used opioid analgesics within 4 weeks prior to Day 1. 
n) Has received lithium, antimalarials, or intramuscular gold within 4 weeks of the first 
administration of any study medication. 
o) Has received phototherapy (including either oral and topical psoralen plus ultraviolet A 
light therapy, UVB, or self-treatment with tanning beds or therapeutic sunbathing) within 
4 weeks prior to Day 1. 
p) Has used topical medications/treatments that could affect psoriasis evaluation (including, 
but not limited to, high potency corticosteroids (WHO Classes IV), > 3% salicylic acid, 
urea, alpha- or beta-hydroxy acids, anthralin, calcipotriene, topical vitamin D derivatives, 
retinoids, tazarotene, methoxsalen, trimethylpsoralens, pimecrolimus, and tacrolimus) and 
intralesional corticosteroids within 2 weeks prior to Day 1. 
Note: Low potency topical steroids (WHO Class VI and VII) are permitted on the palms, 
soles, face (in the GenPs sub-protocol), and on the face and intertriginous areas (in the PP 
psoriasis sub-protocol) but should not be used within 24 hours prior to any study visit. 
Bland emollients (defined as emollients without urea or alpha or beta-hydroxy acids or 
other ingredients which are pharmacologically active) are allowed on all body regions but 
should not be used within 24 hours prior to any study visit. 
q) Use of shampoos that contain corticosteroids, coal tar, > 3% salicylic acid, or vitamin D3 
analogues within 2 weeks prior to Day 1. 
r) Has received an experimental antibody or experimental biologic therapy within the 
previous 6 months OR received any other experimental therapy or new investigational 
agent, including those for SARS-CoV-2, within 30 days or 5 half-lives (whichever is 
longer) prior to Day 1 OR is currently enrolled in an investigational study. 
s) Any other sound medical, psychiatric, and/or social reasons as determined by the 
investigator. 
6) Physical and Laboratory Test Findings 
a) At screening 
i) 
Absolute white blood cell count < 3,000/mm3 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
73 
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) 
vii) Total, unconjugated, and/or conjugated bilirubin > 2× ULN 
viii) ECG abnormalities that are considered clinically significant and would pose an 
unacceptable risk to the participant if participating in the study. 
ix) Inability to undergo venipuncture and/or tolerate venous access. 
x) 
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 
a) History of any significant drug allergy (such as anaphylaxis). 
8) Other Exclusion Criteria 
a) Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific 
circumstances, a person who has been imprisoned may be included or permitted to continue 
as a participant. Strict conditions apply, and Sponsor approval is required.) 
b) Participants who are 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. 
 
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
participants and that the results of the study can be used. It is imperative that participants fully 
meet all eligibility criteria. 
6.3 
Lifestyle Restrictions 
General skin care measures (with above restrictions for topical interventions) are recommended 
that are standard for participants with plaque psoriasis. Participants should avoid excessive sun 
exposure or use of tanning booths or other ultraviolet light sources and avoid risks that are known 
to provoke flare of psoriasis. 
6.3.1 
Meals and Dietary Restrictions 
Study intervention may be taken without regard to meals; however, participants are required to 
fast for a minimum of 10 hours before visits during which fasting lipid samples will be drawn. 
6.3.2 
Caffeine, Alcohol, and Tobacco 
No restrictions are required; however, extensive use of alcohol, tobacco, and vaping should be 
avoided. 
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6.3.3 
Activity 
No restrictions are required.  
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 adverse events (SAEs) that occurred following consent.  
6.4.1 
Re-testing During Screening or Re-screening 
For laboratory parameters that initially do not meet eligibility requirements, a single retest within 
the 28-day screening period is permitted before participant is declared a screen failure. This is an 
effort to find all possible well-qualified participants. Consultation with the Medical Monitor or 
designee may be needed to identify whether repeat testing of any particular parameter would be 
clinically relevant.  
The study permits the rescreening (after the end of the initial 28-day screening period) of a 
participant who discontinues the study as a pretreatment failure (ie, the participant fails to meet 
eligibility criteria and has not been treated). If re-enrolled, the participant must be reconsented, 
assigned a new identification number by interactive response technology (IRT), and a full 
screening visit must be performed again. A participant can only be rescreened 1 time (ie, if the 
participant fails 1 rescreening attempt, no additional rescreening is allowed). Depending on the 
timing of re-screening, repetition of some assessments may not be required. The fewest number of 
procedures from the initial screening should be repeated to qualify the participant, while 
maintaining participant safety and eligibility. In these cases, the site should consult with the BMS 
Medical Monitor (or designee). Similarly, repeat 
, if performed during screening, 
may not be required. The study also permits the re-screening of a participant to a second 
sub-protocol if they fail to meet eligibility criteria for the first sub-protocol. The participant must 
be assigned a new identification number by IRT.  
Duration of existing interventions and required discontinuation periods shall be considered relative 
to the new screening visit and/or randomization.  
The most current result(s) prior to randomization is the value by which study inclusion will be 
assessed, because it represents the participant’s most current clinical state.  
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. 
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Study intervention includes both Investigational [Medicinal] Product (IP/IMP) and 
Non-investigational [Medicinal] Product (Non-IP/Non-IMP) as indicated in Table 7.1-1. 
An IP, also known as an IMP in some regions, is defined as 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, 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-IMPs. 
7.1 
Study Interventions Administered 
The selection and timing of dose for each participant are as follows in Table 7.1-1. 
Table 7.1-1: 
Study Interventions 
ARM Name 
Deucravacitinib 
(BMS-986165) 
Placebo 
Intervention name 
Deucravacitinib 
Placebo  
Type  
Drug 
Drug 
Dose Formulation 
Tablet 
Placebo tablet   
Unit Dose Strength(s) 
6 mg 
n/a 
Dosage Level(s) 
1 active tablet QD in the morning 
1 placebo QD in the morning 
Route of Administration 
Oral 
Oral 
Use 
Experimental 
Placebo 
IMP and NIMP/AxMP 
IMP 
IMP 
Sourcing 
Provided centrally by the 
Sponsor 
Provided centrally by the Sponsor 
Packaging and Labeling 
Study intervention will be provided 
in a bottle. Each bottle will be 
labeled as required per country 
requirement. 
Study intervention will be provided 
in a bottle. Each bottle will be 
labeled as per country requirement. 
Abbreviations: AxMP, auxiliary medicinal products; n/a, not applicable; IMP, investigational medicinal product; 
NIMP, non-investigational medicinal product; QD, once daily.  
 
7.2 
Assignment to Study Intervention 
Before the study is initiated, each user (at investigative sites) will receive login information and 
directions on how to access the IRT system. 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 of the IRT system for assignment of a 
participant number for all participants, including participants not subsequently randomized or 
treated. The participant number is assigned sequentially by the system and will be unique across 
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all sites. All enrolled participants will be assigned sequential participant numbers. The participant 
number will not be used for any other participant. If a participant is rescreened, they will be given 
a new identification number. Participants with both PP and genital involvement can only be 
enrolled to 1 of the sub-protocols, and this decision is at the discretion of the investigator. 
At Week 0 (Day 1), participants who meet all criteria for enrollment for PP sub-protocol at 
screening and Day 1 will be centrally randomized in a 2:1 ratio to deucravacitinib 6 mg QD or 
placebo as determined by a computer-generated randomization schedule using IRT. The 
randomization lists will be generated by the IRT vendor using a permuted block design within 
each stratum level. 
 
 Participants with the presence of pustules (see Section 6.1) would be limited to a 
maximum of 10% of all randomized participants.   
At Week 0 (Day 1), participants who meet all criteria for enrollment for genital sub-protocol at 
screening and Day 1 will be centrally randomized in a 2:1 ratio to deucravacitinib 6 mg QD or 
placebo as determined by a computer-generated randomization schedule using IRT. The 
randomization lists will be generated by the IRT vendor using a permuted block design within 
each stratum level. 
 
 The study will aim to enroll at least 40% of female 
participants into the study.  
After all eligibility criteria have been met for a participant (ie, all inclusion criteria met, and all 
exclusion criteria not met), the investigative site will access the IRT on Day 1 for the purpose of 
randomizing a participant for each sub-protocol. A treatment group will be assigned by IRT based 
on the above-described randomization schedule, and each participant will be assigned a unique 
randomization number. In addition, a unique kit number will be assigned to the participant 
corresponding to the treatment assignment.  
Study treatment for each sub-protocol will be dispensed at study visits as shown in the Schedule 
of Activities (Section 2). When new treatment kits need to be provided, the investigative site will 
access the IRT to obtain the kit number to assign to the participant.  
At Week 16 in both sub-protocols, all participants regardless of their blinded intervention, will be 
switched to open-label deucravacitinib 6 mg QD bottles through Week 52. 
7.3 
Blinding 
This is a randomized, double-blind, placebo-controlled study. 
7.3.1 
Maintaining the Blind 
Blinded treatment assignments will be managed using IRT. IP supply will be controlled by IRT at 
each visit. 
All tablets are identical in appearance and will be supplied in bottles with each daily dose made 
up of the appropriate combination of active and/or placebo tablets to provide the correct treatment, 
as shown in Table 7.1-1. Investigative site staff, Sponsor and designated personnel, and 
participants and their families will remain blinded to treatment assignments.  
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The Sponsor and site-facing study team will be unblinded to the individual treatment assignments 
at the primary endpoint database lock after the last participant has completed the Week 16 visit 
independently for each sub-protocol. The primary analysis database lock will occur after all 
randomized participants completed their Week 16 visit or discontinued prior to Week 16 
independently for each sub-protocol. The study participants and investigators will remain blinded 
to the initial treatment assignment received from Day 1 to Week 16 throughout the study. 
7.3.2 
Circumstances for Unblinding 
Blinding of study intervention 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 whether 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 described in 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 non-emergency purposes should be discussed with the 
Medical Monitor. 
In case of an emergency, the investigator has unrestricted access to randomization information via 
IRT and is capable of breaking the blind through the IRT system without prior approval from the 
Sponsor. After the unblinding, the investigator shall notify the Medical Monitor or designee and/or 
study director. Participant and unblinded treatment information and the reason for the blind being 
broken must be recorded on the appropriate study status page of the eCRF. After unblinding via 
IRT, the investigator shall notify the Medical Monitor or designee. 
If a participant is unblinded for any reason, the participant will be discontinued from treatment. 
7.4 
Dosage Modification 
There is no provision for dose modification of study treatment. If a participant interrupts treatment 
due to an AE, study treatment can be restarted in consultation with the Medical Monitor. 
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7.5 
Preparation/Handling/Storage/Accountability 
The IP 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 is only dispensed to study participants. 
The IP 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 the Sponsor. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention 
should not be dispensed, and the Sponsor should be contacted immediately. 
Study intervention not supplied by the Sponsor will be stored in accordance with the package 
insert. 
IP documentation (whether supplied by the Sponsor or not) must be maintained and must include 
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). 
• The investigator or designee must confirm that appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before the use of the study intervention. 
• Only participants enrolled in the study may receive study intervention, and only authorized site 
staff may supply, prepare, or administer study intervention.  
• All study intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access limited 
to the investigator and authorized site staff. 
• The investigator, institution, head of the medical institution (where applicable), or authorized 
site staff is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition of records). 
• Further guidance and information for the final disposition of unused study interventions are 
provided in the Pharmacy Manual. 
 
7.6 
Study Intervention Compliance 
When participants self-administer study interventions at home, compliance with study intervention 
will be assessed at each visit. Compliance will be assessed by direct questioning, and counting 
returned tablets, etc. during the site visits and documented in the source documents and relevant 
form. Deviations from the prescribed dosage regimen should be recorded in the eCRF. 
A record of the quantity of Deucravacitinib and Placebo for Deucravacitinib dispensed to and 
administered by each participant must be maintained and reconciled with study intervention and 
compliance records. Intervention start and stop dates, including dates for intervention delays 
and/or dose reductions, will also be recorded in the CRF. 
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7.7 
Concomitant Therapy 
 
 
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7.7.2 
Permitted Concomitant Medication 
Participants may take any medication that is not restricted by the protocol, is not expected to 
interfere with the conduct of the study, and will not affect study assessments. Stable doses of 
concomitant medication for chronic medical conditions are permitted as long as neither the 
medication nor the medical condition meets exclusion criteria as detailed in Section 6. Dose 
adjustments of these medications should be avoided during the study unless clinically indicated. 
If a dose adjustment of these medications should occur, they must be recorded on the Concomitant 
Medications eCRF. Any concomitant therapies must be recorded on the (e)CRF. The investigator 
should instruct the participant to notify the study site about any new treatment he/she takes after 
the start of the study intervention. All medications and significant nondrug therapies (including 
physical therapy and blood transfusions) administered after the participant starts study intervention 
must be listed on the Concomitant Medications 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. 
Low potency topical steroids (WHO Class VI and VII) are permitted on the palms, soles, face (in 
the GenPs sub-protocol), and on the face and intertriginous areas (in the PP psoriasis sub-protocol) 
but should not be used within 24 hours prior to any study visit. Bland emollients (defined as 
emollients without urea or alpha- or beta-hydroxy acids or other ingredients which are 
pharmacologically active) are allowed on all body regions but should not be used within 24 hours 
prior to any study visit. 
7.7.4 
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 are unknown. The following are examples of non-live vaccines: inactivated 
vaccines (eg, heat-killed and formalin-killed vaccines), subunit vaccines (eg, influenza and 
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pneumococcal vaccines), toxoid vaccines, nucleic acid vaccines that do not encode potentially 
infectious 
virus 
(eg, 
Pfizer/BioNTech 
and 
Moderna 
COVID-19 
vaccines) 
and 
replication-incompetent recombinant vector vaccines (eg, AstraZeneca/University of Oxford 
COVID-19 vaccine). 
• For COVID-19 vaccines requiring more than 1 dose, the full series (eg, both doses of a 2-dose 
series) should be completed 30 days prior to Day 1. Ideally, AEs attributable to a vaccine 
should have resolved prior to enrollment. 
• If a participant receives a COVID-19 vaccination during the study, details such as type and 
date of vaccine received should be recorded on the COVID-19 vaccination eCRF page. For 
COVID-19 vaccines administered prior to enrollment, the types, details, and dates should be 
also recorded on the appropriate COVID-19 vaccination eCRF page. 
• Please contact the Medical Monitor or designee with any questions related to COVID-19 
vaccines. 
 
7.7.5 
Other Restrictions and Precautions 
Participants are prohibited from joining another clinical trial while they are participating in this 
study. 
7.8 
Continued Access to Study Intervention After the End of the Study 
At the end of the study, the Sponsor will not continue to provide Sponsor-supplied study 
intervention to participants/investigators unless the Sponsor chooses to extend the study. The 
investigator should ensure that the participant receives appropriate standard of care to treat the 
condition under study. 
8 
DISCONTINUATION CRITERIA 
Discontinuation of specific sites or of the study as a whole is detailed in Appendix 2. 
8.1 
Discontinuation of Study Intervention 
Participants MUST discontinue IP 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 test result 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 the Sponsor. 
• Loss of ability to freely provide consent through imprisonment or involuntary incarceration for 
treatment of either a psychiatric or physical illness (eg, infectious disease). (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 
Sponsor approval is required.) 
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• Abnormal liver tests suggestive of drug-induced liver injury (DILI), as defined in Section 9.2.7 
or if the investigator believes that it is in the best interest of the participant. 
• The participant develops a malignancy, with the exception of a participant who develops 
nonmelanoma skin cancer who may continue in the study at the discretion of the investigator. 
• Pregnancy, positive pregnancy test or participant expresses an interest in becoming pregnant 
(refer to Section 9.2.5).  
• Participant develops active TB during the study or prematurely discontinues intervention for 
LTBI, or participant is noncompliant with LTBI therapy (Section 6.2). 
• Unblinding of a participant’s intervention assignment for any reason (emergency or 
nonemergency). 
• Inability or failure to comply with protocol requirements in the opinion of the investigator (eg, 
procedures, assessments, medications, etc.). The investigator should discuss such issues with 
the Medical Monitor. 
 
Refer to Section 2 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: Schedule of Activities. The only exception 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 CRF page. 
8.1.1 
Temporary Discontinuation From Study Intervention 
Temporary study intervention discontinuation is only allowed if the participant develops an AE 
which, in the opinion of the investigator, indicates that it is in the participant’s best interest that 
the study intervention be placed on hold. Study intervention in this situation should be stopped 
until the AE is medically treated and has resolved per the principal investigator’s judgment. 
Temporary interruption of study treatment should be implemented in the context of clinical 
suspicion for SARS-CoV-2 or a positive diagnostic test for SARS-CoV-2. When study treatment 
is interrupted in a confirmed case of SARS-CoV-2, the investigator, in consultation with the 
Medical Monitor, should determine whether the resolution of symptoms alone (ie, without repeat 
diagnostic testing for SARS-CoV-2) is sufficient to resume study treatment. 
Temporary interruption of study intervention may be considered in the event of SARS-CoV-2 
vaccination according to local guidelines.  
Any temporary study intervention discontinuation, as well as restart, must be documented in the 
corresponding eCRF. 
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8.1.2 
Post-study Intervention Study Follow-up 
In this study, efficacy is a key endpoint of the study. Post-study follow-up is of critical importance 
and is essential to preserving participant safety and the integrity of the study. Participants who 
discontinue study intervention must continue to be followed in this study for collection of outcome 
data as required and in line with Section 5 until the conclusion of the study.  
8.2 
Discontinuation From the Study 
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.  
• 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 (Section 2). See the Schedule of 
Activities (Section 2) 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 from both the study intervention and 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: 
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• 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 3 documented phone calls, faxes, or emails, as well as lack of response by participant 
to 1 registered mail letter. All attempts should be documented in the participant’s 
medical records. 
• 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, such as public health registries and 
databases, 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, 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.  
• If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death. 
 
9 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and timing are summarized in the Schedule of Activities (Section 2).  
• Protocol waivers or exemptions are not allowed. 
• All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
intervention. 
• Adherence to the study design requirements, including those specified in the Schedule of 
Activities (Section 2), is essential and required for study conduct. 
• 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) and obtained before signing of informed consent may be utilized for screening or 
baseline purposes provided the procedure meets the protocol-defined criteria and has been 
performed within the timeframe defined in the Schedule of Activities (Section 2). 
• For several assessments, appropriate training will be provided to investigators and designated 
personnel at sites. Only those individuals trained and certified to perform these assessments 
will be performing them during the study.  
• Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
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• As part of the online questionnaire (eCOA), the study Sponsor may collect and use information 
about the gender that participants identify with, sexual orientation, and intersex status. At the 
conclusion of the study, summaries of this information, including information already collected 
about race, ethnicity, and gender, across all study participants will be developed to understand 
the populations that participated in the study. In addition, in the future, this data may be 
combined with data from other BMS studies to conduct subsequent research on how the disease 
or treatments impacts certain populations. Answering the questions about the gender you 
identify with, sexual orientation, and intersex status is voluntary, and participants are not 
required to answer these questions in the questionnaire to take part in this clinical study. 
 
9.1 
Efficacy Assessments 
Every effort must be made to ensure that the same evaluator(s) complete the assessment for each 
participant. If the evaluator(s) is/are unable to complete the evaluation, then a qualified individual 
with overlapping experience may perform the evaluation. Documentation of who performed the 
evaluation is to be recorded in source documents. Assessments are to be performed at 
approximately the same time of day throughout the duration of the study.  
Baseline assessments must be performed per protocol (standard-of-care assessments may not be 
used for baseline). Procedures not specified in the protocol that are part of standard care may be 
performed if they do not interfere with study procedures; any data arising from such procedures 
are not to be reported in the eCRF. 
9.1.1 
Assessments used in both sub-protocols 
9.1.1.1 
Investigator-administered Assessments 
9.1.1.1.1 
Psoriasis Area and Severity Index (PASI) 
The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions 
(each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, 
and legs to top of buttocks).26 The PASI produces a numeric score that can range from 0 to 72, 
with higher PASI scores denoting more severe disease activity. The PASI can also be used to 
assess response to treatment. The PASI-50 is the proportion of participants who experience at least 
a 50% improvement in PASI score as compared with the baseline value. The PASI-75, PASI-90, 
and PASI-100 are defined similarly. BMS will host a training session prior to initiation of the study 
to demonstrate proper PASI scoring. All PASI assessments should be performed by a trained 
physician (dermatologist) or appropriately trained investigator who is experienced in the 
assessment of psoriasis patients. 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
86 
9.1.1.1.3 
Static Physician’s Global Assessment (s-PGA) 
The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, 
scale, and induration.30 The s-PGA measure determines psoriasis severity at a single point in time 
(without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), 
moderate (3), or severe (4). All s-PGA assessments should be performed by a trained physician 
(eg, dermatologist) or appropriately trained investigator who is experienced in the assessment of 
psoriasis patients. Every effort should be made to ensure that the physician or designee who 
performed the s-PGA evaluations for a participant at randomization performs the s-PGA for that 
participant at all subsequent visits. 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
87 
9.1.2 
Palmoplantar Sub-protocol Specific Assessments 
9.1.2.1 
Investigator-administered Assessments 
9.1.2.1.1 
Palmoplantar Physician’s Global Assessment (pp-PGA) 
The pp-PGA is a 5-point scale of an average assessment of PP involvement.34 The pp-PGA 
measure determines psoriasis severity at a single point in time (without taking into account the 
baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). All 
pp-PGA assessments should be performed by a trained physician (eg, dermatologist) or 
appropriately trained investigator who is experienced in the assessment of psoriasis patients. Every 
effort should be made to ensure that the physician or designee who performed the pp-PGA 
evaluations for a participant at randomization performs the pp-PGA for that participant at all 
subsequent visits. 
9.1.2.1.2 
Palmoplantar-Psoriasis Area and Severity Index (pp-PASI) 
The pp-PASI is an adaptation of the PASI grading system to evaluate the severity of PP (including 
the finger and toe surfaces) psoriatic lesions and their response to treatment. 35 The pp-PASI 
produces a numeric score that can range from 0 to 72. 
The pp-PASI is divided into 4 regions: the right palm, the left palm, the right sole, and the left 
sole. Each palm contributes 20% and each sole contributes 30% to the total PP surface area. Each 
of these areas are evaluated for erythema, induration, and scaling, which are rated on a scale from 
0-4. Each of these areas are evaluated for percent involvement and assigned a score based on a 
0-6 scale. The pp-PASI should be performed by a dermatologist or appropriately trained 
investigator who is experienced in the assessment of psoriasis patients. 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
88 
9.1.3 
Genital Psoriasis Sub-protocol Specific Assessments 
9.1.3.1 
Investigator-administered Assessments 
9.1.3.1.2 
s-PGA of Genitalia (s-PGA-G) 
The s-PGA-G is the clinician’s determination of the participant’s psoriasis lesions’ overall severity 
in the genital area (labia majora, labia minora, and perineum in females; penis, scrotum, and 
perineum in males) at a given timepoint. Overall, lesions are categorized by descriptions for 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
89 
elevation, erythema, and scaling.39 It is not necessary that all 3 criteria be fulfilled. The s-PGA-G 
score is based on a combination of erythema and the secondary features (plaque elevation and/or 
scale). Since erythema is the most robust finding, it should be the dominant feature influencing the 
s-PGA-G rating in the majority of cases. For the analysis of responses, the patient’s psoriasis is 
assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). All 
s-PGA-G assessments should be performed by a trained physician (eg, dermatologist) or 
appropriately trained investigator who is experienced in the assessment of psoriasis patients. Every 
effort should be made to ensure that the physician or designee who performed the s-PGA-G 
evaluations for a participant at randomization performs the s-PGA-G for that participant at all 
subsequent visits. 
9.1.3.1.4 
Comprehensive Assessment of Psoriasis Patient (CAPP)– Genital Subindex 
Objective 
Comprehensive Assessment of the Psoriasis Patient (CAPP) is a disease severity measure to assess 
the full burden of plaque psoriasis and subtypes, including inverse, scalp, nail, PP, and GenPs.43 
Only the genital subindex will be utilized for this study. Severity of genital areas involved by 
psoriasis (suprapubic area, perineum and in male: scrotum, penis; in female: labia major and/or 
minora) will be graded as 0 = clear; 2 = erythema, no raised plaques, no scale; 4 = erythema, 
mildly thick plaques, mild scale; 6 = erythema, moderately thick plaques, mild scale; 
8 = prominent erythema, moderately thick plaques, moderate scale OR fissuring present; 
10 = prominent erythema, thick plaques, hypertrophic scale with/without excoriations, irrespective 
of area involved OR skin tearing present. (For severity scores 2 to 8: +2 if labia minora or glans 
penis involvement). PROs of pain and intimacy would be evaluated using VAS (minimal score 0, 
maximum score 10). The final genital severity score = measured genital severity plus the higher 
of the 2 PRO VAS scores (minimal score 0, maximum score 20). 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

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Additional Assessments 
 
 
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
Approved
1.0
v

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9.2 
Adverse Events 
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9.2.1 
Period and Frequency for Collecting AE and SAE Information 
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9.2.2 
Method of Detecting AEs and SAEs 
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
92 
9.2.3 
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 non-serious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate. 
• All identified non-serious 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 test result abnormalities that are reported/identified during the study. 
 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, 
 
, will be followed until resolution, 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). 
9.2.4 
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 IB 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 suspected, unexpected serious adverse 
reaction is a subset of SAEs and must be reported to the appropriate regulatory authorities and 
investigators following local and global guidelines and requirements. 
9.2.5 
Pregnancy 
This section is not applicable for Women Not of Childbearing Potential. 
If, following initiation of the study intervention, it is discovered that a participant is pregnant or 
may have been pregnant at the time of study intervention exposure, including at least 30 days after 
study product administration, the investigator must immediately notify the Sponsor Medical 
Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form to the 
Sponsor designee within 24 hours of awareness of the event and in accordance with SAE reporting 
procedures described in Appendix 3. 
In all cases, the study intervention will be discontinued immediately. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcomes 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. 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

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Laboratory Test Result Abnormalities 
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9.2.7 
Potential Drug-induced Liver Injury 
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9.2.8 
Other Safety Considerations 
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
Approved
1.0
v

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Overdose 
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9.4 
Safety 
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9.4.1 
Physical Examinations 
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9.4.2 
Vital Signs 
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
PPD
Approved
1.0
v

Clinical Protocol 
IM0111112 
BMS-986165 
Deucravacitinib 
 
Date: 08-May-2023 
95 
9.4.3 
Electrocardiograms 
A 12-lead ECG will be performed at the screening visit. The participant will remain supine for 5 to 
10 minutes prior to the ECG and must have their lab work done after the tracing so that the ECG 
results remain as accurate as possible. The ECG results will be read by the primary study 
investigator or a designee. 
1.0
Approved
930205993
1.0
v
Approved
1.0
v
Approved
1.0
v

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9.5 
Pharmacokinetics 
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Immunogenicity Assessments  
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1.0
Approved
930205993
1.0
v
Approved
1.0
v
PPD
Approved
1.0
v

Clinical Protocol 
IM0111112 
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9.8 
Optional Future Research 
This protocol will include residual sample storage for optional future research. 
Samples kept for future research will be stored at the Sponsor-designated storage facility. 
The manager of these samples will ensure that they are properly used throughout their usable life 
and will destroy the samples at the end of the scheduled storage period, no longer than 25 years 
after the end of the study or the maximum period allowed by applicable law. 
Samples will be stored in a coded fashion, and no researcher will have access to the key. The key 
will be securely held by the investigator at the clinical site, so there is no direct ability for a 
researcher to connect a sample to a specific individual. 
Further details of sample collection and processing will be provided to the site in the 
laboratory/procedure manual.  
9.9 
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 Hypotheses 
For the non-pustular PP psoriasis sub-protocol, the primary hypothesis is that the odds of achieving 
pp-PASI-75 at Week 16 in participants receiving deucravacitinib 6 mg QD are improved compared 
to participants receiving placebo.  
The null hypothesis to be tested for the primary endpoint is the following: 
• The odds of achieving pp-PASI-75 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
The null hypothesis corresponding to the key secondary endpoint is: 
• The odds of achieving pp-PGA 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
For the GenPs sub-protocol, the primary hypothesis is that the odds of achieving s-PGA-G 0/1 at 
Week 16 in participants receiving deucravacitinib 6 mg QD are improved compared to participants 
receiving placebo. 
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The null hypothesis to be tested for the primary endpoint is the following: 
• The odds of achieving s-PGA-G 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
The null hypothesis corresponding to the key secondary endpoint is: 
• The mean change from baseline in GenPs Itch NRS score at Week 16 in participants receiving 
deucravacitinib 6 mg QD is not different from participants receiving placebo.  
 
The null hypothesis corresponding to the second key secondary endpoint is: 
• The odds of achieving s-PGA 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo.  
 
Multiplicity Adjustment 
The statistical comparisons for the primary efficacy endpoint and the key secondary endpoint will 
be carried out in a hierarchical order for each sub-protocol. The hierarchical testing will preserve 
the overall Type I error at 0.05 for each sub-protocol.  
The primary endpoint for each sub-protocol will be tested with a 2-sided Type 1 error (α) of 0.05, 
and if statistical significance is met for the primary endpoint, testing will proceed with the 2-sided 
α of 0.05 passed down to each respective key secondary endpoint. 
If statistical significance is not met for the primary endpoint, then subsequent p-values will be 
considered descriptive for that sub-protocol.  
There will be no multiplicity adjustment for other additional endpoints in either sub-protocol; 
however, nominal p-values will be provided as descriptive statistics.  
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10.3 
Analysis Sets 
For the purposes of analysis, the following analysis sets will be used for each sub-protocol in this 
trial: 
Table 10.3-1: 
Palmoplantar Psoriasis Sub-Protocol Analysis Sets 
Population 
Description 
Enrolled 
All participants who sign informed consent. 
Randomized (Full Analysis Set [FAS]) 
All participants who were randomized to any treatment 
arm in the study. 
Safety 
All randomized participants who take at least 1 dose of 
study intervention. Participants will be analyzed 
according to intervention received. 
Defined Analysis Data Sets 
Description 
Analysis set for primary estimand of pp-PASI-75 
All randomized participants; all available data up to 
Week 16 database lock. Participants who discontinued 
prior to Week 16 will be imputed as non-responders in 
the analysis dataset. Following the intent-to-treat 
principle, participants will be analyzed according to the 
intervention group assigned at randomization. 
Analysis set for secondary estimand of pp-PGA 0/1 
All randomized participants; all available data up to 
Week 16 database lock. Participants who discontinued 
prior to Week 16 will be imputed as non-responders in 
the analysis dataset. Following the intent-to-treat 
principle, participants will be analyzed according to the 
intervention group assigned at randomization. 
Analysis set for safety 
All safety events reported for all randomized 
participants who are exposed to study intervention. For 
participants who discontinue study intervention all post 
discontinuation up to Day 28 post last dose of study 
intervention will be included in the safety summaries. 
Participants will be analyzed according to intervention 
received. 
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Abbreviations: pp-PASI, palmoplantar Psoriasis Area and Severity Index; pp-PGA, palmoplantar physician global 
assessment. 
Table 10.3-2: 
Genital Psoriasis Sub-Protocol Analysis Sets 
Population 
Description 
Enrolled 
All participants who sign informed consent. 
Randomized (Full Analysis Set [FAS]) 
All participants who were randomized to any treatment 
arm in the study. 
Safety 
All randomized participants who take at least 1 dose of 
study intervention. Participants will be included in the 
treatment group to which they were randomized. 
Defined Analysis Data Sets 
Description 
Analysis set for primary estimand of s-PGA-G 0/1 
All randomized participants; all available data up to 
Week 16 database lock. Participants who discontinued 
prior to Week 16 will be imputed as non-responders in 
the analysis dataset. Following the intent-to-treat 
principle, participants will be analyzed according to the 
intervention group assigned at randomization. 
Analysis set for secondary estimand of GenPs itch 
NRS 
All randomized participants; all available data up to 
Week 16 database lock. Participants who discontinued 
prior to Week 16 will be imputed using multiple 
imputation in the analysis dataset. Following the 
intent-to-treat principle, participants will be analyzed 
according to the intervention group assigned at 
randomization. 
Analysis set for safety 
All safety events reported for all randomized 
participants who are exposed to study intervention. For 
participants who discontinue study intervention all post 
discontinuation up to Day 28 post last dose of study 
intervention will be included in the safety summaries. 
Participants will be analyzed according to intervention 
received. 
Abbreviations: GenPs, genital psoriasis; NRS, numerical rating scale; s-PGA-G, static Physician’s Global Assessment 
of Genitalia. 
10.4 
Statistical Analyses 
The statistical analysis plan (SAP) will be developed and finalized before database lock at week 
16 and will describe the selection of participants to be included in the analyses and procedures for 
accounting for missing, unused, and spurious data for each sub-protocol. Below is a summary of 
planned statistical analyses of the primary and secondary endpoints. 
A description of the participant population will be included in the clinical study report (CSR), 
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 CSR. 
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Participant characteristics and/or demographic data may be pooled across studies for future 
analysis. 
10.4.1 
General Considerations 
Efficacy Analyses 
Descriptive statistics will be presented by the treatment group. Categorical data will be 
summarized as frequency counts and percentages. Continuous data will be summarized using n, 
mean, standard deviation (SD), median, minimum, and maximum unless otherwise specified. 
Efficacy values will be summarized for all visits in which the variable is assessed. Details of the 
planned analyses of endpoints during the 16-week double-blinded placebo-controlled period will 
be documented in the SAP and finalized before the primary analysis database lock for each 
sub-protocol. 
During the first 16 weeks of treatment, data will be presented for the following treatments for each 
sub-protocol: 
•
deucravacitinib 6 mg QD
•
placebo
After Week 16, data for each sub-protocol will be presented for the following treatments: 
•
deucravacitinib 6 mg QD
•
placebo  deucravacitinib 6 mg QD (starting at Weeks 16 through 52)
The main estimands for the primary and key secondary objectives are summarized below in Table 
10.4.1-1 for non-pustular PP psoriasis and in Table 10.4.1-2 for GenPs, respectively. 
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Table 10.4.1-1: 
Summary of the Attributes of the Main Estimand for the Primary 
and Key Secondary Objectives of Palmoplantar Psoriasis 
Sub-protocol 
Primary Objective 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus Placebo 
Population 
Participants with moderate-to-severe non-pustular palmoplantar psoriasis 
Variable 
pp‑PASI-75: Individual patient’s binary outcome (Yes or No) of achieving 75% 
improvement at Week 16 in pp‑PASI score from baseline. 
Intercurrent Events 
(ICEs) 
Event 
Strategy 
Description 
Discontinuation of 
intervention and 
study early prior to 
Week 16 assessment 
Composite variable 
Participant will be counted 
as a non-responder 
Lost to follow-up 
prior to Week 16 or 
otherwise missed 
assessment at Week 
16 
Composite variable 
Participant will be counted 
as a non-responder 
Population-level 
Summary 
Odds ratio of achieving 75% improvement in pp‑PASI score from baseline between 
treatment groups. 
Key Secondary Objective 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus Placebo 
Population 
Participants with moderate-to-severe non-pustular palmoplantar psoriasis 
Variable 
pp-PGA 0/1: Individual patient’s binary outcome (Yes or No) of achieving pp-PGA 
0/1 at Week 16 
Intercurrent Events 
(ICEs) 
Event 
Strategy 
Description 
Discontinuation of 
intervention and study 
early prior to Week 16 
assessment  
Composite variable 
Participant will be 
counted as a non-
responder 
Lost to follow-up prior to 
Week 16 or otherwise 
missed assessment at 
Week 16 
Composite variable 
Participant will be 
counted as a non-
responder 
Population-level 
Summary 
Odds ratio of achieving pp-PGA 0/1 at Week 16 between treatment groups. 
Abbreviations: pp‑PASI, palmoplantar Psoriasis Area and Severity Index; pp‑PGA, palmoplantar Physician Global 
Assessment; QD, once daily. 
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Table 10.4.1-2:  
Summary of the Attributes of the Main Estimand for the Primary 
and Key Secondary Objectives of Genital Psoriasis Sub-protocol 
Primary Objective 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus Placebo 
Population 
Participants with Moderate-to-severe genital psoriasis 
Variable 
s-PGA‑G 0/1: Individual patient’s binary outcome (Yes or No) of achieving 
s-PGA‑G score of 0 or 1 at Week 16 
Intercurrent Events 
(ICEs) 
Event 
Strategy 
Description 
Discontinuation of 
intervention and study 
early prior to Week 16 
assessment  
Composite variable 
Participant will be 
counted as a non-
responder 
Lost to follow-up prior to 
Week 16 or otherwise 
missed assessment at 
Week 16 
Composite variable 
Participant will be 
counted as a non-
responder 
Population-level 
Summary 
Odds ratio of achieving s-PGA‑G score of 0 or 1 at Week 16 between treatment 
groups. 
Key Secondary Objective 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus Placebo 
Variable 
Change from baseline GenPs itch numerical rating scale (NRS) 
Intercurrent Events 
(ICEs) 
Event 
Strategy 
Description 
Discontinuation of 
intervention and study 
early prior to Week 16 
assessment  
Composite variable 
 Baseline Observation 
Carried Forward (BOCF) 
will be applied. 
Lost to follow-up prior to 
Week 16 or otherwise 
missed assessment at 
Week 16 
Composite variable 
Last Observation Carried 
Forward (LOCF) will be 
applied (including the 
baseline value if 
necessary). 
Population-level 
Summary 
Adjusted mean difference between treatment groups. 
Second Key Secondary Objective 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus Placebo 
Variable 
s-PGA 0/1: Proportion of participants achieving s-PGA score of 0 or 1 at Week 16 
Intercurrent Events 
(ICEs) 
Event 
Strategy 
Description 
Discontinuation of 
intervention and study 
early prior to Week 16 
assessment  
Composite variable 
Participant will be 
counted as a non-
responder 
Lost to follow-up or 
otherwise missing 
Composite variable 
Participant will be 
counted as a non-
responder 
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Table 10.4.1-2: 
Summary of the Attributes of the Main Estimand for the Primary 
and Key Secondary Objectives of Genital Psoriasis Sub-protocol 
endpoint data at or prior 
to Week 16 assessment 
Population-level 
Summary 
Odds ratio of achieving s-PGA score of 0 or 1 at Week 16 between treatment 
groups. 
Abbreviations: QD, once daily; s-PGA, static Physician’s Global Assessment; s-PGA‑G, static Physician Global 
Assessment Genitals; NRS, Numerical Rating Scale.  
10.4.2 
Primary Endpoint(s) 
Table 10.4.2-1: 
Primary Endpoint for Palmoplantar Psoriasis Sub-protocol 
Primary Endpoint 
Description of Analysis 
Time Frame 
pp‑PASI-75 response rate is defined 
as a proportion of participants 
achieving 75% improvement in 
pp‑PASI score 
The analysis model for the primary endpoint, 
pp‑PASI-75 (responder/non-responder) at Week 16, 
 
 
 to compare the 
response rates of deucravacitinib 6 mg QD to placebo 
using the Week 16 data of the Full Analysis Set 
population. The odds ratio (ratio of odds in 
deucravacitinib 6 mg QD to the odds in placebo group) 
and the corresponding 2‑sided 95% confidence interval 
(CI) will be provided. Estimates of proportions and
their 2‑sided 95% CIs will be provided.
Non-responder imputation (NRI) will be used for the
primary efficacy endpoint for participants who
discontinue intervention or study prior to Week 16 or
who have otherwise missing endpoint data at Week 16.
NRI will be the primary method of imputation for the
primary efficacy endpoint.
Sensitivity and supportive analyses to be performed for
the primary endpoint will be described in the SAP.
Week 16 
Abbreviations: pp‑PASI, palmoplantar Psoriasis Area and Severity Index; SAP, statistical analysis plan; QD, once 
daily. 
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Table 10.4.2-2: 
Primary Endpoint for Genital Psoriasis Sub-protocol 
Primary Endpoint 
Description of Analysis 
Time Frame 
s-PGA‑G response rate is defined as a
proportion of participants achieving
participants achieving s-PGA‑G score
of 0 or 1 with at least a 2-point
reduction from baseline at Week 16
The analysis model for the primary endpoint, s-PGA‑G 
(responder/non-responder) at Week 16, 
 
 
 
) to compare the response 
rates of deucravacitinib 6 mg QD to placebo using the 
Week 16 data of the Full Analysis Set population. The 
odds ratio (ratio of odds in deucravacitinib 6 mg QD to 
the odds in placebo group) and the corresponding 
2‑sided 95% confidence interval (CI) will be provided. 
Estimates of proportions and their 2‑sided 95% CIs 
will be provided.  
Non-responder imputation (NRI) will be used for the 
primary efficacy endpoint for participants who 
discontinue intervention or study prior to Week 16 or 
who have otherwise missing endpoint data at the 
specified timepoint. NRI will be the primary method of 
imputation for the primary efficacy endpoint.  
Sensitivity and supportive analyses to be performed for 
the primary endpoint will be described in the SAP. 
Week 16 
Abbreviations: SAP, statistical analysis plan; s-PGA‑G, static physician global assessment genitals; QD, once daily. 
10.4.3 
Secondary Endpoint(s) 
Key Secondary Endpoints 
Table 10.4.3-1: 
Key Secondary Endpoint for Palmoplantar Psoriasis Sub-protocol 
Key Secondary Endpoint 
Description of Analysis 
Time Frame 
pp‑PGA 0/1 is defined as a 
proportion of participants 
achieving pp‑PGA 0/1 at Week 16 
The analysis model for pp-PGA 0/1 (responder/non-
responder) at Week 16, will use 
 
 
to compare the response 
rates of deucravacitinib 6 mg QD to placebo for the FAS 
population. The odds ratio (ratio of odds in 
deucravacitinib 6 mg QD to the odds in placebo group) 
and the corresponding 2‑sided 95% confidence interval 
(CI) will be provided. Estimates of proportions and their
2‑sided 95% CIs will be provided.
The NRI method will be applied to the analysis of the
binary secondary efficacy endpoint for participants who
discontinue early or who have otherwise missing
endpoint data at the specified timepoint.
Week 16 
Abbreviations: 
; FAS, full analysis set; pp‑PGA, palmoplantar physician global 
assessment; QD, once daily. 
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Table 10.4.3-2:  
Key Secondary Endpoints for Genital Psoriasis Sub-protocol 
Key Secondary Endpoint 
Description of Analysis 
Time Frame 
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Safety Analyses 
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Other Analyses  
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10.5 
Interim Analyses 
No interim is currently planned. 
Week 16 Primary Analysis 
A 16-week primary analysis will occur once all randomized participants have completed through 
Week 16 or have discontinued prior to Week 16 in each sub-protocol independently. Analyses of 
the collected efficacy and safety data will be performed independently also. The study participants 
and investigators will remain blinded to the initial treatment assignment received from Day 1 to 
Week 16 and the results of this analysis throughout the study. The Sponsor and site-facing study 
team will be unblinded to the individual treatment assignments following the last Week 16 visit.  
Additional details of these analyses will be described in the SAP. A final analysis will be 
performed after all participants complete the Week 52 visit or discontinue prior to the Week 52 
visit. 
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REFERENCES 
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1
Blauvelt, A., Rich, P., Sofen, H., et al. Deucravacitinib, an oral, selective, allosteric tyrosine 
kinase 2 inhibitor, in scalp, nail, and palmoplantar psoriasis: subgroup analyses of the phase 3 
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Parisi R, Symmons DP, Griffiths CE, et al. Global epidemiology of psoriasis: a systematic 
review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-385. 
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Kupetsky EA, Keller M. Psoriasis vulgaris: an evidence-based guide for primary care. J Am 
Board Fam Med. 2013;26(6):787-801. 
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World Health Organization. Global Report on psoriasis. WHO 2016. 
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Langely RG, Kruger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality 
of life. Ann Rheum Dis. 2005;64(Suppl II):ii18-ii23. 
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Quiero R, Tejon P, Alonso S, Coto P. Age at disease onset: a key factor for understanding 
psoriatic disease. Rheumatology (Oxford). 2014;53(7):1178-1185. 
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Merola JF, Qureshi A, Husni ME. Underdiagnosed and undertreated psoriasis: Nuances of 
treating psoriasis affecting the scalp, face, intertriginous areas, genitals, hands, feet, and nails. 
Dermatol Ther 2018;31(3):e12589. 
8
Ryan C, Menter A, Guenther, et al. Efficacy and safety of ixekizumab in a randomized, double 
blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital 
psoriasis. Br J Dermatol 2018;179(4):844-852. 
9
Gottlieb A, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in 
palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial. J Am Acad 
Dermatol 2017;76(1):70-80. 
10  Elmets C, Korman N, Farley Prater E, et al. Joint AAD-NPF Guidelines of care for the 
management and treatment of psoriasis with topical therapy and alternative medicine 
modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84(2):432-470. 
11  Novartis. Rheumatrex® (methotrexate). United States Prescribing Information. 2016. 
12  Novartis. Neoral® (cyclosporine). United States Prescribing Information. 2009. 
13  Celgene. Otezla® (apremilast). United States Prescribing Information. 2017. 
14  Abbvie. Humira® (adalimumab). United States Prescribing Information. 2017. 
15  Janssen Biotech. Remicade® (infliximab). United States Prescribing Information. 2013. 
16  Janssen Biotech. Stelara® (ustekinumab). United States Prescribing Information. 2016. 
17  Novartis. Cosentyx® (sekukinumab). United States Prescribing Information. 2015. 
18  Eli Lilly. Taltz® (ixekizumab). United States Prescribing Information. 2017. 
19  Valeant. Siliq® (brodalumab). United States Prescribing Information. 2017. 
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20  Armstrong AW, Robertson AD, Wu J, et al. Undertreatment, treatment trends, and treatment 
dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: 
findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol 
2013;149(10):1180-1185. 
21  Nestle FO, Kaplan DH, Barker J. Mechanisms of Disease: Psoriasis. N Engl J Med 
2009;361:496-509. 
22  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;290:11061-11074. 
23  Watford WT, Hissong BD, Bream JH, et al. Signaling by IL-12 and IL-23 and the 
immunoregulatory roles of STAT4. Immunol Rev 2004;202:139-156. 
24  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;100:11594-11599. 
26  Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 
1978;157(4):238-244. 
30  Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 
2005;64:ii65-ii68. 
34  Bissonnette R, Pariser DM, Wasel NR, et al. Apremilast, an oral phosphodiesterase-4 inhibitor, 
in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR- 
005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis 
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(ESTEEM) clinical trials in patients with moderate to severe psoriasis. J Am Acad Dermatol. 
2016;75:99-105. 
35  Gottlieb A, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in 
palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial. J Am Acad 
Dermatol 2016;76(1):70-80. 
39  Merola J, Bleakman A, Gottlieb A, et al. The Static Physician's Global Assessment of 
Genitalia: a clinical outcome measure for the severity of genital psoriasis. J Drugs Dermatol 
2017;16(8):793-799. 
43  Paek SY, Thompson JM, Qureshi AA, et al. Comprehensive Assessment of the Psoriasis 
Patient (CAPP): A Report from the GRAPPA 2015 Annual Meeting. J Rheumatol 
2016;43(5):961-964. 
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12 
APPENDICES 
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APPENDIX 1 
ABBREVIATIONS 
Term 
Definition 
ADD 
American Academy of Dermatology 
AE 
Adverse event 
 
 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ANC 
absolute neutrophil count 
AST 
aspartate aminotransferase 
AT 
aminotransaminase 
AUC(TAU) 
area under the concentration-time curve in 1 dosing interval 
BID 
twice daily 
BMI 
body mass index 
BMS 
Bristol-Myers Squibb Company 
BP 
blood pressure 
 
 
C 
Celsius 
CAPP 
Comprehensive Assessment of the Psoriasis Patient 
CBC 
complete blood count 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
Cmax 
maximum observed concentration 
COVID-19 
Coronavirus disease 2019 
CRF 
Case Report Form, paper or electronic (eCRF) 
CRO 
Contract Research Organization 
CSR 
Clinical Study Report 
DILI 
Drug induced liver injury 
ECG 
electrocardiogram 
eCOA 
electronic clinical outcomes assessments 
eCRF 
electronic Case Report Form 
EE 
Ethinyl estradiol 
EOT 
End of treatment 
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Term 
Definition 
ET 
Early termination 
EU 
European Union 
EudraCT 
European Union Drug Regulating Authorities Clinical Trials Database 
FDA 
US Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GenPs 
genital psoriasis 
GI 
Gastrointestinal 
HBsAg/HBsAb 
hepatitis B surface antigen/antibody 
HBcAb 
hepatitis B core antibody 
HBV 
hepatitis B virus 
HCG 
human chorionic gonadotropin 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
IB 
Investigator brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IMP 
Investigational Medicinal Product 
IND 
Investigational New Drug 
IP 
Investigational Product 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IU 
international unit 
IV 
intravenous(ly) 
(J)AAD
Joint American Academy of Dermatology 
LTBI 
latent TB infection 
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Term 
Definition 
mm Hg 
millimeters of mercury 
N 
number of participants or observations 
N/A 
not applicable 
NCT (number) 
National Clinical Trial number 
Non-IMP 
Non-investigational Medicinal Product 
NPF 
National Psoriasis Foundation 
NRS 
numeric rating scale 
PASI 
Psoriasis Area and Severity Index 
pp-PASI 
palmoplantar Psoriasis Area and Severity Index 
PBO 
Placebo 
PE 
physical examination 
pp-PGA 
palmoplantar physician global assessment 
PK 
pharmacokinetic(s) 
PP 
palmoplantar 
PRO 
patient-reported outcomes 
PSA 
psoriatic arthritis 
PSO 
psoriasis 
QD 
once daily 
QoL 
quality of life 
SAE 
serious adverse event 
SD 
standard deviation 
s-PGA
static Physician Global Assessment 
s-PGA-G
static physician global assessment genitals 
SSC 
Study Steering Committee 
ULN 
upper limit of normal 
US 
United States 
UV 
ultraviolet 
VAS 
visual analog scale 
WHO 
World Health Organization 
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Term 
Definition 
WOCBP 
women of childbearing potential 
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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
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 
the 
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, 1 or more of the following: (1) the rights, physical safety, or mental integrity 
of 1 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. 
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 (US) Code of Federal Regulations, Title 21, Part 50 (21CFR50)
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•
European Union (EU) Directive 2001/20/EC
•
European Regulation 536/2014 for clinical studies (if applicable)
•
European Medical Device Regulation 2017/745 for clinical device research (if applicable)
•
the IRB/IEC
•
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, 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 the following: 
•
IRB/IEC
•
Regulatory authority(ies), if applicable according to 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, by the local Health Authority must be sent to Bristol-Myers 
Squibb Company (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 study and for 1 year 
after completion of the study. 
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.  
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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 and answer all questions regarding the study.
•
Inform the participant that his/her participation is voluntary. The participant will be required
to sign a statement of informed consent that meets the requirements of 21 CFR Part 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 the participant to inquire about the details of the study.
•
Obtain an ICF signed and personally dated by the participant and by the person who conducted
the informed consent discussion.
•
Include a statement in the participant’s medical record that written informed consent was
obtained before the participant was enrolled in the study and the date the written consent was
obtained. The authorized person obtaining the informed consent must also sign the ICF.
•
Re-consent the participant to the most current version of the ICF(s) during his/her participation.
•
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 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.
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.  
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.  
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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. 
RECRUITMENT STRATEGY 
A patient engagement and recruitment program will be developed and implemented to assist sites 
with patient recruitment efforts. Tactics will support patient education and awareness, and HCP 
outreach. This program will also include solutions to address anticipated recruitment challenges.  
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 
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:  
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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 Case Report Form (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.
•
Definition of what constitutes source data and its origin can be found in the source data location
list/map or equivalent document.
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 the following: 
•
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
•
non-study 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 per the Delegation of
Authority Form
Sourced by site and not 
supplied by BMS or its 
vendors (examples 
include Investigational 
Product sourced from the 
site’s stock or 
commercial supply or a 
specialty pharmacy) 
The investigator or designee accepts responsibility for 
documenting traceability and study intervention 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 
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). 
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 test result 
abnormalities that are reported or identified during the study. 
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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 serious adverse events (SAEs) and 
pregnancy, which will be reported on the electronic SAE form and Pregnancy Surveillance Form, 
respectively. If the electronic SAE form is not available, a paper SAE form can be used.  
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. 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 non-compliance 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. 
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.  
Records collected throughout the study will be stored in the BMS clinical data management system 
for a duration of the life of the product plus 25 years. 
RETURN OF STUDY INTERVENTION 
For this study, study interventions (those supplied by BMS or a vendor or sourced by the 
investigator), such as partially used study intervention containers, vials, and syringes, may be 
destroyed on site.  
If 
Then 
Study interventions 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 intervention 
containers must be immediately destroyed as required for 
safety or to meet local regulations (eg, cytotoxic or biologic 
agents). 
Partially used study interventions and/or empty containers 
may be destroyed after proper reconciliation and 
documentation. However, unused Investigational Medicinal 
Product must be reconciled by the site monitor/clinical 
research associate prior to destruction. 
If study interventions will be returned, the return will be 
arranged by the responsible study monitor. 
Study interventions sourced by 
site, not supplied by BMS (or 
its vendors; eg, study 
interventions 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 interventions provided by BMS (or its vendors). Destruction of non-study 
interventions sourced by the site, not supplied by BMS, is solely the responsibility of the 
investigator or designee.  
STUDY AND SITE 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, the following: 
For study termination: 
•
Discontinuation of further study intervention development
For site termination:
•
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 or no recruitment (evaluated after a reasonable amount of time) of participants by
the investigator
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 ensure 
appropriate participant therapy and/or follow-up. 
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DISSEMINATION OF CLINICAL STUDY DATA 
To benefit potential study participants, patients, health care 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 per regulatory and BMS 
requirements. BMS will post study information on local, national, or regional databases in 
compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases. 
In the European Union (EU), the summary of results and summary for laypersons will be submitted 
within 1 year of the end of trial in the EU/European Economic Area and third countries. 
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 designee
•
Participant recruitment (eg, among the top quartile of enrollers)
•
Involvement in trial design
•
Regional representation (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 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 the Sponsor is aligned with the criteria of the International 
Committee of Medical Journal Editors (ICMJE; www.icmje.org). Authorship selection is based on 
significant contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE 
criteria for authorship: 
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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)
2) Drafting the work or revising it critically for important intellectual content
3) Final approval of the version to be published
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.
Those who make the most significant contributions, as defined above, will be considered by the 
Sponsor 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 occurring in a clinical investigation participant after signing of 
informed consent, whether or not considered related to the study intervention. 
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
test result), symptom, or disease temporally associated with the study intervention. 
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 sign
measurements), including those that worsen from baseline, considered clinically significant
in the medical and scientific judgment of the investigator. Note that abnormal laboratory test
results or other safety assessment findings 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
the condition 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).
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DEFINITION OF SAE 
If an event is not an AE per the definition above, then it cannot be an SAE, even if serious 
conditions are met. 
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 that 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 BMS clinical studies: 
•
A visit to the emergency department or other hospital department < 24 hours that does not
result in admission (unless considered an important medical or life-threatening event).
•
Elective surgery that was planned prior to signing consent.
•
Admissions 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 enrollment
in 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 results 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 department 
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: Potential Drug-induced Liver Injury of the protocol for the 
definition of a potential DILI.)  
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Pregnancy and DILI must follow the same transmission timing and processes to BMS as those 
used for SAEs. (See Section 9.2.5: Pregnancy of the protocol 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 1 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 pre-defined 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 intervention or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or the designee) using the same procedure used for transmitting the initial SAE 
report. 
All AEs/SAEs must be followed to resolution or stabilization. 
REPORTING OF SAES TO SPONSOR OR DESIGNEE 
•
SAEs, whether related or not related to study intervention, and pregnancies must be reported
to BMS (or the designee) promptly and not to exceed 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 the designee).
♦In this case, the paper form is transmitted via email or confirmed fax 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 fax transmission.
SAE Email Address: worldwide.safety@BMS.com 
SAE Fax 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 Women of Childbearing 
Potential (WOCBP) 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: Inclusion Criteria of the protocol. Only the 
contraceptive methods as described in Section 6.1: Inclusion Criteria of the protocol are 
acceptable for this study. 
DEFINITIONS 
Women 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
•
Pre-menopausal female with 1 of the following:
−
Hysterectomy
−
Bilateral salpingectomy
−
Bilateral oophorectomy
•
Post-menopausal female
−
A post-menopausal state is defined as 12 months of amenorrhea in a woman over the
age of 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 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 judgment 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
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 time point at which the study intervention 
(Investigational Medicinal Product [IP/IMP] and other study interventions ie, Non-IMP/AxMP 
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required for study) or any active major metabolites have decreased to a concentration that is no 
longer considered 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 study intervention to pass. 
METHODS OF CONTRACEPTION 
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 in which 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 in which
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 in which hormonal contraception is permitted by the study protocol.)b
•
Intrauterine device.
•
Intrauterine system (IUS). (This method of contraception can only be used by WOCBP
participants in studies in which 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. 
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•
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 intervention.
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 of the protocol.
•
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, post-ovulation
methods), withdrawal (coitus interruptus), spermicides only, and lactation 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 intervention, which may reduce the
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the Investigational Medicinal Product 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 Section 6.1: Inclusion Criteria 
 
 
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 
study regarding permissibility of hormonal contraception, refer to Section 6.1: Inclusion Criteria 
 
 
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 in which hormonal contraception is prohibited.)
Unacceptable Methods of Contraception 
•
Periodic abstinence (calendar, symptothermal, post-ovulation methods).
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•
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: Pregnancy of the protocol and Appendix 3. 
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APPENDIX 6 
HEPATITIS B VIRUS (HBV) SCREENING 
Participants must undergo screening for hepatitis B virus (HBV). At a minimum, this includes 
testing for HBsAg (HBV surface antibody), and anti-HBc total (HBV core antibody total): 
•
Participants who test negative for all HBV screening tests (ie, HBsAg-, anti HBc-, and anti-
HBs-) are eligible for this study.
•
Participants who test negative for surface antigens (HBsAg-) and test positive for core
antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.
•
Participants who test positive only for surface antibody (anti-HBs+) are eligible for this study
•
Participants who test positive for surface antigen (HBsAg+) are NOT eligible for this study
regardless of results of other hepatitis B tests.
•
Participants who test positive only for core antibody (anti-HBc+) are NOT eligible for this
study.
Participants who are not eligible for this study due to HBV results, consultation with a physician 
with expertise in the treatment of hepatitis B virus is recommended.  
Table 2: 
Eligibility Based on Hepatitis B Virus Test Results 
Hepatitis B Test Result 
Action 
Hepatitis B Surface 
Antigen (HBsAg) 
Hepatitis B Surface 
Antibody (anti-HSs) 
Hepatitis B Core 
Antibody (anti-HBC total) 
- 
- 
- 
Include 
- 
+ 
- 
- 
+ 
+ 
Exclude 
+ 
- Or + 
- or +
- 
- 
+
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