A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting
Phase: PHASE4
Conditions: Psoriasis
Sponsor: Bristol-Myers Squibb

Official Title of Study:  
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of 
Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting 
(ARTISTYK) 
 
 
NCT Number: NCT05701995 
Document Date (Date in which document was last revised): May 25, 2023 
 
 
 

Page: 1 
Protocol Number: IM011237 
Date: 10-May-2022
Revised Date: 25-May-2023
9BCLINICAL PROTOCOL IM011237 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY 
EVALUATING THE EFFECT OF DEUCRAVACITINIB ON QUALITY OF LIFE IN 
PARTICIPANTS WITH PLAQUE PSORIASIS IN A COMMUNITY SETTING (ARTISTYK) 
Compound: BMS-986165 
Brief Title: Randomized, double-blind, placebo-controlled study to evaluate the effect of 
deucravacitinib on quality of life in participants with plaque psoriasis in a community setting 
Protocol Amendment 02 
 
Clinical Trial Physician-Medical Monitor 
Bristol-Myers Squibb Company 
86 Morris Ave  
Summit, NJ 07901 
Telephone: 
 
Email: 
 
 Clinical Scientist 
Bristol-Myers Squibb Company 
3401 Princeton Pike  
Lawrenceville, NJ 08648 
Telephone: 
 
Email: 
24-hr Emergency Telephone Number
USA: 1-866-470-2267
International: +1-248-844-7390
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 
NCT: NCT05701995
UTN: U1111-1276-5158 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-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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930186868
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
3 
DOCUMENT HISTORY 
Document 
Date of Issue 
Summary of Changes 
Protocol Amendment 
02 
25-May-2023 
• 
The compound number was added to the title page. 
• 
The Sponsor contact information was updated 
 
 and the Sponsor contact information for the 
medical monitor was updated 
 
. 
• 
Text was revised to reflect approval of SOTYKTU™ 
(deucravacitinib) 
 in multiple countries at a 
dose of 6 mg QD. 
• 
An additional key inclusion criterion was added: moderate-to-
severe plaque psoriasis 
. The 
text throughout multiple sections was updated accordingly to 
reflect this change. 
• 
s-PGA 0/1 at Week 16 was added as a key secondary endpoint 
and s-PGA assessment was added to the Screening visit. 
• 
 
 
 
 
 
  
• 
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, 
 
 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 02.” 
• 
Additional details were added to clarify guidance for 
investigators to check and provide counseling to the participants 
with regard to vaccinations. 
4.0
Approved
930186868
4.0
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Approved
1.0
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
4 
Document 
Date of Issue 
Summary of Changes 
•
The collection of non-serious AEs was removed from Week -2
(Visit 1).
•
Details of the external SSC were added.
•
Updated the Schedule of Activities Table to include efficacy
assessment of scalp, nail, palmoplantar, inverse, genital, or facial
psoriasis at every study visit.
•
Collection of the TSQM was removed from Day 1 (Visit 2) with
subsequent change in the endpoint to reflect that the TSQM will
be collected starting at Week 4.
•
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.”
•
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.
4.0
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930186868
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1.0
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
5 
Document 
Date of Issue 
Summary of Changes 
 
 
• 
A row was added to the Schedule of Activities Table to dispense 
the e-diary device at Screening. 
• 
A row was added to the Schedule of Activities Table to collect 
the e-diary device at Week 52. 
• 
 
 
Protocol Amendment 
01 
21-Nov-2022 
• 
 
 
• 
The US FDA approval date was added for the study drug. 
• 
The duration that participants will wear the wristwatch was 
increased from 7 days to 14 days before each wear period (ie, 
prior to Day 1, Week 16, and Week 52). 
• 
Details about completed and ongoing studies were updated. 
• 
Pregnant partner surveillance language was removed. 
• 
 
• 
Clarifying additions/deletions were made throughout the 
protocol. 
• 
Minor administrative changes were made throughout the 
protocol. 
Original Protocol 
19-May-2022 
Not applicable. 
(e)CRF, electronic case report form; AE, adverse event; 
 
 FDA, Food and Drug Administration; 
 IRT, interactive response 
technology; 
 QD, once daily; SARS-CoV-2, severe acute 
respiratory syndrome coronavirus 2; s-PGA, static Physician Global Assessment; SSC, Study Steering Committee; 
 TSQM, Treatment Satisfaction Questionnaire for Medication; 
 US, United 
States; 
 
 
 
4.0
Approved
930186868
4.0
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Approved
1.0
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
6 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 02 
Overall Rationale for Protocol Amendment 02, 25-May-2023 
This protocol has been revised 
 
 
 
. 
Additionally, the rationale for Protocol Amendment 02 was to ensure that the study will enroll 
participants with moderate-to-severe plaque psoriasis 
 
. 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
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 was 
updated 
 
 and the Sponsor contact 
information for the medical monitor 
was updated 
 
. 
• 
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 
• 
Text was revised to reflect approval of 
SOTYKTU™ (deucravacitinib) by 
Health 
Authorities 
in 
multiple 
countries. 
 
 
 
• 
This revision was made to reflect 
approval of deucravacitinib by 
Health Authorities in additional 
countries beyond the US. 
 
 
 
Section 6.1 
Inclusion Criteria 
 
Section 1 
Protocol Summary 
 
Section 3.1 
• 
An additional key inclusion criterion 
was 
added: 
 
 
  
 
 
• 
 
 
 
 
 
 
 
  
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
7 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
Study Rationale 
 
Section 5.1.1  
Screening Period 
 
Section 5.4 
Scientific Rationale for 
Study Design 
 
Section 2 
Schedule 
of 
Activities 
(Table 2-1) 
 
 
• 
The text throughout multiple sections 
was updated accordingly to reflect 
this change.  
 
 
• 
s-PGA assessment was added to the 
Screening visit. 
 
 
• 
To reflect this additional key 
inclusion criteria, the text was 
updated throughout the protocol.  
 
 
• 
 
 
 
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. 
• 
 
 
 
  
 
 
• 
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, 
 
. 
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 Sub-Population of 
participants 
with 
s-PGA ≥ 3 
at 
baseline). 
• 
Added corresponding text on the null 
hypothesis, 
 
 
 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. 
4.0
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
8 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
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 
02.” 
• 
To minimize barriers for participant 
enrollment, this exclusion criteria 
was removed. 
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. 
Section 2 
Schedule 
of 
Activities 
(Table 2-2) 
Section 2 
Schedule 
of 
Activities 
(Table 2-1) 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
9 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
 
 
 
 
 
 
  
 
 
Section 12 
  
 
Section 2 
Schedule 
of 
Activities 
(Table 2-1) 
 
Section 6.2 
Exclusion Criteria 
 
  
 
  
 
 
Section 12 Appendices  
APPENDIX 6 
HEPATITIS B VIRUS 
(HBV) SCREENING 
• 
HBV DNA viral load was removed as 
a required test at 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.  
 
Section 2 
Schedule 
of 
Activities 
(Table 2-2) 
• 
The collection of non-serious AEs 
was removed from Week -2 (Visit 1). 
• 
To align with the description in the 
protocol 
(Section 9.2.2) 
which 
indicates 
AEs 
(non-serious) 
collection begins with the initiation 
of study treatment. 
4.0
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930186868
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
10 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
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 and Table 2-3) 
• 
Updated the Schedule of Activities 
Table to include efficacy assessment 
of scalp, nail, palmoplantar, inverse, 
genital, or facial psoriasis at every 
study visit. 
• 
In order to be able to capture 
response and/or potentially disease 
flare in any of these ‘difficult-to-
treat’ sites throughout the study 
Section 2 
Schedule 
of 
Activities 
(Table 2-2) 
 
Section 1 
Protocol Summary 
 
Section 4 
Objectives and Endpoints 
(Table 4-1) 
• 
Collection of the TSQM was removed 
from Day 1 (Visit 2) with subsequent 
change in the endpoint to reflect that 
the TSQM will be collected starting at 
Week 4. 
• 
TSQM 
questionnaire 
was 
not 
applicable to be administered prior 
to the initiation of the IP and was 
thus removed from Day 1. 
 
• 
The TSQM will be collected 
starting at Week 4 after the 
participant has begun treatment. 
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 and Table 2-3) 
 
 
 
 
• 
To 
have 
consistent 
language 
throughout the protocol.  
Section 6.2 
Exclusion Criteria 
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
11 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
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 After 
the End of the Study 
• 
The 
following 
paragraph 
was 
removed: “BMS reserves the right to 
terminate access to BMS-supplied 
study intervention if any of the 
following occur: 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.” 
• 
This paragraph was not applicable 
to this Phase 4 study.  
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
12 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 2 
Schedule 
of 
Activities 
(Table 2-1) 
• 
A row was added to the Schedule of 
Activities Table to dispense the e-
diary device at Screening.  
• 
To clarify for Investigators that e-
diary is dispensed at screening.  
Section 2 
Schedule 
of 
Activities 
(Table 2-3) 
• 
A row was added to the Schedule of 
Activities Table to collect the e-diary 
device at Week 52. 
• 
To clarify and remind Investigators 
that e-diary must be collected at 
Week 52 visit. 
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; COVID-19, 
coronavirus disease 2019; DNA, deoxyribonucleic acid; FDA, Food and Drug Administration; e-diary, electronic 
diary; 
 
HBV, hepatis B virus; IB, Investigator’s Brochure; IP, investigational product; IRT, interactive response technology; 
PE, physical examination; 
 QD, once daily; QoL, quality of life; SAE, serious adverse 
event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; s-PGA, static Physician Global Assessment; 
 SSC, Study Steering Committee; TSQM, Treatment Satisfaction Questionnaire for Medication; 
TYK2, tyrosine kinase 2; US, United States; WHO, World Health Organization. 
 
 
4.0
Approved
930186868
4.0
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Approved
1.0
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
13 
TABLE OF CONTENTS 
CLINICAL PROTOCOL IM011237 ...............................................................................................1 
DOCUMENT HISTORY .................................................................................................................3 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 02 ................................................6 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 02 ............................................6 
TABLE OF CONTENTS ...............................................................................................................13 
1 
PROTOCOL SUMMARY ..........................................................................................16 
2 
SCHEDULE OF ACTIVITIES ..................................................................................23 
3 
INTRODUCTION ......................................................................................................33 
3.1 
Study Rationale ...........................................................................................................34 
3.2 
Background .................................................................................................................35 
3.2.1 
Clinical Development .................................................................................................36 
36 
37 
37 
38 
39 
4 
OBJECTIVES AND ENDPOINTS ............................................................................40 
5 
STUDY DESIGN .......................................................................................................41 
5.1 
Overall Design ............................................................................................................41 
5.1.1 
Screening Period ........................................................................................................42 
5.1.2 
Intervention Period .....................................................................................................42 
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 ..................................................43 
5.2 
Number of Participants ...............................................................................................44 
5.3 
End of Study Definition ..............................................................................................44 
5.4 
Scientific Rationale for Study Design ........................................................................44 
 
45 
6 
STUDY POPULATION .............................................................................................45 
6.1 
Inclusion Criteria ........................................................................................................45 
6.2 
Exclusion Criteria .......................................................................................................47 
6.3 
Lifestyle Restrictions ..................................................................................................51 
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 ......................................................................52 
7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ........................53 
7.1 
Study Interventions Administered ..............................................................................53 
7.2 
Method of Study Intervention Assignment .................................................................54 
7.3 
Blinding ......................................................................................................................54 
7.3.1 
Maintaining the Blind .................................................................................................54 
7.3.2 
Circumstances for Unblinding ....................................................................................55 
7.4 
Dosage Modification ..................................................................................................55 
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
14 
7.5 
Preparation/Handling/Storage/Accountability ............................................................55 
7.6 
Treatment Compliance ................................................................................................56 
7.7 
Concomitant Therapy .................................................................................................56 
7.7.1 
Prohibited and/or Restricted Treatments ...................................................................56 
7.7.2 
Permitted Concomitant Medications ..........................................................................57 
 
58 
7.7.4 
Permitted Vaccines (Including COVID-19 Vaccine) ..................................................58 
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 ...................................................................60 
8.2 
Discontinuation From the Study .................................................................................60 
8.2.1 
Individual Discontinuation Criteria ...........................................................................61 
8.3 
Lost to Follow-up .......................................................................................................61 
9 
STUDY ASSESSMENTS AND PROCEDURES ......................................................62 
9.1 
Efficacy Assessments .................................................................................................62 
9.1.1 
Investigator-Administered Assessments ......................................................................63 
 
65 
9.2 
Adverse Events ...........................................................................................................68 
 
68 
9.2.2 
Time Period and Frequency for Collecting AE and SAE Information .......................69 
9.2.3 
Method of Detecting AEs and SAEs ............................................................................69 
9.2.4 
Follow-up of AEs and SAEs ........................................................................................69 
9.2.5 
Regulatory Reporting Requirements for SAEs ...........................................................70 
9.2.6 
Pregnancy ...................................................................................................................70 
9.2.7 
Laboratory Test Result Abnormalities ........................................................................70 
9.2.8 
Potential Drug-induced Liver Injury (DILI) ...............................................................71 
9.2.9 
Other Safety Considerations .......................................................................................71 
9.3 
Overdose .....................................................................................................................71 
9.4 
Safety ..........................................................................................................................71 
9.4.1 
Physical Examinations ................................................................................................71 
9.4.2 
Vital Signs ...................................................................................................................72 
9.4.3 
Electrocardiograms ....................................................................................................72 
72 
72 
74 
74 
74 
74 
75 
75 
75 
75 
75 
9.10 
Health Economics OR Medical Resource Utilization and Health Economics ...........75 
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Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
15 
10 
STATISTICAL CONSIDERATIONS .......................................................................75 
10.1 
Statistical Hypotheses .................................................................................................75 
 
76 
 
77 
10.3 
Analysis Sets ...............................................................................................................79 
10.4 
Statistical Analyses .....................................................................................................80 
10.4.1 
General Considerations ..............................................................................................80 
10.4.2 
Primary Endpoint(s) ...................................................................................................83 
10.4.3 
Secondary Endpoint(s) ................................................................................................84 
 
85 
10.4.5 
Safety Analysis ............................................................................................................85 
10.4.6 
Other Analyses ............................................................................................................85 
10.5 
Interim Analyses .........................................................................................................86 
10.6 
Week 16 Primary Analysis .........................................................................................86 
11 
REFERENCES ...........................................................................................................87 
12 
APPENDICES ............................................................................................................91 
APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS .............................................92 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ......................................96 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING ............................107 
ADVERSE EVENTS ..................................................................................................................107 
DEFINITION OF SAE ................................................................................................................107 
SERIOUS ADVERSE EVENTS .................................................................................................108 
EVALUATING AES AND SAES...............................................................................................109 
FOLLOW-UP OF AES AND SAES ...........................................................................................110 
REPORTING OF SAES TO SPONSOR OR DESIGNEE ..........................................................110 
APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION ............................................111 
DEFINITIONS 
..................................................................................................................111 
METHODS OF CONTRACEPTION ..........................................................................................112 
COLLECTION OF PREGNANCY INFORMATION ................................................................114 
 
 
 
 
115 
APPENDIX 6 
HEPATITIS B VIRUS (HBV) SCREENING .........................................117 
APPENDIX 7 
PROTOCOL AMENDMENT SUMMARY OF CHANGE 
HISTORY ................................................................................................118 
 
 
 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
16 
1 
PROTOCOL SUMMARY 
Protocol Title: 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY 
EVALUATING THE EFFECT OF DEUCRAVACITINIB ON QUALITY OF LIFE IN 
PARTICIPANTS WITH PLAQUE PSORIASIS IN A COMMUNITY SETTING (ARTISTYK) 
Brief Title: Randomized, double-blind, placebo-controlled study to evaluate the effect of 
deucravacitinib on quality of life in participants with plaque psoriasis in a community setting 
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 Phase 3 studies, in addition to achieving both co-primary clinical efficacy endpoints 
(Psoriasis Area and Severity Index [PASI] 75 and static Physician Global Assessment 
[s-PGA] 0/1), deucravacitinib also improved Dermatology Life Quality Index (DLQI) scores. 
Mean changes from baseline in DLQI were greater for deucravacitinib as early as Week 1 versus 
placebo in PSO-1 (-3.67 vs -2.18) and PSO-2 (-3.49 vs -2.82) and Week 4 versus apremilast in 
PSO-1 (-5.63 vs -4.83) and Week 8 in PSO-2 (-7.35 vs -6.31). More deucravacitinib-treated 
patients achieved ≥ 4-point improvement on DLQI meaningful change threshold (MCT ≥ 4) at 
Week 16 versus placebo-treated and apremilast-treated patients in PSO-1 (77.6% vs 43.4% and 
68.8%, respectively) and PSO-2 (78.6% vs 44.9% and 69.3%). Similarly, higher responses versus 
apremilast were maintained through Week 24 in PSO-1 (79.5% vs 67.9%) and PSO-2 (79.2% vs 
67.5%). In PSO-1, 81.6% achieved MCT ≥ 4 at Week 52 with continuous deucravacitinib 
treatment. Results were similar when applying an MCT ≥ 5. Higher DLQI 0/1 responses were seen 
with deucravacitinib vs apremilast and placebo arms at Week 16 in POETYK PSO-1 (40.7% vs 
28.6% vs 10.6%) and POETYK PSO-2 (38.0% vs 23.1% vs 9.8%). Better DLQI 0/1 responses 
were also noted at Week 24 in deucravacitinib vs apremilast in POETYK PSO-1 (47.8% vs 24.2%) 
and PSO-2 (38.0% vs 23.1%). At Week 52, 46.1% of patients in POETYK PSO-1 maintained their 
DLQI 0/1 score. 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
17 
Additionally, this is a US-based study that aims to engage community-based dermatologists to 
facilitate a more diverse patient enrollment and to assess deucravacitinib in a patient population in 
a setting more real-world than the Phase 3 clinical trial setting. 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
• 
To compare the efficacy, as measured by DLQI 
0/1, of deucravacitinib versus placebo at 
Week 16: 
o 
in participants with plaque psoriasis  
o 
in the sub-population of participants 
with s-PGA ≥ 3 at baseline 
• 
DLQI 0/1, defined as proportion of participants 
achieving DLQI score of 0 or 1 at Week 16 
Key Secondary 
• 
To compare the efficacy, as measured by 
reduction 
from 
baseline 
in 
DLQI, 
of 
deucravacitinib versus placebo at Week 16:  
o 
in participants with plaque psoriasis 
o 
in the sub-population of participants 
with s-PGA ≥ 3 at baseline 
• 
Proportion of participants at Week 16, who achieve a ≥ 
4-point reduction from baseline in DLQI  
• 
To compare the efficacy, as measured by 
whole-body itch NRS score, of deucravacitinib 
versus placebo at Week 16: 
o 
in participants with plaque psoriasis 
o 
in the sub-population of participants 
with s-PGA ≥ 3 at baseline 
• 
Change from baseline in whole-body 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  s-PGA ≥ 3 at baseline 
• 
s-PGA 0/1 response 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 
Other Secondary  
• 
To assess the safety of deucravacitinib versus 
placebo in participants with plaque psoriasis 
between Week 0 and Week 16 
• 
AEs, SAEs, laboratory parameters, and vital signs 
between Week 0 and Week 16 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
18 
Objectives 
Endpoints 
AE, adverse event; 
 DLQI, Dermatology Life Quality 
Index; 
 NRS, Numerical Rating Scale; 
 
 
 
 SAE, serious adverse event; 
 
4.0
Approved
930186868
4.0
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Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
19 
 s-PGA, static Physician Global Assessment; 
 
 
 
Overall Design: 
This is a Phase 4, multicenter, randomized, double-blind placebo-controlled study comparing the 
effect of deucravacitinib versus placebo on QoL in patients with moderate-to-severe plaque 
psoriasis and impaired HRQoL. Participants will undergo screening evaluations within 28 days 
prior to administration of study intervention to determine eligibility. Following the screening 
process, approximately 174 participants will be randomized in a 2:1 ratio to either deucravacitinib 
6 mg once daily (QD) or placebo, respectively. 
 
 
 
 It is estimated that approximately 90% of randomized participants (ie, 
approximately 156 participants) would have baseline s-PGA scores ≥ 3. 
The duration of study participation is approximately 60 weeks and will be divided into the 
following periods: screening (up to 4 weeks), treatment (52 weeks), and follow-up (4 weeks). 
At Week 16, all participants regardless of their blinded intervention, will be switched to open-label 
deucravacitinib 6 mg QD bottles through Week 52. Participants and investigators remain blinded 
to double-blind placebo-controlled period study intervention until the end of the study at Week 52. 
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 250 enrolled participants will be required to achieve 
174 randomized. Approximately 174 participants will be randomized in a 2:1 fashion to 
deucravacitinib 6 mg QD or placebo matching deucravacitinib QD, respectively. 
 
 
 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
20 
Study Population: 
Men and women ≥ 18 years of age diagnosed with stable (defined as no morphology changes or 
significant flares of disease activity in the opinion of the investigator) moderate-to-severe plaque 
psoriasis 
 for 6 months or more, and impaired QoL (DLQI 
score > 5), 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. 
Study Intervention: 
Study Intervention for IM011237 
Arm Name  
Deucravacitinib 
(BMS-986165) 
Placebo 
Intervention Name 
Deucravacitinib  
(BMS-986165) 
Placebo for deucravacitinib 
Type 
Drug 
Drug 
Dose Formulation 
Tablet 
Placebo tablet to match 
deucravacitinib 
Unit Dose Strength(s) 
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.  
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
21 
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. 
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. Sensitivity analyses to be performed for the primary endpoint will be described in the 
statistical analysis plan. 
The analysis model for the continuous secondary endpoint will use analysis of covariance with 
study intervention 
 
. 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 completed their 
Week 16 visit or 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. 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
22 
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 evaluate the effect of deucravacitinib on QoL in patients with 
moderate-to-severe plaque 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 randomized, double-blind placebo-controlled study across multiple 
centers in a community setting. 
The study will compare improvement in QoL in participants treated with deucravacitinib to those 
treated with placebo during the first 16 weeks. This improvement is defined as DLQI 0/1 score 
and will be assessed at Week 16. The primary hypotheses are that the odds of achieving DLQI 0/1 
score 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, the proportion of participants at Week 16 who achieve a ≥ 4-point reduction from 
baseline in DLQI, the change from baseline in whole-body itch Numerical Rating Scale score at 
Week 16, 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 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), treatment (52 weeks), and follow-up (4 weeks). 
Following the initial screening study visit, subsequent visits will occur at Week −2, 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 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. 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
IM011237 
BMS-986165 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
23 
2 
SCHEDULE OF ACTIVITIES 
Schedules of activities and procedures are documented in Table 2-1 for the Screening Visit, Table 2-2 for Day -14 and Day 1 through 
Week 20, and Table 2-3 for Week 24 through Week 52. 
Table 2-1: 
Screening Procedural Outline (IM011237) 
Procedure 
Screening Visit 
(−28 Days to −1 Day) 
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 by 
the investigator 
Medical History 
X 
History of Tobacco Use 
X 
Include description of current tobacco use (Includes medical marijuana or prescription 
marijuana taken for medicinal reasons)  
Psoriasis-related History 
X 
Includes scalp symptoms, psoriatic arthritis, nail involvement, palmoplantar involvement, 
genital involvement, inverse psoriasis, history of other forms of psoriasis 
Psoriasis-related Systemic Treatment 
X 
History of conventional systemic (eg, methotrexate), biologic, and/or phototherapy. For 
each therapy, include length of time on treatment and reason(s) for discontinuation 
(eg, lack of efficacy, intolerance, side effects, loss of access to treatment), if applicable 
Other Prior and Concomitant Treatments 
X 
Includes topical treatments and shampoos for psoriasis and all medications for other 
conditions such as cardiovascular disorders and mood disorder 
Safety Assessments 
PE 
X 
Complete PE 
4.0
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4.0
v
Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
24 
Table 2-1: 
Screening Procedural Outline (IM011237) 
Procedure 
Screening Visit 
(−28 Days to −1 Day)  
Notes 
 
Physical Measurements  
X 
Includes height, weight, and BMI 
Vital Signs 
X 
Includes (ear or oral) body temperature, respiratory rate, seated blood pressure and heart 
rate. Blood pressure and heart rate should be measured after the participant has been resting 
quietly for at least 5 minutes 
12-lead ECG 
X 
12-lead ECGs should be recorded after the participant has been supine for at least 
5 minutes. A single ECG would be collected 
Laboratory Tests 
Pregnancy Test (Serum) 
X 
For WOCBP only; see APPENDIX 4. 
4.0
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930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
25 
Table 2-1: 
Screening Procedural Outline (IM011237) 
Procedure 
Screening Visit 
(−28 Days to −1 Day)  
Notes 
 
Serum (minimum sensitivity equivalent units 25 IU/L or equivalent units of hCG) to be 
done at the Screening Visit. 
The participant must be excluded from participation if the serum pregnancy result is 
positive. 
FSH 
X 
If needed to document postmenopausal 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. 
AE, adverse event; 
 BMI, body mass index; 
 
 ECG, electrocardiogram; 
 FSH, follicle-stimulating hormone; 
 
 hCG, human chorionic gonadotropin; 
 
 IRT, interactive response technology; 
 
PE, physical examination; 
 
 
 
 SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; 
 
 WHO, World Health Organization; WOCBP, women of childbearing potential. 
 
 
4.0
Approved
930186868
4.0
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Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
26 
Table 2-2: 
Day -14 and On-Intervention Procedural Outline (IM011237), Day 1 Through Week 20 
Procedure 
Week −2 
D −14 
(±1 d) 
Visit 1 
Day 1 
Visit 2 
Week 1 
D8 
(±3 d) 
Visit 3 
Week 2 
D15 
(±3 d) 
Visit 4 
Week 4 
D29 
(±3 d) 
Visit 5 
Week 8 
D57 
(±3 d) 
Visit 6 
Week 12 
D85 
(±3 d) 
Visit 7 
Week 16 
D113 
(±3 d) 
Visit 8 
Week 20 
D141 
(±3 d) 
Visit 9 
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 
 
 
 
 
 
X 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication 
Use  
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
AE Reporting 
Monitor for SAEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Monitor for Nonserious 
AEs 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
4.0
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930186868
4.0
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Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
27 
Table 2-2: 
Day -14 and On-Intervention Procedural Outline (IM011237), Day 1 Through Week 20 
Procedure 
Week −2 
D −14 
(±1 d) 
Visit 1 
Day 1 
Visit 2 
Week 1 
D8 
(±3 d) 
Visit 3 
Week 2 
D15 
(±3 d) 
Visit 4 
Week 4 
D29 
(±3 d) 
Visit 5 
Week 8 
D57 
(±3 d) 
Visit 6 
Week 12 
D85 
(±3 d) 
Visit 7 
Week 16 
D113 
(±3 d) 
Visit 8 
Week 20 
D141 
(±3 d) 
Visit 9 
Notes 
Laboratory Tests 
Pregnancy Test (Urine)  
 
X 
 
 
X 
X 
X 
X 
X 
WOCBP only 
Efficacy Assessments 
PASI 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
s-PGA 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
ss-PGA 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
PGA-F 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
pp-PGA 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
I-s-PGA 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
s-PGA-G 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
sf-PGA 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
4.0
Approved
930186868
4.0
v
Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
28 
Table 2-2: 
Day -14 and On-Intervention Procedural Outline (IM011237), Day 1 Through Week 20 
Procedure 
Week −2 
D −14 
(±1 d) 
Visit 1 
Day 1 
Visit 2 
Week 1 
D8 
(±3 d) 
Visit 3 
Week 2 
D15 
(±3 d) 
Visit 4 
Week 4 
D29 
(±3 d) 
Visit 5 
Week 8 
D57 
(±3 d) 
Visit 6 
Week 12 
D85 
(±3 d) 
Visit 7 
Week 16 
D113 
(±3 d) 
Visit 8 
Week 20 
D141 
(±3 d) 
Visit 9 
Notes 
4.0
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930186868
4.0
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Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
29 
Table 2-2: 
Day -14 and On-Intervention Procedural Outline (IM011237), Day 1 Through Week 20 
Procedure 
Week −2 
D −14 
(±1 d) 
Visit 1 
Day 1 
Visit 2 
Week 1 
D8 
(±3 d) 
Visit 3 
Week 2 
D15 
(±3 d) 
Visit 4 
Week 4 
D29 
(±3 d) 
Visit 5 
Week 8 
D57 
(±3 d) 
Visit 6 
Week 12 
D85 
(±3 d) 
Visit 7 
Week 16 
D113 
(±3 d) 
Visit 8 
Week 20 
D141 
(±3 d) 
Visit 9 
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 
 
Dispense Wristwatch 
X 
 
 
 
 
 
X 
 
 
 
Collect Wristwatch 
 
X 
 
 
 
 
 
X 
 
 
AE, adverse event; 
 d, days; D, Day; 
 IRT, interactive response 
technology; I-s-PGA, Intertriginous-area static; IP, investigational product; Physician Global Assessment; 
PASI, Psoriasis Area and 
Severity Index; 
 PE, physical examination; PGA-F, Physician Global Assessment-Fingernails; 
 
pp-PGA, 
palmoplantar Physician Global Assessment; 
 
 SAE, serious adverse event; 
 sf-PGA, Static Physician Global 
Assessment for the Face; s-PGA, static Physician Global Assessment; s-PGA-G, static Physician Global Assessment of Genitalia; ss-PGA, scalp-specific Physician 
Global Assessment; 
 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). 
 
 
 
4.0
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930186868
4.0
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Approved
1.0
v

Clinical Protocol 
 
IM011237 
BMS-986165 
 
Deucravacitinib 
Protocol Amendment 02 
Date: 25-May-2023 
 
30 
Table 2-3: 
On-Intervention Procedural Outline, (IM011237) Week 24 Through Week 52 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 10 
Week 28 
D197 
(±3 d) 
Visit 11 
Week 32 
D225 
(±3 d) 
Visit 12 
Week 40 
D281 
(±3 d) 
Visit 13 
Week 52 
(EOT or ETa) 
D365 
(±3 d) 
Visit 14 
Safety Follow-up 
(Week 56 or 
Post-Treatment 
Follow upa) 
D393 
(±3 d) 
Visit 15 
Notes 
Safety Assessments 
Complete PE 
 
 
 
 
X 
X 
 
Targeted PE 
X 
X 
X 
X 
 
 
 
Body Weight 
 
 
 
 
X 
X 
 
Vital Signs 
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 
Pregnancy Test (Urine)  
X 
X 
X 
X 
X 
X 
WOCBP only 
Clinical Efficacy Assessments 
PASI 
X 
X 
X 
X 
X 
 
 
BSA 
X 
X 
X 
X 
X 
 
 
s-PGA 
X 
X 
X 
X 
X 
 
 
ss-PGA 
X 
X 
X 
X 
X 
 
 
PGA-F 
X 
X 
X 
X 
X 
 
 
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Table 2-3: 
On-Intervention Procedural Outline, (IM011237) Week 24 Through Week 52 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 10 
Week 28 
D197 
(±3 d) 
Visit 11 
Week 32 
D225 
(±3 d) 
Visit 12 
Week 40 
D281 
(±3 d) 
Visit 13 
Week 52 
(EOT or ETa) 
D365 
(±3 d) 
Visit 14 
Safety Follow-up 
(Week 56 or 
Post-Treatment 
Follow upa) 
D393 
(±3 d) 
Visit 15 
Notes 
pp-PGA 
X 
X 
X 
X 
X 
 
 
I-s-PGA 
X 
X 
X 
X 
X 
 
 
s-PGA-G 
X 
X 
X 
X 
X 
 
 
sf-PGA 
X 
X 
X 
X 
X 
 
 
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Table 2-3: 
On-Intervention Procedural Outline, (IM011237) Week 24 Through Week 52 
Procedures 
Week 24 
D169 
(±3 d) 
Visit 10 
Week 28 
D197 
(±3 d) 
Visit 11 
Week 32 
D225 
(±3 d) 
Visit 12 
Week 40 
D281 
(±3 d) 
Visit 13 
Week 52 
(EOT or ETa) 
D365 
(±3 d) 
Visit 14 
Safety Follow-up 
(Week 56 or 
Post-Treatment 
Follow upa) 
D393 
(±3 d) 
Visit 15 
Notes 
Study Intervention 
Dispense Study Intervention 
X 
X 
X 
X 
 
 
 
Study Intervention Compliance 
X 
X 
X 
X 
X 
 
 
Dispense Wristwatch 
 
 
 
X 
 
 
 
Collect Wristwatch 
 
 
 
 
X 
 
 
Collect e-diary 
 
 
 
 
X 
 
 
AE, adverse event; BSA, body surface area; d, days; D, Day; 
 e-diary, electronic diary; 
EOT, end of treatment; ET, early termination; I-s-PGA, Intertriginous-area static Physician Global Assessment; IP, investigational product; 
 
 PASI, Psoriasis Area and Severity Index; 
 PE, physical examination; PGA-F, Physician Global Assessment-Fingernails; 
 pp-PGA, palmoplantar 
Physician Global Assessment; 
 
SAE, serious adverse event; 
 sf-PGA, static Physician Global Assessment for the 
Face; s-PGA, static Physician Global Assessment; s-PGA-G, static Physician Global Assessment of Genitalia; 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). 
 
 
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3 
INTRODUCTION 
Plaque Psoriasis 
Psoriasis is a chronic inflammatory 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 variants 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, genital, and nails. Psoriasis has been associated with 
major changes in patients’ psychosocial, emotional, and physical functioning. Psoriasis may 
impact patients’ lives as much or more than other major medical conditions. These may include 
psychological stress, embarrassment, stigma, and physical discomfort, which are not reflected in 
objective measures of skin disease severity (Psoriasis Area Severity Index [PASI], body surface 
area [BSA], static Physician Global Assessment [s-PGA]). Over time, these may result in 
significant worsening in overall emotional well-being, social functioning, productivity at work or 
school, self-care activities and self-esteem may worsen. Furthermore, the quality of life (QoL) of 
patients with psoriasis affecting sensitive areas may be disproportionately impacted relative to the 
affected area.6 For example, the presence of lesions in highly visible areas can affect a patient’s 
self-esteem, whereas involvement of the palms can make activities of daily living challenging. 
Nail or hand psoriasis can be a financial burden due to reduced workplace productivity. Scalp 
psoriasis is frequently associated with pain, itching, and bleeding, and is associated with a 
disproportionate impact on QoL and psychosocial impairment.6 
Clinician-reported outcomes for disease severity (PASI, BSA, and s-PGA) may not adequately 
capture patients’ lived experience of the disease. Patient-reported outcome (PRO) measures may 
provide complementary information, allowing clinicians to better understand the patient’s unique 
experience of living with psoriasis, which could facilitate individualized treatment. Evaluating 
patients with clinician-reported outcomes (BSA or PASI) or PRO measures alone could lead to an 
incomplete understanding of disease severity, which may lead to undertreatment or 
overtreatment.7,8,9 
Importantly, correlation between Dermatology Life Quality Index (DLQI), which is a standard 
tool to assess the impact of psoriasis on patients’ QoL in clinical studies, and PASI in patients with 
BSA < 10% has not been fully determined. Furthermore, the National Psoriasis Foundation survey 
(2003 to 2011) revealed that 30% of patients with 3% to 10% BSA received treatment solely with 
topical medications and 24% to 36% of psoriasis patients felt that they were untreated. Many 
patients with BSA < 10% (range: 7.1% to 8.4%) report a large impact on their QoL (DLQI range: 
10.2 to 12.2).10,11 
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Treatments for psoriasis include topical preparations (eg, corticosteroids, vitamin D analogues, 
calcineurin inhibitors, salicylic acid, urea, and coal tar); phototherapy modalities, including 
broad-band and narrow-band ultraviolet (UV)B; and systemic therapies. In moderate-to-severe 
disease, systemic treatments are usually needed and may include oral agents (retinoids, 
methotrexate, cyclosporine, and apremilast) or injectables (eg, biologics such as tumor necrosis 
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 treatments 
are associated with increased risk of adverse events (AEs) such as hepatotoxicity and neutropenia 
(methotrexate);12 nephrotoxicity (cyclosporine);13 depression and weight loss (apremilast);14 
serious infections (cytokine inhibitors);15,16,17,18 and candidiasis and Crohn’s disease (IL-17 
antagonists).18,19,20 
Although effective therapeutic options are available, undertreatment or nontreatment of psoriasis 
has been reported in up to half of surveyed patients (based on absence of treatment and/or 
dissatisfaction with treatment).11 Many patients with moderate-to-severe disease are still being 
managed with only topicals,4,21 and many patients consider their psoriasis treatment to be 
inadequate. Accordingly, there remains a need for more effective oral options, when compared 
with currently available agents, that would improve efficacy responses, increase adherence to 
treatment and improve various domains of patients’ QoL. 
3.1 
Study Rationale 
SOTYKTU™ (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 
(TYK2) inhibitor is approved in multiple countries for the treatment of adults with moderate-to-
severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 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 Phase 3 studies, in addition to achieving both co-primary clinical efficacy endpoints 
(PASI 75 and s-PGA 0/1), deucravacitinib also improved DLQI scores. Mean changes from 
baseline in DLQI were greater for deucravacitinib as early as Week 1 versus placebo in PSO-1 
(-3.67 vs -2.18) and PSO-2 (-3.49 vs -2.82) and Week 4 versus apremilast in PSO-1 (-5.63 vs -4.83) 
and Week 8 in PSO-2 (-7.35 vs -6.31). More deucravacitinib-treated patients achieved ≥ 4-point 
improvement on DLQI meaningful change threshold (MCT ≥ 4) at Week 16 versus 
placebo-treated and apremilast-treated patients in PSO-1 (77.6% vs 43.4% and 68.8%, 
respectively) and PSO-2 (78.6% vs 44.9% and 69.3%). Similarly, higher responses versus 
apremilast were maintained through Week 24 in PSO-1 (79.5% vs 67.9%) and PSO-2 (79.2% vs 
67.5%). In PSO-1, 81.6% achieved MCT ≥ 4 at Week 52 with continuous deucravacitinib 
treatment. Results were similar when applying an MCT ≥ 5. Higher DLQI 0/1 responses were seen 
with deucravacitinib vs apremilast and placebo arms at Week 16 in POETYK PSO-1 (40.7% vs 
28.6% vs 10.6%) and POETYK PSO-2 (38.0% vs 23.1% vs 9.8%). Better DLQI 0/1 responses 
were also noted at Week 24 in deucravacitinib vs apremilast in POETYK PSO-1 (47.8% vs 24.2%) 
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and PSO-2 (38.0% vs 23.1%). At Week 52, 46.1% of patients in POETYK PSO-1 maintained their 
DLQI 0/1 score.  
Additionally, this is a US-based study that aims to engage community-based dermatologists to 
facilitate a more diverse patient enrollment and to provide a more real-world patient population 
than was studied in Phase 3 studies. 
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 distinctly different effects than 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 
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in the TYK2 signaling cascade (IL-23 and the downstream mediators IL-17 and IL-22; IFNα) are 
involved in the pathogenesis of psoriasis.21 2) Biologic agents targeting the IL-17, IL-23p19, and 
IL-12/23 p40 pathways have been approved for and are highly efficacious in the treatment of 
psoriasis. 
 
 
 
 
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 once daily (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 
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4 
OBJECTIVES AND ENDPOINTS 
Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
• 
To compare the efficacy, as measured by 
DLQI 0/1, of deucravacitinib versus placebo 
at Week 16: 
o 
in participants with plaque psoriasis 
o 
in the sub-population of participants 
with s-PGA ≥ 3 at baseline 
• 
DLQI 0/1, defined as proportion of participants achieving 
DLQI score of 0 or 1 at Week 16 
Key Secondary  
• 
To compare the efficacy, as  measured by 
reduction from baseline in DLQI, of 
deucravacitinib versus placebo at Week 16:  
o 
in participants with plaque psoriasis  
o 
in the sub-population of participants 
with s-PGA ≥ 3 at baseline 
• 
Proportion of participants at Week 16, who achieve a ≥ 
4-point reduction from baseline in DLQI  
• 
To compare the efficacy, as measured by 
whole-body 
itch 
NRS 
score, 
of 
deucravacitinib versus placebo at Week 16: 
o 
in participants with plaque psoriasis  
o 
in the sub-population of participants 
with s-PGA ≥ 3 at baseline 
• 
Change from baseline in whole-body 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 s-PGA ≥ 3 at baseline 
• 
s-PGA 0/1 response 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  
Other Secondary 
• 
To assess the safety of deucravacitinib versus 
placebo in participants with plaque psoriasis 
between Week 0 and Week 16  
• 
AEs, SAEs, laboratory parameters, and vital signs 
between Week 0 and Week 16 
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Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
AE, adverse event; 
 DLQI, Dermatology Life Quality Index; 
 
 NRS, Numerical Rating Scale; 
 
 
 
 
 
 SAE, serious adverse event; 
 
 
 
5 
STUDY DESIGN 
5.1 
Overall Design 
This study (IM011237) is a Phase 4, multicenter, randomized, double-blind, placebo-controlled 
study to evaluate the effect of deucravacitinib on QoL in patients with plaque psoriasis and 
impaired HRQoL. A total of approximately 174 qualified participants with moderate-to-severe 
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plaque psoriasis will be randomized. 
 It is estimated that approximately 90% of 
randomized participants (ie, approximately 156 participants) would have baseline s-PGA scores 
≥ 3. 
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, 
 s-PGA 
score, DLQI score, and history of systemic intervention will be assessed at Screening. 
 
 
 
 
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 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 (Section 7.1).  
All participants will receive a wristwatch to monitor sleep quality for 14 days prior to Day 1 to be 
worn for 14 days. This wristwatch will be returned to the study site on Day 1 as listed in the 
Schedule of Activities (Section 2). This wristwatch will be returned to all participants again on 
Weeks 12 and 40 to be worn for 14 days prior to Week 16 and Week 52 and will be returned to 
the study sites as per the Schedule of Activities (Section 2). 
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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. All participants will return their wristwatches at the Week 16 visit. 
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. 
All participants will return their wristwatches at the Week 52 visit. 
The study design schematic is presented in Figure 5.1.5-1. 
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.  
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5.2 
Number of Participants 
It is estimated that approximately 250 enrolled participants will be required to achieve 
174 randomized. Approximately 174 participants will be randomized in a 2:1 fashion to 
deucravacitinib 6 mg QD or placebo matching deucravacitinib QD, respectively. 
 
 
 It is estimated that 
approximately 90% of randomized participants (ie, approximately 156 participants) would have 
baseline s-PGA scores ≥ 3. 
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 
(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 is expected to be collected if 
this is not the same. 
5.4 
Scientific Rationale for Study Design 
This Phase 4 study will be conducted in a population of participants with stable moderate-to-severe 
plaque psoriasis 
 who are candidates for systemic 
psoriasis therapy. Additional key inclusion criterion is DLQI score > 5, which captures participants 
with moderate-to-severe impact on HRQoL. The study is designed to compare the efficacy of 
deucravacitinib to placebo in achieving DLQI 0/1 at Week 16. DLQI 0/1 is a standard measure in 
clinical studies of demonstrating efficacy of systemic psoriasis treatments on QoL. 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 
 
. 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 psoriasis treatment 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.  
A randomized, double-blind, placebo-controlled study provides the most robust assessment of 
efficacy and safety. 
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6 
STUDY POPULATION 
Eligibility criteria for this study have been carefully considered to ensure: 1) selection of 
appropriate participants with psoriasis and 2) safety of the study participants. It is imperative that 
participants fully meet all eligibility criteria. 
All screening and randomization evaluations must be completed and reviewed to confirm that 
potential participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for screening 
failure, as applicable. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
6.1 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1) Signed Written Informed Consent 
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 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) ≥ 3% of BSA involvement at the Screening Visit and Day 1 
d) DLQI score > 5 at the Screening Visit and Day 1 
e) Moderate-to-severe plaque psoriasis 
 at the Screening Visit and 
Day 1 
3) Age of Participant 
Participant must be ≥ 18 years of age inclusive at the time of signing the informed consent. 
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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 the Schedule of Activities (Section 2). 
• The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy. 
iii) WOCBP must agree to follow instructions for method(s) of contraception defined in 
APPENDIX 4 and as described below and included in the ICF. 
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.  
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6.2 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1) Target Disease Exceptions 
a) Has non-plaque psoriasis (ie, guttate, pustular, erythrodermic, palmoplantar only 
involvement 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 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 02: Participants who are not fully vaccinated 
against SARS-CoV-2 as defined by the local and current national guidelines 
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 02: Presence of hepatitis B virus 
deoxyribonucleic acid (DNA) 
OR 
 
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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 virus antibody AND 2) positive via a 
confirmatory test for HCV (eg, HCV polymerase chain reaction) 
m) Positive for human immunodeficiency virus (HIV) by antibody testing (HIV-1 and HIV-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 study physician, there are no 
sequelae that would place the participant at a higher risk of receiving investigational 
intervention. 
4) Any of the following TB criteria 
a) Participant has a history of active TB prior to Screening Visit, regardless of completion of 
adequate treatment 
b) Participant has signs or symptoms of active TB (eg, fever, cough, night sweats, and weight 
loss) during Screening as judged by the investigator 
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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) Drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day 1 
c) Medical marijuana or prescription marijuana taken for medicinal reasons 
d) Any major 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 
judgement 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 
e) Unstable cardiovascular disease, defined as a recent clinical cardiovascular event 
(eg, unstable angina, myocardial infarction, stroke, rapid atrial fibrillation) in the last 
3 months prior to screening, or a cardiac hospitalization (eg, revascularization procedure, 
pacemaker implantation) within 3 months prior to screening 
f) Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) 
> 160 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 
g) Class III or IV congestive heart failure by New York Heart Association criteria 
h) Has cancer or history of cancer (solid organ or hematologic including myelodysplastic 
syndrome) or lymphoproliferative disease within the previous 5 years (other than resected 
cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has 
been treated with no evidence of recurrence) 
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k) 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 
l) 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 
m) Has used leflunomide within 6 months prior to Day 1 
n) Has used opioid analgesics within 4 weeks prior to Day 1 
o) Has received lithium, antimalarials, or intramuscular gold within 4 weeks of the first 
administration of any study medication  
p) Has received phototherapy (including either oral and topical psoralens with ultraviolet A 
light therapy, ultraviolet B, or self-intervention with tanning beds or therapeutic 
sunbathing) within 4 weeks prior to Day 1 
q) 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 
r) Use of shampoos that contain corticosteroids, coal tar, > 3% salicylic acid, or vitamin D3 
analogues within 2 weeks prior to Day 1 
s) 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 
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t) 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) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 × upper 
limit of normal (ULN) 
vii) Total, unconjugated, and/or conjugated bilirubin > 2 × ULN 
b) Electrocardiograms (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 
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 study 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 UV light sources and avoid risks that are known to 
provoke flare of psoriasis. 
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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.  
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 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). 
 
 Duration of existing 
interventions and required discontinuation periods shall be considered relative to the new 
Screening Visit and/or randomization. 
 
 
 
 
  
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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-IPs. 
7.1 
Study Interventions Administered 
The selection and timing of dose for each participant is presented in in Table 7.1-1. 
Table 7.1-1: 
Study Interventions 
Arm Name 
Deucravacitinib  
(BMS-986165) 
Placebo  
Intervention Name 
Deucravacitinib  
(BMS-986165) 
Placebo for deucravacitinib 
Type  
Drug  
Drug 
Dose Formulation 
Tablet 
Placebo tablet to match 
deucravacitinib 
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. 
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AxMP, auxiliary medicinal products; IMP, investigational medicinal product; n/a, not applicable; 
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. 
 
 
 
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. 
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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, but the investigator always has ultimate authority for the decision to unblind. 
The actual task of unblinding can be delegated by the investigator to a designee assigned the task 
on the Delegation of Authority. The Principal Investigator or appointed designee should only 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 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 IP is only dispensed to study participants. 
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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 appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before use of the study intervention. 
• The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records). 
• Further guidance and information for 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, 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 Case 
Report Form (CRF). 
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 CRF. 
7.7 
Concomitant Therapy 
7.7.1 
Prohibited and/or Restricted Treatments 
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 studies for COVID-19, 
including investigational COVID-19 vaccination studies that are not authorized or approved 
by relevant Health Authorities, should not participate in BMS clinical studies 
• Use of any medications/therapy that would aggravate psoriasis. These include agents such as 
lithium, antimalarials (quinacrine, chloroquine, and hydroxychloroquine), propranolol, 
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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 D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, 
pimecrolimus, and tacrolimus) and intralesional corticosteroids. 
• Any medicated shampoos that contain corticosteroids, coal tar, > 3% salicylic acid, or 
vitamin D3 analogues 
 
 
 
• 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 if neither the medication nor 
the medical condition meet exclusion criteria as detailed in Section 6.2. Dose adjustments of these 
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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. 
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. 
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7.8 
Continued Access to Study Intervention After the End of the Study 
At the end of the study, BMS will not continue to provide BMS-supplied study intervention to 
participants/investigators unless BMS chooses to extend the study. The investigator should ensure 
that 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 involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness. 
Note: Under specific circumstances and only in countries where local regulations permit, a 
participant who has been imprisoned may be permitted to continue as a participant. Strict 
conditions apply, and BMS approval is required 
• 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 
(Section 9.2.6) 
 
 
 
• 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. 
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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 CRF page. 
8.1.1 
Temporary Discontinuation from Study Intervention 
Temporary study intervention discontinuation is only allowed if the participant develops an AE 
which, in the opinion of the investigator, indicates that it is in the participant’s best interest that 
the study intervention be placed on hold. Study intervention in this situation should be stopped 
until the AE is medically treated and has resolved per investigator’s judgement. 
Temporary interruption of study treatment should be implemented in the context of clinical 
suspicion for SARS-CoV-2 or a positive diagnostic test for SARS-CoV-2. When study treatment 
is interrupted in a confirmed case of SARS-CoV-2, the investigator, in consultation with the 
Medical Monitor, should determine whether the resolution of symptoms alone (ie, without repeat 
diagnostic testing for SARS-CoV-2) is sufficient to resume study treatment. 
Temporary interruption of study intervention may be considered in the event of SARS-CoV-2 
vaccination according to local guidelines. 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 on 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 5 until the conclusion of the study. 
8.2 
Discontinuation From the Study 
Participants who request to discontinue study intervention will remain in the study and must 
continue to be followed for protocol-specified follow-up procedures. The only exception to this is 
when a participant specifically withdraws consent for any further contact with him/her or persons 
previously authorized by participant to provide this information. 
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• Participants should notify the investigator of the decision to withdraw consent from future 
follow-up. 
• The withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is from further treatment with study intervention 
only or also from study procedures and/or post-treatment study follow-up, and entered on the 
appropriate CRF page. 
• In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law. 
• If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
8.2.1 
Individual Discontinuation Criteria 
• A participant may withdraw completely from the study at any time at his/her own request, or 
may be withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. This is expected to be uncommon. Stopping study 
intervention is not considered withdrawal from the study. 
• At the time of discontinuing from the study, if possible, an early termination visit should be 
conducted, as shown in the Schedule of Activities (Section 2). See the Schedule of Activities 
(Section 2) for data to be collected at the time of study discontinuation and follow-up and for 
any further evaluations that need to be completed. 
• The participant will be permanently discontinued both from the study intervention and from 
the study at that time. 
• If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
8.3 
Lost to Follow-up 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant. 
• Lost to follow-up is defined by the inability to reach the participant after a minimum of 
3 documented phone calls, faxes, or emails, as well as lack of response by participant to 
1 registered mail letter. All attempts should be documented in the participant’s medical 
records. 
• If 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. 
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• 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). 
• 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. 
 
 
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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 0–4 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 
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. 
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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 
Physician Global Assessment-Fingernails (PGA-F) 
In this assessment,33 the overall condition of the fingernails is rated on a 5-point scale:  
0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. 
The Physician Global Assessment-Fingernails (PGA-F) will be performed only in participants 
with psoriatic fingernail involvement to assess severity and subsequent improvement. The PGA-F 
should be performed by a dermatologist or appropriately training investigator who is experienced 
in the assessment of psoriasis patients. 
9.1.1.6 
Palmoplantar PGA (pp-PGA) 
This measure will be used for participants with palmoplantar involvement.34 The palmoplantar 
Physician Global Assessment (pp-PGA) uses a 5-point (0-4) scale: 
0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe.  
The pp-PGA should be performed by a dermatologist or appropriately trained investigator who is 
experienced in the assessment of psoriasis patients. 
9.1.1.7 
Intertriginous-area s-PGA (I-s-PGA) 
The intertriginous-area s-PGA (I-s-PGA) is a 5-point scale of an average assessment of 
intertriginous psoriatic lesions based on erythema, scale, and induration.35 It is not necessary that 
all 3 criteria be fulfilled. The I-s-PGA score is based on a combination of erythema and the 
secondary features (plaque elevation and/or scale). Since erythema is the most robust finding, it 
should be the dominant feature influencing the I-s-PGA rating in the majority of cases. This 
intertriginous-area specific 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). Intertriginous skin, also known as skin folds, are sites in which 
opposing skin surfaces come into contact while at rest, resulting in chronic skin occlusion. The 
primary intertriginous skin areas include the groin folds, axillae, gluteal cleft and perianal area. 
Body habitus may contribute to additional intertriginous sites, such as inframammary skin and 
abdominal folds. All I-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 
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performed the I-s-PGA evaluations for a participant at randomization performs the I-s-PG for that 
participant at all subsequent visits. 
9.1.1.8 
s-PGA of Genitalia (s-PGA-G) 
The s-PGA of Genitalia (s-PGA-G) is the clinician’s determination of the participant’s psoriasis 
lesions’ overall severity in the genital area (labia majora, labia minora, and perineum in females; 
penis, scrotum, and perineum in males) at a given timepoint. Overall, lesions are categorized by 
descriptions for elevation, erythema, and scaling.36 It is not necessary that all 3 criteria be fulfilled. 
The s-PGA-G score is based on a combination of erythema and the secondary features (plaque 
elevation and/or scale). Since erythema is the most robust finding, it should be the dominant feature 
influencing the s-PGA-G rating in the majority of cases. For the analysis of responses, the patient’s 
psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe 
(5). All s-PGA-G assessments should be performed by a trained physician (eg, dermatologist) or 
appropriately trained investigator who is experienced in the assessment of psoriasis patients. Every 
effort should be made to ensure that the physician or designee who performed the s-PGA-G 
evaluations for a participant at randomization performs the s-PGA-G for that participant at all 
subsequent visits. 
9.1.1.9 
Static Physician Global Assessment for the Face (sf-PGA) 
The static Physician Global Assessment for the face (sf-PGA) of face is a 5-point scale of an 
average assessment of all psoriatic lesions based on erythema, scale, and induration only on the 
face. The sf-PGA of face 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 sf-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 sf-PGA evaluations for a participant at randomization performs the sf-PGA for that 
participant at all subsequent visits. 
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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.  
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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. 
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 CRF module. 
• All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as indicated 
in APPENDIX 3. 
• The investigator will submit any updated SAE data to the Sponsor or designee within 24 hours 
of updated information being available. 
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
However, if the investigator learns of any SAE, including a death, at any time after a participant 
has been 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 judgement in the context of known 
AEs, when appropriate for the program or protocol. 
9.2.4 
Follow-up of AEs and SAEs 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see APPENDIX 3). 
• Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate. 
• All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, 
 will be 
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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. 
• 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. 
9.2.7 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page or SAE eCRF, as appropriate. Paper forms are only intended as a back-up option when the 
electronic system is not functioning. 
• Any laboratory test result that is clinically significant or meets the definition of an SAE 
• Any laboratory test result abnormality that required the participant to have study intervention 
discontinued or interrupted 
• Any laboratory test result abnormality that required the participant to receive specific 
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). 
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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 (alanine aminotransferase [ALT] or aspartate aminotransferase [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. 
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, vital signs, 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. 
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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 
Vital signs include (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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9.10 
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 s-PGA ≥ 3 at baseline. 
The statistical hypotheses associated with the primary endpoint (DLQI 0/1) and the secondary 
endpoints (at least a 4-point reduction from baseline in DLQI, whole-body itch NRS score and s-
PGA 0/1 [s-PGA ≥ 3 Sub-Population only]), will be formally tested in each population group 
 
. 
10.1 
Statistical Hypotheses 
The primary hypotheses for the study are that the odds of achieving DLQI 0/1 at Week 16 in 
participants receiving deucravacitinib 6 mg QD are improved compared to participants receiving 
placebo on both the Overall Population and s-PGA ≥ 3 Sub-Population. 
The null hypotheses to be tested for the primary endpoint are the following: 
• The odds of achieving DLQI 0/1 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 DLQI 0/1 at Week 16 in participants receiving deucravacitinib 6 mg 
QD are the same as participants receiving placebo on the s-PGA ≥ 3 Sub-Population. 
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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 4-point reduction from baseline in DLQI at Week 16 in 
participants receiving deucravacitinib 6 mg QD are the same as participants receiving placebo. 
• The mean change from baseline in whole-body itch NRS score at Week 16 in participants 
receiving deucravacitinib 6 mg QD is not different from participants receiving placebo. 
s-PGA ≥ 3 Sub-Population: 
• The odds of achieving at least a 4-point reduction from baseline in DLQI at Week 16 in 
participants receiving deucravacitinib 6 mg QD are the same as participants receiving placebo. 
• The mean change from baseline in whole-body itch NRS score 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. 
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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 
DLQI 0/1 
All randomized participants with baseline s-PGA ≥ 3; all available data 
up to Week 16 database lock. Participants who discontinue 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 discontinue 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 with baseline s-PGA ≥ 3; all available data 
up to Week 16 database lock. Participants who discontinue prior to 
Week 16 will be imputed as non-responders in the analysis dataset. 
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Defined Analysis Data Sets 
Description 
Analysis set for secondary estimand of 
≥ 4-point reduction in DLQI from 
baseline 
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 discontinue 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 
whole-body itch NRS 
All randomized participants; all available data up to Week 16 database 
lock. Participants who discontinue 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 with baseline s-PGA ≥ 3; all available data 
up to Week 16 database lock. Participants who discontinue 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. 
DLQI, Dermatology Life Quality Index; FAS, Full Analysis Set; NRS, Numerical Rating Scale; s-PGA, static 
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 (CSR), including subgroups of age, gender, 
race and other study specific populations and demographic characteristics. A description of 
participant disposition will also be included in the CSR. 
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. 
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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 16 through Week 52) 
The primary endpoint, DLQI 0/1 response, is defined as a proportion of participants achieving 
DLQI score of 0 or 1 at Week 16. The key secondary endpoints assessed at Week 16 are ≥ 4-point 
reduction from baseline in DLQI, change from baseline in whole-body itch NRS score and s-PGA 
0/1 response. 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 
DLQI 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 
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 DLQI 0/1 
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Table 10.4.1-1: 
Definition of Estimands for Primary and Key Secondary Endpoints 
Key Secondary Endpoints 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus placebo 
Population 
FAS population and FAS sub-population 
Variable 
≥ 4-point reduction from baseline in DLQI 
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 ≥ 4-point reduction from baseline in DLQI 
Estimand Attribute 
Definition 
Treatment 
Deucravacitinib 6 mg QD versus placebo 
Population 
FAS population and FAS sub-population 
Variable 
Change from baseline in whole-body itch NRS score 
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. 
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Table 10.4.1-1: 
Definition of Estimands for Primary and Key Secondary Endpoints 
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 
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 
DLQI, Dermatology Life Quality Index; FAS, Full Analysis Set; ICE, intercurrent event; NRS, Numerical Rating 
Scale; QD, once daily; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; s-PGA, static Physician 
Global Assessment.  
 
10.4.2 
Primary Endpoint(s) 
Table 10.4.2-1: 
Primary Endpoint 
Primary Endpoint 
Description 
Timeframe 
DLQI 0/1 
Proportion of participants achieving 
DLQI score of 0 or 1 
Week 16 
DLQI, Dermatology Life Quality Index. 
 
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Table 10.4.2-2: 
Summary of Primary Endpoint 
Endpoint 
Statistical Analysis Methods 
DLQI 0/1 
response rate 
is defined as a 
proportion of 
participants 
with a DLQI 
score 0 or 1 
The analysis model for the primary endpoint, DLQI 0/1 (responder/non-responder) at Week 16, 
will use a stratified CMH test 
 
 to compare the response rates of deucravacitinib 6 mg QD to placebo 
using the Week 16 data of the FAS population as well as the FAS subgroup where baseline 
s-PGA ≥ 3. If expected cell counts are not sufficient for each strata level, then strata levels 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. 
 CI, confidence interval; CMH, Cochran-Mantel-Haenszel; DLQI, Dermatology Life Quality 
Index; NRI, non-responder imputation; QD, once daily; SAP, statistical analysis plan; s-PGA, static Physician Global 
Assessment. 
10.4.3 
Secondary Endpoint(s) 
Table 10.4.3-1: 
Summary of Key Secondary Endpoints 
Endpoint 
Statistical Analysis Methods 
Time Frame 
≥ 4-point 
reduction from 
baseline in 
DLQI is 
defined as a 
proportion of 
participants 
achieving at 
least a 4-point 
reduction from 
baseline in 
DLQI  
The analysis model for ≥ 4-point reduction from baseline in DLQI 
(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. If expected cell counts are not sufficient for each strata 
level, then strata levels will be combined for the analysis. The odds ratio 
(ratio of odds in deucravacitinib BMS-986165 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 
whole-body itch 
NRS score 
The analysis model for the continuous secondary endpoint, change from 
baseline in whole-body itch NRS at Week 16, will use ANCOVA with 
intervention 
 
. 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% 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 
Proportion of 
participants 
with a s-PGA 
score of 0 
The analysis model for the secondary endpoint, s-PGA 0/1 (responder/non-
responder) at Week 16, will use a stratified CMH) test 
 
 to 
compare the response rates of deucravacitinib 6 mg QD to placebo using the 
Week 16 
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Endpoint 
Statistical Analysis Methods 
Time Frame 
(clear) or 1 
(almost clear) 
with at least a 
2-point 
reduction from 
baseline. 
Week 16 data of the FAS sub-population 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.  
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. 
ANCOVA, analysis of covariance; 
 CI, confidence interval; CMH, Cochran-Mantel-Haenszel; 
DLQI, Dermatology Life Quality Index; FAS, Full Analysis Set; NRI, non-responder imputation; NRS, numerical 
rating scale; QD, once daily; s-PGA, static Physician Global Assessment. 
 
10.4.5 
Safety Analysis 
Safety data will be analyzed for AEs, SAEs, laboratory parameters, and vital signs. 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, SAEs, deaths, AEs leading to study intervention discontinuation, 
 
 will be summarized by the Medical Dictionary for Regulatory Activities (MedDRA) system 
organ class and preferred term. 
10.4.5.2 
Vital Signs 
Vital signs 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. 
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10.5 
Interim Analyses 
Not applicable. 
10.6 
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 
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34  Bissonnette R, Pariser DM, Wasel NR, et al. Apremilast, an oral phosphodiesterase-4 inhibitor, 
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35  Lebwohl M, Papp K, Stein Gold L, et al. Trial of roflumilast cream for chronic plaque psoriasis. 
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2017;16(8):793-799. 
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50 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 
 
 
 
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 
AxMP 
auxiliary medicinal product 
BID 
twice daily 
BMI 
body mass index 
BMS 
Bristol-Myers Squibb Company 
BP 
blood pressure 
BSA 
body surface area 
 
 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
 
 
CMH  
Cochran-Mantel-Haenszel 
COVID-19 
coronavirus disease 2019 
CRF 
Case Report Form 
CSR 
clinical study report 
CTAg 
Clinical Trial Agreement 
CYP450  
cytochrome P450 
 
 
DILI 
drug-induced liver injury 
 
 
DLQI 
Dermatology Life Quality Index 
DNA 
deoxyribonucleic acid 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
e-diary 
electronic diary 
 
 
 
 
EOT 
end of treatment 
ET 
early termination 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
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Term 
Definition 
FSH 
follicle-stimulating hormone 
 
 
 
 
GCP 
Good Clinical Practice 
GIC-SI 
Global Impression of Change-Scalp Itch 
 
 
 
 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
 
 
hCG 
human chorionic gonadotropin 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HRQoL 
health-related quality of life 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
ICE 
intercurrent events 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IFN 
interferon 
 
 
 
 
IL 
interleukin 
IMP 
investigational medicinal product 
IP 
investigational product 
IRT 
interactive response technology 
I-s-PGA 
Intertriginous-area static Physician Global Assessment 
IUS 
intrauterine hormone-releasing system 
JAK 
Janus kinase 
LAM 
lactational amenorrhea method 
 
 
 
 
MCT 
meaningful change threshold 
 
 
 
 
MedDRA 
Medical Dictionary for Regulatory Activities 
n/a 
not applicable 
 
 
NIMP 
non-investigational medicinal product 
 
 
NRI 
non-responder imputation 
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Term 
Definition 
NRS 
Numerical Rating Scale 
PASI 
Psoriasis Area and Severity Index 
 
 
PBO 
placebo 
 
 
 
 
PE 
physical examination 
PGA-F 
Physician Global Assessment-Fingernails 
PGA-G 
Physician Global Assessment-Genitals 
 
 
 
 
 
 
 
 
PK 
pharmacokinetics 
 
 
pp-PGA 
palmoplantar Physician Global Assessment 
PRO 
patient-reported outcome 
 
 
 
PSO 
psoriasis 
 
 
QD 
once daily 
QoL 
quality of life 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
 
 
 
 
sf-PGA 
static face Physician Global Assessment 
s-PGA 
static Physician Global Assessment 
s-PGA-G 
static Physician Global Assessment Genitalia 
SSC 
Study Steering Committee 
ss-PGA 
scalp-specific Physician Global Assessment 
STAT 
signal transducer and activator of transcription 
 
 
 
 
TB 
tuberculosis 
TNF 
tumor necrosis factor 
TSQM 
Treatment Satisfaction Questionnaire for Medication 
TYK2 
tyrosine kinase 2 
 
 
ULN 
upper limit of normal 
US 
United States 
UV 
ultraviolet 
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Term 
Definition 
 
 
WOCBP 
women of childbearing potential 
 
 
 
 
 
 
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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
The terms “participant” and “subject” refer to a person who has consented to participate in the 
clinical research study. Typically, the term “participant” is used in the protocol and the term 
“subject” is used in the Case Report Form (CRF). 
REGULATORY AND ETHICAL CONSIDERATIONS 
This study will be conducted in accordance with: 
• Consensus ethical principles derived from international guidelines, including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences 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 study (eg, reliability and 
robustness of generated data). Items (1) or (2) can be associated with either GCP regulation(s) or 
study protocol(s). 
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks. 
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE 
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, Investigator’s Brochure, product labeling information, ICF, 
participant recruitment materials (eg, advertisements), and any other written information to be 
provided to participants. 
The investigator, Sponsor, or designee should provide the IRB/IEC with reports, updates, and other 
information (eg, expedited safety reports, amendments, administrative letters) annually, or more 
frequently, in accordance with regulatory requirements or institution procedures. 
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The investigator is responsible for providing oversight of the conduct of the study at the site and 
adherence to requirements of the following where applicable: 
• ICH guidelines, 
• United States Code of Federal Regulations, Title 21, Part 50 (21 CFR 50) 
• 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 Company (BMS). 
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the ICF must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from participants 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new participants prior to enrollment. 
FINANCIAL DISCLOSURE 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information, in accordance with regulations, to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate Health Authorities. Investigators 
are responsible for providing information on financial interests during the 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 the 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. 
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 United States (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. 
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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. 
Participants who are unable to give their written informed consent (eg, due to stroke or participants 
with severe dementia) may only be enrolled in the study with the consent of a legally acceptable 
representative. The participant must also be informed about the nature of the study to the extent 
compatible with his or her understanding, and should this participant become capable, he/she 
should personally sign and date the ICF as soon as possible. The explicit wish of a participant who 
is unable to give his or her written consent, but who is capable of forming an opinion and assessing 
information to refuse participation in, or to be withdrawn from, the clinical study at any time, 
should be considered by the investigator. 
The rights, safety, and well-being of the study participants are the most important considerations 
and should prevail over interests of science and society. 
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS 
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases.  
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes. 
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical study becomes more reflective of the real-world population and the people impacted 
by the diseases studied. 
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY 
BMS collects and processes personal data of study participants, patients, health care providers, 
and researchers for biopharmaceutical research and development to advance innovative, 
high-quality medicines that address the medical needs of patients. BMS ensures the privacy, 
protection, and confidentiality of such personal data to comply with applicable laws. To achieve 
these goals, BMS has internal policies that indicate measures and controls for processing personal 
data. BMS adheres to these standards to ensure that collection and processing of personal data are 
limited and proportionate to the purpose for which BMS collects such personal data. This purpose 
is clearly and unambiguously notified to the individual at the time of collection of personal data. 
In the true 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 
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pharmacovigilance activities on key-coded health data transferred by BMS across national borders 
is done in compliance with the relevant data protection laws in the country and GCP requirements. 
BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of its 
processing. 
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data. 
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 
adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information:  
1. Responsibilities of IT Personnel 
2. Securing the BMS Digital Infrastructure 
3. Identity and Access Management 
4. External Partner Connections 
5. Cyber Threat Detection and Response 
6. Internal Cyber Incident Investigation 
 
SOURCE DOCUMENTS 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site. 
Data reported on the CRF or entered in the electronic CRF (eCRF) that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be explained. 
• The investigator may need to request previous medical records or transfer records, depending 
on the study. Also, current medical records must be available. 
• Definitions of what constitutes source data can be found in the source data location list/map or 
equivalent document. 
The investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original, and attributable, whether the data are handwritten on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical study activities, such systems must be compliant with all 
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applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical records/electronic health 
records, adverse event (AE) tracking/reporting, protocol-required assessments, and/or drug 
accountability records. 
When paper records from such systems are used in place of an electronic format to perform 
regulated activities, such paper records should be certified copies. A certified copy consists of a 
copy of original information that has been verified, as indicated by a dated signature, as an exact 
copy having all of the same attributes and information as the original. 
STUDY INTERVENTION RECORDS 
Records for study intervention (whether supplied by BMS, its vendors, or the site) must 
substantiate study intervention integrity and traceability from receipt, preparation, administration, 
and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority. 
If 
Then 
Supplied by BMS (or its vendors): 
Records or logs must comply with applicable 
regulations and guidelines and should include: 
• amount received and placed in storage area 
• amount currently in storage area 
• label identification number or batch number 
• amount dispensed to and returned by each 
participant, including unique participant 
identifiers 
• amount transferred to another area/site for 
dispensing or storage 
• nonstudy disposition (eg, lost, wasted) 
• amount destroyed at study site, if applicable 
• amount returned to BMS 
• retain samples for 
bioavailability/bioequivalence/biocomparability, 
if applicable 
• dates and initials of person responsible for 
Investigational Product 
dispensing/accountability, as per the Delegation 
of Authority Form 
Sourced by site and not supplied by BMS 
or 
its 
vendors 
(examples 
include 
Investigational Product 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 
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BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements. 
CASE REPORT FORMS 
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents, or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study. 
For sites using the Sponsor or designee electronic data capture (EDC) tool, eCRFs will be prepared 
for all data collection fields except for fields specific to serious adverse events (SAEs) and 
pregnancy, which will be reported on the electronic SAE form and Pregnancy Surveillance Form, 
respectively. If the electronic SAE form is not available, a paper SAE form can be used. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF and SAE/pregnancy CRFs must be promptly reviewed, signed, and dated by 
the investigator or qualified physician who is a sub-investigator and who is delegated this task on 
the Delegation of Authority Form. Sub-investigators in Japan may not be delegated the CRF 
approval task. The investigator must retain a copy of the CRFs, including records of the changes 
and corrections. 
Each individual electronically signing eCRFs must meet Sponsor or designee training 
requirements and must only access the BMS EDC tool using the unique user account provided by 
the Sponsor or designee. User accounts are not to be shared or reassigned to other individuals. 
MONITORING 
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan. 
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. 
Certain CRF pages and/or electronic files may serve as the source documents. 
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In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to CRFs, source documents, other study files, 
and study facilities. BMS audit reports will be kept confidential. 
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee. 
RECORDS RETENTION 
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or its designee, whichever is longer. 
The investigator (or head of the study site in Japan) must contact BMS prior to destroying any 
records associated with the study. 
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 
Investigational Medicinal Product (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. 
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If 
Then 
Study treatments sourced by site, not 
supplied by BMS (or its vendors; eg, study 
treatments sourced from the site’s stock or 
commercial supply or a specialty pharmacy) 
It 
is 
the 
investigator’s 
or 
designee’s 
responsibility to dispose of all containers 
according to the institutional guidelines and 
procedures. 
It is the investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met: 
• On-site disposal practices must not expose humans to risks from the drug. 
• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
• 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 study 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 nonstudy 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee. 
STUDY AND SITE CLOSURE 
The Sponsor/designee reserves the right to close the study site or to terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies have 
been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
• Reasons for the early closure of a study site by the Sponsor or investigator may include, but 
are not limited to, the following: 
• For study termination: 
• Discontinuation of further study intervention development 
• For site termination: 
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• Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local Health Authorities, the Sponsor’s procedures, or GCP guidelines 
• Inadequate or no recruitment (evaluated after a reasonable amount of time) of participants by 
the investigator 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
DISSEMINATION OF CLINICAL STUDY DATA 
In order to benefit potential study participants, patients, healthcare providers and researchers, and 
to help BMS honor its commitments to study participants, BMS will make information about 
clinical research studies and a summary of their results available to the public as per regulatory 
and BMS requirements. BMS will post-study information on local, national or regional databases 
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 study 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 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. 
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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 
investigator, sub-investigator, or any other member of the study staff without the prior written 
consent of the Sponsor. 
Authorship of publications at Sponsor is aligned with the criteria of the International Committee 
of Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon 
significant contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE 
criteria for authorship: 
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the 
work (eg, problem solving, advice, evaluation, insights and conclusion); AND 
2) Drafting the work or revising it critically for important intellectual content; AND 
3) Final approval of the version to be published; AND 
4) Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
Those who make the most significant contributions, as defined above, will be considered by BMS 
for authorship of the primary publication. Sub-investigators will generally not be considered for 
authorship in the primary publication. Geographic representation will also be considered. 
Authors will be listed by order of significant contributions (highest to lowest), with the exception 
of the last author. Authors in first and last position have provided the most significant contributions 
to the work. 
For secondary analyses and related publications, author list and author order may vary from 
primary to reflect additional contributions. 
 
 
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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING 
ADVERSE EVENTS 
Adverse Event Definition: 
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a 
pre-existing medical condition in a clinical investigation participant administered study 
treatment that does not necessarily have a causal relationship with this treatment.  
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of study treatment, whether or 
not considered related to the study treatment. 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, electrocardiograms, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgement of the investigator. Note that abnormal lab tests or 
other safety assessments should only be reported as AEs if the final diagnosis is not 
available. Once the final diagnosis is known, the reported term should be updated to be the 
diagnosis. 
• Exacerbation of a chronic or intermittent pre-existing condition, including either an increase 
in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration, even though 
it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator), 
should not be reported as an AE/serious adverse event (SAE) unless it is an intentional 
overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae and should specify “intentional overdose” as the verbatim 
term. 
Events NOT Meeting the AE Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy); the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE, even if serious conditions 
are met. 
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SERIOUS ADVERSE EVENTS 
An 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 Company 
(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 judgement, 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).  
Pregnancy and DILI must follow the same transmission timing and processes to BMS as used for 
SAEs (see Section 9.2.6 for reporting pregnancies). 
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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 judgement to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration, 
will be considered and investigated. 
• The investigator will also consult the Investigator’s Brochure and/or product information for 
marketed products in his/her assessment. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to the Sponsor. 
• The investigator may change his/her opinion of causality in light of follow-up information 
and send an SAE follow-up report with the updated causality assessment. 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
• Assessment of Intensity 
The investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to 1 of the following categories: 
• Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not 
interfering with everyday activities. 
• Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities. 
• Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with an SAE. Severe is a category utilized for rating the intensity of 
an event, and both AEs and SAEs can be assessed as severe. 
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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. 
FOLLOW-UP OF AES AND SAES 
If only limited information is initially available, follow-up reports are required. (Note: Follow-up 
SAE reports must include the same investigator term[s] initially reported) 
If an ongoing SAE changes in its intensity or relationship to study treatment or if new information 
becomes available, the SAE report must be updated and submitted within 24 hours to BMS (or 
designee) using the same procedure used for transmitting the initial SAE report. 
All SAEs must be followed to resolution or stabilization. 
REPORTING OF SAES TO SPONSOR OR DESIGNEE 
• SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event. 
• SAEs must be recorded on the SAE Report Form. 
The required method for SAE data reporting is through the electronic case report form (eCRF). 
The paper SAE Report Form is intended only as a back-up option when the electronic data 
capture system is unavailable/not functioning for transmission of the eCRF to BMS (or 
designee). 
In this case, the paper form is transmitted via email or confirmed facsimile transmission. 
When paper forms are used, the original paper forms are to remain on site. 
• Pregnancies must be recorded on paper Pregnancy Surveillance Forms and transmitted via 
email or confirmed facsimile transmission. 
SAE Email Address: worldwide.safety@BMS.com 
SAE Facsimile Number: Will be provided by local site monitor. 
SAE Telephone Contact (required for SAE and pregnancy reporting): Will be provided by local 
site monitor. 
 
 
 
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APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION 
Appendix 4 provides general information and definitions related to Woman of Childbearing 
Potential (WOCBP) and methods of contraception that can be applied to most clinical studies. 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 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Women in the following categories are not considered WOCBP: 
• Premenarchal 
• Premenopausal female with 1 of the following: 
• Documented hysterectomy 
• Documented bilateral salpingectomy 
• Documented bilateral oophorectomy 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
• Postmenopausal female 
A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 45 years in 
the absence of other biological or physiological causes. In addition, females under the age of 
55 years must have a serum follicle-stimulating hormone (FSH) level > 40 mIU/mL to confirm 
menopause. 
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used. Suggested 
guidelines for the duration of the washout periods for HRT types are presented below. Investigators 
should use their judgement in checking serum FSH levels. 
• 1-week minimum for vaginal hormonal products (rings, creams, gels) 
• 4-week minimum for transdermal products 
• 8-week minimum for oral products 
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. 
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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 
• Bilateral tubal occlusion. 
• Vasectomized partner 
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Having a vasectomized partner is a highly effective contraception method provided that the 
partner is the sole male sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be used.  
A vasectomy is a highly effective contraception method provided that the participant is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used.  
• Sexual abstinence. 
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant. 
• Continuous abstinence must begin at least 30 days prior to initiation of study therapy. 
• It is not necessary to use any other method of contraception when complete abstinence is 
elected. 
• WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2. 
• Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence. 
• 
Periodic abstinence (including, but not limited to, calendar, symptothermal, postovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea 
method (LAM) are not acceptable methods of contraception for this study.  
NOTES: 
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the IMP and other study medications will not alter hormonal exposures such that contraception 
would be ineffective or result in increased exposures that could be potentially hazardous. In this case, alternative 
methods of contraception should be utilized. For information specific to this study regarding permissibility of 
hormonal contraception, refer to Section 6.1 INCLUSION CRITERIA and Section 7.7.1 PROHIBITED 
AND/OR RESTRICTED TREATMENTS of the protocol. 
c IUSs are acceptable methods of contraception in the absence of definitive drug interaction studies when hormone 
exposures from intrauterine devices do not alter contraception effectiveness. For information specific to this 
study regarding permissibility of hormonal contraception, refer to Section 6.1 INCLUSION CRITERIA and 
Section 7.7.1 PROHIBITED AND/OR RESTRICTED TREATMENTS 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. 
 
 
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APPENDIX 7 
PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY 
Overall Rationale for Protocol Amendment 01, 21-Nov-2022 
The protocol has been revised to add 
collection at Day 1 (baseline), Week 16, 
Week 24, and Week 52. The duration that participants will wear the wristwatch increased from 
7 days to 14 days prior to each data collection timepoint. 
Summary of Changes for Protocol Amendment 01 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Title Page 
Correction of phone number and zip code 
for 
 address 
Updated contact information 
Schedule of Activities 
(Table 2-2) 
Timepoint of Week −1/Day –7 was changed 
to Week −2/Day −14 
To reflect current 14-day collection of 
sleep data prior to Day 1 
Schedule of Activities 
(Table 2-2 and  
Table 2-3)  
Section 3.1 
Study Rationale 
 
The following text was added to reflect FDA 
approval:  
“The US Food and Drug Administration 
(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 5.1.2 
Intervention Period  
 
The period that participants will wear the 
wristwatch was increased from 7 days to 14 
days before all wear periods (ie, prior to Day 
1, Week 16, and Week 52). Language 
To clarify that the wearable is a 
wristwatch and to gather more data to 
better assess the impact of 
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Summary of Changes for Protocol Amendment 01 
Section Number & 
Title 
Description of Change 
Brief Rationale 
Section 6.3.1  
Meals and Dietary 
Restrictions 
Section 9.2.5 
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 
All 
Minor formatting and typographical 
corrections 
Minor edits made to improve overall 
readability, consistency, etc 
 
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