An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis
Phase: PHASE2
Conditions: Crohn Disease, Ulcerative Colitis
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety 
and Efficacy of Deucravacitinib in Participants with Moderate to Severe Crohn’s Disease or 
Moderate to Severe Ulcerative Colitis 
 
NCT Number: NCT04877990 
Document Date (Date in which document was last revised): 04 March 2022 
 
 
 

Page:
1
Protocol Number:
IM011077
Date:
25-Nov-2020
Revised Date:
04-Mar-2022
REGULATORY AGENCY IDENTIFIER NUMBER(S)
IND: 134444
EudraCT: 2020-004461-40
NCT: N/A
WHO: U1111-1258-3838
EUDAMED: N/A
Other: N/A
CLINICAL PROTOCOL IM011077
An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of 
Deucravacitinib in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe 
Ulcerative Colitis
Short Title: Long-term Safety and Efficacy of Deucravacitinib in Participants with Crohn’s 
Disease or Ulcerative Colitis
Protocol Amendment 01
Incorporates Administrative Letters 01 and 02
Clinical Trial Physician- Medical Monitor
Bristol Myers Squibb Company
86 Morris Avenue Summit, NJ 07901
Phone: 
Email: 
 Clinical Scientist
Bristol Myers Squibb Company
86 Morris Avenue Summit, NJ 07901
Phone: 
Email: 
24-hr Emergency Telephone Number
USA: 
International: 
Bristol-Myers Squibb Company
3401 Princeton Pike
Lawrenceville, NJ 08648
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
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Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Protocol Amendment No.: 01
Date: 04-Mar-2022
2
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).
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IM011077
BMS-986165
deucravacitinib
Protocol Amendment No.: 01
Date: 04-Mar-2022
3
DOCUMENT HISTORY
Document
Date of Issue
Summary of Change
Protocol Amendment 
01
04-Mar-2022
The purpose for Protocol Amendment 01 is to include the 
following updates:
•
Added individual Day 1 Schedule of Activities (Section 
2) tables for each parent study. 
•
Clarified study procedures that may need to be repeated 
based on the timing of entering Study IM011077.
•
Clarified 
Prohibited 
Prior 
and 
Concomitant 
Medications.
•
Clarified Exclusion Criteria.
•
Clarified timing for first dose of study treatment in 
Study IM011077.
•
Added additional Hematology testing for routine safety 
laboratory assessments.
•
Added additional investigational laboratory testing for 
participants with abnormal Hematology results that 
meet the discontinuation criteria. 
•
Added information to clarify the collection of Adverse 
Events and Medical History.
•
Added preventative care for inflammatory bowel 
disease (IBD) to the Safety Section. 
•
Updated BMS-986165 to “deucravacitinib” throughout 
document.
•
Incorporated HEOR editorial updates. 
•
Revised or removed language related to Screening, 
Randomization, and Lead-In Period to align with the 
protocol design.
•
Added language for periodic surveillance for IBD-
associated colonic dysplasia or screening for colorectal 
carcinoma.
Administrative Letter 
02
15-Sep-2021
Study personnel updated
Administrative Letter 
01
23-Feb-2021

Corrected erroneous cross-references to the Schedule of 
Activities in Sections 9.1.6 and 9.4.4

Clarifies typographical error in Section 9.1.6
Original Protocol
25-Nov-2020
Not applicable
 
 
 
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Clinical Protocol
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BMS-986165
deucravacitinib
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 01:
The purpose for Protocol Amendment 01 is to include the following updates:

Added individual Day 1 Schedule of Activities (Section 2) tables for each parent study.

Clarified study procedures that may need to be repeated based on the timing of entering Study 
IM011077.

Clarified Prohibited Prior and Concomitant Medications.

Clarified Exclusion Criteria. 

Clarified timing for first dose of study treatment in Study IM011077.

Added additional Hematology testing for routine safety laboratory assessments.

Added additional investigational laboratory testing for participants with abnormal Hematology 
results that meet discontinuation criteria.

Added information to clarify the collection of Adverse Events and Medical History.

Added preventative care for inflammatory bowel disease (IBD) to the Safety Section.

Updated BMS-986165 to “deucravacitinib” throughout document.

Incorporated health economics and outcomes research editorial updates.

Revised or removed language related to Screening, Randomization, and Lead-In Period to 
align with the protocol design.

Added language for periodic surveillance for IBD-associated colonic dysplasia or screening 
for colorectal carcinoma.
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Title Page
Updated the Name and 
Contact information of the 
Medical Monitor and Clinical 
Scientist. 
Updated per Administrative Letter 02.
Section 2: 
Schedule of 
Activities
Added Table 2-1: Day 1 
Procedural Outline 
IM011077 From Parent 
Study IM011023 -
Crohn’s Disease.
Deleted Day 1 column 
from Table 2-2: Year 1 
Procedural Outline 
(IM011077) - Crohn’s 
Disease.
To clarify Day 1 procedures for 
participants from parent study 
IM011023.
Deleted column because we made a 
separate table for Day 1.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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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
Added Table 2-4: Day 1 
Procedural Outline 
IM011077 From Parent 
Study IM011024 -
Ulcerative Colitis.
Added Table 2-5: Day 1 
Procedural Outline 
IM011077 From Parent 
Study IM011027 -
Ulcerative Colitis.
Deleted Day 1 column 
from Table 2-6: Year 1 
Procedural Outline 
(IM011077) - Ulcerative 
Colitis.
To clarify Day 1 procedures for 
participants from parent study 
IM011024.
To clarify Day 1 procedures for 
participants from parent study 
IM011127.
Deleted column because we made a 
separate table for Day 1.
Section 5.1.1: 
Qualification and 
Enrollment into 
Study
Added text for clarification of 
same-day transition between 
the parent study end of 
treatment and Day 1 of Study 
IM011077. As well as. deleted 
text regarding the number of 
days from which a participant 
would be ineligible for this 
study after last visit in the 
prior study.
Added text clarifying that 
certain procedures may or may 
not be repeated depending on 
timing of entering Study 
IM011077, after informed 
consent.
To clarify the protocol-allowed number 
of days between the parent study End of 
Treatment Visit and Study IM011077. 
To clarify if the Day 1 procedures need 
to be repeated as per the number of days 
between the parent study End of 
Treatment Visit and Day 1.
Section 5.1.2: 
Treatment Period
Added text stating that the 
morning dose of study 
treatment on Day 1, should be 
taken at the site from Study 
IM011-077.
Added additional information 
for participants who wish to 
To clarify Day 1 dosing.
For accuracy and to ensure that 
participants who discontinue the study 
complete the safety follow-up visit.
Protocol Amendment No.: 01
Date: 04-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
discontinue from study 
treatment.
Section 5.1.3:
Follow-up Period
Added additional information 
for participants who wish to 
discontinue from study 
treatment.
For accuracy and to ensure that 
participants who discontinue the study 
complete the safety follow-up visit.
Section 5.1.4: 
Treatment Failure
Added a fifth definition of 
treatment failure to exclude 
participants requiring 
 
 
 
Added to further specify treatment 
failure. 
Section 6.2: 
Exclusion Criteria
Deleted text under criterion
1) b).
Added and deleted text 
under criterion 3) a) for 
antibiotic use and deleted 
text under criterion 3) b).
Added text under criteria 
4) a) and deleted text 
under 4) c) and d) and 
added additional criterion 
4) e).
Deleted text under criteria 
5) a), c), and d) and added 
text under criterion 5) e).
1) b) Deleted criterion does not 
apply to extension study. 
3) a) To clarify prophylactic 
antibiotic use should be discussed 
with the BMS Medical 
Monitor/designee.
3) b) Deleted criterion, does not 
apply to extension study.
4) a) To clarify prohibited 
concomitant medications are 
exclusionary until Day 1
4) c) and d) Deleted criteria, does 
not apply to extension study.
5) a)
 
 
 
 
 
 
 
5) c) Deleted criterion, does not 
apply to extension study.
5) d) Deleted criterion, does not 
apply to extension study.
Protocol Amendment No.: 01
Date: 04-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
Added text under criteria 
7) a).
5) e) To clarify laboratory testing at 
the second to last visit in the parent 
study or most current result 
available prior to Day 1 needs to be 
assessed for exclusion criterion.
7) a) To clarify participants with 
Nonmelanoma Skin Cancer are not 
excluded.
Section 6.4: 
Enrollment 
Failures
Replaced “screen” for 
“enrollment.”
For accuracy since study does not have a 
Screening Period.
Section 6.4.1: 
Retesting During 
Lead-in Period
Deleted this section.
For accuracy as study does not have a 
Lead-in Period.
Section 7.2: 
Method of 
Treatment 
Assignment
Adjusted the text describing 
the number assignment process 
for participants.
To eliminate repetitious information 
stated in Section 7.2.
Section 7.7.1: 
Prohibited 
Treatments
Added text to Table 7.7.1-1: 
Summary of Prohibited 
Concomitant Medications.
To clarify in the notes the timing and 
criteria of prohibited concomitant 
medications.
Section 8.1: 
Discontinuation 
From Study 
Treatment
Added text to clarify 
laboratory test result
abnormalities regarding 
Hemoglobin levels.
For participant safety.
Section 8.1.1: 
Temporary 
Discontinuation 
From Study 
Treatment
Deleted text regarding 
restarting study treatment.
To eliminate repetitious information 
stated in Section 8.1.1.
Section 9: Study 
Assessments and 
Procedures
Deleted text referring to 
screening evaluations.
Added text describing the 
information collected from this 
study will be used to help 
understand certain health 
conditions.
For accuracy. Study does not have a 
Screening Period.
To clarify how the study data collected 
will be used.
Protocol Amendment No.: 01
Date: 04-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 9.1.4.2: 
Ulcerative Colitis 
Added text elaborating when 
the modified Mayo score is to 
be calculated. 
Added to clarify as to which study’s end 
of treatment visit may be used.
Section 9.1.6: 
Laboratory 
Assessments
Added text stating additional 
tests that are recommended to 
exclude infectious causes of 
disease exacerbation.
Updated per Administrative Letter 01.
Section 9.2.1: 
Time Period and 
Frequency for 
Collecting AE 
and SAE 
Information
Added information regarding 
the timepoints at which 
adverse events (AEs) will be 
collected and reported. 
For clarity.
Section 9.4.1: 
Preventative Care
Added new section for up-to-
date preventative care for IBD.
For participant safety due to length of 
study.
Section 9.4.2: 
Physical 
Examinations
Added text referring to 
schedules for targeted physical 
examination in Section 2.
To clarify when targeted physical 
examinations should be performed 
during the study and added skin 
examination to the targeted physical 
examination.
Section 9.4.3: 
Vital Signs
Added information and 
description of vital signs to be 
collected.
To clarify method for collecting vital 
signs.
Section 9.4.5: 
Clinical Safety 
Laboratory 
Assessments
Added more Hematology 
Parameters to be assessed in 
Table 9.4.5-1: Summary of 
Laboratory Parameters Used to 
Assess Clinical Safety.
For participant safety.
Section 9.4.7: 
Imaging Safety
Assessment
Added text referencing Section 
9.4.1 for periodic surveillance 
for IBD associated colonic 
dysplasia or screening for 
colorectal carcinoma. 
For participant safety.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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IM011077
BMS-986165
deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
Section 9.5: 
Pharmacokinetics
Added new footnotes to Table 
9.5-1: Pharmacokinetic 
Sampling Schedule for All 
Participants (Study 
IM011077).
To clarify Day 1 dosing and the drawing 
of the pre-dose samples.
Section 10.4.2: 
Safety Analyses
Deleted text stating that 
“participants will be 
summarized according to the 
treatment they receive in their
parent trial.”
The statement was redundant.
Section 10.4.2.1: 
Adverse Events
Added information regarding 
the timepoints at which AEs
will be collected and reported.
For clarity.
Appendix 2: 
Study 
Governance 
Considerations
Updated language for 
monitoring.
This was done to align with standard 
language updates to the Protocol Model 
Document.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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IM011077
BMS-986165
deucravacitinib
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section Number 
& Title
Description of Change
Brief Rationale
All
Changed the drug name from 
“BMS-986165” to 
“deucravacitinib” here and 
throughout the protocol.
Updated as per the Deucravacitinib 
Usage Guidance (updated January 
2021).
Protocol Amendment No.: 01
Date: 04-Mar-2022
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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 ....................................................................................................... 
 
3.2.1 Nonclinical Toxicology ............................................................................ 
 
3.2.2 Early Clinical Experience ........................................................................ 
 
3.2.2.1 Deucravacitinib Dose Regimen Studies .......................................... 
 
3.3 Benefit/Risk Assessment .................................................................................. 
 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
 
5 STUDY DESIGN....................................................................................................... 
 
5.1 Overall Design .................................................................................................. 
 
5.1.1 Qualification and Enrollment into Study ................................................. 
 
5.1.2 Treatment Period ..................................................................................... 
 
5.1.3 Follow-up Period ..................................................................................... 
 
5.1.4 Treatment Failure .................................................................................... 
 
5.1.5 Data Monitoring Committee and Other External Committees ................ 
 
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 .............................................................................................. 
 
6.2 Exclusion Criteria ............................................................................................. 
 
6.2.1 Enrollment Criteria .................................................................................. 
 
6.3 Lifestyle Restrictions ........................................................................................ 
 
6.3.1 Meals and Dietary Restrictions ............................................................... 
 
6.3.2 Tobacco and e-Cigarettes ........................................................................ 
 
6.3.3 Activity ..................................................................................................... 
 
6.4 Enrollment Failures ........................................................................................... 
 
7 TREATMENT ........................................................................................................... 
 
7.1 Treatments Administered .................................................................................. 
 
7.2 Method of Treatment Assignment .................................................................... 
 
7.3 Blinding............................................................................................................. 
 
7.4 Dosage Modification ......................................................................................... 
 
7.5 Preparation/Handling/Storage/Accountability .................................................. 
 
7.5.1 Retained Samples for Bioavailability/Bioequivalence/Biocomparability 
 
7.6 Treatment Compliance ...................................................................................... 
 
7.7 Concomitant Therapy........................................................................................ 
 
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7.7.1 Prohibited Treatments ............................................................................. 
 
7.7.2 Restricted Concomitant Medications ....................................................... 
 
7.7.3 Permitted Medications ............................................................................. 
 
7.7.4 Disease Exacerbation, Corticosteroid Rescue Therapy, and Tapering ... 
 
7.7.4.1 Disease Exacerbation ..................................................................... 
 
7.7.4.2 Corticosteroid Rescue Therapy and Tapering ................................ 
 
7.8 Treatment After the End of the Study ............................................................... 
 
8 DISCONTINUATION CRITERIA ........................................................................... 
 
8.1 Discontinuation From Study Treatment............................................................ 
 
8.1.1 Temporary Discontinuation From Study Treatment ................................ 
 
8.1.2 Post Study Treatment Study Follow-up.................................................... 
 
8.2 Discontinuation From the Study ....................................................................... 
 
8.3 Lost to Follow-up .............................................................................................. 
 
8.4 Replacement of Participants ............................................................................. 
 
8.5 Study Discontinuation ....................................................................................... 
 
9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
 
9.1 Efficacy Assessments ........................................................................................ 
 
9.1.1 Endoscopies and Endoscopic Biopsies .................................................... 
 
 
 
9.1.3 Capturing Data to Assess Disease Activity .............................................. 
 
9.1.4 Disease Activity Indices ........................................................................... 
 
9.1.4.1 Crohn’s Disease .............................................................................. 
 
9.1.4.2 Ulcerative Colitis ............................................................................ 
 
 
 
9.1.6 Laboratory Assessments........................................................................... 
 
9.2 Adverse Events ................................................................................................. 
 
9.2.1 Time Period and Frequency for Collecting AE and SAE Information .... 
 
9.2.2 Method of Detecting AEs and SAEs ......................................................... 
 
9.2.3 Follow-up of AEs and SAEs ..................................................................... 
 
9.2.4 Regulatory Reporting Requirements for SAEs ......................................... 
 
9.2.5 Pregnancy ................................................................................................ 
 
9.2.6 Laboratory Test Result Abnormalities ..................................................... 
 
9.2.7 Potential Drug-induced Liver Injury ....................................................... 
 
9.2.8 Adverse Events of Interest ........................................................................ 
 
9.2.9 Other Safety Considerations .................................................................... 
 
9.3 Overdose ........................................................................................................... 
 
9.4 Safety ................................................................................................................ 
 
9.4.1 Preventative Care .................................................................................... 
 
9.4.2 Physical Examinations ............................................................................. 
 
9.4.3 Vital Signs ................................................................................................ 
 
9.4.4 Electrocardiograms ................................................................................. 
 
9.4.5 Clinical Safety Laboratory Assessments .................................................. 
 
9.4.6 Tuberculosis Screening ............................................................................ 
 
9.4.7 Imaging Safety Assessment ...................................................................... 
 
9.5 Pharmacokinetics .............................................................................................. 
 
 
 
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9.7 Pharmacogenomics ........................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.9 Health Economics OR Medical Resource Utilization and Health Economics . 
 
9.10 Electronic Informed Consent .......................................................................... 
 
10 STATISTICAL CONSIDERATIONS .................................................................... 
 
10.1 Sample Size Determination ............................................................................. 
 
10.2 Populations for Analyses ................................................................................ 
 
10.3 Endpoints ........................................................................................................ 
 
10.3.1 Primary Endpoints ................................................................................. 
 
 
 
 
 
 
 
 
10.4 Statistical Analyses ......................................................................................... 
 
10.4.1 Efficacy Analyses ................................................................................... 
 
10.4.1.1 Definition of Baseline ................................................................... 
 
10.4.2 Safety Analyses....................................................................................... 
 
10.4.2.1 Adverse Events .............................................................................. 
 
10.4.2.2 Vital Signs and Physical Examinations ........................................ 
 
10.4.2.3 Clinical Laboratory Tests ............................................................. 
 
10.4.3 Other Analyses ....................................................................................... 
 
10.4.3.1 Demographics and Baseline Data ................................................ 
 
10.4.3.2 Prior and Concomitant Medications ............................................ 
 
10.4.3.3 Pharmacokinetics .......................................................................... 
 
 
 
10.4.4 Interim Analyses ..................................................................................... 
 
11 REFERENCES ........................................................................................................ 
 
12 APPENDICES ......................................................................................................... 
 
APPENDIX 1 ABBREVIATIONS AND TRADEMARKS ........................................ 
 
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 TUBERCULOSIS RISK ASSESSMENT TOOL ................................. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX 13 MAYO SCORE: COMPONENT SUBSCORES 
 
 ................................................... 
 
 
 
 
 
 
 
 
 
 
 
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Clinical Protocol
IM011077
BMS-986165
deucravacitinib
1
SYNOPSIS
Protocol Title: An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety 
and Efficacy of Deucravacitinib in Participants with Moderate to Severe Crohn’s Disease or 
Moderate to Severe Ulcerative Colitis
Short Title: Long-term Safety and Efficacy of Deucravacitinib in Participants with Crohn’s 
Disease or Ulcerative Colitis
Study Phase: 2
Rationale:
IM011077 is an open-label, long-term extension study designed to evaluate the long-term safety 
and efficacy of deucravacitinib (BMS-986165) 6 mg twice daily (BID) in participants who have 
previously been enrolled in a Phase 2 deucravacitinib study for moderate to severe Crohn’s disease 
(CD) (Study IM011023) or moderate to severe ulcerative colitis (UC) (Studies IM011024 and 
IM011127).
 
 
 
Study Population: Adults with CD or UC who have completed participation in a preceding study,
including Studies IM011023, IM011024, or IM011127, may be eligible to enroll in Study
IM011077.
Objectives and Endpoints - Crohn’s Disease
Objective
Endpoint
Primary

To assess the safety and tolerability of long-term 
use of deucravacitinib in participants with 
moderate to severe CD.

Number and proportion of participants experiencing 
AEs, SAEs, AEs leading to study discontinuation, and 
AEIs.

Number and proportion of participants experiencing 
abnormalities in laboratory testing, ECG, and vital 
sign parameters over time.

Changes from Day 1 for laboratory testing, ECG, and 
vital signs.
Exploratory
Protocol Amendment No.: 01
Date: 04-Mar-2022
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1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Objective
Endpoint
Abbreviations: AE = adverse event; AEI = adverse event of interest; CD = Crohn’s disease; ECG = electrocardiogram; 
 
 SAE = serious adverse event; 
 
Objectives and Endpoints - Ulcerative Colitis:
Objective
Endpoint
Primary

To assess the safety and tolerability of long-term 
use of deucravacitinib in participants with moderate 
to severe UC.

Number and proportion of participants experiencing 
AEs, SAEs, AEs leading to study discontinuation, 
and AEIs.

Number and proportion of participants experiencing 
abnormalities in laboratory testing, ECG, and vital 
sign parameters over time.

Changes from baseline for laboratory testing, ECG, 
and vital signs.
Exploratory
Protocol Amendment No.: 01
Date: 04-Mar-2022
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2.0
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930162131
2.0
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Objective
Endpoint
Abbreviations: AE = adverse event; AEI = adverse event of interest; ECG = electrocardiogram; 
 
 
 
 
 
 
 
 
 SAE = serious adverse event; 
 
 UC = ulcerative colitis; 
Overall Design:
This is an open-label, multi-center study to evaluate the long-term safety and tolerability of 
deucravacitinib in participants with moderate to severe CD or moderate to severe UC who have 
completed one of the applicable parent studies (IM011023, IM011024, and IM011127), are likely 
to safely derive a clinical benefit from ongoing treatment with deucravacitinib, and are willing and 
able to participate. Participants will receive deucravacitinib 6 mg BID by mouth (PO) in a tablet 
formulation.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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Clinical Protocol
IM011077
BMS-986165
deucravacitinib
The study design schematic is presented in the figure below.
Study Design Schematic
Abbreviations: BID = twice daily; BMS-986165 = deucravacitinib; DB = double-blind; EOT = end of treatment; F/U
= follow-up; OLE = open-label extension; Q12W = every 12 weeks.
Number of Participants: Approximately 300 participants are expected to rollover from the parent 
studies into Study IM011077. All participants must have completed 1 of the parent studies (Studies 
IM011023, IM011024, or Study IM011127) and must meet all eligibility criteria.
Treatment Arms and Duration:
Participants will receive deucravacitinib 6 mg BID PO in a tablet formulation.
The duration of the study is approximately 296 weeks (2,072 day) as follows:

Qualification and enrollment: up to 28 days 

Open-label study period: 288 weeks (2,017 days)

Post-treatment follow-up period: 4 weeks (28 days)
Study Treatment:
Study Drug for IM011077
Medication 
Potency 
IP/Non-IP 
Deucravacitinib (BMS-986165)
6 mg
IP
Abbreviation: IP = Investigational Product.
Data Monitoring Committee: Yes
Protocol Amendment No.: 01
Date: 04-Mar-2022
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Clinical Protocol
IM011077
BMS-986165
deucravacitinib
2
SCHEDULE OF ACTIVITIES
Protocol Amendment No.: 01
Date: 04-Mar-2022
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930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-1:
Day 1 Procedural Outline IM011077 From Parent Study IM011023 - Crohn’s Disease
Procedure
Day 1
Notes
Visit Window (n days from 
parent study EOT)
< 14
≥ 14 through ≤ 28 a
Eligibility and Disease Assessments
Informed Consent
X
X
Appendix 2 (Study Governance)
Inclusion/Exclusion Criteria
X
X
Section 6 (Study Population)
Obtain Participant Number 
(IRT)
X
X
Section 7.2 (Method of Treatment Assignment)
Tobacco/e-Cigarette Use
X
X
Section 6.3.2 (Tobacco and e-Cigarettes)
Medical Historyb
X
X
Section 9.2.1
Concomitant Medication Use c
PSEOT k
X
Section 7.7 (Concomitant Therapy)
Physical Examination
Physical Examination
PSEOT k
X
Section 9.4.2 (Physical Examinations)
Vital Signs (heart rate, blood 
pressure, temperature)
PSEOT k
X
Includes body temperature and seated blood pressure and heart rate. 
Blood pressure and heart rate should be measured after the participant 
has been resting quietly for at least 5 minutes.
Height
X
X
The height measurement should not be collected at Day 1. This height 
measurement should be carried over from the parent study screening
visit and entered into Study IM011077 database (eg, eCRF).
Weight
PSEOT k
X
Protocol Amendment No.: 01
Date: 04-Mar-2022
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2.0
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-1:
Day 1 Procedural Outline IM011077 From Parent Study IM011023 - Crohn’s Disease
Procedure
Day 1
Notes
Visit Window (n days from 
parent study EOT)
< 14
≥ 14 through ≤ 28 a
ECG
PSEOT k
X
Section 9.4.4 (Electrocardiograms)
Blood, Urine, and Fecal Tests
Hematology and Chemistry
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs)
Calculate eGFR
X
X
Exclusion Criterion 5(e)(ii)
Coagulation
PSEOT k
X
Fasting Lipid Panel and Glucose
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs)
Tuberculosis Risk Assessment
X
X
Appendix 5 (TB)
FSH
X
X
Appendix 4
Urine Pregnancy Test f
PSEOT k
X
Section 9.2.5 (Pregnancy); Section 9.4.5 (Clinical Safety Labs);
Appendix 4
Urinalysis and Urine Chemistry
X
X
Section 9.4.5 (Clinical Safety Labs)
Pharmacokinetic Assessments
PSEOT k
X
See Table 9.5-1 for sample collection details.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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2.0
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930162131
2.0
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-1:
Day 1 Procedural Outline IM011077 From Parent Study IM011023 - Crohn’s Disease
Procedure
Day 1
Notes
Visit Window (n days from 
parent study EOT)
< 14
≥ 14 through ≤ 28 a
Endoscopy and Endoscopic Biopsies
Endoscopy (ileocolonoscopy)
PSEOT
Section 9.1.1 (Endoscopies and Biopsies)
Additional Efficacy Assessments
Health-Outcomes Assessments
Register and Train Participant 
on Slate Device
X
Safety Assessment (in addition to the above)
SAE Assessment
PSEOT k
X
Section 9.2 (AEs); Appendix 3
AE Assessment
PSEOT k
X
Section 9.2 (AEs); Appendix 3
Protocol Amendment No.: 01
Date: 04-Mar-2022
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2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-1:
Day 1 Procedural Outline IM011077 From Parent Study IM011023 - Crohn’s Disease
Procedure
Day 1
Notes
Visit Window (n days from 
parent study EOT)
< 14
≥ 14 through ≤ 28 a
Study Treatment
Dispense Study Treatment
X
deucravacitinib
Clinic Study Treatment 
Administration j
X
Section 9.5 (Pharmacokinetics)
Abbreviations: AE = adverse event; 
 BMS = Bristol-Myers Squibb; 
 
ECG = electrocardiogram; 
 eCRF = electronic case report form; EOT = end of treatment; 
eGFR = estimated glomerular filtration rate; FSH = follicle-stimulating hormone; 
 
 
 
 IEC = Independent Ethics Committee; 
 
 IP = 
Investigational Product; IRB = Institutional Board Review; IRT = interactive response technology; n = number; 
 PSEOT 
= parent study end of treatment; 
 
 
 SAE = serious adverse event; 
 
 TB = tuberculosis; 
 WOCBP 
= women of childbearing potential.
a If same-day transition does not occur between the parent study EOT and Day 1 of Study IM011077; participants should enter the study within 
 of the 
last visit of the parent study and assessments should be repeated as indicated. If the number of days since the last visit of the parent study exceeds 
, 
participants are not eligible for participation in this study. The only exception to this 
 is when the delay is due to clinical or regulatory issues (eg, 
resolution or treatment for an otherwise exclusionary AE or clinical laboratory value, or delayed IRB/IEC approval), investigators must discuss a participant’s 
continued participation with the BMS Medical Monitor/designee prior to enrolling the participant.
b Medical History will consist of medical history and adverse events from parent Study IM011023. Parent Study AEs that have either resolved or are ongoing 
 
 after the PSEOT visit will be considered medical history in Study IM011077. These data will need to be manually entered into the Study IM011077 database 
(eg, eCRFs).
c Concomitant Medications taken within 
of Day 1 will need to be manually entered into the Study IM011077 database (eg, eCRFs).
 
f 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.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
 
j
On Day 1, after informed consent, study treatment should be taken from Study IM011077.
k Assessment will be performed during the PSEOT visit per protocol. Any missing data should be collected on Day 1.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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930162131
2.0
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-2:
Year 1 Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Visit Window (± n days)
14
14
14
14
3
Eligibility and Disease Assessments
Tobacco/e-Cigarette Use
X
X
X
X
X
Section 6.3.2 (Tobacco and 
e-Cigarettes)
Concomitant Medication 
Use
X
X
X
X
X
Section 7.7 (Concomitant 
Therapy)
Physical Examination
Physical Examination
X
X
Section 9.4.2 (Physical 
Examinations)
Targeted Physical 
Examination
X
X
X
Section 9.4.2 (Physical 
Examinations)
Vital Signs (heart rate, 
blood pressure, 
temperature)
X
X
X
X
X
Includes body temperature 
and seated blood pressure 
and heart rate. Blood 
pressure and heart rate should 
be measured after the 
participant has been resting 
quietly for at least 5 minutes.  
Weight
X
X
X
X
X
ECG
X
X a
Section 9.4.4
Protocol Amendment No.: 01
Date: 04-Mar-2022
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-2:
Year 1 Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Blood, Urine, and Fecal Tests
Hematology and Chemistry
X
X
X
X
X
Section 9.4.5 (Clinical Safety 
Labs)
Coagulation
X
X
Fasting Lipid Panel and 
Glucose
X
Section 9.4.5 (Clinical Safety 
Labs)
Tuberculosis Risk 
Assessment
X
Appendix 5 (TB)
Urine Pregnancy Test d
X
X
X
X
X
Section 9.2.5 (Pregnancy); 
Section 9.4.5 (Clinical Safety 
Labs); Appendix 4
Urinalysis and Urine 
Chemistry
X
X
X
Section 9.4.5 (Clinical Safety 
Labs)
Pharmacokinetic 
Assessments
See Table 9.5-1 for sample collection details.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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2.0
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930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-2:
Year 1 Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Endoscopy and Endoscopic Biopsies
Endoscopy 
(ileocolonoscopy) f
X
Section 9.1.1 (Endoscopies 
and Biopsies)
Additional Efficacy Assessments
Health-Outcomes Assessments
Protocol Amendment No.: 01
Date: 04-Mar-2022
27
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-2:
Year 1 Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Safety Assessment (in addition to the above)
SAE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 
3
AE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 
3
Study Treatment
Dispense Study Treatment
X
X
X
X i
deucravacitinib
Clinic Study Treatment 
Administration
X
X
X
X
Section 9.5
(Pharmacokinetics)
Review Study Treatment 
Compliance
X
X
X
X
Section 7.6 (Treatment 
Compliance)
Abbreviations: AE = adverse event; 
 
 
ECG = electrocardiogram; 
 EOT = end of treatment; ET = early termination; FSH = follicle-stimulating hormone; 
 
 
 
 
 IRT = interactive response technology; n = number; 
 
 SAE = serious adverse event; 
 
 
 
 
 
 
 
 
 
 
 
 
 TB = tuberculosis; 
 WOCBP = women of childbearing 
potential.
a Required only if ECG at ET is abnormal.
 
d 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 study treatment administration in WOCBP where a urine pregnancy test does not adequately exclude a clinical suspicion of 
pregnancy.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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930162131
2.0
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
 
f
i
Study treatment will not be dispensed at the EOT or ET visit.
General procedural note: The protocol does not mandate specific investigations at unscheduled visits. Unscheduled visit study procedures should be based on the 
clinical judgment of the investigator.
Protocol Amendment No.: 01
Date: 04-Mar-2022
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930162131
2.0
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Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-3:
Long-term Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)
EOT
Visit Window (± n days)
14
14
14
14
3
Disease Assessments
Concomitant Medication Use
X
X
X
X
X
Section 7.7 (Concomitant Therapy)
Tobacco/e-Cigarette Use
X
X
X
X
X
Section 6.3.2 (Tobacco and e-
Cigarettes)
Physical Examination
Physical Examination
X
X
Section 9.4.2 (Physical 
Examinations)
Targeted Physical Examination
X
X
X
Section 9.4.2 (Physical 
Examinations)
Vital Signs
X
X
X
X
X
Includes body temperature and 
seated blood pressure and heart 
rate. Blood pressure and heart rate 
should be measured after the 
participant has been resting quietly 
for at least 5 minutes.  
Weight
X
X
X
X
X
Protocol Amendment No.: 01
Date: 04-Mar-2022
30
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-3:
Long-term Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)
EOT
Visit Window (± n days)
14
14
14
14
3
ECG
X
X a
Section 9.4.4 (Electrocardiograms)
Blood , Urine, and Fecal Tests
Hematology and Chemistry
X
X
X
X
X
Section 9.4.5 (Clinical Safety Labs)
Coagulation
X
X
Section 9.4.5 (Clinical Safety Labs)
Fasting Lipid Panel and Glucose
X
Section 9.4.5 (Clinical Safety Labs)
Tuberculosis Risk Assessment
X
Appendix 5 (TB)
Protocol Amendment No.: 01
Date: 04-Mar-2022
31
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-3:
Long-term Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)
EOT
Visit Window (± n days)
14
14
14
14
3
Urine Pregnancy Test d
X
X
X
X
X
Section 9.2.5 (Pregnancy); Section 
9.4.5 (Clinical Safety Labs);
Appendix 4
Urinalysis and Urine Chemistry
X
X
Section 9.4.5 (Clinical Safety Labs)
Pharmacokinetic Assessments
See Table 9.5-1 for sample collection details.
Endoscopy and Endoscopic Biopsies
Endoscopy (ileocolonoscopy) f
X
Section 9.1.1 (Endoscopies and 
Biopsies)
Protocol Amendment No.: 01
Date: 04-Mar-2022
32
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-3:
Long-term Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)
EOT
Visit Window (± n days)
14
14
14
14
3
Additional Efficacy Assessments
Health-Outcomes Assessments and Medical Resource Utilization
Protocol Amendment No.: 01
Date: 04-Mar-2022
33
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-3:
Long-term Procedural Outline (IM011077) - Crohn’s Disease
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)
EOT
Visit Window (± n days)
14
14
14
14
3
Safety Assessments (in addition to the above)
SAE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 3
AE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 3
Study Treatment
Dispense Study Treatment
X
X
X
Xi
deucravacitinib
Clinic Study Treatment
Administration
X
X
X
X
Section 9.5 (Pharmacokinetics)
Review Study Treatment
Compliance
X
X
X
X
Section 7.6 (Treatment 
Compliance)
Abbreviations: AE = adverse event; 
 
 
ECG = electrocardiogram;
EOT = end of treatment; ET = early termination; 
 
 
 
 
Protocol Amendment No.: 01
Date: 04-Mar-2022
34
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
 
n = number; 
 
 SAE = serious adverse event; 
 
 TB = tuberculosis; 
 
 WOCBP = women of childbearing potential.
a Required only if ECG at ET is abnormal.
 
d 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 study treatment administration in WOCBP where a urine pregnancy test does not adequately exclude a clinical suspicion of 
pregnancy.
 
f
i
Study treatment will not be dispensed at the EOT or ET visit.
General procedural note: The protocol does not mandate specific investigations at unscheduled visits. Unscheduled visit study procedures should be based on the 
clinical judgment of the investigator.
Protocol Amendment No.: 01
Date: 04-Mar-2022
35
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-4:
Day 1 Procedural Outline IM011077 From Parent Study IM011024 - Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
Eligibility and Disease Assessments
Informed Consent
X
X
Appendix 2 (Study Governance)
Inclusion/Exclusion Criteria
X
X
Section 6 (Study Population)
Obtain Participant Number (IRT)
X
X
Section 7.2 (Method of Treatment 
Assignment)
Tobacco/e-Cigarette Use
PSEOT k
X
Section 6.3.2 (Tobacco and e-
Cigarettes)
Medical History b
X
X
Section 9.2.1
Concomitant Medication Use c
PSEOT k
X
Section 7.7 (Concomitant Therapy)
Physical Examination
Physical Examination
PSEOT k
X
Section 9.4.2 (Physical Examinations)
Vital Signs (heart rate, blood pressure, 
temperature)
PSEOT k
X
Includes body temperature and seated 
blood pressure and heart rate. Blood 
pressure and heart rate should be 
measured after the participant has been 
resting quietly for at least 5 minutes.
Height
X
X
The height measurement should not be 
collected at Day 1. This height 
measurement should be carried over 
from the parent study screening visit
and entered into Study IM011077 
database (eg, eCRF).
Weight
PSEOT k
X
Protocol Amendment No.: 01
Date: 04-Mar-2022
36
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-4:
Day 1 Procedural Outline IM011077 From Parent Study IM011024 - Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
ECG
PSEOT k
X
Section 9.4.4 (Electrocardiograms)
Blood, Urine, and Fecal Tests
Hematology and Chemistry 
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs) 
Calculate eGFR
X
X
Exclusion Criterion 5(e)(ii)
Coagulation
X
X
Section 9.4.5 (Clinical Safety Labs)
Fasting Lipid Panel and Glucose
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs) 
Tuberculosis Risk Assessment 
X
X
Appendix 5 (TB)
Protocol Amendment No.: 01
Date: 04-Mar-2022
37
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-4:
Day 1 Procedural Outline IM011077 From Parent Study IM011024 - Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
FSH
X
X
Appendix 4
Urine Pregnancy Test f
PSEOT k
X
Section 9.2.5 (Pregnancy); Section 
9.4.5 (Clinical Safety Labs); Appendix 
4
Urinalysis and Urine Chemistry
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs)
Pharmacokinetic Assessments
PSEOT k
X
See Table 9.5-1 for sample collection 
details.
Endoscopy and Endoscopic Biopsies
Endoscopy 
(colonoscopy/sigmoidoscopy)
PSEOT
Section 9.1.1 (Endoscopies and 
Biopsies)
Additional Efficacy Assessments
Site Calculates the Modified Mayo 
Score h
PSEOT
Section 9.1.4 (Disease Activity 
Indices); Appendix 13 (Mayo)
Protocol Amendment No.: 01
Date: 04-Mar-2022
38
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-4:
Day 1 Procedural Outline IM011077 From Parent Study IM011024 - Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
Health-Outcomes Assessments
Register and Train Participant on Slate 
Device
X
Safety Assessment (in addition to the above)
SAE Assessment
PSEOT k
X
Section 9.2 (AEs); Appendix 3
AE Assessment
PSEOT k
X
Section 9.2 (AEs); Appendix 3
Study Treatment
Dispense Study Treatment
X
deucravacitinib
Clinic Study Treatment 
Administration j
X
Section 9.5 (Pharmacokinetics) 
Abbreviations: AE = adverse event; 
BMS = Bristol-Myers Squibb; 
 ECG = electrocardiogram; 
 eCRF = electronic case report form; eGFR = estimated glomerular filtration rate; EOT = end of treatment; FSH 
= follicle-stimulating hormone; 
 
 IEC = Independent Ethics Committee; 
 
IP = Investigational Product; IRB = Institutional Review Board; IRT 
= interactive response technology; n = number; PSEOT = parent study end of treatment; 
 
 SAE = serious 
adverse event; 
 TB = tuberculosis; 
 
 WOCBP = women of childbearing potential.
Protocol Amendment No.: 01
Date: 04-Mar-2022
39
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
a If same-day transition does not occur between the parent study EOT and Day 1 of Study IM011077; participants should enter the study within 
 of the
last visit of the parent study and assessments should be repeated as indicated. If the number of days since the last visit of the parent study exceeds 
, 
participants are not eligible for participation in this study. The only exception to this 
 is when the delay is due to clinical or regulatory issues (eg, 
resolution or treatment for an otherwise exclusionary AE or clinical laboratory value, or delayed IRB /IEC, investigators must discuss a participant’s continued 
participation with the BMS Medical Monitor/designee prior to enrolling the participant.
b Medical History will consist of medical history and adverse events from parent Study IM011024. Parent Study AEs that have either resolved or are ongoing 
 after the PSEOT visit will be considered medical history in Study IM011077. These data will need to be manually entered into the Study IM011077 database 
(eg, eCRFs).
c Concomitant Medications taken within 
 of Day 1 will need to be manually entered into the Study IM011077 database (eg, eCRFs).
f 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.
h The modified Mayo score calculated at this visit may be used for eligibility assessment if the score is not available from the central reader.
j
On Day 1, after informed consent, study treatment should be taken from Study IM011077.
k Assessment will be performed during the PSEOT visit per protocol. Any missing data should be collected on Day 1.
Protocol Amendment No.: 01
Date: 04-Mar-2022
40
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-5:
Day 1 Procedural Outline IM011077 From Parent Study IM011127- Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
Eligibility and Disease Assessments
Informed Consent
X
X
Appendix 2 (Study Governance)
Inclusion/Exclusion Criteria
X
X
Section 6 (Study Population)
Obtain Participant Number (IRT)
X
X
Section 7.2 (Method of Treatment 
Assignment)
Tobacco/e-Cigarette Use
PSEOT k
X
Section 6.3.2 (Tobacco and e-Cigarettes)
Medical History b
X
X
Section 9.2.1
Concomitant Medication Use c
PSEOT k
X
Section 7.7 (Concomitant Therapy)
Physical Examination
Physical Examination
PSEOT k
X
Section 9.4.2 (Physical Examinations)
Vital Signs (heart rate, blood 
pressure, temperature)
PSEOT k
X
Includes body temperature and seated 
blood pressure and heart rate. Blood 
pressure and heart rate should be measured 
after the participant has been resting quietly 
for at least 5 minutes. 
Height
X
X
The height measurement should not be 
collected at Day 1. This height 
measurement should be carried over from 
the parent study screening visit and entered 
into Study IM011077 database (eg, eCRF).
Weight
PSEOT k
X
Protocol Amendment No.: 01
Date: 04-Mar-2022
41
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-5:
Day 1 Procedural Outline IM011077 From Parent Study IM011127- Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
ECG
PSEOT k
X
Section 9.4.4 (Electrocardiograms)
Blood, Urine, and Fecal Tests
Hematology and Chemistry 
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs) 
Calculate eGFR
X
X
Exclusion Criterion 5(e)(ii)
Coagulation
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs)
Fasting Lipid Panel and Glucose
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs) 
Tuberculosis Risk Assessment 
X
X
Appendix 5 (TB)
FSH
X
X
Appendix 4
Urine Pregnancy Test f
PSEOT k
X
Section 9.2.5 (Pregnancy); Section 9.4.5
(Clinical Safety Labs); Appendix 4
Protocol Amendment No.: 01
Date: 04-Mar-2022
42
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-5:
Day 1 Procedural Outline IM011077 From Parent Study IM011127- Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
Urinalysis and Urine Chemistry
PSEOT k
X
Section 9.4.5 (Clinical Safety Labs)
Pharmacokinetic Assessments
PSEOT k
X
See Table 9.5-1 for sample collection 
details.
Endoscopy and Endoscopic Biopsies
Endoscopy 
(colonoscopy/sigmoidoscopy)
PSEOT
Section 9.1.1 (Endoscopies and Biopsies)
Additional Efficacy Assessments
Site Calculates the Modified Mayo 
Score h
PSEOT
Section 9.1.4 (Disease Activity Indices); 
Appendix 13 (Mayo) 
Health-Outcomes Assessments
Register and Train Participant on 
Slate Device
X
Protocol Amendment No.: 01
Date: 04-Mar-2022
43
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-5:
Day 1 Procedural Outline IM011077 From Parent Study IM011127- Ulcerative Colitis
Procedure
Day 1
Notes
Visit Window (n days from parent 
study EOT)
<14
≥ 14 through ≤ 28 a
Safety Assessment (in addition to the above)
SAE Assessment
PSEOT k
X
Section 9.2 (AEs); Appendix 3
AE Assessment
PSEOT k
X
Section 9.2 (AEs); Appendix 3
Study Treatment
Dispense Study Treatment
X
deucravacitinib
Clinic Study Treatment 
Administration j
X
Section 9.5 (Pharmacokinetics) 
Abbreviations: AE = adverse event; 
 BMS = Bristol-Myers Squibb; 
 ECG = electrocardiogram; 
eCRF = electronic case report case; eGFR = estimated glomerular filtration rate; EOT = end of treatment; FSH 
= follicle-stimulating hormone; 
 IBD = inflammatory bowel 
disease; 
 IEC = Independent Ethics Committee; 
 
 IP = Investigational Product; IRB = Institutional Review Board; IRT 
= interactive response technology; n = number; PSEOT = parent study end of treatment;
 
 SAE = serious 
adverse event; 
 TB = tuberculosis; 
 
 WOCBP = women of childbearing potential.
a If same-day transition does not occur between the parent study EOT and Day 1 of Study IM011077; participants should enter the study within 
 of the 
last visit of the parent study and assessments should be repeated as indicated. If the number of days since the last visit of the parent study exceeds 
, 
participants are not eligible for participation in this study. The only exception to this 
 is when the delay is due to clinical or regulatory issues (eg, 
resolution or treatment for an otherwise exclusionary AE or clinical laboratory value, or delayed IRB/IEC approval), investigators must discuss a participant’s 
continued participation with the BMS Medical Monitor/designee prior to enrolling the participant.
Protocol Amendment No.: 01
Date: 04-Mar-2022
44
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
b Medical History will consist of medical history and adverse events from parent Study IM011127. Parent Study AEs that have either resolved or are ongoing
 
 after the PSEOT visit will be considered medical history in Study IM011077. These data will need to be manually entered into the Study IM011077 database 
(eg, eCRFs).
c Concomitant Medications taken within 
 of Day 1 will need to be manually entered into the Study IM011077 database (eg, eCRFs).
 
f 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.
 
h The modified Mayo score calculated at this visit may be used for eligibility assessment if the score is not available from the central reader.
j
On Day 1, after informed consent, study treatment should be taken from Study IM011077.
k Assessment will be performed during the PSEOT visit per protocol. Any missing data should be collected on Day 1.
Protocol Amendment No.: 01
Date: 04-Mar-2022
45
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-6:
Year 1 Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Visit Window (± n days)
14
14
14
14
3
Eligibility and Disease Assessments
Tobacco/e-Cigarette Use
X
X
X
X
X
Section 6.3.2 (Tobacco and e-
Cigarettes)
Concomitant Medication Use
X
X
X
X
X
Section 7.7 (Concomitant Therapy)
Physical Examination
Physical Examination
X
X
Section 9.4.2 (Physical Examinations)
Targeted Physical Examination
X
X
X
Section 9.4.2 (Physical Examinations)
Vital Signs (heart rate, blood 
pressure, temperature)
X
X
X
X
X
Includes body temperature and seated 
blood pressure and heart rate. Blood 
pressure and heart rate should be 
measured after the participant has been 
resting quietly for at least 5 minutes.  
Weight
X
X
X
ECG
X
X a
Section 9.4.4 (Electrocardiograms)
Blood, Urine, and Fecal Tests
Hematology and Chemistry 
X
X
X
X
X
Section 9.4.5 (Clinical Safety Labs) 
Coagulation
X
X
Section 9.4.5 (Clinical Safety Labs)
Fasting Lipid Panel and Glucose
X
Section 9.4.5 (Clinical Safety Labs) 
Protocol Amendment No.: 01
Date: 04-Mar-2022
46
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-6:
Year 1 Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Visit Window (± n days)
14
14
14
14
3
Tuberculosis Risk Assessment
X
Appendix 5 (TB)
Urine Pregnancy Test d
X
X
X
X
X
Section 9.2.5 (Pregnancy); Section 
9.4.5 (Clinical Safety Labs); Appendix 
4
Urinalysis and Urine Chemistry
X
X
X
Section 9.4.5 (Clinical Safety Labs)
Pharmacokinetic Assessments
See Table 9.5-1 for sample collection details.
Endoscopy and Endoscopic Biopsies
Endoscopy 
(colonoscopy/sigmoidoscopy) f
X
Section 9.1.1 (Endoscopies and 
Biopsies)
Protocol Amendment No.: 01
Date: 04-Mar-2022
47
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-6:
Year 1 Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Visit Window (± n days)
14
14
14
14
3
Additional Efficacy Assessments
Health-Outcomes Assessments 
Protocol Amendment No.: 01
Date: 04-Mar-2022
48
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-6:
Year 1 Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Week 12
(Day 85)
Week 24
(Day 169)
Week 36
(Day 253)
Week 48
(Day 337)
(or ET)
Final Safety Visit
(28 days after 
ET)
Notes
Visit Window (± n days)
14
14
14
14
3
Safety Assessment (in addition to the above)
SAE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 3
AE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 3
Study Treatment
Dispense Study Treatment
X
X
X
X h
deucravacitinib
Clinic Study Treatment 
Administration
X
X
X
X
Section 9.5 (Pharmacokinetics) 
Review Study Treatment 
Compliance
X
X
X
X
Section 7.6 (Treatment Compliance)
Abbreviations: AE = adverse event; 
 
 ECG = electrocardiogram; 
 
 EOT = end of treatment; ET = early termination; FSH = follicle-stimulating hormone; 
 
 
 IRT = 
interactive response technology; n = number; 
 
 SAE = serious adverse event; 
 
 TB = tuberculosis; 
 WOCBP = women of childbearing potential.
a Required only if ECG at ET is abnormal.
 
d 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 study treatment administration in WOCBP where a urine pregnancy test does not adequately exclude a clinical suspicion of 
pregnancy.
 
Protocol Amendment No.: 01
Date: 04-Mar-2022
49
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
f
h Study treatment will not be dispensed at the ET visit.
General procedural note: The protocol does not mandate specific investigations at unscheduled visits. Unscheduled visit study procedures should be based on the 
clinical judgment of the investigator.
Protocol Amendment No.: 01
Date: 04-Mar-2022
50
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-7:
Long-term Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)/ 
EOT
Visit Window (± n days)
14
14
14
14
3
Disease Assessments
Concomitant Medication Use
X
X
X
X
X
Section 7.7 (Concomitant 
Therapy)
Tobacco/e-Cigarette Use
X
X
X
X
X
Section 6.3.2 (Tobacco and e-
Cigarettes)
Physical Examination
Physical Examination
X
X
Section 9.4.2 (Physical 
Examinations)
Targeted Physical Examination
X
X
X
Section 9.4.2 (Physical 
Examinations)
Vital Signs
X
X
X
X
X
Includes body temperature and 
seated blood pressure and heart 
rate. Blood pressure and heart 
rate should be measured after the 
participant has been resting 
quietly for at least 5 minutes.  
Weight
X
X
Protocol Amendment No.: 01
Date: 04-Mar-2022
51
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-7:
Long-term Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)/ 
EOT
Visit Window (± n days)
14
14
14
14
3
ECG
X
X a
Section 9.4.4
(Electrocardiograms)
Blood, Urine, and Fecal Tests
Hematology and Chemistry
X
X
X
X
X
Section 9.4.5 (Clinical Safety 
Labs)
Coagulation
X
X
Section 9.4.5 (Clinical Safety 
Labs)
Fasting Lipid Panel and Glucose
X
Section 9.4.5 (Clinical Safety 
Labs)
Tuberculosis Risk Assessment
X
Appendix 5 (TB)
Protocol Amendment No.: 01
Date: 04-Mar-2022
52
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-7:
Long-term Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)/ 
EOT
Visit Window (± n days)
14
14
14
14
3
Urine Pregnancy Test d
X
X
X
X
X
Section 9.2.5 (Pregnancy);
Section 9.4.5 (Clinical Safety 
Labs); Appendix 4
Urinalysis and Urine Chemistry
X
X
Section 9.4.5 (Clinical Safety 
Labs)
Pharmacokinetic Assessments
See Table 9.5-1 for sample collection details.
Protocol Amendment No.: 01
Date: 04-Mar-2022
53
2.0
Approved
930162131
2.0
v
Approved
1.0
v

Clinical Protocol
IM011077
BMS-986165
deucravacitinib
Table 2-7:
Long-term Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)/ 
EOT
Visit Window (± n days)
14
14
14
14
3
Endoscopy and Endoscopic Biopsies
Endoscopy 
(colonoscopy/sigmoidoscopy) f
X
Section 9.1.1 (Endoscopies and 
Biopsies)
Additional Efficacy Assessments
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Table 2-7:
Long-term Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)/ 
EOT
Visit Window (± n days)
14
14
14
14
3
Health-Outcomes Assessments 
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Table 2-7:
Long-term Procedural Outline (IM011077) - Ulcerative Colitis
Procedure
Q1
Q2
Q3
Q4
ET
Final
Safety 
Visit (28
days 
after 
EOT or 
ET)
Notes
Year 2
Week 60
(Day 421)
Week 72 
(Day 505)
Week 84
(Day 589)
Week 96
(Day 673)
Year 3
Week 108 
(Day 757)
Week 120
(Day 841)
Week 132
(Day 925)
Week 144
(Day 1,009)
Year 4
Week 156
(Day 
1,093)
Week 168
(Day 1,177)
Week 180
(Day 1,261)
Week 192
Day (1,345)
Year 5
Week 204
(Day 
1,429)
Week 216
(Day 1,513)
Week 228
(Day 1,597)
Week 240
(Day 1,681)
Year 6
Week 252
(Day 
1,765)
Week 264
(Day 1,849)
Week 276
(Day 1,933)
Week 288
(Day 2,017)/ 
EOT
Visit Window (± n days)
14
14
14
14
3
Safety Assessments (in addition to the above)
SAE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 3
AE Assessment
X
X
X
X
X
Section 9.2 (AEs); Appendix 3
Study Treatment
Dispense Study Treatment
X
X
X
X h
deucravacitinib
Clinic Study Treatment
Administration
X
X
X
X
Section 9.5 (Pharmacokinetics)
Review Study Treatment
Compliance
X
X
X
X
Section 7.6 (Treatment 
Compliance)
Abbreviations: AE = adverse event; 
 
 
ECG = electrocardiogram; 
 EOT = end of treatment; ET = early termination; 
 
 
 IP = Investigational Product; 
n = number; 
 Q = Quarter; 
 SAE = serious adverse event; 
 
 TB = tuberculosis; 
 
 WOCBP = women of childbearing potential.
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a Required only if ECG at ET is abnormal.
 
d 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 study treatment administration in WOCBP where a urine pregnancy test does not adequately exclude a clinical suspicion of 
pregnancy.
 
f The endoscopy should be done within a 14-day window of the scheduled visit.
h Study treatment will not be dispensed at an EOT or ET visit.
General procedural note: The protocol does not mandate specific investigations at unscheduled visits. Unscheduled visit study procedures should be based on the 
clinical judgment of the investigator.
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3
INTRODUCTION
Inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and ulcerative colitis (UC), 
are chronic, remitting, and relapsing inflammatory disorders of the gastrointestinal (GI) tract. Both 
diseases are associated with significant morbidity, impact on quality of life, and healthcare 
expenditures with increasing incidence throughout the world. The etiology of IBD is multifactorial 
and includes a dysregulated mucosal immune response against commensal nonpathogenic bacteria 
of the colon, resulting in bowel inflammation.1,2
Despite the differences in pathology, the clinical presentation of CD and UC may be similar, with
patients suffering from diarrhea, rectal bleeding (RB), weight loss, and abdominal pain.3,4,5
Extra-intestinal manifestations such as uveitis, arthritis, ankylosing spondylitis, or primary 
sclerosing cholangitis may also be seen in conjunction with either CD or UC.6
The overall goal of treatment for patients with active IBD is to induce and maintain remission as 
well as to induce and maintain mucosal healing.7,8,9 Treatment consists of anti-inflammatory and 
immunomodulatory therapies that are chosen to maximize efficacy while minimizing toxicity. 
Despite advances in available therapies, there remains a substantial unmet need for novel effective 
and safe treatments for patients with moderate to severe IBD.
3.1
Study Rationale
IM011077 is an open-label, long-term extension study designed to evaluate the long-term safety 
and efficacy of deucravacitinib 6 mg twice daily (BID) in participants who have previously been 
enrolled in a Phase 2 deucravacitinib study for moderate to severe CD (Study IM011023) or 
moderate to severe UC (Studies IM011024 and IM011127). The objectives and endpoints for this 
study are listed in Section 4. The approach to analyzing study data are discussed in Section 10.
 
 
 
3.2
Background
Tyrosine kinase 2 (TYK2) is an intracellular signaling kinase that mediates cytokine-driven 
immune and proinflammatory signaling pathways that are critical in the cycle of chronic 
inflammation central to a number of immune-mediated diseases.10 TYK2-dependent pathways and 
the cytokine networks they modulate have been implicated in the pathophysiology of multiple 
immune-mediated diseases, including CD, UC, psoriasis, psoriatic arthritis, systemic lupus 
erythematosus (SLE), and spondyloarthropathies.11,12
Deucravacitinib is an orally administered selective TYK2 inhibitor with a unique mechanism of 
action with the potential to treat a wide spectrum of immune-mediated diseases.11,12
 
 
 
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Inhibition of TYK2 is expected to provide therapeutic benefit for patients with CD and UC for 
multiple reasons: 1) IL-12 and IL-23 have been implicated in the pathogenesis of these 
diseases13,14,15; 2) ustekinumab, a biologic targeting IL-12/IL-23p40, has been approved for the 
treatment of CD16 and UC 17 (other biologic agents that target IL-23p19 are in clinical development 
and have shown promising results in CD and UC18,19,20); and 3) deucravacitinib has shown 
positive results in psoriasis and psoriatic arthritis, IL-23-mediated diseases, in recent Phase 2 and 
Phase 3 studies.21,22
 
 
 
 
 
Three Phase 2 clinical studies are ongoing to determine the safety and efficacy of deucravacitinib
in CD and UC:

Study IM011023 is a multicenter, Phase 2, randomized, double-blind, placebo-controlled 
clinical study designed to assess the safety and efficacy of oral deucravacitinib 6 mg BID and 
3 mg BID compared with placebo in participants with moderate to severe CD.

Study IM011024 is a multicenter, Phase 2, randomized, double-blind, placebo-controlled 
clinical study designed to assess the safety and efficacy of oral deucravacitinib 6 mg BID 
compared with placebo in participants with moderate to severe UC.

Study IM011127 is multicenter, Phase 2, randomized, double-blind, placebo-controlled 
clinical study designed to assess the safety and efficacy of oral deucravacitinib 12 mg BID and
6 mg BID compared with placebo in participants with moderate to severe UC.
Studies IM011023 and IM011024 include a double-blind placebo-control period of 52 weeks 
followed by a 52-week open-label extension (OLE) period. Study IM011127 includes a 12-week 
double-blind control period followed by a 40-week OLE period. Deucravacitinib is dosed at 6 mg 
BID in all parent study OLE periods.
3.2.1
Nonclinical Toxicology
A comprehensive battery of nonclinical toxicology studies were completed in compliance with the 
International Council for Harmonisation guidelines and good laboratory practice regulations to 
fully assess the toxicologic profile of deucravacitinib. Key findings are briefly summarized below, 
and the additional toxicology results are listed in the Investigator’s Brochure (IB).24

Deucravacitinib was tolerated at all doses in rats (75 mg/kg for 1 month; 15 mg/kg for 
3 months; and 50 mg/kg for 6 months [106area under the concentration-time curve 
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(AUC) multiple]).
 
 
 
 All changes were reversible 
except for the decreased food consumption body weight and spleen weights, and nonadverse 
increased incidence of macrophage aggregation in the lung. 
 

In repeat-dose (3 months) oral toxicity studies in monkeys, deucravacitinib was tolerated at
all doses (5 mg/kg). In the 9-month monkey toxicity study with a 2-month recovery, the main
findings at all doses (1 mg/kg, 3AUC multiple) included generally dose-dependent and
various skin changes (swollen, dry, lesion, flaking, papule, red, white, scab) throughout the
body, 

Deucravacitinib was not genotoxic or phototoxic, was not a human skin or ocular irritant, was
not a sensitizer in a mouse local lymph node assays, and was well tolerated at all doses in the
single-dose oral studies in rats, dogs, and monkeys.

Deucravacitinib was not carcinogenic in rasH2 transgenic mice when dosed orally at doses
≤60 mg/kg (≤ 80× AUC multiple) or in rats at doses ≤ 15 mg/kg (≤ 22× AUC multiple).

There was no evidence of teratogenicity or effects on embryo-fetal development in pregnant
rats (≤ 75 mg/kg; ≤ 115× AUC multiple) and rabbits (≤ 10 mg/kg; ≤ 39×/8× total/free-fraction
AUC multiples).
In summary, the totality of the nonclinical toxicity assessments demonstrate that deucravacitinib
has an acceptable dose-related nonclinical safety profile with findings that are fully reversible or 
trending toward recovery, clinically monitorable, and manageable.
3.2.2
Early Clinical Experience
The clinical data available to date supporting the safety of deucravacitinib are from 12 completed 
Phase 1 studies of deucravacitinib in healthy volunteers (Studies IM011002, IM011015, 
IM011016, IM011019, IM011025, IM011031, IM011039, IM011045, IM011048, IM011067, 
IM011068, and IM011071), and completed Phase 2 (Study IM011011) and Phase 3 (Study 
IM011046) studies in adult participants with moderate to severe plaque psoriasis.
The following deucravacitinib studies are currently ongoing: Phase 2 studies in CD (Study 
IM011023), UC (Studies IM011024 and IM011127), SLE (Studies IM011021 and IM011074), 
lupus nephritis (Study IM011073), and psoriatic arthritis (Study IM011084); and Phase 3 studies 
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in psoriasis (Studies, IM011047, IM011065, IM011066, and IM011075), studying dose regimens 
up to deucravacitinib 6 mg BID or 12 mg once daily (QD) orally (PO).
In the Phase 1 trials of deucravacitinib, acneiform skin reactions, including folliculitis lesions, 
have been observed. The reactions appear to be dose related, 
 
 All of the reactions have been mild or moderate, nonserious, and reversible and 
have rarely led to discontinuation of study treatment. There have been no signs or symptoms of 
circulatory or respiratory impairment and no suggestions of a systemic hypersensitivity reaction. 
The acneiform skin reactions requiring treatment have been well managed with topical treatment 
such as benzoyl peroxide cream, clindamycin solution, chlorhexidine ointment, salicylic acid 
ointment, or retinoid gel. The mechanism(s) behind the acneiform dermatitis is not currently 
known. Other than these skin findings, there have not been other significant adverse events (AEs)
that have been consistently observed with deucravacitinib.
Deucravacitinib was shown to be effective in Phase 2 studies of moderate to severe plaque 
psoriasis (IM011011) and psoriatic arthritis (IM011084), both diseases considered to be IL-
23-mediated diseases.25 The most common AEs reported in the overall study population in Study 
IM011011 were nasopharyngitis, upper respiratory tract infection, headache, diarrhea, and nausea. 
Overall, the majority of the AEs were mild or moderate in intensity. An increased occurrence of 
mild to moderate acne was observed in the deucravacitinib treatment groups compared with 
placebo and were manageable with topical medications as needed and did not result in 
discontinuation. Treatment was also generally well-tolerated in the Phase 2 psoriatic arthritis
study, and the safety and laboratory parameter profile of deucravacitinib was consistent with that 
observed in the Phase 2 psoriasis study.
Deucravacitinib was generally well-tolerated across all studies, and no safety issues have been 
identified to limit the investigation of deucravacitinib in further clinical studies.
A detailed description of the chemistry, pharmacology, efficacy, and safety of deucravacitinib is 
provided in the IB.24
3.2.2.1
Deucravacitinib Dose Regimen Studies
Several studies of deucravacitinib have been conducted using single- or multiple-dose regimens of 
deucravacitinib 6 mg BID PO or higher. These studies demonstrated that deucravacitinib has a 
favorable pharmacokinetic (PK) profile characterized by consistent oral absorption, dose-related 
increase in exposure, no evident time dependency, and no clinically significant food effect.
Drug-drug interaction (DDI) studies showed no impact on exposure to rosuvastatin and did not 
meaningfully alter the exposures to methotrexate, mycophenolate mofetil, and oral contraceptives 
like ethinyl estradiol and norethindrone. Finally, in a study evaluating the cardio dynamic effects 
of deucravacitinib, no clinically relevant effect on heart rate or on electrocardiogram (ECG) 
parameters was observed.
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3.3
Benefit/Risk Assessment
Multiple lines of evidence suggest that inhibition of TYK2 signaling by deucravacitinib may be 
beneficial in patients with active CD or UC.
Deucravacitinib is being developed as an oral treatment for CD, UC, psoriasis, psoriatic arthritis, 
SLE, and lupus nephritis. Based on its mechanism of action as an inhibitor of TYK2-mediated 
signaling pathways downstream of well-characterized pharmaceutical targets for the treatment of 
CD and UC, 
 it is anticipated that participants with IBD may
benefit from treatment with deucravacitinib.
 
 
 
 
The eligibility criteria, efficacy assessments, 
 for this study are aligned
with Studies IM011023, IM011024 
 
 
 
 
 
 
 
 
Close safety monitoring for this study, which is designed to expedite the 
detection of treatment-emergent AEs (TEAEs), is described in Section 9.4.
Deucravacitinib is an immunomodulatory Investigational Product
(IP) and a potential 
immunosuppressant. The inclusion (Section 6.1) and exclusion (Section 6.2) criteria have been 
designed to minimize the risk for serious infections and malignancies. The study has been designed 
with study visits that allow for close monitoring of study participants’ safety throughout the 
duration of the study, and additional data collection will be triggered if any AEs of interest (AEIs)
are observed in this study.
In addition to comprehensive monitoring of safety with oversight by the investigators, Medical 
Monitors from BMS, and the BMS Safety Physician, the safety of participants will also be 
monitored by an independent Data Monitoring Committee (DMC). Furthermore, all participants
may remain on permitted background standard-of-care (SOC) therapy.
The global coronavirus disease 2019 (COVID-19) pandemic has been identified as a potential risk 
to clinical trial participants in general, and it may particularly affect individuals with underlying 
chronic diseases.
 
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The individual benefit-risk 
considerations 
regarding 
COVID-19 
infection 
remains 
the 
responsibility 
of 
the 
investigator. Testing to exclude COVID-19 infection prior to enrollment and to inform decisions 
about subject care during the study should follow local standard practice and requirements. Study 
treatment must be interrupted in the context of clinical suspicion for COVID-19, or a positive 
diagnostic test for SARS-CoV-2 (Section 8.1.1), and requires recovery of a COVID-19 infection, 
 In 
order to facilitate reporting of COVID-19 events that occur during the study, all AEs and serious 
AEs (SAEs) related to SARS-CoV-2 or COVID-19 must be reported from the time of consent
(Section 9.2.1). In addition, such AEs or SAEs will trigger additional data collection through 
specialized electronic case report form (eCRF) pages, which will allow the Sponsor to further 
evaluate these events (Section 9.2.8).
Participants in IBD clinical trials may experience an increase in disease activity (ie, disease 
exacerbation or a “flare”) during their participation. This protocol contains detailed criteria for 
treatment failure (Section 5.1.4) and detailed discontinuation criteria (Section 8) to assist 
investigators in the recognition and management of treatment failure within the study. SOC rescue 
therapy can be initiated at any time, at the investigator’s discretion (Section 5.1.4).
At the maximum concentrations expected in this study (in portal vein or systemic circulation, as 
appropriate), the potential for DDIs involving cytochrome P450 (CYP450) enzymes and most 
transporters is low. Deucravacitinib has low turnover in in vitro metabolism studies, and several 
enzymes are involved in its metabolism. Deucravacitinib is not an inhibitor or inducer of CYP450 
enzymes at the expected clinical concentrations. Therefore, the potential for DDIs resulting from 
deucravacitinib–induced CYP450 inhibition or induction is low.
DDI studies have also shown that although deucravacitinib is a substrate of the efflux transporters
breast cancer resistance protein (BCRP) and permeability glycoprotein, and hepatic uptake 
transporter OCT1, there is low impact on the exposures of potential concomitant medications that 
are BCRP substrates, such as rosuvastatin. Additionally, data from a study evaluating the impact 
of deucravacitinib in women taking oral contraceptives found no impact on exposure of ethinyl 
estradiol or norethindrone. These studies are detailed in the IB.24
The reproductive toxicology studies for deucravacitinib are complete; these are detailed in the 
IB.24 Briefly, deucravacitinib is not genotoxic. Deucravacitinib was neither teratogenic nor 
fetotoxic, and it had no effect on female or male rat reproductive parameters (mating, fertility, and 
sperm morphology) in reproductive and developmental toxicity studies in rats and/or rabbits. 
These findings support the contraception requirements for this study.26
 
 
 Early detection of common TEAEs 
observed in previous studies and the minimum of 40 weeks of prior exposure to deucravacitinib in 
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the parent studies suggest that this study can be performed safely with appropriate precautions in 
place. In addition, multiple early-phase studies that characterize the safety profile of 
deucravacitinib are now complete, including a thorough QT/QTc study, multiple DDI studies, and
reproductive toxicology studies. Taken together, the benefit-risk profile supports exploration of 
the long-term efficacy, tolerability, 
 of deucravacitinib 6 mg BID PO in 
this study.
More detailed information about the known and expected benefits and risks and reasonably 
anticipated AEs of deucravacitinib may be found in the IB.24
4
OBJECTIVES AND ENDPOINTS
Table 4-1:
Objectives and Endpoints - Crohn’s Disease
Objective
Endpointa
Primary

To assess the safety and tolerability of long-term 
use of deucravacitinib in participants with 
moderate to severe CD.

Number and proportion of participants experiencing 
AEs, SAEs, AEs leading to study discontinuation, and 
AEIs.

Number and proportion of participants experiencing 
abnormalities in laboratory testing, ECG, and vital 
sign parameters over time.

Changes from Day 1 for laboratory testing, ECG, and 
vital signs.
Exploratory
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Table 4-1:
Objectives and Endpoints - Crohn’s Disease
Objective
Endpointa
Abbreviations: AE = adverse event; AEI = adverse event of interest; CD = Crohn’s disease; ECG = electrocardiogram; 
 
 
 
 
 
 
 
 SAE = serious adverse event; 
a See Section 10.4.1.1 for the definition of baseline for efficacy assessments.
Table 4-2:
Objectives and Endpoints - Ulcerative Colitis
Objective
Endpoint a
Primary

To assess the safety and tolerability of long-term 
use of deucravacitinib in participants with moderate
to severe UC.

Number and proportion of participants experiencing 
AEs, SAEs, AEs leading to study discontinuation, 
and AEIs.

Number and proportion of participants experiencing 
abnormalities in laboratory testing, ECG, and vital 
sign parameters over time.

Changes from baseline for laboratory testing, ECG, 
and vital signs.
Exploratory
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Table 4-2:
Objectives and Endpoints - Ulcerative Colitis
Objective
Endpoint a
Abbreviations: AE = adverse event; AEI = adverse event of interest; ECG = electrocardiogram; 
 
 SAE = serious adverse event; 
 
 UC = ulcerative colitis; 
a See Section 10.4.1.1 for the definition of baseline for efficacy assessments.
Table 4-3:
Selected Endpoint Definitions
Endpoint
Definition
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Table 4-3:
Selected Endpoint Definitions
Endpoint
Definition
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Table 4-3:
Selected Endpoint Definitions
Endpoint
Definition
 
 
 
 
 
 
 
5
STUDY DESIGN
5.1
Overall Design
This is an open label, multi-center study to evaluate the long-term safety and tolerability of 
deucravacitinib in participants with moderate to severe CD or moderate to severe UC who have 
completed one of the applicable parent studies (IM011023, IM011024, or IM011127), are likely 
to safely derive a clinical benefit from ongoing treatment with deucravacitinib, and are willing and 
able to participate. Participants will receive deucravacitinib 6 mg BID PO in a tablet formulation.
The duration of the study is approximately 296 weeks (2,072 days) as follows:

Qualification and enrollment: up to 28 days (Section 5.1.2 [Treatment Period])
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
Open-label study period: 288 weeks (2,017 days)

Post-treatment follow-up period: 4 weeks (28 days; Section 5.1.3 [Follow-up Period])
The study design schematic is presented in Figure 5.1-1.
Figure 5.1-1:
Study Design Schematic
Abbreviations: BID = twice daily; BMS-986165 = deucravacitinib; DB = double-blind; EOT = end of treatment; F/U
= follow-up; OLE = open-label extension; Q12W = every 12 weeks.
Physical exams, clinical laboratory evaluations, and other assessments, including the collection of 
blood 
 for 
 PK analysis, will be done at select visits during the 
study. Participants will be closely monitored for AEs throughout the study.
Blood samples will be collected prior to study treatment administration for PK analysis.
Unscheduled visits will be allowed throughout the study period as needed for additional safety 
monitoring.
Throughout the study, participants who permanently discontinue study treatment prior to Week 
288 are expected to be followed for protocol-specified follow-up procedures at the Final Safety 
Visit (4 weeks after the last dose of IP).
Blood samples will be collected prior to study treatment administration for PK analysis.
5.1.1
Qualification and Enrollment into Study
At the end of treatment visit for the parent IBD study (ie, Studies IM011023, IM011024, and 
IM011127), the end of treatment procedures will be performed per protocol. Participants who 
successfully complete the protocol-required treatment period with an acceptable safety profile, are 
in clinical response or clinical remission, and who have no worsening on endoscopy by Simple 
Endoscopic Score for CD (SES-CD)
or Mayo endoscopic subscore (Appendix 13)
from the parent study baseline (as assessed by local read) may be eligible to participate in Study
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IM011077. The end of treatment visit for the parent IBD study will also be the baseline visit (Day 
1) of Study IM011077.
Prior to enrollment into Study IM011077, the investigator will evaluate whether the participants 
remain qualified for continued long-term participation based on the inclusion and exclusion criteria 
listed in Section 6 (Study Population).
Participants entering Study IM011077 will not be expected to complete the 
 safety 
follow-up period of the parent study and are expected to transition into Study IM011077 from the 
end of treatment visit of the parent study. If same-day transition does not occur between the parent 
study end of treatment and Day 1 of Study IM011077, participants must enter the study within 
 (see below for exceptions) of the end of treatment visit of the parent study. The end of 
treatment assessments should be repeated as indicated in Section 2 (Schedule of Activities). The 
only exception to this 
is when the delay is due to clinical or regulatory issues 
(eg, resolution or treatment for an otherwise exclusionary AE, clinical laboratory value, or delayed 
Institutional Review Board [IRB]/Independent Ethics Committee [IEC] approval), investigators 
must discuss a participant’s continued participation with the BMS Medical Monitor/designee prior 
to enrolling the participant.
Relevant laboratory and endoscopy data, along with clinical and patient-reported outcome (PRO)
assessments from the end of treatment visit in the parent study will constitute the baseline measures 
for Study IM011077 (see Section 10.4.1.1 [Definition of Baseline] for a full description of how 
baseline will be derived for efficacy parameters). Depending on the timing of when a participant 
enters Study IM011077 (ie, visit window), these procedures may or may not be repeated at the
Day 1 visit as indicated in Section 2 (Schedule of Activities). The data from this visit will be 
entered into both the parent study and Study IM011077 databases (eg, eCRFs). Any assessments 
specific to Study IM011077 must be performed after the informed consent and prior to
dispensation of study treatment.
5.1.2
Treatment Period
At the Day 1 study visit, participants who have met the eligibility criteria for this study will be
assigned a unique study identification number (Section 7.2 [Method of Treatment Assignment]) 
and study treatment will be dispensed. On Day 1, after the informed consent is obtained, study 
treatment should be taken at the site from Study IM011077. 
Prior to each scheduled visit, the participant 
 should be reviewed to ensure 
 
 stool frequency (SF)
and RB data 
for participants with UC. Prior to each scheduled visit at 
which Mayo scores are to be calculated, study personnel should ascertain whether an adequate 
number of days 
 have been made. If adequate 
 have not been made, the site 
should contact the participant to reschedule the visit (within the allowed 
) to 
allow time for a sufficient number 
 for endpoint assessments, and the 
participant should be counseled about proper study procedures.
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It is recommended that the 
endoscopy be done as close as possible to the relevant visit.
If a colonoscopy is performed at the end of treatment visit of the parent study, colonoscopy will 
be the preferred endoscopic procedure for subsequent endoscopies within the study. This approach 
will facilitate comparison between the individual colonic segments assessed at the Day 1 visit and 
subsequent assessments.
Discontinuation criteria are detailed in Section 8. Participants who temporarily discontinue study 
treatment will remain in the study and continue to participate in study procedures (Section 8.1.1).
Participants who permanently discontinue study treatment will complete an early termination (ET) 
visit and must enter the 4-week post-treatment follow-up period and complete the final safety visit.
5.1.3
Follow-up Period
Participants who complete the treatment period (ie, Week 288) or permanently discontinue study 
treatment at any time during the study (Section 8) will enter a 4-week post-treatment follow-up
period and complete the final safety visit.
5.1.4
Treatment Failure
For the purpose of this study, treatment failure will be defined as:
1) Requirement for
 over the course of a participant’s time 
on study due to increased CD or UC activity, 
 
 
 
 
2) Requirement for an alternative, efficacious therapy for CD or UC (eg, initiation of biologics, 
prednisone (or equivalent)
 daily).
OR
3) Participants with CD with a loss of response at 
with loss 
of response defined as:
 
OR
4) Participants with UC with disease worsening at 
 apart, with a 
worsening of clinical disease activity defined as:
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5) Participants requiring a
 symptoms. 
5.1.5
Data Monitoring Committee and Other External Committees
An external, independent DMC will provide oversight on the safety of trial participants within this 
study. The DMC will regularly review accumulating data from this study and advise the Sponsor 
regarding the continuing safety of trial participants, as well as the continuing validity and scientific 
merit of the trial.
Data summaries and listings will be provided to the DMC to facilitate their safety assessment at 
regularly scheduled meetings and on an ad hoc basis if needed. The DMC will also be provided 
with suspected, unexpected serious adverse reaction (SUSAR) reports relating to deucravacitinib
and recommendations from other DMCs supporting the deucravacitinib clinical development
program.
Regular DMC safety reviews will include all AEs, SAEs, and AEIs. Based on their review of safety 
data, the DMC will make recommendations regarding the appropriateness of continuing the study, 
with or without study modifications, or stopping the study. The DMC may request select efficacy 
data from the blinded parent studies for benefit-risk assessment and study continuation.
Additional details on the DMC’s processes and procedures will be outlined in the DMC Charter.
5.2
Number of Participants
Approximately 300 participants are expected to rollover from the parent studies into Study 
IM011077. All participants must have completed 1 of the parent studies (Studies IM011023, 
IM011024, or IM011127) and must meet all eligibility criteria as specified in Section 6.1
(Inclusion Criteria) and Section 6.2 (Exclusion Criteria).
5.3
End-of-Study Definition
The start of the trial is defined as the first visit for the first participant enrolled. End of trial is 
defined as the last scheduled procedure shown in Section 2 (Schedule of Activities). Study 
completion is defined as the final date on which data were or are expected to be collected.
 
5.4
Scientific Rationale for Study Design
This is an open-label, multicenter study to evaluate the long-term safety and efficacy of 
deucravacitinib 6 mg BID in participants with moderate to severe UC and moderate to severe CD.
Deucravacitinib acts by inhibiting TYK2, a protein involved in IL-12 and IL-23 signaling, in 
addition to Type I IFN signaling. Deucravacitinib allosterically inhibits the kinase activity of 
TYK2 by binding to the regulatory pseudokinase JH2 domain, which prevents receptor-stimulated 
activation of TYK2.12,27 The TYK2 locus is associated with IBD in genome-wide association 
studies.28 Carriage of a naturally occurring variant in TYK2 is associated with a reduced risk of 
IBD.23,29
 
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The IL-12/IL-23 axis has been implicated in the pathogenesis of IBD in humans,14 as described in 
Section 3.2 (Background). These data from antibodies under development13,19,20 and the 
commercial availability of ustekinumab16,17,30 provide proof of concept that IL-23 inhibition 
(either alone or together with IL-12 inhibition) is likely to be therapeutically beneficial in patients 
with active CD or UC. Providing an opportunity for participants who are likely to derive benefit 
from long-term dosing with deucravacitinib to continue into this study will allow further evaluation 
of the long-term safety and efficacy in this patient population.
As a long-term safety and efficacy study, the intent is to assess both the safety and tolerability of 
long-term exposure to deucravacitinib and the maintenance of clinical response and other efficacy 
endpoints seen in the parent studies. This study will estimate the effect of deucravacitinib on 
efficacy using standard CD and UC efficacy instruments to determine eligibility and assess 
efficacy (Section 9.1).31,32,33 Disease activity eligibility criteria are clearly defined in Sections 6.1
and 6.2.
 
This 
approach is intended to maximize the efficacy data acquired in this study. Design elements in the 
current study, namely inclusion/exclusion criteria and safety and efficacy assessments, are based 
on the design of the phase 2 parent studies. This is designed to facilitate both separate and 
integrated analyses of exposure/clinical response and exposure
response, which may 
inform the selection of a deucravacitinib regimen to be evaluated in an adequately powered Phase 3 
clinical trial program.
Section 3.3 contains an additional discussion on the benefit-risk profile of this study.
Justification of the dose levels used in this study is discussed in Section 5.5.
The rationale for the study’s sample size is discussed in Section 10.1.
5.5
Justification for Dose
The recommended 6-mg BID dose is based on the current understanding of the PK/PD relationship 
for deucravacitinib. 
 Additional assessments based 
on competitor IL-12 and IL-23 antibodies also support higher and more frequent dosing to provide 
robust efficacy. The recommended dose is based on implementation of appropriate safety margins 
and is within the range of doses tested in the first-in-human study, Phase 2 psoriasis and other 
indications, and is also within margins based on comparisons of systemic exposure and body 
surface area.
The following points were considered for dose selection:
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1) The data from preclinical studies of deucravacitinib that showed an exposure-response 
relationship between deucravacitinib PK, target engagement assays, and efficacy indicators of 
interest in animal models of IBD.
2) CD, UC, and psoriasis are all highly dependent upon the IL-17/IL-23 pathway.35 Thus, the 
observed efficacy and dose response observed in psoriasis are assumed to be informative for 
dose selection in CD and UC. 
 
 
 
 
 
 
 
 
 Additionally, other IL-12/IL-23 inhibitor antibodies (ustekinumab and 
risankizumab) have also demonstrated that higher dose and more frequent dosing is required 
for IBD relative to the dosing in psoriasis. The preclinical data and competitive data support a 
higher dose (6 mg/day) and more frequent dosing (BID dosing) of deucravacitinib in IBD 
patients.
3) The PK properties and target engagement assessment in healthy volunteers were also used to 
inform the dose selection. 
 
 
4) All participants entering this study (Study IM011077) from the parent studies will have 
received deucravacitinib at 6 mg BID for a minimum of 
 weeks (Study IM011127) up to 
weeks (Studies IM011023 and IM011024) prior to entering. With eligibility dependent on 
participants’ demonstration of clinical response at the end of the parent study with an 
acceptable safety profile, continuing participants at this dose for the long-term extension would 
be appropriate.
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 Study IM011077 and must have the ability to 
sign the informed consent form.
b) Willing and able to complete all study specific procedures and visits.
2) Type of Participant and Target Disease Characteristics
a) Previously completed OLE treatment in 1 of the parent CD or UC studies;
b) Be in clinical response or clinical remission at Week 104 of Study IM011023 or Study 
IM011024, or Week 52 of Study IM011127;
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i)
Evidence of clinical response or clinical remission (compared with baseline in the 
parent study) as defined by CDAI (refer to Table 4-3
) or modified 
Mayo score (refer to Table 4-3 and Appendix 13);
AND
ii) No worsening of endoscopy (by SES-CD [refer to 
or Mayo endoscopic 
subscore [refer to Appendix 13]) from the parent study baseline (as assessed by local 
read).
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.
a) Female Participants
i)
Females, age 18 or local age of majority and older at the time of enrollment.
ii) Women who are not of childbearing potential 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 highly sensitive 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.
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) For additional requirements for pregnancy testing during and after study intervention,
see 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)WOCBP must agree to follow instructions for method(s) of contraception defined in 
Appendix 4 and as described below and included in the ICF.
viii)
WOCBP are permitted to use hormonal contraception methods as described in 
Appendix 4.
ix) A female participant is eligible to participate if she is not pregnant or breastfeeding and 
at least one of the following conditions applies:
(1) Is not a WOCBP,
OR
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(2) Is a WOCBP and using a contraceptive method(s) as described in Appendix 4, 
during the treatment period (at a minimum until after the last dose of study 
treatment).
b) Male Participants
i)
Males, age 18 or local age of majority and older at the time of enrollment.
ii) Male participants should maintain their usual practice with regard to contraception (if 
any); however, no specific contraceptive measures are required.
6.2
Exclusion Criteria
1) Medical Conditions
a) Women who are pregnant or breastfeeding.
b) Not applicable per Global Protocol Amendment 01.
2) Gastrointestinal Exclusion Criteria
a) Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end 
of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study 
that has not been eradicated. 
A participant with adenomatous polyps may be eligible if the polyps have been completely 
removed (documented) and the participant is free of polyps at enrollment (Day 1).
A participant with mucosal dysplasia may be eligible if the dysplasia has been completely 
removed/resected/eradicated (as applicable, documented), and the participant is free of 
dysplasia at enrollment (Day 1). This should be discussed with the BMS Medical 
Monitor/designee prior to enrollment.
Participants must be current with surveillance for dysplasia and screening for colorectal 
cancer (based on local guidelines).
3) Immune and Infectious Disease Exclusion Criteria
a) Known serious infection, defined as any infection requiring hospitalization or treatment 
with parenteral (intramuscular [IM] or IV) antimicrobial agents (eg, antibiotics, antiviral, 
antifungal, or antiparasitic agents) within 
 of the first dose of study treatment.
Antibiotics used to cover a procedure such as endoscopy would not exclude the participant.
Prophylactic antibiotic use should be discussed with the BMS Medical Monitor/designee.
Additionally, in the case of prior SARS-CoV-2 infection, symptoms must have resolved and,
based on investigator assessment in consultation with the BMS Medical Monitor/designee, 
there are no sequelae that would place the participant at a higher risk by receiving 
investigational treatment.
b) Not applicable per Global Protocol Amendment 01. 
4) Prior/Concomitant Therapy
Prohibited concomitant medications are further detailed in Section 7.7.1. Participants 
must also comply with the protocol requirements for restricted concomitant medications in 
Section 7.7.2 and permitted medications in Section 7.7.3.
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a) Have received any of the following therapies since the first dose of study treatment in the 
parent study or before Day 1 in Study IM011077:
i)
Treatment with an immunomodulatory or biologic agent for the treatment of IBD.
ii) Treatment with an investigational agent other than deucravacitinib.
iii) Treatment 
with
D-penicillamine, 
leflunomide, thalidomide, 
S1P 
inhibitors 
(eg, ozanimod, fingolimod, and etrasimod), or JAK inhibitors (eg, tofacitinib, 
upadacitinib, and filgotinib).
b) Are currently receiving or require initiation of any of the following therapies:
i)
Treatment with corticosteroids at a dose that exceeds the prednisone equivalent of 
 for adrenal insufficiency.
ii) Treatment with immunomodulatory agents (eg, azathioprine, 6-mercaptopurine, or 
methotrexate).
c) Treatment with a live vaccine or live attenuated vaccine within 
 prior to Visit 1 of 
this trial.
Not applicable per Global Protocol Amendment 01.
Not applicable per Global Protocol Amendment 01.
Not applicable per Global Protocol Amendment 01.
d) Not applicable per Global Protocol Amendment 01.
e) Prophylactic antibiotic use should be discussed with the BMS Medical Monitor/designee. 
5) Physical and Laboratory Test Findings
a) Evidence of active or latent tuberculosis (TB; see Section 9.4.6)
Participants diagnosed with latent TB infection (LTBI) in the parent study are eligible to 
continue in this study if (1) there are no current signs or symptoms of active TB, (2) the 
participant has received adequate documented treatment for LTBI within 5 years of 
screening in the parent study.
b) Evidence of active hepatitis B virus (HBV) infection as defined in
 
 
c) Not applicable per Global Protocol Amendment 01.
d) Not applicable per Global Protocol Amendment 01.
e) Clinically significant abnormalities in laboratory testing at the second to last visit in the 
parent study or most current result available prior to Day 1 including (but not limited to):
i)
Hematology:
(1) Hemoglobin level 
g/dL 
(2) White blood cell (WBC) count 
 × 109/L (< 3000/mm3)
(3) Lymphocyte count 
 × 109/L (< 750/mm3)
(4) Neutrophil count 
 × 109/L (< 1000/mm3)
(5) Platelet count 
 × 109/L (< 100,000/mm3)
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ii) Renal Function:
(1) Serum creatinine > 2 × upper limit of normal (ULN) or renal impairment based on 
an estimated glomerular filtration rate < 45 mL/min/1.73 m2 (calculated using the 
Modification of Diet in Renal Disease equation)
iii) Liver-related Blood Tests and Liver Function:
(1) Serum alanine aminotransferase (ALT) > 2 × ULN
(2) Serum aspartate aminotransferase (AST) > 2 × ULN
(3) Serum total bilirubin > 1.5 × ULN 
Participants with total bilirubin > 1.5 × ULN who have a confirmed diagnosis of 
Gilbert’s syndrome are not excluded from this study but must be discussed with the 
BMS Medical Monitor/designee.
(4) Alkaline phosphatase (ALP) > 1.5 × ULN
f)
Any other findings on physical examination, vital signs, or clinical laboratory testing that, 
in the opinion of the investigator, may place the participant at an unacceptable risk for 
participation in this study.
6) Allergies and Adverse Drug Reaction
a) History of any significant drug allergy (eg, anaphylaxis) or significant adverse drug 
reaction (eg, hepatotoxicity).
7) Other Exclusion Criteria
a) Participants with cancer screening or surveillance that is suspicious for malignancy, or 
where the possibility of malignancy cannot be reasonably excluded after additional clinical, 
laboratory, or other diagnostic evaluations. Participants with non-melanoma skin cancer 
are not excluded.
b) Class III or IV congestive heart failure, as classified by the New York Heart Association 
(NYHA) Functional Classification or any recent onset of heart failure resulting in NYHA 
Class III/IV symptoms.
c) Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and/or any 
history of significant cerebrovascular disease (eg, stroke, cerebral hemorrhage, transient 
ischemic attack) within 24 weeks before enrollment.
d) Known history of hereditary galactose intolerance, total lactase deficiency, or glucose-
galactose malabsorption.
e) Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific 
circumstances and only in countries where local regulations permit, a person who has been 
imprisoned may be included or permitted to continue as a participant. Strict conditions 
apply, and Bristol-Myers Squibb approval is required.
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.
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6.2.1
Enrollment Criteria
Participants must meet the following criteria at the enrollment visit on Day 1 in order to be eligible 
to be enrolled into Study IM011077 and to receive the first dose of deucravacitinib on this study:
1) The participant continues to meet the inclusion criteria, listed in Section 6.1.
2) The participant continues to not meet any of the exclusion criteria, listed in Section 6.2.
3) The participant has discontinued any prohibited treatments (Section 7.7.1).
6.3
Lifestyle Restrictions
Participants are required to fast for a minimum of 
 before the enrollment visit (Day 1), 
 because fasting lipid 
panel and glucose samples will be obtained at these visits.
6.3.1
Meals and Dietary Restrictions
Study treatment may be taken without regard to meals.
6.3.2
Tobacco and e-Cigarettes
Smoking can have an influence on the severity of IBD disease symptoms. Consequently, use of 
tobacco products will be assessed at each study visit. Use of a nicotine patch or other nicotine 
supplements should be recorded as concomitant medication.
6.3.3
Activity
No activity restrictions are required.
6.4
Enrollment Failures
Enrollment failures are defined as participants who consent to participate in the clinical study but 
who are not subsequently entered in the study/included in the analysis population. A minimal set 
of enrollment failure information is required to ensure transparent reporting of enrollment failure 
participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing 
requirements, as applicable, and to respond to queries from regulatory authorities. Minimal 
information includes date of consent, demography, enrollment failure details, eligibility criteria, 
and any SAEs.
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 
Non-investigational [Medicinal] Product (Non-IP/Non-IMP) and can consist of the following:

IP

Deucravacitinib
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An IP, also known as IMP in some regions, is defined a pharmaceutical form of an active substance 
or placebo being tested or used as a reference in a clinical study, including products already with 
a marketing authorization but used or assembled (formulated or packaged) differently 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 SOC for a given diagnosis, may be considered as Non-IP.
Table 7-1:
Study Treatments for Study IM011077
Product Description/ 
Class and Dosage Form
Potency
IP/Non-
IP
Blinded or 
Open 
Label
Packaging/ 
Appearance
Storage Conditions
(per label)
Deucravacitinib (BMS-
986165) oral tablet
6 mg
IP
Open label
Bottles 
containing 
tablets
Store at 15°-25°C in a 
tightly closed container
and protected from 
light
Abbreviation: IP = Investigational Product.
7.1
Treatments Administered
Participants will take deucravacitinib 6 mg BID by taking 1 tablet in the morning and 1 tablet in 
the evening. Study treatment will be supplied in bottles containing 
 tablets. Bottles are to be 
stored at 15°C to 25°C in a tightly closed container and protected from light.
The selection and timing of dose for each participant is as follows:
Table 7.1-1:
Selection and Timing of Dose
Study Treatment
Unit Dose 
Strength(s)/Dosage 
level(s)
Dosage Formulation
Frequency of 
Administration
Route of Administration
6 mg BID 
Deucravacitinib
(BMS-986165)
6 mg
1 active tablet in the 
morning; 1 active tablet 
in the evening
Oral
Abbreviation: BID = twice daily.
Deucravacitinib can be administered with or without food, and there are no precautions or 
restrictions to the administration of antacids with deucravacitinib.
7.2
Method of Treatment Assignment
All participants will be assigned to treatment using an Interactive Response Technology (IRT). 
Before the study is initiated, each user will receive login information and directions on how to 
access the IRT.
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At the time of the first visit in Study IM011077, immediately after informed consent is obtained 
and before any study-related procedures are performed, the investigative site will access the 
enrollment option of the IRT system for assignment of a participant number for all participants 
into the open-dose panel. Enrolled participants, including those not dosed, will be assigned 
sequential participant numbers starting with 
 The
participant identification number (PID) will be comprised of a 4-digit site number and 5-digit 
participant number. For example, the first participant enrolled at site number 1 will have a PID of 
. The participant number will not be used for any other participant. For continuity 
purposes, the participant number from the parent study will be recorded for each participant 
enrolled in IM011077.
Study treatment will be dispensed at the study visits as listed in Schedule of Activities (Section 2).
7.3
Blinding
This is a nonrandomized, open-label study; blinding procedures are not applicable.
7.4
Dosage Modification
There is no provision for dose modification of study treatment. Dose modification of study 
treatment may be allowed for safety reasons or if recommended by the independent DMC. Such 
cases will be discussed with the BMS Medical Monitor/designee prior to any study treatment 
modification.
Modification of permitted CD or UC treatments or dose regimens is allowed for safety reasons, or 
if a participant experiences an AE attributable to that treatment. Participants should continue to 
take their assigned treatment even if their clinical condition worsens (ie, they experience disease 
exacerbation or a “flare”), unless any of the criteria in Section 8.1 (Discontinuation Criteria) are 
met. If a participant’s clinical condition worsens to the extent that rescue therapy (other than 
permitted therapy) is required, based on the investigator’s judgment, the participant must 
discontinue study treatment in favor of appropriate alternative available treatment.
If treatment is interrupted for a participant due to an AE, study treatment can be restarted in 
consultation with the BMS Medical Monitor/designee if the AE is not serious and assessed as not 
related to study treatment.
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.
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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 storage temperatures.
Please refer to the current version of the IB for complete storage and handling information.
Further guidance and information for final disposition of unused study treatment are provided in 
Appendix 2 and the Study Reference Manual.
7.5.1
Retained Samples for Bioavailability/Bioequivalence/Biocomparability
Not applicable.
7.6
Treatment Compliance
Study treatment compliance will be monitored as indicated in Section 2 (Schedule of Activities)
using standard drug accountability procedures (comparing the number of 
 returned to 
number dispensed, considering the expected regimen and any reported missed doses). Drug 
accountability will be reviewed by the investigative site staff at each visit to confirm treatment 
compliance. Site staff will discuss any discrepancies with the participant and remind the participant
of the importance of compliance with the assigned regimen.
7.7
Concomitant Therapy
All medications taken from within 
 before the first dose of study treatment until 
 
after the last dose of study treatment or last visit (whichever comes later) must be recorded on the 
appropriate eCRF.
Other than existing treatment for CD or UC (with restrictions as described in the eligibility criteria 
(Section 6 [Study Population]), concomitant medications (prescription, over-the-counter [OTC], 
or herbal) should be administered during the study only if they are prescribed for treatment of 
specific medical reasons separate from CD or UC.
7.7.1
Prohibited Treatments
Prohibited prior and current concomitant medications are summarized in Table 7.7.1-1. 
Medications taken within 
 prior to study treatment administration must be recorded on the 
eCRF.
Table 7.7.1-1:
Summary of Prohibited Concomitant Medications
Prohibited Treatments
Medication/Formulation
Notes
Corticosteroids:
Prednisone 
 or 
budesonide MMX 
, for the treatment of 
CD or UC.
Corticosteroids:
A course of IV or IM corticosteroids (> 24 hours in 
duration) or more than 1 discrete exposure to IV or IM 
IV or IM corticosteroids are prohibited prior to Day 1
and during the study treatment period.
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Table 7.7.1-1:
Summary of Prohibited Concomitant Medications
Prohibited Treatments
Medication/Formulation
Notes
corticosteroids (< 24 hours in duration) required to 
treat CD or UC.
Immunomodulatory drugs
Prohibited during study
Biologic drugs for IBD
Prohibited during study
Live vaccines
Prohibited from the parent study EOT visit, during the 
study, or within the 
 after the last dose.a
Apheresis
Prohibited from parent study EOT visit and during the 
study.
Investigational agents (other than deucravacitinib)
Prohibited from the parent study EOT visit and during 
the study.
Traditional Chinese medicines, herbal medicines, or 
herbal supplements
Prohibited from the parent study EOT visit and during 
the study; only exceptions are: medicines/supplements 
that were previously approved by the BMS Medical 
Monitor/designee in the parent study or a new 
exception that has been cleared by the BMS Medical 
Monitor/designee.
Abbreviations: BMS = Bristol-Myers Squibb; CD = Crohn’s disease; EOT = end of treatment; IBD = inflammatory 
bowel disease; IM = intramuscular; IV = intravenous; mg = milligram; MMX = Multi-Matrix System; 
 
UC = ulcerative colitis.
a Heat-killed (or otherwise inactivated) or protein or subunit vaccines such as influenza and pneumococcal vaccines 
may be received at any time during the study. 
 
7.7.2
Restricted Concomitant Medications
Restricted concomitant medications are summarized in Table 7.7.2-1. Restricted medications 
taken within 
 prior to study treatment administration must be recorded on the eCRF.
Table 7.7.2-1:
Summary of Restricted Concomitant Medications
Restricted Treatments
Medication/Formulation
Notes
Corticosteroid Rescue Therapy (Section 7.7.4)
Systemic corticosteroids required to treat CD or
UC
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Table 7.7.2-1:
Summary of Restricted Concomitant Medications
Restricted Treatments
Medication/Formulation
Notes
Corticosteroids:
Topical, inhaled, intra-articular or intrabursal, to treat 
non-IBD medical conditions
Allowed but must be discussed with the BMS Medical 
Monitor/designee.
Corticosteroids:
Systemic corticosteroids 
 to 
treat non-IBD medical conditions
Allowed but must be discussed with the BMS Medical 
Monitor/designee to determine if the intercurrent illness 
affects the safety of the participant or if the 
corticosteroid treatment is likely to confound efficacy 
assessment.
Nonsteroidal anti-inflammatory drugs
May be used on an as needed basis during the study, but 
use is not recommended, as NSAIDs may be associated 
with GI toxicity, including mucosal injury.
Abbreviations: BMS = Bristol-Myers Squibb; CD = Crohn’s disease; GI = gastrointestinal; IBD = inflammatory bowel 
disease; NSAID = nonsteroidal anti-inflammatory drug; UC = ulcerative colitis.
7.7.3
Permitted Medications
Use of concomitant rectally administered corticosteroids and 5-aminosalicylic acid (5-ASA) are 
permitted throughout the study.
Use of concomitant oral 5-ASA is permitted per the country label or institutional practice. Dose 
modification of 5-ASA is allowed during the study if this is required to optimize therapy and for 
participant safety reasons, such as if a participant experiences an AE attributable to 5-ASA. The 
rationale for dose modification must be documented in source documents. The AE or SAE eCRF 
must be completed, if applicable.
Oral corticosteroids for adrenal insufficiency are allowed at a maximum dose of prednisone 
 or equivalent. Probiotics are allowed with no restrictions on use. Participants will 
continue their existing IBD treatment(s) during the study, provided the treatment complies with 
the eligibility criteria (see Sections 6.1 [Inclusion Criteria] and 6.2 [Exclusion Criteria] and Table
7.7.1-1 and Table 7.7.2-1).
7.7.4
Disease Exacerbation, Corticosteroid Rescue Therapy, and Tapering
7.7.4.1
Disease Exacerbation
Participants who are experiencing symptoms of possible disease exacerbation (loss of response for 
CD or disease worsening for UC as defined in Table 4-1 and Table 4-2) should be evaluated as 
deemed appropriate by the investigator in order to determine whether corticosteroid rescue therapy 
may be appropriate. Participants who are seen by the investigator due to disease exacerbation 
should undergo the following assessments:

Symptom-directed physical examination including vital signs

Assessment of disease activity
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
 complete blood count, and additional laboratory assessments, as indicated

Stool sample for culture, ova, and parasite evaluation, and Clostridioides. difficile assay

Endoscopy may be considered and performed
Upon confirmation of loss of response or disease worsening, corticosteroid rescue therapy or
alternative efficacious therapy for IBD may be initiated. If the participant still meets the criteria 
for loss of response or disease worsening 
 after first presenting with symptoms and 
despite treatment, he/she should be identified as a treatment failure, be discontinued from study
treatment (Sections 5.1.4 and 8.1), and enter the post-treatment follow-up period (Section 5.1.3).
If an alternative, efficacious therapy for IBD is determined to be the appropriate course of action, 
the participant will be identified as a treatment failure and must be discontinued from study 
treatment (Sections 5.1.4 and 8.1).
Corticosteroid rescue therapy and the subsequent tapering is described in detail in Section 7.7.4.2.
7.7.4.2
Corticosteroid Rescue Therapy and Tapering
 
 
 
 Failure to taper the corticosteroid dose to 0 mg daily 
 of 
initiation will be considered treatment failure, and participants must discontinue from the study, 
unless the participants require glucocorticoid treatment for adrenal insufficiency. Participants who 
remain on corticosteroids to treat adrenal insufficiency must be discussed with the BMS Medical 
Monitor/designee to continue the study. Rescue therapy with medications other than oral 
corticosteroids, including immunosuppressants or biologics for IBD, are not permitted.
Oral corticosteroid rescue therapy 
 
 may be used 
in response to an increase in CD or UC disease activity at the 
investigator’s discretion (refer to 
 
. The oral corticosteroid should be tapered upon demonstrated disease improvement per 
investigator judgement. The recommended corticosteroid taper is as follows:
 
 
 
 
 
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7.8
Treatment After the End of the Study
At the conclusion of the study, participants who continue to demonstrate clinical benefit will be 
eligible to receive BMS-supplied study treatment. Study treatment will be provided via an 
extension of the study, a rollover study requiring approval by the responsible Health Authority and 
IEC, or through another mechanism at the discretion of BMS.
BMS reserves the right to terminate access to BMS-supplied study treatment if any of the following 
occur: 1) the study is terminated due to safety concerns; 2) the development of deucravacitinib is 
terminated for other reasons, including, but not limited to, lack of efficacy and/or not meeting the 
study objectives; or 3) the participant can obtain medication from a government-sponsored or 
private health program. In all cases, BMS will follow local regulations.
8
DISCONTINUATION CRITERIA
8.1
Discontinuation From Study Treatment
Participants MUST discontinue study treatment (and non-study treatment at the discretion of the 
investigator) for any of the following reasons:

Participant’s request to stop study treatment. Participants who request to discontinue study 
treatment will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by participant to 
provide this information.

Participant meets any of the criteria for treatment failure defined in Section 5.1.4 (Treatment 
Failure), 
.

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.

Participant who develops a significant infection during the study defined as any infection
(viral, bacterial, and fungal) considered by the investigator to be related to IP 
 
 

Any drug-related rash or hypersensitivity reaction (eg, anaphylaxis, angioedema, urticaria, 
Stevens-Johnson syndrome, 
 

Pregnancy, 

Participant meets any of the following criteria for liver-related laboratory abnormalities. If 
these abnormalities are identified, repeat testing should occur within 48 to 72 hours and these 
results should be discussed with the BMS Medical Monitor/designee. Additional 
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recommendations on the recognition and investigation of potential drug-induced liver injury
(DILI) are given in Section 9.2.7 (Potential Drug-induced Liver Injury).

ALT or AST > 8 × ULN on a single occasion

ALT or AST > 5 × ULN for more than 2 weeks

ALT or AST > 3 × ULN and total bilirubin > 2 × ULN or international normalized ratio 
(INR) > 1.5

ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%)

Participant meets 1 of the following criteria for laboratory abnormalities in 2 sequential 
laboratory measurements taken 3 to 5 days apart:

Hemoglobin < 7.0 g/dL 
 
 
 
 
 
 
 
 

WBC count < 1.5 × 109/L (< 1,500/mm3)

Absolute lymphocyte count < 0.5 × 109/L (< 500/mm3)

Absolute neutrophil count < 0.75 × 109/L (< 750/mm3)

Platelet count < 75 × 109/L (< 75,000/mm3)

An increase in serum creatinine > 50% over the IM011077 study baseline (Day 1) values 
and an absolute increase in serum creatinine > 0.5 mg/dL (> 44.2 µmol/L)

Creatine kinase elevations > 10 × ULN, unless the causality is known not to be medically 
serious (eg, exercise induced)

Inability or failure to comply with protocol requirements.

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.)
Refer to Section 2 (Schedule of Activities) for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed.
All participants who discontinue study treatment should comply with protocol specified follow-up 
procedures as outlined in Section 2 (Schedule of Activities). The only exception to this requirement 
is when a participant withdraws consent for all study procedures, including post-treatment study 
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follow-up, or loses the ability to consent freely (ie, is imprisoned or involuntarily incarcerated for 
the treatment of either a psychiatric or physical illness).
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 eCRF page.
8.1.1
Temporary Discontinuation From Study Treatment
If treatment is interrupted for a participant due to an AE, study treatment may be restarted in 
consultation with the BMS Medical Monitor/designee if the AE is not serious and is assessed as 
not related to study treatment (see Section 7.4 [Dosage Modification]).
Study treatment must be interrupted for participants who test positive for SARS-CoV-2 until 
recovery 
 
.
8.1.2
Post Study Treatment Study Follow-up
Participants who discontinue study treatment will continue to be followed for 28 days post-last 
dose of study treatment, or longer, as required, and in line with Section 9.2.3 (Follow-up of AEs 
and SAEs).
8.2
Discontinuation From the Study
Participants who request to discontinue study treatment (Section 8.1 [Discontinuation From Study 
Treatment]) will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by participant to 
provide this information.

Participants should notify the investigator of the decision to withdraw consent from future 
follow-up 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 eCRF page.

In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.

If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
8.3
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.
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
Lost to follow-up is defined by the inability to reach the participant after a minimum of three
documented phone calls, faxes, or emails as well as lack of response by participant to one 
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.
8.4
Replacement of Participants
Participant replacement is not permitted.
8.5
Study Discontinuation
A DMC will provide oversight of the safety of trial participants as outlined in Section 5.1.5 of the 
protocol and in the DMC Charter.
The DMC will periodically review safety data and make recommendations regarding the 
appropriateness of continuing the study, with or without study modifications, or stopping the study.
BMS reserves the right to terminate access to BMS-supplied study treatment if any of the following 
occur: a) the study is terminated due to safety concerns; b) the development of deucravacitinib is 
terminated for other reasons, including, but not limited to, lack of efficacy and/or not meeting the 
study objectives; c) the participant can obtain medication from a government-sponsored or private 
health program. In all cases BMS will follow local regulations.
9
STUDY ASSESSMENTS AND PROCEDURES

Study procedures and timing are summarized in the Section 2 (Schedule of Activities).

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 Day 1 evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria before first dose of deucravacitinib is provided on Study IM011077
as described in Section 2 (Schedule of Activities).
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
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 enrollment or baseline 
purposes provided the procedure meets the protocol-defined criteria and has been performed 
within the timeframe defined in Section 2 (Schedule of Activities).

Procedures not specified in the protocol that are part of standard care may be performed if they 
do not interfere with study procedures. Any data arising from such procedures are not to be 
reported in the eCRF.

The study data includes all the information collected as a result of the study, including 
participant demographics, disease characteristics (eg, Montreal classification), clinical 
information, blood tests, 
 endoscopic videos, intestinal biopsies obtained 
during endoscopy, and other tests listed in Section 2 (Schedule of Activities). Study data 
collected during this study will be used to help us understand how deucravacitinib works in 
people with IBD, and related health conditions. The study data may also be used to help us 
understand the biology of IBD and related health conditions, how study tests perform in people 
with IBD, and for other relevant health research relating to deucravacitinib or these health 
conditions.
9.1
Efficacy Assessments
Every effort must be made to ensure that the same evaluator(s) complete the assessment for each 
participant. If the evaluator(s) is unable to complete the evaluation, then a qualified individual with 
overlapping experience may perform the evaluation. Documentation of who performed the 
evaluation is to be recorded in source documents. Assessments are to be performed at 
approximately the same time of day throughout the duration of the study.
9.1.1
Endoscopies and Endoscopic Biopsies
Endoscopies and endoscopic biopsies will be submitted to an imaging core lab. Image acquisition 
guidelines and the submission process will be outlined in the Study IM011077 Image Review 
Charters to be provided by the core lab.
Endoscopy: Endoscopy (colonoscopy or flexible sigmoidoscopy, as appropriate for the disease 
indication) will be performed 
 as indicated in Section 2 (Schedule of Activities).
Endoscopy should be performed at the ET visit if this occurs
after the last endoscopy, 
and, if clinically indicated, at unscheduled visits.
 
 
When possible, and if clinically acceptable, the same type of endoscopy should be performed at
specified time points indicated in Section 2 (Schedule of Activities). The video recording of each 
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procedure will be reviewed by a central reader, or readers, in order to determine the SES-CD and 
a global index of severity for participants with CD, and the modified Mayo endoscopic (ES)
subscore (refer to Appendix 13), 
 
Additional details on the standardization of equipment, video recordings, endoscopic assessment,
and scoring will be provided in the Endoscopy Image Review Charter.
 
Endoscopic biopsies:
 
 
 
 
 
 
Additional details on the standardization of sample processing, histopathologic assessment, and 
scoring will be provided in the Histopathology Image Review Charter.
 
 
 
 
 
 
 
 
9.1.3
Capturing Data to Assess Disease Activity
Data will be captured using Medidata Rave electronic data capture (EDC)
 
 
.
The Physician’s Global Assessment (PGA; see Mayo score in Section 9.1.4 [Disease Activity 
Indices]) for participants with UC, and 
(see Section 9.9
[Health Economics or Medical Resource Utilization and Health Economics]) for all participants
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will be captured by the investigator or designee using the Medidata Rave EDC system at the 
timepoints indicated in Section 2 (Schedule of Activities).
 
 
 
 
 
 
 
 
 
 
 
9.1.4
Disease Activity Indices
9.1.4.1
Crohn’s Disease
The following instruments will be used to assess disease activity and health-related quality of life 
during the study as indicated in Section 2 (Schedule of Activities). Selected endpoints that use 
these indices are defined in Section 4 (Objectives and Endpoints) and described in detail in 
:
CDAI19,38,39 and PRO240: The CDAI and PRO2 scores will be calculated 
 
 
 
 
 
 
 
 
 
 
 
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
Prior to each scheduled visit at which CDAI and PRO2 are to be calculated, determine whether 
an adequate number 
 have been made. Should the participant miss 
 
prior to a study visit, the investigator should assess if the visit should be rescheduled to ensure 
that an adequate number 
 for efficacy assessment are recorded.

SES-CD41: 
 
 
 
 
Histologic Disease Activity Instruments
Histologic disease activity instruments include:
 
 
 
 
 
 
Endoscopic biopsy samples will be obtained from each of the 5 ileocolonic segments (rectum, 
descending colon/sigmoid, transverse colon, ascending colon, and ileum) on the days indicated in 
Section 2 (Schedules of Activities). 
 
 Further details on the biopsy 
collection and processing for this histological assessment will be provided to the site in the Study 
Reference Manual.
9.1.4.2
Ulcerative Colitis
The following instruments will be used to assess disease activity and health-related quality of life 
during the study as indicated in Section 2 (Schedule of Activities). Selected endpoints that use 
these indices are defined in Section 4 (Objectives and Endpoints) and described in detail in 
Appendix 13 (Mayo):
Total Mayo score: The total Mayo score is a composite disease activity index that comprises
4 subscores: SF, RB, and ES subscores and a PGA subscore.3 Consistent with regulatory draft 
guidance, the ES subscore scale has been modified so that friability is no longer included in the 
definition of an ES subscore = 1.31,45 Each subscore is scored on a 4-point scale, ranging 
from 0 to 3, leading to a maximum total score of 12. Higher scores indicate more severe disease. 
The total Mayo score will be used in endpoint assessment.
Modified Mayo score: The modified Mayo score is a composite of the following total Mayo score 
subscores: SF, RB, and ES.31 Friability is not included in the definition of an ES subscore = 1, and 
the PGA is not included in the calculation of the modified Mayo score.31,32,45 The maximum total 
score of the modified Mayo score is 9. The modified Mayo score calculated during the parent study
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end of treatment visit may be used to assess eligibility at Day 1. The modified Mayo score will be 
used in endpoint assessment.
Details regarding the recording of the individual Mayo score components and the calculation of 
the total Mayo score and modified Mayo score are provided in Appendix 13, whereas timing of 
assessments are detailed in Section 2 (Schedule of Activities). Briefly, the investigator records the 
IM011077 study baseline SF at the Day 1 visit, and the PGA at each study visit, 
 
. The ES subscore will be determined 
by a central reader. The central reader will also determine a global severity score. The investigator 
will also record a ES subscore and global severity score, which will be used for post hoc analyses.
 
 
 
 
 If a 
participant is unable to collect an adequate number 
 prior to starting bowel 
preparation for his/her endoscopy, the collection window may be extended 
 
 
 
 
Partial Mayo Score: The partial Mayo score is a composite of the following total Mayo score 
subscores: SF, RB, and PGA.46 The partial Mayo score may be determined at the timepoints 
indicated in Section 2 (Schedule of Activities).
Symptomatic Mayo Score: The symptomatic Mayo score is a composite of the total Mayo score 
SF and RB subscores. It may be calculated at various timepoints and will be used in endpoint 
assessment.
 
 
 
Additional details on endoscopy image acquisition, image quality control, and central reading for 
the assessment of Mayo ES subscore 
 will be provided in the Endoscopy Image Review 
Charter.
 
 
 
 
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Geboes Score and RHI43,49: The Geboes score and the RHI are instruments used to assess the 
histological appearance of the mucosa in UC.49 The Geboes score evaluates 6 histological features 
(termed Grades), each of which are scored on ordinal scales. The RHI uses the weighted scores 
from 4 Grades of the Geboes score to derive a score that ranges from 0 to 33, where higher scores 
indicate a greater degree of histological disease activity. Both Geboes scores50,51 and the RHI52
have been used to characterize histological activity in UC.
For determination of the Geboes score and the RHI, biopsies for histological assessment will be 
obtained as indicated in Section 2 (Schedule of Activities) and evaluated by a central reader. 
Further details on the biopsy collection and processing for this histological assessment will be 
provided in the Histopathology Image Review Charter.
The Geboes and RHI assessments will be carried out by the central vendor, who will be responsible 
for reading and scoring all endoscopies and biopsies.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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9.1.6
Laboratory Assessments
The following laboratory tests will be performed according to Section 2 (Schedule of Activities) 
to gather more information about CD and UC activity: 
 
 
 
Stool culture, ova, and parasite evaluation, and Clostridioides difficile toxin testing are 
recommended in order to exclude infectious causes of disease exacerbation, as deemed appropriate 
by the investigator.
9.2
Adverse Events
The definitions of an AE or SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver, 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 or 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.
9.2.1
Time Period and Frequency for Collecting AE and SAE Information
Sections 5.6.1 and 5.6.2 in the IB represent the Reference Safety Information to determine 
expectedness of SAEs for expedited reporting.
All AEs (SAEs and nonserious AEs) for this study will be collected from the time the participant 
signs the informed consent form until the Final Safety Visit (ie, 28 days after EOT or ET) at the 
timepoints specified in Section 2 (Schedule of Activities). All AEs reported during the parent study
that have either resolved or are ongoing 
 after the PSEOT visit will be recorded as 
Medical History in Study IM011077. AEs that are ongoing from the parent study and worsen after 
the participant signs the informed consent form will be reported as new AEs in Study IM011077.
The investigator must report any SAE that occurs after these time periods and that is believed to 
be related to study treatment or protocol-specified procedure (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 eCRF module.
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
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.
9.2.2
Method of Detecting AEs and SAEs
AEs can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. Care should be taken not to introduce bias when collecting AE and/or 
SAEs. Inquiry about specific AEs should be guided by clinical judgement in the context of known 
AEs, when appropriate for the program or protocol.
9.2.3
Follow-up of AEs and SAEs

Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3).

Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study treatment and for those present at the end of study treatment as appropriate.

All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study.
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, nonserious AEs of special interest (as defined in 
Section 9.2) and SARS-CoV-2-related AEs 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.
9.2.4
Regulatory Reporting Requirements for SAEs

Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met.

An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the IB and will notify the IRB/ IEC, if appropriate according to local requirements.
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Sponsor or designee will be reporting AEs to regulatory authorities and IECs according to local 
applicable laws, including European Directive 2001/20/EC and Food and Drug Administration
Code of Federal Regulations 21 CFR Parts 312 and 320. A SUSAR is a subset of SAEs and will 
be reported to the appropriate regulatory authorities and investigators following local and global 
guidelines and requirements.
9.2.5
Pregnancy
In the event a participant becomes pregnant during the trial, the study treatment must be 
discontinued immediately. If the participant becomes pregnant during the study period until the 
end of study, 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.
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 informed consent form for 
disclosure of this information. Information on this pregnancy will be collected on the Pregnancy 
Surveillance Form.
9.2.6
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the nonserious AE eCRF 
or SAE Report Form 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 vs low hemoglobin value).
9.2.7
Potential Drug-induced Liver Injury
Clinical chemistry and coagulation tests will be assessed as indicated in Section 2 (Schedule of 
Activities). Participants with abnormal liver blood tests should be further assessed to determine if 
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these meet the criteria for discontinuation of the study treatment (see Section 8.1 [Discontinuation 
From Study Treatment]) or the criteria for potential DILI.
Potential DILI is defined as:
1) Aminotransferase (ALT or AST) elevation > 3 × ULN,
AND
2) Total bilirubin > 2 × ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase),
AND
3) No other immediately apparent possible causes of 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.
Identification of a clinically significant elevation(s) in liver-related chemistry or coagulation tests 
(including those defined in Section 8.1 [Discontinuation From Study Treatment], or meeting the 
definition for potential DILI) should be followed by repeat testing of ALT, AST, total bilirubin, 
ALP, and INR within 48 to 72 hours to: (1) confirm the abnormalities, and (2) determine if they 
are increasing or decreasing.
Investigators must consult with the BMS Medical Monitor/designee immediately if a participant
meets the laboratory criteria for potential DILI.
Investigators should consider gathering additional clinical information and laboratory and imaging 
tests to seek other possible causes of the observed liver blood test abnormalities, including (but 
not limited to) acute viral hepatitis, alcoholic and autoimmune hepatitis, biliary obstruction (small 
and large duct), cardiovascular causes (eg, ischemic hepatitis), nonalcoholic steatohepatitis, and 
the effect of concomitant treatments.
A review of all concomitant medications should include herbal medicines, dietary supplements, 
nonprescription OTC medications, including acetaminophen/paracetamol, and occupational 
exposure to chemical agents.
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILI, meeting 
the defined criteria must be reported as SAEs (see Section 9.2 [Adverse Events] and Appendix 3
for reporting details). All participants with clinically significant abnormalities in liver-related 
blood tests, or potential DILI, must be followed until all abnormalities return to normal or to the 
IM011077 study baseline state.
9.2.8
Adverse Events of Interest
All AEs and SAEs that arise in the study will be reported and investigated. However, because of 
the characteristics of the disease under study, and deucravacitinib in particular, some AEs are 
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considered AEIs. AEIs may be serious or nonserious. Such events may require further 
investigation to better characterize and understand them.
In the deucravacitinib clinical development program, certain skin-related AEs (eg, acne), infection 
AEs, and creatine kinase elevation have been identified as potential AEIs. However, there has been 
no definitive assessment on the causal relationship between these events and treatment with 
deucravacitinib.
In addition, given that immunosuppression is consistent with the mechanism of action of 
deucravacitinib, malignancies are considered to be an important potential risk of therapy with 
deucravacitinib and will be monitored as AEIs. Malignancies were not identified as adverse 
findings in nonclinical studies or in clinical studies of deucravacitinib.
Additional information on AEIs will be collected in this study. Reporting of an AE or SAE that 
includes a Preferred Term that is linked to an AEI will trigger specialized eCRF pages to collect 
additional information related to characterization, social/family history, risk factors, 
signs/symptoms, diagnostics, and treatments. Additional information may also be requested to aid 
in the evaluation of these AEIs.
9.2.9
Other Safety Considerations
Any significant worsening noted during interim or final physical examinations, ECG, x-ray 
filming, or any other potential safety assessment required or not required by protocol should also 
be recorded as a nonserious or serious AE, as appropriate, and reported accordingly.
9.3
Overdose
 
In the event of an overdose the investigator/treating physician should:
1) Contact the BMS Medical Monitor/designee immediately.
2) Closely monitor the participant for AEs/SAEs and laboratory abnormalities until 
deucravacitinib can no longer be detected systemically 
3) Document the quantity of the excess dose as well as the duration of the overdosing in the eCRF.
Decisions regarding study treatment interruptions or modifications will be made by the 
investigator in consultation with the BMS Medical Monitor/designee based on the clinical 
evaluation of the participant.
9.4
Safety
Planned time points for all safety assessments are listed in Section 2 (Schedule of Activities). All 
urgent safety concerns must be discussed with the Sponsor immediately upon occurrence or 
awareness to determine if the participant should continue or discontinue study treatment.
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Safety evaluations that will be performed in addition to AE monitoring are physical examinations 
(Section 9.4.2), vital signs (Section 9.4.3), ECGs (Section 9.4.4), laboratory tests (Section 9.4.5), 
TB screening (Section 9.4.6), and concomitant medication use (Section 7.7).
9.4.1
Preventative Care 
Investigators are encouraged to ensure that participants are up-to-date with preventative care for 
IBD, based on local standard of care. This may include:

Non-live vaccinations
o
Non-live vaccinations can be administered during the study (including SARS-CoV-2
messenger ribonucleic acid (mRNA) vaccines). The efficacy and safety of vaccines in 
participants receiving deucravacitinib have not been studied.

Periodic surveillance for IBD associated colonic dysplasia or screening for colorectal 
carcinoma, based on local standard of care.
o
Biopsies collected for suspected colonic dysplasia should follow site-specific process for 
screening for colorectal carcinoma.

Additional preventative care outlined in research society guidance (eg, American College of 
Gastroenterology guide).55
9.4.2
Physical Examinations
Schedules for physical examinations are provided in the Section 2 (Schedule of Activities). 
Complete physical examinations should be performed by a medical doctor or someone who is 
authorized to perform the examinations by training and performs this task under the supervision 
of the investigator. Key aspects of the examination should evaluate important body systems, 
including skin, as clinically indicated. Every effort should be made to ensure the same evaluator 
will complete the examination for each participant at all visits throughout the study. 
Documentation of who performed the examination is to be recorded in source notes.
Significant findings should be recorded as AEs on the AE eCRF. AEs that are continuing from the 
parent study will be captured in both parent study and Study IM011077 databases.
Schedules for targeted physical examinations are provided in Section 2 (Schedule of Activities).
The targeted physical examination will include (at a minimum) an abdominal examination, skin 
examination, and an examination of body systems with previously noted abnormalities and/or
those body systems associated with any new complaints from the participant.
9.4.3
Vital Signs
Vital signs including body weight, body temperature, and seated blood pressure and heart rate will 
be obtained as indicated in Section 2 (Schedule of Activities) and recorded in the relevant eCRF.
Seated blood pressure and heart rate should be measured after the participant has been resting 
quietly for at least 5 minutes. The Day 1 height measurement should not be collected. This height 
measurement should be carried over from the parent study screening visit and entered into Study 
IM011077 database (eg, eCRF).
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9.4.4
Electrocardiograms
ECGs will be performed as indicated in Section 2 (Schedule of Activities). ECGs will be read 
locally. Clinically significant ECG findings will be recorded in the relevant eCRF and should be 
discussed with the BMS Medical Monitor/designee. Any clinically significant ECG findings 
should be recorded on the appropriate AE page of the eCRF.
9.4.5
Clinical Safety Laboratory Assessments
Investigators must document their review of each laboratory safety report.
A central or local laboratory (where allowed by local laws, regulations, and guidance) will perform 
safety laboratory assessments (as indicated in operational documents; except urine pregnancy tests, 
which may be performed in clinic, as per local SOC) and provide reference ranges and laboratory 
reports.
Any laboratory test result that the investigator considers clinically relevant for safety is to be 
recorded on the appropriate AE eCRF.
The timing of laboratory assessments is indicated in Section 2 (Schedule of Activities).
The laboratory parameters to be assessed for clinical safety throughout the study are listed in Table 
9.4.5-1.
Table 9.4.5-1:
Summary of Laboratory Parameters Used to Assess Clinical Safety
Hematology
Hemoglobin
Hematocrit
Iron
Ferritin
Total iron-binding capacity (TIBC)
Total leukocyte count, including absolute neutrophil 
count (ANC) and absolute lymphocyte count
Platelet count
Red blood cell (RBC) count
Complete blood count (CBC) differential (manual 
separate smear preferred; automatic differential 
acceptable when manual is not available); must include
MCV, MCHC, MCH
Chemistry
Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Gamma glutamyltransferase (GGT)
Total bilirubin
Direct bilirubin
Alkaline phosphatase (ALP)
Lactate dehydrogenase (LDH)
Creatinine
Blood urea nitrogen (BUN)
Uric acid
Total protein
Albumin
Sodium
Potassium
Chloride
Calcium
Phosphorus
Magnesium
Creatine kinase
Performed after ≥10-hour fast at annual visits 
(Weeks 48, 96, 144, 192, 240, and 288):
Fasting lipid panel (total cholesterol, high-density 
lipoprotein cholesterol, low-density lipoprotein 
cholesterol, and triglycerides)
Fasting glucose
Coagulation
Prothrombin time (PT)
International normalized ratio (INR)
Either partial thromboplastin time or activated partial 
thromboplastin time (aPTT)
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Table 9.4.5-1:
Summary of Laboratory Parameters Used to Assess Clinical Safety
Urinalysis
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
pH
Microscopic examination of the sediment if blood, 
protein, or leukocyte esterase are positive on the 
dipstick

Spot urine will be assessed for urine protein and 
urine creatinine
Other Analyses

Follicle-stimulating hormone: to confirm postmenopausal status in females (refer to Appendix 4)

Urine and/or serum pregnancy testing (β-hCG): performed for WOCBP
Stool Tests (to be performed when deemed appropriate by investigator)

Stool culture: culture for potentially pathogenic enteric bacteria, including (but not limited to) Salmonella, 
Shigella, Campylobacter, and enterohemorrhagic Escherichia coli. Testing for additional enteric pathogens,
including bacteria, protozoa, ova, and parasites, may be performed based on the investigator’s clinical 
judgment.

Stool for Clostridioides (formerly Clostridium) difficile testing: stool for C. difficile Toxin A and B test (EIA) 
and GDH antigen test (EIA), with reflex to NAAT (C. difficile polymerase chain reaction) if either positive.
Abbreviations: 
 β-hCG = beta-human chorionic gonadotropin; 
 EIA = enzyme-linked immunosorbent assay; GDH = glutamate dehydrogenase; 
 MCH = mean 
corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean corpuscular volume; 
NAAT = nucleic acid amplification test; WOCBP = women of childbearing potential.
9.4.6
Tuberculosis Screening
In order to be eligible for the study, a participant must not have symptoms or signs of active TB, 
as judged by the investigator.
Evidence of active or latent TB includes:

History of active TB prior to the Day 1 visit of this study (IM011077); or

Signs or symptoms of active TB as judged by the investigator; or

A chest x-ray obtained anytime within 
prior to Day 1 of this study, with 
documentation, and evidence of current active or old active pulmonary TB; or
 
 
 
 
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Prior to receiving the first dose of study treatment in this study and approximately every year, 
participants should be assessed using the Tuberculosis Risk Assessment Tool (refer to Appendix 
5). 
 
 
 
 
A participant with a negative QuantiFERON or T-Spot test may be eligible to participate in the 
study provided he/she does not have any clinical or radiologic evidence supporting a diagnosis of 
active TB or LTBI.
A participant with an indeterminate QuantiFERON test or a borderline T-Spot test must have a 
retest before he/she is eligible to participate in the study. If the second result is again indeterminate 
or borderline, the participant will be excluded from the study. If the second result is negative, the 
participant may be eligible provided there is no clinical or radiologic suspicion of active TB or 
LTBI.
 
A participant diagnosed with LTBI at the end of treatment visit of the parent study should be 
referred to an appropriate specialist for consideration for prophylactic treatment for LTBI, per local 
guidelines. 
 
9.4.7
Imaging Safety Assessment
Please refer to Section 9.4.1 for periodic surveillance (including study-related endoscopy) for IBD 
associated colonic dysplasia or screening for colorectal carcinoma.
9.5
Pharmacokinetics
The PK of deucravacitinib and metabolites (if applicable) will be derived from plasma 
concentration vs time data. The trough observed plasma concentration (Ctrough) will be 
summarized as part of the PK parameters summary.
The plasma samples will be analyzed for deucravacitinib and metabolites (if applicable) by a 
validated liquid chromatography tandem mass spectrometry assay. In addition, plasma samples 
will be archived for potential analysis of other analytes, if the need arises and to the extent possible. 
Detailed instructions for the PK blood collection, labeling, processing, storage, and shipping will 
be provided to the site in the Laboratory Manual.
The sampling schedule for the assessment of PK and PD is provided in Table 9.5-1.
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Table 9.5-1:
Pharmacokinetic Sampling Schedule for All Participants (Study 
IM011077)
Study Day of Sample 
Collection
Visit window (± 14 days)
Event
Time Relative to 
Deucravacitinib Dose a
(hr:min)
Deucravacitinib PK 
Plasma Sample
Day 1
Predose b
00:00
X
Day 169 (Year 1, Week 24)
Predose c
00:00
X
Day 337 (Year 1, Week 48)
Predose c
00:00
X
Day 505 (Year 2, Week 72)
Predose c
00:00
X
Day 673 (Year 2, Week 96)
Predose c
00:00
X
Day 841 (Year 3, Week 120)
Predose c
00:00
X
Day 1009 (Year 3, Week 144)
Predose c
00:00
X
Day 1177 (Year 4, Week 168)
Predose c
00:00
X
Day 1345 (Year 4, Week 192)
Predose c
00:00
X
Day 1513 (Year 5, Week 216)
Predose c
00:00
X
Day 1681 (Year 5, Week 240)
Predose c
00:00
X
Day 1849 (Year 6, Week 264)
Predose c
00:00
X
Day 2017 (Year 6, Week 288)
Predose c
00:00
X
End of Treatment/Early 
Termination
X
Abbreviations: hr = hour; min = minute; PK = pharmacokinetic.
a PK sample is expected to be collected as close to the planned time as operationally feasible and always records the 
exact PK collection date and time.
b The Day 1 pre-dose sample must be drawn before the morning dose of study treatment on the visit date. The post-
PK dose of study treatment should be taken at the site from Study IM011077.
c Pre-dose samples must be drawn before the morning dose of study treatment on the visit day; at these visits, study 
treatment will be taken at the site.
9.7
Pharmacogenomics
Not applicable.
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9.9
Health Economics OR Medical Resource Utilization and Health 
Economics
Medical resource utilization and health economics data associated with medical encounters
(disease-related healthcare utilization) will be collected in the eCRF by the investigator and 
study-site personnel for all participants throughout the study. This instrument provides 
questions/prompts representative of the data to be collected through eCRF 
 
Protocol-mandated procedures, tests, and 
encounters are excluded. 
 
 
9.10
Electronic Informed Consent
Where applicable according to regional, local, and institutional regulations, sites may opt to use 
electronic informed consent (eConsent). eConsent uses digital technology to provide interactive 
tools for obtaining informed consent. IRBs/IECs should review the content of any multimedia 
components prior to launch of the digital platform as part of the informed consent review process.
Participants will be provided with a printed copy of the eConsent. In some cases, depending on 
local regulations, the multimedia components may be delivered electronically, whereas signatures 
will be collected on paper. Paper informed consent forms will be available in the event the 
regulations do not allow the use of eConsent and to allow both options for participants and sites.
10
STATISTICAL CONSIDERATIONS
10.1
Sample Size Determination
Because this uncontrolled, open-label, long-term extension study is for observational purposes 
only, no formal calculations of sample size and power determination will be made. All qualified 
participants who complete the final treatment visit from an applicable parent study will be eligible 
to participate. Approximately 300 participants are expected to roll over into this study from the 
parent studies.
10.2
Populations for Analyses
For purposes of analysis, the following populations are defined:
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Population
Description
Enrolled Population
All participants who sign informed consent for entry into Study 
IM011077.
As-treated
All enrolled participants who took at least 1 dose of study 
treatment in Study IM011077.
Biomarker Population
All participants who receive at least 1 dose of study treatment in 
Study IM011077 and have at least 1 post-treatment biomarker 
measurement.
PK Population
All participants who receive at least 1 dose of study treatment in 
Study IM011077 and have any available concentration-time data.
Abbreviation: PK = pharmacokinetic.
10.3
Endpoints
10.3.1
Primary Endpoints
The primary objective of this study is to assess the safety and tolerability of long-term use of 
deucravacitinib in participants with moderate to severe CD or moderate to severe UC. To support 
this objective, the following endpoints will be assessed:

Number and proportion of participants experiencing AEs, SAEs, AEs leading to study 
discontinuation, and AEIs.

Number and proportion of participants experiencing abnormalities in laboratory testing, ECG, 
and vital sign parameters over time.

Changes from IM011077 study baseline for laboratory testing, ECG, and vital signs.
 
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10.4
Statistical Analyses
10.4.1
Efficacy Analyses
Because this study is for observational purposes, no statistical tests for treatment comparisons will 
be conducted. Categorical data will be summarized as frequency counts and percentages. 
Continuous data will be summarized using number of participants (n), mean, standard deviation
(SD), median, minimum, and maximum unless otherwise specified. Efficacy variables will be 
summarized for all visits in which the variable is assessed. Complete details of the planned 
analyses will be documented in the SAP and finalized before database lock. Summaries will be 
provided for the As-treated population. Participants will be summarized according to the treatment 
they received in their parent trial.
10.4.1.1
Definition of Baseline
Baseline data are defined as:
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
The parent study baseline is the baseline efficacy assessment performed in Study IM011023, 
IM011024, or IM011127 during the enrollment period or the Day 1 visit, as applicable.

The IM011077 study baseline is the last measurement collected on or prior to the date of the 
first dose in Study IM011077. Relevant laboratory data, along with clinical and PRO 
assessments from the end of treatment visit in IM011023, IM011024, or IM011127, may 
constitute the baseline measures for IM011077. These procedures need not be repeated at the 
baseline visit in IM011077. Any assessments specific to IM011077 will be performed prior to 
assignment of IM011077 study treatment.
 
 
 
 
10.4.2
Safety Analyses
Safety data will be analyzed for AEs, SAEs, laboratory analytes, and vital signs. Safety will be 
summarized using the As-treated population. Participants will be summarized according to the 
treatment they received in their parent trial, as well as by indication and overall. Categorical data 
will be summarized as frequency counts and percentages. Continuous data will be summarized 
using n, mean, SD, median, minimum, and maximum unless otherwise specified. 
10.4.2.1
Adverse Events
AEs for this study will be collected from the time the participant signs the informed consent form 
until the Final Safety Visit (ie, 28 days after EOT or ET) at the timepoints specified in Section 2
(Schedule of Activities). AEs that are ongoing from parent studies that worsen after the participant
signs the informed consent form will be reported as new AEs in Study IM011077. AEs reported 
during parent studies that have either resolved or are ongoing 
 from the parent study end 
of treatment visit will be recorded as Medical History in Study IM011077.
TEAEs are events that occur after the administration of the first dose of study treatment in Study 
IM011077. AEs that were ongoing during the parent study and worsen once study treatment is 
initiated in this study will also be considered treatment emergent. All AEs will be coded using the 
Medical Dictionary for Regulatory Activities (MedDRA) and presented by System Organ Class 
and Preferred Term. Serious AEs and deaths, AEs leading to study treatment discontinuation, AEs 
by maximum severity, and AEs by relationship will also be summarized by the MedDRA System 
Organ Class and Preferred Term. All TEAEs will also be summarized by Preferred Term sorted 
by decreasing frequency.
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10.4.2.2
Vital Signs and Physical Examinations
Vital signs will be summarized as raw, change from IM011077 study baseline, and change from 
maximum post-baseline value. Incidence of abnormal physical examination findings will also be 
summarized.
10.4.2.3
Clinical Laboratory Tests
Laboratory analytes will be summarized as raw, change from IM011077 study baseline, and 
change from maximum post-baseline value. Incidence of abnormal, high, or low values will be 
summarized. Shift tables will also be provided.
10.4.3
Other Analyses
Other analysis summaries will be presented as defined in the SAP.
10.4.3.1
Demographics and Baseline Data
Demographics and baseline data obtained during the screening visit of the parent study will be 
summarized for participants entering Study IM011077 and will be summarized by randomized 
treatment (on the parent studies) for each applicable analysis population. Categorical data will be 
summarized as frequency counts and percentages. Continuous data will be summarized using n, 
mean, SD, median, minimum, and maximum, unless otherwise specified.
10.4.3.2
Prior and Concomitant Medications
Prior and concomitant medications, categorized by medication group and subgroup according to 
the World Health Organization Drug Dictionary, will be summarized by treatment for the 
As-treated population. Medications with an end date prior to the first dose of study treatment in
Study IM011077 will be considered prior medications.
10.4.3.3
Pharmacokinetics
Ctrough will be summarized by dose and timepoint for the PK population. If warranted, analysis 
of PK and exposure-response relationships of deucravacitinib will be conducted using a population 
approach as appropriate and reported separately from the Clinical Study Report.
 
10.4.4
Interim Analyses
Interim analyses may be performed, and, if planned, the SAP will further describe those planned 
interim analyses.
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Ng SC, Kamm MA. Therapeutic strategies for the management of ulcerative colitis. Inflamm 
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Heyman MB, Kirschner BS, Gold BD, et al. Children with early-onset inflammatory bowel 
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11 Baker KF, Isaacs JD. Novel therapies for immune-mediated inflammatory diseases: what can 
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13 Sandborn WJ, Ferrante M, Bhandari BR, et al. Efficacy and safety of mirikizumab in a 
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16 Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy 
for Crohn's disease. New Engl J Med 2016;375(20):1946-60.
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therapy for ulcerative colitis. New Engl J Med 2019;381(13):1201-14.
18 Sands BE. Inhibition of interleukin-12 and/or -23 for the treatment of inflammatory bowel 
disease. Gastroenterol Hepatol (N Y) 2016;12(12):784-6.
19 Feagan BG, Sandborn WJ, D'Haens G, et al. Induction therapy with the selective interleukin-23 
inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, 
double-blind, placebo-controlled phase 2 study. Lancet 2017;389(10080):1699-709.
20 Sands BE, Chen J, Feagan BG, et al. Efficacy and safety of MEDI2070, an antibody against 
interleukin 23, in patients with moderate to severe Crohn's disease: a phase 2a study. 
Gastroenterology 2017;153(1):77-86.e6.
21 Papp K, Gordon K, Thaci D, et al. Phase 2 trial of selective tyrosine kinase 2 inhibition in
psoriasis. New Engl J Med 2018;379(14):1313-21.
22 Mease PJ, Deodhar A, van der Heijde D, et al. Efficacy and safety of deucravacitinib (BMS-
986165), an oral, selective tyrosine kinase 2 inhibitor, in patients with active psoriatic arthritis: 
results from a phase 2, randomized, double-blind, placebo-controlled trial [abstract]. Arthritis 
Rheumatol. 2020; 72 (suppl 10).
 
24 BMS-986165: Investigator’s Brochure Version 8. Bristol-Myers Squibb Company; 2020. 
Document Control No. 930090873.
25 Boutet MA, Nerviani A, Afflitto GG, et al. Role of the IL-23/IL-17 axis in psoriasis and 
psoriatic arthritis: the clinical importance of its divergence in skin and joints. Int J Mol Sci 
2018;19(2):530.
26 Clinical Trial Facilitation and Coordination Group (CTFG). Recommendations related to 
contraception and pregnancy testing in clinical trials. Version 1.1. Published 2020 Sep 21.
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About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Ver
sion_1.1_updated.pdf
27 Wrobleski ST, Moslin R, Lin S, et al. Highly selective inhibition of tyrosine kinase 2 (TYK2) 
for the treatment of autoimmune diseases: discovery of the allosteric inhibitor BMS-986165. 
Presented at American Chemical Society. J Med Chemistry 2019;62(20):8973-95.
28 Jostins L, Ripke S, Weersma RK, et al. Host-microbe interactions have shaped the genetic 
architecture of inflammatory bowel disease. Nature 2012;491(7422):119-24.
29 Diogo D, Bastarache L, Liao KP, et al. TYK2 Protein-coding variants protect against 
rheumatoid arthritis and autoimmunity, with no evidence of major pleiotropic effects on non-
autoimmune complex traits. PLoS ONE 2015;10(4):e0122271.
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30 Ustekinumab (Stelara) Package Insert. Raritan, NJ: Janssen Pharmaceutical Companies. 
Revised July 2020. Available from: http://www.janssenlabels.com/package-insert/product-
monograph/prescribing-information/STELARA-pi.pdf. Accessed 2020 Nov 12.
31 U.S. Department of Health and Human Services. Ulcerative Colitis: Clinical Trial Endpoints. 
Guidance for industry.
Available from: https://www.fda.gov/media/99526/download. 
Published August 2016. Accessed 2020 Nov 12.
32 European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP).
Guideline on the Development of New Medicinal Products for the Treatment of Ulcerative 
Colitis. 
Available 
from: 
https://www.ema.europa.eu/en/documents/scientific-
guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-
revision-1_en.pdf. Published 2018 Jun 28. Accessed 2020 Nov 12.
33 European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). 
Guideline on the Development of New Medicinal Products for the Treatment of Crohn’s 
Disease. 
Available 
from: 
https://www.ema.europa.eu/en/documents/scientific-
guideline/guideline-development-new-medicinal-products-treatment-crohns-disease-revision-
2_en.pdf Published 2018 Jun 28. Accessed 2020 Nov 29.
 
 
35 Kim J, Krueger JG. Highly effective new treatments for psoriasis target the IL-23/type 17 T 
cell autoimmune axis. Annu Rev Med 2017;68:255-69.
 
 
38 Best WR, Becktel JM, Singleton JW, et al. Development of a Crohn's disease activity index. 
National cooperative Crohn's disease study. Gastroenterology 1976;70(3):439-44.
39 Sandborn WJ, Feagan BG, Hanauer SB, et al. A review of activity indices and efficacy 
endpoints for clinical trials of medical therapy in adults with Crohn's disease. Gastroenterology 
2002;122(2):512-30.
40 Khanna R, Zou G, D'Haens G, et al. A retrospective analysis: the development of patient 
reported outcome measures for the assessment of Crohn's disease activity. Aliment Pharmacol 
Ther 2015;41(1):77-86.
41 Daperno M, D'Haens G, Van Assche G, et al. Development and validation of a new, simplified 
endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc 
2004;60(4):505-12.
 
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45 Scherl EJ, Pruitt R, Gordon GL, et al. Safety and efficacy of a new 3.3 g b.i.d. tablet 
formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, 
randomized, double-blind, placebo-controlled study. Am J Gastroenterol 2009;104(6):1452-9.
46 Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the Mayo score to 
assess clinical response in ulcerative colitis. Inflamm Bowel Dis 2008;14(12):1660-6.
 
 
 
49 Geboes K, Riddell R, Ost A, et al. A reproducible grading scale for histological assessment of 
inflammation in ulcerative colitis. Gut 2000;47(3):404-9.
50 Geboes K, Rutgeerts P, Olson A, et al. Infliximab results in reduction of inflammation and 
inflammatory markers in the mucosa of ulcerative colitis patients: the ACT 1 trial. Am J
Gastroenterol 2005;100:S292-3.
51 Bessissow T, Lemmens B, Ferrante M, et al. Prognostic value of serologic and histologic 
markers on clinical relapse in ulcerative colitis patients with mucosal healing. Am J
Gastroenterol 2012;107(11):1684-92.
52 Pai RK, Khanna R, D’Haens GR, et al. Definitions of response and remission for the Robarts 
Histopathology Index. Gut 2019;68(11):2101-02.
 
 
55 Farraye, F. A., Melmed, G. Y., Lichtenstein, G. R., & Kane, S. V. (2017). ACG Clinical 
Guideline: Preventive Care in Inflammatory Bowel Disease. The American journal of 
gastroenterology, 112(2), 241–258. https://doi.org/10.1038/ajg.2016.537.
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APPENDICES
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
5-ASA
5-aminosalicylic acid
AE
adverse event
AEI
adverse event of interest
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AT
aminotransferase
-HCG
beta-human chorionic gonadotrophin
BID
twice daily
BMS
Bristol-Myers Squibb
BMS-986165
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BCRP
breast cancer resistance protein
CD
Crohn’s disease
CDAI
Crohn’s Disease Activity Index
CFR
Code of Federal Regulations 
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
coronavirus disease 2019
Ctrough
trough observed plasma concentration
CYP450
cytochrome P450
DB
double-blind
DDI
drug-drug interaction
DILI
drug-induced liver injury
DMC
Data Monitoring Committee
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Term
Definition
ECG
electrocardiogram
eConsent
electronic informed consent
eCRF
electronic case report form
EDC
electronic data capture
eGFR
estimated glomerular filtration rate
EIA
enzyme-linked immunosorbent assay
EOT
end of treatment
ES
endoscopic
ET
early termination
FSH
follicle-stimulating hormone
F/U
follow-up
GDH
glutamate dehydrogenase
GI
gastrointestinal
HBV
hepatitis B virus
hr
hour
IB
Investigator’s Brochure
IBD
inflammatory bowel disease
IEC
Independent Ethics Committee
IFN
interferon
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Term
Definition
IL
interleukin
IM
intramuscular
IMP
Investigational Medicinal Product
INR
international normalized ratio
IP
Investigational Product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IV
intravenous
JAK
Janus kinase
LTBI
latent tuberculosis infection
MCH
mean corpuscular hemoglobin
MCHC
mean corpuscular hemoglobin concentration
MCV
mean corpuscular volume
MedDRA
Medical Dictionary for Regulatory Activities
min
minute
MMX
Multi-Matrix System
mRNA
messenger ribonucleic acid
N
number of participants or observations
NAAT
nucleic acid amplification test
NOAEL
no-observed-adverse-effect level
NSAID
nonsteroidal anti-inflammatory drug
NYHA
New York Heart Association
OLE
open-label extension
OTC
over-the-counter
PD
pharmacodynamic
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Term
Definition
PGA
Physician Global Assessment
PID
participant identification number
PK
pharmacokinetic
PO
orally
PRO
patient-reported outcome
PRO2
patient-reported outcome based on the stool frequency and abdominal 
pain components of the CDAI
PSEOT
parent study end of treatment
Q
quarter
Q12W
every 12 weeks
QD
once daily
RB
rectal bleeding
RBC
red blood cell
RHI
Robarts Histopathology Index
RNA
ribonucleic acid
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SD
standard deviation
SES-CD
Simple Endoscopic Score for Crohn’s Disease
SF
stool frequency
SLE
systemic lupus erythematosus
SOC
standard of care
SUSAR
suspected, unexpected serious adverse reaction
TB
tuberculosis
TEAE
treatment-emergent adverse event
TIBC
total iron binding capacity
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Term
Definition
TNF
tumor necrosis factor
TYK2
tyrosine kinase 2
UC
ulcerative colitis
ULN
upper limit of normal
US
United States
WBC
white blood cell
WOCBP
women of childbearing potential
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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 Good Clinical Practice (GCP),

as defined by the International Council on 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.
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 
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 
) 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).
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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 
commercial supply, or a specialty 
pharmacy)
The investigator or designee accepts responsibility 
for documenting traceability and study treatment 
integrity in accordance with requirements applicable 
under law and the standard operating procedures 
(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.
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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.
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 
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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 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.
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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 non- study 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee.
CLINICAL STUDY REPORT
A Signatory Investigator must be selected to sign the clinical study report.
For each CSR related to this protocol, the signatory investigator will fulfill at least one of the 
following criteria:

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 
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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.
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 (e.g., 
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 (e.g., 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 [e.g., 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 9.2.5 for reporting pregnancies).
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EVALUATING AES AND SAES
Assessment of Intensity
The intensity of AEs is determined by a physician and will use the following levels:

Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not 
interfering with everyday activities.

Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities.

Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with an SAE. Severe is a category utilized for rating the intensity of 
an event; both AEs and SAEs can be assessed as severe.
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
DEFINITIONS
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming post-menopausal 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. The duration of 
the washout period below are suggested guidelines and the investigators should use their 
judgement in checking serum FSH levels.

1 week minimum for vaginal hormonal products (rings, creams, gels)

4 week minimum for transdermal products

8 week minimum for oral products
Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/ml at any time during the washout period, the woman can be considered
postmenopausal.
End of Relevant Systemic Exposure

End of relevant systemic exposure is the time point where the IMP or any active major 
metabolites has 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 
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from the no-observed adverse effect level (NOAEL) or the time required for 5 half-lives of the 
IMP to pass.
METHODS OF CONTRACEPTION
For WOCBP, one of the “highly effective” or “less than highly effective” methods of contraception 
listed below should be commenced at least 30 days prior to initiation of study therapy and should 
be continued until at a minimum after the last dose of the study treatment.
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 (vaginal birth control suppositories, rings, creams, gels)

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 (IUD)

Intrauterine hormone-releasing system (IUS) (This method of contraception can only be 
used by WOCBP participants in studies where hormonal contraception is permitted by the 
study protocol)b,c

Bilateral tubal occlusion

Vasectomized partner

Having a vasectomized partner is a highly effective contraception method provided that the 
partner is the sole male sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be used.
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
Sexual abstinence
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study 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 (Schedule of Activities).

Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participants chooses to forego complete abstinence.

Periodic abstinence (including but not limited to calendar, symptothermal, post-ovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea 
method (LAM) are not acceptable methods of contraception for this study.
NOTES:
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent 
with local regulations regarding the use of contraceptive methods for participants participating 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.
c Intrauterine hormone releasing systems are acceptable methods of contraception in the absence of definitive drug 
interaction studies when hormone exposures from intrauterine devices do not alter contraception effectiveness.
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, post-ovulation methods)

Withdrawal(coitus interruptus)

Spermicide only

Lactation amenorrhea method (LAM)
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COLLECTION OF PREGNANCY INFORMATION
Guidance for collection of Pregnancy Information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.5 and the Appendix for Adverse Events and Serious 
Adverse Events Definitions and procedures for Evaluating, Follow-up and Reporting.
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APPENDIX 5
TUBERCULOSIS RISK ASSESSMENT TOOL
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deucravacitinib
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deucravacitinib
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APPENDIX 13
MAYO SCORE: COMPONENT SUBSCORES 
 
The Mayo score is a composite instrument designed to assess ulcerative colitis (UC) disease 
activity. It includes patient-reported outcomes (PROs), an objective assessment of disease activity 
by endoscopy, and a Physician’s Global Assessment (PGA). The Mayo score was first proposed 
by Schroeder et al.1 Scherl et al2 proposed that the Mayo score should be modified by removing 
“mild friability” from the definition of an endoscopic (ES) subscore = 1. This was supported by 
draft guidance from the US Food and Drug Administration (FDA) that states the presence of 
friability is not consistent with the concept of “clinical remission” (lines 249-251).3 Because the 
PGA is neither a PRO nor an objective assessment of disease activity, and the concept that it 
purports to measure is not distinct from the other components of the modified Mayo score, use of 
the PGA as a component of the modified Mayo score is no longer recommended by US3 or 
European regulatory authorities.4
Consequently, disease activity assessments for inclusion and efficacy assessment will use the 
9-point modified Mayo score (ie, excluding PGA). The PGA will continue to be captured as part 
of this study to facilitate the calculation of the total Mayo score, which will allow these data to be 
compared with previous clinical trials. Table 1 outlines the components and scoring used to
calculate the modified and total Mayo scores.
Table 1:
Components of the Modified and Total Mayo Scores
Stool Frequency (SF)a
0
Normal number of stools for this patient
1
1 to 2 stools/day more than normal
2
3 to 4 stools/day more than normal
3
> 4 stools/day more than normal
Rectal Bleeding (RB)b
0
None
1
Streaks of blood with stool less than half the time
2
Obvious blood with stool most of the time
3
Blood alone passed
Findings of flexible proctosigmoidoscopy (endoscopy used to determine endoscopic [ES] subscore)
0
Normal or inactive disease
1
Mild disease (erythema, decreased vascular pattern)c
2
Moderate disease (marked erythema, absent vascular pattern, friability, erosions)
3
Severe disease (spontaneous bleeding ulceration)
Physician’s Global Assessment (PGA) of Disease Activity (not included in the 9-point modified Mayo score)
0
Normal
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Table 1:
Components of the Modified and Total Mayo Scores
1
Mild disease
2
Moderate disease
3
Severe disease
a Each subject serves as his or her own control to establish the degree of abnormality of the stool frequency.
b The daily bleeding score represents the most severe bleeding of the day.
c The original description of the Mayo score included “mild friability” in an ES subscore = 1. The modified Mayo
score removed friability from an ES subscore = 0.
Adapted from: Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to 
moderately active ulcerative colitis. a randomized study. New Engl J Med 1987;317:1625-29.
MAYO SCORES: DEFINITIONS
Two different versions of the Mayo score will be used as efficacy endpoints:
Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points 
(inclusive), which is required for randomization, denotes moderate-to-severe disease (by protocol 
definition). The modified Mayo score is an adaptation of the total Mayo score (defined below) that 
excludes the PGA subscore.
The modified Mayo score incorporates the following 3 components:

Stool frequency (SF) subscore (0 to 3)

Rectal bleeding (RB) subscore (0 to 3)

Endoscopic (ES) subscore (0 to 3)
Total Mayo Score: The original total Mayo score incorporates all 4 components of UC severity 
listed in Table 1; each component subscore ranges from 0 to 3. The total Mayo score is a 12-point 
scale in which a higher score equals more severe disease. The modified and total Mayo scores will 
be calculated using component subscores entered into the electronic case report form (eCRF).
MAYO SCORES: SF AND RB COMPONENT SUBSCORES
SF and RB data will be 
 calculated 
.
Stool Frequency and Rectal Bleeding Subscores
 
 
 
 
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The following will be considered invalid data and excluded from SF and RB subscore calculations:
 
NOTE: Formal calculation of SF and RB subscores 
 
 
 will be calculated and used to represent 
SF and RB subscores in Mayo score determination; averages will be rounded up and down at the 
0.5 cutoff.
For the pre-endoscopy screening visit (ie, prior to the availability of 
 data)
from the parent study:
 
 
 
This baseline SF from the parent study is used as the reference for subsequent SF subscores in 
Study IM011077.
For the endoscopy screening visit:
The endoscopy obtained for the last visit on the parent study (IM011023, IM011024, or IM011127) 
will be used as the first endoscopy for Study IM011077. The following information should be used 
in the context of the parent study or when, for any reason, an endoscopy is being obtained prior to 
the first dose of deucravacitinib on Study IM011077: Best practice is to complete the other 
screening investigations first and check results to ensure that a subject continues to be potentially 
eligible for the study prior to commencing bowel preparation for the endoscopy. When the 
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endoscopy is scheduled, SF and RB data 
 from the 
 
the bowel preparation day for the endoscopy will be evaluated to ensure eligibility is maintained.
Following endoscopy, the ES subscore will be received via email from the central reader (Robarts 
Clinical Trials). This centrally read screening ES subscore will be entered into the eCRF, in 
addition to the SF and RB subscores, and the modified Mayo score calculated to determine subject 
eligibility.
For subsequent study visits at which Mayo scores are calculated:
For the annual visits, endoscopy timing should be reviewed prior to the visit to ensure adequate 
 are available for SF and RB subscore determination. The averages 
 
 
 prior to the bowel preparation day for the endoscopy will be used.
If adequate entries have not been made, the site should contact the subject to reschedule the visit, 
and the subject should be counseled about proper study procedures. Following endoscopy, ES 
subscores will be emailed from the central vendor as noted above and entered into the eCRF 
together with the SF and RB subscores to calculate the modified Mayo score for a given visit.
Missing Data:
Assessments with fewer 
 prior to 
the bowel preparation day for endoscopy are considered missing data and will not count toward 
assessment of disease activity during the screening period or for endpoint assessment.
 
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ES Subscore
ES subscores will be provided via email by the independent central endoscopy vendor (Alimentiv) 
for all eligibility and efficacy assessments, at all timepoints. The endoscopy procedure from 
screening (central read) will be used to determine the baseline (Week 0 [Day 1]) ES subscore 
component of the Mayo score. The ES subscores of the Mayo score will be modified 
 
.
Local assessment of the endoscopy will be utilized to derive the ES component of the Mayo score; 
this is used for determination eligibility. The central read of the endoscopy will be used for efficacy 
analysis at all timepoints.
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Physician’s Global Assessment
The investigator will directly provide the PGA at every required visit.
Physician’s Global Assessment (PGA)a
0
Normal
1
Mild disease
2
Moderate disease
3
Severe disease
a The PGA is not included in the modified Mayo score. It is included as a stand-alone assessment and as part of the 
total Mayo score.
©2011 Mayo Foundation for Medical Education and Research
REFERENCES:
1
Schroeder KW, Tremaine WJ, Ilstrup DM. Coated Oral 5-aminosalicylic Acid Therapy for Mildly to 
Moderately Active Ulcerative Colitis. A Randomized Study. N Engl J Med 1987;317(26):1625-9.
2
Scherl EJ, Pruitt R, Gordon GL, et al. Safety and Efficacy of a New 3.3 g b.i.d. Tablet Formulation in 
Patients with Mild-to-moderately-active Ulcerative Colitis: A Multicenter, Randomized, Double-blind, 
Placebo-controlled Study. Am J Gastroenterol 2009;104(6):1452-9.
3
US Department of Health and Human Services. Ulcerative colitis: clinical trial endpoints. Draft guidance 
for industry. Available from: https://www.fda.gov/files/drugs/published/Ulcerative-Colitis--Clinical-Trial-
Endpoints-Guidance-for-Industry.pdf. Published August 2016. Accessed 2020 Nov 12.
4
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on 
the Development of New Medicinal Products for the Treatment of Ulcerative Colitis. Available from: 
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-
products-treatment-ulcerative-colitis-revision-1_en.pdf. Published 2018 June 28. Accessed 2020 Nov 12.
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