A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Phase: PHASE3
Conditions: Psoriatic Arthritis
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the 
Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis (PsA) who 
are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received 
TNFα Inhibitor Treatment 
 
NCT Number: NCT04908189 
Document Date (Date in which document was last revised): 20 March 2022 
 
 
 

Page:
1
Protocol Number:
IM011055
Date:
12-Mar-2021
Revised Date:
20-Mar-2022
REGULATORY AGENCY IDENTIFIER NUMBER(S)
IND: 137,445
EudraCT: 2020-005099-36
UTN: U1111-1259-9466
CLINICAL PROTOCOL IM011055
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the 
Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis (PsA) who 
are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received 
TNFα Inhibitor Treatment
Protocol Amendment Number 01
Short Title:
Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active 
Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or 
had Previously Received TNFα Inhibitor Treatment
Medical Monitoring Contact Information
 Clinical Scientist
Bristol-Myers Squibb Company
86 Morris Avenue
Summit, NJ 07901
Telephone (office): 
Email: 
Clinical Trial Physician - Medical Monitor
Bristol-Myers Squibb Company
86 Morris Avenue
Summit, NJ 07901
Telephone (office): 
 
Email: 
 Clinical Scientist
Bristol-Myers Squibb Company
86 Morris Avenue
Summit, NJ 07901
Telephone (office):
Email:
Clinical Trial Physician - Medical Monitor
Bristol-Myers Squibb Company
3401 Princeton Pike
Lawrenceville, NJ 08648
Telephone (office):
Email: 
24-hr Emergency Telephone Number
USA: 
International: 
Japan: 
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Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Protocol Amendment No.: 01
Date: 20-Mar-2022
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Bristol-Myers Squibb Company
Route 206 & Province Line Road
Lawrenceville, NJ 08543
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
6-5-1 Nishi-Shinjuku, Shinjuku-ku,
Tokyo, 163-1327, Japan
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company and its global affiliates (BMS). 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. All other rights reserved. References to BMS in this protocol may apply 
to partners to which BMS has transferred obligations, eg, a Contract Research Organization 
(CRO).
© 2022 Bristol-Myers Squibb Company
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BMS-986165
Deucravacitinib
Protocol Amendment No.: 01
Date: 20-Mar-2022
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DOCUMENT HISTORY
Document
Date of Issue
Summary of Change
Protocol Amendment 
01
20-Mar-2022
 
 
 
 
 
 
 
 
 
 
 
Original Protocol
12-Mar-2021
Not applicable
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BMS-986165
Deucravacitinib
 
 
 
 
 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Title Page
Updated contact information.
Updated due to administrative changes.
Section 1: 
Synopsis
Updated section with applicable 
changes made as described 
below throughout the body.
Updated for consistency across the 
protocol.
Table 2-1: 
Screening 
Procedural 
Outline 
(IM011055)

Added body weight to 
height row.

Updated adverse event 
(AE) and serious adverse 
event (SAE) assessment 
note.

Added for creatinine clearance 
calculation.

To clarify reporting and follow-
up of all AEs and SAEs, and 
severe acute respiratory 
syndrome coronavirus 2 
(SARS-CoV-2)-related AEs and 
SAEs.
Table 2-2: 
Procedural 
Outline: Baseline 
through Week 16 
(IM011055)

Updated AE and SAE 
assessment note.

Added footnote “b” to 
Safety Assessments, 
eight-item Patient Health 
Questionnaire depression 
scale (PHQ-8), and 
electronic Columbia-
Suicide Severity Rating 
Scale (eC-SSRS)
assessments, noting 
these may be performed 
at unscheduled visits.

To clarify collection, reporting,
and follow-up of all AEs and 
SAEs, and severe acute 
respiratory syndrome 
coronavirus 2 (SARS-CoV-2)-
related AEs and SAEs.

To clarify that unscheduled 
visits study procedures should 
be based on the clinical 
judgment of the investigator, 
and that the PHQ-8 and 
eC-SSRS assessments are 
available at unscheduled safety 
visits if needed.
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Date: 20-Mar-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Table 2-3: 
Procedural 
Outline: Week 20 
through Week 56
(IM011055)

Added that Week 56 
Visit is 30 days after last 
dose.

Updated AE and SAE 
assessment note.

Added to the Pregnancy 
Test notes that telephone 
visits will be performed 
to obtain monthly 
pregnancy test results.

 
 
 
 
 
 
 
 
 
 
 

Updated footnote “b” to 
say that participants who 
discontinue from study 
treatment and request to 
discontinue from the 
study will be asked to 
complete an Early 
Termination (ET) Visit
and a Safety Follow-up 
Visit 30 days following 
last dose of study 
treatment. 
 
 
 

To clarify when visit will be 
performed.

To clarify collection, reporting,
and follow-up of all AEs and 
SAEs, 
and 
severe 
acute 
respiratory syndrome 
coronavirus 2 (SARS-CoV-2)-
related AEs and SAEs.

At-home pregnancy test kits will 
be provided to maintain monthly 
pregnancy 
testing 
between 
visits.

 
 
 

A participant will be asked to 
complete an ET Visit and a 
Safety Follow-up Visit 30 days 
following last dose.

 
 
 
 
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
 
 
 
 
 

Added footnote “d” that 
all participants must be 
evaluated for safety 30 
days following last dose 
of study treatment. 

Added footnote “e” to 
Safety Assessments, 
PHQ-8, and eC-SSRS 
assessments, noting 
these may be performed 
at unscheduled visits.

Added footnote “l” to 
state that at-home urine 
pregnancy test kits will 
be provided.

Added footnote “m” that 
states for participants 
who discontinue study 
treatment and continue 
in the study until Week 
52, 
 
 
.
 
 
 
 

All 
participants 
must 
be 
evaluated for safety 30 days 
following last dose of study 
treatment.

To clarify that unscheduled 
visits study procedures should 
be 
based 
on 
the 
clinical 
judgment of the investigator, 
and 
that 
the 
PHQ-8 
and 
eC-SSRS 
assessments 
are 
available at unscheduled safety 
visits if needed.

At-home pregnancy test kits will 
be provided to maintain monthly 
pregnancy 
testing 
between 
visits.

 
 
Section 3.1: 
Study Rationale
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Section 3.3: 
Benefit/Risk 
Assessment
Table 4-1: 
Objectives and 
Endpoints
Section 5.1: 
Overall Design
Figure 5.1-1: 
Study Design 
Schematic

 

Updated length of study.

Added text regarding 
rescue therapy and
discontinuation of study 
treatment.

 
 
Section 5.3: End 
of Study 
Definition
Section 6.1: 
Inclusion Criteria

Updated criterion 2) f) i)
with 
names
of 
conventional 
synthetic 
disease-modifying anti-
rheumatic 
drugs
(csDMARDs).

Updated criterion 3) a) 
viii)
to include study 
completion or 30 days 
after discontinuation of 
the 
study 
treatment, 
whichever is longer.

Criterion revised to clarify that 
failure or intolerance to one of 
the csDMARDs (methotrexate, 
sulfasalazine, 
leflunomide, 
hydroxychloroquine) listed will 
qualify a participant for the 
study.

Criterion revised to clarify time 
period 
for 
contraceptive 
requirements for participants 
completing all expected study 
visits 
on 
treatment 
versus 
participants who discontinue 
study treatment early but remain 
in the study for follow-up.
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Section 6.1.1: 
Inclusion Criteria 
at Week 52OLE
for the optional 
Open-label 
Long-term 
Extension Period
Section 6.2.1: 
Exclusion 
Criteria at Week 
52OLE for 
Optional Open-
label Long-term 
Extension Period
Added sections for 
inclusion/exclusion criteria for 
participants entering the 
optional OLE Period.
Updated to include optional OLE
Period.
Section 6.2: 
Exclusion 
Criteria

Added examples of 
bDMARDs that are 
excluded to criterion 2) 
a).

Added that criterion 2) 
g) is no longer 
applicable.

Added new criterion 2) 
y) with added details 
clarifying that systemic 
non-biologic 
medications and/or any 
systemic 
immunosuppressant 
therapy for psoriasis 
(PsO) and/or psoriatic 
arthritis (PsA) other than 
what is permitted in the 
inclusion criteria is 
within 28 days prior to 
Day 1.

Added new criterion 2) 
z) regarding use of 
traditional Chinese 
medicines.
Updated to provide examples of 
commonly prescribed medications that 
are excluded. 
Protocol Amendment No.: 01
Date: 20-Mar-2022
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IM011055
BMS-986165
Deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Protocol Amendment No.: 01
Date: 20-Mar-2022
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BMS-986165
Deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Section 7.7.2:
SARS-CoV-2 
Permitted 
Treatments
 
 
; therefore, the 
severe acute respiratory syndrome 
coronavirus 2 vaccination guidelines 
are aligned with key visits. 
Section 7.7.3.1: 
Prohibited 
Treatments

Updated that 
phototherapy, oral PsO 
medications, high-
potency glucocorticoids, 
and use of strong 
CYP450 inducers are 
prohibited up to Week 
52.

Clarified that oral 
vitamin D supplements 
are permitted.

Removed natalizumab 
and vedolizumab and 
added anti-IL-23 to list 
of immune-suppressing 
immunomodulatory 
agents that are 
prohibited.
Updated to clarify what is permitted for 
study participants and when.
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IM011055
BMS-986165
Deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Section 8.1: 
Discontinuation 
from Study 
Treatment
Section 9.4.5: 
Estimated 
Glomerular 
Filtration Rate
Modified text regarding 
estimated glomerular filtration 
rate.
Criterion revised to provide 
investigators and Medical Monitor the 
discretion to make a more informed 
decision and use clinical judgment to 
determine whether or not it is in the 
best interest of the participant to 
continue in the study while providing 
close oversight of the safety.
Section 8.1: 
Discontinuation 
from Study 
Treatment
Section 8.1.2: 
Post Study 
Treatment Study 
Follow-up
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BMS-986165
Deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Section 8.2: 
Discontinuation 
from the Study
Section 9.2.2: 
Time Period and 
Frequency for 
Collecting AE 
and SAE 
Information

Added language 
regarding collection of 
nonserious AEs.

Updated when SAEs and 
all AEs related to SARS-
CoV-2 infection must be 
collected.

Added to clarify time period 
nonserious AEs must be 
collected.

Updated to clarify they should 
be collected from the time of 
signing consent and within 30 
days of discontinuation of 
dosing or participants’ 
participation in the study if the 
last scheduled visit occurs at a 
later time.
Section 9.2.6: 
Pregnancy
Updated duration the 
investigator is required to notify 
the BMS Medical 
Monitor/designee of pregnancy.
To align with tyrosine kinase 
program-wide safety guidance on the 
collection of pregnancy information.
Section 9.4.4: 
Clinical Safety 
Laboratory 
Assessments
Added instruction to refer to 
Appendix 4 for detailed 
information on the definitions of 
women of childbearing potential 
(WOCBP) and post-menopausal 
female.
Added to clarify follicle-stimulating 
hormone analysis and definitions of 
WOCBP and post-menopausal female.
Section 9.4.8: 
Unscheduled 
Safety Visits
Added section for unscheduled 
safety visits.
To clarify that the protocol does not 
mandate specific investigations at 
unscheduled visits, and that study 
procedures at unscheduled visits should 
be based on the clinical judgment of the 
investigator. The PHQ-8 and eC-SSRS 
assessments are also available at 
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BMS-986165
Deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
unscheduled safety visits, if needed at 
the investigator’s discretion.
Section 10.3: 
Statistical 
Analyses
Added that a primary analysis 
will be conducted after the 
Week 56 database lock and 
treatment unblinding.
The planned submission activities rely 
only on safety and efficacy data 
collected through Week 52. Data that 
report the long-term safety profile and 
maintenance of efficacy after up to 
3 years of exposure to active treatment 
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IM011055
BMS-986165
Deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
 
 
 
Appendix 2: 
Study 
Governance 
Considerations

Added new sections, 
BMS Commitment to 
Diversity in Clinical 
Trials, Data Protection, 
Data Privacy, and Data 
Security, and 
Dissemination of 
Clinical Study Data.

Updated first paragraph 
in Monitoring section to 
include remote 
monitoring.
Updated to align with updated BMS 
policies and procedures.
Appendix 6: 
Subject 
Assessment of 
Disease Activity 
(Psoriatic 
Arthritis) Visual 
Assessment 
Scale
Appendix 7: 
Subject 
Assessment of 
Pain Scale 
(Psoriatic 
Arthritis)
Appendix 8: 
American 
College of 
Rheumatology 
Subject 
Assessment of 
Physical 
Function Scale: 
Health 
Assessment 
Updated participant-reported 
outcomes appendices.
Appendices have been modified to 
reflect the exact participant-facing text 
that the participant will see on the 
electronic Clinical Outcomes
Assessment device.
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BMS-986165
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Questionnaire 
(HAQ)
Appendix 9: 
Short Form 
Health Survey-36 
Item (SF-36)
Appendix 10: 
Functional 
Assessment of 
Chronic Illness 
Therapy Fatigue
Appendix 12: 
Dermatology 
Life Quality 
Index (DLQI)
Appendix 15: 
Work 
Productivity and 
Activity 
Impairment 
Questionnaire: 
Psoriatic 
Arthritis 
(WPAI:PsA)
Appendix 22: 
Interpretation of 
Hepatitis B 
Serologic Test 
Results
All
Minor formatting and 
typographical corrections.
Minor, therefore have not been 
summarized.
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TABLE OF CONTENTS 
 
 
TITLE PAGE ................................................................................................................ 
 
DOCUMENT HISTORY .............................................................................................. 
 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 01: ............................ 
 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 ................ 
 
TABLE OF CONTENTS .............................................................................................. 
 
1 SYNOPSIS ................................................................................................................. 
 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
 
3 INTRODUCTION ..................................................................................................... 
 
3.1 Study Rationale ................................................................................................. 
 
3.2 Background ....................................................................................................... 
 
3.3 Benefit/Risk Assessment .................................................................................. 
 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
 
5 STUDY DESIGN....................................................................................................... 
 
5.1 Overall Design .................................................................................................. 
 
5.1.1 Data Monitoring Committee 
 ................ 
 
5.1.1.1 Data Monitoring Committee ........................................................... 
 
 
 
 
 
 
 
5.2 Number of Participants ..................................................................................... 
 
5.3 End of Study Definition .................................................................................... 
 
5.4 Scientific Rationale for Study Design............................................................... 
 
5.5 Justification for Dose ........................................................................................ 
 
6 STUDY POPULATION ............................................................................................ 
 
6.1 Inclusion Criteria .............................................................................................. 
 
6.1.1 Inclusion Criteria at Week 52OLE for the Optional Open-label Long-
term Extension Period ................................................................................. 
 
6.2 Exclusion Criteria ............................................................................................. 
 
6.2.1 Exclusion Criteria at Week 52OLE for Optional Open-label Long-term 
Extension Period ......................................................................................... 
 
6.3 Lifestyle Restrictions ........................................................................................ 
 
6.3.1 Meals and Dietary Restrictions ............................................................... 
 
6.3.2 Caffeine, Alcohol, and Tobacco ............................................................... 
 
6.3.3 Activity ..................................................................................................... 
 
6.4 Screen Failures .................................................................................................. 
 
6.4.1 Retesting During Screening or Lead-in Period ....................................... 
 
7 TREATMENT ........................................................................................................... 
 
7.1 Treatments Administered .................................................................................. 
 
7.1.1 Titration Kit for Active and Placebo Apremilast ..................................... 
 
7.2 Method of Treatment Assignment .................................................................... 
 
7.3 Blinding for the 52-week Treatment Period ..................................................... 
 
7.3.1 Maintaining the Blind .............................................................................. 
 
7.3.2 Circumstances for Unblinding ................................................................. 
 
7.4 Dosage Modification ......................................................................................... 
 
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7.5 Preparation/Handling/Storage/Accountability .................................................. 
 
7.5.1 Retained Samples for Bioavailability/Bioequivalence/Biocomparability 
 
7.6 Treatment Compliance ...................................................................................... 
 
7.7 Concomitant Therapy........................................................................................ 
 
7.7.1 Permitted Treatments ............................................................................... 
 
7.7.2 SARS-CoV-2 Permitted Treatments ......................................................... 
 
7.7.3 Prohibited and/or Restricted Treatments................................................. 
 
7.7.3.1 Prohibited Treatments .................................................................... 
 
 
 
 
 
 
 
8 DISCONTINUATION CRITERIA ........................................................................... 
 
8.1 Discontinuation from Study Treatment ............................................................ 
 
8.1.1 Temporary Discontinuation ..................................................................... 
 
8.1.2 Post Study Treatment Study Follow-up.................................................... 
 
8.2 Discontinuation from the Study ........................................................................ 
 
8.3 Lost to Follow-up .............................................................................................. 
 
9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
 
9.1 Efficacy Assessments ........................................................................................ 
 
9.1.1 Rater Qualifications ................................................................................. 
 
9.1.2 American College of Rheumatology Improvement Criteria .................... 
 
9.1.3 Health Assessment Questionnaire - Disability Index ............................... 
 
9.1.4 Short Form-36 .......................................................................................... 
 
9.1.5 Fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue) . 
 
9.1.6 Psoriatic Arthritis Impact of Disease 12 ................................................. 
 
9.1.7 Dermatology Life Quality Index .............................................................. 
 
9.1.8 5-level EuroQoL 5-dimension .................................................................. 
 
9.1.9 Patient-Reported Outcome Measures Information System Sleep 
Disturbance Short Form 8b ........................................................................ 
 
9.1.10 Work Productivity and Activity Impairment Questionnaire .................. 
 
9.1.11 Bath Ankylosing Spondylitis Disease Activity Index .............................. 
 
9.1.12 Depression Monitoring .......................................................................... 
 
9.1.12.1 Eight-item Patient Health Questionnaire ..................................... 
 
9.1.13 Suicidal Risk Monitoring ....................................................................... 
 
9.1.14 Suicidal Ideation and Behavior Monitoring .......................................... 
 
9.1.14.1 electronic Columbia-Suicide Severity Rating Scale ..................... 
 
9.1.15 Enthesitis (Leeds Enthesitis Index, Spondyloarthritis Research 
Consortium of Canada) .............................................................................. 
 
9.1.16 Dactylitis (Tender Count, Leeds Dactylitis Index) ................................ 
 
9.1.17 Psoriasis Area and Severity Index ......................................................... 
 
9.1.18 Static Physician’s Global Assessment ................................................... 
 
9.1.19 Physician Global Assessment-Fingernails ............................................ 
 
9.1.20 Psoriatic Arthritis Disease Activity Score ............................................. 
 
9.1.21 Disease Activity Score 28 CRP .............................................................. 
 
9.1.22 Minimal Disease Activity and Very Low Disease Activity ..................... 
 
9.1.23 Disease Activity Index for Psoriatic Arthritis Score .............................. 
 
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9.1.24 Modified Composite Psoriatic Disease Activity Index .......................... 
 
9.1.25 Psoriatic Arthritis Response Criteria .................................................... 
 
9.1.26 Ankylosing Spondylitis Disease Activity Score with CRP ...................... 
 
9.1.27 Imaging Assessment for the Study.......................................................... 
 
9.2 Adverse Events ................................................................................................. 
 
 
 
9.2.2 Time Period and Frequency for Collecting AE and SAE Information .... 
 
9.2.3 Method of Detecting AEs and SAEs ......................................................... 
 
9.2.4 Follow-up of AEs and SAEs ..................................................................... 
 
9.2.5 Regulatory Reporting Requirements for SAEs ......................................... 
 
9.2.6 Pregnancy ................................................................................................ 
 
9.2.7 Laboratory Test Result Abnormalities ..................................................... 
 
9.2.8 Potential Drug-induced Liver Injury ....................................................... 
 
9.2.9 Other Safety Considerations .................................................................... 
 
9.3 Overdose ........................................................................................................... 
 
9.4 Safety ................................................................................................................ 
 
9.4.1 Physical Examinations ............................................................................. 
 
9.4.2 Vital Signs ................................................................................................ 
 
9.4.3 Electrocardiograms ................................................................................. 
 
9.4.4 Clinical Safety Laboratory Assessments .................................................. 
 
9.4.5 Estimated Glomerular Filtration Rate ..................................................... 
 
9.4.6 Tuberculosis Testing ................................................................................ 
 
9.4.6.1 Tuberculosis Screening and Chest Imaging ................................... 
 
 ......................... 
 
9.4.7 Imaging Safety Assessment ...................................................................... 
 
9.4.8 Unscheduled Safety Visits ........................................................................ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.9 Health Economics OR Medical Resource Utilization and Health Economics . 
 
10 STATISTICAL CONSIDERATIONS .................................................................... 
 
10.1 Sample Size Determination ............................................................................. 
 
10.2 Populations for Analyses ................................................................................ 
 
10.3 Statistical Analyses ......................................................................................... 
 
10.3.1 Efficacy Analyses ................................................................................... 
 
10.3.2 Safety Analyses....................................................................................... 
 
10.3.3 Other Analyses ....................................................................................... 
 
10.3.4 Interim Analyses ..................................................................................... 
 
11 REFERENCES ........................................................................................................ 
 
12 APPENDICES ......................................................................................................... 
 
APPENDIX 1 ABBREVIATIONS AND TRADEMARKS ........................................ 
 
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IM011055
Deucravacitinib
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APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. 
 
APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW UP, AND REPORTING ........................................................................ 
 
APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION ..................................................................... 
 
APPENDIX 5 CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
(CASPAR) CRITERIA ........................................................................................... 
 
APPENDIX 6 SUBJECT ASSESSMENT OF DISEASE ACTIVITY (PSORIATIC 
ARTHRITIS) VISUAL ASSESSMENT SCALE .................................................. 
 
APPENDIX 7 SUBJECT ASSESSMENT OF PAIN SCALE (PSORIATIC 
ARTHRITIS) .......................................................................................................... 
 
APPENDIX 8 AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT 
ASSESSMENT OF PHYSICAL FUNCTION SCALE: HEALTH ASSESSMENT 
QUESTIONNAIRE (HAQ) .................................................................................... 
 
APPENDIX 9 SHORT FORM HEALTH SURVEY-36 ITEM (SF-36) ...................... 
 
APPENDIX 10 FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS 
THERAPY FATIGUE ............................................................................................ 
 
APPENDIX 11 THE EULAR PSORIATIC ARTHRITIS IMPACT OF DISEASE: 
PSAID 12 FOR CLINICAL PRACTICE ............................................................... 
 
APPENDIX 12 DERMATOLOGY LIFE QUALITY INDEX (DLQI) ....................... 
 
APPENDIX 13 EURO QUALITY OF LIFE FIVE DIMENSIONS 
QUESTIONNAIRE: 5-LEVEL VERSION (EQ-5D-5L) ....................................... 
 
APPENDIX 14 PATIENT-REPORTED OUTCOME MEASURES INFORMATION 
SYSTEM SLEEP DISTURBANCE SHORT FORM............................................. 
 
APPENDIX 15 WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT 
QUESTIONNAIRE: PSORIATIC ARTHRITIS (WPAI:PSA) ............................. 
 
APPENDIX 16 THE BATH ANKYLOSING SPONDYLITIS DISEASE  ACTIVITY 
INDEX (BASDAI) .................................................................................................. 
 
APPENDIX 17 PHYSICIAN’S GLOBAL ASSESSMENT OF PSORIATIC 
ARTHRITIS ............................................................................................................ 
 
APPENDIX 18 PSORIASIS AREA AND SEVERITY INDEX (PASI) ..................... 
 
APPENDIX 19 STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF PSORIASIS 
(SPGA) .................................................................................................................... 
 
APPENDIX 20 PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS (PGA-F)
................................................................................................................................. 
 
APPENDIX 21 DISEASE ACTIVITY SCORE 28 WITH C-REACTIVE PROTEIN
................................................................................................................................. 
 
APPENDIX 22 INTERPRETATION OF HEPATITIS B SEROLOGIC TEST 
RESULTS ............................................................................................................... 
 
APPENDIX 23 MULTI-DRUG RESISTANT TUBERCULOSIS HIGH-BURDEN 
COUNTRIES .......................................................................................................... 
 
APPENDIX 24 COMMONLY USED CORTICOSTEROID EQUIVALENTS ......... 
 
APPENDIX 25 AMERICAN COLLEGE OF RHEUMATOLOGY CORE DATASET 
AND RESPONSE DEFINITIONS ......................................................................... 
 
APPENDIX 26 EIGHT-ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8) ... 
 
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BMS-986165
IM011055
Deucravacitinib
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APPENDIX 27 SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS ........................................................................................................ 
 
 
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Clinical Protocol
BMS-986165
IM011055
Deucravacitinib
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Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
1
SYNOPSIS
Protocol Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to 
Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis 
(PsA) who are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously 
Received TNFα Inhibitor Treatment
Short Title:
Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active 
Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or 
had Previously Received TNFα Inhibitor Treatment
Study Phase: Phase 3
Rationale:
Deucravacitinib (BMS-986165) is being evaluated as a therapeutic option for the treatment of 
participants with psoriatic arthritis (PsA). This Phase 3 study is a part of development program for 
PsA and follows the Phase 2 study (IM011084) that has met its primary and key secondary 
objectives. The population for this Phase 3 study (IM011055) includes participants with prior 
exposure to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or 
nonsteroidal anti-inflammatory drug (NSAIDs), and participants who have failed or have been 
intolerant to tumor necrosis factor (TNF) inhibitors, similar to the predominant patient population 
studied in a Phase 2 study. 
In IM011084, 203 participants were randomized to: 6 mg deucravacitinib once daily (QD) (n = 66), 
12 mg deucravacitinib QD (n = 70), and placebo (n = 67). The primary objective of dose-response 
relationship in American College of Rheumatology (ACR) 20 responses after 16 weeks of 
treatment, was met (p < 0.001). In the 6 mg deucravacitinib QD group 52.9% of participants and 
in the 12 mg deucravacitinib QD group 62.7% of participants achieved ACR 20 responses versus 
31.8% of participants in the placebo group (p = 0.0134 and p = 0.004, respectively).
The Phase 3 IM011055 study is designed to confirm the efficacy and safety of 6 mg deucravacitinib
QD versus placebo in larger PsA population and with longer duration of treatment.
 
 
Study Population:
Male and female participants, ≥18 years of age (or local age of majority), with a diagnosis of PsA 
for ≥3 months and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening, 
with an active plaque psoriasis (PsO) skin lesion(s) or documented medical history of plaque PsO, 
active arthritis (≥3 swollen joints and ≥3 tender joints in 66/68 joint count assessments), and high 
sensitivity C-reactive protein (hsCRP) concentration ≥3 mg/L will be recruited. 
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IM011055
BMS-986165
Deucravacitinib
All participants must have had documented inadequate response, loss of response, or intolerance 
to at least 1 csDMARD and/or NSAID given for the treatment of PsA. Participants who have failed 
or been intolerant to 1 TNF-inhibitor (TNFi) and/or have had prior exposure to not more than 
2 TNFis (TNFi-experienced), taken for PsA and/or PsO, will also be eligible to participate in the 
study, and will represent approximately 30% of the total study population.
Participants will be allowed to continue on background medications (csDMARD and/or NSAID 
and/or glucocorticoids) during the study as specified by the inclusion criteria. Participants with 
nonplaque PsO (eg, guttate, pustular, erythrodermic or drug-induced PsO), and/or rheumatoid 
arthritis will not be eligible for the study. 
Men and women ≥18 years of age (or local age of majority) must meet the following criteria for 
entry into the study.
Key Inclusion Criteria: 

Signed Written Informed Consent
o
Participants must be willing to participate in the study and sign the informed consent form.

Type of Participant and Target Disease Characteristics
o
Participant has been diagnosed to have PsA (by any criteria) of at least 3 months duration
at Screening.
o
Participant meets the CASPAR criteria at Screening.
o
Participant has active plaque psoriatic skin lesion(s) or documented medical history of 
plaque PsO at Screening.
o
Participant has active arthritis as shown by ≥3 swollen joints and ≥3 tender joints 
(66/68 joint counts) at Screening and Day 1.
o
Participant has hsCRP ≥3 mg/L at Screening.
o
Participant has had documented inadequate response, loss of response, or intolerance to at 
least 1 of the following:
A csDMARD at maximally tolerated dose after a minimum of 12 weeks duration of 
therapy given for the treatment of PsA.
An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of 
PsA.
A TNFi after a minimum of 12 weeks of etanercept, adalimumab, golimumab, or 
certolizumab pegol therapy (or biosimilar), or a minimum of 14 weeks (ie, at least 
4 doses) of infliximab (or biosimilar) given for the treatment of PsA and/or PsO. A 
shorter duration may be considered if documentation of inadequate response can be 
obtained and provided to the Medical Monitor for review.
o
Concurrent use of 1 csDMARD, and/or NSAID, and/or oral glucocorticoid is permitted but 
not required during the study. 
If such treatment was administered, then participants must meet the following 
requirements:
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BMS-986165
Deucravacitinib
o
If on csDMARD (methotrexate [MTX], sulfasalazine [SSZ], leflunomide [LEF], 
hydroxychloroquine [HCQ]), the participant must have been on it for at least 
12 weeks and be on a stable dose for at least 28 days prior to Day 1.

If on MTX, the route of administration and dose must be stable and the dose 
must be ≤25 mg/week.

If on SSZ, the dose must be ≤3 g/day.

If on HCQ, the dose must be ≤400 mg/day.

If on LEF, the dose must be ≤20 mg/day.
Note: If currently not on MTX, SSZ, or HCQ, the participant must have not 
received it for at least 28 days prior to Day 1. If currently not on LEF, the participant 
must not have received it for at least 12 weeks prior to Day 1.
If on an NSAID, the participant must be on a stable dose for at least 14 days prior to 
Day 1.
If on oral glucocorticoids, the participant must be on a stable dose of ≤10 mg/day 
prednisone equivalent for at least 28 days prior to Day 1.
Note: If currently not on oral glucocorticoids, the participant must not have received 
oral glucocorticoids within 28 days prior to Day 1.
o
Concurrent permitted topical therapy for plaque PsO must be stable for at least 14 days 
prior to Day 1.
 
 
 
 
Key Exclusion Criteria:

Target Disease Exceptions
o
Participant has nonplaque PsO (ie, guttate, pustular, erythrodermic or drug-induced PsO) 
at Screening or Day 1.
o
Participant has any other autoimmune condition such as systemic lupus erythematous, 
mixed connective tissue disease, multiple sclerosis, or vasculitis.
o
Participant has prior history of or current inflammatory joint disease other than PsA 
(eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
o
Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or 
therapy will significantly impact the assessment of PsA disease manifestations and activity 
in the opinion of the investigator.

Concomitant Medication and Medical History/Concurrent Diseases
o
Participant has received a biologic disease-modifying anti-rheumatic drug (bDMARD)
other than TNFi for the treatment of PsA and/or PsO (eg, agents that modulate lymphocyte 
trafficking [eg, natalizumab, efalizumab], agents that modulate B cells or T cells [eg, 
alemtuzumab, abatacept, alefacept, or visilizumab], monoclonal antibodies against 
interleukin [IL]-17 [eg, secukinumab, ixekizumab, brodalumab, bimekizumab], IL-12/IL-
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BMS-986165
Deucravacitinib
23p40 [eg, ustekinumab], or IL-23 [eg, guselkumab, risankizumab, tildrakizumab, 
mirikizumab]).
o
Participant has received > 2 TNFis or has had documented inadequate response or loss of 
response to > 1 TNFi for the treatment of PsA and/or PsO.
o
Participant has received a Janus kinase inhibitor (eg, baricitinib, tofacitinib, upadacitinib) 
for the treatment of PsA and/or PsO.
o
Participant has received a phosphodiesterase 4 inhibitor (eg, apremilast) for the treatment 
of PsA and/or PsO.
Objectives and Endpoints:
Objective
Endpoint
Primary
To compare the efficacy of deucravacitinib to 
placebo in the treatment of participants with 
active PsA 
Proportion of participants meeting ACR 20
response at Week 16
Key Secondary
To compare the efficacy of deucravacitinib to 
placebo at Week 16 as assessed by 
DAS28-CRP
Change from baseline in DAS28-CRP score
at Week 16
To compare the efficacy of deucravacitinib to 
placebo as assessed by HAQ-DI at Week 16
Change from baseline in HAQ-DI score at 
Week 16
To compare the efficacy of deucravacitinib to 
placebo as assessed by PASI 75 response at 
Week 16 
Proportion of participants meeting PASI 75 
response at Week 16, in participants with at 
least 3% BSA involvement AND at least
sPGA 2 at baseline
To compare the efficacy of deucravacitinib to 
placebo as assessed by SF-36 PCS score at 
Week 16
Change from baseline in the SF-36 PCS score 
at Week 16
To compare the efficacy of deucravacitinib to 
placebo in enthesitis resolution at Week 16
Proportion of participants meeting enthesitis 
resolution (score of 0) among participants 
with enthesitis at baseline by LEI at Week 16
To compare the efficacy of deucravacitinib to 
placebo in MDA response at Week 16
Proportion of participants meeting 
achievement of MDA where an MDA 
response is achievement of 5 of 7 following 
outcomes at Week 16:
a) Tender joint count ≤ 1
b) Swollen joint count ≤ 1
c) PASI ≤ 1 or BSA ≤ 3%
d) Patient assessment of PsA pain ≤ 15
e) Patient Global Assessment of PsA 
disease activity ≤ 20
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BMS-986165
Deucravacitinib
Objective
Endpoint
f)
HAQ-DI ≤ 0.5
g) Tender enthesial points ≤ 1
To compare the efficacy of deucravacitinib to 
placebo in FACIT-Fatigue score at Week 16
Change from baseline in FACIT-Fatigue
score at Week 16
To compare the efficacy of deucravacitinib to 
placebo in dactylitis resolution at Week 16
Proportion of participants meeting dactylitis 
resolution at Week 16 among the participants 
with dactylitis at baseline, where resolution is 
defined as a tender dactylitis count of 0 in 
participants with a tender dactylitis count 
≥1 at baseline
Abbreviations: BSA, body surface area; CRP, C-reactive protein; DAS, Disease Activity Score; FACIT, Functional 
Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire - Disability Index; LEI, Leeds 
Enthesitis Index; MDA, minimal disease activity; PASI, Psoriasis Area and Severity Index; PCS, Physical 
Component Summary; SF-36, Short Form-36; sPGA, static Physician’s Global Assessment.
Overall Design:
This is a Phase 3, 52-week, multi-center, randomized, double-blind, placebo-controlled study to 
evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active PsA 
who are naïve to bDMARDs or had previously received TNFα inhibitor treatment. 
 
 
The duration of study participation 
 will be divided into the following 
periods:

Screening Period (28 days)

Treatment Period (52 weeks), comprised of:
o
Placebo-controlled Treatment Period (16 weeks) (Week 0 to Week 16)
o
Reallocation and continued Active Treatment Period (36 weeks) (Week 16 to Week 52)


Safety Follow-up Period (30 days) (following last dose of investigational product [IP] unless 
participant has continued in study for 30 days or more after discontinuation of IP)  
Participants will undergo screening evaluations to determine eligibility within 28 days prior to 
administration of study medication. Following the screening process, eligible participants will be 
randomized in a 3:3:1 ratio to one of the following 3 treatment groups 
 
 
1. 6 mg deucravacitinib QD
2. Placebo
3. 30 mg apremilast twice daily (BID) (with initial titration per label)
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Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
At Week 16, participants originally randomized to placebo will be reallocated in a blinded fashion 
to receive 6 mg deucravacitinib QD through Week 52. Participants originally randomized to 6 mg 
deucravacitinib QD or 30 mg apremilast BID will continue to receive the same treatment and dose 
in a blinded fashion through Week 52. 
 
 
 
 
 
 
Assessments for efficacy, safety, tolerability, quality of life, pharmacokinetics,
and 
pharmacodynamics will be performed at specified time points. 
During the 52-week treatment period, participants who discontinue study treatment are required to 
complete an Early Termination (ET) Visit, a Safety Follow-up Visit 30 days following last dose 
of study treatment, and should continue to be followed for protocol-specified follow-up procedures 
through Week 52. Only participants who are lost to follow-up will have no further study visits. 
 
 
 
Participants who request to withdraw at any time from the study are required to have an ET Visit 
and will be asked to complete a Safety Follow-up Visit 30 days following last dose of study 
treatment. The only exception to this requirement is when a participant withdraws consent for all 
study procedures, including post-treatment study follow-up, or loses the ability to consent freely 
(eg, is imprisoned or involuntarily incarcerated for the treatment of either a psychiatric or physical 
illness).
The study design schematic is presented in Figure 1.
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BMS-986165
Deucravacitinib
Figure 1:
Study Design Schematic
Note: Apremilast is titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing.
Abbreviations: BID, twice daily; N, number;
; QD, once daily. 
Number of Participants: 
A total sample size of approximately 700 participants randomized in a 3:3:1 ratio, in a blinded 
fashion (approximately 300 participants each randomized to 6 mg deucravacitinib QD arm and 
placebo and 100 participants randomized to 30 mg apremilast BID).
This sample size will provide > 99% power to detect an 18% treatment difference between 6 mg 
deucravacitinib QD and placebo at Week 16 for ACR 20 response assuming a response of 51% for 
6 mg deucravacitinib QD and of 33% for placebo (2-sided alpha = 0.05, chi-square test). 
The sample size of 300 participants treated with 6 mg deucravacitinib QD in this study 
(IM011-055) was also chosen to provide, along with participants from other Phase 3 PsA studies 
with deucravacitinib, an adequate number of participants for the overall safety database for the 
PsA program. In addition, this sample size will also provide enough power for all key secondary 
endpoints (that will be tested in a testing strategy to control type I error).
The primary efficacy analysis model for the primary endpoint, ACR 20 response at Week 16 
(responder/nonresponder),
will use a Cochran-Mantel-Haenszel test stratified by the 
randomization stratification variables. Nonresponder imputation will be used at Week 16 for 
participants who have a missing ACR 20 response at Week 16 or who discontinued treatment (for 
any reason) prior to Week 16.
Treatment Arms and Duration:
Participants will be randomized in a 3:3:1 ratio, in a blinded fashion, to receive deucravacitinib
6 mg QD, placebo, or apremilast 30 mg BID (titrated as per label). While maintaining the blind,
participants randomized to placebo will be reallocated at Week 16 to deucravacitinib 6 mg QD 
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IM011055
BMS-986165
Deucravacitinib
through Week 52. Participants originally randomized to deucravacitinib 6 mg QD or apremilast 
30 mg BID will continue to receive the same treatment and dose in a blinded fashion through 
Week 52. 
 
Study Treatment: 
Study Treatment for Treatment Period (Week 0 to Week 52) IM011055
Medication 
Potency
IP/Non-IP 
Deucravacitinib tablet
6 mg 
IP
Placebo tablet
Not applicable
IP
Apremilast tablet
10 mg*
IP
Apremilast tablet
20 mg**
IP
Apremilast tablet
30 mg***
IP
* Used for titration Day 1 through Day 3 morning dose.
**Used for titration Day 3 evening dose through Day 5 morning dose.
***
From Day 5 evening dose onwards.
Abbreviation: IP, investigational product.
Data Monitoring Committee: Yes
An independent external Data Monitoring Committee (DMC) will be charged with monitoring 
accumulating data from the trial, as well as general aspects of trial conduct. The committee will 
meet periodically during the study to review aggregate analyses concerning efficacy and safety 
data from the trial. All members are selected with consideration for their respective expertise in 
the subject matter and/or in their experience in convening or participating in a DMC. Based on 
their overall benefit/risk evaluation, the DMC recommendations may include proceeding with the 
study per protocol, proceeding with the study with modifications, or study suspension. The scope, 
conduct, membership, processes, and accountabilities of the DMC are specified in the DMC 
Charter.
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BMS-986165
Deucravacitinib
2
SCHEDULE OF ACTIVITIES
The schedule of activities are outlined in Table 2-1 (Screening procedural outline), Table 2-2 (procedural outline from baseline through 
Week 16), Table 2-3 (procedural outline from Week 20 through Week 56), 
 
Table 2-1:
Screening Procedural Outline (IM011055)
Procedure
Screening
Visit
Notes
Eligibility Assessments
Informed Consent
X
A participant is considered enrolled only when a protocol-specific informed consent is 
signed.
Inclusion/Exclusion Criteria
X
Includes CASPAR criteria (see Appendix 5), active arthritis (tender/swollen joints), and 
plaque PsO.
PsA History, Treatment
X
PsA history to include investigator assessment of the participant’s phenotype as peripheral 
arthritis or peripheral plus psoriatic spondyloarthritis, including available evidence of disease 
(eg, clinical manifestations, imaging, etc).
Type of PsA (polyarthritis, oligoarthritis, predominant distal interphalangeal joint 
involvement, predominant axial involvement, and arthritis mutilans).
History of csDMARDs (eg, MTX) and systemic treatment of PsO and PsA. For each therapy, 
include length of time on treatment and reason(s) for discontinuation (eg, lack of efficacy, 
intolerance, AEs, loss of access to treatment) if applicable.
Current use of topical treatments and therapeutic shampoos.
Other Medical History
X
See inclusion/exclusion criteria for complete eligibility criteria associated with medical 
history. Of note, participants need to be screened for any current uncontrolled 
neuropsychiatric illness or history of suicidality, any history of TB, any congenital or 
acquired immunodeficiency, and any significant drug allergy such as anaphylaxis, and any 
cancer currently or in the previous 5 years. Investigators are encouraged to check whether 
participants have had preventive health measures such as cancer screening (eg, Pap smear, 
colonoscopy, mammograms) that are up-to-date according to local guidelines.
History of Tobacco Use
X
Include description of current tobacco use.
Other Prior and Concomitant Treatments
X
All medications for other conditions (includes prescription, over the counter medications, and 
herbal supplements).
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Deucravacitinib
Table 2-1:
Screening Procedural Outline (IM011055)
Procedure
Screening
Visit
Notes
Safety Assessments
Physical Examination
X
Complete physical examination. See Section 9.4.1.
Height and Body Weight
X
Vital Signs
X
Includes (ear or oral) body temperature, respiratory rate, and seated blood pressure and heart 
rate. See Section 9.4.2.
ECG
X
Single ECGs should be recorded. See Section 9.4.3.
Chest Imaging (eg, Chest X-ray)
X
Chest imaging is required if not performed within 6 months of Screening Visit, copy of 
radiology report must be on file and reviewed by the investigator. See Section 9.4.6.
Neuropsychiatric Illness Assessment
X
Based on participant/family response, medical history/medical records, investigator
judgment.
PHQ-8
X
For establishing baseline depression severity. See Section 9.1.12.1 and Appendix 26.
Suicidal Ideation and Behavior 
Assessment
X
Based on participant/family response, medical history/medical records, investigator
judgment.
eC-SSRS
X
Response of “Actual Suicide Attempt-Lifetime” or suicidal ideation (Severity of 4 or 5) or 
suicidal behavior will be exclusionary. Rescreening will not be allowed. See Section 9.1.14.1
and Appendix 27.
AE and SAE Assessment
X
All AEs (SAEs or non-serious AEs) related to SARS-CoV-2 infection must be collected from 
time of consent and continuously during the study including at the Safety Follow-up Visit(s). 
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs and non-serious AEs, including SARS-
CoV-2, will be followed until resolution, until the condition stabilizes, until the event is 
otherwise explained, or until the participant is lost to follow-up. SARS-CoV-2-related 
AEs/SAEs will be captured in specific CSP CRF pages in addition to the AE/SAE pages 
where event was originally reported. See Section 9.2 and Appendix 3. 
Laboratory Tests
Includes blood and urine samples.
Hematology
X
CBC with differential. See Section 9.4.4.
Chemistry
X
See Section 9.4.4.
Protocol Amendment No.: 01
Date: 20-Mar-2022
30
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-1:
Screening Procedural Outline (IM011055)
Procedure
Screening
Visit
Notes
eGFR
X
See Section 9.4.5.
Urinalysis
X
See Section 9.4.4.
Hemoglobin A1c
X
See Section 9.4.4.
TSH
X
See Section 9.4.4.
hsCRP
X
See Section 9.4.4.
Serology
X
Includes HCV antibody, HBsAg, HBsAb, HBcAb, and HIV antibodies. See Section 9.4.4. 
TB Test
X
In accordance with QuantiFERON® TB Gold. See Section 6.2 and Section 9.4.6.
Serum Immunoglobulin Levels (IgM, 
IgG, IgA, IgE)
X
See Section 9.4.4.
Pregnancy Test (Serum or Urine)
X
WOCBP only. See Section 9.4.4. 
FSH
X
For post-menopausal women only. Serum FSH level will be determined to confirm 
menopausal status. See Section 9.4.4.
β-D glucan
X
See Section 9.4.4 (requirement for Japanese sites only).
Study Treatment
IRT Enrollment
X
Enroll participant in the IRT system.
Abbreviations: AE, adverse event; BSA, body surface area; CASPAR, Classification Criteria for Psoriatic Arthritis; CBC, complete blood count; CRF, case report 
form; csDMARD, conventional synthetic disease-modifying anti-rheumatic drug; CSP, clinical safety program; ECG, electrocardiogram; eC-SSRS, electronic 
Columbia-Suicide Severity Rating Scale; eGFR, estimated glomerular filtration rate; FSH, follicle-stimulating hormone; HBcAb, hepatitis B core antibody; HBsAb, 
hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; hsCRP, high-sensitivity C-reactive 
protein; IgA, immunoglobulin A; IgE, immunoglobulin E; IgG, immunoglobulin G; IgM, immunoglobulin M; IRT, Interactive Response Technology; 
MTX, methotrexate; PHQ-8, eight-item Patient Health Questionnaire depression scale; PsA, psoriatic arthritis; PsO, psoriasis; SAE, serious adverse event; 
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TB, tuberculosis; TSH, thyroid stimulating hormone; WOCBP, women of childbearing potential.
Protocol Amendment No.: 01
Date: 20-Mar-2022
31
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-2:
Procedural Outline: Baseline through Week 16 (IM011055)
Procedure
D1
W2
D15
(±3 d)
W4
D29
(±3 d)
W8
D57
(±3 d)
W12
D85
(±3 d)
W16a
D113
(±3 d)
Notes
Eligibility Assessments
Inclusion/Exclusion Criteria
X
See Section 6.1 and 6.2, respectively.
Medical History
X
Safety Assessmentsb
Physical Examination
X
X
See Section 9.4.1.
Targeted Physical Examination
X
X
X
X
See Section 9.4.1.
Vital Signs
X
X
X
X
X
X
Includes (ear or oral) body temperature, 
respiratory rate, and seated blood pressure 
and heart rate. See Section 9.4.2.
Body Weight
X
X
X
ECG
X
X
See Section 9.4.3.
AE and SAE Assessment
X
X
X
X
X
X
All non-serious AEs must be collected 
from the time of initiation of study 
treatment until discontinuation of study. 
All AEs related to SARS-CoV-2 must be 
collected from time of consent and
continuously during the study including at 
the Safety Follow-up Visit(s). 
After the initial AE/SAE report, the 
investigator is required to proactively 
follow each participant at subsequent 
visits/contacts. 
All SAEs and non-serious AEs, including 
SARS-CoV-2 will be followed until 
resolution, until the condition stabilizes, 
until the event is otherwise explained, or 
until the participant is lost to follow-up.
SARS-CoV-2-related AEs/SAEs will be 
Protocol Amendment No.: 01
Date: 20-Mar-2022
32
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-2:
Procedural Outline: Baseline through Week 16 (IM011055)
Procedure
D1
W2
D15
(±3 d)
W4
D29
(±3 d)
W8
D57
(±3 d)
W12
D85
(±3 d)
W16a
D113
(±3 d)
Notes
captured in specific CSP CRF pages in 
addition to AE/SAE pages where the 
event was originally reported.
Concomitant Medication Use
X
X
X
X
X
X
See Section 7.7.
Patient-Reported Outcomes 
Subject Global Assessment of 
Disease Activity
X
X
X
X
X
X
See Appendix 6.
Subject Global Assessment of 
Pain
X
X
X
X
X
X
See Appendix 7.
HAQ-DI
X
X
X
X
X
X
See Section 9.1.3 and Appendix 8. 
SF-36
X
X
X
X
See Section 9.1.4 and Appendix 9.
Fatigue (FACIT Fatigue)
X
X
X
X
X
X
See Section 9.1.5 and Appendix 10.
PsAID 12
X
X
X
X
X
X
See Section 9.1.6 and Appendix 11. 
DLQI
X
X
X
X
X
X
See Section 9.1.7 and Appendix 12.
EQ-5D-5L
X
X
X
See Section 9.1.8 and Appendix 13.
PROMIS Sleep Disturbance 
Short Form-8b
X
X
X
X
See Section 9.1.9 and Appendix 14.
WPAI
X
X
See Section 9.1.10 and Appendix 15.
BASDAIc
X
X
X
X
X
X
See Section 9.1.11 and Appendix 16. 
PHQ-8b
X
X
X
See Section 9.1.12.1 and Appendix 26.
Clinician-reported Outcomes
Protocol Amendment No.: 01
Date: 20-Mar-2022
33
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-2:
Procedural Outline: Baseline through Week 16 (IM011055)
Procedure
D1
W2
D15
(±3 d)
W4
D29
(±3 d)
W8
D57
(±3 d)
W12
D85
(±3 d)
W16a
D113
(±3 d)
Notes
eC-SSRS Assessmentb
X
X
X
Suicidal Ideation and Behavior since last 
visit. See Section 9.1.14.1 and 
Appendix 27.
Physician Global Assessment 
of PsA
X
X
X
X
X
X
See Appendix 17.
Tender Joint Count (68 Joint 
Count)
X
X
X
X
X
X
See Section 9.1.2.
Swollen Joint Count (66 Joint 
Count)
X
X
X
X
X
X
See Section 9.1.2.
Enthesitis (LEI, SPARCC)
X
X
X
X
X
See Section 9.1.15.
Dactylitis (Count, LDI)
X
X
X
X
X
See Section 9.1.16.
PASId
X
X
X
X
X
See Section 9.1.17 and Appendix 18.
sPGA
X
X
X
X
X
See Section 9.1.18 and Appendix 19.
Nail Changes (PGA-F)e
X
X
X
X
X
See Section 9.1.19 and Appendix 20.
Composite Measuresf
ACR 20/50/70
X
X
X
X
X
X
See Section 9.1.2.
PASDAS
X
X
X
X
See Section 9.1.20.
DAS28-CRP
X
X
X
X
X
X
See Section 9.1.21 and Appendix 21.
MDA/VLDA
X
X
X
X
X
See Section 9.1.22.
DAPSA
X
X
X
X
X
X
See Section 9.1.23.
mCPDAI
X
X
X
X
X
See Section 9.1.24.
PsARC
X
X
X
X
X
X
See Section 9.1.25.
Protocol Amendment No.: 01
Date: 20-Mar-2022
34
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-2:
Procedural Outline: Baseline through Week 16 (IM011055)
Procedure
D1
W2
D15
(±3 d)
W4
D29
(±3 d)
W8
D57
(±3 d)
W12
D85
(±3 d)
W16a
D113
(±3 d)
Notes
ASDAS-CRP 
X
X
X
X
X
X
See Section 9.1.26.
Healthcare Utilization
Healthcare Utilization
X
X
See Section 9.9.
Laboratory Tests
Hematology
X
X
X
X
X
X
CBC with differential. See Section 9.4.4.
Chemistry
X
X
X
X
X
X
See Section 9.4.4.
eGFR
X
X
X
X
X
X
See Section 9.4.5.
Glucose (Fasting)g
X
X
X
See Section 9.4.4.
Lipid Panel (Fasting)
X
X
X
See Section 9.4.4.
Urinalysis
X
X
See Section 9.4.4.
Serum Immunoglobulin Levels 
(IgM, IgG, IgA, IgE)
X
X
X
See Section 9.4.4.
Hemoglobin A1c
X
X
See Section 9.4.4.
hsCRPh
X
X
X
X
X
X
See Section 9.4.4.
Pregnancy Test (Urine or 
Serum) and Counseling
X
X
X
X
X
WOCBP only. See Section 9.4.4.
HBV DNA Test
X
X
X
X
X
See Section 9.4.4. (For participants with a 
negative HBsAg, but a positive HBcAb 
and/or HBs Ab at Screening. Requirement 
for Japan and other select countries, see 
Appendix 22)
Protocol Amendment No.: 01
Date: 20-Mar-2022
35
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-2:
Procedural Outline: Baseline through Week 16 (IM011055)
Procedure
D1
W2
D15
(±3 d)
W4
D29
(±3 d)
W8
D57
(±3 d)
W12
D85
(±3 d)
W16a
D113
(±3 d)
Notes
Study Treatment
Randomizei
X
Dispense Study Treatment
X
X
X
X
X
X
Study Treatment Compliance
X
X
X
X
X
See Section 7.6.
a If rescue is needed at this visit, all efficacy and safety assessments must be performed prior to starting rescue therapy.
b For unscheduled visits, see Section 9.4.8.
Protocol Amendment No.: 01
Date: 20-Mar-2022
36
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
c In participants with baseline evidence of PsA spondylitis.
d BSA calculation will be an automated calculation.
e In participants with nail PsO at baseline.
f Composite measures will not be performed by sites and will be calculated based on assessments received.
g Glucose is part of the chemistry panel. Fasting glucose will be collected at time points indicated.
h Post-baseline hsCRP results will remain blinded to the site, participant, and Sponsor to preserve the blinded treatment assignments.
i
At Week 16, placebo participants will be re-allocated to 6 mg deucravacitinib QD through Week 52 in a blinded manner.
Note: When multiple assessments are conducted at a single visit, it is recommended that patient-reported outcomes assessments are performed first. Please refer to 
.
Abbreviations: ACR, American College of Rheumatology; AE, adverse event; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score with C-reactive 
protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; CBC, complete blood count; CRF, case report form; 
CRP, C-reactive protein; CSP, clinical safety program; D/d, day; DAPSA, Disease Activity Index for Psoriatic Arthritis Score; DAS, Disease Activity Score; DLQI, 
Dermatology Life Quality Index; DNA, deoxyribonucleic acid; ECG, electrocardiogram; eC-SSRS, electronic Columbia-Suicide Severity Rating Scale; eGFR, 
estimated glomerular filtration rate; EQ-5D-5L, 5-level EuroQoL 5-dimension; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health 
Assessment Questionnaire - Disability Index; HBcAb, hepatitis B core antibody; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; 
hsCRP, high-sensitivity C-reactive protein; IgA, immunoglobulin A; IgE, immunoglobulin E; IgG, immunoglobulin G; IgM, immunoglobulin M; LDI, Leeds 
Dactylitis Index; LEI, Leeds Enthesitis Index; mCPDAI, modified Composite Psoriatic Disease Activity Index; MDA, minimal disease activity; PASDAS, Psoriatic 
Arthritis Disease Activity Score; PASI, Psoriatic Area and Severity Index; PGA-F, Physician Global Assessment-Fingernails; PHQ-8, eight-item Patient Health 
Questionnaire depression scale; 
 PROMIS, Patient-Reported Outcome Measures Information System; PsA, psoriatic arthritis; PsAID, 
Psoriatic Arthritis Impact of Disease; PsARC, Psoriatic Arthritis Response Criteria; PsO, psoriasis; QD, once daily; 
; SAE, serious adverse 
events; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SF-36, Short Form-36; SPARCC, Spondyloarthritis Research Consortium of Canada; 
sPGA, static Physician’s Global Assessment; 
; VLDA, very low disease activity; W, Week; WOCBP, women of 
childbearing potential; WPAI, Work Productivity and Activity Impairment.
Protocol Amendment No.: 01
Date: 20-Mar-2022
37
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-3:
Procedural Outline: Week 20 through Week 56 (IM011055)
Procedure
W20
D141
(±5 
d)
W24
D169
(±5 
d)
W28
D197
(±5 
d)
W32
D225
(±5 
d)
W40
D281
(±5 d)
W48
D337
(±5 d)
W52a
or ETb
D365
(±5 d)
Safety Follow-
up/
W56c
D395
(30 days after 
last dose)d
(+5 d)
Notes
Safety Assessmentse
Physical Examination
X
X
See Section 9.4.1.
Targeted Physical 
Examination
X
X
X
X
X
X
See Section 9.4.1.
Vital Signs
X
X
X
X
X
X
X
X
Includes (ear or oral) body temperature, 
respiratory rate, and seated blood pressure and 
heart rate. See Section 9.4.2.
Body Weight
X
X
X
X
ECG
X
X
See Section 9.4.3.
AE and SAE Assessment
X
X
X
X
X
X
X
X
All non-serious AEs must be collected from the 
time of initiation of study treatment until 
discontinuation of study.
All AEs related to SARS-CoV-2 must be 
collected from time of consent and continuously 
during the study including at the Safety 
Follow-up Visit(s).
After the initial AE/SAE report, the investigator 
is required to proactively follow each participant 
at subsequent visits/contacts. 
All SAEs and non-serious AEs, including 
SARS-CoV-2 will be followed until resolution, 
until the condition stabilizes, until the event is 
otherwise explained, or until the participant is 
Protocol Amendment No.: 01
Date: 20-Mar-2022
38
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-3:
Procedural Outline: Week 20 through Week 56 (IM011055)
Procedure
W20
D141
(±5 
d)
W24
D169
(±5 
d)
W28
D197
(±5 
d)
W32
D225
(±5 
d)
W40
D281
(±5 d)
W48
D337
(±5 d)
W52a
or ETb
D365
(±5 d)
Safety Follow-
up/
W56c
D395
(30 days after 
last dose)d
(+5 d)
Notes
lost to follow-up.
SARS-CoV-2-related AEs/SAEs will be captured 
in specific CSP CRF pages in addition to 
AE/SAE pages where the event was originally 
reported.
Concomitant Medication 
Use
X
X
X
X
X
X
X
X
See Section 7.7.
Patient-Reported Outcomes
Subject Global 
Assessment of Disease 
Activity
X
X
X
X
X
X
X
See Appendix 6.
Subject Global 
Assessment of Pain
X
X
X
X
X
X
X
See Appendix 7.
HAQ-DI
X
X
X
X
X
X
X
See Section 9.1.3 and Appendix 8. 
SF-36
X
X
X
X
X
See Section 9.1.4 and Appendix 9.
Fatigue (FACIT Fatigue)
X
X
X
See Section 9.1.5 and Appendix 10.
PsAID 12
X
X
X
X
See Section 9.1.6 and Appendix 11. 
DLQI
X
X
X
X
X
See Section 9.1.7 and Appendix 12.
EQ-5D-5L
X
X
X
X
See Section 9.1.8 and Appendix 13.
Protocol Amendment No.: 01
Date: 20-Mar-2022
39
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-3:
Procedural Outline: Week 20 through Week 56 (IM011055)
Procedure
W20
D141
(±5 
d)
W24
D169
(±5 
d)
W28
D197
(±5 
d)
W32
D225
(±5 
d)
W40
D281
(±5 d)
W48
D337
(±5 d)
W52a
or ETb
D365
(±5 d)
Safety Follow-
up/
W56c
D395
(30 days after 
last dose)d
(+5 d)
Notes
PROMIS Sleep 
Disturbance Short Form-
8b
X
X
X
X
X
See Section 9.1.9 and Appendix 14.
WPAI
X
X
See Section 9.1.10 and Appendix 15.
BASDAIf
X
X
X
X
X
X
See Section 9.1.11 and Appendix 16. 
PHQ-8e
X
X
X
See Section 9.1.12.1 and Appendix 26.
Clinician-reported Outcomes
eC-SSRSe
X
X
X
Suicidal Ideation and Behavior since last visit. 
See Section 9.1.14.1 and Appendix 27.
Physician Global 
Assessment of PsA
X
X
X
X
X
X
X
See Appendix 17.
Tender Joint Count 
(68 Joint Count)
X
X
X
X
X
X
X
See Section 9.1.2.
Swollen Joint Count (66 
Joint Count)
X
X
X
X
X
X
X
See Section 9.1.2.
Enthesitis (LEI, 
SPARCC)
X
X
X
X
X
X
See Section 9.1.15.
Dactylitis (Count, LDI)
X
X
X
X
X
X
See Section 9.1.16.
PASIg
X
X
X
X
X
X
See Section 9.1.17 and Appendix 18.
Protocol Amendment No.: 01
Date: 20-Mar-2022
40
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-3:
Procedural Outline: Week 20 through Week 56 (IM011055)
Procedure
W20
D141
(±5 
d)
W24
D169
(±5 
d)
W28
D197
(±5 
d)
W32
D225
(±5 
d)
W40
D281
(±5 d)
W48
D337
(±5 d)
W52a
or ETb
D365
(±5 d)
Safety Follow-
up/
W56c
D395
(30 days after 
last dose)d
(+5 d)
Notes
sPGA
X
X
X
X
X
X
See Section 9.1.18 and Appendix 19.
Nail Changes (PGA-F)h
X
X
X
X
X
X
See Section 9.1.19 and Appendix 20.
Composite Measuresi
ACR 20/50/70
X
X
X
X
X
X
X
See Section 9.1.2.
PASDAS
X
X
X
X
X
See Section 9.1.20.
DAS28-CRP
X
X
X
X
X
X
X
See Section 9.1.21 and Appendix 21.
MDA/VLDA
X
X
X
X
X
X
See Section 9.1.22.
DAPSA
X
X
X
X
X
X
X
See Section 9.1.23.
mCPDAI
X
X
X
X
X
See Section 9.1.24.
PsARC
X
X
X
X
X
X
See Section 9.1.25.
ASDAS-CRP
X
X
X
X
X
X
See Section 9.1.26.
Healthcare Utilization
Healthcare Utilization
X
X
See Section 9.9.
Laboratory Tests
Hematology
X
X
X
X
X
X
X
X
CBC with differential. See Section 9.4.4.
Chemistry
X
X
X
X
X
X
X
X
See Section 9.4.4.
eGFR
X
X
X
X
X
X
X
X
See Section 9.4.5.
Protocol Amendment No.: 01
Date: 20-Mar-2022
41
2.0
Approved
930167016
2.0
v
Approved
1.0
v

Clinical Protocol
IM011055
BMS-986165
Deucravacitinib
Table 2-3:
Procedural Outline: Week 20 through Week 56 (IM011055)
Procedure
W20
D141
(±5 
d)
W24
D169
(±5 
d)
W28
D197
(±5 
d)
W32
D225
(±5 
d)
W40
D281
(±5 d)
W48
D337
(±5 d)
W52a
or ETb
D365
(±5 d)
Safety Follow-
up/
W56c
D395
(30 days after 
last dose)d
(+5 d)
Notes
Glucose (Fasting)j
X
X
See Section 9.4.4.
Lipid Panel (Fasting)
X
X
See Section 9.4.4.
Urinalysis
X
X
X
See Section 9.4.4.
Serum Immunoglobulin 
Levels (IgM, IgG, IgA, 
IgE)
X
X
See Section 9.4.4.
Hemoglobin A1c
X
X
See Section 9.4.4.
hsCRPk
X
X
X
X
X
X
X
See Section 9.4.4.
Pregnancy Test (Urine or 
Serum) and Counselingl
X
X
X
X
X
X
X
X
WOCBP only. See Section 9.4.4. Telephone 
visit(s) will be performed to verbally obtain 
monthly pregnancy test results between office 
visits.
HBV DNA Test
X
X
X
X
Testing will occur every 4 to 8 weeks 
(frequency of testing is at the discretion of 
the investigator)
See Section 9.4.4. (Requirement for Japan and 
other select countries, see Appendix 22) For 
participants with a negative HBsAg, but a 
positive HBcAb and/or HBs Ab at Screening.
 
.m
Protocol Amendment No.: 01
Date: 20-Mar-2022
42
2.0
Approved
930167016
2.0
v
Approved
1.0
v

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Table 2-3:
Procedural Outline: Week 20 through Week 56 (IM011055)
Procedure
W20
D141
(±5 
d)
W24
D169
(±5 
d)
W28
D197
(±5 
d)
W32
D225
(±5 
d)
W40
D281
(±5 d)
W48
D337
(±5 d)
W52a
or ETb
D365
(±5 d)
Safety Follow-
up/
W56c
D395
(30 days after 
last dose)d
(+5 d)
Notes
Study Treatment
Dispense Study 
Treatment
X
X
X
X
X
X
Study Treatment 
Compliance
X
X
X
X
X
X
X
See Section 7.6.
a
 
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b Participants who discontinue from study treatment are required to complete an ET Visit and must be evaluated for safety 30 days following last dose of study 
treatment. All participants should remain in the study for follow-up until the Week 52 Visit (see Section 8.1). Participants who discontinue study treatment and 
request to discontinue from the study will be asked to complete an ET Visit and a Safety Follow-up Visit (or phone call if a visit is not possible) 30 days following 
last dose of study treatment to determine the status of any ongoing AEs/SAEs or the occurrence of any new AEs/SAEs (see Section 8.2).
c
 
d All participants must be evaluated for safety 30 days following last dose of IP (see Section 8.2). If the Safety Follow-up Visit occurs within window of the next 
planned study visit, then only assessments from the planned study visit should be performed in addition to a full physical exam and body weight.
e For unscheduled visits, see Section 9.4.8.
f In participants with baseline evidence of PsA spondylitis.
g BSA calculation will be an automated calculation.
h In participants with nail PsO at baseline.
i
Composite measures will not be performed by sites and will be calculated based on assessments received.
j
Glucose is part of the chemistry panel. Fasting glucose will be collected at time points indicated.
k Post-baseline hsCRP results will remain blinded to the site, participant, and Sponsor to preserve the blinded treatment assignments.
l
At-home urine pregnancy test kits will be provided to maintain monthly pregnancy testing between Weeks 32 and 48. Site staff will record the telephone visit 
and result in the participant’s source document.
m For participants who discontinue study treatment and continue in the study until Week 52, a final 
 sample will be collected at the ET Visit. No additional 
 
samples will be collected.
Note: When multiple assessments are conducted at a single visit, it is recommended that patient-reported outcomes assessments are performed first. Please refer to 
.
Abbreviations: ACR, American College of Rheumatology; AE, adverse event; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score with C-reactive 
protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; CBC, complete blood count; CRF, case report form; 
CRP, C-reactive protein; CSP, clinical safety program; D/d, day; DAPSA, Disease Activity Index for Psoriatic Arthritis Score; DAS, Disease Activity Score; DLQI, 
Dermatology Life Quality Index; DNA, deoxyribonucleic acid; ECG, electrocardiogram; eC-SSRS, electronic Columbia-Suicide Severity Rating Scale; eGFR, 
estimated glomerular filtration rate; EQ-5D-5L, 5-level EuroQoL 5-dimension; ET, Early Termination; FACIT, Functional Assessment of Chronic Illness Therapy; 
HAQ-DI, Health Assessment Questionnaire-Disability Index; HBV, hepatitis B virus; hsCRP, high-sensitivity C-reactive protein; IgA, immunoglobulin A; 
IgE, immunoglobulin E; IgG, immunoglobulin G; IgM, immunoglobulin M; IP, investigational product; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; 
mCPDAI, modified Composite Psoriatic Disease Activity Index; MDA, Minimal Disease Activity;
; PASDAS, Psoriatic 
Arthritis Disease Activity Score; PASI, Psoriatic Area and Severity Index; PGA-F, Physician Global Assessment-Fingernails; PHQ-8, eight-item Patient Health 
Questionnaire depression scale; 
 PROMIS, Patient-Reported Outcome Measures Information System; PsA, psoriatic arthritis; PsAID, 
Psoriatic Arthritis Impact of Disease; PsARC, Psoriatic Arthritis Response Criteria; PsO, psoriasis; 
; SAE, serious adverse events; 
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SF-36, Short Form-36; SPARCC, Spondyloarthritis Research Consortium of Canada; sPGA, static 
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Physician’s Global Assessment; 
; VLDA, very low disease activity; W, Week; WPAI, Work Productivity and Activity 
Impairment; WOCBP, women of childbearing potential.
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3
INTRODUCTION
Psoriatic arthritis (PsA) is a chronic inflammatory articular disease that occurs in up to 30% of 
patients with psoriasis (PsO). PsA has manifestations that include peripheral arthritis, axial disease, 
enthesitis, dactylitis, and skin and nail disease. This condition can lead to disability and reduced 
quality of life over time without adequate treatment.
Deucravacitinib (BMS-986165) is an oral, potent, highly selective inhibitor of the intracellular 
signaling kinase, tyrosine kinase 2 (TYK2). Selective inhibition of TYK2 may provide a unique 
mechanism to treat conditions dependent upon interleukin (IL) 23 and its downstream signaling 
pathways such as PsO and PsA.
3.1
Study Rationale
Deucravacitinib is being evaluated as a therapeutic option for the treatment of participants with 
PsA. This Phase 3 study is a part of development program for PsA and follows the Phase 2 study 
(IM011084) that has met its primary and key secondary objectives. The population for this Phase 
3 study (IM011055) includes participants with prior exposure to conventional synthetic disease-
modifying anti-rheumatic drugs (csDMARDs) and/or nonsteroidal anti-inflammatory drug 
(NSAIDs) and participants who have failed or have been intolerant to tumor necrosis factor (TNF)
inhibitors, similar to the predominant patient population studied in a Phase 2 study. 
In IM011084, 203 participants were randomized to: 6 mg deucravacitinib once daily (QD) (n = 66), 
12 mg deucravacitinib QD (n = 70), and placebo (n = 67). The primary objective of dose-response 
relationship in American College of Rheumatology (ACR) 20 responses after 16 weeks of 
treatment, was met (p < 0.001). In the 6 mg deucravacitinib QD group 52.9% of participants and 
in the 12 mg deucravacitinib QD group 62.7% participants achieved ACR 20 responses versus 
31.8% of participants in the placebo group (p = 0.0134 and p = 0.004, respectively).
All key secondary endpoints were also achieved as measured by mean change from baseline in 
Health Assessment Questionnaire - Disability Index (HAQ-DI) scores (-0.37 on 6 mg QD 
and -0.39 on 12 mg QD versus -0.11 on placebo, p = 0.0020 and p = 0.0008, respectively), Psoriatic 
Area and Severity Index (PASI) 75 responses (42.4 on 6 mg QD and 59.6 on 12 mg QD versus 
20.4 on placebo, p = 0.0136 and p < 0.0001, respectively) and mean change from baseline in Short 
Form-36 (SF-36) Physical Component Summary (PCS) scores (5.6 on 6 mg QD and 5.8 on 12 mg 
QD versus 2.3 on placebo, p = 0.0062 and p = 0.0042, respectively). Participants in both 6 mg 
deucravacitinib and 12 mg deucravacitinib treatment groups achieved higher ACR 50 responses 
versus placebo (24.3% on 6 mg QD and 32.8% on 12 mg QD versus 10.6% on placebo, p = 0.0326 
and p = 0.0016, respectively), and higher ACR 70 responses versus placebo (14.3% on 6 mg QD 
and 19.4% on 12 mg QD versus 1.5% on placebo, p = 0.0044 and p = 0.0003, respectively) after 
16 weeks of treatment. Although efficacy was numerically higher for 12 mg QD versus 6 mg QD 
for some measures, meaningful dose separation in responses was not consistently observed. 
Deucravacitinib was generally well tolerated at both doses with adverse events (AEs) that were 
mostly mild to moderate in severity and were able to be managed, monitored, and resulted in few 
discontinuations. Based on the totality of data available to date, these data support the potential 
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benefit of deucravacitinib in the treatment of PsA. There are no significant safety issues to limit 
further clinical investigation of deucravacitinib in PsA.
To provide controlled, 1-year safety data for deucravacitinib in PsA, Study IM011055 is planned 
to include a safety reference arm of patients who receive treatment with apremilast. Apremilast is 
selected as a most appropriate active comparator safety control for the deucravacitinib Phase 3 
program because it is an oral agent approved for PsA and the safety profile is well characterized 
and generally well tolerated. It is approved for use in PsA patients with and without concomitant 
csDMARDs and can be used in patients with or without prior exposure to biologic 
disease-modifying anti-rheumatic drugs (bDMARDs). Its approved uses match well with the 
population to be included in IM011055 Phase 3 study. The active control safety reference arm is 
expected to provide an adequate reference for overall benefit-risk.
The Phase 3 IM011055 study is designed to confirm the efficacy and safety of 6 mg deucravacitinib
QD versus placebo in larger PsA population and with longer duration of treatment.
 
 
3.2
Background
PsA is a chronic, heterogeneous disorder characterized by progressive inflammatory arthritis that 
can occur in up to 30% of patients with PsO and may result in permanent joint damage and 
disability as well as health consequences beyond joint function, such as cardiovascular disease.1,2,3
It is estimated that the prevalence of PsA is about 2% to 4% in the Western population.4 The 
incidence of PsA in the general population is reported as approximately 3.6 to 7.2 per 100,000 per 
year.3 Disease onset occurs between the ages of 40 and 50 years and affects both sexes equally. It 
is estimated that 80% of patients with PsA have active concurrent PsO, with 10% to 15% of 
patients developing arthritis prior to developing PsO.5
PsA is one of the seronegative spondyloarthropathies and affects multiple tissues, including 
peripheral joints, skin and nails, axial joints (spondylitis), entheses (enthesitis), and digits 
(dactylitis). At initial presentation, oligoarticular disease is the most common subtype but as the 
disease evolves, the polyarticular variant becomes more prevalent.5,6,7 Approximately 25% of 
patients with PsA have spondylitis in addition to peripheral arthritis. Other, less common clinical 
patterns of PsA include distal arthritis that is characterized by an involvement of distal 
interphalangeal (DIP) joints and arthritis mutilans that is characterized by deforming and 
destructive arthritis. 
Progressive joint inflammation and destruction over time is detectable radiographically in at least 
40% of patients.8 Radiographic features of PsA include (but are not limited to) osteolysis, 
“pencil-in-cup” deformity and ankylosis.
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The treatment options for PsA include NSAIDs; oral csDMARDs (eg, csDMARDs: methotrexate 
[MTX], leflunomide
[LEF], sulfasalazine
[SSZ]); targeted
synthetic disease-modifying 
anti-rheumatic drugs (DMARDs) (tofacitinib); apremilast; biologic disease-modifying 
anti-rheumatic drugs (bDMARDs)
such as TNF antagonists (golimumab, adalimumab, 
certolizumab, etanercept, infliximab); inhibitors of co-stimulation of T-cells (abatacept); 
IL-12/IL-23p40 inhibitor (ustekinumab); IL-23 inhibitor (guselkumab); and IL-17A inhibitors 
(secukinumab, ixekizumab).9,10,11,12
For patients with PsA, there is a need for alternative treatment options, beyond currently available 
csDMARDs, to treat multiple manifestations of the disease with an acceptable safety and 
tolerability profile. MTX is frequently used but has limited efficacy and tolerability. Patients 
experience nausea, headache, and fatigue, and there is a need for regular monitoring of laboratory 
tests for potential hematologic and liver toxicities.1,13,14,15,16,17,18,19
Targeted synthetic DMARDs, like the Janus kinase (JAK) 1 and JAK3 inhibitor tofacitinib, could 
provide better efficacy than csDMARDs but may have potential safety issues (as per the label) that 
preclude very early use in patients with PsA.
TNF antagonists form the mainstay of treatment for patients with an inadequate response to 
csDMARDs.15 TNF antagonists are biological drugs efficacious for both skin and joint diseases, 
but approximately 40% of patients treated with these agents do not reach ACR 20, and these drugs 
are associated with the risk of some significant safety concerns and require monitoring.19
A number of other biologic therapies have been developed to inhibit different targets of the IL-23 
signaling pathway. Blocking antibodies of either the IL-23p40 subunit with ustekinumab or IL-17 
with secukinumab and ixekizumab is highly effective but has not been shown to have meaningfully 
improved efficacy with regards to musculoskeletal manifestations compared with anti-TNF agents.
While bDMARDs are found to be well tolerated and efficacious in some patients, they must be 
administered intravenously (IV) or subcutaneously (SC).20
Deucravacitinib is an oral therapy and the advantages of an oral route of administration are well 
known. These include improvement in patient compliance, avoidance of infusion and injection site 
reactions, and quicker washout in case there is a need for study treatment discontinuation due to 
adverse effects.
Thus, for treatment options for PsA, there is a need for a new therapy with a novel mechanism of 
action and an acceptable safety profile without the need for periodic laboratory monitoring and the 
convenience of QD oral dosing.
Tyrosine Kinase 2
TYK2 is a nonreceptor tyrosine kinase associated with receptors for the p40 subunit-containing 
cytokines IL-12 and IL-23, as well as the Type I interferon (IFN) receptor, and it is required for 
downstream activation of those signaling pathways. IL-23 is produced by keratinocytes and 
activated antigen-presenting cells, including Langerhans cells, macrophages and dendritic cells. 
IL-23 binds to its receptor IL-23R and the complex activates JAK2 and TYK2, members of the 
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Janus family of tyrosine kinases.21,22,23 Upon cytokine binding to the receptor, TYK2 and JAK2, 
trans-activate to initiate signal transduction. 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. 
IL-23 is critical in the expansion and survival of pathogenic T-helper 17 cells as well as the 
induction of innate lymphoid cells in autoimmunity.24,25 TH17 cells produce key proinflammatory 
cytokines, including IL-17 and IL-22. IL-17 and IL-22 are effector molecules important for the 
pathogenesis of immune-mediated conditions including PsA and PsO. IL-17 and IL-22 are 
overexpressed in psoriatic skin and in the synovial membrane in PsA.26,27,28,29 TYK2-dependent 
pathways (IL-23, IL-12, and Type I IFNs) and the cytokine networks they modulate (eg, IL-17, 
IL-22, IFN-γ) have been implicated in the pathophysiology of multiple immune-mediated diseases, 
including PsA, PsO, and Crohn’s disease.
Deucravacitinib
Deucravacitinib is a potent, highly selective, oral small molecule inhibitor of TYK2 that binds to 
the regulatory pseudokinase domain of TYK2. The binding of deucravacitinib to the pseudokinase 
domain of TYK2 stabilizes the inhibitory interactions between the pseudokinase and the catalytic 
domains of the enzyme, causing a blockade of receptor-mediated activation of TYK2 and its 
downstream functions in cells stimulated through the IL-23, IL-12, and Type I IFN pathways. The 
binding mode of deucravacitinib takes advantage of unique structural features of the TYK2 
pseudokinase domain compared to other kinases and pseudokinases to provide high biochemical, 
cellular, and functional selectivity. This approach differentiates deucravacitinib from non-selective 
inhibitors of the JAK family of kinases that target the highly conserved adenosine triphosphate
binding site within the active site of the catalytic domain.
Selective inhibition of TYK2 may provide a unique avenue to treat conditions dependent upon
IL-23 and its downstream signaling pathways. A key element in this hypothesis is the selectivity 
of the drug. Cytokine or growth factor pathways dependent on TYK2 (IL-23, IL-12, Type I IFNs) 
are distinct from those dependent on the other family members JAK1/JAK3 (eg, IL-2, IL-15, IL-7); 
JAK2/JAK2 (eg, erythropoietin, thrombopoietin, granulocyte macrophage colony stimulating 
factor); or JAK1/JAK2 (eg, IFN, IL-6). Non-selective inhibitors of JAK family members can 
result in AEs such as dyslipidemia, lymphopenia, neutropenia, and anemia.30 Selective TYK2 
inhibition is expected to result in a differentiated profile from the inhibitors of multiple JAK family 
kinases.
3.3
Benefit/Risk Assessment
A dosage of 6 mg deucravacitinib QD was selected to be used in this Phase 3 study to further 
characterize the benefit-risk of deucravacitinib in adult participants with active PsA. The dose 
selection is based on observed efficacy and safety data, and exposure-response relationship 
analysis in the Phase 2 placebo-controlled study in participants with active PsA (IM011084).
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In the Phase 2 study (IM011084) of 203 participants with active PsA, efficacy was assessed by the 
dose-response relationship in ACR 20 responses after 16 weeks of treatment. The primary and key 
secondary objectives of the study were met. See Section 3.1. 
The overall safety of deucravacitinib was acceptable in the Phase 2 study in PsA. There were no
serious adverse events (SAEs) reported in active treatment arms and there was 1 SAE of deep vein
thrombosis in the placebo arm. There were no cases of herpes zoster, systemic opportunistic 
infections in active treatment arms. The incidence of participants with AEs was numerically higher 
in active treatment groups compared to placebo (42.4% [placebo] versus 65.7% [6 deucravacitinib
QD group] and 65.7% [12 mg deucravacitinib QD group], respectively).
The most common AEs in the 6 mg deucravacitinib QD arm were headache (7.1%), 
nasopharyngitis, upper respiratory tract infections, bronchitis and diarrhea (each in 5.7% of 
participants). All AEs in this treatment group were mild or moderate and rarely led to 
discontinuation of treatment (3 participants).
The favorable benefit-risk profile of deucravacitinib in Phase 2 suggests that a wide range of PsA 
patients can benefit from treatment and that 6 mg deucravacitinib QD could be a useful addition 
to the therapeutic armamentarium across varied therapeutic settings: after NSAID failure, 
concurrent with or following treatment with csDMARD agents and/or following inadequate 
response or intolerance to bDMARD therapy.31
 
 
Safety will be monitored by the study Sponsor as well as by an independent Data Monitoring 
Committee (DMC). Details of DMC responsibilities and procedures will be specified in the DMC 
Charter.
 
 
.
 
The blinding is maintained beyond the primary endpoint at Week 16 to ensure reliable efficacy 
and safety measures. 
Severe Acute Respiratory Syndrome Coronavirus 2 Pandemic-related Risk Assessment 
While the global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has 
been identified as a potential risk to clinical trial participants in general, and it may particularly 
affect individuals with underlying chronic diseases and on immunosuppressive therapies, the 
overall benefit-risk for participation in this PsA study with deucravacitinib appears favorable. The 
individual benefit-risk considerations regarding SARS-CoV-2 infection remains the responsibility 
of the investigator. Testing to exclude SARS-CoV-2 infection prior to enrollment and to inform 
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decisions about participant care during the study should follow local standard practice and 
requirements.
4
OBJECTIVES AND ENDPOINTS
The objectives and endpoints for IM011055 are listed in Table 4-1.
Table 4-1:
Objectives and Endpoints
Objective
Endpoint
Primary
To compare the efficacy of deucravacitinib to 
placebo in the treatment of participants with 
active PsA 
Proportion of participants meeting ACR 20
response at Week 16
Key Secondary
To compare the efficacy of deucravacitinib to 
placebo at Week 16 as assessed by 
DAS28-CRP
Change from baseline in DAS28-CRP score at 
Week 16
To compare the efficacy of deucravacitinib to 
placebo as assessed by HAQ-DI at Week 16
Change from baseline in HAQ-DI score at 
Week 16
To compare the efficacy of deucravacitinib to 
placebo as assessed by PASI 75 response at 
Week 16
Proportion of participants meeting PASI 75 
response at Week 16, in participants with at 
least 3% BSA involvement AND at least 
sPGA 2 at baseline
To compare the efficacy of deucravacitinib to 
placebo as assessed by SF-36 PCS score at 
Week 16
Change from baseline in the SF-36 PCS score
at Week 16
To compare the efficacy of deucravacitinib to 
placebo in enthesitis resolution at Week 16
Proportion of participants meeting enthesitis 
resolution (score of 0) among participants 
with enthesitis at baseline by LEI at Week 16
To compare the efficacy of deucravacitinib to 
placebo in MDA response at Week 16
Proportion of participants meeting
achievement of MDA where an MDA 
response is achievement of 5 of 7 following 
outcomes at Week 16:
a) Tender joint count ≤ 1
b) Swollen joint count ≤ 1
c) PASI ≤ 1 or BSA ≤ 3%
d) Patient assessment of PsA pain ≤ 15
e) Patient Global Assessment of PsA 
disease activity ≤ 20
f)
HAQ-DI ≤0.5
g)
Tender enthesial points ≤1
To compare the efficacy of deucravacitinib to 
placebo in FACIT-Fatigue score at Week 16
Change from baseline in FACIT-Fatigue
score at Week 16
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
To compare the efficacy of deucravacitinib to 
placebo in dactylitis resolution at Week 16
Proportion of participants meeting dactylitis 
resolution at Week 16 among the participants 
with dactylitis at baseline, where resolution is 
defined as a tender dactylitis count of 0 in 
participants with a tender dactylitis count 
≥1 at baseline
Additional Secondary Objectives and Endpoints (At Each Time Point up to Week 16)
To assess the efficacy of deucravacitinib to 
placebo in ACR 20, ACR 50, and ACR 70 up 
to Week 16
Proportion of participants meeting ACR 20, 
ACR 50, and ACR 70 response
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as assessed by HAQ-DI 
up to Week 16

Change from baseline in HAQ-DI score

Proportion of participants who achieve a 
clinically meaningful improvement 
(≥0.35 improvement from baseline) in 
HAQ-DI score among participants with a 
HAQ-DI score ≥0.35 at baseline
To assess the efficacy of deucravacitinib
(6 mg QD) to placebo as assessed by PASI 
response up to Week 16 
Proportion of participants with achievement of 
PASI 75/90/100 response, in participants with 
at least 3% BSA and at least sPGA 2 at baseline
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by SF-36 
PCS score up to Week 16
Change from baseline in the SF-36 PCS score
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo in enthesitis resolution up 
to Week 16
Proportion of participants meeting enthesitis 
resolution among participants with enthesitis 
at baseline by LEI and SPARCC
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo in MDA response up to 
Week 16
Proportion of participants meeting
achievement of MDA where an MDA 
responder is based on a participant fulfilling 
5 of 7 below outcomes:
a) Tender joint count ≤ 1
b) Swollen Joint Count ≤ 1
c) PASI ≤ 1 or BSA ≤ 3%
d) Patient assessment of PsA pain ≤ 15
e) Patient Global Assessment of PsA 
disease activity ≤ 20
f)
HAQ-DI ≤ 0.5
g) Tender enthesial points ≤ 1
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo in SF-36 MCS score up to 
Week 16
Change from baseline in SF-36 MCS score
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo in FACIT-Fatigue score 
up to Week 16
Change from baseline in FACIT-Fatigue
score
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo in dactylitis resolution up 
to Week 16
Proportion of participants meeting dactylitis 
resolution among the participants with 
dactylitis at baseline, where resolution is 
defined as a tender dactylitis count of 0 in 
participants with a tender dactylitis count 
≥1 at baseline
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as assessed by PsAID 12 
score up to Week 16
Change from baseline in PsAID 12 score
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as assessed by DAPSA 
score up to Week 16

Change from baseline in DAPSA score

Proportion of participants with 
achievement of DAPSA low disease 
activity response

Proportion of participants with 
achievement of DAPSA disease remission
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by PGA-F up 
to Week 16
Proportion of participants meeting
achievement of PGA-F of 0/1 in participants 
with a baseline PGA-F score of ≥3
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo up to Week 16 in DAS28-
CRP

Change from baseline in DAS28-CRP 
score

Proportion of participants with 
achievement of a DAS28-CRP Low 
Disease Activity response 

Proportion of participants with 
achievement of a DAS28-CRP disease 
remission
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by the 
PASDAS up to Week 16
Change from baseline in PASDAS
To assess the efficacy of deucravacitinib (6 
mg QD) in mCPDAI score up to Week 16
Change from baseline in mCPDAI score
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by the 
PsARC up to Week 16
Proportion of participants achieving PsARC, 
where participants must achieve improvement 
in 2 of 4 measures, 1 of which must be joint 
pain or swelling, without worsening in any 
measure. 
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by the 
BASDAI score up to Week 16
Proportion of participants meeting
achievement of improvement from baseline in 
BASDAI score among participants with 
spondylitis in addition to peripheral joint 
involvement as their presentation of PsA
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by 
improvement in domain scales scores, PCS
score, and MCS score of SF-36 up to Week 
16
Change from baseline in domain scales 
scores, PCS score, and MCS score of SF-36
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo as measured by 
improvement in WPAI up to Week 16
Change from baseline in the subcomponents 
of the WPAI questionnaire
To assess the efficacy of deucravacitinib (6 
mg QD) to placebo on general quality of life 
up to Week 16
Change from baseline in the EQ-5D-5L utility 
scores and its subcomponents
To assess the efficacy of 6 mg deucravacitinib
QD to placebo on sleep disturbance up to
Week 16
Change from baseline in PROMIS sleep 
disturbance score (short form)
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
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Objectives and Endpoints
Objective
Endpoint
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
Safety
To assess the safety and tolerability of 
deucravacitinib in participants with active 
PsA
Incidence of AEs, SAEs, AEs leading to 
discontinuation of treatment and study 
discontinuation, and target AEIs; change in 
laboratory, ECG, and vital signs; and 
abnormalities in laboratory, ECG, and vital
signs
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
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Table 4-1:
Objectives and Endpoints
Objective
Endpoint
Abbreviations: ACR, American College of Rheumatology; AE, adverse event; AEI, adverse event of interest; 
BASDAI, Bath Ankylosing Spondylitis Disease Activity; BSA, body surface area;
; 
 
; CRP, C-reactive protein; DAPSA, Disease Activity Index for Psoriatic Arthritis; DAS, Disease Activity 
Score; ECG, electrocardiogram; EQ-5D-5L, 5-level EuroQol 5-dimension; FACIT, Functional Assessment of Chronic 
Illness Therapy; HAQ-DI, Health Assessment Questionnaire - Disability Index;
 
 
 LEI, Leeds Enthesitis Index; mCPDAI, modified Composite Psoriatic Disease Activity Index; MCS, 
Mental Component Summary; MDA, minimal disease activity; 
; 
 
; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI, Psoriasis Area and Severity Index; 
PCS, Physical Component Summary; PGA-F, Physician Global Assessment-Fingernails; PROMIS, Patient-Reported 
Outcome Measures Information System; PsA, psoriatic arthritis; PsAID, Psoriatic Arthritis Impact of Disease; PsARC, 
Psoriatic Arthritis Response Criteria; QD, once daily; SAE, serious adverse event;
 
; , SF-36, Short Form-36; SPARCC, Spondyloarthritis Research Consortium of 
Canada; sPGA, static Physician’s Global Assessment; 
 WPAI, Work Productivity and Activity 
Impairment.
5
STUDY DESIGN
5.1
Overall Design
This is a Phase 3, 52-week, multi-center, randomized, double-blind, placebo-controlled study to 
evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active PsA 
who are naïve to bDMARDs or had previously received TNFα inhibitor treatment.
 
 
Approximately 700 qualified participants will be randomized in a 3:3:1 ratio to receive either 6 mg 
deucravacitinib QD, placebo, or 30 mg apremilast twice daily (BID) for 16 weeks. All participants 
must have had documented inadequate response, loss of response, or intolerance to at least 
1 csDMARD and/or NSAID given for the treatment of PsA. Participants who have failed or been 
intolerant to TNFi will also be eligible for the study. Participants must be off treatment from TNFi
prior to randomization for duration specified in inclusion criteria. Participants who are 
TNFi-experienced will represent approximately 30% of the total study population. Participants 
with prior exposure to apremilast, JAK inhibitors, or bDMARDs other than TNFi for the treatment 
of PsO or PsA are excluded from the study. Participants will be allowed to continue on background 
medications (csDMARD and/or NSAID and/or glucocorticoids) during the study as specified by 
the inclusion criteria.
The duration of study participation 
 will be divided into the following 
periods: 
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
Screening Period (28 days)

Treatment Period (52 weeks), comprised of 

Placebo-controlled Treatment Period (16 weeks) (Week 0 to Week 16)

Reallocation and continued Active Treatment Period (36 weeks) (Week 16 to Week 52)

Safety Follow-up Period (30 days) (following last dose of investigational product [IP] unless 
participant has continued in study for 30 days or more after discontinuation of IP)
Participants will undergo screening evaluations to determine eligibility within 28 days prior to 
administration of study medication. Following the screening process, eligible participants will be 
randomized in a 3:3:1 ratio to one of the following 3 treatment groups:
1. 6 mg deucravacitinib QD
2. Placebo
3. 30 mg apremilast BID as follows:

Day 1: 10 mg tablet in the morning

Day 2: 10 mg tablet in the morning and evening

Day 3: 10 mg tablet in the morning and 20 mg tablet in the evening

Day 4: 20 mg tablet in the morning and the evening

Day 5: 20 mg tablet in the morning and 30 mg tablet in the evening

Day 6 and thereafter: 30 mg tablet in the morning and the evening
Dummy tablets (placebo to the deucravacitinib 6 mg tablet, placebo to apremilast 30 mg 
tablet BID, and placebo to apremilast 10 mg, 20 mg, and 30 mg during titration) will be 
administered to the participants to maintain blinding. Additional details are provided in 
Section 7.1. 
 
 
At Week 16, participants originally randomized to placebo will be reallocated in a blinded fashion 
to receive 6 mg deucravacitinib QD through Week 52. Participants originally randomized to 6 mg 
deucravacitinib QD or 30 mg apremilast BID will continue to receive the same treatment and dose 
in a blinded fashion through Week 52. 
 
 
 
 
 
 
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Assessments for efficacy, safety, tolerability, quality of life, 
 
 will be performed at specified time points as outlined in the Schedule of 
Activities (see Section 2).
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants who discontinue study treatment will complete an Early Termination (ET) Visit, a 
Safety Follow-up Visit 30 days following the last dose of study treatment, and should complete 
each study visit through Week 52. Only participants who are lost to follow-up will have no further 
study visits (see Section 8).
The study design schematic is presented in Figure 5.1-1.
Figure 5.1-1:
Study Design Schematic
Note: Apremilast is titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing as described in Section 5.1.
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Abbreviations: BID, twice daily; N, number; 
; QD, once daily. 
5.1.1
Data Monitoring Committee 
5.1.1.1
Data Monitoring Committee
An independent external DMC will be charged with monitoring accumulating data from the trial, 
as well as general aspects of trial conduct. The committee will meet periodically during the study 
to review aggregate analyses concerning efficacy and safety data from the trial. All members are 
selected with consideration for their respective expertise in the subject matter and/or in their 
experience in convening or participating in a DMC. Based on their overall benefit/risk evaluation, 
the DMC recommendations may include proceeding with the study per protocol, proceeding with 
the study with modifications, or study suspension. The scope, conduct, membership, processes, 
and accountabilities of the DMC are specified in the DMC Charter.
5.2
Number of Participants
A total sample size of approximately 700 participants randomized in a 3:3:1 ratio, in a blinded 
fashion (approximately 300 participants each randomized to 6 mg deucravacitinib QD arm and 
placebo and 100 participants randomized to 30 mg apremilast BID).
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5.3
End of Study Definition
The start of the trial is defined as the first visit for the first participant screened. End of trial is 
defined as the last visit or scheduled procedure as shown in the Schedule of Activities (Section 2) 
for the last participant. Completion of the double-blinded portion of the study is defined as the 
final date on which data was or is expected to be collected up to Week 56 for all participants. 
5.4
Scientific Rationale for Study Design
As described in Section 3.2, there is an unmet need for novel treatment options for PsA.
Deucravacitinib, 6 mg QD was shown to be safe and efficacious in Phase 2 clinical trial in PsA 
(IM011084) and is now proposed to be studied in a Phase 3 study.
The study is intended to confirm the safety and efficacy of 6 mg deucravacitinib QD compared 
with placebo in adults with active PsA.
Study Population
The target study population includes participants with active PsA who are biologic naïve and have 
had documented inadequate response, loss of response, or intolerance to standard therapies 
(eg, csDMARDs and/or NSAIDs). In addition approximately 30% of study population will consist 
of participants who have failed or have been intolerant to TNFi. An apremilast safety reference
arm is included in this study; therefore, patients that have failed apremilast previously will not be 
included in this study. This population should maximize the applicability of the results of 
IM011055 to the broad and heterogeneous bDMARD-naïve and TNFi experienced patients 
typically seen in clinical practice. Furthermore, this population is similar to that in the Phase 2 
study (IM011084) and is considered appropriate to provide relevant efficacy and safety 
information for the intended use of deucravacitinib in PsA.
Study Control, Blinding
A placebo control will be used to establish the frequency and magnitude of changes in endpoints 
that may occur in the absence of active treatment. The duration of placebo-controlled treatment is 
limited to 16 weeks to avoid potential disease progression and at the same time to allow sufficient 
duration for detection of treatment effect in multiple domains of disease. As it is justified to use 
placebo control for a limited time only and in order to collect controlled safety data for duration 
of 1 year, a safety control arm with apremilast will be used in this study. Apremilast was selected 
as the most appropriate active comparator safety control for this study as it has a well-established 
safety profile confirmed in PsA registrational studies, and through widespread use in a variety of 
settings within clinical practice. The population studied in IM011055 fits well with the approved 
uses of apremilast: participants receiving treatment with or without concomitant csDMARDs and 
those with or without prior exposure to bDMARDs.
Utilizing an active apremilast arm of 100 participants is expected to provide context for the 
observed safety of deucravacitinib. Inclusion of a safety reference arm without formal statistical 
comparisons has widespread precedence across development programs in PsA and in other 
inflammatory arthritides like rheumatoid arthritis. The 100 participants randomized to apremilast 
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within IM011055 is similar to the number assigned to the adalimumab reference arms in the 
registrational studies of ixekizumab32 (101 patients) and tofacitinib (106 patients).
Blinded treatment will be used to reduce potential bias during data collection and evaluation of 
clinical endpoints.
Study Evaluations
The primary endpoint chosen for the study of ACR 20 response has been very well established in 
previous studies of therapeutic agents for PsA and has been accepted by regulatory authorities
globally, including European Medicines Agency Guideline on Clinical Investigation of Medicinal 
Products Indicated for the Treatment of Psoriatic Arthritis.33 Similarly, key secondary endpoints 
are well established, validated, clinically relevant, and have been used in previous and ongoing 
clinical trials in PsA.34,35,36,37 Key secondary endpoints in the study include the following: Disease 
Activity Score (DAS) 28 C-reactive protein (CRP) score, HAQ-DI, SF-36 PCS, Functional 
Assessment of Chronic Illness Therapy (FACIT)-Fatigue, PASI 75 response, achievement of 
minimal disease activity (MDA), resolution of enthesitis, and resolution of dactylitis. 
Patient-reported outcomes (PROs) selected as key secondary endpoints are consistent with 
clinically relevant measurements that are accepted in the medical literature for other studies in 
PsA. 38,39,40,41
5.5
Justification for Dose
The Phase 3 IM011055 study is designed to confirm the efficacy and safety of 6 mg deucravacitinib
QD versus placebo in PsA. This dose was selected based on observed efficacy and safety data in 
the Phase 2 study in participants with PsA as described above (see Section 3.1), 
 
.
Results from the Phase 2 study (IM011084) indicated that both the 6 mg QD and 12 mg QD doses 
achieved higher ACR 20/50/70 responses compared to placebo. At Week 16, ACR 20/50/70 
responses were met in the 6 mg QD group in 52.9%, 24.3%, and 14.3% of participants, 
respectively, and in the 12 mg QD group in 62.7%, 32.8%, and 19.4% of participants, respectively
(refer to Section 3.1 for additional details). 
 
 
 
 
The overall safety of deucravacitinib was acceptable in the Phase 2 study in PsA. The incidence 
of participants with AEs was numerically higher in both active treatment groups compared to 
placebo (42.4%, 65.7%, and 65.7% in the placebo and 6 mg and 12 mg deucravacitinib QD groups, 
respectively). Participants in the 6 mg deucravacitinib versus the 12 mg deucravacitinib group had 
less frequent nasopharyngitis (5.7% versus 17.9%), sinusitis (none versus 7.5%), and rash 
(4.3% versus 6.0%). Infections were numerically lower in the placebo and 6 mg deucravacitinib
treatment groups (22.7% and 28.6%, respectively) compared with the 12 mg deucravacitinib group 
(35.8%). The most common infections were respiratory tract-related. Importantly, there were no 
serious or severe infections, no herpes zoster, and no systemic opportunistic infections. Infections 
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only rarely led to discontinuation of treatment (1 participant in each active treatment group). All 
AEs in 6 mg deucravacitinib QD treatment group were mild or moderate and rarely led to 
discontinuation of treatment (3 participants), similarly most AEs in 12 mg deucravacitinib QD 
treatment group were mild or moderate (except 1 participant with severe AE of creatine kinase 
(CK) elevation that has resolved without treatment) and rarely led to discontinuation of treatment 
(4 participants). There were no SAEs reported in active treatment arms. There were no cases of 
herpes zoster or opportunistic infections in active treatment arms.
6
STUDY POPULATION
For entry into the study, the following criteria MUST be met.
6.1
Inclusion Criteria
1) Signed Written Informed Consent
a) Participants must be willing to participate in the study and sign the informed consent form 
(ICF).
2) Type of Participant and Target Disease Characteristics
a) Participant has been diagnosed to have PsA (by any criteria) of at least 3 months duration
at Screening.
b) Participant meets the Classification Criteria for Psoriatic Arthritis (see Appendix 5) at 
Screening.
c) Participant has active plaque psoriatic skin lesion(s) or documented medical history of 
plaque PsO at Screening.
d) Participant has active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints 
(66/68 joint counts) at Screening and Day 1.
e) Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
f)
Participant has had documented inadequate response, loss of response, or intolerance to at 
least 1 of the following:
i)
A csDMARD (MTX, SSZ, LEF, or hydroxychloroquine [HCQ]) at maximally 
tolerated dose after a minimum of 12 weeks duration of therapy given for the treatment 
of PsA.
ii) An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of 
PsA.
iii) A TNFi after a minimum of 12 weeks of etanercept, adalimumab, golimumab, or 
certolizumab pegol therapy (or biosimilar), or a minimum of 14 weeks (ie, at least 
4 doses) of infliximab (or biosimilar) given for the treatment of PsA and/or PsO. A 
shorter duration may be considered if documentation of inadequate response can be 
obtained and provided to the Medical Monitor for review.
Note: Participant must be off TNFi for:
(1) ≥8 weeks before randomization (Day 1) for infliximab (or its biosimilars) or 
golimumab (IV).
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(2) ≥6 weeks before randomization (Day 1) for golimumab SC, adalimumab (or its 
biosimilars) or certolizumab pegol.
(3) ≥ 4 weeks before randomization (Day 1) for etanercept (or its biosimilars).
g) Concurrent use of 1 csDMARD, and/or NSAID, and/or oral glucocorticoid is permitted but 
not required during the study.
i)
If such treatment was administered, then participants must meet the following 
requirements:
(1) If on csDMARD (MTX, SSZ, LEF, hydroxychloroquine [HCQ]), the participant 
must have been on it for at least 12 weeks and be on a stable dose for at least 28 days 
prior to Day 1.
(a) If on MTX, the route of administration and dose must be stable and the dose 
must be ≤25 mg/week.
(b) If on SSZ, the dose must be ≤3 g/day.
(c) If on HCQ, the dose must be ≤400 mg/day.
(d) If on LEF, the dose must be ≤20 mg/day.
Note: If currently not on MTX, SSZ, or HCQ, the participant must have not 
received it for at least 28 days prior to Day 1. If currently not on LEF, the participant 
must not have received it for at least 12 weeks prior to Day 1.
ii) If on NSAID, the participant must be on a stable dose for at least 14 days prior to Day 1.
iii) If on oral glucocorticoids, the participant must be on a stable dose of ≤10 mg/day 
prednisone equivalent for at least 28 days prior to Day 1.
Note: If currently not on oral glucocorticoids, the participant must not have received oral 
glucocorticoids within 28 days prior to Day 1.
h) Concurrent permitted topical therapy for plaque PsO must be stable for at least 14 days 
prior to Day 1. 
 
 
 
 
3) Age and Reproductive Status
Investigators shall counsel women of childbearing potential (WOCBP) participants, and male 
participants who are sexually active with WOCBP, on the importance of pregnancy prevention 
and the implications of an unexpected pregnancy.
The investigator shall evaluate the effectiveness of the contraceptive method in relationship to the 
first dose of study intervention.
Local laws and regulations may require the use of alternative and/or additional contraception 
methods.
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a) Female participants:
i)
Female, age at least 18 years or local age of majority at Screening.
ii) Women who are not of childbearing potential (as defined in Appendix 4) are exempt 
from contraceptive requirements.
iii) Women participants must have documented proof that they are not of childbearing 
potential.
iv) WOCBP must have a negative serum pregnancy test at Screening Visit, and a negative 
urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human 
chorionic gonadotropin) within 24 hours prior to the start of study treatment.
(1) 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.
v) Additional requirements for pregnancy testing during and after study intervention are 
located in Section 2, Schedule of Activities.
vi) 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.
vii)Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during 
the study period.  
viii)
WOCBP must agree to use highly effective (with a failure rate of < 1% per year) 
method(s) of contraception, preferably with low user dependency, as described in 
Appendix 4 of the protocol, during the study period until study completion or 30 days 
after discontinuation of the study treatment, whichever is longer (See Section 5.3).
ix) WOCBP are permitted to use hormonal contraception methods (as described in 
Appendix 4 of the protocol).
Note: Local laws and regulations may require use of alternative and/or additional 
contraception methods; additionally, alternative and/or additional contraceptives may be 
required (eg, based on background DMARDs the participant may be taking, such as MTX, 
LEF, etc).
b) Male participants:
i)
Males, age at least 18 years or local age of majority at Screening.
ii) Male participants should maintain their usual practice with regard to contraception (if 
any); however, no specific contraceptive measures are required.
Note: Local laws and regulations may require use of alternative and/or additional 
contraception methods; additionally, alternative and/or additional contraceptives may be 
required (eg, based on background DMARDs the participant may be taking, such as MTX, 
LEF, etc).
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6.1.1
Inclusion Criteria at Week 52OLE for the Optional Open-label Long-term 
Extension Period
1) Signed Written Informed Consent
a) Participants must be willing to participate in the study and sign the informed consent form 
(ICF).
2) Type of Participant and Target Disease Characteristics
a) Completion of study treatment through Week 52. 
b) In the opinion of the investigator, the participant may benefit from continuation in the 
optional OLE Period.
3) Reproductive Status
a) WOCBP must have a negative urine pregnancy test at Initial Visit (minimum sensitivity 
25 IU/L or equivalent units of human chorionic gonadotropin).
i)
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 discontinued from 
participation if the serum pregnancy result is positive.
ii) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during 
the study period.  
iii) WOCBP must agree to continue using highly effective (with a failure rate of < 1% per 
year) method(s) of contraception, preferably with low user dependency, as described 
in Appendix 4 of the protocol, during the study period until study completion or 30 
days after discontinuation of the study treatment, whichever is longer (See Section 5.3).
(1) WOCBP are permitted to use hormonal contraception methods (as described in 
Appendix 4 of the protocol).
(2) Male participants should maintain their usual practice with regard to contraception 
(if any); however, no specific contraceptive measures are required.
Note: Local laws and regulations may require use of alternative and/or additional 
contraception methods; additionally, alternative and/or additional contraceptives
may be required (eg, based on background DMARDs the participant may be taking, 
such as MTX, LEF, etc).
6.2
Exclusion Criteria
1) Target Disease Exceptions
a) Participant has nonplaque PsO (ie, guttate, pustular, erythrodermic, or drug-induced PsO) 
at Screening or Day 1.
b) Participant has any other autoimmune condition such as systemic lupus erythematous, 
mixed connective tissue disease, multiple sclerosis, or vasculitis.
c) Participant has prior history of or current inflammatory joint disease other than PsA 
(eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
d) Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or 
therapy will significantly impact the assessment of PsA disease manifestations and activity 
in the opinion of the investigator.
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2) Concomitant Medication and Medical History/Concurrent Diseases
a) Participant has received a bDMARD other than TNFi for the treatment of PsA and/or PsO
(eg, agents that modulate lymphocyte trafficking [eg, natalizumab, efalizumab], agents that 
modulate B cells or T cells [eg, alemtuzumab, abatacept, alefacept, or visilizumab], 
monoclonal antibodies against IL-17 [eg, secukinumab, ixekizumab, brodalumab, 
bimekizumab], IL-12/IL-23p40 [eg, ustekinumab], or IL-23 [eg, guselkumab, 
risankizumab, tildrakizumab, mirikizumab]).
b) Participant has received > 2 TNFi or has had documented inadequate response or loss of 
response to > 1 TNFi for the treatment of PsA and/or PsO.
c) Participant has received a Janus kinase (JAK) inhibitor (eg, baricitinib, tofacitinib, 
upadacitinib) for the treatment of PsA and/or PsO.
d) Participant has received a phosphodiesterase 4 inhibitor (eg, apremilast) for the treatment 
of PsA and/or PsO.
e) Participant has received intra-articular, intramuscular, or IV glucocorticoids, including 
adrenocorticotropic hormone, within the 28 days prior to Day 1.
f)
Participant has had prior exposure to the investigational product (IP, ie, deucravacitinib).
g) Not applicable per Protocol Amendment 01: Participant has received systemic 
non-biologic PsO medications and/or any systemic immunosuppressants therapy other than 
what is permitted in inclusion criteria (see Section 6.1).
h) Participant has used any opioid analgesic at average daily doses of > 30 mg/day of 
morphine or its equivalent or use of variable doses of any opiate analgesic within 28 days 
prior to Day 1.
i)
Participant has used medical marijuana or prescription marijuana for medicinal reasons.
j)
Participant has received phototherapy (including either oral or topical psoralen ultraviolet 
A light therapy, ultraviolet B, or self-treatment with tanning beds or therapeutic 
sunbathing) within 28 days prior to Day 1.
k) Participant has used topical medications/treatments that could affect PsO evaluation, 
including, but not limited to, medium- or high-potency glucocorticoids (WHO Classes I 
through V), anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, 
methoxsalen, trimethylpsoralen, picrolimus, and tacrolimus, within 14 days of Day 1.
Note: Low-potency topical steroids (WHO Class VI and VII) are permitted on the palms, 
soles, face, and intertriginous areas as well as bland emollients (without urea or alpha or 
beta hydroxy acids) to be used on skin lesions; those should not be used within 24 hours 
prior to any study visit.
l)
Participant has used any strong cytochrome P450 (CYP450) inducers (eg, rifampin, 
phenobarbital, carbamazepine, phenytoin) within 28 days prior to Day 1.
m) Participant has used shampoos that contain glucocorticoids, coal tar, or vitamin D3 
analogues within 14 days prior to Day 1.
n) Participant who has received any experimental therapy or new investigational agent, 
including those for SARS-CoV-2, may not participate in the study until the 
protocol-specific washout period is achieved (4 weeks or 5 half-lives, whichever is longer)
prior to Day 1 or is currently enrolled in an investigational study.
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Note: As outlined in exclusion criterion 3), if a study participant has received an 
investigational SARS-CoV-2 vaccine prior to Screening, enrollment should be delayed 
until the biologic impact of the vaccine is stabilized, as determined by discussion between 
the investigator and the Bristol-Myers Squibb Company (BMS) Medical Monitor.
o) Participant has had any major surgery within 8 weeks prior to Day 1, or any planned 
surgery for the first 52 weeks of the study.
p) Participant has donated blood > 500 mL within 28 days prior to Day 1 or intends to donate 
blood during the course of the study.
q) Participant has abused drugs or alcohol, as determined by the investigator, within 6 months 
prior to Day 1.
r)
Participant has had any major illness/condition or evidence of an unstable clinical condition 
(eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, 
immunologic, or local active infection/infectious illness) that, in the investigator’s 
judgment or after consultation with the Medical Monitor, will substantially increase the 
risk to the participant if he or she participates in the study.
s) Participant has had unstable cardiovascular disease, defined as a recent clinical 
deterioration (eg, unstable angina, myocardial infarction, stroke, rapid atrial fibrillation) in 
the last 6 months prior to Screening, or a cardiac hospitalization within the 6 months prior 
to Screening.
t)
Participant has uncontrolled arterial hypertension characterized by a systolic blood 
pressure (BP) > 160 mm Hg or diastolic BP > 100 mm Hg at Day 1.
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.
u) Participant has Class III or IV congestive heart failure by New York Heart Association 
Criteria.
v) Participant has cancer, history or recurrence of cancer (including skin cancer, carcinoma 
of the cervix or high grade cervical intraepithelial neoplasia, irrespective of past treatment), 
or lymphoproliferative disease within the previous 5 years. 
w) Participant has had any significant/uncontrolled neuropsychiatric illness as clinically 
judged by the investigator during Screening or at Day 1.
OR
Any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by medical 
history or by electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) documentation, 
or by answering “yes” to Question 4 or Question 5 which indicates a suicidal ideation 
severity level of 4 or 5 on the eC-SSRS at Screening or at Day 1, or is clinically deemed to 
have a suicide risk by the investigator.
x) Participant has any other sound medical and/or social reason as determined by the 
investigator.
y) Participant has received systemic non-biologic medications and/or any systemic 
immunosuppressant therapy for PsO and/or PsA other than what is permitted in inclusion 
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criteria (see Section 6.1) (including, but not limited to, azathioprine, cyclosporine, 6-
thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus, retinoids, 
1,25-dihydroxy vitamin D3 [oral vitamin D supplements are permitted] and analogues, 
psoralens, or fumaric acid derivatives) within 28 days prior to Day 1.
z) Participant has received and/or used any traditional Chinese medicines intended to treat 
PsA and/or PsO within 4 weeks prior to Study Day 1.
3) Infectious/Immune-related Exclusions
a) Participant has a history or evidence of participant’s active infection and/or febrile illness 
within 14 days prior to Day 1.
b) Participant has a history of serious bacterial, fungal, or viral infection requiring 
hospitalization and IV antimicrobial treatment within 60 days prior to Day 1. Additionally, 
in the case of prior SARS-CoV-2 infection, symptoms must have completely resolved and,
based on investigator assessment in consultation with the Medical Monitor, there are no 
sequelae that would place the participant at a higher risk of receiving investigational 
treatment.
c) Participant has a history of an infected joint prosthesis or has ever received antibiotics for 
a suspected infection of a joint prosthesis, if that prosthesis has not been removed or 
replaced.
d) Participant has received live vaccine(s) within 60 days prior to Day 1 or plans to receive a 
live vaccine during the study or within 60 days after completing study treatment.
Heat-killed or otherwise inactivated vaccines or protein or subunit vaccines (eg, influenza 
and pneumococcal vaccines) may be received at any time on study.   
Note: If a study participant has received a SARS-CoV-2 vaccine authorized under an 
Emergency Use Authorization or alternative authorization prior to Screening, enrollment 
should be delayed until the biologic impact of the vaccine is stabilized, as determined by 
discussion between the investigator and the BMS Medical Monitor.
e) Not applicable per Protocol Amendment 01: If a study participant has received a SARS-
CoV-2 vaccine authorized under an Emergency Use Authorization or alternative 
authorization prior to Screening, enrollment should be delayed until the biologic impact of 
the vaccine is stabilized, as determined by discussion between the investigator and the 
BMS Medical Monitor.
f)
Participant has a presence of herpes zoster lesions at Screening or Day 1 or history of 
serious herpes zoster or serious herpes simplex infection, which includes, but is not limited 
to, any episode of disseminated herpes simplex, multidermatomal herpes zoster, herpes 
encephalitis, ophthalmic herpes, or recurrent herpes zoster.
g) Participant has evidence of, or positive test for, hepatitis C virus or hepatitis B virus (HBV) 
at Screening
(For Japan and selected
countries: Hepatitis B surface antigen 
[HBsAg]-positive participants are excluded from the study. Participants who are 
HBsAg-negative but positive for hepatitis B surface antibody [HBsAb] and/or hepatitis B 
core antibody [HBcAb] may be eligible and must also be tested for quantitative HBV 
deoxyribonucleic acid [DNA]. Participants with detectable levels as specified by local 
guidelines at Screening are excluded; see Appendix 22).
h) Participant is positive for human immunodeficiency virus (HIV-1 or -2) antibody at 
Screening. A positive test result will disqualify the participant from participation in the 
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study. The investigator should refer any participant who tests positive for HIV to the 
appropriate HIV counsellor or health advisor (per the investigator’s medical practice 
procedure) for further follow-up.
i)
For participants in Japan only: Positive result of beta-D-glucan.
j)
Participant has 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).
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.
c) Participant has any imaging of the chest (eg, chest X-ray, chest computed tomography 
scan) obtained during the Screening Period, or anytime within 6 months prior to Screening 
with documentation, showing evidence of current active or history of active pulmonary 
TB.
d) Participant has latent TB infection (LTBI), defined as positive IFN gamma release assay 
(IGRA) by QuantiFERON®-TB Gold testing at Screening in the absence of clinical 
manifestations.
i)
Participant may be eligible if (i) there are no current signs or symptoms of active TB 
and (ii) participant has received adequate documented treatment for LTBI within 
5 years of Screening or has initiated prophylactic treatment for LTBI per local 
guidelines and is rescreening now after 1 month of treatment. To continue in the study, 
participant must agree to complete a locally recommended course of treatment for 
LTBI.
ii) For participants who are not currently on prophylactic treatment for LTBI per local 
guidelines, including participants who have documented completed treatment for LTBI 
within 5 years of Screening, results of initial IGRA test that is indeterminate with no 
signs or symptoms of active TB must be retested for confirmation. If the second test is 
again indeterminate, the participant will be excluded from the study. If the retest is 
positive, the participant must be treated as having LTBI. If the retest is negative, the 
participant may be eligible provided no other exclusion criteria for TB are met.
iii) For participants who are on prophylactic treatment for LTBI per local guidelines, and 
there are no current signs or symptoms of active TB, retesting of an initial positive or 
indeterminate result is not required and participants may be eligible provided no other 
exclusion criteria for TB are met, and participants continue to complete treatment for 
LTBI per local guidelines.
e) Participant has a history of active or latent TB infection, and participant lives in, or has 
emigrated from, a multi-drug resistant TB high-burden country (see Appendix 23).
f)
Participant has had a household contact with a person with active TB and participant did 
not receive appropriate and documented prophylaxis for TB.
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Note: Household contact is a person who shared the same enclosed living space as the 
index case for 1 or more nights or for frequent or extended daytime periods during the 
3 months prior to Day 1.
5) Physical and Laboratory Test Findings
a) Absolute white blood cell count < 3000/mm3 at Screening.
b) Absolute lymphocyte count < 500/mm3 at Screening.
c) Absolute neutrophil count < 1000/mm3 at Screening.
d) Platelet count < 100,000/mm3 at Screening.
e) Hemoglobin < 9 g/dL at Screening.
f)
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2× upper limit 
of normal (ULN) at Screening.
g) Total, unconjugated, and/or conjugated bilirubin > 1.5× ULN at Screening, except for any 
participant with a confirmed diagnosis of Gilbert’s syndrome.
h) Estimated glomerular filtration rate (eGFR) < 45 mL/min.
i)
Any other significant laboratory or procedure abnormalities that, in the opinion of the 
investigator, might place the participant at unacceptable risk for participation in this study.
6) Allergies and Adverse Drug Reactions
a) History of any significant drug allergy or intolerance (such as anaphylaxis).
7) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated.
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness.
c) Inability to comply with restrictions and prohibited activities/treatments as listed in body 
of protocol.
d) Site personnel or their immediate family.
6.2.1
Exclusion Criteria at Week 52OLE for Optional Open-label Long-term 
Extension Period
An individual who meets any of the following criteria will be excluded from participation in the 
optional OLE Period of the study: 
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1) Medical History and Concurrent Diseases 
a) Any disease or medical condition that, in the opinion of the investigator, would make the 
participant unsuitable for this study, would interfere with the interpretation of participant
safety or study results, or is considered unsuitable by the investigator for any other reason.
2) Findings Related to Possible TB Infection 
 
 
 
 
 
 
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 treatments) are recommended that 
are standard for patients with plaque PsO. Participants should avoid excessive sun exposure and 
avoid risks that are known to provoke flare of PsO and/or PsA.
6.3.1
Meals and Dietary Restrictions
Study treatment may be taken without regard to meals. However, samples are to be collected in a 
fasted state during specified visits. Refer to Schedule of Activities (Section 2).
6.3.2
Caffeine, Alcohol, and Tobacco
No restrictions are required; however, extensive use of caffeine, alcohol, and tobacco or other 
nicotine-containing products should be avoided.
6.3.3
Activity
No restrictions are required; however, unusual physical exertion should be avoided during the 
study.
6.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized in the study/included in the analysis population. A minimal set 
of screen failure information is required to ensure transparent reporting of screen failure 
participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing 
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requirements, as applicable, and to respond to queries from regulatory authorities. Minimal 
information includes date of consent, demography, screen failure details, eligibility criteria, and 
any serious AEs.
6.4.1
Retesting During Screening or Lead-in Period
For laboratory parameters that initially do not meet eligibility requirements, a single retest within 
the 28-day Screening Period is permitted before a participant is declared a screen failure. This is 
an effort to find all possible well-qualified participants. Consultation with the Medical Monitor 
may be needed to identify whether repeat testing of any particular parameter 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). The participant must be re-consented and will be 
assigned a new identification number, and a full Screening Visit must be performed again. A 
participant can only be rescreened 1 time (ie, if the participant fails 1 rescreening attempt, no 
additional rescreening is allowed). Duration of existing treatments and required discontinuation 
periods shall be considered relative to the new Screening Visit and/or randomization.
The most current result prior to randomization is the value by which study inclusion will be 
assessed, as it represents the participant’s most current clinical state.
Rescreening is allowed once with consultation with the Medical Monitor.
7
TREATMENT
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo, or 
medical device intended to be administered to a study participant according to the study 
randomization or treatment allocation.
Study treatment includes both investigational (medicinal) product (IP/IMP) and noninvestigational 
(medicinal) product (Non-IP/Non-IMP) and can consist of the following: deucravacitinib, 
apremilast, and placebo.
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 
than 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.
Study treatments for IM011055 are listed in Table 7-1.
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Table 7-1:
Study Treatments (Week 0 to Week 52) IM011055
Product 
Description/Class and 
Dosage Form
Potency
IP/Non-IMP
Blinded or Open 
Label
Packaging/Appearance
Storage Conditions
(per label)
6 mg deucravacitinib
(BMS-986165) tablet
6 mg
IP
Blinded
Bottle
Refer to the label on 
container and/or 
Pharmacy Manual
Placebo matching 6 mg 
deucravacitinib
(BMS-986165) tablet
N/A
IP
Blinded
Bottle
Refer to the label on 
container and/or 
Pharmacy Manual
Apremilast tablet
10 mg*
IP
Blinded
Blister Card
Refer to the label on 
container and/or 
Pharmacy Manual
Placebo matching 
Apremilast 10 mg tablet
N/A*
IP
Blinded
Blister Card
Refer to the label on 
container and/or 
Pharmacy Manual
Apremilast tablet
20 mg**
IP
Blinded
Blister Card
Refer to the label on 
container and/or 
Pharmacy Manual
Placebo matching 
Apremilast 20 mg tablet
N/A**
IP
Blinded
Blister Card
Refer to the label on 
container and/or 
Pharmacy Manual
Apremilast tablet
30 mg***
IP
Blinded
Blister Card and Bottle
Refer to the label on 
container and/or 
Pharmacy Manual
Placebo matching 
Apremilast 30 mg tablet
N/A***
IP
Blinded
Blister Card and Bottle
Refer to the label on 
container and/or 
Pharmacy Manual
*Used for titration Day 1 through Day 3 morning dose.
**Used for titration Day 3 evening dose through Day 5 morning dose.
***From Day 5 evening dose onwards.
Abbreviations: IP, investigational product; IMP, investigational medicinal product; N/A, not applicable.
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7.1
Treatments Administered
The study treatment will be administered in a double-blind, double-dummy fashion for the 52-
week treatment period
, as 
described in Section 5.1. The selection and timing of dose for each participant is as follows:
Table 7.1-1:
Selection and Timing of Dose for 52-week Treatment Period
Study Treatment
Unit Dose 
Strength(s)/Dosage 
Level(s)
Dosage Formulation
Frequency of 
Administration
Route of Administration
Deucravacitinib
6 mg
1 active tablet QD in 
the morning; 1 placebo 
titration kit* then 
2 apremilast placebo 
(1 tablet in the morning, 
1 tablet in the evening)
Oral
Placebo
N/A
1 placebo apremilast 
titration kit* then 
2 apremilast placebo 
(1 tablet in the morning, 
1 tablet in the evening) 
and 1 deucravacitinib
placebo QD in the 
morning
Oral
Apremilast
30 mg
1 active titration kit* 
then 1 active morning 
and evening and 
1 deucravacitinib
placebo QD in the 
morning 
Oral
*Titration kit is described in Section 7.1.1.
Abbreviations: N/A, not applicable; QD, once daily.
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7.1.1
Titration Kit for Active and Placebo Apremilast
Apremilast will be titrated over 5 days to a maintenance dose of 30 mg BID. To maintain the blind 
between participants receiving apremilast and deucravacitinib during the titration period, active 
apremilast and matching apremilast placebo tablets will be provided. This will be supplied in an 
18-day titration kit as follows:
One 10 mg tablet in the morning on Day 1; two 10 mg tablets (one in the morning, one in the 
evening) on Day 2; one 10 mg tablet in the morning and one 20 mg tablet in the evening on Day 3; 
two 20 mg tablets (one tablet in the morning, one tablet in the evening) on Day 4; one 20 mg tablet 
in the morning and one 30 mg tablet in the evening on Day 5; one 30 mg tablet in the morning and 
one 30 mg tablet in the evening for each Day 6 through Day 18.
7.2
Method of Treatment Assignment
All participants will be centrally randomized using Interactive Response Technology (IRT). 
Before the study is initiated, each user will receive log in information and directions on how to 
access IRT.
Study treatment will be dispensed at the study visits as listed in Schedule of Activities (Section 2). 
Those enrolled participants meeting inclusion and exclusion criteria will be eligible to be 
randomized. 
7.3
Blinding for the 52-week Treatment Period
7.3.1
Maintaining the Blind
Blinded treatment assignments will be managed using IRT. IP supply will be controlled by IRT at 
each visit. 
All tablets are identical in appearance and will be supplied in bottles, with each daily dose made 
up of the appropriate combination of active and/or placebo tablets to provide the correct treatment, 
as shown in Table 7.1-1. Investigative site staff, Sponsor and designee personnel, and participants
and their families will remain blinded to treatment assignments.
Designated staff of Bristol-Myers Squibb Research & Development may be unblinded (obtain the
randomization codes) prior to Week 56 database lock to facilitate the bioanalytical analysis of PK 
samples. A bioanalytical scientist in the Bioanalytical Sciences department of Q2 Solutions and 
BMS Research and Development (or a designee in the external central bioanalytical laboratory) 
will be unblinded to (may obtain) the randomized treatment assignments to minimize unnecessary 
bioanalytical analysis of samples.
7.3.2
Circumstances for Unblinding
This is a randomized, double-blind study
. 
 
 
Access to treatment codes will be restricted from all participants and site and BMS personnel prior 
to Week 56 database lock, with exceptions as specified below.
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Blinding of 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 active 
product. 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 through the IRT system.
In cases of accidental unblinding, contact the Medical Monitor and ensure every attempt is made 
to preserve the blind.
Any request to unblind a participant for nonemergency purposes should be discussed with the 
Medical Monitor.
In case of an emergency, the investigator(s) has unrestricted access to randomization information 
via the IRT and is capable of breaking the blind through the IRT system without prior approval 
from the Sponsor. Following the unblinding the investigator shall notify the Medical Monitor
and/or study director.
Designated staff of BMS Company may be unblinded (obtain the randomization codes) prior to 
Week 56 database lock to facilitate the bioanalytical analysis of pharmacokinetic samples. A 
bioanalytical scientist in the Bioanalytical Sciences department of BMS (or a designee in the 
external central bioanalytical laboratory) will be unblinded to (may obtain) the randomized 
treatment assignments in order to minimize unnecessary bioanalytical analysis of samples.
Additionally, the DMC will assess safety on an ongoing basis and will have access to unblinded 
treatment for individual participants. An analysis team, including a reporting statistician and 
programming support who are not involved with the conduct of the study, will provide analyses to 
the DMC. The procedures to be respected and the reasons for unblinding of the DMC are outlined 
in the DMC Charter.
7.4
Dosage Modification
There is no provision for dose modification of study treatment.
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7.5
Preparation/Handling/Storage/Accountability
The IP should be stored in a secure area according to local regulations. It is the responsibility of 
the investigator to ensure that IP is only dispensed to study participants. The IP must be dispensed 
only from official study sites by authorized personnel according to local regulations.
The product storage manager should ensure that the study treatment 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 treatment arise, the study treatment
should not be dispensed and contact BMS immediately.
Study treatment 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 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).
Please refer to the current version of the investigator’s Brochure and/or Pharmacy Manual for 
complete preparation, storage, and handling information.
Further guidance and information for final disposition of unused study treatment are provided in 
Appendix 2.
7.5.1
Retained Samples for Bioavailability/Bioequivalence/Biocomparability
Not applicable.
7.6
Treatment Compliance
Study treatment compliance will be periodically monitored using standard drug accountability
procedures (comparing the number of tablets returned to number dispensed). Drug accountability 
should be reviewed by the site study staff at each visit to confirm treatment compliance. Sites 
should discuss discrepancies with the participant at each on-treatment study visit.
7.7
Concomitant Therapy
All previous and current systemic medications taken for PsA and PsO must be reported. 
Current medications and medications taken within 4 weeks prior to IP administration for 
conditions other than PsA and PsO must be recorded on the case report form (CRF).
7.7.1
Permitted Treatments

Use of NSAIDs for the treatment of PsA during the study is permitted for participants enrolled 
on a stable dose of NSAIDs.

Use of csDMARD (MTX, SSZ, LEF, HCQ) for the treatment of PsA is permitted for 
participants enrolled in the study on a stable dose of csDMARD.

If on MTX, the route of administration and dose must be stable and the dose must be 
≤25 mg/week.

If on SSZ, the dose must be ≤3 g/day.
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
If on HCQ, the dose must be ≤400 mg/day.

If on LEF, the dose must be ≤20 mg/day.
Note: Use of only 1 csDMARD at a time is permitted unless used for rescue therapy (see 
Section 7.7.4).

Use of oral glucocorticoids (≤ 10 mg/day prednisone equivalent) for the treatment of PsA 
during the study is permitted for participants enrolled on a stable dose of oral glucocorticoids;
however, they must remain on a stable dose until Week 32.

 
7.7.2
SARS-CoV-2 Permitted Treatments
SARS-CoV-2 vaccines that are NOT live are permitted during the study. Details of the vaccine 
and date should be recorded. If a participant receives a SARS-CoV-2 vaccination during the study, 
key study visits (ie, Day 1, Week 16, Week 52/
) should not take place 
within 5 days after vaccine administration so that any acute reaction to the vaccine will not be 
reflected in the study assessments. The BMS Medical Monitor should be consulted with any 
questions.
7.7.3
Prohibited and/or Restricted Treatments
Prohibited and/or restricted medications during the study are described below. 
7.7.3.1
Prohibited Treatments
Use of opioid analgesics, if the average daily dose is > 30 mg/day of morphine or its equivalent
(see Section 6.2), 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 are prohibited up to Week 52.

Any use of the following oral PsO medications: cyclosporine, retinoids, fumaric acid 
derivatives are prohibited up to Week 52.

High-potency glucocorticoids (WHO Classes I through V), > 3% salicylic acid, urea, alpha or 
beta hydroxy acids, anthralin, calcipotriene, vitamin D derivatives (oral vitamin D supplements 
are permitted), retinoids, tazarotene. Any medicated shampoos that contain glucocorticoids, 
coal tar, > 3% salicylic acid, or vitamin D3 analogues up to Week 52.

Live vaccination, including live SARS-CoV-2 vaccines, during the study or within 60 days 
after completing study treatment (Section 6.2).

Immune-suppressing immunomodulatory agents such as tacrolimus, sirolimus, mycophenolate 
mofetil, JAK inhibitors, and immunosuppressant biologic agents, including, but not limited to,
TNF antagonists, anti-IL-17, anti-IL-12/23, anti-IL-23, and abatacept.

Any concurrent use of strong CYP450 inducers are prohibited up to Week 52, as it may reduce 
apremilast efficacy according to the United States (US) package insert. Examples include 
rifampin, phenobarbital, carbamazepine, and phenytoin, unless it is considered necessary for 
the participant’s welfare and/or treatment of an AE/SAE.
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8
DISCONTINUATION CRITERIA
8.1
Discontinuation from Study Treatment
Participants MUST discontinue IP (and non-IP at the discretion of the investigator) for any of the 
following reasons:

Clinically significant worsening of disease that requires medications other than those permitted 
for rescue therapy at any time during the study.

Use of bDMARDs or JAK inhibitors taken as a rescue therapy.

Participant’s request to stop study treatment. 

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.
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
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.

eGFR < 45 mL/min confirmed on a repeat assessment within 7 days unless the investigator, in 
consultation with the Medical Monitor, deems that it is in the best interest of the participant to 
repeat testing and further evaluate participant’s eligibility to continue in the study.

The participant develops a malignancy, with the exception of a participant who develops 
nonmelanoma skin cancer who may continue in the study at the discretion of the investigator.

Pregnancy, positive pregnancy test, or participant expresses an interest in becoming pregnant 
(refer to Section 9.2.6).

Participant develops active TB during the study or prematurely discontinues treatment for 
LTBI, or participant is noncompliant with LTBI therapy (refer to Section 9.4.6).

Participant with positive HBsAb or positive HBcAb with undetectable HBV DNA at 
Screening, for whom the quantitative HBV DNA test becomes detectable anytime during 
treatment with the IP.

Unblinding of a participant’s treatment 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
randomization, or documents suicidal ideation by answering “Yes” to Question 4 or 5 on the 
eC-SSRS, or documents suicidal behavior on the eC-SSRS at any time during the study. The 
participant should then be immediately referred to a mental health professional for evaluation 
of suicide risk.
Discontinuation of the study treatment for abnormal liver tests should be considered by the 
investigator when a participant meets 1 of the conditions outlined in Section 9.2.8 or if the 
investigator believes that it is in the best interest of the participant.
Refer to the Schedule of Activities (Section 2) for data to be collected at the time of study treatment 
discontinuation and follow-up and for any further evaluations that can be completed.
In the case of pregnancy, the investigator must immediately, within 24 hours of awareness of the 
pregnancy, notify the BMS Medical Monitor/designee of this event. The study treatment will be 
permanently discontinued. See Section 9.2.6. 
If study treatment 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 and entered on the 
appropriate CRF page.
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Participants who discontinue study treatment are required to complete an ET Visit, a Safety 
Follow-up Visit 30 days following last dose of study treatment, and should complete each study 
visit through Week 52. 
 
 
Only participants who are lost to follow-up will have no further study visits. Participants who 
request to withdraw at any time from the study will be asked to complete the Safety Follow-up 
Visit 30 days following last dose of study treatment. The only exception to this requirement is 
when a participant withdraws consent for all study procedures, including post-treatment study 
follow-up, or loses the ability to consent freely (eg, is imprisoned or involuntarily incarcerated for 
the treatment of either a psychiatric or physical illness). 
8.1.1
Temporary Discontinuation
Temporary study treatment 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 treatment be placed on hold. Study treatment in this situation should be stopped until the 
AE is medically treated and has resolved per principal investigator’s judgment. Any temporary 
study treatment discontinuation as well as restart must be documented on the corresponding 
electronic CRF (eCRF).
Temporary discontinuation of IP is allowed in the context of clinical suspicion for SARS-CoV-2
or a positive diagnostic test for SARS-CoV-2, and requires complete resolution of a SARS-CoV-2
infection, which must be confirmed by a negative diagnostic test prior to re-commencing IP. 
Temporary discontinuation of IP may be considered in the event of SARS-CoV-2 vaccination 
according to local guidelines. In order to facilitate reporting of SARS-CoV-2 events that occur 
during the study, all AEs and SAEs related to SARS-CoV-2 must be reported from the time of 
consent. In addition, AEs or SAEs will trigger additional data collection through dedicated eCRF
pages which will allow the Sponsor to further evaluate these events. 
8.1.2
Post Study Treatment Study Follow-up
Participants who discontinue study treatment are required to complete an ET Visit, a Safety 
Follow-up Visit 30 days following last dose of study treatment, and should complete each study 
visit through Week 52. 
 
 
8.2
Discontinuation from the Study
Participants who request to discontinue study treatment will remain in the study and should
continue to be followed for protocol-specified follow-up procedures through Week 52 (See Section 
2 and Section 8.1.2). The only exception to this requirement is when a participant specifically 
withdraws consent for all study procedures, including post-treatment study follow-up, or loses the 
ability to consent freely will have no further study visits. 
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
Participants should notify the investigator of the decision to withdraw consent from future 
follow-up in writing, whenever possible.

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 treatment 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.
Participants who request to discontinue from the study are required to complete the ET Visit and 
will be asked to complete a Safety Follow-up Visit 30 days following last dose of study treatment
(or phone call if a visit is not possible) to determine the status of any ongoing AEs/SAEs or the 
occurrence of any new AEs/SAEs.  
 
8.3
Lost to Follow-up

All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant.

Lost to follow-up is defined by the inability to reach the participant after a minimum of 
three (3) documented phone calls, faxes, or emails as well as lack of response by participant
to 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 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 participant’s 
contact information or other public vital status data necessary to complete the follow-up 
portion of the study.

The site staff and representative will consult publicly available sources, such as public health 
registries and databases, in order to obtain updated contact information.

If after all attempts, the participant remains lost to follow-up, then the last known alive date as 
determined by the investigator should be reported and documented in the participant’s medical 
records.
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9
STUDY ASSESSMENTS AND PROCEDURES

When multiple assessments are conducted at a single visit, it is recommended that 
patient-reported outcomes assessments are performed first. Please refer to 
 
.
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 
treatment.

Adherence to the study design requirements, including those specified in the Schedule of 
Activities, 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.

The duration of the Screening Period is up to 28 days. If eligibility parameters cannot be 
obtained within this time period, the Screening Period may be extended by up to 10 days 
if approved by the Sponsor. In addition, rules for retesting and rescreening are provided in 
Section 6.4.1.

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).
9.1
Efficacy Assessments
9.1.1
Rater Qualifications
Clinical efficacy assessments must be performed by a qualified assessor. At minimum, there are 
2 qualified assessors required to complete the clinical efficacy assessments at each site: 1) an 
independent Joint Assessor (who should not have access to previous efficacy assessments and 
safety data) to complete the tender and swollen joint count; the Joint Assessor may also complete 
the enthesitis and dactylitis assessment, Physician Global Assessment - Fingernails (PGA-F), and 
PASI and static Physician’s Global Assessment (sPGA) scoring unless the site designates an 
alternate staff member(s) to complete these assessments; and 2) an investigator to perform the 
Physician Global Assessment of PsA. Every effort must be made to ensure the same assessor 
completes the clinical efficacy assessments for each participant at all visits at approximately the 
same time throughout the study, according to the Schedule of Activities (Section 2). Visits should 
be scheduled with the availability of the assessor taken into account.
To be an eligible Joint Assessor, individuals must receive standardized joint count training 
provided by BMS, be trained by an individual who completed the standardized training, or 
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complete an alternative training method approved by BMS (eg, training documentation provided 
for another Sponsor’s study in a similar indication). Documentation should be filed in the 
investigator File or the Study File. Such individuals should have appropriate medical credentials 
and/or should be individuals with appropriate scientific/medical background who are experienced 
in performing joint assessments. If the individual does not have medical credentials, 
documentation of their experience (preferably on a curriculum vitae) must be provided to the study 
site manager, and their eligibility as Joint Assessor must be confirmed by the BMS Medical 
Monitor before the individual’s participation in the study as Joint Assessor.
The individual performing the Physician’s Global Assessment of PsA must be an investigator who 
is competent to perform the assessment.
In order to minimize variability, the same assessor should evaluate the participant at each visit for 
the duration of the trial, and a back-up assessor should be identified. The assessor should be a 
qualified medical professional (eg, nurse, physician’s assistant, or physician). Any assessor must 
be trained and competent in performing such assessments. It is the responsibility of the investigator
to ensure that all assessors are qualified and trained to perform assessments and that all training is 
documented. If the assessor is not available, the pre-identified back-up assessor should perform 
such assessments. Participants will complete all participant-reported questionnaires, which will be 
considered source documents in this study.
9.1.2
American College of Rheumatology Improvement Criteria 
The ACR 20, ACR 50, or ACR 70 definition of improvement is a 20%, 50%, or 70% improvement, 
respectively, over baseline in tender (68) and swollen (66) joint counts and a 20%, 50%, or 70% 
improvement, respectively, in 3 of the 5 remaining core data set measures (see Appendix 25):

Subject Global Assessment of Disease Activity (see Appendix 6)

Subject Global Assessment of Pain (see Appendix 7)

HAQ-DI (see Appendix 8)

Physician Global Assessment of PsA (see Appendix 17)

hsCRP
9.1.3
Health Assessment Questionnaire - Disability Index 
The HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a 
participant has experienced during the past week in 8 domains of daily living activities: dressing 
and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity 
category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored 
from 0 to 3, with 0 representing “no difficulty,” 1 representing “some difficulty,” 2 representing 
“much difficulty,” and 3 representing “unable to do.” Any activity that requires assistance from 
another individual or requires the use of an assistive device adjusts to a minimum score of 2 to 
represent a more limited functional status (see Appendix 8).
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9.1.4
Short Form-36
The SF-36 version 2 standard was designed as an indicator of health status in population surveys
and health policy evaluations and for use as an outcome measure in clinical research. The 
instrument includes 36 items in a Likert-type format to measure the following 8 health dimensions: 

The Physical Component Summary (PCS) of the SF-36 consists of these 4 subscales:

physical functioning

role-physical

bodily pain, and

general health.

The Mental Component Summary of the SF-36 consists of these 4 subscales:

vitality

social functioning

role-emotional, and

mental health.
Scores for each domain range from 0 to 100, with high scores indicating a better health status. An 
example of the SF-36 is provided in Appendix 9.
9.1.5
Fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue)
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild 
subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion 
that likely decreases one’s ability to execute daily activities and function normally in family or 
social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, 
and intensity) and the impact of fatigue on physical, mental, and social activities. 
The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = “not at 
all” to 4 = “very much.” Sum scores for the 13 items range from 0 through 52, where higher scores
indicate less fatigue. An example is provided in Appendix 10.
9.1.6
Psoriatic Arthritis Impact of Disease 12
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA
symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a
1-week recall period. The PsAID has a total score, with a higher value indicating worse health (see 
Appendix 11).
9.1.7
Dermatology Life Quality Index
The Dermatology Life Quality Index (DLQI) is a participant-reported quality-of-life index which 
consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, 
personal relationships, and treatment during the past week.42 Each question is scored on a scale of 
0 to 3 by a tick box: 0 = “not at all,” 1 = “a little,” 2 = “a lot,” or 3 = “very much.” The scores are 
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summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment) 
(see Appendix 12).
9.1.8
5-level EuroQoL 5-dimension 
The 5-level EuroQoL 5-dimension is an instrument widely used in cost-utility analysis. Using a 
system of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression) and 5 levels (1 = no problems, 2 = slight problems, 3 = moderate problems, 
4 = severe problems, 5 = extreme problems) for each dimension, it provides utility values for a 
total of 3,125 health states. The utility values are measured from the general population using the 
time trade-off method. An example is provided in Appendix 13.
9.1.9
Patient-Reported Outcome Measures Information System Sleep 
Disturbance Short Form 8b
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b 
assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. 
This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as 
perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point 
Likert scale ranging from 1 = “not at all” to 5 = “very much” with a 7-day recall period. An 
example is provided in Appendix 14.
9.1.10
Work Productivity and Activity Impairment Questionnaire 
The Work Productivity and Activity Impairment (WPAI) questionnaire will be used to measure 
aspects of productivity and activity impairment over the previous 7 days. The WPAI is a 6-item 
questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact 
of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), 
presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall 
work impairment/absenteeism plus presenteeism), and activity impairment. An example is 
provided in Appendix 15.
9.1.11
Bath Ankylosing Spondylitis Disease Activity Index
In participants with baseline evidence of PsA spondylitis, symptoms will be evaluated using the 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; see Appendix 16), which consists 
of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to 
the 5 major symptoms of ankylosing spondylitis: 

Fatigue (medical) 

Spinal pain 

Joint pain and swelling

Areas of localized tenderness 

Morning stiffness duration 

Morning stiffness severity 
A higher count indicates worse disease. The recall period is 1 week.
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9.1.12
Depression Monitoring
Depression will be monitored by administration of the eight-item Patient Health Questionnaire 
depression scale (PHQ-8) at Screening and during visits as outlined in Section 2. 
9.1.12.1
Eight-item Patient Health Questionnaire 
The PHQ-8 is established as a valid diagnostic and severity measure for depressive disorders in 
large clinical studies.43 Each of the 8 questions is based on a 2-week recall and scored on a scale 
of 0 to 3 by a tick box as: Not at All, Several Days, More than Half the Days, and Nearly Every 
Day. A score of ≥10 is suggestive of moderate depressive symptoms (see Appendix 26).44 If a 
subject scores ≥15 on the PHQ-8 during the study, the investigator will review the situation and 
refer the subject to a mental health professional if deemed necessary.
9.1.13
Suicidal Risk Monitoring
Treatment with apremilast is associated with an increase in adverse reactions of depression. 
Further participants with chronic illnesses may be prone to depression and be at risk for suicide. 
Given these concerns, participants in the Phase 3 Study (IM011055) will be closely monitored for 
depression and suicidal ideation. Participants, investigators, and study personnel will be informed 
that apremilast is associated with depression. Participants experiencing signs and symptoms of 
depression or suicidal ideation should be evaluated and referred, as needed, for psychiatric 
evaluation and treatment as appropriate. The investigator should discuss with the Medical Monitor 
if study treatment should be held or discontinued. Any participant who is identified as having made 
a suicide attempt, or experienced a psychiatric event requiring hospitalization, must be withdrawn 
from the study and referred for further medical and/or psychiatric care.
 
 
 
 
9.1.14
Suicidal Ideation and Behavior Monitoring
Participants will be monitored for suicidal ideation and behavior (SIB) by the eC-SSRS (Section
9.1.14.1) at the visits outlined in the Schedule of Activities (Section 2). Participants who answer 
yes to Questions 4 or 5 which indicates a suicidal ideation severity level of 4 or 5 or document 
suicidal behavior or suicidal attempts on the eC-SSRS will have their treatments discontinued and 
be immediately referred to a mental health professional for further evaluation. In addition, family 
members or caregivers of the participants will be instructed to immediately report any suicidal 
ideation, suicidal behavior, or suicide attempt to the investigator.
9.1.14.1
electronic Columbia-Suicide Severity Rating Scale
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a computer-automated, 
physician-administered version of the C-SSRS instrument that defines 11 categories of SIB 
events.45,46,47 The categories are as follows:

Suicidal ideation
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
Passive

Active: Nonspecific (no method, intent, or plan)

Active: Method, but no intent or plan

Active: Method and intent, but no plan

Active: Method, intent, and plan

Suicidal behavior

Completed suicide

Suicide attempt

Interrupted attempt

Aborted attempt

Preparatory actions toward imminent suicidal behaviors

Self-injurious behavior, no suicidal intent
Appendix 27 provides definitions of these categories.48
9.1.15
Enthesitis (Leeds Enthesitis Index, Spondyloarthritis Research 
Consortium of Canada)
The number of sites with enthesitis will be evaluated by a blinded assessor using the 
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index and the Leeds 
Enthesitis Index (LEI).
The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: 
the greater trochanter (right [R]/left [L]), quadriceps tendon insertion into the patella (R/L), patellar 
ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), 
plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion 
(R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. It has 
been validated in ankylosing spondylitis and correlates well with the Leeds Dactylitis Index 
(LDI).49
The LEI was developed specifically for PsA. An overall score of 0 to 6 is derived from the presence 
or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral 
condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater 
enthesitis burden.50
9.1.16
Dactylitis (Tender Count, Leeds Dactylitis Index)
The number of digits in hands and feet with dactylitis will be counted by a blinded assessor. The 
LDI Basic is a quantitative measurement of dactylitis in the 20 digits using a dactylometer. The 
circumference of the affected and contralateral digits and tenderness of the affected digits are 
measured to generate a total score. A higher score indicates worse dactylitis and is based on the 
current evaluation. Training will be provided so dactylitis will be evaluated in a consistent manner 
throughout the study.51
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9.1.17
Psoriasis Area and Severity Index
The PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin 
lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to 
groin, and legs to top of buttocks).52 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 assessor experienced in the assessment of PsO patients (see Appendix 18).
9.1.18
Static Physician’s Global Assessment
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, 
scale, and induration.53 The sPGA measure determines psoriasis severity at a single point in time 
(without taking into account the baseline disease condition) as clear (0), minimal (1), mild (2), 
moderate (3), or severe (4). sPGA assessments should be performed by a trained physician 
(eg, dermatologist) or appropriately trained investigator who is experienced in the assessment of 
PsO patients. Every effort should be made to ensure that the physician or designee who performed 
the sPGA evaluations for a participant at randomization performs the sPGA for that participant at 
all subsequent visits (see Appendix 19). 
9.1.19
Physician Global Assessment-Fingernails
In this assessment, 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 PGA-F will be performed only in participants with psoriatic fingernail involvement to assess 
severity and subsequent improvement. An example is provided in Appendix 20. The PGA-F should 
be performed by an appropriately trained assessor experienced in the assessment of PsO patients.
9.1.20
Psoriatic Arthritis Disease Activity Score
The Psoriatic Arthritis Disease Activity Score is a composite measure calculated from the 
Physician Global Assessment of PsA, the Subject Global Assessment of Disease Activity, the 
SF-36 PCS, the swollen joint count, the tender joint count, the LEI, the LDI (Basic), and the 
hsCRP.
9.1.21
Disease Activity Score 28 CRP
A DAS can be used to assess patients’ PsA disease activity, to determine whether it is under control 
and if any treatment adjustments are required. It can also assist in establishing a target score to aim 
for, to help inform treatment decisions and optimize disease management. See Appendix 21.
The DAS28-CRP is a composite outcome measure that assesses: 
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
How many joints in the hands (including metacarpophalangeal and proximal interphalangeal 
joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out 
of a total of 28 

CRP in the blood to measure the degree of inflammation 

Subject Global Assessment of Disease Activity (see Appendix 6)
The results are combined to produce the DAS28-CRP score, which correlates with the extent of 
disease activity: 

< 2.6: Disease remission

2.6 to 3.2: Low disease activity 

3.2 to 5.1: Moderate disease activity 

> 5.1: High disease activity
9.1.22
Minimal Disease Activity and Very Low Disease Activity
MDA response is where an MDA responder is defined as a participant fulfilling 5 of 7 of the 
following outcomes: 

Tender joint count ≤ 1 

Swollen joint count ≤ 1 

PASI ≤ 1 or body surface area (BSA) ≤ 3% (see Appendix 18)

Subject Global Assessment of Disease Activity ≤ 20 (see Appendix 6)

Subject Global Assessment of Pain ≤ 15 (see Appendix 7)

HAQ-DI ≤ 0.5 (see Appendix 8)

Tender enthesial points ≤ 1 
Very low disease activity (VLDA) response is where a VLDA responder is defined as a participant
fulfilling all 7 of 7 of the MDA outcomes.
9.1.23
Disease Activity Index for Psoriatic Arthritis Score
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess 
peripheral joint involvement that is based upon numerical summation of 5 variables of disease 
activity: tender joint count, swollen joint count, Subject Global Assessment of Disease Activity 
(see Appendix 6), Subject Global Assessment of Pain (see Appendix 7), and CRP.
9.1.24
Modified Composite Psoriatic Disease Activity Index
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index
(mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment 
Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and 
enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based 
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on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored 
using a 4-point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an 
mCPDAI score range of 0 through 12.54
9.1.25
Psoriatic Arthritis Response Criteria
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, 
swollen joint count, Physician Global Assessment of PsA, and Subject Global Assessment of 
Disease Activity.
In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 
4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. 
Improvement in each of the measures is defined below:

Decrease of ≥30% in tender joint counts

Decrease of ≥30% in swollen joint counts

Decrease of ≥20% in Physician Global Assessment of PsA

Decrease of ≥20% in Subject’s Global Assessment of Disease Activity
9.1.26
Ankylosing Spondylitis Disease Activity Score with CRP
The Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS–CRP) is a 
validated disease activity index in ankylosing spondylitis that combines patient-reported 
assessments of back pain (BASDAI question 2), duration of morning stiffness (BASDAI question 
6), peripheral joint pain and/or swelling (BASDAI question 3), general well-being, and CRP, in a 
weighted manner.55 The cut-off values for disease activity states and improvement scores are 
defined as follows: < 1.3 inactive disease, ≥ 1.3 and < 2.1 low disease activity, ≥ 2.1 and ≤ 3.5 high 
disease activity, and > 3.5 very high disease activity. The minimum clinically important difference 
is defined as: change of at least 1.1 unit for “clinically important improvement” and change of at 
least 2.0 units for “major improvement.”56,57
9.1.27
Imaging Assessment for the Study
Not applicable.
9.2
Adverse Events
The definitions of an AE and SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally authorized representative). 
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up AEs that 
are serious, that are considered related to the study treatment or the study, or that caused the 
participant to discontinue before completing the study. 
Contacts for SAE reporting specified in Appendix 3.
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9.2.2
Time Period and Frequency for Collecting AE and SAE Information
All non-serious AEs must be collected from the time of initiation of study treatment until 
discontinuation of study. All SAEs and all AEs (SAEs or non-serious AEs) related to SARS-CoV-
2 infection must be collected from the time of signing the consent, including those thought to be 
associated with protocol-specified procedures and within 30 days of discontinuation of dosing or 
participants’ participation in the study if the last scheduled visit occurs at a later time.
The investigator must report any SAE that occurs after these time periods and that is believed to 
be related to IP or protocol-specified procedures (eg, a follow-up skin biopsy).

Medical occurrences that begin before the start of study treatment 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 
treatment 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.
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9.2.4
Follow-up of AEs and SAEs

Non-serious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3).

Follow-up is also required for non-serious AEs that cause interruption or discontinuation of 
study treatment and for those present at the end of study treatment as appropriate.

All identified non-serious AEs must be recorded and described on the non-serious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study.
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs and non-serious AEs of special interest (as defined in 
Section 9.2) will be followed until resolution, until the condition stabilizes, until the event is 
otherwise explained, or until the participant is lost to follow-up (as defined in Section 8.3).
Further information on follow-up procedures is given in Appendix 3.
9.2.5
Regulatory Reporting Requirements for SAEs

Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met.

An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the Investigator’s Brochure and will notify the Institutional Review Board (IRB)/Independent 
Ethics Committee if appropriate according to local requirements.
Sponsor or designee will be reporting AEs to regulatory authorities and ethics committees 
according to local applicable laws, including European Directive 2001/20/EC and United States 
of America (USA) Food and Drug Administration Code of Federal Regulations Title 21 Parts 312 
and 320. A suspected, unexpected serious adverse reaction is a subset of SAEs and will 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 treatment, 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 the 
study period until study completion or 30 days after discontinuation of study treatment, whichever 
is longer (see Section 5.3), the investigator must immediately notify the BMS Medical 
Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form to BMS 
designee within 24 hours of awareness of the event and in accordance with SAE reporting 
procedures described in Appendix 3.
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In the event a participant becomes pregnant during the trial, the study treatment must be 
discontinued immediately. Protocol-required procedures for study discontinuation and follow-up 
must be performed on the participant.
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.
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
the Sponsor or designee. In order for the Sponsor or designee to collect any pregnancy surveillance 
information from the female partner, the female partner must sign an ICF for disclosure of this 
information. Information on this pregnancy will be collected on the Pregnancy Surveillance Form.
9.2.7
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the non-serious AE CRF 
page or SAE CRF electronic, 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 treatment
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 versus low hemoglobin value).
9.2.8
Potential Drug-induced Liver Injury
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential drug-induced liver injury (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).
Potential DILI is defined as: 
1) Aminotransferase (AT; ALT or AST) elevation > 3 times ULN
AND
2) Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase),
AND
3) No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic.
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9.2.9
Other Safety Considerations
Any significant worsening noted during interim or final physical examinations, electrocardiogram
(ECG), X-ray filming, any other potential safety assessment required or not required by the 
protocol should also be recorded as a non-serious or serious AE, as appropriate, and reported 
accordingly.
9.3
Overdose
 
In the event of an overdose, the investigator should:

Contact the Medical Monitor immediately

Closely monitor the participant for AEs/SAEs and laboratory abnormalities
Decisions regarding dose interruptions will be made by the investigator in consultation with the 
Medical Monitor based on the clinical evaluation of the participant.
9.4
Safety
Planned time points for all safety assessments are listed in the Schedule of Activities (Section 2).
9.4.1
Physical Examinations
Refer to Schedule of Activities (Section 2). A complete physical examination will include general 
appearance, 
eyes, 
ears, 
nose,
mouth, 
throat, 
neck, 
respiratory, 
cardiovascular,  
gastrointestinal/abdomen, lymphatic, musculoskeletal, skin, psychiatric, and neurologic exams. A 
targeted physical examination will include any organ system associated with an AE or a laboratory 
abnormality.
9.4.2
Vital Signs
Vital signs include (ear or oral) body temperature, respiratory rate, and seated blood pressure and 
heart rate. Refer to Schedule of Activities (Section 2).
9.4.3
Electrocardiograms
Refer to Schedule of Activities (Section 2). A 12-lead electrocardiogram (ECG) will be performed 
at the visits indicated in the Schedule of Activities. The participant must have his or her lab work 
done after the ECG 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.
9.4.4
Clinical Safety Laboratory Assessments
Investigators must document their review of each laboratory safety report.
A central/local laboratory will perform the analyses and will provide reference ranges for these 
tests.
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Hematology
Complete blood count:
Hemoglobin
Hematocrit
Total leukocyte count, including differential
Platelet count
Chemistry
Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Total bilirubin
Direct bilirubin
Alkaline phosphatase
Lactate dehydrogenase (LDH)
Creatinine
Blood urea nitrogen (BUN)
Uric acid
Glucosea
Total protein
Albumin
Sodium
Potassium
Chloride
Calcium
Phosphorus
Magnesium
Creatine kinase
Creatinine clearance (CLcr)- Screening only
Lipid Panel (Fasting)
Cholesterol (total)
High-density lipoprotein (HDL)
Low-density lipoprotein (LDL)
Triglycerides
Urinalysis
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
pH
Microscopic examination of the sediment if blood, protein, or leukocytes esterase are positive 
on the dipstick
Serology
Hepatitis C antibody confirmed by HCV-ribonucleic acid (RNA) testing if required
Hepatitis B surface antigen (HBsAg)
Hepatitis B surface antibody (HBsAb)
Hepatitis B core antibody (HBcAb)
HBV DNA as required with confirmed HBV infection; see Appendix 22
HIV antibody (Screening only)
Other Analyses
Serum immunoglobulin levels (immunoglobulin M/G/A/E [IgM/IgG/IgA/IgE])
Pregnancy test (WOCBP only: Screening, prior to first IP administration, and every 4 weeks 
thereafter, including the Safety Follow-up Visit)b
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Follicle-stimulating hormone (FSH) (Screening 
 only for post-menopausal 
women only [see Appendix 4 for detailed information on the definitions of WOCBP and post-
menopausal female])
High-sensitivity C-reactive protein (hsCRP)
Hemoglobin A1c
Thyroid-stimulating hormone (TSH)
β - D glucan (requirement for Japanese sites only)
a Fasting glucose will be collected at time points indicated in the Schedule of Activities; nonfasting glucose will be 
collected at all other time points.
b Serum pregnancy test can be performed as an alternative to urine pregnancy test, based on the clinical judgment of 
the investigator. A serum pregnancy test should be performed prior to IP administration in WOCBP where a urine 
pregnancy test does not adequately exclude a clinical suspicion of pregnancy.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; 
CLcr, creatinine clearance; DNA, deoxyribonucleic acid; FSH, follicle-stimulating hormone; HBcAb, hepatitis B core 
antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; 
HCV, hepatitis 
C 
virus; 
HDL, 
high-density 
lipoprotein; 
HIV, 
human 
immunodeficiency 
virus; 
hsCRP, high-sensitivity C‑reactive protein; IgM/IgG/IgA/IgE, immunoglobulin M/G/A/E; IP, investigational product; 
LDH, lactate dehydrogenase; LDL, low-density lipoprotein; RNA, ribonucleic acid; TSH, thyroid-stimulating 
hormone; WOCBP, women of childbearing potential.
9.4.5
Estimated Glomerular Filtration Rate
Glomerular filtration rate will be estimated using the Modification of Diet in Renal Disease 
(MDRD) equation at Screening and during the study at select visits.
The MDRD equation is as follows:
eGFR = 175 × standardized serum creatinine (SCr)−1.154 × age−0.203 × 1.212 (if Black) or 
0.742 (if female)
Note: GFR is expressed as mL/min/1.73 m2 of BSA and SCr is expressed in mg/dL.
Participants with an eGFR < 45 mL/min will be excluded from participation.
9.4.6
Tuberculosis Testing
9.4.6.1
Tuberculosis Screening and Chest Imaging
Chest imaging results and physical examinations are part of the process to assess a participant’s 
eligibility, as outlined in Section 2 and as defined in exclusion criterion 4c, Section 6.2. Chest 
imaging (eg, chest X-ray, chest computed tomography scan) at the Screening Visit is required if 
not already performed and documented within 6 months of Screening Visit. A participant must not 
have active signs or symptoms of TB, as judged by the investigator, to be eligible for the study. 
In addition to a complete physical examination and medical history to evaluate exposure to TB, all 
participants will have a screening test, an IGRA (eg, QuantiFERON®-TB Gold), performed 
centrally. If unable to obtain central laboratory results, an IGRA test could be obtained locally, 
after consultation with the Medical Monitor. A participant with an indeterminate IGRA test result 
must be re-tested for confirmation. If the second result is again indeterminate, the participant will 
be excluded from the study. If the second result is positive, the participant should be considered 
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as having LTBI provided there are no signs or symptoms of active TB. If the second result is 
negative, the participant may be eligible provided no other exclusion criterion for TB is met.
9.4.7
Imaging Safety Assessment
Not applicable.
9.4.8
Unscheduled Safety Visits
The protocol does not mandate specific investigations at unscheduled visits. Unscheduled visit 
study procedures should be based on the clinical judgment of the investigator. To assess
participant’s depression and suicidal ideation or behavior, PHQ-8 and eC-SSRS assessments will 
be available if needed.
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9.9
Health Economics OR Medical Resource Utilization and Health 
Economics
PsA imposes substantial economic burden on patients, and the medical cost has been shown to be 
strongly associated with patient functional status.58
 
 
 
 
 
 
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10
STATISTICAL CONSIDERATIONS
10.1
Sample Size Determination 
A total sample size of approximately 700 participants randomized in a 3:3:1 ratio in a blinded 
fashion (approximately 300 participants each randomized to 6 mg deucravacitinib QD arm and 
placebo and 100 participants randomized to 30 mg apremilast BID) will provide > 99% power to 
detect an 18% treatment difference between 6 mg deucravacitinib QD and placebo at Week 16 for 
ACR 20 response assuming a response of 51% for 6 mg deucravacitinib QD and of 33% for 
placebo (2-sided alpha = 0.05, chi-square test).
The sample size of 300 participants treated with 6 mg deucravacitinib QD in this study 
(IM011-055) was also chosen to provide, along with participants from other Phase 3 PsA studies 
with deucravacitinib, an adequate number of participants for the overall safety database for the 
PsA program.
In addition, this sample size will also provide enough power for all key secondary endpoints (that 
are tested in a testing strategy to control Type I error) as given in Table 10.3.1-1.
10.2
Populations for Analyses
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled 
All participants who sign informed consent
All Randomized
All randomized participants. Following the intent-to-treat 
principle, participants will be analyzed according to the treatment 
assigned at randomization. The efficacy analysis population will 
be the All Randomized Population.
All Treated
All participants who were randomized and took at least 1 dose of 
study medication. Data in this data set will be analyzed based on 
randomized treatment, except in the following cases:

If a participant received the same incorrect treatment 
throughout the study, then the participant will be analyzed 
based on the treatment received.

If a participant received IP from more than 1 treatment 
group, and none of the administrations were consistent 
with the assigned randomized treatment group, then the 
participant will be analyzed based on the first treatment 
received.
The safety analysis population will be the All Treated Population.
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10.3
Statistical Analyses
The statistical analysis plan (SAP) will be developed and finalized before Week 56 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 a statistical output report, including 
subgroups of age, gender, and race.
A primary analysis will be conducted after the Week 56 database lock and treatment unblinding 
and will include a full assessment of safety, efficacy analyses for primary, secondary, 
 
 assessed at all available time points up to and including at least Week 52, 
and may include additional analyses of 
 data collected at time points up to 
and including at least Week 52.  
10.3.1
Efficacy Analyses
Endpoint
Statistical Analysis Methods
Primary
The primary efficacy analysis model for the primary endpoint, ACR 20 
response 
at 
Week 
16 
(responder/nonresponder),
will 
use 
a 
Cochran-Mantel-Haenszel test 
 
 
 to compare the response rates of 6 mg deucravacitinib QD to placebo. 
The risk difference and odds ratio and the corresponding 2-sided 95% 
confidence interval will be provided.
Nonresponder imputation will be used at Week 16 for participants who have a 
missing ACR 20 response at Week 16 or who discontinued treatment (for any 
reason) prior to Week 16. The same imputation will be used for the analysis of 
this outcome at other time points. 
The primary estimand for the primary endpoint, ACR 20 response at Week 16,
will be the treatment difference between deucravacitinib 6 mg QD and placebo 
in ACR 20 response at Week 16 for all randomized participants. The 
occurrence of the intercurrent event of study treatment discontinuation (for any 
reason) prior to Week 16 or a missing ACR 20 response at Week 16 will be 
considered as a measure of nonresponse to treatment at Week 16 if the 
participant would have continued on the study treatment up to Week 16. 
Nonresponder imputation will be used for the above intercurrent event. Study 
treatment discontinuation is the only intercurrent event that will be accounted 
for in the primary estimand and a composite variable strategy is applied.
2 sensitivity analyses using different imputation methods will be conducted for 
the primary endpoint at Week 16 to examine the impact of missing data:

A multiple imputation (MI) approach 
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
A tipping point approach 
A supportive analysis will be provided for the primary endpoint at Week 16,
including all available efficacy measurement for all randomized participants. 
These available data will include efficacy measurements observed after study 
treatment discontinuation and efficacy measurements observed after switch to 
other treatments. 
Details will be given in the SAP.
Secondary
Binary Endpoints
Binary endpoints (other than ACR 20 response at Week 16) up to Week 16 will 
be analyzed using the same method as for the primary endpoint.
Continuous Endpoints 
Change from baseline at Week 16 will be analyzed using an analysis of 
covariance model. The model will include treatment, randomization 
stratification variables, and baseline value. 
The primary estimand at Week 16 will be the treatment difference between 
deucravacitinib 6 mg QD and placebo for changes from baseline at Week 16 
for all randomized participants. 
In case an intercurrent event of study treatment discontinuation (for any reason) 
prior to Week 16 occurs, the efficacy assessments after the discontinuation of 
treatment will be considered missing. Missing values will be imputed with MI 
method assuming missing not at random (MNAR) The MNAR imputation 
assumes that after discontinuation of treatment, participants from the 
deucravacitinib 6 mg QD group (if they would have continued deucravacitinib 
6 mg QD) exhibit a similar future evolution as participants from the placebo 
group. Study treatment discontinuation is the only intercurrent event that will 
be accounted for in the primary estimand and a composite variable strategy is 
applied.
Details will be provided in the SAP.
Multiplicity
In order to control the overall Type I error rate at 5%, a testing strategy for the primary and key 
secondary endpoints will be implemented. The primary endpoint, ACR 20 response at Week 16, 
will be tested at an alpha = 0.05. If the primary endpoint is significant at alpha = 0.05, then a testing 
strategy for the key secondary endpoints will be applied to control for the overall Type I error of 
5%. The details about the full testing strategy including any hierarchy of key secondary endpoints 
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will be provided in the SAP that will be finalized prior to Week 56 database lock and treatment 
unblinding. For the analysis of the key secondary endpoints, enthesitis and dactylitis, the data will 
be pooled for the studies IM011054 and IM011055.
No comparisons versus apremilast, a reference safety arm, will be provided.
The key secondary endpoints displayed in Table 10.3.1-1 will be included in a testing strategy to 
control for multiplicity to protect the overall 2-sided Type I error. Additional endpoints may also 
be included in the testing strategy (eg, ACR 50 and ACR 70) and will be detailed in the SAP. 
The power for those key secondary endpoints for a sample size of 300 participants each 
randomized to placebo and 6 mg deucravacitinib QD is given in Table 10.3.1-1.
Table 10.3.1-1:
Power
Key 
Secondary 
Endpoint
(Week 16)
Assumption - Treatment Effect
Power (with Nominal 
2-sided Alpha = 0.05)
HAQ-DI
PASI 75
Enthesitis 
resolution
Dactylitis 
resolution
SF-36 PCS
MDA
FACIT-Fatigue
DAS28-CRP
Note: Chi-square test applied for binary variables, t-test for continuous variables, alpha = 5% (2-sided).
Abbreviations: 
; DAS28-CRP, Disease Activity Score 28 with C-reactive protein; 
FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire - Disability 
Index; MDA, minimal disease activity; PASI, Psoriatic Area and Severity Index; 
; PCS, Physical 
Component Summary; 
; SF-36, Short Form-36.
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The treatment estimates are based on results from the deucravacitinib Phase 2 study IM011084.
Further details will be provided in the SAP.
10.3.2
Safety Analyses
All safety analyses will be performed on the All Treated analysis population.
Endpoint
Statistical Analysis Methods
Safety
Treatment-emergent AEs and SAEs, AEs leading to discontinuation of 
treatment, and AEs of special interest will be summarized using counts and 
percentages of participants experiencing the event by System Organ Class, 
Preferred Term, and treatment group. Vital signs, clinical laboratory test 
results, and ECG test results will be summarized by treatment group using 
descriptive statistics (n, mean, standard deviation, median, minimum, and 
maximum) for continuous variables and frequency distributions (counts and 
percentages) for categorical variables.
Will be further described in the SAP finalized before Week 56 database lock.
10.3.3
Other Analyses 
 analyses will be described in the SAP finalized before 
Week 56 database lock. The population PK analysis and PD analyses will be presented separately 
from the main clinical study report, if conducted.
10.3.4
Interim Analyses 
Not applicable.
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11
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29 van Baarsen LGM, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of 
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interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients 
with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-
controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann 
Rheum Dis 2017;76:79-87.
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37 Deodhar A, Helliwell PS, Boehncke W-H, et al. Guselkumab in patients with active psoriatic 
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38 Kavanaugh A, McInnes IB, Krueger GG, et al. Patient-reported outcomes and the association 
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controlled trial. Arthritis Care Res (Hoboken) 2013;65:1666-73. 
39 Coates LC, Strand V, Wilson H, et al. Measurement properties of the minimal disease activity 
criteria for psoriatic arthritis. RMD Open 2019;5:e001002. 
40 Mease PJ, Woolley JM, Bitman B, et al. Minimally important difference of Health Assessment 
Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to 
patient-rated importance and satisfaction. J Rheumatol 2011;38:2461-5. 
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41 van der Heijde D, Mease PJ, Landewé RBM, et al. Secukinumab provides sustained low rates 
of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, 
FUTURE 5. Rheumatology (Oxford) 2020;59:1325-34.
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Major Depressive Disorder (MDD) severity. Popul Health Metr 2011;9:11.
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Severity Rating Scale. J Clin Psychiatry 2013;74:887-893.
48 Posner K, Oquendo MA, Gould M, et al. Columbia Classification Algorithm of Suicide 
Assessment (C-CASA): classification of suicidal events in the FDA’s pediatric suicidal risk 
analysis of antidepressants. Am J Psychiatry 2007;164:1035-43.
49 Maksymowych WP, Mallon C, Morrow S, et al. Development and validation of the 
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index. Ann Rheum 
Dis 2009;68:948-53.
50 Healy PJ, Helliwell PS. Measuring clinical enthesitis in psoriatic arthritis: assessment of 
existing measures and development of an instrument specific to psoriatic arthritis. Arthritis 
Rheum 2008;59:686-91.
51 Helliwell PS, Firth J, Ibrahim GH, et al. Development of an assessment tool for dactylitis in 
patients with psoriatic arthritis. J Rheumatol 2005;32:1745-50.
52 Bowes J, Orozco G, Flynn E, et al. Confirmation of TNIP1 and IL23A as susceptibility loci
for psoriatic arthritis. Ann Rheum Dis 2011;70:1641-4.
53 Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 
2005;64:ii65-ii68.
54 FitzGerald O, Helliwell P, Mease P, et al. Application of composite disease activity scores in 
psoriatic arthritis to the PRESTA data set. Ann Rheum Dis 2012;71:358-62.
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disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:1811-
8.
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56 Machado P, Landewé R, Lie E, et al. Ankylosing Spondylitis Disease Activity Score 
(ASDAS): defining cut-off values for disease activity states and improvement scores. Ann 
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57 Machado PM, Landewé R, van der Heijde D, et al. Ankylosing Spondylitis Disease Activity 
Score (ASDAS): 2018 update of the nomenclature for disease activity states. Ann Rheum Dis 
2018;77:1539-40.
58 McHugh N, Maguire Á, Handel I, Tillett W, Morris J, Hawkins N, Cavill C, Korendowych E, 
Mughal F. Evaluation of the economic burden of psoriatic arthritis and the relationship 
between functional status and healthcare costs. J Rheumatol 2020;47(5):701-7. 
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APPENDICES
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
ACR
American College of Rheumatology
AE
adverse event
AEI
adverse event of interest
ALT
alanine aminotransferase 
ANCOVA
analysis of covariance 
anti-HBc
hepatitis B core antibody
anti-HBs
hepatitis B surface antibody
ASDAS-CRP
Ankylosing Spondylitis Disease Activity Score with C-reactive protein
AST
aspartate aminotransferase 
AT
aminotransferase
BASDAI 
Bath Ankylosing Spondylitis Disease Activity Index
bDMARD
biologic disease-modifying anti-rheumatic drug
BID
twice daily
BMS
Bristol-Myers Squibb Company
BP
blood pressure
BSA
body surface area 
BUN
blood urea nitrogen 
CASPAR
Classification Criteria for Psoriatic Arthritis 
CBC
complete blood count
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CLcr
creatinine clearance
CONSORT
Consolidated Standards of Reporting Trials 
CRF 
case report form
CRP
C-reactive protein 
csDMARD
conventional synthetic disease-modifying anti-rheumatic drug
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Term
Definition
CSP 
clinical safety program
CSR
clinical study report
CTAg
clinical trial agreement
CYP450
cytochrome P450
d
days
D
Day
DAPSA 
Disease Activity Index for Psoriatic Arthritis Score
DAS
Disease Activity Score 
DAS28-CRP
Disease Activity Score 28 with C-reactive protein
DILI
drug-induced liver injury 
DIP
distal interphalangeal 
DLQI
Dermatology Life Quality Index
DMARD
disease-modifying anti-rheumatic drug
DMC
Data Monitoring Committee
DNA
deoxyribonucleic acid
ECG
electrocardiogram
eCRF
electronic case report form
eC-SSRS
electronic Columbia-Suicide Severity Rating Scale
EDC
electronic data capture
eGFR
estimated glomerular filtration rate
EHR
electronic health record
ELISA
enzyme-linked immunosorbent assay
EMR
electronic medical record
EQ-5D-5L
5-level EuroQoL 5-dimension
ET
Early Termination
FACIT
Functional Assessment of Chronic Illness Therapy
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
HAQ-DI
Health Assessment Questionnaire - Disability Index 
HBcAb
hepatitis B core antibody
HBsAb
hepatitis B surface antibody 
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Term
Definition
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCQ
hydroxychloroquine
HCV
hepatitis C virus 
HDL
high-density lipoprotein 
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
HRT
hormone replacement therapy
hsCRP
high-sensitivity C-reactive protein
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council for Harmonisation
ICMJE
International Committee of Medical Journal Editors
IFN
interferon
IgA
immunoglobulin A
IgE
immunoglobulin E
IgG
immunoglobulin G
IgM
immunoglobulin M
IGRA
interferon gamma release assay
IL
interleukin
IMP
investigational medicinal product
IP
investigational product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IUS
intrauterine hormone-releasing system
IV
intravenous
JAK
Janus kinase
L
left
LAM
lactational amenorrhea method
LDH
lactate dehydrogenase
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Term
Definition
LDI
Leeds Dactylitis Index
LDL
low-density lipoprotein
LEF
leflunomide
LEI
Leeds Enthesitis Index
LTBI
latent tuberculosis infection
mCPDAI 
modified Composite Psoriatic Disease Activity Index
MCS
Mental Component Summary
MDA
minimal disease activity
MDRD
Modification of Diet in Renal Disease
MI
multiple imputation
Min
minute
MNAR
missing not at random
MTX
methotrexate
N
number
N/A
not applicable
neg
negative
NSAID
nonsteroidal anti-inflammatory drug
OLE
Open-label Long-term Extension
PASDAS 
Psoriatic Arthritis Disease Activity Score
PASI 
Psoriatic Area and Severity Index
PCS
Physical Component Summary
PD
pharmacodynamics
PGA-F 
Physician Global Assessment-Fingernails
PHQ-8
eight-item Patient Health Questionnaire
PK
pharmacokinetics
POS
positive
PRN
pro re nata (when necessary)
PRO
patient-reported outcome
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Term
Definition
PROMIS 
Patient-Reported Outcome Measures Information System
PsA
psoriatic arthritis
PsAID 
Psoriatic Arthritis Impact of Disease
PsARC
Psoriatic Arthritis Response Criteria
PsO
psoriasis
QD
once daily
R
right
RNA 
ribonucleic acid
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SC
subcutaneous
SCr
serum creatinine
SF-36
Short Form-36
SIB
suicidal ideation and behavior
SOP
standard operating procedure
SPARCC
Spondyloarthritis Research Consortium of Canada
sPGA
static Physician’s Global Assessment
SSZ
sulfasalazine
STAT
signal transducer and activator of transcription
TB
tuberculosis
TH
T-helper
TNF
tumor necrosis factor
TNFi
tumor necrosis factor inhibitor
TSH
thyroid-stimulating hormone
TYK2
tyrosine kinase 2
ULN
upper limit of normal
US
United States
USA
United States of America
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Term
Definition
VLDA 
very low disease activity
W
Week
WHO
World Health Organization
WOCBP
women of childbearing potential
WPAI
Work Productivity and Activity Impairment 
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APPENDIX 2
STUDY GOVERNANCE CONSIDERATIONS
The term ‘Participant’ is used in the protocol to refer to a person who has consented to participate 
in the clinical research study. The term ‘Subject’ used in the CRF is intended to refer to a person 
(Participant) who has consented to participate in the clinical research study.
REGULATORY AND ETHICAL CONSIDERATIONS
GOOD CLINICAL PRACTICE
This study will be conducted in accordance with:

Consensus ethical principles derived from international guidelines including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical Guidelines and Good Clinical Practice (GCP), 

as defined by the International Council for Harmonisation (ICH)

in accordance with the ethical principles underlying European Union Directive 2001/20/EC

United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 

applicable local requirements.
The study will be conducted in compliance with the protocol. The protocol and any amendments 
and the participant informed consent will receive approval/favorable opinion by Institutional 
Review Board/Independent Ethics Committee (IRB/IEC), and regulatory authorities according to 
applicable local 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, etc) that is likely to 
affect, to a significant degree one or more of the following:  (1) the physical, safety or mental 
integrity of one or more subjects/participants; (2) the scientific value of the trial (eg, reliability and 
robustness of generated data). Items (1) or (2) can be associated with either GCP Regulation(s) or 
Trial protocol(s).
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks.
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, consent form, participant recruitment materials 
(eg, advertisements), and any other written information to be provided to subjects/participants. The 
investigator or BMS should also provide the IRB/IEC with a copy of the Investigator Brochure or 
product labeling information to be provided to subjects/participants and any updates. 
The investigator, Sponsor or designee should provide the IRB/IEC with reports, updates and other 
information (eg, expedited safety reports, amendments, and administrative letters) according to 
regulatory requirements or institution procedures.
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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 local health authority) except where necessary to eliminate an immediate 
hazard(s) to study subjects/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 local health authority must be sent to BMS.
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the consent form 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 
subjects/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 subjects/participants prior to enrollment.
If the revision is done via an administrative letter, investigators must inform their IRB(s)/IEC(s).
FINANCIAL DISCLOSURE
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information in accordance with local 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.
INFORMED CONSENT PROCESS
Investigators must ensure that subjects/participants are clearly and fully informed about the 
purpose, potential risks, and other critical issues regarding clinical studies in which they volunteer 
to participate. 
In situations where consent cannot be given by subjects/participants, their legally acceptable 
representatives (as per country guidelines) are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which the participant 
volunteers to participate. 
Sponsor or designee will provide the investigator with an appropriate (ie, Global or Local) sample 
informed consent form which will include all elements required by ICH, GCP and applicable 
regulatory requirements. The sample informed consent form will adhere to the ethical principles 
that have their origin in the Declaration of Helsinki.
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Investigators must:

Provide a copy of the consent form and written information about the study in the language in 
which the participant is most proficient prior to clinical study participation. The language must 
be non-technical and easily understood. 

Allow time necessary for participant or participant’s legally acceptable representative to 
inquire about the details of the study.

Obtain an informed consent signed and personally dated by the participant or the participant’s 
legally acceptable representative and by the person who conducted the informed consent 
discussion. 

Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent form 
and any other information to be provided to the subjects/participants, prior to the beginning of 
the study, and after any revisions are completed for new information.
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.
Revise the informed consent 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 the participant’s legally acceptable representative or legal 
guardian, 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 subjects/participants must be protected, 
respecting the privacy and confidentiality rules applicable to regulatory requirements, the 
subjects’/participants’ signed ICF and, in the US, the subjects’/participants’ signed HIPAA 
Authorization.
The consent form must also include a statement that BMS and regulatory authorities have direct 
access to participant records. 
The rights, safety, and well-being of the study subjects/participants are the most important 
considerations and should prevail over interests of science and society.
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes.
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical trial becomes more reflective of the real-world population and the people impacted by 
the diseases studied.
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DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY
BMS collects and processes personal data of study participants, patients, health care providers,
and researchers for biopharmaceutical research and development to advance innovative, high-
quality medicines that address the medical needs of patients. BMS ensures the privacy, protection,
and confidentiality of such personal data to comply with applicable laws. To achieve these goals, 
BMS has internal policies that indicate measures and controls for processing personal data. BMS 
adheres to these standards to ensure that collection and processing of personal data are limited and 
proportionate to the purpose for which BMS collects such personal data. This purpose is clearly 
and unambiguously notified to the individual at the time of collection of personal data. In the true 
spirit of science, BMS is dedicated to sharing clinical trial information and data with participants, 
medical/research communities, the media, policy makers, and the general public. This is done in a 
manner that safeguards participant privacy and informed consent while respecting the integrity of 
national regulatory systems. Clinical trial data, health-related research, and pharmacovigilance 
activities on key-coded health data transferred by BMS across national borders is done in 
compliance with the relevant data protection laws in the country and GCP requirements.
BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of 
its processing.
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data.
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 
adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information: 
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
The Investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original and attributable, whether the data are hand-written on paper or entered 
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electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical/health records (EMRs/EHRs), 
adverse event tracking/reporting, protocol required assessments, and/or drug accountability 
records).
When paper records from such systems are used in place of 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 TREATMENT RECORDS
Records for study treatments (whether supplied by BMS, its vendors, or the site) must substantiate 
study treatment 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 IP 
sourced 
from 
the 
sites 
stock or 
The investigator or designee accepts responsibility 
for documenting traceability and study treatment 
integrity in accordance with requirements applicable 
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If
Then
commercial supply, or a specialty 
pharmacy)
under law and the standard operating procedures 
(SOPs)/standards of the sourcing pharmacy.
BMS or 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 tool, electronic CRFs will be 
prepared for all data collection fields except for fields specific to SAEs and pregnancy, which will 
be reported on the electronic SAE form and Pregnancy Surveillance form, respectively. If 
electronic SAE form is not available, a paper SAE form can be used. Spaces may be left blank 
only in those circumstances permitted by study-specific CRF completion guidelines provided by 
Sponsor or designee. 
The confidentiality of records that could identify subjects/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, SAE/pregnancy CRFs, must be promptly reviewed, signed, and dated by the 
investigator or qualified physician who is a subinvestigator and who is delegated this task on the 
Delegation of Authority Form. Subinvestigators in Japan may not be delegated the CRF approval 
task. For electronic CRFs, review and approval/signature is completed electronically through the 
BMS electronic data capture tool. The investigator must retain a copy of the CRFs including 
records of the changes and corrections.
Each individual electronically signing electronic CRFs must meet Sponsor or designee training 
requirements and must only access the BMS electronic data capture tool using the unique user 
account provided by Sponsor or designee. User accounts are not to be shared or reassigned to other 
individuals
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MONITORING
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan.
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. Certain CRF pages and/or electronic files may serve as the source 
documents.
In addition, the study may be evaluated by 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 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 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 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 designee. 
RETURN OF STUDY TREATMENT
For this study, study treatments (those supplied by BMS, 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 treatments 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 
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to meet local regulations (eg, cytotoxics or 
biologics).
If study treatments will be returned, the return 
will be arranged by the responsible Study 
Monitor.
Study treatments sourced by site, not supplied 
by BMS (or its vendors) (examples include 
study treatments sourced from the sites 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, 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 SOPs 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 (ie, 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 Monitor to 
review throughout the clinical trial period.
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers.
If conditions for destruction cannot be met, the responsible Study Monitor will make arrangements 
for return of study treatments provided by BMS (or its vendors). Destruction of nonstudy 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee.
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.
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CLINICAL STUDY REPORT
A Signatory Investigator must be selected to sign the clinical study report. 
For each clinical study report related to this protocol, the following criteria will be used to select 
the signatory investigator:

External Principal Investigator designated at protocol development

National Coordinating Investigator 

Study Steering Committee chair or their designee

Participant recruitment (eg, among the top quartile of enrollers)

Involvement in trial design

Regional representation (eg, among top quartile of enrollers from a specified region or country)
SCIENTIFIC PUBLICATIONS
The data collected during this study are confidential and proprietary to Sponsor or designee. Any 
publications or abstracts arising from this study must adhere to the publication requirements set 
forth in the clinical trial agreement (CTAg) governing [Study site or Investigator] participation in 
the study. These requirements include, but are not limited to, submitting proposed publications to 
Sponsor or designee at the earliest practicable time prior to submission or presentation and 
otherwise within the time period set forth in the CTAg.
Scientific Publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors.  No public presentation or publication of any interim results may be made by any 
principal investigator, sub-investigator or any other member of the study staff without the prior 
written consent of the Sponsor.  
Authorship of publications at BMS is aligned with the criteria of the International Committee of 
Medical Journal Editors (ICMJE, www.icmje.org). Authorship selection is based upon significant 
contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE criteria for 
authorship:
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable subjects 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.  
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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 
preexisting medical condition in a clinical investigation participant administered study treatment
and 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, ECG, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal lab tests or 
other safety assessments should only be reported as AEs if the final diagnosis is not 
available. Once the final diagnosis is known, the reported term should be updated to be the 
diagnosis.

Exacerbation of a chronic or intermittent pre-existing condition including either an increase 
in frequency and/or intensity of the condition.

New conditions detected or diagnosed after study intervention administration even though it 
may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator), 
should not be reported as an AE/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
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any 
dose:
Results in death
Is life-threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe)
Requires inpatient hospitalization or causes prolongation of existing hospitalization (see NOTE 
below)
NOTE: 
The following hospitalizations are not considered SAEs in BMS clinical studies: 

a visit to the emergency room or other hospital department < 24 hours, that does not result 
in admission (unless considered an important medical or life-threatening event)

elective surgery, planned prior to signing consent

admissions as per protocol for a planned medical/surgical procedure

routine health assessment requiring admission for baseline/trending of health status (eg, 
routine colonoscopy)

medical/surgical admission other than to remedy ill health and planned prior to entry into 
the study. Appropriate documentation is required in these cases

admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason)

admission for administration of anticancer therapy in the absence of any other SAEs (applies 
to oncology protocols)
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
Is an important medical event (defined as a medical event(s) that may not be immediately 
life-threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or at 
home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization.) Potential drug induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.7 for the definition of potential DILI.) 
Pregnancy and potential drug induced liver injury (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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Any component of a study endpoint that is considered related to study therapy should be reported 
as SAE (eg, death is an endpoint, if death occurred due to anaphylaxis, anaphylaxis must be 
reported).
EVALUATING AES AND SAES
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration 
will be considered and investigated.

The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment.

For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to 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 Sponsor.

The investigator may change his/her opinion of causality in light of follow-up information 
and send a SAE follow-up report with the updated causality assessment.

The causality assessment is one of the criteria used when determining regulatory reporting 
requirements.
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.
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REPORTING OF SAES TO SPONSOR OR DESIGNEE

SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event.

SAEs must be recorded on the SAE Report Form.

The required method for SAE data reporting is through the eCRF.

The paper SAE Report Form is only intended as a back-up option when the electronic 
data capture (EDC) 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 (fax) 
transmission
When paper forms are used, the original paper forms are to remain on site

Pregnancies must be recorded on a paper Pregnancy Surveillance Form and transmitted via email or 
confirmed facsimile (fax) transmission 
SAE Email Address: Refer to Contact Information list.
SAE Facsimile Number: Refer to Contact Information list.
SAE Telephone Contact (required for SAE and pregnancy reporting): Refer to Contact 
Information list
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APPENDIX 4
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION
Appendix 4 provides general information and definitions related to women of childbearing 
potential and methods of contraception that can be applied to most clinical trials. For information 
specific to this study regarding acceptable contraception requirements for female and male 
participants, refer to Section 6.1 of the protocol. Only the contraception methods as described in 
Section 6.1 are acceptable for this study.
DEFINITIONS
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy.
Women in the following categories are not considered WOCBP:

Premenarchal

Premenopausal female with 1 of the following:

Documented hysterectomy

Documented bilateral salpingectomy

Documented bilateral oophorectomy
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview.

Postmenopausal female

A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 
45 years in the absence of other biological or physiological causes. In addition, females 
under the age of 55 years must have a serum follicle-stimulating hormone (FSH) level 
> 40 mIU/mL to confirm menopause.
Note: Females treated with hormone replacement therapy (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used. Suggested 
guidelines for the duration of the washout periods for HRT types are presented below. Investigators 
should use their judgement in checking serum FSH levels. 

1-week minimum for vaginal hormonal products (rings, creams, gels)

4-week minimum for transdermal products

8-week minimum for oral products
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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the woman can be considered 
postmenopausal.
End of Relevant Systemic Exposure
End of relevant systemic exposure is the timepoint where the Investigational Medicinal Product 
(IMP) or any active major metabolites have decreased to a concentration that is no longer 
considered to be relevant for human teratogenicity or fetotoxicity. This should be evaluated in 
context of safety margins from the no-observed-adverse-effect level or the time required for 5 half-
lives of the IMP to pass.
METHODS OF CONTRACEPTION
Local laws and regulations may require use of alternative and/or additional contraception methods.
Highly Effective Contraceptive Methods That Are User Dependent
Failure rate of < 1% per year when used consistently and correctly.a

Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation and/or implantation. (This method of contraception can only be used 
by WOCBP participants in studies where hormonal contraception is permitted by the study 
protocol.)b

Oral (birth control pills)

Intravaginal (rings)

Transdermal

Combined (estrogen-and progestogen-containing) hormonal contraception must begin at 
least 30 days prior to initiation of study therapy.

Progestogen-only hormonal contraception associated with inhibition of ovulation. (This 
method of contraception can only be used by WOCBP participants in studies where 
hormonal contraception is permitted by the study protocol.)b

Oral

Injectable

Progestogen-only hormonal contraception must begin at least 30 days prior to initiation of 
study therapy.
Highly Effective Methods That Are User Independent

Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation and/or implantation. (This method of contraception can only be used by WOCBP 
participants in studies where hormonal contraception is permitted by the study protocol.)b

Intrauterine device.

Intrauterine hormone-releasing system (IUS). (This method of contraception can only be 
used by WOCBP participants in studies where hormonal contraception is permitted by the 
study protocol.)b,c
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
Bilateral tubal occlusion.

Vasectomized partner 
Having a vasectomized partner is a highly effective contraception method provided that the 
partner is the sole male sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be used.
A vasectomy is a highly effective contraception method provided that the participant is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used.

Sexual abstinence.
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant.

Continuous abstinence must begin at least 30 days prior to initiation of study therapy.

It is not necessary to use any other method of contraception when complete abstinence is 
elected.

WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2.

Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence.

Periodic abstinence (including, but not limited to, calendar, symptothermal, postovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea 
method (LAM) are not acceptable methods of contraception for this study. 
NOTES: 
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the IMP and other study medications will not alter hormonal exposures such that contraception 
would be ineffective or result in increased exposures that could be potentially hazardous. In this case, alternative 
methods of contraception should be utilized. For information specific to this study regarding permissibility of 
hormonal contraception, refer to Sections 6.1 INCLUSION CRITERIA and 7.7.2 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 Sections 6.1 INCLUSION CRITERIA and 
7.7.2 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, the appendix for Adverse Events 
and Serious Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, 
and Reporting.
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APPENDIX 5
CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
(CASPAR) CRITERIA
CASPAR CRITERIA (Specificity 0.987, Sensitivity 0.914)
Inflammatory articular disease (joint, spine, or entheseal)
With 3 or more points from the following
1. Current psoriasis (scores 2 points) 
Psoriatic skin or scalp disease present today as judged 
by a rheumatologist
2. Personal history of psoriasis (if current psoriasis not 
present)
A history of psoriasis that may be obtained from 
patient, family doctor, dermatologist, or rheumatologist
3. Family history of psoriasis (if personal history of 
psoriasis or current psoriasis not present)
A history of psoriasis in a first or second degree relative 
according to patient report
4. Psoriatic nail dystrophy
Typical psoriatic nail dystrophy including onycholysis, 
pitting, and hyperkeratosis observed on current 
physical examination
5. A negative test for rheumatoid factor
By any method except latex but preferably by ELISA or 
nephlemetry, according to the local laboratory 
reference range
6. Current dactylitis
Swelling of an entire digit
7. History of dactylitis (if current dactylitis is not 
present)
A history of dactylitis recorded by a rheumatologist
8. Radiological evidence of juxta-articular new bone 
formation
Ill-defined ossification near joint margins (but 
excluding osteophyte formation) on plain X-rays of 
hand or foot
Reference:
Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: development of new criteria 
from a large international study. Arthritis Rheum 2006;54:2665-73.
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APPENDIX 6
SUBJECT ASSESSMENT OF DISEASE ACTIVITY (PSORIATIC 
ARTHRITIS) VISUAL ASSESSMENT SCALE
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APPENDIX 7
SUBJECT ASSESSMENT OF PAIN SCALE (PSORIATIC 
ARTHRITIS)
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APPENDIX 8
AMERICAN COLLEGE OF RHEUMATOLOGY SUBJECT
ASSESSMENT OF PHYSICAL FUNCTION SCALE: HEALTH 
ASSESSMENT QUESTIONNAIRE (HAQ)
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APPENDIX 9
SHORT FORM HEALTH SURVEY-36 ITEM (SF-36)
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APPENDIX 10
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY 
FATIGUE
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APPENDIX 11
THE EULAR PSORIATIC ARTHRITIS IMPACT OF DISEASE: 
PSAID 12 FOR CLINICAL PRACTICE
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APPENDIX 12
DERMATOLOGY LIFE QUALITY INDEX (DLQI)
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APPENDIX 13
EURO QUALITY OF LIFE FIVE DIMENSIONS QUESTIONNAIRE: 
5-LEVEL VERSION (EQ-5D-5L)
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APPENDIX 14
PATIENT-REPORTED OUTCOME MEASURES INFORMATION 
SYSTEM SLEEP DISTURBANCE SHORT FORM
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APPENDIX 15
WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT 
QUESTIONNAIRE: PSORIATIC ARTHRITIS (WPAI:PSA)
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APPENDIX 16
THE BATH ANKYLOSING SPONDYLITIS DISEASE
ACTIVITY INDEX (BASDAI)
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APPENDIX 17
PHYSICIAN’S GLOBAL ASSESSMENT OF PSORIATIC 
ARTHRITIS
How would you rate global skin and musculoskeletal disease in this patient?
Quiet
Very
Severe
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APPENDIX 18
PSORIASIS AREA AND SEVERITY INDEX (PASI)
Psoriasis Area and Severity Index (PASI): a quantitative rating scale for measuring the severity of 
psoriatic lesions based on area coverage and plaque appearance. Please complete all sections of 
the table.
Plaque Characteristic
Rating score
Body region (and weighting factor)
Head
Upper Extremities
Trunk
Lower Extremities
Erythema (Redness)
0 = None
1 = Slight
2 = Moderate
3 = Severe
4 = Very severe
Infiltration (Thickness)
Desquamation (Scaling)
Add together each of the 3 scores for each of the body regions to give 4 separate subtotals.
Sub Totals A1 =
A2 =
A3 =
A4 =
Multiply each subtotal by amount of body surface area represented by that region i.e. A1 x 0.1 for head, A2 x 0.2 for upper 
extremities, A3 x 0.3 for trunk, A4 x 0.4 for lower extremities to give a value B1, B2, B3, and B4 for each body region respectively
A1 x 0.1 = B1
A2 x 0.2 = B2
A3 x 0.3 = B3
A4 x 0.4 = B4
B1 =
B2 =
B3 =
B4 =
Degree of involvement 
as % for each body 
region affected; (score 
each region with score 
between 0-6)
0 = None
1 = 1-9 %
2 = 10-29%
3 = 30-49%
4 = 50 -69%
5 = 70-89%
6 = 90-100%
For each body region multiply subtotal B1, B2, B3, and B4 by the score (0-6) of the % of body region involved to give 4 subtotals 
C1, C2, C3, and C4
B1 x score = C1
B2 x score = C2
B3 x score = C3
B4 x score = C4
C1 =
C2 =
C3 =
C4 =
The patient’s PASI score is the sum of C1 + C2 + C3 + C4
PASI =
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APPENDIX 19
STATIC PHYSICIAN’S GLOBAL ASSESSMENT OF PSORIASIS 
(SPGA)
The static Physician’s Global Assessment (sPGA) is used to determine the participant’s psoriasis 
lesions overall at a given time point. Overall lesions will be graded for erythema, induration, and 
scaling based on the scales below. The average of the 3 scales, which is rounded to the nearest 
whole number, is the final sPGA score.
Characteristics
Score
Rating Score
Erythema (E)
(averaged over the whole 
body)
0 = No evidence of erythema, but post inflammatory 
hyper/hypopigmentation changes may be 
present
1 = Faint erythema
2 = Light red coloration
3 = Moderate red 
coloration 
4 = Bright red coloration
Induration (I)
(averaged over the whole 
body)
0 = No evidence of plaque elevation
1 = Minimal plaque elevation, barely palpable, = 0.25 
mm
2 = Mild plaque elevation, slight but 
definite elevation, indistinct edge, 
= 0.5 mm
3 = Moderate plaque elevation, elevated with distinct 
edges, = 0.75 mm
4 = Severe plaque elevation, 
hard/sharp borders ≥1 mm
Scaling (S)
(averaged over the whole 
body)
0 = No evidence of scaling
1 = Minimal; occasional fine scaling
2 = Mild; fine scale dominates
3 = Moderate; coarse scale predominates
4 = Severe; thick scale predominates
E + I + S = / 3 = (Total Average)
sPGA based upon above total average 
0 = Clear, except for residual discoloration 
1 = Almost clear -majority of lesions have individual scores for E + I + S / 3 that averages 1 
2 = Mild -majority of lesions have individual scores for E + I + S / 3 that averages 2 
3 = Moderate -majority of lesions have individual scores for E + I + S / 3 that averages 3 
4 = Severe -majority of lesions have individual scores for E + I + S / 3 that averages 4 
Note: Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total 
≥1.50, score = 2.
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APPENDIX 20
PHYSICIAN’S GLOBAL ASSESSMENT-FINGERNAILS (PGA-F)
For this assessment in participants with psoriasis fingernail involvement, the overall condition of 
the fingernails is rated by the investigator on a 0 to 4 (5-point) scale. The overall score assigned 
based on the higher of the nail bed/nail matrix score:
Nail Bed Signs
Nail Matrix Signs
Clear
0
Onycholysis- consistent with a normal nail
No non-psoriatic nail plate
AND
irregularities including
Hyperkeratosis- none
pitting, crumbling, Beau’s
AND
lines, senile onychorrhexis,
Splinter Hemorrhages-consistent with non-psoriatic splinter
and non-psoriatic
hemorrhages
leukonychia
AND
Nail Bed Erythema- none
Minimal
1
Onycholysis- < 10% involved on all nails
No more than 5 pits or
OR
psoriatic leukonychia on any
Hyperkeratosis- present, but barely detectable elevation of
nail
nail plate
AND
OR
No crumbling
Nail Bed Erythema- faint
AND
Splinter Hemorrhages- consistent with non-psoriatic splinter
hemorrhages
Mild
2
Onycholysis- > 10% on five or more nails
Five or more nails with mild
OR
pitting (eg, > 10 pits/nail) or
Hyperkeratosis- present with mild elevation of nail plate
psoriatic leukonychia
OR
AND
Splinter Hemorrhages- present on four or fewer nails
No crumbling
OR
Nail Bed Erythema- mild
Moderate
3
Onycholysis- > 30% on at least one nail
Five or more nails with
OR
moderate pitting (eg, > 25
Hyperkeratosis- present with moderate elevation of nail plate
pits/nail)
OR
AND
Splinter Hemorrhages-  scattered and present on five or more
≤ 25% crumbling on any nails
nails
OR
Nail Bed Erythema- moderate
Severe
4
Onycholysis- > 50% on at least one nail
Five or more nails with
OR
severe pitting (> 50 pits/nail)
Hyperkeratosis- present with severe elevation of nail plate
AND
OR
> 25% crumbling on any nail
Splinter Hemorrhages- numerous and present on five or more
nails
OR
Nail Bed Erythema- severe
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APPENDIX 21
DISEASE ACTIVITY SCORE 28 WITH C-REACTIVE PROTEIN
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APPENDIX 22
INTERPRETATION OF HEPATITIS B SEROLOGIC TEST 
RESULTS 
HEPATITIS C VIRUS
Testing for hepatitis C virus (HCV) is a 2-step process: (i) anti-HCV antibody and (ii) HCV 
ribonucleic acid (RNA).
Participants with a negative anti-HCV antibody may be eligible for the study.
Participants with a positive or indeterminate anti-HCV antibody require additional HCV RNA 
testing to determine eligibility. Participants with negative or undetectable HCV RNA may be 
eligible for the study. Participants with positive or detectable HCV RNA have HCV infection, are 
excluded from the study, and should be referred for appropriate assessment and consideration for 
treatment.
Participants who were previously treated with an approved treatment regimen for HCV infection 
may be eligible to participate in the study provided they achieve a Week 24 sustained virologic 
response; that is, negative or undetectable HCV RNA 24 weeks after completion of a full course 
of an approved treatment regimen for HCV infection. Such participants must be discussed with 
the Medical Monitor prior to screening.
HEPATITIS B SEROLOGIC TEST RESULTS
As study treatment in this study is expected to demonstrate immunosuppressive effects, it is 
imperative to carefully evaluate and exclude participants with potentially active hepatitis B 
infection. For this reason, in order to fully evaluate a participant’s eligibility for enrollment, the 
exclusion criterion (see Section 6.2) requires interpretation of data from 3 standard tests for 
hepatitis B (ie, measurement of hepatitis B surface antigen [HBsAg], hepatitis B core antibody 
[HBcAb], and hepatitis B surface antibody [HBsAb]).
Participants’ eligibility for enrollment should be assessed as described below. Participants who 
are:

Hepatitis B serological test negative (neg) for all results may be included in the study

HBsAg (neg), HBcAb (neg), and HBsAb positive (POS) may be included in the study 
(immunized due to hepatitis B vaccination)

HBsAg (neg), HBcAb (POS), and HBsAb (POS) are to be excluded from the study (immune 
due to natural infection exposure)

HBsAg (POS) are excluded from the study (acute or chronic infection)

HBcAb (POS) are excluded from the study (acute or chronic infection)

HBsAg (neg), HBcAb (POS), and HBsAb (neg) are to be excluded from the study 
(interpretation unclear)
Please refer to the below “Interpretation of Hepatitis B Serologic Test Results” provided by the 
Department of Health and Human Services, Centers for Disease Control and Prevention.
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FOR JAPAN AND SELECTED COUNTRIES
Participants with a positive HBcAb and/or HBsAb and a negative HBsAg may be eligible for the 
study. HBV deoxyribonucleic acid (DNA) testing will be performed in participants with a negative 
HBsAg, but a positive HBcAb and/or HBsAb at Screening. Participants with detectable HBV DNA
levels, which are defined as per the local guidelines at Screening, are excluded. Participants in this 
subgroup (with a negative HBsAg, but a positive HBcAb and/or HBsAb) will be allowed to be 
randomized if HBV DNA levels, which are defined as per the local guidelines, are undetectable
on this assay during Screening. These participants will have follow-up HBV DNA testing and 
review of liver chemistries throughout their participation in the study.
During the study, participants in this subgroup will have HBV DNA tested every 4 weeks, up to 
and including the Week 32 visit and every 4 to 8 weeks thereafter at the discretion of the 
investigator.
 
If participants in this subgroup have detectable HBV DNA levels, which are defined as per the 
local guidelines at any time, they must permanently discontinue study treatment; the investigator 
should consider referring them for appropriate specialty care and follow-up. Participants should 
continue in the study as described in Section 8.1.
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APPENDIX 23
MULTI-DRUG RESISTANT TUBERCULOSIS HIGH-BURDEN 
COUNTRIES

Angola

Bangladesh

Brazil

China

Democratic Peoples Republic of Korea

Democratic Republic of Congo

Ethiopia

India

Indonesia

Kenya

Mozambique

Myanmar

Nigeria

Pakistan

Philippines

Russian Federation

South Africa

Thailand

Tanzania, United Republic of

Viet Nam

Cambodia

Central African Republic

Congo

Lesotho

Liberia

Namibia

Papua New Guinea

Sierra Leone

Zambia

Zimbabwe
World Health Organization. Stop TB Partnership; high burden countries. UNOPS 2021 [accessed 
2021 Feb 23]. Available from: http://www.stoptb.org/countries/tbdata.asp.
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APPENDIX 24
COMMONLY USED CORTICOSTEROID EQUIVALENTS
Medication
Dose Equivalent
Prednisone
20 mg
Cortisone
100 mg
Hydrocortisone
80 mg
Prednisolone
20 mg
Methylprednisolone
16 mg
Triamcinolone
16 mg
Budesonide
4 mg
Dexamethasone
3 mg
Betamethasone
2.4 mg
Deflazacort
26 mg
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APPENDIX 25
AMERICAN COLLEGE OF RHEUMATOLOGY CORE DATASET 
AND RESPONSE DEFINITIONS
American College of Rheumatology (ACR) 
Core Data Set Component
Validated Measurement Tool
Tender joint count
Standardized 68 joint count
Swollen joint count
Standardized 66 joint count
Subject global assessment of pain
A 0-100 mm visual analog scale
Subject global assessment of disease activity
A 0-100 mm visual analog scale
Physician global assessment of psoriatic 
arthritis
A 0-100 mm visual analog scale
Subject assessment of physical function
Health Assessment Questionnaire
Acute phase reactant value
ESR (Westergren) and C-reactive protein
The ACR 20, ACR 50, or ACR 70 definition of improvement is a 20%, 50%, or 70% 
improvement, respectively, over baseline in tender and swollen joint counts (#1 and #2) and a 
20%, 50%, or 70% improvement, respectively, in 3 of the 5 remaining core data set measures 
(components #3 to #7).
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APPENDIX 26
EIGHT-ITEM PATIENT HEALTH QUESTIONNAIRE (PHQ-8)
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APPENDIX 27
SUICIDAL IDEATION AND BEHAVIOR CATEGORIES AND 
DEFINITIONS
Suicidal Ideation
Passive suicidal ideation: wish to be dead
Patient has thoughts about a wish to be dead or not alive anymore, or wish to fall asleep 
and not wake up.
Active suicidal ideation: nonspecific (no method, intent, or plan)
General nonspecific thoughts of wanting to end one’s life or commit suicide (eg, “I’ve 
thought about killing myself”) without general thoughts of ways to kill oneself/associated 
methods, intent, or plan during the assessment period.
Active suicidal ideation: method, but no intent or plan
Patient has thoughts of suicide and has thought of at least one method during the assessment 
period.  This situation is different than a specific plan with time, place, or method details 
worked out (eg, thought of method to kill self but not a specific plan). Includes person who 
would say, “I thought about taking an overdose but I never made a specific plan as to when, 
where, or how I would actually do it . . . and I would never go through with it.”
Active suicidal ideation: method and intent, but no plan
Active suicidal thoughts of killing oneself, and patient reports having some intent to act on 
such thoughts, as opposed to “I have the thoughts but I definitely will not do anything about 
them.”
Active suicidal ideation:  method, intent, and plan
Thoughts of killing oneself with details of plan fully or partially worked out and patient 
has some intent to carry it out (ie, some degree of intent is implicit in the concept of plan).
Suicidal Behavior
Completed suicide
A self-injurious behavior that resulted in fatality and was associated with at least some 
intent to die as a result of the act. Evidence that the individual intended to kill him- or 
herself, at least to some degree, can be explicit or inferred from the behavior or 
circumstance.
Suicide attempt
A potentially self-injurious behavior, associated with at least some intent to die as a result 
of the act. Evidence that the individual intended to kill him- or herself, at least to some 
degree, can be explicit or inferred from the behavior or circumstance. A suicide attempt 
may or may not result in actual injury.
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Interrupted suicide attempt
When the person is interrupted (by an outside circumstance) from starting a potentially 
self-injurious act (if not for that, actual attempt would have occurred).
Aborted suicide attempt
When person begins to take steps toward making a suicide attempt, but stops before 
actually engaging in any self-destructive behavior. Examples are similar to interrupted 
attempts, except that the individual stops before being stopped by something else.
Preparatory acts toward imminent suicidal behaviors
This category can include anything beyond a verbalization or thought, but it stops short of 
a suicide attempt, an interrupted suicide attempt, or an aborted suicide attempt. This might 
include behaviors related to assembling a specific method (eg, buying pills, purchasing a 
gun) or preparing for one’s death by suicide (eg, giving things away, writing a suicide 
note).
Self-Injurious Behavior Without Suicidal Intent
Self-injurious behavior associated with no intent to die. The behavior is intended purely for other 
reasons, either to relieve distress (often referred to as self-mutilation [eg, superficial cuts or 
scratches, hitting or banging, or burns]) or to effect change in others or the environment.
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