Clinical trial NCT05478499
Conditions: Psoriasis
Keywords: Scalp Psoriasis BMS-986165 Deucravacitinib Psoriasis Psoriasis Special Sites
Sponsor: Bristol-Myers Squibb
Start date: 2022-10-06; Completion date: 2024-10-17
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Detailed description:

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

Protocol documents:
Prot_SAP_000.pdf: 
Official Title of Study: 
A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the 
Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis 
(PSORIATYK SCALP) 
 
NCT Number: NCT05478499 
Document Date (Date in which document was last revised): 23 May 2023 
 
 
 


Page: 1 
Protocol Number: IM011220 
Date: 23-Mar-2022
Revised Date: 23-May-2023
CLINICAL PROTOCOL IM011220 
A PHASE 3B/4, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 
DEUCRAVACITINIB IN PARTICIPANTS WITH MODERATE-TO-SEVERE SCALP 
PSORIASIS (PSORIATYK SCALP) 
Compound: BMS-986165 
Brief Title: Efficacy and safety of deucravacitinib versus placebo in participants with moderate-
to-severe scalp psoriasis 
Protocol Amendment 03 
 
Clinical Trial Physician-Medical Monitor 
Bristol-Myers Squibb Company 
86 Morris Ave  
Summit, NJ 07901  
Telephone: 
 
Email:
 
 
Clinical Scientist 
Bristol-Myers Squibb Company 
86 Morris Ave  
Summit, NJ 07901 
Telephone: 
 
Email: 
 
24-hr Emergency Telephone Number
USA: 
International: 
Bristol-Myers Squibb Company
Route 206 & Province Line Road
Lawrenceville, NJ 08543 
Avenue de Finlande 4 
B-1420 Braine-l’Alleud, Belgium
REGULATORY AGENCY IDENTIFIER NUMBER(S) 
IND: 131,993 
EudraCT/EU Trial Number: 2022-000797-26 
NCT Number: NCT05478499 
UTN: U1111-1274-7417 
5.0
Approved
930183774
4.0
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Approved
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
2 
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). 
© 2023 Bristol-Myers Squibb Company 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
3 
DOCUMENT HISTORY 
Document 
Date of Issue 
Summary of Changes 
Protocol 
Amendment 03 
23-May-2023
•
The compound number was added to the title page.
•
The Sponsor contact information was updated from 
•
Text was revised to reflect approval of SOTYKTU™ (deucravacitinib)
 in multiple countries at a dose of 6 mg QD.
•
s-PGA 0/1 at Week 16 was added as a key secondary endpoint.
•
•
The statistical methods were updated to include a description of the
2 populations of interest (Overall Population and the s-PGA Sub-
Population [participants with s-PGA ≥ 3 at baseline]).
•
Added corresponding text on the null hypothesis, multiplicity
assessment, sample size determination analysis set, definition of
estimands, etc for s-PGA 0/1.
•
The following exclusion criterion: “Participants who are not fully
vaccinated against SARS-CoV-2 as defined by the local and current
national guidelines” was made “Not applicable per Protocol
Amendment 03.”
•
Additional details were added to clarify guidance for Investigators to
check and provide counseling to the participants with regard to
vaccinations.
•
•
•
Text was clarified to highlight that “Participants with a positive IGRA
must obtain a chest x-ray.”
•
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
4 
Document 
Date of Issue 
Summary of Changes 
•
•
Table 3.2.3-1 language was updated and streamlined.
•
Details of the external SSC were added.
•
Added the following footnote to Table 2-2: “The Week 1 visit should
not be entered into the IRT system because study intervention is not
dispensed at Week 1.”
•
Added a footnote (similar to already included in Table 2-3) for the
order of assessments.
•
•
•
The following exclusion criterion: “Has donated blood > 500 mL
within 4 weeks prior to Day 1, or plans to donate blood during the
course of the study” was made “Not applicable per Protocol
Amendment 03.”
•
Text was updated to clarify that any planned “major” surgery within
the first 52 weeks will be exclusionary.
•
Removed 1,25-dihydroxy vitamin D3 and analogues from the list of
exclusionary systemic non-biologic medications.
•
The following text: “No concomitant medications (prescription, over-
the-counter, or herbal) are to be administered during the study unless
prescribed for intervention of specific clinical AEs. Any concomitant
therapies must be recorded on the (e)CRF. The Investigator should
contact and confirm agreement with the Medical Monitor or designee
prior to the administration of any concomitant medications.” was
replaced with: “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.”
•
Additional details were added to clarify which assessments are to be
repeated during rescreening.
•
•
Protocol 
Amendment 02 
05-Dec-2022
•
•
The US FDA approval date was added for the study drug
•
Details about completed and ongoing studies were updated
•
Pregnant partner surveillance language was removed
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
5 
Document 
Date of Issue 
Summary of Changes 
•
•
Incorporated language from French specific protocol amendment
•
Clarifying additions/deletions were made throughout the protocol
•
Minor administrative changes were made throughout the protocol
Protocol 
Amendment 01 
19-May-2022
•
•
•
Updated language in the multiplicity adjustment section to reflect the
primary endpoint is included in the hierarchal order.
•
Change of safety endpoint from exploratory to "other” secondary
endpoint.
•
Update to the definition of estimands table for primary and key
secondary endpoints per the estimand guidance document
•
APPENDIX 2 updated with Data Protection, Data Privacy, and Data
Security and Diversity Sections
•
References to BMS-986165 were changed to deucravacitinib
throughout the protocol and in the title
•
PSORIATYK SCALP added to the title
•
Clarifying additions/deletions were made throughout the protocol
•
Minor administrative changes were made throughout the protocol
Original Protocol 
23-Mar-2022
Not applicable 
(e)CRF, electronic case report form; AE, adverse event, 
; BMS, Bristol-Myers Squibb
Company; 
 FDA, Food and Drug Administration; 
 
 IP, investigational product; IRT, interactive response technology;
PE, physical examination; 
; QD, once daily; SARS-CoV-2, severe acute respiratory
syndrome coronavirus 2; s-PGA, static Physician Global Assessment; SSC, Study Steering Committee; TB,
tuberculosis; TYK2, tyrosine kinase 2; US, United States; WHO, World Health Organization.
5.0
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
6 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 03: 
Overall Rationale for Protocol Amendment 03, 19-May-2023 
This protocol has been revised to remove the serology testing requirement for HBV-DNA viral 
load from the screening procedures in the Schedule of Activity table (ie, Screening Procedural 
Outline), the Infectious/Immune-related Exclusions, and the Clinical Laboratory Assessments 
table. 
Additionally, Protocol Amendment 03 defined an additional sub-population for the primary and 
secondary analyses to demonstrate deucravacitinib efficacy in the sub-population of participants 
with s-PGA ≥ 3. 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Title Page 
•
The compound number was added to the
title page.
•
This change was made to reflect
the Sponsor’s protocol template.
Title Page 
•
The Sponsor contact information for the
medical monitor was updated from
•
This change was made to reflect
changes in the study personnel.
Section 1 
Protocol Summary 
Section 3.1 
Study Rationale 
Section 3.2.1 
Clinical Development 
Section 3.2.5 
Benefit Assessment 
Section 5.5  
Justification for Dose 
•
Text was revised to reflect approval of
SOTYKTU™ (deucravacitinib)
 in multiple countries.
•
Text was revised to reflect approval of
SOTYKTU™ (deucravacitinib) 
 in multiple countries at a dose
of 6 mg QD.
•
This revision was made to reflect
approval of deucravacitinib 
 in additional
countries beyond the US.
•
To highlight that the 6 mg QD
dose of deucravacitinib is now
approved 
in multiple countries.
Section 1 
Protocol Summary 
Section 4 
Objectives and 
Endpoints 
(Table 4-1) 
Throughout 
•
s-PGA 0/1 at Week 16 was added as a
key secondary endpoint.
•
The text was updated in multiple sections.
•
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
7 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & 
Title 
Description of Change 
Brief Rationale 
•
The text throughout the protocol
was updated to reflect this
change.
Section 10 
Statistical 
Considerations 
Throughout 
•
An additional sub-population was defined
for the primary and secondary analyses.
Due to additional hypothesis tests within
each endpoint using 2 analysis
populations, new multiplicity adjustment
method was employed. Sample sizes and
their corresponding powers are
reassessed. for each study endpoint for
the additional population.
•
The statistical methods were updated to
include a description of the 2 populations
of interest (Overall Population and the s-
PGA Sub-Population [participants with s-
PGA ≥ 3 at baseline]).
•
Added corresponding text on the null
hypothesis, multiplicity assessment,
sample size determination analysis set,
definition of estimands, etc for s-PGA
0/1.
•
The text was updated in multiple sections.
•
•
To provide additional
description of the analyses that
would be performed for sub-
population of participants with s-
PGA ≥ 3 at baseline
•
The text throughout the protocol
was updated to reflect this
change.
Section 6.2 
Exclusion Criteria 
•
The following exclusion criterion:
“Participants who are not fully vaccinated
against SARS-CoV-2 as defined by the
local and current national guidelines” was
made “Not applicable per Protocol
Amendment 03.”
•
To minimize barriers for
participant enrollment, this
exclusion criteria was made “Not
applicable per Protocol
Amendment 03.”.
Section 2 
Schedule of Activities 
(Table 2-1) 
•
Additional details were added to clarify
guidance for Investigators to check and
provide counseling to the participants
with regard to vaccinations as follows:
Investigators are encouraged to check
whether participants have had preventive
health measures such as cancer screening
(eg, Pap smear, colonoscopy,
mammograms) and are up-to-date with
recommended vaccinations according to
local guidelines (eg, influenza, herpes
zoster, SARS-CoV-2).
•
To clarify and provide guidance
for Investigators to counsel
participants with regard to
vaccinations.
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
8 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Section 2 
Schedule of Activities 
(Table 2-2) 
Section 9.8 
Biomarkers 
•
Section 2 
Schedule of Activities 
(Table 2-1) 
 
 
  
Section 12 
 
 
•
•
•
•
•
•
To provide detailed information
for Investigators to perform
adequate assessment of
participants’ risk for TB.
Section 6.2 
Exclusion Criteria 
•
Text was clarified to highlight that
“Participants with a positive IGRA must
obtain a chest x-ray.”
•
Section 2 
Schedule of Activities 
(Table 2-1) 
Section 6.2 
•
HBV DNA viral load was removed as a
required test at screening.
•
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
9 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Exclusion Criteria 
 
 
 
  
Section 12 Appendices 
APPENDIX 6 
HEPATITIS B VIRUS 
(HBV) SCREENING 
•
Additionally, a new appendix
(APPENDIX 6) providing detailed HBV
screening approach was added.
 
 
 
 
 
 
 
•
To provide detailed instructions
for HBV screening.
Section 1 
Protocol Summary 
Section 4 
Objectives and 
Endpoints 
(Table 4-1) 
•
 Similar changes were
made to the text describing the safety
analyses.
•
Any abnormal PE finding during
the study will be recorded as an
AE/SAE, which is an already a
safety endpoint
Section 3.2.3 
Risk Assessment 
(Table 3.2.3-1) 
•
Table 3.2.3-1 language was updated and
streamlined.
•
Given the SOTYKTU™ FDA
approval in the US and the
updated IB version, this section
was updated and streamlined for
this Phase 4 study.
Section 1 
Protocol Summary 
Section 5.1.6 
Data Monitoring 
Committee and Other 
Committees 
•
Details of the external SSC were added.
•
To provide the description and
the roles of the SSC in the
protocol.
Section 2 
Schedule of Activities 
(Table 2-2) 
•
Added the following footnote: “The
Week 1 visit should not be entered into
the IRT system because study
intervention is not dispensed at Week 1.”
•
This revision was made to
clarify the IRT system
procedures.
Section 2 
Schedule of Activities 
(Table 2-2) 
•
Added a footnote (similar to already
included in Table 2-3) for the order of
assessments.
•
This revision made for
consistency throughout the
document.
Section 2 
Schedule of Activities 
(Table 2-2 and 
Table 2-3) 
•
All references to “health outcomes” were
revised to “patient-reported outcomes”
(PRO).
•
To have consistent language
throughout the protocol.
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
10 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Section 6.2 
Exclusion Criteria 
•
•
Section 6.2 
Exclusion Criteria 
•
The following exclusion criterion: “Has
donated blood > 500 mL within 4 weeks
prior to Day 1, or plans to donate blood
during the course of the study” was made
“Not applicable per Protocol
Amendment 03.”
•
To minimize the participant
burden in this Phase 3b/4 study
this exclusion criteria was made
“Not applicable per Protocol
Amendment 03.”.
Section 6.2 
Exclusion Criteria 
•
Text was updated to clarify that any
planned “major” surgery within the first
52 weeks will be exclusionary.
•
To optimize participant
enrollment and to minimize the
participant burden in this
Phase 3b/4 study.
Section 6.2  
Exclusion Criteria 
•
Removed 1,25-dihydroxy vitamin D3 and
analogues from the list of exclusionary
systemic non-biologic medications.
•
To reduce participant burden and
optimize enrollment this
prohibited medication/exclusion
criteria was removed.
Section 7.7.1 
Prohibited and/or 
Restricted Interventions 
Section 7.7.2 
Permitted Concomitant 
Medications  
•
The following text: “No concomitant
medications (prescription, over-the-
counter, or herbal) are to be administered
during the study unless prescribed for
intervention of specific clinical AEs. Any
concomitant therapies must be recorded
on the (e)CRF. The Investigator should
contact and confirm agreement with the
Medical Monitor or designee prior to the
administration of any concomitant
medications.” was replaced with:
“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.”
•
This requirement was removed
from this Phase 4 study to
minimize participant and
Investigator burden.
•
Provided clarification to
streamline administration and
capturing concomitant
medications during the study on
the eCRF.
Section 6.4.1 
Retesting During the 
Screening Period 
•
Additional details were added to clarify
which assessments are to be repeated
during rescreening.
•
To minimize participant burden
and optimize enrollment.
Section 7.8 
Continued Access to 
Study Intervention 
•
The following paragraph was removed:
“BMS reserves the right to terminate
access to BMS-supplied study
intervention if any of the following occur:
•
This paragraph was not
applicable to this Phase 4 study.
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
11 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & 
Title 
Description of Change 
Brief Rationale 
After the End of the 
Study 
a) the study is terminated due to safety
concerns; b) the development of
deucravacitinib is terminated for other
reasons, including but not limited to lack
of efficacy and/or not meeting the study
objectives; c) the participant can obtain
medication from a government sponsored
or private health program. In all cases
BMS will follow local regulations.”
All 
•
Minor administrative changes and
clarifying edits were made throughout the
protocol.
•
Minor edits were made to
improve overall readability,
consistency, and to streamline
this phase 4 Study protocol
following the FDA approval of
SOTYKTU™.
(e)CRF, electronic case report form; AE, adverse event; BMS, Bristol-Myers Squibb Company; DNA,
deoxyribonucleic acid; FDA, Food and Drug Administration; 
 IB, Investigator’s Brochure; IGRA,
interferon gamma release assay; IP, investigational product; IRT, interactive response technology; PE, physical
examination; 
 QD, once daily; SAE, serious adverse event; SARS-CoV-2, severe acute 
respiratory syndrome coronavirus 2; s-PGA, static Physician Global Assessment; SSC, Study Steering Committee;
TB, tuberculosis; TYK2, tyrosine kinase 2; US, United States; WHO, World Health Organization.
5.0
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930183774
4.0
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Approved
1.0
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
12 
TABLE OF CONTENTS 
TITLE PAGE 
......................................................................................................................1 
DOCUMENT HISTORY .................................................................................................................3 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 03: ...............................................6 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 03 ...................................6 
TABLE OF CONTENTS ...............................................................................................................12 
1 
PROTOCOL SUMMARY ..........................................................................................15 
2 
SCHEDULE OF ACTIVITIES ..................................................................................22 
3 
INTRODUCTION ......................................................................................................34 
3.1 
Study Rationale ...........................................................................................................35 
3.2 
Background .................................................................................................................36 
3.2.1 
Clinical Development .................................................................................................37 
3.2.2 
Benefit/Risk Assessment ..............................................................................................37 
3.2.3 
Risk Assessment ..........................................................................................................38 
3.2.4 
SARS-CoV-2 Pandemic-related Risk Assessment .......................................................39 
3.2.5 
Benefit Assessment ......................................................................................................39 
3.2.6 
Overall Benefit/Risk Conclusion .................................................................................40 
4 
OBJECTIVES AND ENDPOINTS ............................................................................40 
5 
STUDY DESIGN .......................................................................................................42 
5.1 
Overall Design ............................................................................................................42 
5.1.1 
Screening Period ........................................................................................................42 
5.1.2 
Intervention Period .....................................................................................................43 
5.1.3 
Week 16 .......................................................................................................................43 
5.1.4 
Week 20 .......................................................................................................................43 
5.1.5 
Week 52 and Safety Follow-up Period .......................................................................43 
5.1.6 
Data Monitoring Committee and Other Committees ..................................................44 
5.2 
Number of Participants ...............................................................................................44 
5.3 
End of Study Definition ..............................................................................................44 
5.4 
Scientific Rationale for Study Design ........................................................................45 
5.5 
Justification for Dose ..................................................................................................45 
6 
STUDY POPULATION .............................................................................................45 
6.1 
Inclusion Criteria ........................................................................................................46 
6.2 
Exclusion Criteria .......................................................................................................47 
6.3 
Lifestyle Restrictions ..................................................................................................52 
6.3.1 
Meals and Dietary Restrictions ..................................................................................52 
6.3.2 
Caffeine, Alcohol, and Tobacco ..................................................................................52 
6.3.3 
Activity ........................................................................................................................52 
6.4 
Screen Failures ............................................................................................................52 
6.4.1 
Retesting During the Screening Period ......................................................................53 
7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ........................53 
7.1 
Study Interventions Administered ..............................................................................54 
7.2 
Method of Study Intervention Assignment .................................................................54 
7.3 
Blinding ......................................................................................................................55 
7.3.1 
Maintaining the Blind .................................................................................................55 
7.3.2 
Circumstances for Unblinding ....................................................................................55 
7.4 
Dosage Modification ..................................................................................................56 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
13 
7.5 
Preparation/Handling/Storage/Accountability ............................................................56 
7.6 
Treatment Compliance ................................................................................................57 
7.7 
Concomitant Therapy .................................................................................................57 
7.7.1 
Prohibited and/or Restricted Interventions ................................................................57 
7.7.2 
Permitted Concomitant Medications ..........................................................................58 
 
58 
7.7.4 
Permitted Vaccines (including COVID-19 Vaccine) ..................................................59 
7.8 
Continued Access to Study Intervention After the End of the Study .........................59 
8 
DISCONTINUATION CRITERIA ............................................................................59 
8.1 
Discontinuation from Study Intervention ...................................................................59 
8.1.1 
Temporary Discontinuation from Study Intervention .................................................60 
8.1.2 
Post-Study Intervention Study Follow-up ...................................................................61 
8.2 
Discontinuation From the Study .................................................................................61 
8.2.1 
Individual Discontinuation Criteria ...........................................................................61 
8.3 
Lost to Follow-up .......................................................................................................62 
9 
STUDY ASSESSMENTS AND PROCEDURES ......................................................62 
9.1 
Efficacy Assessments .................................................................................................63 
9.1.1 
Investigator-Administered Assessments ......................................................................63 
 
64 
9.2 
Adverse Events ...........................................................................................................66 
 
66 
9.2.2 
Time Period and Frequency for Collecting AE and SAE Information .......................66 
9.2.3 
Method of Detecting AEs and SAEs ............................................................................67 
9.2.4 
Follow-up of AEs and SAEs ........................................................................................67 
9.2.5 
Regulatory Reporting Requirements for SAEs ...........................................................67 
9.2.6 
Pregnancy ...................................................................................................................68 
9.2.7 
Laboratory Test Result Abnormalities ........................................................................68 
9.2.8 
Potential Drug-induced Liver Injury (DILI) ...............................................................69 
9.2.9 
Other Safety Considerations .......................................................................................69 
9.3 
Overdose .....................................................................................................................69 
9.4 
Safety ..........................................................................................................................70 
9.4.1 
Physical Examinations ................................................................................................70 
9.4.2 
Vital Signs ...................................................................................................................70 
9.4.3 
Electrocardiograms ....................................................................................................70 
 
70 
 
71 
 
72 
 
72 
9.5 
Pharmacokinetics ........................................................................................................73 
 
73 
9.6 
Immunogenicity Assessments ....................................................................................73 
9.7 
Genetics ......................................................................................................................73 
9.8 
Biomarkers ..................................................................................................................73 
9.9 
Additional Research ....................................................................................................73 
9.10 
Health Economics OR Medical Resource Utilization and Health Economics ...........74 
10 
STATISTICAL CONSIDERATIONS .......................................................................74 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
14 
10.1 
Statistical Hypotheses .................................................................................................74 
10.1.1 
Multiplicity Adjustment ...............................................................................................75 
10.2 
Sample Size Determination ........................................................................................76 
10.3 
Analysis Sets ...............................................................................................................78 
10.4 
Statistical Analyses .....................................................................................................79 
10.4.1 
General Considerations ..............................................................................................80 
10.4.2 
Primary Endpoints ......................................................................................................83 
10.4.3 
Secondary Endpoints ..................................................................................................84 
 
85 
10.4.5 
Safety Analysis ............................................................................................................85 
10.4.6 
Other Analyses ............................................................................................................85 
10.4.7 
Interim Analyses .........................................................................................................85 
10.5 
Week 16 Primary Analysis .........................................................................................85 
11 
REFERENCES ...........................................................................................................86 
12 
APPENDICES ............................................................................................................89 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS .............................................90 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ......................................94 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING ............................105 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................109 
 
 
 
 
113 
APPENDIX 6 
HEPATITIS B VIRUS (HBV) SCREENING .........................................115 
APPENDIX 7 
PROTOCOL AMENDMENT SUMMARY OF CHANGE 
HISTORY ................................................................................................116 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
15 
1 
PROTOCOL SUMMARY 
Protocol Title: 
A Phase 3b/4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The 
Efficacy and Safety of Deucravacitinib in Participants with Moderate-To-Severe Scalp Psoriasis 
(Psoriatyk Scalp) 
Brief Title: Efficacy and safety of deucravacitinib versus placebo in participants with 
moderate-to-severe scalp 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. These approvals 
were based on the results of the 52-week, randomized, Phase 3, placebo-controlled studies of 
deucravacitinib 6 mg daily versus placebo and apremilast 30 mg twice daily (BID) (POETYK 
PSO-1 and PSO-2). 
In these 2 studies, in addition to the co-primary endpoints, scalp psoriasis was assessed using the 
scalp-specific Physician Global Assessment (ss-PGA) 0/1 and Psoriasis Scalp Severity Index 
(PSSI) 90 scores. For the purposes of the analyses in both of these studies, the scalp response 
assessment only included participants with a ss-PGA score ≥ 3 (moderate-to-severe scalp 
psoriasis) at baseline. Approximately 64% of participants in the Phase 3 studies met this criterion. 
Significantly higher ss-PGA 0/1 responses were seen in participants in the deucravacitinib arm as 
compared to those in the placebo and apremilast arms at Week 16 in POETYK PSO-1 (70.8% vs 
17.4% vs 39.1% respectively) and POETYK PSO-2 (60.3% vs 17.3% vs 37.3% respectively). 
66.5% of participants on deucravacitinib maintained a ss-PGA 0/1 response at Week 52 in 
POETYK PSO-1. Additionally, significantly higher PSSI 90 responses were seen in the 
deucravacitinib arm compared with apremilast arm through Week 24 both in POETYK PSO-1 
(61.2% vs 29.1% respectively) and POETYK PSO-2 (48.9% vs 28.9% respectively). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Approved
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
16 
. Additional analyses, including formal 
statistical hypothesis testing, will also be performed in the participant sub-population with static 
Physician Global Assessment (s-PGA) ≥ 3 at baseline for s-PGA 0/1 response at Week 16 to 
demonstrate 
 
 
 
 
 
 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
•
To compare the efficacy, as measured by ss-PGA
0/1, of deucravacitinib versus placebo at Week 16:
o
in participants with moderate-to-severe scalp
plaque psoriasis
o
in the sub-population of participants with a s-
PGA ≥ 3 at baseline
•
ss-PGA 0/1 response as a proportion of participants
with an ss-PGA 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 PSSI 90
response, of deucravacitinib versus placebo at
Week 16:
o
in participants with moderate-to-severe scalp
plaque psoriasis
o
in the sub-population of participants with a s-
PGA ≥ 3 at baseline
•
PSSI 90 response as a proportion of participants who
achieve at least 90% improvement from baseline in
the PSSI score at Week 16
•
To compare the efficacy, as measured by scalp-
specific itch NRS score, of deucravacitinib versus
placebo at Week 16:
o
in participants with moderate-to-severe scalp
plaque psoriasis
o
in the sub-population of participants with a s-
PGA ≥ 3 at baseline
•
Change from baseline in scalp-specific 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 the sub-population of participants with a s-
PGA ≥ 3 at baseline
•
s-PGA 0/1 response as a proportion of participants
with an 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 moderate-to-severe
scalp plaque psoriasis between Week 0 and Week
16
•
AEs, SAEs, laboratory parameters, and VS between
Week 0 and Week 16
5.0
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
17 
Objectives 
Endpoints 
Selected Exploratory 
AE, adverse event; 
 
 
 PE, physical examination; 
; 
 
 
 SAE, serious adverse event; Scalpdex, scalp 
dermatitis-specific quality of life instrument; 
 
 
 VS, vital signs. 
Overall Design: 
This is a 52-week, Phase 3b/4, multicenter, randomized, double-blind, placebo-controlled study 
comparing the efficacy and safety of deucravacitinib versus placebo in participants with 
moderate-to-severe scalp psoriasis. Participants will undergo screening evaluations within 28 days 
prior to administration of study intervention to determine eligibility. Following the screening 
process, approximately 150 participants will be randomized in a 2:1 ratio to either deucravacitinib 
6 mg once daily (QD) or placebo, respectively. 
 
 
 
 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
18 
 It is anticipated that 95% (n=143) of the 150 randomized participants will have 
s-PGA ≥ 3 at baseline.
The duration of study participation is approximately 60 weeks and will be divided into the 
following periods: Screening (up to 4 weeks), Intervention (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 and Investigators remain blinded 
to double-blind, placebo-controlled period study intervention until the end of the study. 
 
 
 
 
Participants will be followed up for safety for 4 additional weeks, from Week 52 through Week 56. 
Participants who discontinue study intervention early/withdraw prematurely must complete the 
End of Treatment 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 or adverse events 
experienced during this time. 
Number of Participants: 
It is estimated that approximately 220 enrolled participants will be required to achieve 
150 randomized. Approximately 150 participants will be randomized in a 2:1 ratio to 
deucravacitinib 6 mg QD or placebo matching deucravacitinib QD, respectively. Sample size 
considerations are described in the Sample Size Determination section. 
Study Population: 
Men and women ≥ 18 years of age diagnosed with stable plaque psoriasis ≥ 6 months (defined as 
no morphology changes or significant flares of disease activity in the opinion of the Investigator) 
with moderate-to-severe scalp psoriasis (ss-PGA ≥ 3, PSSI ≥ 12, and SSA ≥ 20%), BSA ≥ 3%, 
and who are candidates for phototherapy or systemic therapy will be eligible to participate in the 
study. 
Intervention Groups and Duration: 
Participants in both intervention groups will take oral doses of one of the investigational 
[medicinal] product (IP/IMP), 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.  
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
19 
Study Intervention: 
Study Intervention for IM011220 
Arm Name  
Deucravacitinib 
(BMS-986165) 
Placebo 
Intervention Name 
Deucravacitinib 
(BMS-986165) 
Placebo  
Type 
Drug 
Drug 
Dose Formulation 
Tablet 
Placebo tablet  
Unit Dose Strength 
6 mg 
n/a 
Dosage Level(s) 
1 active tablet QD in the morning 
1 placebo tablet 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. 
AxMP, auxiliary medicinal products; IMP, investigational medicinal product; n/a, not applicable; 
NIMP, non-investigational medicinal product; QD, once daily.  
 
Statistical Methods: 
There are 2 population groups of interest in this study. The Overall Population consists of all 
participants who were randomized to any treatment arm. The s-PGA ≥ 3 Sub-Population consists 
of all participants who were randomized to any treatment arm in the study with s-PGA ≥ 3 at 
baseline. 
Two types of multiplicity adjustment are implemented to ensure that the family-wise Type I error 
rate is controlled to be no more than 2-sided 5% in the study. 
• Union-Intersection principle between the 2 populations and corresponding hypotheses within 
each endpoint. 
• Hierarchical gatekeeping procedure for the primary and secondary endpoints and associated 
hypotheses. 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
20 
The 2 primary hypotheses will be tested simultaneously with a significance level (alpha) of 0.05 
(2‑sided). If either of the test results is not statistically significant (ie, at least one of null hypotheses 
is not rejected), then it is deemed that the study objective is not met. Key secondary endpoints will 
be tested in a hierarchical order only if the primary endpoint achieved statistical significance at the 
2-sided 0.05 level on both the Overall Population and the s-PGA ≥ 3 Sub-Population. A
hierarchical test may proceed to the next key secondary endpoint only if both null hypotheses
within a key secondary endpoint are rejected.
The analysis model for the primary efficacy endpoint and secondary binary endpoint will use 
stratified Cochran-Mantel-Haenszel tests 
 
 
 to compare the response rates of deucravacitinib 6 mg QD to placebo. If expected cell 
counts are not sufficient for each strata level, then strata levels will be combined for the analysis. 
Non-responder imputation will be used for binary endpoints for participants who discontinue early 
or who have otherwise missing endpoint data at the specified timepoint. 
The analysis model for the continuous secondary endpoint will use analysis of covariance 
(ANCOVA) with study intervention and 
 
 
 The baseline value will be added into the model as a covariate. 
Intervention differences based on least-squares means and the corresponding 2-sided 95% 
confidence intervals will be provided for the difference between deucravacitinib 6 mg QD and 
placebo. 
For the continuous secondary efficacy endpoint, multiple imputation will be used for missing data. 
The primary analysis at Week 16 will occur once all randomized participants have completed their 
Week 16 visit or have discontinued prior to Week 16. Analyses of the collected efficacy and safety 
data through Week 16 will be performed. A final analysis will be performed after all participants 
complete the final safety follow-up visit at Week 56 or post-discontinuation follow-up visit. 
Data Monitoring Committee and Other Committees: 
A Data Monitoring Committee will not be used in the study. This study will use an external Study 
Steering Committee.  
Brief Summary: 
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in 
participants with moderate-to-severe scalp psoriasis. The study will also compare the efficacy and 
safety of deucravacitinib to placebo in participants with moderate-to-severe plaque psoriasis 
. This will be a multicenter, randomized, double-blind, placebo-controlled 
study.  
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
21 
The study will compare improvement in scalp psoriasis in participants treated with deucravacitinib 
to those treated with placebo during the first 16 weeks. This improvement is defined as ss-PGA 
0/1 score and will be assessed at Week 16. The primary hypotheses are that the odds of achieving 
a ss-PGA 0/1 score with at least a 2-point reduction from baseline at Week 16 in participants 
receiving deucravacitinib 6 mg QD are improved compared to participants receiving placebo in 
both the Overall Population and the s-PGA ≥ 3 Sub-Population. In addition, PSSI 90 response, 
improvement in scalp itching, and the proportion of participants with s-PGA ≥ 3 at baseline who 
achieve s-PGA 0/1 at Week 16 will also be assessed. Similar assessments for improvement and 
maintenance of scalp psoriasis treatment response will be performed at Week 52. 
The duration of study participation is approximately 60 weeks and will be divided into the 
following periods: Screening (up to 4 weeks), Intervention (52 weeks), and Follow-up (4 weeks). 
Following the initial Screening 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 will be randomized on Day 1 in a 2:1 ratio to receive either deucravacitinib 6 mg QD or 
placebo, respectively, for the first 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 and Investigators will remain blinded to the double-blind study intervention until the 
end of the study. 
At Week 20 and at any of the subsequent study visits, a participant with insufficient treatment 
response may be treated with rescue topical medications/shampoos at the discretion of the 
Investigator, which may be continued through the end of study.  
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
22 
2 
SCHEDULE OF ACTIVITIES 
Schedules of activities and procedures are documented in Table 2-1 for the Screening Visit, Table 2-2 for Day 1 through Week 20, and 
Table 2-3 for Week 24 through Week 52. 
Table 2-1: 
Screening Procedural Outline (IM011220) 
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 and documentation of presence of plaque psoriasis with 
scalp involvement by the Investigator. 
Medical History 
X 
 
 
 
 
 
 
 
 
 
History of Tobacco Use 
X 
Include description of current tobacco use. 
Psoriasis-Related History 
X 
Includes scalp symptoms, PsA, history of other forms of psoriasis. 
Psoriasis-Related Systemic 
Intervention 
X 
History of conventional systemic (eg, methotrexate), biologic, and/or phototherapy. For each 
therapy, include length of time on intervention and reason(s) for discontinuation (eg, lack of 
efficacy, intolerance, side effects, loss of access to intervention), if applicable. 
Other Prior and Concomitant 
Interventions 
X 
Includes topical interventions and shampoos for psoriasis and all medications for other 
conditions such as cardiovascular disorders and mood disorder. 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
23 
Table 2-1: 
Screening Procedural Outline (IM011220) 
Procedure 
Screening Visit  
(Day –28 to Day –1) 
Notes 
 
Safety Assessments 
PE 
X 
Complete PE 
Physical Measurements  
X 
Includes height, weight, and BMI.  
VS 
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 would be collected.  
Laboratory Tests 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
24 
Table 2-1: 
Screening Procedural Outline (IM011220) 
Procedure 
Screening Visit  
(Day –28 to Day –1) 
Notes 
TSH 
X 
Abnormal TSH will be exclusionary. If TSH above normal reference range, test free T4; if 
TSH below normal range, test free T4 and T3 (see Section 6.2). 
Pregnancy test (serum) 
X 
For WOCBP only; see APPENDIX 4 
Serum (minimum sensitivity equivalent units 25 IU/L or equivalent units 
of hCG) to be done at Screening Visit. 
The participant must be excluded from participation if the serum pregnancy result is 
positive. 
FSH 
X 
If needed to document post-menopausal status, as defined in Section 9.4. 
Females under the age of 55 years must have a serum FSH level > 40 mIU/mL to 
confirm menopause. 
AE Reporting 
Monitor for SAEs 
X 
All 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. All AE (SAEs or nonserious AE) related to SARS-CoV-2 infection 
collected from time of consent. 
Clinical Efficacy Assessments 
ss-PGA 
X 
SSA 
X 
PSSI 
X 
BSA 
X 
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; BSA, body surface area; ECG, electrocardiogram; 
FSH, follicle-stimulating hormone; 
; 
; hCG, human 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
25 
chorionic gonadotropin; 
; 
; IRT, interactive response technology; LDH, lactate dehydrogenase; 
MDR/RR-TB, multidrug/rifampicin-resistant tuberculosis; PASI, Psoriasis Area and Severity Index; PE, physical examination; PHQ-8, 8-item Patient Health 
Questionnaire; PsA, psoriatic arthritis; PSSI, Psoriasis Scalp Severity Index; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome 
coronavirus 2; ss-PGA, scalp-specific Physician Global Assessment; SSA, scalp surface area; T3, triiodothyronine; T4, thyroxine; 
 
TSH, thyroid-stimulating hormone; ULN, upper limit of normal; V, visit; VS, vital signs; WHO, World Health Organization; WOCBP, women of childbearing 
potential. 
* - WHO global lists of high burden countries for TB, TB/HIV, and MDR/RR-TB, 2021–2025; APPENDIX 5. 
 
 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
26 
Table 2-2: 
On-Intervention Procedural Outline (IM011220), Day 1 through Week 20 
Procedure 
Visit 1 
(Day 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 
 
Body Weight 
X 
 
 
 
 
 
 
 
 
VS 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication Use  
X 
X 
X 
X 
X 
X 
X 
X 
 
AE Reporting  
Monitor for AEs and 
SAEs 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory Tests 
Hematology 
X 
 
 
X 
X 
X 
X 
X 
 
Chemistry Panel  
X 
 
 
X 
X 
X 
X 
X 
 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
27 
Table 2-2: 
On-Intervention Procedural Outline (IM011220), Day 1 through Week 20 
Procedure 
Visit 1 
(Day 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 
Urinalysis  
X 
 
 
 
 
 
X 
 
 
Pregnancy Test 
(Urine)  
X 
 
 
X 
X 
X 
X 
X 
WOCBP only 
Clinical Efficacy Assessments 
ss-PGA 
X 
X 
X 
X 
X 
X 
X 
X 
 
SSA 
X 
 
 
 
 
 
 
 
 
PSSI 
X 
X 
X 
X 
X 
X 
X 
X 
 
BSA 
X 
X 
X 
X 
X 
X 
X 
X 
 
s-PGA 
X 
X 
X 
X 
X 
X 
X 
X 
 
PASI 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
28 
Table 2-2: 
On-Intervention Procedural Outline (IM011220), Day 1 through Week 20 
Procedure 
Visit 1 
(Day 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 
Interventiona 
X 
 
X 
X 
X 
X 
X 
X 
 
Study Intervention 
Compliance 
 
X 
X 
X 
X 
X 
X 
X 
 
AE, adverse event; BSA, body surface area; d, days; D, day; 
 
 
 IP, investigational product; IRT, interactive response technology; 
; PASI, Psoriasis 
Area and Severity Index; PE, physical examination; PHQ-8, 8-item Patient Health Questionnaire; PRO, patient-reported outcome; 
 
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Clinical Protocol 
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BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
29 
 PSSI, Psoriasis Scalp Severity Index; SAE, serious adverse event; Scalpdex, Scalp dermatitis-specific quality of life 
instrument; s-PGA, static Physician Global Assessment; ss-PGA, scalp-specific Physician Global Assessment; SSA, scalp surface area; V, visit; WOCBP, women 
of childbearing potential. 
a The Week 1 visit should not be entered into the IRT system because study intervention is not dispensed at Week 1. 
Note: When multiple assessments are conducted at a single visit, the following is the order in which they should be done as applicable: 
1) 
 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests (eg, safety laboratory tests). The dose of the IP on a visit day is to be taken after blood draws for laboratory tests. 
 
 
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Clinical Protocol 
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BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
30 
Table 2-3: 
On-Intervention Procedural Outline, (IM011220) Week 24 through Week 52 
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 
 
 
VS 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication Use  
X 
X 
X 
X 
X 
X 
 
AE Reporting  
Monitor for AEs and 
SAEs 
X 
X 
X 
X 
X 
X 
 
Laboratory Tests 
Hematology 
X 
X 
X 
X 
X 
X 
 
Chemistry Panel  
X 
X 
X 
X 
X 
X 
 
Pregnancy Test 
(Urine)  
X 
X 
X 
X 
X 
X 
WOCBP only 
 
French participants only: 
WOCBP only Between 
visit windows, at weeks 
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
31 
Table 2-3: 
On-Intervention Procedural Outline, (IM011220) Week 24 through Week 52 
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 
36, 44, and 48, an at 
home urine pregnancy 
test will be performed. 
Participants will provide 
the results by phone. See 
Section 9.2.6. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
Clinical Efficacy Assessments 
ss-PGA 
X 
X 
X 
X 
X 
 
 
PSSI 
X 
X 
X 
X 
X 
 
 
BSA 
X 
X 
X 
X 
X 
 
 
s-PGA 
X 
X 
X 
X 
X 
 
 
PASI 
X 
X 
X 
X 
X 
 
 
 
 
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Table 2-3: 
On-Intervention Procedural Outline, (IM011220) Week 24 through Week 52 
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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Table 2-3: 
On-Intervention Procedural Outline, (IM011220) Week 24 through Week 52 
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 
 
 
AE, adverse event; BSA, body surface area; d, days; D, Day; 
 EOT, End of Treatment; ET, early termination; 
 
 
 IP, investigational product; IRT, interactive response technology; 
 PASI, Psoriasis Area and Severity Index; PE, physical examination; PRO, patient-reported outcome; 
 
 PSSI, Psoriasis Scalp Severity Index; SAE, serious adverse event; Scalpdex, Scalp dermatitis-specific quality of life 
instrument; s-PGA, static Physician Global Assessment; ss-PGA, scalp-specific Physician Global Assessment; WOCBP, women of childbearing potential. 
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 days ± 3 days after the last dose of study treatment. 
Note: When multiple assessments are conducted at a single visit, the following is the order in which they should be done as applicable: 
1) 
 
2) Safety assessments (eg, vitals, AEs) 
3) Clinical efficacy assessments 
4) Laboratory tests (eg, safety laboratory tests). The dose of the IP on a visit day is to be taken after blood draws for laboratory tests. 
 
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3 
INTRODUCTION 
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.1,2 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. 3, 4, 5 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.3 Psoriasis can involve skin 
in any part of the body; particularly disabling is the involvement of specific anatomic regions, such 
as hands and feet (palmoplantar), face, scalp, and nails. The scalp is the most commonly affected 
region of the body in psoriasis, involved in about 80% of psoriasis cases. 6 Scalp psoriasis 
represents one of the “special sites,” given its difficult-to-treat nature and disproportionate impact 
on quality of life (QoL). Psoriasis in general has a profound impact on QoL and can lead to 
psychological, social, and economic consequences, especially in moderate-to-severe disease.7,8 
Additionally, scalp disease in particular is associated with pain, itching, and bleeding. It has been 
shown to be associated with a disproportionate impact on QoL with significant impact on 
psychosocial impairment. Effective management of scalp psoriasis is essential to improving a 
participant’s QoL.6 The presence of hair and unacceptable cosmetic appeal of topical therapy are 
barriers to compliance and satisfaction with the currently available topical interventions. Topical 
regimens can be complex and are highly dependent on participant preference. Additionally, some 
participants with severe scalp disease may have minimal body involvement and, hence, may not 
receive systemic therapy indicated for moderate-to-severe chronic plaque psoriasis.6,9,10 
Interventions 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; and systemic therapies. In moderate-to-severe disease, systemic 
interventions are usually needed and may include oral agents (retinoids, methotrexate, 
cyclosporine, and apremilast) or injectables (eg, biologics such as tumor necrosis factor [TNF] 
inhibitors etanercept, infliximab, and adalimumab) anti-interleukin (IL)-12/23p40 antibody 
(ustekinumab), IL-17 antagonists (secukinumab, ixekizumab, and brodalumab), and anti-IL-23p19 
antibody (guselkumab, tildrakizumab and risankizumab). Many of these interventions are 
associated with increased risk of adverse events (AEs) such as hepatotoxicity and neutropenia 
(methotrexate); 11  nephrotoxicity (cyclosporine); 12  depression and weight loss (apremilast); 13 
serious infections (cytokine inhibitors); 14 , 15 , 16 , 17  candidiasis and Crohn’s disease (IL-17 
antagonists).17,18,19 
Although effective therapeutic options are available, undertreatment or nontreatment of psoriasis 
has been reported in up to half of surveyed participants (based on absence of intervention and/or 
dissatisfaction with intervention).20 Only guselkumab, secukinumab, and apremilast have efficacy 
data for scalp psoriasis included in their Food and Drug Administration (FDA) label.13,17,21 Scalp 
psoriasis presents considerable intervention challenges for the patient and practitioner. Psoriasis 
of this site also contributes to a significant burden on patient QoL.6 
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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. 
These approvals were based on the results of completed 52-week, randomized, Phase 3, 
placebo-controlled studies of deucravacitinib 6 mg daily (BMS-986165) versus placebo and 
apremilast 30 mg twice daily (BID) (POETYK PSO-1 and PSO-2). 
In these 2 studies, in addition to the co-primary endpoints, scalp psoriasis was assessed using the 
scalp-specific Physician Global Assessment (ss-PGA) 0/1 and Psoriasis Scalp Severity Index 
(PSSI) 90 scores. For the purposes of the analyses in both studies, the scalp response assessment 
only included participants with a 
 (moderate-to-severe scalp psoriasis) 
 
. Approximately 64% of participants in the Phase 3 studies met this criterion. Significantly 
higher ss-PGA 0/1 responses were seen in participants in the deucravacitinib arm as compared to 
those in the placebo and apremilast arms at Week 16 in both POETYK PSO-1 (70.8% vs 17.4% 
vs 39.1%, respectively) and POETYK PSO-2 (60.3% vs 17.3% vs 37.3%, respectively). 
Furthermore, deucravacitinib was also superior to apremilast at Week 24 in both studies (72.2% 
vs 42.7% and 59.7% vs 41.6%, respectively). 66.5% of participants on deucravacitinib maintained 
a ss-PGA 0/1 response at Week 52 in POETYK PSO-1. Additionally, significantly higher PSSI 90 
responses were seen in the deucravacitinib arm as compared to apremilast through Week 24 in 
both POETYK PSO-1 (61.2% vs 29.1% respectively) and POETYK PSO-2 (48.9% vs 28.9%, 
respectively). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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This Phase 3b/4 study is designed to evaluate the efficacy and safety of deucravacitinib in 
participants with moderate-to-severe scalp psoriasis. The primary hypothesis for the study is that 
the odds of achieving ss-PGA 0/1 with at least a 2-point reduction from baseline at Week 16 in 
participants receiving deucravacitinib 6 mg QD are improved compared to participants receiving 
placebo. The ss-PGA 0/1 is a standard measure in clinical trials of demonstrating efficacy of 
systemic psoriasis interventions. Additional analyses, including formal statistical hypothesis 
testing, will also be performed in the participant sub-population with static Physician Global 
Assessment (s-PGA) ≥ 3 at baseline for s-PGA 0/1 response at Week 16 to 
 
   
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. 
Deucravacitinib is a potent, highly selective, oral, small molecule inhibitor of TYK2. A 
comprehensive in vitro and in vivo characterization of deucravacitinib has been established and 
supports the development of this compound in humans. Inhibition of TYK2 is expected to provide 
therapeutic benefit for participants with psoriasis for multiple reasons: 1) Many of the pathways 
in the TYK2 signaling cascade (IL-23 and the downstream mediators IL-17 and IL-22; IFNα) have 
been implicated in pathogenesis of psoriasis).8 Biologic agents targeting the IL-17, IL-23p19, and 
IL-12/23 p40 pathways have been approved for and are highly efficacious in the intervention of 
psoriasis. Further, it is conceivable that participants with psoriasis could sustain a durable 
therapeutic response after repeated dosing with deucravacitinib. A recent trial using only a single 
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dose of a monoclonal antibody targeting the IL-23p19 subunit resulted in a rapid and sustained 
response for up to 66 weeks in participants with moderate-to-severe psoriasis.25 
A detailed description of the chemistry, pharmacology, efficacy, and safety of deucravacitinib is 
provided in the Investigator’s Brochure (IB).26  
3.2.1 
Clinical Development  
The clinical development program for deucravacitinib consists of multiple studies in healthy 
volunteers, participants with renal or hepatic insufficiency, and participants with psoriasis, 
alopecia areata, psoriatic arthritis, systemic lupus erythematosus, lupus nephritis, Crohn’s disease, 
and ulcerative colitis. 
In adult participants with moderate-to-severe psoriasis, 1 Phase 2 study (IM011011) and 2 Phase 3 
studies (IM011046 and IM011047) have been completed. Study IM011011 was a 12-week, 
randomized, placebo-controlled study conducted with 5 deucravacitinib intervention arms ranging 
from 3 mg every other day to 12 mg QD. Studies IM011046 and IM011047 were pivotal, double-
blind, placebo- and active-controlled 52-week, Phase 3 studies. Based on these studies, 
SOTYKTU™ (deucravacitinib), a first-in-class, oral, selective, allosteric TYK2 inhibitor was 
approved in multiple countries for the treatment of adults with moderate-to-severe plaque psoriasis 
who are candidates for systemic therapy or phototherapy.  
There are 2 other completed Phase 3 studies for adult participants with moderate-to-severe plaque 
psoriasis (IM011065 and IM011066) and an ongoing long-term extension study (IM011075). 
IM011065 is a double-blind, placebo-controlled, 52-week study conducted in China, Singapore, 
South Korea, and Taiwan; IM011066 is a single-arm, open-label study conducted in Japan; 
IM011075 is an open-label study to evaluate the long-term safety, tolerability, and efficacy of 
deucravacitinib in participants with psoriasis who were previously enrolled in an applicable parent 
study (IM011046, IM011047, IM011065, or IM011066). 
The clinical pharmacology profile of deucravacitinib has been characterized based on the results 
of multiple clinical pharmacology studies as well as population pharmacokinetics (PK) and 
exposure-response analyses that incorporated data from Phase 1, Phase 2, and Phase 3 studies in 
adult participants with moderate-to-severe psoriasis. 
A detailed description is provided in the deucravacitinib IB.26 
3.2.2 
Benefit/Risk Assessment  
More detailed information about the known and expected benefits and risks and reasonably 
anticipated adverse events (AEs) of deucravacitinib may be found in the IB.26 
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3.2.3 
Risk Assessment 
Table 3.2.3-1: 
Risk Assessments 
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. 
IB, Investigator’s Brochure; ICF, informed consent form; TYK2, tyrosine kinase 2. 
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3.2.4 
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 
Company (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 IB 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 IP (Section 8.1.1 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 AEs 
(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 prior to enrollment and to inform decisions about 
participant care during the study should follow local standard practice and requirements. 
3.2.5 
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 (IM011046 and IM011047) 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 
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and apremilast. Significantly higher ss-PGA 0/1 responses were seen with deucravacitinib versus 
placebo and apremilast arms at Week 16 in POETYK PSO-and POETYK PSO-2. Furthermore, 
deucravacitinib was also superior to apremilast at Week 24 in both studies. Additionally, 
significantly higher PSSI 90 responses were seen with deucravacitinib versus apremilast through 
Week 24 in POETYK PSO-1 and POETYK PSO-2. 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‑glucoronosyltransferase (UGT) 
enzymes, cytochrome P450s (CYPs), or drug transporters. Details are described in the 
deucravacitinib IB.26 
 
 
 
 
 
 
 
 
 
3.2.6 
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 
deucravacitinib as an oral intervention for adult participants with moderate-to-severe scalp plaque 
psoriasis. 
4 
OBJECTIVES AND ENDPOINTS 
Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
• 
To compare the efficacy, as measured by ss-PGA 
0/1, of deucravacitinib versus placebo at Week 16:  
o 
in participants with moderate-to-severe scalp 
plaque psoriasis  
o 
in the sub-population of participants with a 
s-PGA ≥ 3 at baseline  
• 
ss-PGA 0/1 response as a proportion of participants 
with an ss-PGA score of 0 (clear) or 1 (almost clear) 
with at least a 2-point reduction from baseline at 
Week 16 
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Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Key Secondary 
• 
To compare the efficacy, as measured by PSSI 90 
response, of deucravacitinib versus placebo at 
Week 16: 
o 
in participants with moderate-to-severe scalp 
plaque psoriasis  
o 
in the sub-population of participants with a 
s-PGA ≥ 3 at baseline  
• 
PSSI 90 response as a proportion of participants who 
achieve at least 90% improvement from baseline in 
the PSSI score at Week 16 
• 
To compare the efficacy, as measured by 
scalp-specific itch NRS score, of deucravacitinib 
versus placebo at Week 16: 
o 
in participants with moderate-to-severe scalp 
plaque psoriasis  
o 
in the sub-population of participants with a 
s-PGA ≥ 3 at baseline  
• 
Change from baseline in scalp-specific 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 the sub-population of participants with a s-PGA 
≥ 3 at baseline  
• 
s-PGA 0/1 response as a proportion of participants 
with an 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 moderate-to-severe 
scalp plaque psoriasis between Week 0 and 
Week 16 
• 
AEs, SAEs, laboratory parameters, and VS between 
Week 0 and Week 16 
Selected Exploratory 
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Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
AE, adverse event; 
 NRS, Numerical Rating Scale; 
 
 
 
 
 s-PGA, static Physician Global Assessment; 
 
 VS, vital signs. 
 
5 
STUDY DESIGN 
5.1 
Overall Design 
This study (IM011220) is a 52-week, Phase 3b/4, multicenter, randomized, double-blind, placebo-
controlled study comparing the efficacy and safety of deucravacitinib versus placebo in 
participants with moderate-to-severe scalp psoriasis. A total of approximately 150 qualified 
participants with moderate-to-severe scalp plaque psoriasis will be randomized (see Section 10.2). 
It is anticipated that 95% (n=143) of the 150 randomized participants will have s-PGA ≥ 3 at 
baseline. 
The duration of study participation is approximately 60 weeks and will be divided into the 
following periods: Screening (up to 4 weeks), Intervention (52 weeks), and Safety follow-up 
(4 weeks). 
Physical examination (PE), clinical laboratory evaluations, and other assessments will be done at 
select visits during the study. Participants in this study will be monitored for AEs. 
5.1.1 
Screening Period  
Participants will be evaluated during the screening period (up to 4 weeks/ 28 days) to ensure they 
meet eligibility criteria. A detailed medical history will be done at this time, as well as a complete 
PE. Psoriasis-related history, which will include length of diagnosis, BSA involvement, scalp 
involvement, SSA involvement, and history of systemic intervention, will be assessed at 
Screening. 
 An evaluation for TB 
will be done based on medical history, recent chest imaging 
 
  
If a participant exceeds the 28-day screening period due to a study-related procedure (eg, waiting 
for a study-related laboratory value), the participant must be reconsented. A new participant 
identification number will be assigned by interactive response technology (IRT) at the time of re-
enrollment. In this situation, the fewest number of procedures from the initial screening should be 
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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). 
5.1.2 
Intervention Period 
Participants who have completed the screening procedures and have met the inclusion/exclusion 
criteria will be randomized on Day 1 in a 2:1 ratio to either deucravacitinib 6 mg QD or placebo, 
respectively.  
Dummy tablets (placebo to deucravacitinib 6 mg tablets) will be administered to participants to 
maintain blinding. Additional details are provided in Section 7.1.  
 
 
 
 
 
 
5.1.3 
Week 16 
All efficacy endpoints and safety will be assessed at Week 16. At Week 16, all participants, 
regardless of their blinded intervention, will be switched to open-label deucravacitinib 6 mg QD 
bottles through Week 52. 
5.1.4 
Week 20 
 
 
 
5.1.5 
Week 52 and Safety Follow-up Period 
The safety follow-up period is a 28-day window after the Week 52 visit. The participant will be 
encouraged to report any SAEs or AEs experienced during this time. 
The End of Treatment (EOT) visit will be completed for participants who discontinue study 
intervention early. The participant will be asked to return to the clinic to complete the 28-day safety 
follow-up visit. 
The study design schematic is presented in Figure 5.1.5-1. 
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Figure 5.1.5-1: 
Study Design Schema 
 
PBO, placebo; QD, once daily. 
 
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 
External Study Steering Committee (SSC) 
The 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. 
5.2 
Number of Participants 
It is estimated that approximately 220 enrolled participants will be required to achieve 
150 randomized. Approximately 150 participants will be randomized in a 2:1 ratio to 
deucravacitinib 6 mg QD or placebo matching deucravacitinib QD, respectively.
 
 
 Sample size considerations 
are described in Section 10.2. It is anticipated that 95% (n=143) of the 150 randomized participants 
will have s-PGA ≥ 3 at baseline. 
5.3 
End of Study Definition 
The duration of study participation for individual participants is expected to be up to 60 weeks 
(420 days), which includes Screening (up to 4 weeks), intervention (52 weeks), and follow-up (up 
to 4 weeks) periods. 
The start of the study is defined as the first visit for the first participant screened. 
The end of study is defined as the last participant last visit or scheduled procedure shown in the 
Schedule of Activities (Section 2) for the last participant.  
Study completion is defined as the final date on which data were or are expected to be collected if 
this is not the same.  
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Protocol Amendment 03 
Date: 23-May-2023 
45 
5.4 
Scientific Rationale for Study Design 
This Phase 3b/4 study will be conducted in a population of participants with stable 
moderate -to -severe scalp plaque psoriasis who are candidates for systemic psoriasis therapy. The 
study is designed to compare the efficacy and safety of deucravacitinib to placebo in achieving ss-
PGA of 0/1 at Week 16. The ss-PGA 0/1 is a standard measure in clinical trials of demonstrating 
efficacy of systemic psoriasis interventions. Additional analyses, including formal statistical 
hypothesis testing, will also be performed in the participant sub-population with s-PGA ≥ 3 at 
baseline for s-PGA 0/1 response at Week 16 to 
. s-PGA 0/1 is 
a standard measure in clinical trials of demonstrating efficacy of systemic psoriasis interventions. 
A placebo arm is included in this study for a short duration of 16 weeks to provide a control for 
the natural fluctuation of psoriasis activity that may occur and to provide a safety standard for 
comparison. Participants in the placebo arm will be switched to deucravacitinib at Week 16 to 
provide them with psoriasis intervention after the endpoints are collected. Week 16 was chosen 
for the primary endpoint evaluations, as it will allow enough time for deucravacitinib to treat 
psoriasis and is the endpoint used in preceding psoriasis Phase 3 studies. The purpose of doing a 
52-week study is to demonstrate the maintenance of improvement in PROs and clinical response. 
5.5 
Justification for Dose 
The dose of 6 mg QD is the approved dose by health authorities in multiple countries for the 
treatment of adults with moderate-to-severe plaque psoriasis. The recommended dose for 
deucravacitinib in the current study aims to achieve similar exposure level to that of 6 mg QD used 
in the Phase 3 studies in adult psoriasis participants, which is based on the efficacy and safety 
results from the Phase 2, placebo-controlled, dose-ranging study of this compound in adult 
participants with moderate-to-severe plaque psoriasis (IM011011). The results from the 2 Phase 3 
studies demonstrated that deucravacitinib at 6 mg QD achieved significantly higher PASI 75 
responses compared with placebo at Week 16 and significantly higher ss-PGA 0/1 and PSSI 90 
responses in a subset of participants with moderate-to-severe scalp psoriasis. 
6 
STUDY POPULATION 
Eligibility criteria for this study have been carefully considered to ensure: 1) selection of 
appropriate participants with scalp psoriasis, 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. 
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Date: 23-May-2023 
46 
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 
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 
a) Men and women diagnosed with stable plaque psoriasis with scalp involvement for 
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) Deemed by the Investigator to be a candidate for phototherapy or systemic therapy 
c) Moderate-to-severe scalp psoriasis as defined by ss-PGA ≥ 3; ≥ 20% SSA; PSSI ≥ 12 at 
the Screening Visit and Day 1 
d) ≥ 3% of BSA involvement at the Screening Visit and Day 1 
e) Evidence of plaque psoriasis in a non-scalp area 
f) Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis 
3) Age of Participant  
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 relationship to 
the first dose of study intervention. 
Local laws and regulations may require the use of alternative and/or additional contraception 
methods. 
a) Female Participants:  
i) Women who are not of childbearing potential (as defined in APPENDIX 4) are exempt 
from contraceptive requirements. 
ii) WOCBP must have a negative highly sensitive serum pregnancy test at 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 located 
in Section 2 (Schedule of Activities). 
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Date: 23-May-2023 
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• The Investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
iii) WOCBP must agree to follow instructions for method(s) of contraception defined in 
and as described below and included in the ICF. 
iv) WOCBP are permitted to use hormonal contraception methods (as described in 
APPENDIX 4) 
v) 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 
(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 with regard to contraception (if 
any); however, no specific 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 nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced 
psoriasis) at Screening or Day 1 
2) Reproductive Status 
a) Women who are pregnant 
b) Women who are breastfeeding 
c) Women who are lactating 
d) Women who are 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 intervention 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) Not applicable per Protocol Amendment 03: Participants who are not fully vaccinated 
against SARS-CoV-2 as defined by the local and current national guidelines  
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Clinical Protocol 
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Protocol Amendment 03 
Date: 23-May-2023 
48 
g) 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 intervention 
h) Receipt of any non-live vaccine within 30 days prior to Day 1 including any COVID-19 
vaccine (first, second or booster dose) 
i) Presence of herpes zoster lesions at Screening or Day 1 
j) History of serious herpes zoster or serious herpes simplex infection which includes, but is 
not limited to, any episode of disseminated herpes simplex, multi-dermatomal herpes 
zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (recurrent is 
defined as 2 episodes within 2 years) 
k) Evidence of, or test positive for, hepatitis B virus at Screening. Positive hepatitis B lab 
testing is defined as (please see APPENDIX 6 for details): 
i) Positive hepatitis B surface antigen (HBsAg+) 
OR 
ii) Not applicable per Protocol Amendment 03: Presence of hepatitis B virus 
deoxyribonucleic acid 
OR 
iii) Positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface 
antibody (HBcAb+ and HBsAb−) 
l) Evidence of, or test positive for, hepatitis C virus (HCV) at Screening. A positive test for 
HCV is defined as: 1) positive for hepatitis C antibody (anti-HCVAb) AND 2) positive via 
a confirmatory test for HCV (eg, HCV polymerase chain reaction) 
m) Positive for human immunodeficiency virus by antibody testing (HIV-1 and -2 antibody) 
at Screening 
n) 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) 
o) 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 trial physician, there are no 
sequelae that would place the participant at a higher risk of receiving investigational 
intervention. 
4) Any of the following tuberculosis (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.  
 
 
 
 
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Clinical Protocol 
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BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
49 
5) Medical History and Concurrent Diseases 
a) Any major surgery within 8 weeks prior to Day 1, or any planned major surgery for the 
first 52 weeks of the study 
b) Not applicable per Protocol Amendment 03: Has donated blood > 500 mL within 
4 weeks prior to Day1, or plans to donate blood during the course of the study 
c) Drug or alcohol abuse, as determined by the Investigator, within 6 months prior to Day 1 
d) Medical marijuana or prescription marijuana taken for medicinal reasons 
e) Any major illness/condition or evidence of an unstable clinical condition (eg, renal, 
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, 
immunologic, or local active infection/infectious illness) that, in the Investigator’s 
judgment or after consultation with the Medical Monitor or designee, will substantially 
increase the risk to the participant if he or she participates in the study 
f) Unstable cardiovascular disease, defined as a recent clinical cardiovascular event 
(eg, unstable angina, myocardial infarction, stroke, rapid atrial fibrillation) in the last 
5.0
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Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
50 
3 months prior to Screening, or a cardiac hospitalization (eg, revascularization procedure, 
pacemaker implantation) within 3 months prior to Screening 
g) Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) 
> 160 mm Hg or diastolic BP > 100 mm Hg 
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 
h) Class III or IV congestive heart failure by New York Heart Association criteria 
i) Has cancer or history of cancer (solid organ or hematologic including myelodysplastic 
syndrome) or lymphoproliferative disease within the previous 5 years (other than resected 
cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has 
been treated with no evidence of recurrence) 
j) 
 
 
 
 
  
 
 
k) 
 
 
l) If the participant has received biologics previously, the following exclusion criteria for 
washout will apply: 
i) Antibodies to IL-12, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, 
ixekizumab, or 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 
m) Has received systemic non-biologic 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 
n) Has used leflunomide within 6 months prior to Day 1 
o) Has used opioid analgesics within 4 weeks prior to Day 1 
p) Has received lithium, antimalarials, or intramuscular (IM) gold within 4 weeks of the first 
administration of any study medication 
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Protocol Amendment 03 
Date: 23-May-2023 
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q) Has received phototherapy (including either oral and topical psoralen plus ultraviolet A 
light therapy, ultraviolet B or self-intervention with tanning beds or therapeutic sunbathing) 
within 4 weeks prior to Day 1 
r) Has used topical medications/interventions that could affect psoriasis evaluation 
(including, but not limited to, high potency corticosteroids (World Health Organization 
[WHO] Classes I to V), > 3% salicylic acid, urea, alpha- or beta-hydroxyl acids, anthralin, 
calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, 
trimethylpsoralens, pimecrolimus, and tacrolimus) and intralesional corticosteroids within 
2 weeks prior to Day 1 
 
 
 
 
 
s) Use of shampoos that contain corticosteroids, coal tar, > 3% salicylic acid, or vitamin D3 
analogues within 2 weeks prior to Day 1 
t) 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 
u) 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 < 3000/mm3 
ii) Absolute lymphocyte count < 500/mm3 
iii) Absolute neutrophil count < 1000/mm3 
iv) Platelet count < 100,000/mm3 
v) Hemoglobin < 9 g/dL 
vi) ALT and/or AST > 3 × upper limit of normal (ULN) 
vii) Total, unconjugated, and/or conjugated bilirubin > 2 × ULN 
viii) Thyroid-stimulating hormone (TSH) outside the normal range 
AND 
Free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range 
b) ECG abnormalities that are considered clinically significant and would pose an 
unacceptable risk to the participant if participating in the study 
c) Inability to be venipunctured and/or tolerate venous access 
d) Any other significant laboratory abnormalities that, in the opinion of the Investigator, 
might place the participant at unacceptable risk for participation in this study 
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deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
52 
7) Allergies and Adverse Drug Reaction 
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 and only in countries where local regulations permit, a person who has been 
imprisoned may be included or permitted to continue as a participant. Strict conditions 
apply, and BMS approval is required.) 
b) Participants who are compulsorily detained for intervention of either a psychiatric or 
physical (eg, infectious disease) illness 
c) Inability to comply with restrictions and prohibited activities/interventions as listed in the 
study protocol 
d) Participation in another clinical trial concurrent with this study. 
 
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; 
 
 
6.3.2 
Caffeine, Alcohol, and Tobacco 
No restrictions are required; however, extensive use of caffeine, alcohol, tobacco, and vaping 
should be avoided. 
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 publishing 
requirements, as applicable, and to respond to queries from regulatory authorities. Minimal 
information includes date of consent, demography, screen failure details, eligibility criteria, and 
any serious AEs. 
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deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
53 
6.4.1 
Retesting During the Screening Period 
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, 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 rescreening, 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 chest imaging, if performed during screening, may not be required. 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. 
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 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, or used for an unauthorized indication, or when used to gain further 
information about the authorized form. 
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered as non-
IP. 
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54 
7.1 
Study Interventions Administered 
The selection and timing of dose for each participant is presented in Table 7.1-1. 
Table 7.1-1: 
Study Interventions 
Arm Name 
Deucravacitinib 
(BMS-986165) 
Placebo 
Intervention name 
Deucravacitinib  
(BMS-986165) 
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. 
AxMP, auxiliary medicinal products; n/a, not applicable; IMP, investigational medicinal product; 
NIMP, non-investigational medicinal product; QD, once daily.  
 
7.2 
Method of Study Intervention Assignment 
Before the study is initiated, each user (at investigative sites) will receive log-in 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 
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. 
At Day 1, participants who meet all criteria for enrollment 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. 
 
 
 
5.0
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Protocol Amendment 03 
Date: 23-May-2023 
55 
After all inclusion/exclusion criteria have been met for a participant, the investigative site will 
access the IRT on Day 1 for the purpose of randomizing a participant. An intervention group will 
be assigned by IRT based on the above-described randomization schedule. In addition, a unique 
kit number will be assigned to the participant corresponding to the intervention assignment. 
Study intervention will be dispensed at study visits as shown in the Schedule of Activities 
(Section 2). When new intervention 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, 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 intervention 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 
intervention, as shown in Table 7.1-1. Investigative site staff, Sponsor and designee personnel, and 
participants and their families will remain blinded to intervention assignments. 
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. 
The primary analysis database lock will occur after all randomized participants completed their 
Week 16 visit or discontinued prior to Week 16. The study participants and Investigators will 
remain blinded to the initial treatment assignment throughout the study. 
7.3.2 
Circumstances for Unblinding 
Blinding of study treatment assignment is critical to the integrity of this clinical study. However, 
in the event of a medical emergency or pregnancy in an individual participant in which knowledge 
of the IP is critical to the participant’s management, the blind for that participant may be broken 
by the Investigator. The participant’s safety takes priority over any other considerations in 
determining if a treatment assignment should be unblinded. 
Before breaking the blind of an individual participant’s treatment, the Investigator should 
determine that the unblinded information is necessary (ie, that it will alter the participant’s 
immediate management). In many cases, particularly when the emergency is clearly not related to 
the IP, the problem may be properly managed by assuming that the participant is receiving the IP. 
It is highly desirable that the decision to unblind treatment assignment be discussed with the 
Medical Monitor or designee, 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 
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deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
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should only call in for 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 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. 
 In cases of accidental unblinding, contact the Medical Monitor or designee, and ensure every 
attempt is made to minimize additional disclosure and the impact of unblinding. 
Any request to unblind a participant for nonemergency purposes should be discussed with the 
Medical Monitor. 
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 intervention. If a participant interrupts 
intervention due to an AE, study intervention can be restarted in consultation with the Medical 
Monitor or designee. 
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 the 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 BMS. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention 
should not be dispensed, and BMS should be contacted immediately. 
Study intervention not supplied by BMS will be stored in accordance with the package insert. 
IP documentation (whether supplied by BMS or not) must be maintained that includes all processes 
required to ensure the drug is accurately administered. This includes documentation of drug 
storage, administration and, as applicable, storage temperatures, reconstitution, and use of required 
processes (eg, required diluents, administration sets). 
• The Investigator or designee must confirm that the appropriate temperature conditions have 
been maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention. 
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• The Investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records). 
• Further guidance and information for the final disposition of unused study interventions are 
provided in the Study Reference Manual. 
 
7.6 
Treatment Compliance 
When participants self-administer study intervention(s) at home, compliance with study 
intervention will be assessed at each visit. Compliance will be assessed by direct questioning, 
counting returned tablets/capsules, etc, during the site visits and documented in the source 
documents and relevant form. Deviation(s) from the prescribed dosage regimen should be recorded 
in the eCRF. 
A record of the quantity of deucravacitinib/placebo 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 eCRF. 
7.7 
Concomitant Therapy 
7.7.1 
Prohibited and/or Restricted Interventions 
Prohibited and/or restricted medications taken during the study are described below. 
• Exposure to any investigational drug, investigational vaccine, or placebo outside of the current 
study. Specifically, participants currently in other interventional trials for COVID-19, 
including investigational COVID-19 vaccination trials that are not authorized or approved by 
relevant Health Authorities, should not participate in BMS clinical trials. 
• Use of any medications/therapies that would aggravate psoriasis. These include agents such as 
lithium, antimalarials (quinacrine, chloroquine, and hydroxychloroquine), propranolol, 
indomethacin, and quinidine unless it is considered necessary for the participant’s welfare 
and/or intervention of an AE/SAE 
• Use of opioid analgesics unless it is considered necessary for the participant’s welfare and/or 
treatment of an AE/SAE 
• Phototherapy; use of tanning booths or therapeutic sunbathing 
• Any use of biologic medications (eg, adalimumab, etanercept, infliximab, ustekinumab). 
• Any use of oral psoriasis medications (eg, apremilast, methotrexate, cyclosporine, retinoids, 
fumaric acid derivatives) for any indication. 
• Any use of oral or injectable corticosteroids (prednisone, methylprednisolone, etc), unless it is 
considered necessary for the participant’s welfare and/or intervention of an AE/SAE. 
Note: optic, ophthalmic, nasal, and inhaled corticosteroids within recommended doses and 
with no systemic effects are permitted. 
• Any topical medications/interventions, which are used for any indication, that could affect 
psoriasis evaluation (including, but not limited to, high potency corticosteroids [WHO Classes 
I to V], > 3% salicylic acid, urea, alpha- or beta-hydroxy acids, anthralin, calcipotriene, vitamin 
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D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, pimecrolimus, and 
tacrolimus) and intralesional corticosteroids. 
Exception: The following topical interventions may be initiated at Week 20 and at any of the 
subsequent study visits per Investigator’s discretion in participants who have ss-PGA ≥ 3 or 
s-PGA ≥ 3 (see Section 7.7): High potency corticosteroids (Classes I to V) 
 
 
 
 
 
• Any medicated shampoos that contain corticosteroids, coal tar, > 3% salicylic acid, or vitamin 
D3 analogues 
Exception: The shampoos that contain corticosteroids may be initiated at Week 20 and at any 
of the subsequent study visits per Investigator’s discretion in participants who have ss-PGA 
scores ≥ 3 (Section 7.7). 
• Live attenuated vaccines (including, but not limited to, any live attenuated COVID-19 
vaccines) should not be used during the study, including the safety follow-up period of 60 days 
following last dose of IP (see Section 7.7.4 for permitted vaccines). 
 
7.7.2 
Permitted Concomitant Medications 
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 meet 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. 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. 
 
 
 
 
 
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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 is unknown. The following are examples of non-live vaccines: inactivated 
vaccines (eg, heat-killed and formalin-killed vaccines), subunit vaccines (eg, influenza and 
pneumococcal vaccines), toxoid vaccines, nucleic acid vaccines that do not encode potentially 
infectious 
virus 
(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 enrollment. 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 concomitant medication page. For COVID-19 
vaccines administered prior to enrollment, the types, details, and dates should be also recorded on 
the appropriate eCRF page.  
Please contact the Medical Monitor or designee with any questions related to COVID-19 vaccines. 
7.8 
Continued Access to Study Intervention After the End of the Study 
At the end of the study, BMS will not continue to provide BMS-supplied study intervention to 
participants/Investigators unless BMS chooses to extend the study. The Investigator should ensure 
that participant receives appropriate standard of care to treat the condition under study. 
8 
DISCONTINUATION CRITERIA 
8.1 
Discontinuation from Study Intervention 
Participants MUST discontinue IP/IMP for any of the following reasons: 
• Participant’s request to stop study intervention. Participants who request to discontinue study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by the participant 
to provide this information 
• Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of the 
Investigator, indicates that continued participation in the study is not in the best interest of the 
participant  
• Termination of the study by BMS 
• Loss of ability to freely provide consent through imprisonment or involuntary incarceration for 
treatment of either a psychiatric or physical (eg, infectious disease) illness. (Note: Under 
specific circumstances and only in countries where local regulations permit, a participant who 
has been imprisoned may be permitted to continue as a participant. Strict conditions apply, and 
BMS approval is required.) 
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• Abnormal liver tests suggestive of drug-induced liver injury (DILI), as defined in Section 9.2.8 
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 
non-melanoma 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 9.2.6). 
• 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. 
• Participant reports suicidal ideation, suicidal behavior, or suicide attempts at any time after 
inclusion. The participant should then be immediately referred to a mental health professional 
for evaluation of suicide risk. 
 
Refer to the Schedule of Activities (Section 2) for data to be collected at the time of intervention 
discontinuation and follow-up and for any further evaluations that can be completed. 
In the case of pregnancy, the Investigator must immediately, within 24 hours of awareness of the 
pregnancy, notify the BMS Medical Monitor/designee of this event. The study treatment will be 
permanently discontinued. See Section 8. 
All participants who discontinue study intervention should comply with protocol-specified 
follow-up procedures as outlined in Section 2. 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 
intervention 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 eCRF 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 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. 
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Temporary interruption of study intervention may be considered in the event of SARS-CoV-2 
vaccination according to local guidelines. In order to facilitate reporting of SARS-CoV-2 events 
that occur during the study, all AEs and SAEs related to SARS-CoV-2 must be reported from the 
time of consent. In addition, AEs or SAEs will trigger additional data collection through dedicated 
eCRF pages, which will allow the Sponsor to further evaluate these events.  
Any temporary study intervention discontinuation as well as restart must be documented in the 
corresponding eCRF. 
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 8.2 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 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 intervention with study intervention 
only or also from study procedures and/or post-treatment study follow-up, and entered on the 
appropriate eCRF 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 
for data to be collected at the time of study discontinuation and follow-up and for any further 
evaluations that need to be completed. 
• The participant will be permanently discontinued both from the study intervention and from 
the study at that time. 
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• If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
 
8.3 
Lost to Follow-up 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant. 
• Lost to follow-up is defined by the inability to reach the participant after a minimum of 
3 documented phone calls, faxes, or emails, as well as lack of response by participant to one (1) 
registered mail letter. All attempts should be documented in the participant’s medical records. 
• If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death. 
• If the Investigator’s use of third-party representative to assist in the follow-up portion of the 
study has been included in the participant’s informed consent, then the Investigator may use a 
Sponsor-retained third-party representative to assist site staff with obtaining the participant’s 
contact information or other public vital status data necessary to complete the follow-up 
portion of the study. 
• The site staff and representative will consult publicly available sources, such as public health 
registries and databases, in order to obtain updated contact information. 
• If, after all attempts, the participant remains lost to follow-up, then the last known alive date 
as determined by the Investigator should be reported and documented in the participant’s 
medical records. 
 
9 
STUDY ASSESSMENTS AND PROCEDURES 
• 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). 
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• 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. 
 
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 
Investigator-Administered Assessments 
9.1.1.1 
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.27 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. 
9.1.1.2 
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).28 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 
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physician (dermatologist) or appropriately trained Investigator who is experienced in the 
assessment of psoriasis patients. 
9.1.1.3 
Body Surface Area (BSA) 
Measurement of psoriasis BSA involvement is estimated using the handprint method with the size 
of a participant’s handprint (including fingers and thumb) representing 1% of BSA 
involved.29,30,31 The total BSA = 100% with breakdown by body region as follows: head and neck 
= 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin 
= 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). All BSA 
assessments should be performed by a dermatologist or appropriately trained Investigator who is 
experienced in the assessment of psoriasis patients. 
9.1.1.4 
Scalp-Specific Physician’s Global Assessment (ss-PGA) 
For this assessment in participants with scalp involvement,32 scalp lesions are evaluated in terms 
of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA 
scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 
4 = severe disease. 
The ss-PGA should be performed by a dermatologist or appropriately trained Investigator who is 
experienced in the assessment of psoriasis patients. 
9.1.1.5 
Psoriasis Scalp Severity Index (PSSI) 
The PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point 
Likert-type scale on the clinical parameters of erythema, induration, and desquamation.33 The 
scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. 
The PSSI score ranges from 0 to 72. The PSSI should be performed by a dermatologist or 
appropriately trained Investigator who is experienced in the assessment of psoriasis patients. 
9.1.1.6 
Scalp Surface Area (SSA) 
Assessment of psoriasis SSA involvement will be estimated by an Investigator at each of the study 
visit as listed in the Schedule of Activities (Section 2). SSA assessment should be performed by a 
dermatologist or appropriately trained Investigator who is experienced in the assessment of 
psoriasis patients. 
 
 
 
 
 
 
 
 
 
 
  
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9.2 
Adverse Events 
The definitions of an AE or SAE can be found in APPENDIX 3. 
AEs will be reported by the participant (or, when appropriate, by a caregiver, or a surrogate, or the 
participant’s legally acceptable representative). 
The Investigator and any qualified designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE and remain responsible for following up 
on AEs that are serious, considered related to the study intervention or the study, or that caused 
the participant to discontinue before completing the study. 
Refer to APPENDIX 3 for SAE reporting. 
9.2.2 
Time Period and Frequency for Collecting AE and SAE Information 
The collection of nonserious AE information should begin at initiation of study intervention until 
discharge from the study (ie, final study visit for a given participant), at the timepoints specified 
in the Schedule of Activities (Section 2). 
Appendix 1 of the IB26 represents the Reference Safety Information to determine expectedness of 
SAEs for expedited reporting.  
All SAEs must be collected from the time of signing the consent, including those thought to be 
associated with protocol-specified procedures, and within 30 days following discontinuation of 
dosing. 
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The Investigator must report any SAE that occurs after these time periods and that is believed to 
be related to study intervention or protocol-specified procedure. 
• Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the appropriate section of the eCRF module. 
• All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as indicated 
in APPENDIX 3. 
• The Investigator will submit any updated SAE data to the Sponsor or designee within 24 hours 
of updated information being available. 
 
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
However, if the Investigator learns of any SAE, including a death, at any time after a participant 
has been discharged from the study, and he/she considers the event reasonably related to the study 
intervention or study participation, the Investigator must promptly notify the Sponsor. 
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in APPENDIX 3. 
9.2.3 
Method of Detecting AEs and SAEs 
AEs can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. Care should be taken not to introduce bias when collecting AEs and/or 
SAEs. Inquiry about specific AEs should be guided by clinical judgment in the context of known 
AEs, when appropriate for the program or protocol. 
9.2.4 
Follow-up of AEs and SAEs 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see APPENDIX 3). 
• Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate. 
• All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the eCRF. Completion of supplemental eCRFs may be requested for AEs and/or laboratory 
abnormalities that are reported/identified during the course of the study. 
 
After the initial AE/SAE report, the Investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs and nonserious 
 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). 
Further information on follow-up procedures is given in APPENDIX 3. 
9.2.5 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the Investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met. 
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• 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 SUSAR (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. 
9.2.6 
Pregnancy 
If, following initiation of the study intervention, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure, including during at least for 
30 days after study product administration, the Investigator must immediately notify the BMS 
Medical Monitor/designee of this event, and complete and forward a Pregnancy Surveillance Form 
to the BMS designee within 24 hours of awareness of the event and in accordance with SAE 
reporting procedures described in APPENDIX 3. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form. Protocol-required procedures for study discontinuation and follow-up must be 
performed on the participant. 
In the event a participant becomes pregnant during the study, the study intervention must be 
discontinued immediately. 
French specific study participants who are WOCBP will utilize urine pregnancy kits so they can 
conduct pregnancy tests at home at Weeks 36, 44, and 48. At-home pregnancy urine hCG test 
testing (WOCBP only) must be done per protocol schedule. Study participants will be instructed 
to communicate the results of the pregnancy tests to the site, with reminders and follow-up from 
the site study team, and pregnancy test results will be documented by the site in study participants’ 
eCRFs. Sites need to obtain and document that the pregnancy test is negative. If at-home urine 
pregnancy test is ambiguous, a serum pregnancy test must be performed and participants should 
be asked to immediately pause taking study intervention until pregnancy status is confirmed. If at-
home urine pregnancy test is positive, the study participant will be discontinued from the study as 
per the protocol discontinuation criteria. If pregnancy testing is not done per protocol schedule, 
the Investigator must contact the Medical Monitor as soon as feasible to discuss the participant’s 
further participation in the study. 
9.2.7 
Laboratory Test Result Abnormalities  
The following laboratory test result abnormalities should be captured on the nonserious AE eCRF 
page or SAE eCRF, as appropriate. Paper forms are only intended as a back-up option when the 
electronic system is not functioning. 
• Any laboratory test result that is clinically significant or meets the definition of an SAE  
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• Any laboratory test result abnormality that required the participant to have study intervention 
discontinued or interrupted 
• Any laboratory test result abnormality that required the participant to receive specific 
corrective therapy 
 
It is expected that, wherever possible, the clinical rather than laboratory term would be used by the 
reporting Investigator (eg, anemia vs low hemoglobin value). 
9.2.8 
Potential Drug-induced Liver Injury (DILI) 
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILIs meeting 
the defined criteria must be reported as SAEs (see Section 9.2.5 and APPENDIX 3 for reporting 
details). 
A potential DILI is defined as:  
1) Aminotransferase (ALT or AST elevation) > 3 × ULN 
AND 
2) Total bilirubin > 2 × ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase) 
AND 
3) No other immediately apparent possible causes of aminotransferase elevation and 
hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute 
liver disease, or the administration of other drug(s) known to be hepatotoxic. 
 
9.2.9 
Other Safety Considerations 
Any significant worsening of conditions noted during interim or final PEs, ECG, x-ray filming, or 
any other potential safety assessment required or not required by the protocol should also be 
recorded as a nonserious AE or SAE, as appropriate, and reported accordingly. 
9.3 
Overdose 
For this study, any dose of deucravacitinib greater than 24 mg within a 24-hour time period will 
be considered an overdose. Overdoses that meet the regulatory definition of SAE will be reported 
as an SAE (see APPENDIX 3). 
In the event of an overdose, the Investigator should: 
1) Contact the Medical Monitor or designee immediately 
2) Closely monitor the participant for AEs/SAEs and laboratory abnormalities for at least 
5 half-lives of deucravacitinib, approximately 3 days 
 
Decisions regarding dose interruptions will be made by the Investigator in consultation with the 
Medical Monitor or designee based on the clinical evaluation of the participant. 
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9.4 
Safety 
Planned timepoints for all safety assessments are listed in the Schedule of Activities (Section 2). 
9.4.1 
Physical Examinations 
A complete PE will include general appearance, VS, eyes, ears, nose, mouth, throat, neck, 
respiratory, cardiovascular, respiratory, gastrointestinal/abdomen, lymphatic, musculoskeletal, 
skin, psychiatric, and neurologic exams. A targeted PE will include any organ system associated 
with an AE or a laboratory abnormality.  
While the targeted PE may not be as comprehensive as the initial full examination, key aspects 
should evaluate important body systems as clinically indicated. These body systems can include 
lymph nodes, liver, spleen, and breast at the discretion of the examiner. A targeted examination 
may note any changes in the participant’s condition (body systems) since the last assessment and 
does not preclude examination of any of the other body systems as clinically indicated. Every 
effort should be made to ensure the same evaluator will complete the examination for each 
participant at all visits throughout the study. Documentation of who performed the examination is 
to be recorded in source notes. 
9.4.2 
Vital Signs 
VS includes (ear or oral) body temperature, respiratory rate, and seated BP and heart rate and will 
be recorded at each visit based on the Schedule of Activities (Section 2). BP and heart rate should 
be measured after the participant has been seated quietly for at least 5 minutes. 
9.4.3 
Electrocardiograms 
A 12-lead ECG will be performed at the Screening Visit indicated in the Schedule of Activities 
(Section 2). 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. 
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9.5 
Pharmacokinetics 
PK parameters will not be evaluated in this study. 
9.6 
Immunogenicity Assessments 
Not applicable. 
9.7 
Genetics 
Not applicable. 
9.8 
Biomarkers 
Biomarkers will not be evaluated in this study. 
9.9 
Additional Research 
This protocol will not include sample collection and/or residual sample storage for additional 
research. 
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9.10 
Health Economics OR Medical Resource Utilization and Health 
Economics 
Health economics/medical resource utilization and health economics parameters will not be 
evaluated in this study. 
10 
STATISTICAL CONSIDERATIONS 
There are 2 population groups of interest in this study: 
• Overall Population: All participants who were randomized to any treatment arm in the study. 
• s-PGA ≥ 3 Sub-Population: All participants who were randomized to any treatment arm in the 
study with s-PGA ≥ 3 at baseline. 
 
The statistical hypotheses associated with the primary endpoint (ss-PGA 0/1) and the secondary 
endpoints (PSSI 90, scalp-specific itch NRS [ss-NRS], and s-PGA 0/1 [s-PGA ≥ 3 Sub-population 
only]), will be formally tested in each population group using the multiplicity adjustment methods 
described in Section 10.1.1. 
10.1 
Statistical Hypotheses 
The primary hypotheses for this study are that the odds of achieving ss-PGA 0/1 with at least a 
2-point reduction from baseline at Week 16 in participants receiving deucravacitinib 6 mg QD are 
improved compared to participants receiving placebo on both the Overall Population and the 
s-PGA ≥ 3 Sub-Population. 
The null hypotheses to be tested for the primary endpoint are the following: 
• The odds of achieving ss-PGA 0/1 with at least a 2-point reduction from baseline at Week 16 
in participants receiving deucravacitinib 6 mg QD are the same as participants receiving 
placebo on the Overall Population. 
• The odds of achieving ss-PGA 0/1 with at least a 2-point reduction from baseline at Week 16 
in participants receiving deucravacitinib 6 mg QD are the same as participants receiving 
placebo on the s-PGA ≥ 3 Sub-Population. 
 
Key secondary endpoints and associated hypotheses will be tested in a hierarchical order only if 
both primary hypotheses achieved statistical significance. The null hypotheses corresponding to 
the key secondary endpoints are described below by population. 
Overall Population: 
• The odds of achieving at least a 90% improvement from baseline in the PSSI score at Week 
16 in participants receiving deucravacitinib 6 mg QD are the same as participants receiving 
placebo. 
• The mean change from baseline in scalp-specific itch NRS at Week 16 in participants receiving 
deucravacitinib 6 mg QD is not different from participants receiving placebo. 
 
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s-PGA ≥ 3 Sub-Population: 
• The odds of achieving at least a 90% improvement from baseline in the PSSI score at Week 16 
in participants receiving deucravacitinib 6 mg QD are the same as participants receiving 
placebo. 
• The mean change from baseline in scalp-specific itch NRS at Week 16 in participants receiving 
deucravacitinib 6 mg QD is not different from participants receiving placebo. 
• The odds of achieving s-PGA 0/1 with at least a 2-point reduction from baseline at Week 16 
in participants receiving deucravacitinib 6 mg QD are the same as participants receiving 
placebo. 
 
10.1.1 
Multiplicity Adjustment 
Two types of multiplicity adjustment are implemented to ensure that the family-wise Type I error 
rate is controlled to be no more than 2-sided 5% in the study 10.1. 
• Union-Intersection principle 41  between the 2 populations and corresponding hypotheses 
within each endpoint. 
• Hierarchical gatekeeping procedure for the primary and secondary endpoints and associated 
hypotheses. 
 
The 2 primary hypotheses will be tested simultaneously with a significance level (alpha) of 0.05 
(2-sided). If either of the test results is not statistically significant (ie, at least one of null hypotheses 
is not rejected), then it is deemed that the study objective is not met. To proceed to the secondary 
hypothesis tests, both primary hypotheses must be met.  
Secondary Family – Key secondary endpoints will be tested in a hierarchical order that presented 
in Figure 10.1.1-1, only if the primary endpoint achieved statistical significance at the 2-sided 
0.05 level on both the Overall Population and the s-PGA ≥ 3 Sub-Population. 
Figure 10.1.1-1 depicts the hierarchical order of hypothesis tests for the primary and secondary 
endpoints implementing the union-intersection principal and hierarchical gatekeeping procedure 
for the secondary hypothesis tests. If both primary hypotheses are satisfied, testing will proceed 
for the key secondary endpoints in a hierarchical order at an alpha level of 0.05. A hierarchical test 
may proceed to the next key secondary endpoint only if both null hypotheses within a key 
secondary endpoint are rejected. If a secondary endpoint fails at any step, then all subsequent 
p-values will be considered descriptive. 
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Figure 10.1.1-1: 
Hierarchical Order of Primary and Secondary Hypothesis Testing 
 
PASI, Psoriasis Area and Severity Index; s-PGA, static Physician Global Assessment; ss-NRS, scalp-specific itch 
numerical rating scale; ss-PGA, scalp-specific Physician Global Assessment. 
 
There will be no multiplicity adjustment for other additional endpoints; however, nominal P-values 
will be provided as descriptive statistics. 
10.2 
Sample Size Determination  
It is estimated that approximately 220 enrolled participants will be required to achieve 
150 randomized. Approximately 150 participants will be randomized in a 2:1 fashion to 
deucravacitinib 6 mg QD or placebo matching deucravacitinib 6 mg QD, respectively. 
Additionally, it is estimated that approximately 95% of randomized subjects (ie, approximately 
143 subjects) would have baseline s-PGA scores ≥ 3. All assumed response rates and averages 
used for the sample size calculation were derived from the Phase 3 BMS studies IM011046 and 
IM011047 data. All sample size estimates were performed using nQuery Advisor version 7.0. 
A total sample size of 150 participants randomized in a blinded fashion in a 2:1 ratio to 
deucravacitinib 6 mg QD and placebo, will provide approximately 95% power based on a 
chi-squared test with Type I error = 0.05, to compare deucravacitinib 6 mg QD to placebo for the 
Key Secondary 3 (α=0.05)
s-PGA 0/1
Sub-Population
Key Secondary 2 (α=0.05)
ss-NRS
Sub-Population
ss-NRS
Overall Population
Key Secondary 1 (α=0.05)
PSSI 90
Sub-Population
PSSI 90
Overall Population
Primary (α=0.05)
ss-PGA 0/1
Sub-Population
ss-PGA 0/1
Overall Population
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primary endpoint, proportion of participants that achieve ss-PGA 0/1 with at least a 2-point 
reduction from baseline at Week 16. Also, a sample size of 143 (sub-population with baseline 
s-PGA ≥ 3) provides approximately 94% power with Type I error = 0.05. This power estimate 
assumes ss-PGA 0/1 response rates of 55% and 25% for deucravacitinib 6 mg QD and placebo, 
respectively. 
The assumed ss-PGA 0/1 response rates of 55% and 25% for deucravacitinib 6 mg QD and 
placebo, respectively, were derived based on a weighted average of response rates such that mild 
plaque psoriasis attributed 30% and moderate/severe plaque psoriasis attributed 70% of the 
population per the study design. The ss-PGA 0/1 response rates at Week 16 (deucravacitinib 6 mg 
QD: 65%, placebo: 20%) from the pooled Phase 3 studies (IM011047 and IM011046) were used 
for the moderate/severe plaque psoriasis and an assumed response rate of 25% in each arm for the 
mild population. With a total of 150 randomized participants (100 deucravacitinib 6 mg QD 
participants and 50 placebo participants), the weighted ss-PGA 0/1 response rates were 
approximately 55% and 25% for deucravacitinib 6 mg QD and placebo, respectively. Given the 
uncertainty in the assumed ss-PGA 0/1 response rates, Table 10.2-1 presents the impact on power 
for other possible response rates; eg, if the placebo rate was as high as 30%, there is still 83% 
power to detect a difference of 25% (OR: 2.852) between deucravacitinib 6 mg QD and placebo 
at an alpha level of 0.05. 
Table 10.2-1: 
Power Calculation for Assumed ss-PGA 0/1 Response Rates with 
Sample Size of 150 
Deucravacitinib 6 mg 
QD 
Placebo 
Difference  
Odds Ratio 
Power at α=0.05 
55% 
25% 
30% 
3.667 
95% 
55% 
30% 
25% 
2.852 
83% 
50% 
25% 
25% 
3.00 
85% 
50% 
30% 
20% 
2.33 
65% 
QD, once daily; ss-PGA, scalp-specific Physician Global Assessment. 
 
The sample size for the study is driven primarily to ensure there is a nominal power of 
approximately 90% for each endpoint including the 3 key secondary endpoints on the Overall 
Population. It is anticipated that 95% (n=143) of the 150 randomized participants will have 
s-PGA ≥ 3 at baseline, and therefore the statistical power is still adequate for the sub-population. 
Table 10.2-2 presents the powers for each endpoint by population at a Type I error rate of 0.05. 
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Table 10.2-2: 
Power Calculation for Each Endpoint by Population 
Variable of Interest 
Assumption: 
Deucravacitinib vs. Placebo 
Sub-Population  
(Baseline s-PGA ≥ 3) 
Overall Population 
n 
Power at 
α=0.05 
n 
Power at 
α=0.05 
Primary 
ss-PGA 0/1 
Response rate of 55% vs. 25% 
143 
94% 
150 
95% 
Key Secondary 
PSSI 90 
Response rate of 40% vs.15% 
143 
88% 
150 
90% 
ss-NRS 
Mean CFB  
-2.0 vs. -0.5 (σ=2.7) 
143 
87% 
150 
89% 
s-PGA 0/1 
50% vs. 10% 
143 
99% 
N/A 
CFB, Change from BL, PSSI, Psoriasis Scalp Severity Index; s-PGA, static Physician Global Assessment; ss-NRS, 
scalp-specific itch numerical rating scale; ss-PGA, scalp-specific Physician Global Assessment 
 
10.3 
Analysis Sets 
For purposes of analysis, the populations and analysis data sets are defined in Table 10.3-1. 
Table 10.3-1: 
Populations and Analysis Data Sets 
Population 
Description 
Enrolled 
All participants who sign informed consent. 
Randomized (FAS) 
All participants who were randomized to any treatment arm in the study. 
Full Analysis Subgroup 
All participants who were randomized to any treatment arm in the study and 
baseline s-PGA ≥ 3. 
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 ss-PGA 0/1 
All randomized participants with baseline s-PGA ≥ 3; 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. 
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. 
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Table 10.3-1: 
Populations and Analysis Data Sets 
Population 
Description 
Analysis set for secondary 
estimand of PSSI 90 
All randomized participants with baseline s-PGA ≥ 3; 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. 
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 Scalp-specific itch 
NRS 
All randomized participants with baseline s-PGA ≥ 3; 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. 
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 secondary 
estimand of s-PGA 0/1 
All randomized participants with baseline s-PGA ≥ 3; 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. 
NRS, numerical rating scale; PSSI, Psoriasis Scalp Severity Index; s-PGA, static Physician Global Assessment; ss-
PGA, scalp-specific Physician Global Assessment. 
 
10.4 
Statistical Analyses 
The statistical analysis plan (SAP) will be developed and finalized before the primary analysis 
database lock and will describe the selection of participants to be included in the analyses, and 
procedures for accounting for missing, unused, and spurious data. Below is a summary of planned 
statistical analyses of the primary and secondary endpoints. A description of the participant 
population will be included in the clinical study report, including subgroups of age, gender, race, 
and other study specific populations and demographic characteristics. A description of participant 
disposition will also be included in the clinical study report. 
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10.4.1 
General Considerations 
Categorical data will be summarized as frequency counts and percentages. Continuous data will 
be summarized using n, mean, standard deviation, median, minimum, and maximum unless 
otherwise specified. Efficacy values will be summarized for all visits in which the variable is 
assessed. Baseline values are defined as the last non-missing value prior to the first dose of study 
drug unless otherwise indicated. 
During the first 16 weeks of treatment, data will be presented for the following interventions: 
• Deucravacitinib 6 mg QD 
• Placebo 
 
After Week 16, data will be presented for the following interventions: 
• Deucravacitinib 6 mg QD 
• Placebo – Deucravacitinib 6 mg QD (starting at Week 20 through Week 52) 
 
The primary endpoint, ss-PGA 0/1 response, is defined as a proportion of participants with an 
ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at 
Week 16. The key secondary endpoints assessed at Week 16 are PSSI 90 response, change from 
baseline in scalp-specific itch NRS score, and s-PGA 0/1 response (sub-population only). PSSI 90 
is defined as a proportion of participants who achieve at least a 90% improvement from baseline 
in the PSSI score, and s-PGA 0/1 is defined as a proportion of participants with a s-PGA score of 
0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. 
  
 
 
 
 
 
Table 10.4.1-1: 
Definition of Estimands for Primary and Key Secondary Endpoints 
Primary Endpoint 
Estimand 
Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus placebo 
Population 
FAS population and FAS sub-population 
Variable 
ss-PGA 0/1 
ICEs 
Event 
Strategy 
Description 
Discontinuation of 
intervention or study early 
prior to Week 16 assessment 
Composite variable 
Participant will be counted as 
a non-responder 
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Table 10.4.1-1: 
Definition of Estimands for Primary and Key Secondary Endpoints 
Lost to follow-up prior to 
Week 16 or otherwise 
missing endpoint data at  
Week 16 assessment 
Composite variable 
Participant will be counted as 
a non-responder 
Start a protocol prohibited 
medication/therapy 
Treatment policy 
Participants will be included 
in the primary analysis 
regardless of the occurrence 
of the ICE according to the 
respective endpoint 
definition. 
Missing assessment at 
Week 16 due to SARS-CoV-
2  
While on treatment 
Participants will be excluded 
from the primary analysis if 
the Week 16 assessment was 
not completed due to 
SARS-CoV-2 
Population-
level 
Summary 
Odds ratio of achieving ss-PGA 0/1 
Key Secondary Endpoints 
Estimand 
Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus placebo 
Population 
FAS population and FAS sub-population 
Variable 
PSSI 90 
ICEs 
Event 
Strategy 
Description 
Discontinuation of 
intervention or 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 
missing endpoint data at 
Week 16 assessment 
Composite variable 
Participant will be counted as 
a non-responder 
Start a protocol prohibited 
medication/therapy 
Treatment policy 
Participants will be included 
in the analysis regardless of 
the occurrence of the ICE 
according to the respective 
endpoint definition. 
Missing assessment at Week 
16 due to SARS-CoV-2  
While on treatment 
Participants will be excluded 
from the analysis if the 
Week 16 assessment was not 
completed due to SARS-
CoV-2 
Population-
level 
Summary 
Odds ratio of achieving PSSI 90 
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Table 10.4.1-1: 
Definition of Estimands for Primary and Key Secondary Endpoints 
Estimand 
Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus placebo 
Population 
FAS population and FAS sub-population 
Variable 
Change from baseline in Scalp-specific itch Numeric Rating Scale (NRS) 
ICEs 
Event 
Strategy 
Description 
Discontinuation of 
intervention or study early 
prior to Week 16 assessment 
Composite variable 
Missing data will be imputed 
using multiple imputation 
Lost to follow-up prior to 
Week 16 or otherwise 
missing endpoint data at 
Week 16 assessment 
Composite variable 
Missing data will be imputed 
using multiple imputation 
Start a protocol prohibited 
medication/therapy 
Treatment policy 
Participants will be included 
in the analysis regardless of 
the occurrence of the ICE 
according to the respective 
endpoint definition. 
Missing assessment at Week 
16 due to SARS-CoV-2  
While on treatment 
Participants will be excluded 
from the analysis if the 
Week 16 assessment was not 
completed due to SARS-
CoV-2 
Population-
level 
Summary 
Adjusted mean difference between deucravacitinib 6 mg QD and placebo 
Estimand 
Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus placebo 
Population 
FAS sub-population  
Variable 
s-PGA 0/1 
ICEs 
Event 
Strategy 
Description 
Discontinuation of 
intervention or 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 
missing endpoint data at 
Week 16 assessment 
Composite variable 
Participant will be counted as 
a non-responder 
Start a protocol prohibited 
medication/therapy 
Treatment policy 
Participants will be included 
in the primary analysis 
regardless of the occurrence 
of the ICE according to the 
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Table 10.4.1-1: 
Definition of Estimands for Primary and Key Secondary Endpoints 
respective endpoint 
definition. 
Missing assessment at Week 
16 due to SARS-CoV-2  
While on treatment 
Participants will be excluded 
from the primary analysis if 
the Week 16 assessment was 
not completed due to 
SARS-CoV-2 
Population-
level 
Summary 
Odds ratio of achieving s-PGA 0/1 
FAS, Full Analysis Set; ICE, intercurrent event; NRS, numerical rating scale; PSSI, Psoriasis Scalp Severity Index; 
QD, once daily; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; ss-PGA, scalp-specific Physician 
Global Assessment; s-PGA, static Physician Global Assessment. 
 
10.4.2 
Primary Endpoints 
Table 10.4.2-1: 
Summary of Primary Endpoints 
Primary Endpoint 
Description of Analysis  
Time Frame 
ss-PGA 0/1 response 
rate is defined as a 
proportion 
of 
participants with an 
ss-PGA score of 0 
(clear) or 1 (almost 
clear) with at least a 
2-point 
reduction 
from baseline. 
The analysis model for the primary endpoint, ss-PGA 0/1 
(responder/non-responder) at Week 16, will use a stratified 
CMH test stratified 
 
 
 to compare the response rates 
of deucravacitinib 6 mg QD to placebo using the Week 16 data 
of the FAS as well as the FAS subgroup where baseline 
s-PGA ≥ 3. If expected cell counts are not sufficient for each 
strata level, then strata level will be combined for the analysis. 
The odds ratio (ratio of odds in deucravacitinib 6 mg QD to the 
odds in placebo group) and the corresponding 2-sided 95% CI 
will be provided. Estimates of proportions and their 2-sided 
95% CIs will be provided.  
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 
CI, confidence interval; CMH, Cochran-Mantel-Haenszel; NRI, non-responder imputation; QD, once daily; SAP, 
statistical analysis plan; s-PGA, static Physician Global Assessment; ss-PGA, scalp-specific Physician Global 
Assessment. 
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10.4.3 
Secondary Endpoints 
Table 10.4.3-1: 
Summary of Key Secondary Endpoints 
Secondary 
Endpoint 
Description of Analysis 
Time Frame 
PSSI 90 response 
rate is defined as a 
proportion 
of 
participants 
who 
achieve at least a 
90% 
improvement 
from baseline in the 
PSSI score. 
The analysis model for PSSI 90 (responder/non-responder) at 
Week 16, will use stratified CMH tests 
 
 
 
 to compare the response rates of deucravacitinib 6 mg 
QD to placebo for the FAS population as well as the FAS sub-
population where baseline s-PGA ≥ 3. The odds ratio (ratio of 
odds in deucravacitinib 6 mg QD to the odds in placebo group) 
and the corresponding 2-sided 95% 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 
Change 
from 
baseline in Scalp-
specific itch NRS 
The analysis model for the continuous secondary endpoint, 
change from baseline in Scalp-specific itch NRS at Week 16, 
will use ANCOVA with intervention and 
 
 
 
 The baseline value will be added into 
the model as a covariate. Intervention differences based on LS 
means and the corresponding 2-sided 95% CIs will be provided 
for the difference between deucravacitinib 6 mg QD and 
placebo for the FAS population as well as the FAS sub-
population where baseline s-PGA ≥ 3. 
For the continuous secondary efficacy endpoint, multiple 
imputation will be used for missing data. 
Week 16 
s-PGA 0/1 response 
rate is defined as a 
proportion 
of 
participants with an 
s-PGA score of 0 
(clear) or 1 (almost 
clear) with at least a 
2-point 
reduction 
from baseline. 
The analysis model for s-PGA 0/1 (responder/non-responder) at 
Week 16, will use stratified CMH tests 
 
 
 
 to compare the response rates of deucravacitinib 6 mg 
QD to placebo for the FAS sub-population where baseline 
s-PGA ≥ 3. The odds ratio (ratio of odds in deucravacitinib 
6 mg QD to the odds in placebo group) and the corresponding 
2-sided 95% 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 
CI, confidence interval; CMH, Cochran-Mantel-Haenszel; FAS, Full Analysis Set; PSSI, Psoriasis Scalp Severity 
Index; QD, once daily; ANCOVA, analysis of covariance; NRI, non-responder imputation; NRS, numerical rating 
scale; LS, least-squares; s-PGA, static Physician Global Assessment. 
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10.4.5 
Safety Analysis 
Safety data will be analyzed for AEs, SAEs, laboratory parameters, and VS. Safety will be 
summarized using the Safety population. Categorical data will be summarized as frequency counts 
and percentages. Continuous data will be summarized using n, mean, standard deviation, median, 
minimum, and maximum unless otherwise specified. Safety will be analyzed through Week 16 
and then up to end of study. 
10.4.5.1 
Adverse Events 
Treatment-emergent AEs (TEAEs), SAEs, deaths, AEs leading to study intervention 
discontinuation, and 
 will be summarized by the Medical Dictionary for Regulatory Activities 
(MedDRA) system organ class and preferred term. 
10.4.5.2 
Vital Signs 
VS will be summarized as raw, change from baseline, including the maximum post-baseline value. 
Baseline values are defined as the last non-missing value prior to the first dose of study drug. The 
number and proportion of participants with vital sign abnormalities will be summarized at each 
scheduled visit. 
10.4.5.3 
Clinical Laboratory Tests 
Laboratory parameters will be summarized as raw, change from baseline, including the maximum 
post-baseline value. Incidence of abnormal, high, or low values will be summarized. Shift tables 
will also be provided. Baseline values are defined as the last non-missing value prior to the first 
dose of study drug. The number and proportion of participants with clinical laboratory 
abnormalities will be summarized at each scheduled visit. 
10.4.6 
Other Analyses  
Not applicable. 
10.4.7 
Interim Analyses  
Not applicable. 
10.5 
Week 16 Primary Analysis 
A 16-week primary analysis will occur once all randomized participants have completed their 
Week 16 visit or have discontinued prior to Week 16. Analyses of the collected efficacy and safety 
data will be performed. The study participants and Investigators will remain blinded to the initial 
treatment assignment 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 final safety follow-up visit at Week 56 or post-
discontinuation follow-up visit. 
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11 
REFERENCES 
 
 
1  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. 
2  Kupetsky EA, Keller M. Psoriasis vulgaris: an evidence-based guide for primary care. J Am 
Board Fam Med. 2013;26(6):787-801.  
3  World Health Organization. Global Report on psoriasis. WHO 2016 
4  Langely RG, Kruger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality 
of life. Ann Rheum Dis. 2005;64(Suppl II): ii18-ii23. 
5  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. 
6  Mosca M, Hong J, Hadeler E, et al. Scalp psoriasis: a literature review of effective therapies 
and updated recommendations for practical management. Dermatol Ther (Heidelb). 
2021;11:769-797. 
7  Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major 
medical diseases. J Am Acad Dermatol. 1999;41:401-407. 
8  Nestle FO, Kaplan DH, Barker J. Mechanisms of disease: psoriasis. N Engl J Med. 
2009;361:496-509. 
9  van de Kerkhof PC, Franssen ME. Psoriasis of the scalp. Diagnosis and management. Am J 
Clin Dermatol. 2001;2(3):159-165. 
10  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. 
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® (secukinumab). 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, Schupp C, Lebwohl MG. Undertreatment, treatment 
trends, and treatment dissatisfaction among subjects 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  Janssen Biotech. TREMFYA® (guselkumab). United States Prescribing Information. 2017. 
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. 
25  Krueger JG, Ferris LK, Menter A, Wagner F, et al. Anti-IL-23A mAb BI 655066 for treatment 
of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of 
a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin 
Immunol. 2015;136(1):116-124. 
26  BMS-986165 Deucravacitinib Investigator Brochure Version 09. Bristol-Myers Squibb 
Company; 2022. Document Control No. 930090873. 
27  Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 
2005;64:ii65-ii68. 
28  Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica. 
1978;157(4):238-244. 
29  Rossiter ND, Chapman P, Haywood IA. How big is a hand. Burns.1996;22:230-231. 
30  Long CC, Finlay AY, Averill RW. The rule of hand: 4 hand areas = 2 FTU = 1 g. Arch 
Dermatol. 1992;128:1129-1130. 
31  Thomas CL, Finlay AY. The ‘handprint’ approximates to 1% of the total body surface area 
whereas the ‘palm minus the fingers’ does not. Br J Dermatol. 2007;157(5):1080-1081. 
32  Kragballe K, Menter A, Lebwohl M, et al. Long-term management of scalp psoriasis: 
perspectives from the international psoriasis council. J Dermatol Treat. 2013;24:188-192. 
33  Thaçi D, Daiber W, Boehncke WH, Kaufmann R. Calcipotriol solution for the treatment of 
scalp psoriasis: evaluation of efficacy, safety and acceptance in 3,396 patients. Dermatology. 
2001;203(2):153-156. 
  
 
 
 
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39  Kroenke K, Strine TW, Spitzer RL, et al. The PHQ-8 as a measure of current depression in the 
general population. J Affect Disord. 2009;114(1-3):163-173.  
  
 
 
 
41  Sen PK. Union-intersection principle and constrained statistical inference. Journal of Statistical 
Planning and Inference. 2007;137(11):3741-3752. 
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12 
APPENDICES 
 
 
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APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS 
Term 
Definition 
AAD-NPF 
American Academy of Dermatology–National Psoriasis Foundation 
AE  
adverse event 
  
 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
anti-HBc 
hepatitis B core antibody 
anti-HBc total 
hepatitis B core antibody total 
anti-HBs 
hepatitis B surface antibody 
AST  
aspartate aminotransferase 
AUC  
area under the concentration-time curve 
AxMP 
auxiliary medicinal product 
BID 
twice daily 
BMI 
body mass index 
BMS 
Bristol-Myers Squibb Company 
BP 
blood pressure 
BSA  
body surface area 
CES2 
carboxylesterase 2 
 
 
CMH 
Cochran-Mantel-Haenszel 
COVID-19 
coronavirus disease 2019 
CSR 
clinical study report 
CT  
computed tomography 
CYP 
cytochrome P450 
DILI  
drug-induced liver injury 
 
 
DNA 
deoxyribonucleic acid 
EAIR 
exposure-adjusted incidence rate 
ECG  
electrocardiogram 
eCRF  
electronic case report form 
EDC 
electronic data capture 
EE 
ethinyl estradiol 
  
 
EOT 
End of Treatment 
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Term 
Definition 
ET 
early termination 
EU 
European Union 
FAS  
Full Analysis Set 
FDA  
Food and Drug Administration 
FSH  
follicle-stimulating hormone 
 
 
GCP 
Good Clinical Practice 
 
 
  
 
  
 
HBsAg  
hepatitis B surface antigen 
HBV 
hepatitis B virus 
 
 
hCG 
human chorionic gonadotropin 
HCV  
hepatitis C virus 
Hgb  
hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV  
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IB  
Investigator Brochure 
ICE 
intercurrent event 
ICF  
informed consent form 
ICH 
International Council for Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IEC  
Independent Ethics Committee 
IFN 
interferon 
IGRA  
interferon gamma release assay 
IL  
interleukin 
IMP  
investigational medicinal product 
IP  
investigational product 
IRB 
Institutional Review Board 
IRT  
interactive response technology 
IUS 
Intrauterine hormone-releasing system 
IV 
intravenous 
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Term 
Definition 
JAK  
Janus kinase 
LAM 
lactational amenorrhea method 
LS 
least squares 
LTBI 
latent tuberculosis infection 
MDR/RR-TB 
multidrug/rifampicin-resistant tuberculosis 
 
 
n/a 
not applicable 
 
 
NIMP 
non-investigational medicinal product 
NMSC 
non‑melanoma skin cancer 
NRI 
non-responder imputation 
NRS 
numerical rating scale 
PASI 
Psoriasis Area and Severity Index 
PE 
physical examination 
PHQ-8  
8-Item Patient Health Questionnaire 
PK  
Pharmacokinetics 
 
 
 
 
PsA  
psoriatic arthritis 
PSSI  
Psoriasis Scalp Severity Index 
p-y 
patient-years 
QD 
once daily 
QoL 
quality of life 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
 
 
SIR 
standardized incidence ratio 
s-PGA  
static Physician Global Assessment 
SSA 
scalp surface area 
SSC 
Study Steering Committee 
ss-PGA 
scalp-specific Physician Global Assessment 
STAT  
signal transducer and activator of transcription 
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Term 
Definition 
T3 
triiodothyronine 
T4 
thyroxine 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
TNF 
tumor necrosis factor 
TSH 
thyroid stimulating hormone 
TYK2 
tyrosine kinase 2 
UGT 
UDP‑glucoronosyltransferase 
ULN 
upper limit of normal 
US 
United States 
VS 
vital signs 
WHO 
World Health Organization 
WOCBP 
women of childbearing potential 
 
 
 
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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
The terms “participant” and “subject” refer to a person who has consented to participate in the 
clinical research study. Typically, the term “participant” is used in the protocol and the term 
“subject” is used in the Electronic Case Report Form (eCRF). 
REGULATORY AND ETHICAL CONSIDERATIONS 
This study will be conducted in accordance with: 
• Consensus ethical principles derived from international guidelines, including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical Guidelines 
• Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) 
Guidelines 
• Applicable laws, regulations, and requirements 
 
The study will be conducted in compliance with the protocol. The protocol, any 
revisions/amendments, and the participant informed consent form (ICF) will receive 
approval/favorable 
opinion 
by 
Institutional 
Review 
Board/Independent 
Ethics 
Committee (IRB/IEC), and regulatory authorities according to applicable regulations prior to 
initiation of the study. 
All potential serious breaches must be reported to the Sponsor or designee immediately. A 
potential serious breach is defined as a Quality Issue (eg, protocol deviation) that is likely to affect, 
to a significant degree, one or more of the following: (1) the rights, physical safety or mental 
integrity of 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, IB, product labeling information, ICF, participant recruitment 
materials (eg, advertisements), and any other written information to be provided to participants.  
The Investigator, Sponsor, or designee should provide the IRB/IEC with reports, updates, and other 
information (eg, expedited safety reports, amendments, administrative letters) annually, or more 
frequently, in accordance with regulatory requirements or institution procedures. 
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The Investigator is responsible for providing oversight of the conduct of the study at the site and 
adherence to requirements of the following where applicable: 
• ICH guidelines, 
• United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 
• European Union Directive 2001/20/EC; or 
• European Regulation 536/2014 for clinical studies (if applicable), 
• European Medical Device Regulation 2017/745 for clinical device research (if applicable), 
• the IRB/IEC 
• and all other applicable local regulations. 
 
COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS 
The Investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and, if 
applicable, also by the local Health Authority), except where necessary to eliminate an immediate 
hazard(s) to study participants. 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s), the deviation or change will be submitted as soon 
as possible to: 
• IRB/IEC 
• Regulatory authority(ies), if applicable by local regulations (per national requirements) 
 
Documentation of approval/favorable opinion signed by the chairperson or designee of the 
IRB(s)/IEC(s) and, if applicable, also by the local Health Authority, must be sent to Bristol-Myers 
Squibb (BMS). 
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the ICF must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from participants 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new participants prior to enrollment. 
FINANCIAL DISCLOSURE 
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information, in accordance with regulations, to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate Health Authorities. Investigators 
are responsible for providing information on financial interests during the course of the study and 
for 1 year after completion of the study. 
 
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INFORMED CONSENT PROCESS 
Investigators must ensure that participants are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which they volunteer to 
participate. 
The Sponsor or designee will provide the Investigator with an appropriate sample ICF, which will 
include all elements required by the ICH GCP, and applicable regulatory requirements. The sample 
ICF will adhere to the ethical principles that have their origin in the Declaration of Helsinki. 
The Investigator or his/her representative must: 
• Obtain IRB/IEC written approval/favorable opinion of the written ICF and any other 
information to be provided to the participant prior to the beginning of the study and after any 
revisions are completed for new information. 
• Provide a copy of the ICF and written information about the study in the language in which 
the participant is proficient prior to clinical study participation. The language must be 
nontechnical and easily understood. 
• Explain the nature of the study to the participant or his/her legally acceptable representative 
and answer all questions regarding the study. 
• Inform participant that his/her participation is voluntary. Participant or his/her legally 
acceptable representative will be required to sign a statement of informed consent that meets 
the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability 
and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study 
center. 
• Allow time necessary for participant or his/her legally acceptable representative to inquire 
about the details of the study. 
 
Obtain an ICF signed and personally dated by participant or his/her legally acceptable 
representative and by the person who conducted the informed consent discussion. 
• Include a statement in participant’s medical record that written informed consent was obtained 
before participant was enrolled in the study and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF. 
• Re-consent participant to the most current version of the ICF(s) during his/her participation in 
the study, as applicable. 
 
Revise the ICF whenever important new information becomes available that is relevant to the 
participant’s consent. The Investigator, or a person designated by the Investigator, should fully 
inform the participant or his/her legally acceptable representative of all pertinent aspects of the 
study and of any new information relevant to the participant’s willingness to continue participation 
in the study. This communication should be documented. 
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The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the participant’s signed 
ICF, and, in the US, the participant’s signed HIPAA Authorization. 
The ICF must also include a statement that BMS and local and foreign regulatory authorities have 
direct access to participant records. 
In situations where consent cannot be given by participants, their legally acceptable representatives 
(as per country regulation) are clearly and fully informed about the purpose, potential risks, and 
other critical issues regarding clinical studies in which the participant volunteers to participate. 
If informed consent is initially given by a participant’s legally acceptable representative or legal 
guardian and the participant subsequently becomes capable of making and communicating his or 
her informed consent during the study, consent must additionally be obtained from the participant. 
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS 
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. BMS is 
committed to doing its part to ensure that patients have a fair and just opportunity to achieve 
optimal health outcomes. BMS is working to improve the recruitment of a diverse participant 
population with the goal that the clinical trial becomes more reflective of the real-world population 
and the people impacted by the diseases studied. 
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY 
BMS collects and processes personal data of study participants, patients, health care providers, 
and researchers for biopharmaceutical research and development to advance innovative, 
high[1]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 
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Institute of Standards and Technology Cybersecurity Framework for studies in the US. BMS aligns 
with these standards to continuously assess and improve its ability to protect, detect, and respond 
to cyber attacks and other unauthorized attempts to access personal data. These standards also aid 
in mitigating possible adverse effects. Furthermore, BMS Information Technology has defined 
6 principles to protect our digital resources and information:  
1) Responsibilities of IT Personnel  
2) Securing the BMS Digital Infrastructure  
3) Identity and Access Management  
4) External Partner Connections  
5) Cyber Threat Detection and Response  
6) Internal Cyber Incident Investigation 
 
SOURCE DOCUMENTS 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the Investigator’s site. 
Data reported on or entered in the electronic CRF (eCRF) that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be explained. 
• The Investigator may need to request previous medical records or transfer records, depending 
on the study. Also, current medical records must be available. 
• Definitions of what constitutes source data can be found in the monitoring plan. 
 
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, 
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and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority. 
If 
Then 
Supplied by BMS  
(or its vendors): 
Records or logs must comply with applicable regulations and 
guidelines and should include: 
• amount received and placed in storage area 
• amount currently in storage area 
• label identification number or batch number 
• amount dispensed to and returned by each 
participant, including unique participant 
identifiers 
• amount transferred to another area/site for 
dispensing or storage 
• 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, as per the Delegation 
of Authority Form 
Sourced by site and not 
supplied by BMS or its 
vendors (examples include 
IP sourced from the sites 
stock or commercial supply 
or a specialty pharmacy) 
The Investigator or designee accepts responsibility for 
documenting traceability and study treatment integrity in 
accordance with requirements applicable under law and the 
standard operating procedures/standards of the sourcing 
pharmacy 
 
BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements. 
CASE REPORT FORMS 
An Investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the eCRF 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 
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understanding of product safety. eCRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study. 
For sites using the Sponsor or designee electronic data capture (EDC) tool, eCRFs will be prepared 
for all data collection fields except for fields specific to SAEs and pregnancy, which will be 
reported on the electronic SAE form and Pregnancy Surveillance Form, respectively. If the 
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 eCRFs. 
The completed eCRF and SAE/pregnancy eCRFs 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 eCRF 
approval task. The Investigator must retain a copy of the eCRFs, including records of the changes 
and corrections. 
Each individual electronically signing eCRFs must meet Sponsor or designee training 
requirements and must only access the BMS EDC tool using the unique user account provided by 
the Sponsor or designee. User accounts are not to be shared or reassigned to other individuals. 
MONITORING 
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan. 
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the Investigator, and verify that the 
facilities remain acceptable. 
Certain eCRF pages and/or electronic files may serve as the source documents. 
In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to eCRFs, 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 
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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. 
BMS or its designee will notify the Investigator (or head of the study site in Japan) when the study 
records are no longer needed. 
If the Investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed-upon designee (eg, another Investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or its designee. 
RETURN OF STUDY TREATMENT 
For this study, study treatments (those supplied by BMS or a vendor or sourced by the 
Investigator), such as partially used study treatment containers, vials, and syringes, may be 
destroyed on site. 
If 
Then 
Study treatments supplied by 
BMS (including its vendors) 
Any unused study interventions supplied by BMS can only be 
destroyed after being inspected and reconciled by the 
responsible Study Monitor, unless study treatments containers 
must be immediately destroyed as required for safety, or to 
meet local regulations (eg, cytotoxics or biologics). 
Partially used study interventions and/or empty containers may 
be destroyed after proper reconciliation and documentation. 
But unused IMP must be reconciled by site monitor/Clinical 
Research Associate prior to destruction. 
If study treatments will be returned, the return will be arranged 
by the responsible Study Monitor. 
Study treatments sourced by 
site, not supplied by BMS 
(or its vendors; eg, study 
treatments sourced from the 
site’s stock or commercial 
supply or a specialty 
pharmacy) 
It is the Investigator’s or designee’s responsibility to dispose of 
all containers according to the institutional guidelines and 
procedures. 
 
It is the Investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met: 
• On-site disposal practices must not expose humans to risks from the drug. 
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• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
• Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s standard operating procedures and a copy provided to BMS upon request. 
• Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal (eg, incinerator, licensed sanitary landfill, or licensed waste-disposal 
vendor) must be documented. 
• Accountability and disposal records are complete, up-to-date, and available for the Study 
Monitor to review throughout the clinical trial period. 
 
It is the Investigator’s or designee’s responsibility to arrange for disposal of all empty containers. 
If conditions for destruction cannot be met, the responsible Study Monitor will make arrangements 
for return of study treatments provided by BMS (or its vendors). Destruction of non-study 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the Investigator 
or designee.  
STUDY AND SITE START AND CLOSURE 
The Sponsor/designee reserves the right to close the study site or to terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies have 
been collected and a study-site closure visit has been performed. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include, but are 
not limited to: 
• Failure of the Investigator to comply with the protocol, the requirements of the IRB/IEC or 
local Health Authorities, the Sponsor’s procedures, or GCP guidelines 
• Inadequate recruitment of participants by the Investigator 
• Discontinuation of further study intervention development 
 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The Investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
DISSEMINATION OF CLINICAL STUDY DATA 
In order to benefit potential study participants, patients, healthcare providers and researchers, and 
to help BMS honor its commitments to study participants, BMS will make information about 
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clinical research studies and a summary of their results available to the public as per regulatory 
and BMS requirements. BMS will post study information on local, national or regional databases 
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 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 their 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 time period set forth in the CTAg. 
Scientific publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors. No public presentation or publication of any interim results may be made by any 
Principal Investigator, sub-Investigator, or any other member of the study staff without the prior 
written consent of the Sponsor. 
Authorship of publications at BMS is aligned with the criteria of the International Committee of 
Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon significant 
contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE criteria for 
authorship: 
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the 
work (eg, problem solving, advice, evaluation, insights and conclusion); AND 
2) Drafting the work or revising it critically for important intellectual content; AND 
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3) Final approval of the version to be published; AND 
4) Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
 
Those who make the most significant contributions, as defined above, will be considered by BMS 
for authorship of the primary publication. Sub-Investigators will generally not be considered for 
authorship in the primary publication. Geographic representation will also be considered. 
Authors will be listed by order of significant contributions (highest to lowest), with the exception 
of the last author. Authors in first and last position have provided the most significant contributions 
to the work.  
For secondary analyses and related publications, author list and author order may vary from 
primary to reflect additional contributions. 
 
 
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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING 
ADVERSE EVENTS 
Adverse Event Definition: 
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing 
medical condition in a clinical investigation participant administered study treatment that does 
not necessarily have a causal relationship with this treatment.  
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of study treatment, whether or 
not considered related to the study treatment. 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, electrocardiograms, radiological scans, VS 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the Investigator. Note that abnormal lab tests or 
other safety assessments should only be reported as AEs if the final diagnosis is not 
available. Once the final diagnosis is known, the reported term should be updated to be the 
diagnosis. 
• Exacerbation of a chronic or intermittent pre-existing condition, including either an increase 
in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration, even though 
it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the Investigator), 
should not be reported as an AE/serious SAE unless it is an intentional overdose taken with 
possible suicidal/self-harming intent. Such overdoses should be reported regardless of 
sequelae and should specify “intentional overdose” as the verbatim term. 
Events NOT Meeting the AE Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy); the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE, even if serious conditions 
are met. 
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SERIOUS ADVERSE EVENTS 
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any 
dose: 
Results in death. 
Is life-threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe). 
Requires inpatient hospitalization or causes prolongation of existing hospitalization (see NOTE 
below). 
NOTE:  
The following hospitalizations are not considered SAEs in Bristol-Myers Squibb (BMS) clinical 
studies:  
• A visit to the emergency room or other hospital department < 24 hours that does not result 
in admission (unless considered an important medical or life-threatening event). 
• Elective surgery, planned prior to signing consent. 
• Admissions as per protocol for a planned medical/surgical procedure. 
• Routine health assessment requiring admission for baseline/trending of health 
status (eg, routine colonoscopy). 
• Medical/surgical admission other than to remedy ill health and planned prior to entry into 
the study. Appropriate documentation is required in these cases. 
• Admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason). 
• Admission for administration of anticancer therapy in the absence of any other 
SAEs (applies to oncology protocols). 
Results in persistent or significant disability/incapacity. 
Is a congenital anomaly/birth defect. 
Is an important medical event (defined as a medical event[s] that may not be immediately 
life-threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or at 
home for allergic bronchospasm and blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.8 for the definition of potential DILI.)  
 
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Pregnancy and DILI must follow the same transmission timing and processes to BMS as used for 
SAEs. (See Section 9.2.5 for reporting pregnancies.) 
EVALUATING AES AND SAES 
Assessment of Causality 
• The Investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE. 
• A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• The Investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration, 
will be considered and investigated. 
• The Investigator will also consult the IB and/or product information for marketed products 
in his/her assessment. 
• For each AE/SAE, the Investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• There may be situations in which an SAE has occurred and the Investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that 
the Investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to the Sponsor. 
• The Investigator may change his/her opinion of causality in light of follow-up information 
and send an SAE follow-up report with the updated causality assessment. 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
Assessment of Intensity 
The Investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to 1 of the following categories: 
• Mild: An event that is easily tolerated by the participant, causing minimal discomfort and 
not interfering with everyday activities. 
• Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with an SAE. Severe is a category utilized for rating the intensity of 
an event, and both AEs and SAEs can be assessed as severe. 
 
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as described 
in the definition of an SAE, NOT when it is rated as severe. 
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Follow-up of AEs and SAEs 
If only limited information is initially available, follow-up reports are required. 
(Note: Follow-up SAE reports must include the same Investigator term[s] initially reported.)  
If an ongoing SAE changes in its intensity or relationship to study treatment or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or designee) using the same procedure used for transmitting the initial SAE report. 
All SAEs must be followed to resolution or stabilization. 
 
REPORTING OF SAES TO SPONSOR OR DESIGNEE 
• SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event. 
• SAEs must be recorded on the SAE Report Form. 
− The required method for SAE data reporting is through the eCRF. 
− The paper SAE Report Form is intended only as a back-up option when the electronic 
data capture system is unavailable/not functioning for transmission of the eCRF to BMS 
(or designee). 
♦ In this case, the paper form is transmitted via email or confirmed facsimile 
transmission. 
♦ When paper forms are used, the original paper forms are to remain on site. 
• Pregnancies must be recorded on paper Pregnancy Surveillance Forms and transmitted via 
email or confirmed facsimile transmission. 
 
SAE Email Address: 
 
SAE Facsimile Number: Will be provided by local site monitor. 
US: 
 
SAE Telephone Contact (required for SAE and pregnancy reporting): Will be provided by local 
site monitor. 
 
 
 
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APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION 
Appendix 4 provides general information and definitions related to Woman of Childbearing 
Potential and methods of contraception that can be applied to most clinical trials. For information 
specific to this study regarding acceptable contraception requirements for female and male 
participants, refer to Section 6.1 of the protocol. Only the contraception methods as described in 
Section 6.1 are acceptable for this study. 
DEFINITIONS 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal female with 1 of the following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
• Postmenopausal female 
− A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 
45 years in the absence of other biological or physiological causes. In addition, females 
under the age of 55 years must have a serum follicle-stimulating hormone (FSH) level 
> 40 mIU/mL to confirm menopause. 
 
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used. Suggested 
guidelines for the duration of the washout periods for HRT types are presented below. Investigators 
should use their 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 
 
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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the woman can be considered 
postmenopausal. 
End of Relevant Systemic Exposure 
End of relevant systemic exposure is the timepoint where the Investigational Medicinal Product 
(IMP) or any active major metabolites have decreased to a concentration that is no longer 
considered to be relevant for human teratogenicity or fetotoxicity. This should be evaluated in 
context of safety margins from the no-observed-adverse-effect level, or the time required for 
5 half-lives of the IMP to pass. 
METHODS OF CONTRACEPTION 
Local laws and regulations may require use of alternative and/or additional contraception methods. 
Highly Effective Contraceptive Methods That Are User Dependent  
Failure rate of < 1% per year when used consistently and correctly.a 
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation and/or implantation. (This method of contraception can only be used 
by WOCBP participants in studies where hormonal contraception is permitted by the study 
protocol.)b 
− Oral (birth control pills) 
− Intravaginal (rings) 
− Transdermal 
• Combined (estrogen-and progestogen-containing) hormonal contraception must begin at 
least 30 days prior to initiation of study therapy. 
• Progestogen-only hormonal contraception associated with inhibition of ovulation. (This 
method of contraception can only be used by WOCBP participants in studies where 
hormonal contraception is permitted by the study protocol.)b 
− Oral 
− 
Injectable 
• Progestogen-only hormonal contraception must begin at least 30 days prior to initiation of 
study therapy. 
Highly Effective Methods That Are User Independent 
• Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation and/or implantation. (This method of contraception can only be used by WOCBP 
participants in studies where hormonal contraception is permitted by the study protocol.)b 
• Intrauterine device. 
• Intrauterine hormone-releasing system (IUS). (This method of contraception can only be 
used by WOCBP participants in studies where hormonal contraception is permitted by the 
study protocol.)b,c 
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• Bilateral tubal occlusion. 
• Vasectomized partner  
Having a vasectomized partner is a highly effective contraception method provided that the 
partner is the sole male sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be used.  
A vasectomy is a highly effective contraception method provided that the participant is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used.  
• Sexual abstinence.  
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study 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. 
• Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence. 
• Periodic abstinence (including, but not limited to, calendar, symptothermal, postovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea 
method (LAM) are not acceptable methods of contraception for this study.  
NOTES:  
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies.  
b Hormonal contraception may be susceptible to interaction with the study intervention, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the IMP and other study medications will not alter hormonal exposures such that contraception 
would be ineffective or result in increased exposures that could be potentially hazardous. In this case, alternative 
methods of contraception should be utilized. For information specific to this study regarding permissibility of 
hormonal contraception, refer to. Sections 6.1 INCLUSION CRITERIA and 7.7.1 PROHIBITED AND/OR 
RESTRICTED INTERVENTIONS of the protocol. 
c IUSs are acceptable methods of contraception in the absence of definitive drug interaction studies when hormone 
exposures from intrauterine devices do not alter contraception effectiveness. For information specific to this 
study regarding permissibility of hormonal contraception, refer to. Sections 6.1 INCLUSION CRITERIA and 
7.7.1 PROHIBITED AND/OR RESTRICTED INTERVENTIONS of the protocol. 
 
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Less Than Highly Effective Contraceptive Methods That Are User Dependent  
Failure rate of > 1% per year when used consistently and correctly. 
• Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously. 
• Diaphragm with spermicide. 
• Cervical cap with spermicide. 
• Vaginal sponge with spermicide. 
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action. (This method of contraception cannot be used by WOCBP 
participants in studies where hormonal contraception is prohibited.) 
Unacceptable Methods of Contraception 
• Periodic abstinence (calendar, symptothermal, postovulation methods). 
• Withdrawal (coitus interruptus). 
• Spermicide only. 
• LAM. 
 
COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of pregnancy information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.6 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 (hepatitis B surface antigen), anti-HBs (hepatitis B surface antibody), and 
anti-HBc total (hepatitis B 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 antigen (HBaAg-) 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 the results of other hepatitis B tests. 
• Participants who test positive only for core antibody (anti-HBc+) are NOT eligible for this 
study. 
For participants who are not eligible for this study due to HBV test results, consultation with a 
physician with expertise in the treatment of HBV infection is recommended. 
Table 1: 
Eligibility Based on Hepatitis B Virus Test Results 
 
HBV Test Results 
Action 
Hepatitis B Surface 
Antigen (HBsAg) 
Hepatitis B Surface 
Antibody (anti-HBs) 
Hepatitis B Core Antibody 
Total (anti-HBc total) 
Include 
- 
- 
- 
- 
+ 
- 
- 
+ 
+ 
Exclude 
+ 
- or + 
- or + 
- 
- 
+ 
anti-HBs, hepatitis B surface antibody; anti-HBc, hepatitis B core antibody; HBsAg, hepatitis B surface antigen; HBV, 
hepatitis B virus. 
 
 
5.0
Approved
930183774
4.0
v
Approved
1.0
v


Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
116 
APPENDIX 7 
PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY 
Overall Rationale for Protocol Amendment 02, 05-Dec-2022 
This protocol has been revised to add fasting lipid collection at Week 24 and Week 52. 
Summary of Key Changes for Protocol Amendment 02 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Title Page 
Correction of phone number and zip code for 
 address and correction of 
phone number 
 
Updated contact information 
Schedule of Activities 
(Table 2-3) 
 
 
 
 
  
Schedule of Activities 
(Table 2-3) 
 
On-Intervention 
Procedural Outline, 
(IM011220) Week 24 
through 52 
Added French specific language: Between 
visit windows, at weeks 36, 44, and 48, an at 
home urine pregnancy test will be performed 
Participants will provide the results by phone. 
See Section 9.2.6 
This French specific change is to add 
pregnancy testing collection in the 
active treatment period between 
visits 
 
 
 
. 
Schedule of Activities 
(Table 2-3) 
 
 
Minor correction 
Section 3.1 
Study Rationale 
The following text was added to reflect FDA 
approval: 
“The US FDA approved SOTYKTU™ 
(deucravacitinib), a first-in-class, oral, 
selective, allosteric tyrosine kinase 2 (TYK2) 
inhibitor, on 09-Sep-2022 for the treatment of 
adults with moderate-to-severe plaque 
psoriasis who are candidates for systemic 
therapy or phototherapy.” 
To reflect FDA approval of 
deucravacitinib in the United States 
Section 3.2.1 
Clinical Development 
The following text was added to reflect FDA 
approval:  
Based on these studies, the US FDA approved 
SOTYKTU™ (deucravacitinib), a 
first-in-class, oral, selective, allosteric TYK2 
inhibitor, on 09-Sep-2022 for the treatment of 
adults with moderate-to-severe plaque 
psoriasis who are candidates for systemic 
therapy or phototherapy. 
To reflect FDA approval of 
deucravacitinib in the United States 
Section 3.2.1 
Clinical Development 
Updated details regarding completed and 
ongoing studies.  
To include the most up-to-date 
information in the protocol 
Section 3.2.5 
Benefit Assessment 
 
Section 5.5 
Justification for Dose 
The following text was added: 
“The dose of 6 mg QD is also the 
FDA-approved dose.” 
To clarify the FDA-approved dose of 
deucravacitinib 
5.0
Approved
930183774
4.0
v
Approved
1.0
v


Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
117 
Summary of Key Changes for Protocol Amendment 02 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Section 9.2.6 
Pregnancy 
The following language was deleted: 
“Any pregnancy that occurs in a female 
partner of a male study participant should be 
reported to Sponsor or designee. In order for 
Sponsor or designee to collect any pregnancy 
surveillance information from the female 
partner, the female partner must sign an ICF 
for disclosure of this information. Information 
on this pregnancy will be collected on the 
Pregnancy Surveillance Form.” 
To align with current protocol model 
document language  
Section 9.2.6 
Pregnancy 
The following French specific text was added: 
Study participants who are WOCBP will use 
urine pregnancy kits so they can conduct 
pregnancy tests at home at Weeks 36, 44, and 
48. At-home pregnancy urine hCG test testing 
(WOCBP only) must be done per protocol 
schedule. Study participants will be instructed 
to communicate the results of the pregnancy 
tests to the site, with reminders and follow-up 
from the site study team, and pregnancy test 
results will be documented by the site in study 
participants’ eCRFs. Sites need to obtain and 
document that the pregnancy test is negative. 
If at-home urine pregnancy test is ambiguous, 
a serum pregnancy test must be performed, 
and participants should be asked to 
immediately pause taking study intervention 
until pregnancy status is confirmed. If at-
home urine pregnancy test is positive, the 
study participant will be discontinued from the 
study as per the protocol discontinuation 
criteria. If pregnancy testing is not done per 
protocol schedule, the Investigator must 
contact the Medical Monitor as soon as 
feasible to discuss the participant’s further 
participation in the study. 
This French specific change is to add 
pregnancy testing collection in the 
active treatment period between 
visits 
 
 
 
 
5.0
Approved
930183774
4.0
v
Approved
1.0
v


Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
118 
Summary of Key Changes for Protocol Amendment 02 
Section Number & 
Title 
Description of Change 
Brief Rationale 
 
  
All 
Minor formatting and typographical 
corrections 
Minor edits made to improve overall 
readability, consistency, etc 
 
Overall Rationale for the Protocol Amendment 01, 19-May-2022 
The primary reason for Protocol Amendment 01 is to clarify medical photography language and 
to update the 
 section. Additionally, there was an update to the language in the multiplicity 
adjustment section to reflect that the primary endpoint is included in the hierarchical order. Change 
of safety endpoint from exploratory to “other” secondary endpoint. Updated the definition of 
estimands table for primary and key secondary endpoints as per estimand guidance. Updated 
APPENDIX 2 with the current BMS language. References to BMS-986165 were changed to 
deucravacitinib throughout the protocol and in the title. Addition of PSORIATYK SCALP to the 
title. Clarifying information and administrative changes were made. 
These changes pertain to all participants. 
Summary of Key Changes for Protocol Amendment 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Title Page 
Addition of PSORIATYK SCALP 
to the title 
To 
be 
consistent 
with 
the 
clinicaltrials.gov listing 
All 
Replaced 
references 
to 
BMS-
986165 to deucravacitinib after 
being described as “also known as” 
throughout the protocol including 
protocol title change 
Updated product number to the 
product name 
Title Page 
Deletion of Syneos Medical Monitor 
contact info 
Updated contact information 
Section 1 
Overall Design 
Added that participant will be 
followed for safety for 4 additional 
weeks from week 52 through 
week 56 
Provides details for follow up period 
Sections 1 and 4, Table 4A 
Objectives and Endpoints 
“To 
assess 
the 
safety 
of 
deucravacitinib 
vs 
placebo 
in 
participants 
with 
moderate-to-
severe scalp plaque psoriasis” The 
endpoint was changed from an 
exploratory endpoint to an “other 
secondary endpoint.” 
Modified language for clarity as to 
how the response will be measured 
Safety 
is 
an 
important 
other 
secondary endpoint 
 
 
 
Provides details as to how objectives 
will be measured 
5.0
Approved
930183774
4.0
v
Approved
1.0
v


Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
119 
Summary of Key Changes for Protocol Amendment 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 1  
Statistical Methods 
Clarified the timepoints to be 
analyzed for the primary analysis 
will occur after the last participant 
completes Week 16 and the final 
analysis 
will 
occur 
after 
all 
participants complete their final 
safety visit at Week 56 or their post-
discontinuation follow-up visit 
Provides a specific timepoint of 
reference 
Section 3.3.1-1 
Risk Assessment 
 Added 
this 
sentence 
for 
clarification 
“Because 
deucravacitinib 
is 
a 
potential 
immunosuppressant and in line with 
standard 
practice 
for 
immunosuppressive therapies, the 
studies have been designed with 
inclusion/exclusion criteria aimed at 
minimizing the 
” 
Provides 
greater 
clarity 
in 
describing risk minimization 
Section 5.5   
Justification for Dose 
Updated the justification for the 
dose 
Provides greater clarity 
Section 7.2 
Method 
of 
Study 
Intervention 
Assignment 
Removed “each participant will be 
assigned a unique randomization 
number   
Per IRT manager 
Section 7.3.1  
Unblinding section 
Maintaining the Blind 
Added 
that 
the 
Sponsor 
and 
site-facing study team will be 
unblinded after the Week 16 
database 
lock 
but 
the 
study 
participants and Investigators will 
remain blinded throughout the 
study. 
Clarification 
of 
who 
will 
be 
unblinded at Week 16 and at the 
completion of the study 
Section 8.1.2 
Post 
Study 
Intervention 
Study 
Follow-Up 
Removed the term “until death” for 
one of the follow-up intervals  
To clarify that the follow-up interval 
is until the conclusion of the study 
(Week 56) 
5.0
Approved
930183774
4.0
v
Approved
1.0
v


Clinical Protocol 
IM011220 
BMS-986165 
deucravacitinib 
Protocol Amendment 03 
Date: 23-May-2023 
120 
Summary of Key Changes for Protocol Amendment 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 9.1.1.1 
Static 
Physician’s 
Global 
Assessment (s-PGA) 
Assessment term # 1 changed from 
“minimal” to “almost clear”,  
Align with standard scales 
Section 10.1.1 
Multiplicity Adjustment 
Updated language of hierarchical 
order since the primary endpoint 
was inadvertently not included 
Clarification of hierarchical order 
Section 10.4.1-1 
Table 10.4.1-1 
Updated Estimand table  
As per the Estimand Guidance 
document 
Section 10.4.5 
Included timing of safety analyses 
Provides clarity 
Appendix 2: Addition of BMS 
Commitment to Diversity in Clinical 
Trials 
Addition of BMS Commitment to 
Diversity in Clinical Trials 
As 
per 
the 
Protocol 
Model 
Document 
Appendix 2:  
Data Protection, Data Privacy, and 
Data Security  
Updated language to the Data 
Protection, Data Privacy, and Data 
Security  
As 
per 
the 
Protocol 
Model 
Document 
All 
The term “subjects” was changed to 
“participants” throughout 
Preferred term 
All 
Administrative changes, ie, for 
further 
clarification, 
spelling, 
spacing, typographical errors.  
Administrative 
changes 
as 
applicable 
 
5.0
Approved
930183774
4.0
v
Approved
1.0
v