A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Phase: PHASE2
Conditions: Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and  
Safety of Deucravacitinib (BMS-986165) in Participants with Active Discoid and/or Subacute  
Cutaneous Lupus Erythematosus (DLE/SCLE) 
 
NCT Number: NCT04857034 
Document Date (Date in which document was last revised): April 15, 2022 
 
 
 

Page:
1
Protocol Number:
IM011132
Date:
28-Aug-2020
Revised Date:
15-Apr-2022
REGULATORY AGENCY IDENTIFIER NUMBER(S)
IND Number: 134,253
EX-US: Non-IND
EUDRACT Number 2020-000071-21
Universal Trial Number U1111-1246-1726
CLINICAL PROTOCOL IM011132
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and 
Safety of Deucravacitinib (BMS-986165) in Participants with Active Discoid and/or Subacute 
Cutaneous Lupus Erythematosus (DLE/SCLE)
Brief Title:
A Phase 2 Clinical Study to Assess the Safety and Efficacy of Deucravacitinib in Participants 
with Active DLE and/or SCLE
Protocol Amendment 02
Incorporates Administrative Letter 02
Clinical Trial Physician-Medical Monitor
Bristol-Myers Squibb Company
Clinical Scientist 
Bristol-Myers Squibb Company
86 Morris Avenue
Summit, NJ 07901
3401 Princeton Pike
Lawrence Township, NJ 08648
Telephone (office): 
Telephone (office): 
24-hr Emergency Telephone Number
USA: 1-866-470-2267
International: +1-248-844-7390
Japan: 
Bristol-Myers Squibb Company
Route 206 & Province Line Road
Lawrenceville, NJ 08543
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
6-5-1 Nishi-Shinjuku, Shinjuku-ku,
Tokyo, 163-1327, Japan
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Protocol Amendment No.: 02
Date: 15-Apr-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).
© 2022 Bristol-Myers Squibb Company
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Protocol Amendment No.: 02
Date: 15-Apr-2022
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DOCUMENT HISTORY
Document
Date of Issue
Summary of Change
Protocol 
Amendment 02
15-Apr-2022
This protocol was amended to:

Permit past use of frequently used second-line therapies that are 
prescribed to treat discoid lupus erythematous (DLE) and/or 
subcutaneous lupus erythematous (SCLE) to allow participants 
whose disease was inadequately controlled with these second-line 
therapies to participate in this Phase 2 study with deucravacitinib.

Add details regarding serious acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2).

Incorporate changes from the approved Administrative Letter 02, 
which updates study contact information.
Administrative 
Letter 02
22-Jan-2021
The purpose of this letter is to change the Contact Information of the 
Medical Monitor
Revised Protocol 
01
01-Dec-2020

Minor typographical errors and clarifications throughout.
Administrative 
Letter 01 
11-Sept-2020

Added EUDRACT Number and Universal Trial Number to the 
original protocol.
Original Protocol
28-Aug-2020
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OVERALL RATIONALE FOR PROTOCOL AMENDMENT 02:
The overall rationale for Protocol Amendment 02 is:

Added details regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
As this is a rare disease population, the following revisions are expected to increase the likelihood
of enrollment of participants whose disease is inadequately controlled with standard of care 
treatment(s) and provide a more robust real world-like study population:

Frequently used second-line therapies that are prescribed to treat discoid lupus erythematous
(DLE) and/or subcutaneous lupus erythematous (SCLE) around the world were removed from
the list of prohibited medications. This revision to the list of prohibited medications and the
provision for a wash-out period prior to study screening will allow more participants whose
disease was inadequately controlled with these therapies to be considered to participate in this
study.

This amendment incorporates the changes from the approved Administrative Letter 02, which
is detailed in the Document History but not listed in the Summary of Key changes table below.

Minor formatting and typographical corrections have been made, therefore, they have not been
summarized.
This protocol amendment applies to all participants.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Title Page

Changed Clinical Trial 
Physician - Medical 
Monitor 
.

Changed Clinical Scientist 
.
To reflect updated personnel. 
Section 1: Protocol Summary
Updated text.
To align the summary with
updates made to the full 
protocol.
Table 2-1: Screening 
Procedural Outline 
(IM011132)
Added “eg.” to packs per day 
under history of marijuana and 
tobacco use.
To clarify that packs per day 
is an example of how to 
measure tobacco use.
Updated ‘Serious Adverse 
Events Assessment’ to 
‘Monitor for AEs and SAEs’ 
and added AEs to notes.
To include AEs in addition to 
SAEs.
Added to follicle stimulating 
hormone (FSH) testing that 
females under age 55 must 
have a serum FSH level > 40 
mIU/mL to confirm 
menopause.
To require FSH testing for 
any woman reported to be 
postmenopausal who is under 
the age of 55, unless 
surgically sterile. 
Added hepatitis B surface 
antibody (anti-HBs) to 
serology testing and updated 
hepatitis B core antibody (HBc 
AB) to anti-HBc.
To ensure consistency with 
Appendix 14: Interpretation 
of Hepatitis B Serologic Test 
Results.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Table 2-2: Placebo-
Controlled Treatment Period 
Procedural Outline Up to 
Week 16 (IM011132)
Added AEs to notes.
To include AEs in addition to 
SAEs.
Table 2-2: Placebo-
Controlled Treatment Period 
Procedural Outline Up to 
Week 16 (IM011132)
Table 2-3: Active Treatment 
Period Activities and 
Assessments (IM011132)
Section 3.2.1: Disease 
Background
Removed belimumab.
This is a clarification as 
belimumab is approved for 
SLE and works by a different 
mechanism of action from 
the other medications noted 
in this section.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Table 4-1: Objectives and 
Endpoints
Section 5.1.1: Screening 
Period
Section 5.1.2: Placebo-
controlled Treatment Period 
(Day 1 to Week 16)
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Section 6: Study Population 
Added language for protocol 
waivers 
.
To clarify that protocol 
waivers or exemptions are 
not permitted 
.
Section 6.1: Inclusion 
Criteria
Added introductory text to 
inclusion criterion 4.
To add details on 
investigator role for WOCBP 
and regulations.
Added inclusion criterion 4) j) 
to include that females under 
age 55 must have a serum FSH 
level > 40 mIU/mL to confirm 
menopause.
To require FSH testing for 
any woman reported to be 
postmenopausal who is under 
the age of 55, unless 
surgically sterile.
Updated inclusion criterion 4) 
k) for egg donation.
To add details for WOCBP 
regarding egg donation 
following receiving study 
product. 
Section 6.2: Exclusion 
Criteria
Updated exclusion criterion 3) 
f) to “not applicable” and
added 3) h) to remove irritable
bowel disease (IBD).
This is a correction as 
inflammatory bowel diseases 
are already excluded in 
criterion 2) b), which 
excludes any major illnesses 
or unstable gastrointestinal 
conditions. Irritable bowel 
syndrome (IBS) was never 
intended as exclusionary.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Updated exclusion criterion 3) 
d) to “not applicable” and
added 3) j) to change topical 
corticosteroid from mild to 
moderate potency.
To be consistent with 
Appendix 12: Topical 
Steroid Potency Table.
Updated exclusion criterion 3) 
h) to “not applicable” and
added 3) i) to change from 90
days to 60 days for receiving a
live vaccine.
To be consistent with SARS-
CoV-2 guidance.
Updated exclusion criterion 4) 
b) vi) to “not applicable” 
.
To allow for more eligible 
participants to be considered 
for participation 
.
Updated numbering for 
exclusion criterion 3) to 5) b) 
To rectify incorrect 
numbering.
Protocol Amendment No.: 02
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
and adjusted numbering for 
subsequent criteria.
Updated exclusion criterion 5)
a) iv) to “not applicable” and 
added 5) a) v) for Latent 
Tuberculosis Infection (LTBI).
To clarify the exception for 
those participants who are 
receiving prophylactic 
treatment for LTBI and the 
Clinical Trial 
Physician/Medical Monitor 
should be consulted on all 
LTBI cases.
Updated exclusion criterion 5) 
f) to “not applicable” and 
added additional new criteria 
with details for exclusionary 
infections prior to screening.
To clarify infections that 
should prevent enrollment.
Updated exclusion criterion 5) 
f) i) to “not applicable” and 
added a new note at the end of 
5) list of sub-criteria.
To clarify details regarding 
serious acute respiratory 
syndrome coronavirus 2 
(SARS-CoV-2) enrollment 
parameters.
Section 6.4.1: Retesting 
During Screening Period -
Rescreening
Clarified that participants can 
be rescreened twice.
To increase the likelihood of 
enrollment. 
Section 7.5: 
Preparation/Handling/
Storage/Accountability
Added details on investigator 
responsibility.
To clarify investigator 
responsibilities.
Section 7.7: Concomitant 
Therapy
Added topical medications.
This is a clarification as 
previous and current topical 
medications used for 
SCLE/DLE should be 
recorded in addition to the 
systemic medications.
Added details on previous and 
current DLE/SCLE and SLE
medications.
To clarify reporting 
requirements.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Section 7.7.1: Prohibited 
and/or Restricted Treatments
Removed reference to Section 
6.2 and moved details to 
Section 7.7.1.1: Prohibited 
Treatments and Section 
7.7.1.2: Restricted Treatments.
To clarify prohibited and 
restricted treatment.
Section 7.7.1.1: Prohibited 
Treatments
Added section.
To clarify which treatments 
are prohibited.
Section 7.7.1.2: Restricted 
Treatments
Added section.
To clarify which treatments 
are restricted.
Section 7.7.2: Permitted 
Background 
DLE/SCLE/SLE Therapies
Added “permitted” and 
“lupus” to section title.
To clarify therapies.
Section 7.7.2.1: 
Corticosteroid Therapy
Section 7.7.3: Rescue 
Therapy
Section 7.7.4: Permitted 
Vaccines (including COVID-
19 Vaccine)
Added section.
To clarify which vaccines are 
permitted.
Section 8.3: Lost to Follow-
Up
Added introductory language 
above bulleted list.
To clarify actions in bulleted 
list.
Protocol Amendment No.: 02
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Section 9.2: Adverse Events
Removed reference to 
Appendix 3 for contacts on 
serious adverse event (SAE) 
reporting and added to refer to 
Appendix 3 for details on SAE 
reporting.
To specify where additional 
details can be found for SAE 
reporting.
Section 9.2.1: Time Period 
and Frequency for Collecting 
AE and SAE Information
Added that AEs will be 
collected from the time of 
signing the consent.
To clarify that AEs in 
addition to SAEs are 
collected.
Removed that non-serious AEs 
should be collected from 
treatment initiation until safety 
follow-up visit.
To clarify that non-serious 
AEs are collected after 
informed consent is 
completed.
Added SARS-CoV-2 language.
To clarify procedures for 
SARS-CoV-2 events.
Section 9.4.5: Clinical 
Safety Laboratory 
Assessments
Added anti-HBs to serology 
testing and updated HBc AB to
anti-HBc.
To ensure consistency with 
Appendix 14: Interpretation 
of Hepatitis B Serologic Test 
Results.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Appendix 2: Study 
Governance Considerations
Updated language for Good 
Clinical Practice (GCP).
To reflect current GCP.
Removed that investigator 
should provide investigator 
brochure or product labelling 
to the institutional review 
board (IRB) and added specific 
investigator responsibilities.
To reflect current processes.
Updated investigator or 
representative process for 
informed consent.
To add details and clarify 
that the investigator or 
representative is responsible.
Added definitions and details 
for source documents.
To provide additional 
clarifications.
Updated first paragraph for 
monitoring to include remote 
monitoring. 
To allow for remote 
monitoring. 
Added new sections: BMS 
Commitment to Diversity in 
Clinical Trials and Data 
Protection, Data Privacy, and 
Data Security, Study and Site 
Start and Closures, 
Dissemination of Clinical 
Study Data, Assessment of 
Intensity.
To provide details on how 
study start and closures will 
occur, how clinical study 
data will be made available, 
to provide guidance for 
assessing AEs/SAEs, to add 
details on commitment to 
diversity in clinical trials, 
and to comply with European 
Clinical Trials Register (EU-
CTR) requirements.
Appendix 4: Women of 
Childbearing Potential 
Added introductory paragraph.
To provide clarity on 
contents for Appendix 4.
Protocol Amendment No.: 02
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02
Section Number & Title
Description of Change
Brief Rationale
Definitions and Methods of 
Contraception
Removed vaginal birth control
suppositories, creams, and gels
from intravaginal option.
To clarify that only rings are 
needed.
Appendix 25: Core and 
Extended ADME Gene List
Added that section is not 
applicable per Protocol 
Amendment 02.
Examples of ADME related 
genes were provided in 
protocol 
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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
DOCUMENT HISTORY .............................................................................................. 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 02: ............................ 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 ................ 
TABLE OF CONTENTS .............................................................................................. 
1 SYNOPSIS ................................................................................................................. 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
3 INTRODUCTION ..................................................................................................... 
3.1 Study Rationale ................................................................................................. 
3.2 Background ....................................................................................................... 
3.2.1 Disease Background ................................................................................ 
 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
5 STUDY DESIGN....................................................................................................... 
5.1 Overall Design .................................................................................................. 
5.1.1 Screening Period ...................................................................................... 
5.1.2 Placebo-controlled Treatment Period (Day 1 to Week 16) ..................... 
5.1.3 Active Treatment Period (Week 16 to Week 52) ...................................... 
5.1.4 Follow-up Period ..................................................................................... 
5.1.5 Data Monitoring Committee and Other Committees ............................... 
 
5.2 Number of Participants ..................................................................................... 
5.3 End of Study Definition .................................................................................... 
5.4 Scientific Rationale for Study Design............................................................... 
 
6 STUDY POPULATION ............................................................................................ 
6.1 Inclusion Criteria .............................................................................................. 
6.2 Exclusion Criteria ............................................................................................. 
6.3 Lifestyle Restrictions ........................................................................................ 
6.3.1 Exposure to Sunlight ................................................................................ 
6.3.2 Meals and Dietary Restrictions ............................................................... 
6.4 Screen Failures .................................................................................................. 
6.4.1 Retesting During Screening Period - Rescreening .................................. 
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........................................................................................ 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
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7.7.1.1 Prohibited Treatments .................................................................... 
 
7.7.1.2 Restricted Treatments ..................................................................... 
 
7.7.2 Permitted Background DLE/SCLE/SLE Therapies ................................. 
 
7.7.2.1 Corticosteroid Therapy ................................................................... 
 
7.7.2.2 Antimalarial Therapy ...................................................................... 
 
7.7.2.3 Immunosuppressant Therapy .......................................................... 
 
7.7.2.4 Nonsteroidal Anti-inflammatory Drugs and Narcotic Analgesics .. 
 
7.7.3 Rescue Therapy ........................................................................................ 
 
7.7.4 Permitted Vaccines (Including COVID-19 Vaccine) ............................... 
 
 
 
8 DISCONTINUATION CRITERIA ........................................................................... 
 
8.1 Discontinuation from Study Treatment ............................................................ 
 
8.1.1 Post Study Treatment Study Follow-up.................................................... 
 
8.2 Discontinuation from the Study ........................................................................ 
 
8.3 Lost to Follow-Up ............................................................................................. 
 
9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
 
9.1 Efficacy Assessments ........................................................................................ 
 
9.1.1 Cutaneous Lupus Erythematosus Disease Area and Severity Index 
(CLASI) ....................................................................................................... 
 
 
 
 
9.1.4 Skin Biopsy ............................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
 
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 ......................................... 
 
 
 
9.2.6 Pregnancy ................................................................................................ 
 
9.2.7 Laboratory Test Result Abnormalities ..................................................... 
 
9.2.8 Potential Drug Induced Liver Injury (DILI) ............................................ 
 
9.2.9 Other Safety Considerations .................................................................... 
 
9.3 Overdose ........................................................................................................... 
 
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9.4 Safety ................................................................................................................ 
9.4.1 Physical Examinations ............................................................................. 
9.4.2 Tuberculosis Screening and Chest X-ray ................................................. 
9.4.3 Vital signs................................................................................................. 
9.4.4 Electrocardiograms ................................................................................. 
9.4.5 Clinical Safety Laboratory Assessments .................................................. 
9.4.6 Imaging Safety Assessment ...................................................................... 
9.9 Health Economics OR Medical Resource Utilization and Health Economics . 
10 STATISTICAL CONSIDERATIONS .................................................................... 
 
10.2 Populations for Analyses ................................................................................ 
10.3 Statistical Analyses ......................................................................................... 
10.3.1 Efficacy Analyses ................................................................................... 
10.3.2 Safety Analyses....................................................................................... 
 
10.3.4 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 8 CUTANEOUS LUPUS ERYTHEMATOSUS DISEASE AREA AND 
SEVERITY INDEX (CLASI)................................................................................. 
APPENDIX 9 COMMONLY USED CORTICOSTEROID EQUIVALENTS ........... 
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APPENDIX 10 DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL 
DISORDERS IV ..................................................................................................... 
 
 
 
APPENDIX 12 TOPICAL STEROID POTENCY TABLE ......................................... 
 
 
 
APPENDIX 14 INTERPRETATION OF HEPATITIS B SEROLOGIC TEST 
RESULTS ............................................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 25 CORE AND EXTENDED ADME GENE LIST ................................ 
 
APPENDIX 26 
 DISCOID LUPUS CLASSIFICATION CRITERIA
................................................................................................................................. 
 
APPENDIX 27 PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY
................................................................................................................................. 
 
 
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BMS-986165
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SYNOPSIS
Protocol Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate 
Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants with Active Discoid 
and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Brief Title: A Phase 2 Clinical Study to Assess the Safety and Efficacy of Deucravacitinib in 
Participants with Active DLE and/or SCLE
Study Phase: 2
Rationale:
This Phase 2 study will assess if deucravacitinib (BMS-986165) is biologically active and 
potentially effective in the treatment of participants with moderate to severe discoid lupus 
erythematosus and/or subacute cutaneous lupus erythematosus (DLE/SCLE) with or without 
systemic lupus erythematosus (SLE), that is inadequately controlled with standard of care therapy.
Study Population:
Male and female participants (18 to 75 years of age) must have a biopsy-confirmed clinical 
diagnosis of DLE/SCLE, and inadequate response, defined as therapeutic failure or intolerance to 
an oral corticosteroid, and/or antimalarial and/or immunosuppressant.
Key Inclusion Criteria:

Participants must have a diagnosis of DLE/SCLE for at least 3 months prior to Screening Visit.

Participants must meet both clinical and histopathological diagnostic cutaneous lupus
erythematosus (CLE) criteria per protocol.

Participants are required to have active moderate to severe cutaneous disease based on the
Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
≥8 at Screening AND Baseline Visit (Day 1).

Participants must currently be receiving treatment for DLE/SCLE with a stable regimen of at
least one of the following medications: oral corticosteroid, and/or antimalarial, and/or
immunosuppressant.
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IM011132
BMS-986165
Deucravacitinib
Key Exclusion Criteria:

Participants with any of the following specific CLE subtypes in isolation: acute cutaneous 
lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains.

Participants with forms of drug-induced CLE and/or drug-induced SLE.

Participants with active kidney disease, defined as an estimated glomerular filtration rate 
(eGFR) of < 60 mL/min/1.7 m2 and/or proteinuria > 0.5 g/24 h (spot urine protein/creatinine 
ratio [UPCR]: > 56.5 mg/mmol).

Participants with antiphospholipid antibody syndrome (APS), serious thrombotic event (eg, 
pulmonary embolism, saddle embolism, stroke, deep vein thrombosis) or unexplained 
pregnancy loss within 1 year before the Screening Visit. Participants with a history of 3 or 
more unexplained consecutive pregnancy losses suspected due to APS.

Participants with active severe or unstable neuropsychiatric SLE including, but not limited to, 
aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, 
transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; 
impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial 
neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex.

Participants with other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory 
bowel disease [IBD], etc) with the exception of those with Type 1 autoimmune diabetes 
mellitus, thyroid autoimmune disease, celiac disease, or secondary Sjögren's syndrome.

Participants with other non-SLE driven inflammatory joint or skin disease or overlap 
syndromes as primary disease (eg, dermatomyositis, fibromyalgia, polymyositis, scleroderma, 
mixed connective tissue disease, rosacea, sarcoidosis, Sjögren’s syndrome) that in the opinion 
of the investigator will significantly impact the assessment of CLE/SLE disease manifestations 
and activity. 
Objectives and Endpoints:
The objectives and endpoints for the primary and secondary analyses of this study are shown in 
Table 1.
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BMS-986165
Deucravacitinib
Table 1:
Objectives and Endpoints
Objectives
Endpoints
Primary 
To evaluate the effect of two doses of 
deucravacitinib (3 mg BID and 6 mg BID) 
compared with placebo on CLASI-A score at 
Week 16.
Percentage change from baseline in CLASI activity (CLASI-
A) score at Week 16.
Secondary 
To evaluate additional clinical measures of 
cutaneous disease manifestations with two doses of 
deucravacitinib (3 mg BID and 6 mg BID) 
compared with placebo at Week 16.

Percentage of participants with an improvement of ≥50% 
from baseline in the CLASI-A score (CLASI-50).

Percentage of participants who have disease improvement 
as defined by a reduction in CLASI-A of ≥4 points from 
baseline.

Mean change from baseline in CLASI-A score.

Percentage of participants who have a Complete Response 
(CR) on CLASI-A defined as a score of “0”.
Safety
To assess the safety and tolerability of two doses of 
deucravacitinib (3 mg BID and 6 mg BID) 
compared with placebo.

Number and proportion of participants experiencing SAEs, 
AEs (with severity and relationship of AEs), and 
abnormalities in laboratory testing, vital signs, and 12-lead 
ECGs.
Abbreviations: AEs = adverse events; BID = twice a day; CLASI = cutaneous lupus erythematosus disease area and 
severity index; CLASI-50 = improvement of ≥ 50% from baseline in the CLASI-A score; CLASI-A = cutaneous lupus 
erythematosus disease area and severity index-activity; CR = complete response; ECGs = electrocardiograms; 
SAEs = serious adverse events.
Overall Design:
This is a Phase 2 randomized, placebo-controlled, double-blind, multicenter study to evaluate the 
safety and efficacy of deucravacitinib 3 mg BID and 6 mg BID given orally in participants with 
moderate to severe active DLE/SCLE, which may or may not be associated with SLE.
Participants must have a biopsy-confirmed clinical diagnosis of DLE/SCLE, and inadequate 
response, defined as therapeutic failure or intolerance to an oral corticosteroid, and/or antimalarial 
and/or immunosuppressant. 
Participants must be on stable background DLE/SCLE therapy, which includes one oral 
corticosteroid, and/or one antimalarial and/or one immunosuppressant, taken alone or in 
combination. 
The study consists of 4 Periods:
1) Screening Period: up to 4 weeks (28 days).
2) Placebo-controlled Treatment Period: 16 weeks (Day 1 to Week 16).
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IM011132
BMS-986165
Deucravacitinib
3) Active Treatment Period: 36 weeks (Week 16 to Week 52).
4) Follow-up Period: 4 weeks from last dose of study treatment (28 days). 
All randomized participants will be encouraged to participate in an additional 
.
Screening Period:
After signing the Informed Consent Form (ICF), participants are considered "enrolled" in the 
study, and will enter the Screening Period. During the 28-day screening period, participants will 
complete the study procedures and screening assessments as outlined in the Schedule of Activities 
to determine if they continue to meet eligibility criteria. If eligibility parameters cannot be obtained 
within the 28-day period, the Screening Period may be extended by up to 7 calendar days, if 
approved by the Clinical Trial Physician/Medical Monitor.
Placebo-Controlled Treatment Period (Day 1 to Week 16): 
CLASI-A assessment must be performed for eligibility at Screening and Baseline (Day 1) prior to 
randomization for confirmation of minimally required disease activity (CLASI-A ≥8). Following 
confirmation of enrolment eligibility by the PI 
, participants will 
be randomized at a 1:1:1 ratio to receive:

Deucravacitinib 3 mg BID 

Deucravacitinib 6 mg BID

Deucravacitinib-matching Placebo BID.
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IM011132
BMS-986165
Deucravacitinib
Participants will be evaluated at study visits every 4 weeks through Week 16. 
Active Treatment Period (Week 16 to Week 52):
Participants who complete the placebo-controlled treatment period will continue into an active 
treatment period for an additional 36 weeks of treatment.
At Week 16, participants receiving placebo during the placebo-controlled treatment period will be 
re-randomized 1:1 in a blinded-fashion to receive active treatment with either deucravacitinib 3 mg 
BID or 6 mg BID until Week 52. Participants receiving deucravacitinib 3 mg BID or 6 mg BID 
through Week 16 will continue the originally randomized treatment in a blinded manner through 
Week 52.
Post-Treatment Follow-up Period: 
All participants will be followed for 28 days (± 3 days) after the last dose of study treatment for 
safety monitoring.
Number of Participants: 
Approximately 75 participants are expected to be randomized. 
Treatment Arms and Duration:
Study treatment: Participants in all treatment groups will take oral doses of investigational 
product (IP) for the 52-week treatment period as presented in Table 2.
Table 2: Study Treatments
Medication
Dose
IP/Non-IP
deucravacitinib BID
3 mg or 6 mg
IP
Placebo BID
Not applicable
IP
Abbreviations: BID = twice a day; IP = Investigational Product; Non-IP = Non-investigational Product.
Notes: In all treatment groups, participants will take their randomly assigned treatment twice daily. No titration or 
modification of IP doses is permitted.
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IM011132
BMS-986165
Deucravacitinib
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IM011132
BMS-986165
Deucravacitinib
Data Monitoring Committee:
A Data Monitoring Committee (DMC) with multi-disciplinary representation will be established 
to evaluate safety data (eg, AEs, laboratory parameters) on a periodic basis  to ensure the ongoing 
safety of study participants and the overall benefit/risk for the study is maintained. The DMC 
responsibilities, authorities, and procedures will be documented and followed according to the 
DMC charter.
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BMS-986165
Deucravacitinib
2
SCHEDULE OF ACTIVITIES
Schedules of assessments and procedures are described in Table 2-1 for the screening period, Table 
2-2 for the placebo-controlled treatment period up to Week 16, and Table 2-3 for the active 
treatment period (up to Week 52), End of Treatment (EOT) Visit, and Safety Follow-up.
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BMS-986165
Deucravacitinib
Table 2-1:
Screening Procedural Outline (IM011132)
Procedurea
Screening
Visit (28 daysb)
Notes
Eligibility Assessments
Informed Consent
X
A participant is considered enrolled only when a protocol-specific informed consent is signed. 
Study allows for re-enrollment of a participant that has discontinued the study as a pretreatment 
failure. If re-enrolled, the participant must be re-consented and assigned a new participant number 
from IRT. See Section 6.4.
Eligibility Assessment
X
Inclusion/Exclusion Criteria
X
See full inclusion/exclusion criteria (see Sections 6.1 and 6.2).
DLE, SCLE, SLE Medical History
X
Disease-specific history will include a detailed CLE and SLE history including previous 
laboratory results and histopathology.
Prior/Concomitant Medications 
X
Documentation of background therapy.
Restricted medications are detailed 
. Medications restricted at screening are 
described in Section 6.2.
General Medical History
X
Include any toxicities or allergy related to previous treatments.
History of Tobacco and Marijuana Use
X
Type(s) of substance; nonsmoker, light or heavy smoker, volume (eg, packs per day) and duration, 
and state if actively using substance or year discontinued (if inactive). 
Prior/Surgeries and Procedures
X
Include prior surgeries and procedures.
Safety Assessments
Complete Physical Examination
X
General, head, eyes, ears, nose, throat, neck, cardiovascular, lungs, abdominal, extremities, 
neurologic, psychiatric, skin, and musculoskeletal.
Vital Signs, Height, Weight
X
Body temperature, blood pressure and heart rate should be measured seated after at least 5 
minutes of rest.
BMI
X
Calculated based on weight and height.
12-lead ECG
X
ECGs should be recorded after the participant has been supine for at least 5 minutes. 
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BMS-986165
Deucravacitinib
Table 2-1:
Screening Procedural Outline (IM011132)
Procedurea
Screening
Visit (28 daysb)
Notes
Chest X-ray (PA and Lateral)
X
Can be performed within 6 months prior to the Screening Visit with documentation on file.
Monitor for AEs And SAEs
X
AE and SAE collection begins from the signing of the informed consent.
Laboratory Tests
Pregnancy Test (Urine)
X
For WOCBP only.
FSH
X
Women only, if needed to confirm postmenopausal status. Females under the age of 55 years must 
have a serum follicle stimulating hormone level > 40 mIU/mL to confirm menopause.
Chemistry, Hematology, Urinalysis, and 
Coagulation Tests
X
Includes blood and urine samples. See Section 9.4.5.
Spot Urine for Protein:Creatinine Ratio
X
See Section 6.2, Exclusion Criteria, 1), c).
Tuberculosis screening
X
See Section 9.4.2.
Serology
X
Hepatitis C antibody, anti-HBs, HBsAg, anti-HBc, HIV-1, and HIV-2 antibody. 
C3, C4, Anti-dsDNA
X
Disease Assessment
CLASI 
X
Refer to Appendix 8.
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BMS-986165
Deucravacitinib
Table 2-1:
Screening Procedural Outline (IM011132)
Procedurea
Screening
Visit (28 daysb)
Notes
Abbreviations: anti-dsDNA =anti-double stranded deoxyribonucleic acid (antibody); anti-HBs = anti-hepatitis B surface antibody; BMI = body mass index; 
C3 = complement 3; C4 = complement 4; CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index; CLE = cutaneous lupus erythematosus; 
DLE = discoid lupus erythematosus;
 ECG(s) = electrocardiograms; 
anti-HBc = hepatitis B core antibody; 
HBsAg = hepatitis B surface antigen; 
 HIV = human immunodeficiency virus; 
 
IRT = Interactive Response Technology; PA = posterioranterior; 
SAE = serious adverse event; SCLE = subacute cutaneous lupus 
erythematosus; SLE = systemic lupus erythematosus; 
 WOCBP = women of 
childbearing potential.
a Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. Some of the safety assessments 
intended to be used as safety monitoring by the treating physician may not be captured as data in the CRF. 
b Screening procedures should be performed within the 28 day window prior to Day 1. If eligibility parameters cannot be obtained within this time period, the 
screening period may be extended by up to 7 calendar days if approved by the Clinical Trial Physician/Medical Monitor.
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IM011132
BMS-986165
Deucravacitinib
Table 2-2:
Placebo-Controlled Treatment Period Procedural Outline Up to Week 16 (IM011132)
Procedurea
D1
(Baseline)
W4
D29
(±3d)
W8
D57
(±3d)
W12
D85
(±3d)
W16
D113
(±3d)
Notes:
Participants who discontinue treatment at any 
time prior to Week 52 should proceed to the 
EOT/ET visit Table 2-3). The Safety Follow-
up visit will occur 28 days ±3 days after last 
treatment visit (Table 2-3).
Eligibility Assessments
Eligibility / Randomization
X
Confirm eligibility criteria and complete 
Baseline assessments prior to randomization. 
Re-randomized for Active 
Treatment Period
X
Only participants on placebo will be 
re-randomized, but IRT will be contacted for 
all participants to maintain the blind.
Safety Assessments
Complete Physical Examination
X
X
General, head, eyes, ears, nose, throat, neck, 
cardiovascular, lungs, abdominal, extremities, 
neurologic, psychiatric, skin, musculoskeletal.
Targeted Physical Examination
X
X
X
As clinically indicated.
Concomitant Medications
X
X
X
X
X
Vital Signs 
X
X
X
X
X
Includes body temperature, body weight, 
respiratory rate, and blood pressure and heart 
rate.
12-lead ECG
X
X
ECGs should be recorded after the participant 
has been supine for at least 5 minutes.
Pregnancy Test (Urine)
X
X
X
X
X
For WOCBP only.
Monitor for AEs and SAEs
Continuously
AE and SAE collection begins from the 
signing of the informed consent.
Laboratory Tests
Hematology, Serum Chemistry 
Panel
X
X
X
X
X
See Section 9.4.5.
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IM011132
BMS-986165
Deucravacitinib
Table 2-2:
Placebo-Controlled Treatment Period Procedural Outline Up to Week 16 (IM011132)
Procedurea
D1
(Baseline)
W4
D29
(±3d)
W8
D57
(±3d)
W12
D85
(±3d)
W16
D113
(±3d)
Notes:
Participants who discontinue treatment at any 
time prior to Week 52 should proceed to the 
EOT/ET visit Table 2-3). The Safety Follow-
up visit will occur 28 days ±3 days after last 
treatment visit (Table 2-3).
 Lipid Panel and Glucose
X
X
X
Predose, after at least 
. See 
Section 9.4.5.
Spot Urine for Protein:Creatinine 
Ratio
X
X
X
X
X
See Section 9.4.5.
Urinalysis
X
X
X
X
X
C3, C4, Anti-dsDNA
X
X
X
X
X
Anti-dsDNA will be collected only for 
participants with antibodies elevated above 
normal at Screening.
Efficacy Assessments
CLASI
X
X
X
X
X
Refer to Appendix 8. 
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IM011132
BMS-986165
Deucravacitinib
Table 2-2:
Placebo-Controlled Treatment Period Procedural Outline Up to Week 16 (IM011132)
Procedurea
D1
(Baseline)
W4
D29
(±3d)
W8
D57
(±3d)
W12
D85
(±3d)
W16
D113
(±3d)
Notes:
Participants who discontinue treatment at any 
time prior to Week 52 should proceed to the 
EOT/ET visit Table 2-3). The Safety Follow-
up visit will occur 28 days ±3 days after last 
treatment visit (Table 2-3).
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IM011132
BMS-986165
Deucravacitinib
Table 2-2:
Placebo-Controlled Treatment Period Procedural Outline Up to Week 16 (IM011132)
Procedurea
D1
(Baseline)
W4
D29
(±3d)
W8
D57
(±3d)
W12
D85
(±3d)
W16
D113
(±3d)
Notes:
Participants who discontinue treatment at any 
time prior to Week 52 should proceed to the 
EOT/ET visit Table 2-3). The Safety Follow-
up visit will occur 28 days ±3 days after last 
treatment visit (Table 2-3).
Clinical Drug Supplies
Dispense IP
X
X
X
X
X*
*If a participant will continue to the Active 
Treatment Period, study drug will be 
dispensed at Week 16/D113.
IP Accountability/
Study Treatment Compliance
X
X
X
X
Unused IP collected.
Abbreviations: AEs = adverse events; anti-dsDNA = anti-double stranded deoxyribonucleic acid (antibody); C3 = complement 3; C4 = complement 4; 
CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index; 
 
ECG(s) = electrocardiogram(s);
 IP = Investigational Product; IRT = Interactive Response Technology;
 SAEs = serious adverse 
events; 
 WOCBP = women of child bearing potential.
a Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. Some of the safety assessments 
intended to be used as safety monitoring by the treating physician may not be captured as data in the CRF.
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BMS-986165
Deucravacitinib
Table 2-3:
Active Treatment Period Activities and Assessments (IM011132)
Procedurea
W20
D141
(±3d)
W24
D169
(±3d)
W28
D197
(±3d)
W40
D281
(±3d)
EOT/ETb,c
W52
D365
(±3d)
Safety FUb,c.
W56
D393
(±3d)
Notes
Safety Assessments
Complete Physical 
Examination
X
X
General, head, eyes, ears, nose, throat, neck, 
cardiovascular, lungs, abdominal, extremities, 
neurologic, psychiatric, skin, musculoskeletal.
Targeted Physical 
Examination
X
X
X
X
General, extremities, skin, musculoskeletal, and 
others as clinically indicated.
Concomitant Medications
X
X
X
X
X
X
Vital Signs 
X
X
X
X
X
X
Includes body temperature, body weight, respiratory 
rate, and seated blood pressure and heart rate. 
12-lead ECG
X
X
ECGs should be recorded after the participant has 
been supine for at least 5 minutes.
Pregnancy Test (Urine)
X
X
X
X
X
X
For WOCBP only.
Monitor for AEs and SAEs
Continuously
See Section 9.2.
Laboratory Tests
Predose.
Hematology, Serum 
Chemistry Panel 
X
X
X
X
X
X
See Section 9.4.5.
 Lipid Panel and 
Glucose
X
X
X
X
X
X
Predose, after at least 
. See Section 
9.4.5.
Urinalysis
X
X
X
X
X
X
See Section 9.4.5.
Spot Urine for 
Protein:Creatinine Ratio
X
X
X
X
X
X
See Section 9.4.5.
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BMS-986165
Deucravacitinib
Table 2-3:
Active Treatment Period Activities and Assessments (IM011132)
Procedurea
W20
D141
(±3d)
W24
D169
(±3d)
W28
D197
(±3d)
W40
D281
(±3d)
EOT/ETb,c
W52
D365
(±3d)
Safety FUb,c.
W56
D393
(±3d)
Notes
C3, C4, Anti-dsDNA
X
X
X
X
X
X
Anti-dsDNA will be collected only for participants
with antibodies elevated above normal at Screening.
Efficacy Assessments
CLASI
X
X
X
X
X
X
Refer to Appendix 8.
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IM011132
BMS-986165
Deucravacitinib
Table 2-3:
Active Treatment Period Activities and Assessments (IM011132)
Procedurea
W20
D141
(±3d)
W24
D169
(±3d)
W28
D197
(±3d)
W40
D281
(±3d)
EOT/ETb,c
W52
D365
(±3d)
Safety FUb,c.
W56
D393
(±3d)
Notes
Clinical Drug Supplies
Dispense IP 
X
X
X*
X*
*IP dispensed at Week 28 and Week 40 will cover a 
12 week duration. 
IP Accountability/
Study Treatment Compliance
X
X
X
X
X
Unused IP collected.
Abbreviations: AEs = adverse events; anti-dsDNA = anti-double stranded deoxyribonucleic acid (antibody); C3 = complement 3; C4 = complement 4;
 CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index; 
ECG(s) = electrocardiograms; EOT = end of treatment; ET = early termination; FU = follow-up 
(period); IP = Investigational Product; 
 SAEs = serious adverse events; 
 WOCBP = women of child bearing potential.
a Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. Some of the safety assessments 
intended to be used as safety monitoring by the treating physician may not be captured as data in the CRF.
b EOT/ET visit for participants who discontinue treatment any time prior to completing Week 52 of active treatment period. Safety FU visit occurs 28 days ±3 
days after the last dose of study treatment.
c
 
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BMS-986165
Deucravacitinib
3
INTRODUCTION
Deucravacitinib (BMS-986165) is the first, potent, orally bioavailable small molecule, selective 
tyrosine kinase 2 (TYK2) inhibitor with a novel, unique mechanism of action that is being 
proposed as a therapy to modulate the dysregulated immune response in autoimmune diseases. 
TYK2 activates signal transducer and activator of transcription (STAT)-dependent transcription 
and functional responses downstream of critical immune mediators, such as interleukin (IL)-12, 
IL-23, and Type I and III interferons (IFNs). Deucravacitinib inhibits TYK2 through a novel 
allosteric mechanism, binding to the unique pseudokinase Janus kinase (JAK) homology 2 (JH2) 
domain, rather than binding directly to the active site on the kinase domain, which differentiates 
deucravacitinib from other inhibitors of the closely related JAK 1-3 of kinases. Deucravacitinib
mechanism of action (MOA) results in the blockade of receptor-mediated activation of TYK2 and 
inhibition of downstream pathways (IL-23, IL-12, and Type I IFNs), and the cytokine networks 
they modulate (eg, IL-17, IL-22, IFN-γ). 1 Genetic evidence implicates TYK2 in the 
pathophysiology of multiple immune-mediated diseases. Those most relevant to this protocol are 
Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), specifically 
Subacute Cutaneous Lupus (SCLE) and Discoid Lupus Erythematosus (DLE).2
Lupus Erythematosus (LE) is a multi-organ autoimmune disease of unknown etiology that can 
have clinical manifestations ranging from mild, localized cutaneous involvement to systemic 
involvement with severe, life threatening internal organ damage. The prevalence of SLE in the 
United States (US) is about 102 to 150 cases per 100,000.3 CLE includes a broad range of 
dermatologic manifestations, which may or may not be associated with SLE, and the prevalence 
of CLE in the US is about 70 to 73 cases per 100,000. The skin is involved in 70% to 85% of LE 
cases and may be the only organ system involved in isolated CLE.4 Epidemiologically, CLE is 
consistently more prevalent in females than males, and there appears to be racial differences among 
CLE patients, with African Americans having a 5.4-fold higher risk for DLE than Caucasians.5,6
Factors that aggravate CLE include sun exposure, cigarette smoking, hormone fluctuation, viral 
infection, and certain drug exposures. The diagnosis of CLE is made using a combination of 
clinical assessments, serologic testing, and histopathologic findings. Gilliam and Sontheimer 
proposed the classification of LE lesions into specific lesions, which are further categorized into 
acute cutaneous lupus erythematosus (ACLE), SCLE, and/or chronic cutaneous lupus 
erythematosus (CCLE).7,8
3.1
Study Rationale
Tyrosine kinase 2 activates intracellular STAT -dependent transcription and functional responses 
downstream of receptors for critical immune mediators, such as interleukin (IL)-12, IL-23, IL-10, 
and Type I and III IFNs.9,10,11
. 
These immune and inflammatory signaling pathways are critical in the pathophysiology of various 
immune-mediated diseases including psoriasis, lupus, spondyloarthritis, inflammatory bowel 
disease (IBD), dermatomyositis, and Type I interferonopathies. 12 ,13 Deucravacitinib potently 
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inhibits IL-23-, IL-12-, IL-10-, and Type I/III IFN-driven responses and has demonstrated proof 
of mechanism in mouse models of autoimmunity (psoriasis, colitis, and SLE) and in healthy 
humans.13,14
There is increased expression of type I IFN-regulated proteins in the blood and target tissues of 
patients with CLE and SLE. A polymorphism in IFN regulatory factor 5 (IRF5) is seen in SLE, 
SCLE and DLE skin biopsy samples.2 It has been documented that patients with SCLE and DLE 
have elevated IFN-I scores (expression level of the five genes are expressed as a cumulative IFN 
score) compared with healthy controls regardless of concomitant SLE. The IFN-I score of 
participants with SCLE or DLE with and without concomitant SLE have been shown to correlate 
with Cutaneous Lupus Area and Severity Index (CLASI) activity score.15 These finding support a 
shared pathogenesis of DLE and/or SCLE (DLE/SCLE) with SLE. Based on the demonstration of 
elevated type I IFN-regulated gene expression in DLE/SCLE, TYK2 inhibitors may be useful for 
the treatment of DLE/SCLE with and without SLE.
This Phase 2 study will assess if deucravacitinib is biologically active and potentially effective in 
the treatment of patients with moderate to severe DLE/SCLE (with or without SLE), that is 
inadequately controlled with standard of care therapy.
3.2
Background
TYK2, a member of the JAK family, catalyzes the phosphorylation of STAT-proteins downstream 
of the receptors for the p40-containing cytokines IL-12 and IL-23 as well as the Type I IFN 
receptor, resulting in the activation of STAT-dependent transcription and functional responses 
specific for those receptors. Deucravacitinib is a first-in-class orally administered small molecule 
inhibitor of TYK2 that has been shown to be superior to blockade of the Type I IFN receptor in an 
IFN-dependent mouse model of SLE. TYK2-dependent cytokines (eg, IL-12, IL-23 and Type I 
IFNs) are distinct from those dependent on closely related JAK family members JAK1, JAK3 (eg, 
IL-2, IL-15, IL-7, IL-6) or JAK2 (eg, erythropoietin, thrombopoietin, and granulocyte-monocyte 
colony-stimulating factor). Consequently, a TYK2 inhibitor is expected to have a highly 
differentiated profile from inhibitors of closely related JAK 1-3 kinases.
Deucravacitinib has a unique mode of binding that provides the high selectivity over the other 
members of the JAK family of non-receptor tyrosine kinases. Deucravacitinib binds to the 
regulatory pseudokinase domain of TYK2, stabilizing an inhibitory interaction between the 
pseudokinase and the catalytic domains of the enzyme, the result of which is blockade of receptor-
mediated activation of TYK2 and inhibition of downstream functions in cells and in vivo. The 
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binding mode of deucravacitinib takes advantage of unique structural features of the TYK2 
pseudokinase domain compared with other kinases and pseudokinases to provide high biochemical 
and cellular functional selectivity. This approach differentiates deucravacitinib from nonselective 
inhibitors of the JAK family of kinases that target the highly conserved active site of the kinase 
domain. Deucravacitinib is an orally administered selective TYK2 inhibitor. In vitro and in vivo 
data for deucravacitinib supports the development of this compound in humans. 
3.2.1
Disease Background
The clinical spectrum of CLE is broad, ranging from isolated discoid plaques to widespread skin 
lesions. Histological, skin lesions present as interface dermatitis (inflammation of the skin in the 
dermal-epidermal junction mediated by anti-epidermal responses), which is orchestrated by both 
innate and adaptive immune pathways that are strongly activated in the formation of skin lesions.
Cutaneous LE is comprised of 3 different subtypes based on clinical presentation and 
histopathology: ACLE, SCLE and CCLE. CCLE is further subdivided and includes DLE, LE 
profundus (LEP), chilblain LE (CHLE), and LE tumidus (LET).20
ACLE may present in a localized or generalized form and is frequently (~90%) associated with 
active SLE. Malar rashes have been reported to be present in up to 52% of SLE patients at the time 
of diagnosis, with clinical activity of the rash paralleling that of the systemic disease.21 The 
localized form is the malar or butterfly rash and the generalized, photosensitive maculopapular 
rash occurs above and below the neck. 
SCLE lesions typically occur on visible sun exposed areas of the body, including the upper thorax, 
upper back, and the extensor surfaces of arms and forearms, and the lesions are highly light 
sensitive. There are two morphologic variants of SCLE, annular and papulosquamous. The annular 
type is characterized by scaly annular erythematous plaques, which tend to coalesce and produce 
a polycyclic array. The papulosquamous variant can resemble eczema or psoriasis, as well as 
pityriasis in some instances.21 An estimated 50% of SCLE patients meet criteria for SLE. 
DLE is the most common form of CCLE, which can be either localized or generalized. The 
localized form, characterized by the limited cutaneous involvement of the head and scalp, usually 
accounts for 70% of DLE, and the generalized form (characterized by the extension to more than 
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the head-body area)22 accounts for 30% of DLE. DLE lesions appear as a well-demarcated, scaly, 
erythematous macule or papule, which gradually develops into an indurated discoid plaque with 
an adherent scale. Treatment resistant discoid lesions cause scarring of the affected skin areas and 
permanent scarring alopecia, which can lead to significant disfigurement. Over time, these lesions 
typically become atrophic, with hyperpigmentation peripherally and depigmentation centrally. 
Approximately 50% of DLE patients are classified as having DLE without SLE; of these, 
approximately 25% have moderate to severe skin disease.22
As UV light has been implicated in the initiation and exacerbation of lesions, photo-protective 
measures including the use of broad-spectrum sunscreens, protective clothing, and wigs are highly 
recommended to prevent exacerbation of lesions.
Along with lifestyle changes, treatment with topical corticosteroids are frequently used; however,
long term use is discouraged due to recognized adverse effects such as atrophy, telengiactasiae, 
striae, and purpura. 
Topical calcineurin inhibitors (such as tacrolimus ointment and pimecrolimus cream) are not 
approved for the treatment of CLE, but are an established therapeutic alternative to corticosteroids 
in CLE. Unlike corticosteroids, these inhibitors do not induce skin atrophy as an adverse effect, 
but they are also less effective.
Antimalarials, such as hydroxychloroquine, chloroquine, and quinacrine represent first-line 
systemic CLE treatment. Hydroxychloroquine is the only systemic treatment approved for DLE. 
Antimalarials have varied levels of effectiveness (up to 45% of patients treated with antimalarials 
require an additional treatment) and 25% of patients remain refractory to available therapies.22,23,24
Other unapproved systemic treatments utilized include prednisone, tacrolimus, mycophenolate 
mofetil, methotrexate, azathioprine, and other cytokine-blocking agents.
Effective control of DLE/SCLE is difficult due to the disease heterogeneity among individuals and 
variability in skin manifestations. There have been few double-blind placebo controlled studies in 
the DLE/SCLE patient population where the lack of safe, effective, well-tolerated medications 
clearly remains an unmet need. The immunosuppressive and immunomodulatory agents have 
varied levels of effectiveness and are associated with serious adverse reactions and dose-limiting 
toxicities. Given the limitations associated with currently used unapproved therapies for active 
DLE/SCLE, there remains an unmet medical need for effective and safe agents.
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4
OBJECTIVES AND ENDPOINTS
The objectives and endpoints for the primary, secondary, 
 analyses of this study 
are shown in Table 4-1.
Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
Primary 
To evaluate the effect of two doses of deucravacitinib
(3 mg BID and 6 mg BID) compared with placebo on 
CLASI-A score at Week 16.
Percentage change from baseline in CLASI activity 
(CLASI-A) score at Week 16.
Secondary 
To evaluate additional clinical measures of cutaneous 
disease manifestations with two doses of deucravacitinib
(3 mg BID and 6 mg BID) compared with placebo at 
Week 16.

Percentage of participants with an improvement of 
≥50% from baseline in the CLASI-A score (CLASI-
50).

Percentage of participants who have disease 
improvement as defined by a reduction in CLASI-A 
of ≥4 points from baseline.

Mean change from baseline in CLASI-A score.

Percentage of participants who have a Complete 
Response (CR) on CLASI-A defined as a score of 
“0”.
Safety
To assess the safety and tolerability of two doses of 
deucravacitinib (3 mg BID and 6 mg BID) compared with 
placebo.

Number and proportion of participants experiencing 
SAEs, AEs (with severity and relationship of AEs), 
and abnormalities in laboratory testing, vital signs, 
and 12-lead ECGs.
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Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
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Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
Abbreviations: AEs = adverse events; 
 BID = twice a day; 
 CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index; 
CLASI-50 = 50% improvement from baseline in CLASI-A score; CLASI-A = CLASI activity;
 
CR = complete response;
 
ECGs = electrocardiograms;
 SAEs = serious 
adverse events; 
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5
STUDY DESIGN
5.1
Overall Design
This is a Phase 2 randomized, placebo-controlled, double-blind, multicenter study to evaluate the 
safety and efficacy of deucravacitinib 3 mg BID and 6 mg BID given orally in participants with 
moderate to severe active DLE/SCLE, which may or may not be associated with SLE.
Participants must have a biopsy-confirmed clinical diagnosis of DLE/SCLE, and inadequate 
response, defined as therapeutic failure or intolerance to an oral corticosteroid, and/or antimalarial 
and/or immunosuppressant. 
Participants must be on stable background DLE/SCLE therapy, which includes one oral 
corticosteroid, and/or one antimalarial and/or one immunosuppressant, taken alone or in 
combination. 
The study consists of 4 Periods:
1) Screening Period: up to 4 weeks (28 days; see Section 2).
2) Placebo-controlled Treatment Period: 16 weeks (Day 1 to Week 16; see Section 5.1.2).
3) Active Treatment Period: 36 weeks (Week 16 to Week 52; see Section 2).
4) Follow-up Period: 4 weeks from last dose of study treatment (28 days; see Section 5.1.4). 
All randomized participants will be encouraged to participate in an optional substudy, evaluating 
biomarkers based on skin biopsies obtained during the study.
Eligible participants will be randomized 1:1:1 to receive one of the following treatments for the 
first 16 weeks:

Deucravacitinib 3 mg BID

Deucravacitinib 6 mg BID

Deucravacitinib-matching Placebo BID
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Physical examinations, vital sign measurements, 12-lead electrocardiograms (ECG), and clinical 
laboratory evaluations will be performed at selected times throughout the dosing interval. 
Participants will be closely monitored for adverse events throughout the study. 
.
5.1.1
Screening Period
After signing the Informed Consent Form (ICF), participants are considered "enrolled" in the 
study, and they enter the screening period. During the 28-day screening period, participants will 
complete the study procedures and screening assessments as outlined in the Schedule of Activities 
(Table 2-1) to determine if they continue to meet eligibility criteria. If eligibility parameters cannot 
be obtained within the 28-day period, the screening period may be extended by up to 7 calendar 
days, if approved by the Clinical Trial Physician/Medical Monitor.
Eligibility will be based on specified inclusion and exclusion criteria (Section 6).
5.1.2
Placebo-controlled Treatment Period (Day 1 to Week 16)
CLASI-A assessment must be performed for eligibility at Screening and Baseline (Day 1) prior to 
randomization for confirmation of minimally required disease activity (CLASI-A ≥8). Following 
confirmation of enrolment eligibility by the PI 
 participants 
will be randomized at a 1:1:1 ratio to receive:

Deucravacitinib 3 mg BID 

Deucravacitinib 6 mg BID

Deucravacitinib-matching Placebo BID.
Participants will be evaluated at study visits every 4 weeks through Week 16 (Table 2-2).
5.1.3
Active Treatment Period (Week 16 to Week 52)
Participants who complete the placebo-controlled treatment period will continue into an active 
treatment period for an additional 36 weeks of treatment.
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At Week 16, participants receiving placebo during the placebo-controlled treatment period will be 
re-randomized 1:1 in a blinded-fashion to receive active treatment with either deucravacitinib 3 mg 
BID or 6 mg BID until Week 52. Participants receiving deucravacitinib 3 mg BID or 6 mg BID 
through Week 16 will continue on the originally randomized treatment in a blinded manner 
through Week 52 (Table 2-3).
5.1.4
Follow-up Period 
All participants will be followed for 28 days (± 3 days) after the last dose of study treatment for 
safety monitoring (Table 2-3).
5.1.5
Data Monitoring Committee and Other Committees
A Data Monitoring Committee (DMC) with multi-disciplinary representation will be established 
to evaluate safety data (eg, AEs, laboratory parameters, etc.) and a favorable benefit/risk for the 
study is maintained. The DMC responsibilities, authorities, and procedures will be documented 
and followed according to the DMC charter.
5.2
Number of Participants
Approximately 75 participants will be randomized in a 1:1:1 ratio to receive deucravacitinib 3 mg 
BID, deucravacitinib 6 mg BID, or deucravacitinib-matching Placebo BID. Sample size 
considerations are described 
.
5.3
End of Study Definition
The start of the trial is defined as the first visit for first participant screened. End of trial is defined 
as the last visit or scheduled procedure shown in the Schedule of Activities for the last participant. 
Study completion is defined as the final date on which data for the primary endpoint was or is 
expected to be collected, if this is not the same. 
5.4
Scientific Rationale for Study Design
The primary purpose of the study is to estimate the treatment effect of deucravacitinib in 
participants with DLE/SCLE. CLASI will be the key efficacy assessment to provide clinical 
evidence of response to deucravacitinib in the CLE population. The primary endpoint will be the 
percent change from baseline in CLASI-A score at Week 16.  
CLASI is a validated instrument that is used in lupus clinical trials to quantify disease activity and 
damage in CLE. CLASI was assessed for content validity, inter-rater validity and intra-rater 
validity, and performed well in all of these aspects.29 CLASI can be used to categorize patients 
into severity groups and to identify clinically significant improvements in disease activity.  
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CLASI consists of two separate scores to allow for descriptions of both disease activity (CLASI-
A) and damage (CLASI-D). This differentiation permits easily quantifiable assessments of activity 
in short-term studies, as well as assessments of disease-induced damage in longer-term studies. 
CLASI-A has been used in large Phase 2 and 3 SLE trials to document efficacy in cutaneous 
disease manifestations in participants with lupus.19,30,31 Randomized, double-blind, placebo-
controlled studies in DLE/SCLE and SLE have included percent change from baseline in CLASI-
A as a primary efficacy measures.39
A placebo control is included up to Week 16 to allow the effects of treatment, both desired and 
adverse, to be appropriately attributed to treatments received, taking into account that all 
participants must be on a stable dose of background therapy for DLE/SCLE consisting of 
antimalarial and/or an immunosuppressant and /or oral corticosteroids 
.
The 16 weeks placebo-controlled treatment duration of this study is considered optimal to assess 
potential clinical benefits of deucravacitinib in DLE/SCLE while minimizing the duration of 
treatment with placebo. This duration is consistent with other studies that evaluated the effect of 
investigational treatment in CLE such as the Phase 2 LILAC Study of BIIB059 in Participants with 
Active Cutaneous Lupus Erythematosus.39
The overall treatment duration of 52 weeks is considered necessary to assess the durability of 
therapy benefits, taking into account the chronic nature of CLE and its waxing and waning course, 
and to obtain 1-year safety data with deucravacitinib.
To study a broader and “real-world” CLE patient population, the study will enroll participants who 
have active disease despite exposure to one or more of a large spectrum of CLE therapies, such as 
oral steroids, antimalarial and/or immunosuppressant. 
The eligibility and randomization criteria and procedures 
are 
designed to ensure that participants have the correct diagnosis and expected level of cutaneous 
lupus disease activity that could benefit from additional treatment with investigational drug. 
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6
STUDY POPULATION
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
participants.
All screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria. The investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure, as 
applicable. 
 However, all laboratory testing must be performed by the study-
specific central laboratory.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted.
For entry into the study, the following criteria MUST be met.
6.1
Inclusion Criteria
1) Signed Written Informed Consent
a) Participants must be willing to participate in the study and sign the ICF.
b) Participants must be willing and able to complete all study-specific procedures and visits.
2) Type of Participant and Target Disease Characteristics
a) Participants must have a diagnosis of DLE/SCLE for at least 3 months prior to Screening 
Visit.
b) Participants must meet both clinical and histopathological diagnostic CLE criteria:
i)
Clinical diagnosis of active DLE/SCLE 
.
Participants with or without concurrent SLE diagnosis are eligible. 
- AND -
ii) Not applicable per Protocol Amendment 02: Biopsy-proven histology consistent 
with DLE/SCLE (based on Gilliam classification
), confirming 
the clinical diagnosis. 
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c) Participants are required to have active moderate to severe cutaneous disease
3) Background Therapies/Concomitant Medications for DLE/SCLE
a) Participants must currently be receiving treatment with a stable regimen of at least one of 
the following medications: an oral corticosteroid, and/or an antimalarial, and/or an 
immunosuppressant per the protocol (see Section 7.7.2 for Background Medications).
4) Age and Reproductive Status
a) Men and women aged 18 (or age of majority) to 75 years at screening.

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.
Female Participants:
b) Women who are not of childbearing potential (as defined in Appendix 4) are exempt from 
contraceptive requirements.
c) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test 
(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin 
[HCG]) within 24 hours prior to the start of study treatment. If a urine test cannot be 
confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In 
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such cases, the participant must be excluded from participation if the serum pregnancy 
result is positive.
d) Additional requirements for pregnancy testing during and after study intervention are 
located in Section 2, Schedule of Assessments.
e) 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.
f)
Women must not be pregnant, lactating, breastfeeding or be planning pregnancy during 
the study period 
g) Not applicable per Protocol Amendment 02: Women of childbearing potential 
(WOCBP) must agree to use highly effective (with a failure rate of <1% per year) 
method(s) of contraception, preferably with low user dependency, as described in 
Appendix 4, during the study period until the end of the study. 
Note: 
(1) Not applicable per Protocol Amendment 02: Local laws and regulations may 
require use of alternative and/or additional contraception methods; additionally, 
alternative and/or additional contraceptive may be required eg, based on 
background DMARDS the participant may be taking, such as methotrexate, 
mycophenolate mofetil, etc. 
(2) Not applicable per Protocol Amendment 02: WOCBP who are continuously not 
heterosexually active are also exempt from contraceptive requirements, but must 
still undergo pregnancy testing as described in this section. 
h) WOCBP are permitted to use hormonal contraception methods (as described in Appendix 
4).
Male Participants:
i)
Male participants should maintain their usual practice with regard to contraception (if 
any); however, no specific contraceptive measures are required.
Note: 
Local laws and regulations may require use of alternative and/or additional contraception methods; 
additionally, alternative and/or additional contraceptive may be required eg, based on background 
DMARDS the participant may be taking, such as methotrexate, mycophenolate mofetil, etc. 
j)
Females under the age of 55 years must have a serum follicle stimulating hormone (FSH) 
level > 40 mIU/mL to confirm menopause.
k) WOCBP must agree to use a contraceptive method that is highly effective (with a failure 
rate of < 1% per year), with low user dependency, as described in Appendix 4 during the 
intervention period and for at least 33 days and agree not to donate eggs (ova, oocytes) 
for the purpose of reproduction for the same time period.
Note: 
(1) Local laws and regulations may require use of alternative and/or additional 
contraception methods; additionally, alternative and/or additional contraceptive 
may be required (eg, based on background DMARDS the participant may be 
taking, such as methotrexate, mycophenolate mofetil, etc). 
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(2) WOCBP who are continuously not heterosexually active are exempt from 
contraceptive requirements, but must still undergo pregnancy testing as described 
in this section. 
6.2
Exclusion Criteria
The presence of any of the following will exclude a participant from enrollment. 
1) Target Disease Exclusion
a) Participants with any of the following specific CLE subtypes in isolation: ACLE, lupus 
tumidus, lupus (profundus) panniculitis, chilblains.
b) Participants with forms of drug-induced CLE and/or drug-induced SLE  
c) Participants with active kidney disease, defined as an estimated glomerular filtration rate 
(eGFR) of < 60 mL/min/1.7 m2 and/or proteinuria > 0.5 g/24 h (spot urine 
protein/creatinine ratio [UPCR]: > 56.5 mg/mmol).
d) Participants with antiphospholipid antibody syndrome, serious thrombotic event (eg, 
pulmonary embolism, saddle embolism, stroke, deep vein thrombosis) or unexplained 
pregnancy loss within 1 year before the Screening Visit. Participants with a history of 3 
or more unexplained consecutive pregnancy losses.
e) Participants with active severe or unstable neuropsychiatric SLE including, but not limited 
to, aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes 
(ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute 
confusional state; impaired level of consciousness; psychosis; acute stroke or stroke 
syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis 
multiplex.
f)
Not applicable per Protocol Amendment 02: Participants with other autoimmune 
diseases (eg, multiple sclerosis, psoriasis, irritable bowel disease [IBD], etc) with the 
exception of those with Type 1 autoimmune diabetes mellitus, thyroid autoimmune 
disease, celiac disease, or secondary Sjögren's syndrome.
g) Participants with other non-SLE driven inflammatory joint or skin disease or overlap 
syndromes as primary disease (eg, dermatomyositis, fibromyalgia, polymyositis, 
scleroderma, mixed connective tissue disease, rosacea, sarcoidosis, Sjögren’s syndrome)
that in the opinion of the investigator will significantly impact the assessment of CLE/SLE
disease manifestations and activity.
h) Participants with other autoimmune diseases (eg, multiple sclerosis, psoriasis, etc) with 
the exception of those with Type 1 autoimmune diabetes mellitus, thyroid autoimmune 
disease, celiac disease, or secondary Sjögren's syndrome.
2) Other Medical History and Conditions 
a) Women who are pregnant or breastfeeding.
b) Any major illness/condition or evidence of an unstable clinical condition (eg, renal, 
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric) 
or local active infection/infectious illness that, as determined by investigator, will 
substantially increase the risk to the participant if he or she participates in the study.
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c) Any major surgery within the last 30 days before the first dose of study treatment, or any 
surgery planned during the course of the study.
d) Participants with cancer or history of cancer or lymphoproliferative disease within the 
previous 5 years except for:
i)
treated (eg, cured) basal cell or squamous cell in situ skin carcinomas
ii) treated (eg, cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix 
with no evidence of recurrence within 5 years of the Screening Visit.
e) Class III or IV congestive heart failure as defined by the New York Heart Association 
(NYHA) or any recent onset of heart failure resulting in NYHA Class III/IV symptoms.
f)
Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and/or any 
history of significant cerebrovascular disease within 24 weeks before Screening Visit.
g) Current or recent (within 3 months before Screening Visit) gastrointestinal disease, 
including gastrointestinal surgery, that could impact the absorption of study treatment.
h) Participant with non-SLE concomitant illness, as determined by investigator, who is likely 
to require additional systemic glucocorticosteroid therapy during the study (eg, asthma).
i)
Significant blood loss (> 500 mL) or blood transfusion within 4 weeks before Screening 
Visit.
j)
Inability to take medication orally.
k) Inability to undergo venipuncture and/or tolerate venous access.
l)
Any other sound medical, psychiatric, and/or social reason as determined by investigator.
m) Recent (within 6 months before randomization) drug or alcohol abuse as defined by the 
Diagnostic Criteria for Drug and Alcohol Abuse in the Diagnostic and Statistical Manual 
of Mental Disorders IV (Appendix 10).
n) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity). 
o) History of congenital or acquired immunodeficiency.
3) Prior and Concomitant Therapy
b) Required discontinuation periods to allow previous exposure to other immunomodulatory 
or biologic drugs are provided 
. If a drug is not specifically listed, consult 
the medical monitor for guidance. Participant has enrolled in a clinical trial and has 
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received an investigational product within 5 pharmacokinetic half-lives or one month, 
whichever is longer, prior to the Screening Visit.
c) Inability to comply with restrictions and prohibited treatments (Section 7.7.1); inability to 
comply with medication discontinuation requirements listed 
.
d) Not applicable per Protocol Amendment 02: Participant has used high or mild potency 
topical corticosteroids (WHO Class 1-5) [refer to Appendix 12], intralesional CS topical 
immunosuppressants (calcineurin inhibitors), or topical retinoids within 2 weeks prior to 
Screening Visit.
e) Participant has used intramuscular, intralesional/intradermal, intra-articular, intrabursal, 
and/or intravenous (IV) CS within 6 weeks prior to Screening Visit. 
f)
Participants using modified-release oral CS formulations.
g) Participants using drugs inducing cutaneous lupus erythematosus 
.
h) Not applicable per Protocol Amendment 02: Participants that have received a live 
vaccine within 90 days or an inactivated vaccine within 30 days before Screening Visit.
i)
Participants that have received live vaccine within 60 days prior to Screening Visit.
j)
Participant has used high or moderate potency topical corticosteroids (WHO Class 1-5;
refer to Appendix 12), topical immunosuppressants (calcineurin inhibitors), or topical 
retinoids within 2 weeks prior to Screening Visit.
4) Physical and Laboratory Test Findings
a) Clinically significant abnormalities on chest X-ray or ECG at Screening Visit.
b) Clinically significant abnormalities in laboratory tests at Screening Visit including the 
following: 
i)
Serum 
alanine 
aminotransferase 
(ALT) 
> 2× 
ULN
or 
serum 
aspartate 
aminotransferase (AST) > 2× ULN. 
ii) Serum total bilirubin > 1.5× ULN, unless due to documented Gilbert's syndrome. 
iii) Hemoglobin < 9 g/dL (90 g/L). 
iv) Estimated glomerular filtration rate < 60 mL/min. 
v) Absolute white blood cell count < 2.0 × 103/μL (2.0 × 109/L).
vii)Any other significant laboratory or procedure abnormalities, as determined by 
investigator that might pose unacceptable risk to the participant during the study.
 
5) Findings Related to Possible Infection
a) Participants with any of the following tuberculosis (TB) criteria:  
i)
History of active TB prior to Screening Visit, regardless of completion of adequate 
treatment.
ii) Signs or symptoms of active TB (eg, fever, cough, night sweats, and weight loss) 
during Screening as judged by the investigator.
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iii) Any imaging of the chest (eg, chest x-ray, chest computed tomography scan) obtained 
during the Screening period or anytime within 6 months prior to Screening with 
documentation, showing evidence of current active or history of active pulmonary TB.
iv) Not applicable per Protocol Amendment 02: Latent TB infection (LTBI) defined as 
positive IGRA, by QuantiFERON-TB Gold testing at Screening, in the absence of 
clinical manifestations.
Not applicable per Protocol Amendment 02: Note: Participants are eligible if:
There are no current signs or symptoms of active TB.
-AND-
(1) Not applicable per Protocol Amendment 02: Participant has received adequate 
documented treatment for LTBI within 5 years of Screening.
-OR-
(2) Not applicable per Protocol Amendment 02: Participant has initiated 
prophylactic treatment for LTBI per local guidelines. 
(a) Not applicable per Protocol Amendment 02: Participants not currently on 
prophylactic treatment per local guidelines, including participants that have 
documented completed treatment within 5 years of Screening: indeterminate 
results of initial IGRA with no signs or symptoms of active TB must be retested 
for confirmation. 
(i) Not applicable per Protocol Amendment 02: If the second test is again 
indeterminate, the participant will be excluded from the study. If the retest 
is positive, the participant will be excluded. If the retest is negative, the 
participant may be eligible provided no other exclusion criteria for TB are 
met. 
(b) Not applicable per Protocol Amendment 02: Participants that are on 
prophylactic treatment for LTBI per local guidelines, and there are no current 
signs or symptoms of active TB, retesting of an initial positive or indeterminate 
result is not required and participants may be eligible provided no other 
exclusion criteria for TB are met, and participants continue to complete 
treatment for LTBI per local guidelines
v) Latent TB infection (LTBI) defined as positive IGRA, by QuantiFERON-TB Gold 
testing at Screening, in the absence of clinical manifestations, or known positive 
Quantiferon-TB Gold testing by history
Note: Participants may be eligible if: 
(1) There are no current signs or symptoms of active TB 
-AND-
(2) Participant has received adequate documented treatment for LTBI within 5 years 
of screening
OR
(3) Participant has initiated prophylactic treatment for LTBI per local guidelines and 
is rescreened after 1 month of treatment. To continue in the study, the participant 
must agree to complete a locally recommended course of treatment for LTBI. The 
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BMS Clinical Trial Physician/Medical Monitor should be consulted on all LTBI
cases.
Note: An IGRA test that is indeterminate with no signs or symptoms of active TB must be 
retested for confirmation. If the second result is indeterminate, the participant will be excluded 
from the study. If the retest is negative, the participant may be eligible provided no other 
exclusion criteria for TB are met. If the retest is positive, the participant may be treated as 
having LTBI with initiation of prophylactic treatment (as above).
(4) Not applicable per Protocol Amendment 02: Participants with evidence of 
hepatitis B or hepatitis C infection determined by serologic testing (described in 
Section 9.4.5) at Screening Visit will be excluded. Participants with isolated 
positive hepatitis B surface antibody are not excluded (refer to Appendix 14). 
b) Not applicable per Protocol Amendment 02: Positive for human immunodeficiency 
virus (HIV) by antibody testing (HIV-1 and -2 Ab) at Screening Visit. Note: Participants 
who are newly found to be HIV-positive should be directed to appropriate follow-up care.
c) Not applicable per Protocol Amendment 02: Currently on any therapy for chronic 
infection (eg, pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, invasive 
bacterial or fungal infections, or atypical mycobacteria).
d) Not applicable per Protocol Amendment 02: Known active infection, or any major 
episode of infection requiring hospitalization or treatment with parenteral (intramuscular 
or IV) antimicrobial agents (eg, antibiotics, antiviral, antifungal, or antiparasitic agents) 
within 30 days of randomization, or completion of oral antimicrobial agents within 2 
weeks of randomization.
e) Not applicable per Protocol Amendment 02: Previous history of herpes zoster, herpes 
simplex, or influenza infection within 12 weeks before randomization or a history of 
disseminated/complicated herpes zoster infection (multidermatomal involvement, 
ophthalmic zoster, central nervous system involvement, or post-herpetic neuralgia).
f)
Not applicable per Protocol Amendment 02: Severe infection within 4 weeks prior to 
screening.
i)
Not applicable per Protocol Amendment 02: Additionally, in the case of prior 
SARS-CoV-2 infection, symptoms must have completely resolved and based on 
investigator assessment in consultation with the clinical trial physician, there are no 
sequelae that would place the participant at a higher risk of receiving investigational 
treatment. 
g) Participants with evidence of hepatitis B or hepatitis C infection determined by serologic 
testing (described in Section 9.4.5) at Screening Visit will be excluded. Participants with 
isolated positive hepatitis B surface antibody are not excluded (refer to Appendix 14). 
h) Positive for human immunodeficiency virus (HIV) by antibody testing (HIV-1 and -2 Ab) 
at Screening Visit. Note: Participants who are newly found to be HIV positive should be 
directed to appropriate follow-up care.
i)
Currently on any therapy for chronic infection (eg, pneumocystis, cytomegalovirus, 
herpes simplex, herpes zoster, invasive bacterial or fungal infections, or atypical 
mycobacteria).
j)
Known active infection, or any major episode of infection requiring hospitalization or 
treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics, 
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antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or 
completion of oral antimicrobial agents within 2 weeks of randomization.
k) Previous history of herpes zoster, herpes simplex, or influenza infection within 12 weeks 
before randomization or a history of disseminated/complicated herpes zoster infection
(multidermatomal involvement, ophthalmic zoster, central nervous system involvement, 
or post-herpetic neuralgia).
l)
Known active infection, or any major episode of infection requiring hospitalization or 
treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics, 
antiviral, antifungal, or antiparasitic within 4 weeks prior to screening.
Note: In the case of prior SARS-CoV-2 infection, symptoms must have completely 
resolved and based on investigator assessment, that could place the participant at risk when 
receiving IP. SARS-CoV 2 testing may be conducted prior to randomization if required by 
and in accordance with national, local, or institutional guidelines.
6) Other Exclusion Criteria
a) Inability to abstain from the use of tanning salons or prolonged intentional sun exposure 
from Screening to Week 52. Usual and reasonable sunlight exposure during daily 
activities is acceptable.
b) 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.
c) Participants who are compulsorily detained for treatment of either a psychiatric or 
physical (eg, infectious disease) illness.
6.3
Lifestyle Restrictions
6.3.1
Exposure to Sunlight
Every precaution needs to be taken to limit excessive sun exposure though out the duration of the 
study. General skin care measures are recommended that are standard for patients with CLE and 
SLE, as follows: use of broad spectrum sunscreen (minimum sun protection factor 30 and with 
inorganic ingredients (zinc oxide, titanium dioxide), avoiding sun exposure, wearing sun-
protective clothing, avoidance of alcohol-based emollients, avoidance of over-the-counter anti-
acne medications and alcohol-based skin care products, and avoidance of perfumed soaps and 
detergents, and similar measures. Participants should avoid tanning (including tanning salons), 
sunbathing, and outdoor activities that require prolonged or extensive sun exposure.
6.3.2
Meals and Dietary Restrictions
Not applicable.
6.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized in the study/included in the analysis population. A minimal set 
of screen failure information is required to ensure transparent reporting of screen failure 
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participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing 
requirements, as applicable, and to respond to queries from regulatory authorities. Minimal 
information includes date of consent, demography, screen failure details, eligibility criteria, and 
any serious AEs.
6.4.1
Retesting During Screening Period - Rescreening
For laboratory parameters and/or assessments that initially do not meet eligibility requirements, a 
single retest within the 28 day screening period is permitted in an effort to find all possible 
well--qualified participants. Consultation with the Clinical Trial Physician/Medical Monitor may 
be needed to identify whether repeat testing of any particular parameter is clinically relevant.
The study permits the rescreening (after the end of the initial 4-week Screening Period) of a 
participant who discontinues the study as a pretreatment failure (ie, the participant fails screening 
or randomization and has not been treated). The participant must be re-consented and will be 
assigned a new identification number, and a full Screening Visit must be performed again. 
A participant can be rescreened twice (ie, if the participant fails 2 rescreening attempts, no 
additional rescreening is allowed). Depending on the timing of rescreening, repetition of some 
assessments may not be required. Duration of existing treatments and required discontinuation 
periods shall be considered relative to the given Screening Visit and/or randomization.
Laboratory parameters and/or assessments that are included in Table 2-1, Screening Procedural 
Outline, may be repeated in an effort to find all possible well-qualified participants. Consultation 
with the Clinical Trial Physician/Medical Monitor may be needed to identify whether repeat testing 
of any particular parameter is clinically relevant.
The most current result prior to randomization is the value by which study inclusion will be 
assessed, as it represents the participant’s most current clinical state.
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: 
deucravacitinib, background medications, and placebo. Information about the pharmacology and 
previous experience with deucravacitinib is provided in Section 3.2.
An investigational product, also known as investigational medicinal product 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.
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Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered as 
non-investigational products.
Study treatment descriptions including dosage form, potency, IP/non-IMP, and storage conditions 
are presented in Table 7-1.
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Table 7-1:
Study Treatments for IM011132
Product Description / 
Class and Dosage Form
Potency
IP/Non-IMP
Blinded or 
Open Label
Packaging / Appearance
Storage Conditions
(per label)
Deucravacitinib Oral Tablet
3 mg or 6 mg
IP
Blinded
Store 15 to 25°C;
Protect from light;
Store in original container.
Deucravacitinib-matching 
Placebo Oral Tablet
Not applicable
IP
Blinded
Store 15 to 25°C;
Protect from light;
Store in original container.
Note: Background therapies will be obtained as per participant’s local standard of care.
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7.1
Treatments Administered
The selection and timing of dose for each participant are presented in Table 7.1-1.
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
Deucravacitinib
(3 mg tablet)
3 mg BID
1 active and 1 placebo tablet in the 
morning and 1 active and 1 placebo 
tablet in the evening.
Oral
Deucravacitinib
(6 mg tablet)
6 mg BID
1 active and 1 placebo tablet in the 
morning and 1 active and 1 placebo 
tablet in the evening.
Oral
Deucravacitinib-matching 
Placebo (oral tablet)
BID
2 placebo tablets in the morning and 
2 placebo tablets in the evening.
Oral
Abbreviation: BID = twice a day.
Blinded study treatment will be supplied 
 at each study visit. The tablets will be 
arranged into sets to be taken in the morning and in the evening, approximately 12 hours apart.
The participant should be instructed to take 2 tablets in the morning and 2 tablets in the evening.
Study treatment may be taken with or without food. If a scheduled dose of study drug is missed 
and the participant remembers within 4 hours of the scheduled dose time, the dose should be taken 
as soon as possible. If the missed dose is remembered later than 4 hours after the scheduled dose 
time, the dose should be skipped and the next dose taken at the appropriate time. Any missed doses 
should be returned at the next study visit.
7.2
Method of Treatment Assignment
At the time of the Screening Visit, immediately after informed consent is obtained and before any 
study-related procedures are performed, the investigative site will access the enrollment option 
utilizing Interactive Response Technology (IRT) for assignment of a participant number (including 
participants not subsequently randomized or treated). This number will be unique across all sites. 
Enrolled participants, including those not dosed, will be assigned sequential participant numbers. 
The participant number may not be used for any other participant. If a potential participant is 
rescreened, they will be given a new identification number.
Eligible participants will be centrally randomized using IRT to receive oral treatment with 
deucravacitinib 3 mg BID, 6 mg BID, or deucravacitinib-matching Placebo BID in accordance 
with stratification criteria (see Section 5.1). At the Week 16 study visit, the participants initially 
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assigned to receive Placebo and who agree to continue study participation will be re-randomized 
by the IRT to receive oral treatment with either deucravacitinib 3 mg BID or 6 mg BID until Week 
52. Re-randomized participants will receive a new randomization number prior to dosing. 
Before the study is initiated, each user (at investigative sites) will receive log-in information and 
directions on how to access the IRT. Treatment codes will be assigned prior to dosing.
7.3
Blinding
This is a randomized, double-blind, placebo-controlled study. During the placebo-controlled 
period and the active treatment period, the IP will remain blinded, to prevent study personnel and 
participants from knowing the IP assignment. For the 
database lock, BMS personnel who 
have access to the unblinded data are not to discuss or make materials available that would unblind 
individual participant data to the personnel involved in the study conduct
. A 
separate blinding charter will detail the unblinding process. Access to treatment codes will be 
restricted from all participants and site personnel prior to final database lock, with exceptions as 
specified below.
Blinding of treatment assignment is critical to the integrity of this clinical study. However, in the 
event of a medical emergency or pregnancy in an individual participant in which knowledge of the 
investigational product is critical to the participant's management, the blind for that participant
may be broken by the investigator. The participant’s safety takes priority over any other 
considerations in determining if a treatment assignment should be unblinded.
Before breaking the blind of an individual participant's treatment, the investigator should 
determine that the unblinded information is necessary, ie, that it will alter the participant's 
immediate management. In many cases, particularly when the emergency is clearly not related to 
the investigational product, the problem may be properly managed by assuming that the participant
is receiving active product. It is highly desirable that the decision to unblind treatment assignment 
be discussed with the Clinical Trial Physician/Medical Monitor, but the investigator always has 
ultimate authority for the decision to unblind. The actual TASK of unblinding can be delegated by 
the investigator to a designee assigned the task on the Delegation of Authority. The Principal 
Investigator or appointed designee should access IRT for emergency unblinding AFTER the 
decision to unblind the participant has been documented.
For this study, the method of unblinding for emergency purposes is IRT. The method of unblinding 
for emergency purposes is described in the IRT manual. In cases of accidental unblinding, contact 
the Clinical Trial Physician/Medical Monitor and ensure every attempt is made to preserve the 
blind. Any request to unblind a participant for non-emergency purposes should be discussed with 
the Clinical Trial Physician/Medical Monitor.
Designated staff of Bristol-Myers Squibb Research & Development may be unblinded (obtain the 
randomization codes) prior to database lock 
.
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7.4
Dosage Modification
There is no provision for dose modification of study treatment. 
If a participant interrupts treatment due to an AE, study treatment may be restarted following 
consultation with the Clinical Trial Physician/Medical Monitor.
In the event a participant requires a surgical or invasive procedure during the course of the study, 
the Clinical Trial Physician/Medical Monitor must be contacted to discuss whether or not the 
participant is eligible to continue study participation.
7.5
Preparation/Handling/Storage/Accountability
The investigational product should be stored in a secure area according to local regulations. It is 
the responsibility of the investigator to ensure that investigational product is only dispensed to 
study participants. The investigational product must be dispensed only from official study sites by 
authorized personnel according to local regulations.
The product storage manager should ensure that the study treatment is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study treatment arise, the study treatment
should not be dispensed and contact BMS immediately.
Study treatment not supplied by BMS will be stored in accordance with the package insert.
Investigational product documentation (whether supplied by BMS or not) must be maintained that 
includes all processes required to ensure drug is accurately administered. This includes 
documentation of drug storage, administration and, as applicable, storage temperatures, 
reconstitution, and use of required processes (eg, required diluents, administration sets).
The investigator or designee must confirm appropriate temperature conditions have been
maintained during transit for all study intervention received and any discrepancies are reported 
and resolved before use of the study intervention.
The investigator, institution, or the head of the medical institution (where applicable) is responsible 
for study intervention accountability, reconciliation, and record maintenance (ie, receipt, 
reconciliation, and final disposition records).
Further guidance and information for final disposition of unused study treatment are provided in 
Appendix 2, Study Governance Considerations.
7.5.1
Retained Samples for Bioavailability / Bioequivalence / 
Biocomparability
Not applicable. 
7.6
Treatment Compliance
Study treatment compliance will be monitored as indicated in the Schedule of Activities 
(Section 2) using standard drug accountability procedures (comparing the number of tablets 
returned with 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 
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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 previous and current systemic and topical medications taken for DLE/SCLE and SLE must be 
reported.
Current medications and medications taken within 4 weeks prior to study drug administration for 
conditions other than DLE/SCLE and SLE must be recorded on the case report form (CRF).
Over the course of the study, changes in concomitant medications or additional medications may 
be required to manage aspects of the disease state of the participants or side effects from 
treatments. 
7.7.1
Prohibited and/or Restricted Treatments
Prohibited and/or restricted medications during the study are described below.
7.7.1.1
Prohibited Treatments

Use of 
.


Phototherapy; use of tanning booths or therapeutic sunbathing.

Topical formulations of high or moderate potency topical corticosteroids (WHO Class 1-5; 
(refer to Appendix 12), topical immunosuppressants (calcineurin inhibitors), or topical 
retinoids.

Non-oral routes of CS administration: intramuscular, intralesional/intradermal, intra-articular, 
intrabursal, and/or intravenous (IV) CS.

Modified-release oral CS formulations.

Investigational COVID-19 vaccines that are not authorized or approved by relevant Health 
Authorities.

Live vaccines during the study and within 60 days after the last dose of study treatment. Heat-
killed or otherwise inactivated or protein vaccines (ie, influenza and pneumococcal) may be 
received at any time on study. Other inactivated vaccines may be used according to local 
guidelines.
7.7.1.2
Restricted Treatments

NSAIDs or narcotic analgesics on an as needed basis are permitted, except for 12 hours prior 
to any study visit with disease activity assessments.
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
Use of medications/therapy that could induce or exacerbate cutaneous lupus erythematosus 
, unless considered necessary for subject’s welfare or treatment of 
adverse events.
In addition, the following applies:

Live vaccines are prohibited 60 days prior to the Screening Visit during the study treatment 
period and within the 60 days after the last dose of study treatment. Heat-killed or otherwise 
inactivated or protein vaccines (ie, influenza and pneumococcal) may be received at any time 
on study. Other inactivated vaccines may be used according to local guidelines. 
7.7.2
Permitted Background DLE/SCLE/SLE Therapies
Usual monitoring for background medications should continue as per local standard of care 
guidelines. Dosing information, including any modifications to dosing of these medications must 
be recorded in the concomitant medication section of the CRF.
7.7.2.1
Corticosteroid Therapy
7.7.2.2
Antimalarial Therapy
Participants are permitted to take one antimalarial medication alone, or in combination with either 
OCS and/or an immunosuppressant. 
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7.7.2.3
Immunosuppressant Therapy
7.7.2.4
Nonsteroidal Anti-inflammatory Drugs and Narcotic Analgesics
 Participants may take NSAIDs or narcotic analgesics on an as 
needed basis, but not 12 hours prior to a scheduled visit. 
7.7.3
Rescue Therapy
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Rescue therapy 
 may include 
topical corticosteroids, including high and moderate potency (WHO Class 1-5). The steroid must 
be tapered 
. Any course of OCS or 
topical steroid above the baseline dose must not extend beyond Week 8, regardless of when the 
course was started.
7.7.4
Permitted Vaccines (Including COVID-19 Vaccine)
Administration of a non-live vaccine is allowed during the study. However, the efficacy and safety 
of non-live vaccines (including non-live COVID-19 vaccines) in participants receiving 
deucravacitinib is unknown. The following are examples of non-live vaccines: inactivated 
vaccines (eg, heat-killed and formalin-killed vaccines), subunit vaccines (eg, influenza and 
pneumococcal vaccines), toxoid vaccines, nucleic acid vaccines that do not encode potentially 
infectious virus (eg, Pfizer/BioNTech and Moderna COVID-19 vaccines), and replication-
incompetent recombinant vector vaccines (eg, AstraZeneca/University of Oxford COVID-19 
vaccine).
For COVID-19 vaccines requiring more than 1 dose, the full series (eg, both doses of a 2-dose 
series) should be completed prior to enrollment when feasible and when a delay in enrollment 
would not put the study subject at risk. Ideally, AEs attributable to a vaccine should have resolved 
prior to enrollment.
If a participant has received a specific COVID-19 vaccination, details such as type and date of 
vaccine received should be recorded on the concomitant medication page, if given during the study, 
or the past history page, if given prior to enrollment.
Please contact the Clinical Trial Physician/Medical Monitor with any questions related to COVID-
19 vaccines.
8
DISCONTINUATION CRITERIA
8.1
Discontinuation from Study Treatment
Participants MUST discontinue investigational product 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 
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consent for any further contact with him/her or persons previously authorized by participant to 
provide this information.

Any clinical AE, laboratory abnormality or intercurrent illness which, in the opinion of the 
investigator, indicates that continued participation in the study is not in the best interest of the 
participant.

Termination of the study by Bristol-Myers Squibb (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.)

Unblinding of a participant’s treatment assignment for any reason (emergency or
nonemergency).

Pregnancy.
Refer to the Schedule of Activities in Section 2 for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed.
In the case of pregnancy, the investigator must immediately, within 24 hours of awareness of the 
pregnancy, notify the Clinical Trial Physician/Medical Monitor/designee of this event. Refer to 
Section 9.2.6, Pregnancy. 
All participants who discontinue study treatment should comply with protocol specified follow-up 
procedures as outlined in Section 2. Participants who discontinue study treatment prior to Week 
52 will proceed to the EOT/ET and Follow-Up visits as described in Table 2-3. The only exception 
to this requirement is when a participant withdraws consent for all study procedures including 
post-treatment study follow-up or loses the ability to consent freely (ie, is imprisoned or 
involuntarily incarcerated for the treatment of either a psychiatric or physical illness). If the 
investigator determines a possible favorable benefit/risk ratio that warrants continuation of study 
treatment, a discussion between the investigator and the Clinical Trial Physician/Medical Monitor
must occur.
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 case report form (CRF) page.
8.1.1
Post Study Treatment Study Follow-up
Participants who discontinue study treatment should be followed as outlined in the schedule of 
assessments for the Safety Follow-up Period (see Table 2-3).
8.2
Discontinuation from the Study
Participants who request to discontinue study treatment will remain in the study and must continue 
to be followed for protocol specified follow-up procedures. Participants who discontinue study 
treatment prior to Week 52 will proceed to the EOT/ET and Follow-up visits as described in Table 
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2-3. 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 CRF page.

In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.

If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
8.3
Lost to Follow-Up
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit:

All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant.

Lost to follow-up is defined by the inability to reach the participant after a minimum of 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.
9
STUDY ASSESSMENTS AND PROCEDURES

Study procedures and timing are summarized in the Schedule of Activities. 

Protocol waivers or exemptions are not allowed.
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
All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
treatment.

Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct.

All screening evaluations and any applicable Baseline assessments must be completed and 
reviewed to confirm that potential participants meet all eligibility criteria before 
randomization. The investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure, as 
applicable.

Screening and baseline assessments must be performed per protocol (standard of care 
assessments may not be used for baseline).
9.1
Efficacy Assessments
Protocol-specific training and assessments must be successfully completed so that investigators or 
designees can be qualified to perform assessments using the CLASI, 
. 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.
The following sections describe the procedures or tools to be used to assess participants’ SLE 
disease activity during the study (also refer to the Schedule of Activities in Section 2).
9.1.1
Cutaneous Lupus Erythematosus Disease Area and Severity Index 
(CLASI)
Refer to Appendix 8. The CLASI is a validated scale used to assess cutaneous manifestations of 
SLE consisting of 2 scores. The first (CLASI-A) summarizes the activity of the disease while the 
second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, 
scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and nonscarring alopecia. 
CLASI-A will be the key efficacy assessment to provide clinical evidence of response to 
deucravacitinib in the active DLE/SCLE population. The second scale (CLASI-D) assesses 
damage and is scored in terms of dyspigmentation and scarring, including scarring alopecia.
Literature suggests that a 4-point or 20% decrease in the CLASI-A score from baseline is
considered an improvement in disease activity.32
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9.1.4
Skin Biopsy
DLE and SCLE lesion biopsy is a standard histopathological diagnostic test performed for 
cutaneous lupus disease. 
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9.2
Adverse Events
The definitions of an AE or serious adverse event (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, considered related to the study treatment or the study, or that caused the participant to 
discontinue before completing the study. 
Refer to Appendix 3 for SAE reporting.
9.2.1
Time Period and Frequency for Collecting AE and SAE Information
Appendix 1 of the IB represents the Reference Safety Information to determine expectedness of 
serious adverse events for expedited reporting.
All AEs and SAEs, including those related to SARS-CoV-2, must be collected from the time of 
signing the consent, including those thought to be associated with protocol-specified procedures
and within 30 days of discontinuation of dosing.
The investigator must report any SAE that occurs after these time periods and that is believed to 
be related to study drug or protocol-specified procedure, 
.

Medical occurrences that begin before the start of study treatment but after obtaining informed 
consent will be recorded on the appropriate section of the CRF module.
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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.
In participants who are exhibiting symptoms consistent with COVID-19, the Sponsor advises the 
investigator to consider holding dosing of investigational product and consult the Clinical Trial 
Physician/Medical Monitor. If a participant has a positive test for COVID-19, or participants with 
suspected COVID post contact if no testing is available, the Sponsor advises the investigator to 
consider holding participant dosing until such time as symptoms resolve. If a positive COVID-19 
test result is reported, please consult with the Clinical Trial Physician/Medical Monitor on whether 
resolution of symptoms alone is sufficient to resume dosing of the IP (Section 3.1). Upon a positive 
test result for SARS-CoV-2 infection, the infection should be reported to the Sponsor within 24 
hours.
COVID-19-related AEs/SAEs will be captured in specific clinical safety program eCRF pages.
9.2.2
Method of Detecting AEs and SAEs
Adverse events 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 adverse events, 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 (refer to 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.

SARS-CoV-2-related AEs/SAEs will be captured in specific clinical safety program (CSP) 
case report form (CRF) pages.
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. 
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Participants will be followed for all SAEs, non-serious AEs of special interest (as defined in 
Section 9.2), and SARS-CoV-2 related AEs until resolution, the condition stabilizes, the event is 
otherwise explained, or 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 towards 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.
Sponsor or designee will be reporting adverse events to regulatory authorities and ethics 
committees according to local applicable laws including European Directive 2001/20/EC and FDA 
Code of Federal Regulations 21 CFR Parts 312 and 320. A SUSAR (Suspected, Unexpected 
Serious Adverse Reaction) is a subset of SAEs and will be reported to the appropriate regulatory 
authorities and investigators following local and global guidelines and requirements.
9.2.6
Pregnancy
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 Clinical Trial Physician/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.
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.
In all cases, the study treatment will be permanently discontinued. 
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Any pregnancy that occurs in a female partner of a male study participant should be reported to 
BMS Drug Safety. For the Sponsor or designee to collect any pregnancy surveillance information 
from the female partner, the female partner must sign an ICF for disclosure of this information. 
Information on this pregnancy will be collected on the Pregnancy Surveillance Form.
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.
9.2.7
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page 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 versus low hemoglobin value).
9.2.8
Potential Drug Induced Liver Injury (DILI)
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential DILI event. All occurrences of potential DILIs, meeting 
the defined criteria, must be reported as SAEs (see Section 9.2 and Appendix 3 for reporting 
details).
Potential drug induced liver injury is defined as: 

AT (ALT or AST) elevation > 3× ULN
- AND -

Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase),
- AND -

No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic.
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9.2.9
Other Safety Considerations
Any significant worsening noted during interim or final physical examinations, electrocardiogram, 
x-ray filming, 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
For this study, any dose of deucravacitinib greater than 24 mg within a 24-hour time period will 
be considered an overdose. However, if a participant takes a higher dose than assigned (even if 
< 24 mg in a 24-hour period), this deviation should be documented appropriately. 
In the event of an overdose, the investigator should carry out all of the following actions:
1) Contact Clinical Trial Physician/Medical Monitor immediately.
2) Closely monitor the participant for AEs, SAEs, and laboratory abnormalities until BMS-
986165 can no longer be detected systemically (at least 3 days).
3) Obtain a plasma sample 
 within 3 days from the date of the last dose of study 
treatment if requested by the Clinical Trial Physician/Medical Monitor (determined on a case-
by-case basis).
4) Document the quantity of the excess dose as well as the duration of the overdosing in the CRF.
9.4
Safety
Planned time points for all safety assessments are listed in the Schedule of Activities (Section 2).
All urgent safety concerns must be discussed with the Sponsor immediately upon occurrence or 
awareness to determine if the participant should continue or discontinue treatment. Safety 
evaluations that will be performed in addition to AE monitoring are physical examinations (Section 
9.4.1), TB screening (Section 9.4.2), vital signs, ECGs, concomitant medication use, and 
laboratory tests (Section 9.4.5).
9.4.1
Physical Examinations
Schedules for physical examinations are provided in Section 2. Complete and/or targeted PEs may 
be performed by a Doctor of Medicine (MD), or someone who is authorized to perform the 
examinations by training and has been delegated this task by the principal investigator. While the 
targeted examination may not be as comprehensive as the initial full examination, key aspects 
should evaluate important body systems as clinically indicated. These body systems can include 
lymph nodes, liver, spleen, and breast at the discretion of the examiner. A targeted examination 
may note any changes in the participant’s condition (body systems) since the last assessment and 
does not preclude examination of any of the other body systems as clinically indicated. Every 
effort should be made to ensure the same evaluator will complete the examination for each 
participant at all visits throughout the study. Documentation of who performed the examination is 
to be recorded in source notes.
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9.4.2
Tuberculosis Screening and Chest X-ray
A chest X-ray and PE are part of the process to assess a participant’s eligibility as defined in 
Section 6.2, Exclusion Criteria, 6) a), and outlined in Section 2. A chest X-ray at the Screening 
Visit is required if not already performed within 6 months of obtaining written informed consent. 
In addition to a complete PE and medical history to evaluate exposure to TB, all participants will 
have a screening test, an IGRA (eg, T-spot® or QuantiFERON®), preferably performed centrally. 
If unable to obtain central laboratory results (eg, repeated test due to indeterminate result), an 
IGRA test could be obtained locally, after consultation with the Clinical Trial Physician/Medical 
Monitor.
9.4.3
Vital signs
Refer to Schedule of Activities in Section 2.
9.4.4
Electrocardiograms
Refer to Schedule of Activities in Section 2.
9.4.5
Clinical Safety Laboratory Assessments
A central laboratory will perform assessments of safety laboratory assessments (except pregnancy 
tests) and provide reference ranges and laboratory reports. Investigators must document their 
review of each laboratory safety report. Any laboratory test result that the investigator considers 
clinically relevant is to be recorded on the appropriate AE page of the CRF (Section 9.2.7). Results 
of clinical laboratory tests performed during screening must be available prior to randomization.
The laboratory parameters to be assessed are as follows: 

Hematology: hemoglobin, hematocrit, total leukocyte count (including differential), platelet 
count, red blood cell count, and manual differential (separate smear). 

Chemistry: AST, ALT, gamma glutamyltransferase, total bilirubin, direct bilirubin, alkaline 
phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, 
 glucose, 
total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, magnesium, creatine 
kinase, creatinine clearance (Screening only).

Coagulation (Screening only): prothrombin time, international normalized ratio, and either 
partial thromboplastin time or activated partial thromboplastin time.

Lipid Panels (Placebo-controlled and Active Treatment Only) tests performed
: lipid panel (total cholesterol, high-density lipoprotein cholesterol, low-density 
lipoprotein cholesterol, and triglycerides).

Urinalysis: protein, glucose, blood, leukocyte esterase, specific gravity, pH; microscopic 
examination of the sediment if blood, protein, or leukocyte esterase are positive on dipstick; 
spot urine will be assessed for urine protein and urine creatinine.

Serology to be performed at screening: Hepatitis C antibody, anti-HBs, HBsAg, anti-HBc, 
HIV-1 and HIV-2 antibody.

TB (screening only).
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C3, C4, Anti-dsDNA: At Screening for all participants, and subsequent collections only for 
participants with antibodies elevated above normal at Screening.
In addition, urine pregnancy testing will be performed for WOCBP, and follicle-stimulating 
hormone will be measured to confirm postmenopausal status (as applicable; at screening only). 
Additional safety assessments may be performed at local laboratories at the investigator’s 
discretion.
9.4.6
Imaging Safety Assessment
Not applicable.
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9.9
Health Economics OR Medical Resource Utilization and Health 
Economics
Health Economics/Medical Resource Utilization and Health Economics parameters will not be 
evaluated in this study.
10
STATISTICAL CONSIDERATIONS
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10.2
Populations for Analyses
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled 
All participants who sign informed consent.
Randomized
All participants who are randomized to a treatment. Participants will be grouped 
according to the treatment to which they are randomized according to IRT at the start 
of the treatment period. 
As Treated
All participants who took at least 1 dose of double blind study treatment in the placebo-
controlled part of the study.
The treatment group “as treated” will be the same as the treatment group “as 
randomized” by IRT, except in the following cases:

If a participant took the same incorrect treatment throughout the study, then the 
participant will be analyzed based on the treatment received.

If a participant took study drug from more than one treatment group, and none of 
the administrations were consistent with the assigned randomized treatment group, 
then the participant will be analyzed based on the first treatment taken.
As-Treated
(Active Treatment 
Period)
All randomized participants who took at least 1 dose of double-blind study treatment 
in the active treatment period. Participants will be included in the treatment path they 
were randomized, except in the following cases: 

If a participant took the same incorrect treatment throughout a respective 
treatment period, then the participant will be analyzed based on the treatment 
received in each treatment period.

If a participant took study drug from more than one treatment group within a 
treatment period, and none of the administrations were consistent with the 
assigned randomized treatment group, then the participant will be analyzed based 
on the first treatment taken within each treatment period. 
Participants will be grouped according to the following treatment sequences:

Deucravacitinib 3 mg BID →deucravacitinib 3 mg BID

Deucravacitinib 6 mg BID →deucravacitinib 6 mg BID

Placebo →:deucravacitinib 3 mg BID
- OR -

Placebo →deucravacitinib 6 mg BID.
Abbreviations: BID = twice a day; IRT = Interactive Response Technology.
10.3
Statistical Analyses
The statistical analysis plan (SAP) will be developed and finalized before database lock and will 
describe the selection of participants to be included in the analyses, and procedures for accounting 
for missing, unused, and spurious data. Below is a summary of planned statistical analyses of the 
primary and secondary endpoints. See Table 4-1 for the list of endpoints.
A description of the participant population will be included in a statistical output report, including 
subgroups of age, gender and race.
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10.3.1
Efficacy Analyses
Endpoint
Statistical Analysis Methods
Primary
Percent change from baseline over time for CLASI-A score will be analyzed using a longitudinal 
repeated measures analysis on the randomized population.  
Adjusted mean % changes (LSMEANS) and unadjusted mean % changes with corresponding SE 
and 95% CI per treatment arm will be provided. The difference in LSMEANS and corresponding 
90% and 95% CIs will be provided for the difference between the 2 combined active arms and the 
placebo arm and for the difference between the individual active arms and the placebo arm at the 
different time points. 
 Nominal p-values will be provided for the difference between the 2 combined 
active arms and the placebo arm and for the difference between the individual active arms and the 
placebo arm at Week 16. No adjustment for multiplicity will be applied. If warranted, 
transformations will be considered.
 
 
Additional 
sensitivity analyses of the primary endpoint, including the handling of intercurrent events, may be 
defined in the statistical analysis plan.
Secondary
Continuous secondary efficacy endpoints will be analyzed similarly to the primary efficacy 
endpoint using a longitudinal repeated measures model. 
For the binary secondary efficacy endpoints (e.g., CLASI-50 response) a logistic regression analysis 
at Week 16 will be provided on the randomized population.
The estimated odds ratio of the 2 combined active arms versus the placebo arm and of the individual 
active arms versus the placebo arm with the corresponding 2-sided 90% CI and 95% CI will be 
presented. In addition, the estimated treatment differences and corresponding 90% CI and 95% CI 
will be provided for the difference in response rate between the 2 combined active arms and the 
placebo arm and for the difference in response rate between the individual active arms and the 
placebo arm at the different time points.
The handling of missing values and intercurrent events will be described in the SAP. No 
adjustments for multiplicity will be done for the secondary endpoints.
Nominal p-values will be provided for the Week 16 timepoint.
Abbreviations: CI = confidence interval; CLASI-50 = 50% improvement from baseline in CLASI-A score; CLASI-A 
= cutaneous lupus erythematosus disease area and severity index activity; LSMEANS = adjusted mean % changes; 
SAP = statistical analysis plan; 
 
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10.3.2
Safety Analyses
All safety analyses will be performed on the As-treated analysis population.
Endpoint
Statistical Analysis Methods
Primary
Not applicable as all safety assessments and variables are considered secondary.
Secondary
Safety assessments and variables during the 16-week placebo-controlled treatment period (TP), 
as specified in Table 4-1, will be summarized descriptively by treatment group (combined BMS 
doses, each BMS dose, and placebo). Adverse events will be listed and tabulated by System 
Organ Class (SOC) and Preferred Term (PT). Categorical data will be summarized as frequency 
counts and percentages. Continuous data for absolute and change from baseline values will be 
summarized using n, mean, standard deviation, median, minimum, and maximum, unless 
otherwise specified.
Abbreviations: n = number of samples; PT = Preferred Term; SOC = System Organ Class; TP = treatment period.
10.3.4
Interim Analyses
Not applicable.
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11
REFERENCES
1
BMS-986165 Investigator Brochure. Bristol-Myers Squibb Research and Development. 
Document Control No. 930090873.
2
Järvinen TM, Hellquist A, Koskenmies S, et al. Tyrosine kinase 2 and interferon regulatory 
factor 5 polymorphisms are associated with discoid and subacute cutaneous lupus 
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Jarukitsopa S, Hoganson DD, Crowson CS, et al. Epidemiology of systemic lupus 
erythematosus and cutaneous lupus erythematosus in a predominantly white population in the 
United States. Arthritis Care Res (Hoboken) 2015;67:817–828.
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Szczęch J, Rutka M, Samotij D, et al. Clinical characteristics of cutaneous lupus 
erythematosus. Postepy Dermatol Alergol 2016;33:13-17.
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Vera-Recabarren MA, García-Carrasco M, Ramos-Casals M, et al. Comparative analysis of 
subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus: clinical 
and immunological study of 270 patients. Br J Dermatol 2010;162:91-101.
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Sontheimer RD, Provost TT, editors. Cutaneous Manifestations of Rheumatic Diseases. 2nd 
ed. Philadelphia: Lippincott Williams & Wilkins; 2003. (Available upon request)
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Sontheimer RD. The lexicon of cutaneous lupus erythematosus--a review and personal 
perspective on the nomenclature and classification of the cutaneous manifestations of lupus 
erythematosus. Lupus 1997;6:84-95.
8
Chong BF and Werth VP. Skin Disease in Cutaneous Lupus Erythematosus. In: Dubois’ Lupus 
(Ed: Wallace D), 9th Edition, Chapter 33, 395-406, 2019.
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Watford WT, Hissong BD, Bream JH, et al. Signaling by IL-12 and IL-23 and the 
immunoregulatory roles of STAT4. Immunol Rev 2004;202:139-56.
10 Tokarski JS, Zupa-Fernandez A, Tredup JA, et al. Tyrosine kinase 2-mediated signal 
transduction in T lymphocytes is blocked by pharmacological stabilization of its pseudokinase 
domain. J Biol Chem 2015;290:11061-74.
11 Shaw MH, Boyartchuk V, Wong S, et al. A natural mutation in the Tyk2 pseudokinase domain 
underlies altered susceptibility of B10.Q/J mice to infection and autoimmunity. Proc Natl Acad 
Sci USA 2003;100:11594-9.
12 Volpe E, Servant N, Zollinger R, et al. A critical function for transforming growth factorbeta, 
interleukin 23 and proinflammatory cytokines in driving and modulating human T(H)-17 
responses. Nat Immunol 2008;9:650-7.
13 Geremia A, Arancibia-Carcamo CV, Fleming MP, et al. IL-23-responsive innate lymphoid 
cells are increased in inflammatory bowel disease. J Exp Med 2011;208:1127-33.
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14 Strober BE, Crowley JJ, Yamauchi PS, et al. Efficacy and safety results from a phase III, 
randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept 
and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol 
2011;165:661-8.
15 Braunstein I, Klein R, Okawa J, et al. The interferon-regulated gene signature is elevated in 
subacute cutaneous lupus erythematosus and discoid lupus erythematosus and correlates with 
the cutaneous lupus area and severity index score. Br J Dermatol 2012;166:971-5.
20 Kuhn A, Landmann A. The classification and diagnosis of cutaneous lupus erythematosus. J 
Autoimmun 2014;48-49:14-19.
21 Okon LG, Werth VP. Cutaneous lupus erythematosus: diagnosis and treatment. Best Pract Res 
Clin Rheumatol 2013;27:391‐ 404.
22 Presto JK, Haber JS, Werth VP. Using the American College of Rheumatology and Systemic 
Lupus International Collaborating Clinics Criteria to Measure Disease Severity in Discoid 
Lupus 
Erythematosus 
[abstract]. 
Arthritis 
Rheumatol. 
2016; 
68 
(suppl 
10). 
https://acrabstracts.org/abstract/using-the-american-college-of-rheumatology-and-systemic-
lupus-international-collaborating-clinics-criteria-to-measure-disease-severity-in-discoid-
lupus-erythematosus/. Accessed March 29, 2020.
23 Chang AY, Ghazi E, Okawa J, et al. Quality of life differences between responders and 
nonresponders in the treatment of cutaneous lupus erythematosus. JAMA Dermatol 
2013;149:104-6.
24 Chasset F, Bouaziz JD, Costedoat-Chalumeau N, et al. Efficacy and comparison of 
antimalarials in cutaneous lupus erythematosus subtypes: a systematic review and meta-
analysis. Br J Dermatol 2017;177:188-196.
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29 Albrecht J, Taylor L, Berlin JA, Dulay S, Ang G, Fakharzadeh S, et al. The CLASI (Cutaneous
Lupus Erythematosus Disease Area and Severity Index): an outcome instrument for cutaneous
lupus erythematosus. J Invest Dermatol. 2005;125:889-94.
30 van Vollenhoven RF, Hahn BH, Tsokos GC, et al. Efficacy and safety of ustekinumab, an IL-
12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a 
multicentre, double-blind, phase 2, randomized, controlled study. Lancet 2018;392:1330‐
1339.
31 NCT02847598: Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With 
or Without Systemic Lupus Erythematosus (SLE) (LILAC); 2016. Available at: 
https://clinicaltrials.gov/ct2/show/NCT02847598 [Accessed on 20-Jul-2020].
32 Klein R, Moghadam-Kia S, LoMonico J, et al. Development of the CLASI as a tool to measure 
disease severity and responsiveness to therapy in cutaneous lupus erythematosus. Arch 
Dermatol 2011;147:203-8.
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39 Werth V, Furie R, Romero-Diaz J on behalf of the LILAC Investigators, et al. OP0193
BIIB059, A Humanized Monoclonal Antibody Targeting BDCA2 On Plasmacytoid Dendritic 
Cells (PDC), Shows Dose-Related Efficacy In The Phase 2 Lilac Study In Patients (Pts) With 
Active 
Cutaneous 
Lupus 
Erythematosus 
(CLE) 
Annals 
of 
the 
Rheumatic 
Diseases 2020;79:120-121.
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APPENDICES
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APPENDIX 1
ABBREVIATIONS AND TRADEMARKS
Term
Definition
ACLE
acute cutaneous lupus erythematosus
ACR
American College of Rheumatology
ADME
absorption, distribution, metabolism, and excretion
AE
adverse event
ALT
alanine aminotransferase
anti-dsDNA
anti-double stranded deoxyribonucleic acid (antibody)
anti-HBs
anti-hepatitis B surface antibody
APS
antiphospholipid antibody syndrome
AST
aspartate aminotransferase
BID
twice a day
BMI
body mass index
BMS
Bristol-Myers Squibb (Company)
C3
complement 3
C4
complement 4
CCLE
chronic cutaneous lupus erythematosus
CI
confidence interval
CLASI
Cutaneous Lupus Erythematosus Disease Area and Severity Index
CLASI-50
50% improvement from baseline in CLASI-A score
CLASI-A
CLASI activity (score)
CLASI-D
CLASI damage (score)
CLE
cutaneous lupus erythematosus
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
coronavirus disease of 2019
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Term
Definition
CR
complete response
CS
corticosteroid(s)
DLE
discoid lupus erythematosus
DMC
Data Monitoring Committee
ECG
Electrocardiogram
EOT
End of Treatment
ET
Early Termination
FDA
Food and Drug Administration
FSH
follicle-stimulating hormone
FU
Follow-up (Period)
 
HBsAg
hepatitis B surface antigen
HIV
human immunodeficiency virus
IB
Investigator's Brochure
IBD
inflammatory bowel disease
ICF
Informed Consent Form
IEC
Independent Ethics Committee
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Term
Definition
IFN(α, β, γ)
interferon (alpha, beta, gamma)
IGRA
interferon-gamma release assay
IL
Interleukin
IMP
Investigational Medicinal Product
IP
Investigational Product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IU
international unit
IV
Intravenous
JAK
Janus kinase
LE
Lupus Erythematosus
LET
lupus erythematosus tumidus
LSMEANS
least-squares mean
MD
Doctor of Medicine
MOA(s)
mechanism(s) of action
NSAID
nonsteroidal anti-inflammatory drug
NYHA
New York Heart Association 
OCS
oral corticosteroid(s)
PA
Posterioranterior
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Term
Definition
PE
physical examination
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
Serious acute respiratory syndrome coronavirus 2
SCLE
subacute cutaneous lupus erythematosus
SLE
systemic lupus erythematosus
SOC
System Organ Class
SPSD
Site Process and Source Documentation
STAT
signal transducer and activator of transcription
SUSAR
Suspected, Unexpected Serious Adverse Reaction
TB
Tuberculosis
TP
Treatment Period
TYK2
tyrosine kinase 2
ULN
upper limit of normal
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Term
Definition
UPCR
urine protein/creatinine ratio
US
United States
UV
Ultraviolet
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 

Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP)
Guidelines

Applicable laws, regulations, and requirements
The study will be conducted in compliance with the protocol. The protocol 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, 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.
The investigator is responsible for providing oversight of the conduct of the study at the site and 
adherence to requirements of the following where applicable:
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
ICH guidelines, 

United States Code of Federal Regulations, Title 21, Part 50 (21CFR50)

European Union Directive 2001/20/EC; or

European Regulation 536/2014 for clinical studies (if applicable), 

European Medical Device Regulation 2017/745 for clinical device research (if applicable),

the IRB/IEC

and all other applicable local regulations.
COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS
The investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and if 
applicable, also by 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. 
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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.
The investigator or his/her representative must:
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.

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. 

Explain the nature of the study to the participant and answer all questions regarding the study.

Inform participant that his/her participation is voluntary. Participant or his/her legally 
acceptable representative will be required to sign a statement of informed consent that meets 
the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability 
and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study 
center.

Allow time necessary for participant or 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. 

Include a statement in participant’s medical record that written informed consent was obtained 
before participant was enrolled in the study and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF.

Re-consent participant to the most current version of the ICF(s) during his/her participation in 
the study, as applicable.
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. 
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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. 
Subjects/participants unable to give their written consent (eg, stroke or subjects/participants with 
or severe dementia) may only be enrolled in the study with the consent of a legally acceptable 
representative. The participant must also be informed about the nature of the study to the extent 
compatible with his or her understanding, and should this participant become capable, he or she 
should personally sign and date the consent form as soon as possible. The explicit wish of a 
participant who is unable to give his or her written consent, but who is capable of forming an 
opinion and assessing information to refuse participation in, or to be withdrawn from, the clinical 
study at any time should be considered by the investigator.
The rights, safety, and well-being of the study subjects/participants are the most important 
considerations and should prevail over interests of science and society.
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes.
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical trial becomes more reflective of the real-world population and the people impacted by 
the diseases studied.
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY
BMS collects and processes personal data of study participants, patients, health care providers,
and researchers for biopharmaceutical research and development to advance innovative, high-
quality medicines that address the medical needs of patients. BMS ensures the privacy, protection,
and confidentiality of such personal data to comply with applicable laws. To achieve these goals, 
BMS has internal policies that indicate measures and controls for processing personal data. BMS 
adheres to these standards to ensure that collection and processing of personal data are limited and 
proportionate to the purpose for which BMS collects such personal data. This purpose is clearly 
and unambiguously notified to the individual at the time of collection of personal data. In the true 
spirit of science, BMS is dedicated to sharing clinical trial information and data with participants, 
medical/research communities, the media, policy makers, and the general public. This is done in a 
manner that safeguards participant privacy and informed consent while respecting the integrity of 
national regulatory systems. Clinical trial data, health-related research, and pharmacovigilance 
activities on key-coded health data transferred by BMS across national borders is done in 
compliance with the relevant data protection laws in the country and GCP requirements.
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BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of 
its processing.
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data.
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 
adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information: 
1)
Responsibilities of IT Personnel
2) Securing the BMS Digital Infrastructure
3) Identity and Access Management
4) External Partner Connections
5) Cyber Threat Detection and Response
6) Internal Cyber Incident Investigation
SOURCE DOCUMENTS
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site.
Data reported on the CRF or entered in the electronic CRF (eCRF) that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be explained. 

The investigator may need to request previous medical records or transfer records, depending 
on the study. Also, current medical records must be available.

Definitions of what constitutes source data can be found in the Site Process and Source 
Documentation (SPSD) form.
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 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical/health records (EMRs/EHRs), 
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adverse event tracking/reporting, protocol required assessments, and/or drug accountability 
records).
When paper records from such systems are used in place of electronic format to perform regulated 
activities, such paper records should be certified copies. A certified copy consists of a copy of 
original information that has been verified, as indicated by a dated signature, as an exact copy 
having all of the same attributes and information as the original. 
STUDY TREATMENT RECORDS
Records for study treatments (whether supplied by BMS, its vendors, or the site) must substantiate 
study treatment integrity and traceability from receipt, preparation, administration, and through 
destruction or return. Records must be made available for review at the request of BMS/designee 
or a Health Authority.
If
Then
Supplied by BMS (or its vendors):
Records or logs must comply with applicable 
regulations and guidelines and should include:

amount received and placed in storage area

amount currently in storage area

label identification number or batch number

amount dispensed to and returned by each 
participant, including unique participant 
identifiers

amount transferred to another area/site for 
dispensing or storage

nonstudy disposition (eg, lost, wasted) 

amount destroyed at study site, if applicable

amount returned to BMS

retain samples for 
bioavailability/bioequivalence/biocomparability, 
if applicable 

dates and initials of person responsible for 
Investigational Product 
dispensing/accountability, as per the Delegation 
of Authority Form.
Sourced by site, and not supplied by 
BMS or its vendors (examples include IP 
sourced 
from 
the 
sites 
stock or 
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 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 
facilities remain acceptable. 
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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.
For sites that will not destroy study treatment on-site, it is the investigator’s or designee’s 
responsibility to arrange for disposal of all empty study treatment containers, 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 return of full or partially used study treatments supplied by BMS or its vendors will be 
arranged by the responsible Study Monitor.
STUDY AND SITE START AND CLOSURE
The Sponsor/designee reserves the right to close the study site or to terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies have 
been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the Sponsor or investigator may include, but are 
not limited to:

Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local Health Authorities, the Sponsor’s procedures, or GCP guidelines
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
Inadequate recruitment of participants by the investigator

Discontinuation of further study intervention development
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
DISSEMINATION OF CLINICAL STUDY DATA
In order to benefit potential study participants, patients, healthcare providers and researchers, and 
to help BMS honor its commitments to study participants, BMS will make information about 
clinical research studies and a summary of their results available to the public as per regulatory 
and BMS requirements. BMS will post study information on local, national or regional databases 
in compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases.
CLINICAL STUDY REPORT
A Signatory Investigator must be selected to sign the clinical study report. 
For each CSR related to this protocol, the following criteria will be used to select the signatory 
investigator:

External Principal Investigator designated at protocol development

National Coordinating Investigator 

Study Steering Committee chair or their designee

Participant recruitment (eg, among the top quartile of enrollers)

Involvement in trial design

Regional representation (eg, among top quartile of enrollers from a specified region or country)
SCIENTIFIC PUBLICATIONS
The data collected during this study are confidential and proprietary to Sponsor or designee. Any 
publications or abstracts arising from this study must adhere to the publication requirements set 
forth in the clinical trial agreement (CTAg) governing [Study site or Investigator] participation in 
the study. These requirements include, but are not limited to, submitting proposed publications to 
Sponsor or designee at the earliest practicable time prior to submission or presentation and 
otherwise within the time period set forth in the CTAg.
Scientific Publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors.  No public presentation or publication of any interim results may be made by any 
principal investigator, sub-investigator or any other member of the study staff without the prior 
written consent of the Sponsor.  
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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 9.2.6 for reporting pregnancies).
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Any component of a study endpoint that is considered related to study therapy should be reported 
as SAE (e.g., death is an endpoint, if death occurred due to anaphylaxis, anaphylaxis must be 
reported).
EVALUATING AES AND SAES
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration 
will be considered and investigated.

The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment.

For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to Sponsor. However, it is very important that the 
investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to Sponsor.

The investigator may change his/her opinion of causality in light of follow-up information 
and send a SAE follow-up report with the updated causality assessment.

The causality assessment is one of the criteria used when determining regulatory reporting 
requirements.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to 1 of the following categories: 

Mild: An event that is easily tolerated by the participant, causing minimal discomfort and 
not interfering with everyday activities.

Moderate: An event that causes sufficient discomfort and interferes with normal everyday 
activities.

Severe: An event that prevents normal everyday activities. An AE that is assessed as severe 
should not be confused with an SAE. Severe is a category utilized for rating the intensity of 
an event, and both AEs and SAEs can be assessed as severe.
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as described 
in the definition of an SAE, NOT when it is rated as severe.
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Follow-up of AEs and SAEs
If only limited information is initially available, follow-up reports are required. (Note: Follow-
up SAE reports must include the same investigator term(s) initially reported.) 
If an ongoing SAE changes in its intensity or relationship to study treatment or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or designee) using the same procedure used for transmitting the initial SAE report.
All SAEs must be followed to resolution or stabilization.
REPORTING OF SAES TO SPONSOR OR DESIGNEE

SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event.

SAEs must be recorded on the SAE Report Form.

The required method for SAE data reporting is through the eCRF.

The paper SAE Report Form is only intended as a back-up option when the electronic 
data capture (EDC) system is unavailable/not functioning for transmission of the eCRF 
to BMS (or designee).
In this case, the paper form is transmitted via email or confirmed facsimile (fax) 
transmission
When paper forms are used, the original paper forms are to remain on site

Pregnancies must be recorded on a paper Pregnancy Surveillance Form and transmitted via 
email or confirmed facsimile (fax) transmission 
SAE Email Address: Refer to Contact Information list.
SAE Facsimile Number: Refer to Contact Information list.
SAE Telephone Contact (required for SAE and pregnancy reporting): Refer to Contact 
Information list
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APPENDIX 4
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION
Appendix 4 provides general information and definitions related to Woman of Childbearing 
Potential and methods of contraception that can be applied to most clinical trials. For information 
specific to this study regarding acceptable contraception requirements for female and male 
participants, refer to Section 6.1 of the protocol. Only the contraception methods as described in 
Section 6.1 are acceptable for this study.
DEFINITIONS
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming 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
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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/ml at any time during the washout period, the woman can be considered 
postmenopausal.
End of Relevant Systemic Exposure

End of relevant systemic exposure is the 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 
from the no-observed adverse effect level (NOAEL) or the time required for 5 half-lives of the 
IMP to pass.
METHODS OF CONTRACEPTION
Local laws and regulations may require use of alternative and/or additional contraception methods.
Highly Effective Contraceptive Methods That Are User Dependent
Failure rate of <1% per year when used consistently and correctly.a

Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation and/or implantation (This method of contraception can only be used 
by WOCBP participants in studies where hormonal contraception is permitted by the study 
protocol)b 

oral (birth control pills)

intravaginal (rings)

transdermal 

Combined (estrogen-and progestogen-containing) hormonal contraception must begin at 
least 30 days prior to initiation of study therapy

Progestogen-only hormonal contraception associated with inhibition of ovulation (This 
method of contraception can only be used by WOCBP participants in studies where 
hormonal contraception is permitted by the study protocol)b 

oral 

injectable 

Progestogen-only hormonal contraception must begin at least 30 days prior to initiation of 
study therapy
Highly Effective Methods That Are User Independent 

Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation and/or implantation (This method of contraception can only be used by WOCBP 
participants in studies where hormonal contraception is permitted by the study protocol)b

Intrauterine device (IUD) 
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
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.
A vasectomy is a highly effective contraception method provided that the participant is the sole male 
sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly 
effective method of contraception should be used.

Sexual abstinence
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study treatment. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the 
study and the preferred and usual lifestyle of the participant.

Continuous abstinence must begin at least 30 days prior to initiation of study therapy

It is not necessary to use any other method of contraception when complete abstinence is 
elected. 

WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2. 

Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP 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
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Less Than Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of >1% per year when used consistently and correctly.

Male or female condom with or without spermicide.  Male and female condoms cannot be 
used simultaneously

Diaphragm with spermicide

Cervical cap with spermicide

Vaginal Sponge with spermicide

Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action (This method of contraception cannot be used by WOCBP 
participants in studies where hormonal contraception is prohibited)
Unacceptable Methods of Contraception

Periodic abstinence (calendar, symptothermal, post-ovulation methods)

Withdrawal (coitus interruptus).

Spermicide only

Lactation amenorrhea method (LAM)
COLLECTION OF PREGNANCY INFORMATION
Guidance for collection of Pregnancy Information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.6 and the Appendix for Adverse Events and Serious 
Adverse Events Definitions and procedures for Evaluating, Follow-up and Reporting
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APPENDIX 8
CUTANEOUS LUPUS ERYTHEMATOSUS DISEASE AREA AND 
SEVERITY INDEX (CLASI)
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APPENDIX 9
COMMONLY USED CORTICOSTEROID EQUIVALENTS
Medication
Dose Equivalence
Prednisone
20 mg
Cortisone
100 mg
Hydrocortisone
80 mg
Prednisolone
20 mg
Methylprednisolone
16 mg
Triamcinolone
16 mg
Budesonide
4 mg
Dexamethasone
3 mg
Betamethasone
2.4 mg
Deflazacort
26 mg
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APPENDIX 10
DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL 
DISORDERS IV
Alcohol abuse:  
In the past year, have you: 

Found that drinking – or being sick from drinking – often interfered with taking care of 
your home or family? Or caused job troubles? Or school problems? 

More than once gotten into situations while or after drinking that increased your chances 
of getting hurt (such as driving, swimming, using machinery, walking in a dangerous area, 
or having unsafe sex)? 

More than once gotten arrested, been held at a police station, or had other legal problems 
because of your drinking? 

Continued to drink even though it was causing trouble with your family or friends? 
The presence of any 1 of the above is considered indicative of alcohol abuse. 
Alcohol dependence: 
In the past year, have you: 

Had to drink much more than you once did to get the effect you want? Or found that your 
usual number of drinks had much less effect than before? 

Found that when the effects of alcohol were wearing off, you had withdrawal symptoms, 
such as trouble sleeping, shakiness, restlessness, nausea, sweating, a racing hear, or a 
seizure? Or sensed things that were not there? 

Had times when you ended up drinking more, or longer, than you intended? 

More than once wanted to cut down or stop drinking, or tried to, but couldn’t?

Spent a lot of time drinking? Or being sick or getting over other aftereffects?

Given up or cut back on activities that were important or interesting to you, or gave you 
pleasure, in order to drink?

Continued to drink even though it was making you feel depressed or anxious or adding to 
another health problem? Or after having had a memory blackout? 
The presence of any 3 of the above is considered indicative of alcohol dependence. 
National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism. Alcohol use 
disorder: a comparison between DSM-IV and DSM-5. NIH Publication No. 13-7999. Reviewed 
July 2016. 
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APPENDIX 12
TOPICAL STEROID POTENCY TABLE
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APPENDIX 14
INTERPRETATION OF HEPATITIS B SEROLOGIC TEST 
RESULTS
As study treatment in this study is expected to demonstrate immunosuppressive effects, it is 
imperative to carefully evaluate and exclude participants with potentially active hepatitis B 
infection. For this reason, in order to fully evaluate a participant’s eligibility for enrollment, the 
exclusion criterion (see Section 6.2) requires interpretation of data from 3 standard tests for 
hepatitis B, ie, measurement of hepatitis B surface antigen (HBsAg), hepatitis B core antibody 
(anti-HBc), and hepatitis B surface antibody (anti-HBs).
Participant’s eligibility for enrollment should be assessed as described below. Participants that are:

Hepatitis B serological test negative (neg) for all results may be included in the study

HBsAg (neg), anti-HBc (neg), and anti-HBs positive (POS) may be included in the study 
(immunized due to hepatitis B vaccination)

HBsAg (neg), anti-HBc (POS), and anti-HBs (POS) are to be excluded from the study (immune 
due to natural infection exposure)

Participants that are HBsAg (POS) are excluded from the study (acute or chronic infection)

Participants that are anti-HBc (POS) are excluded from the study (acute or chronic infection)

Participants that are HBsAg (neg), anti-HBc (POS), and anti-HBs (neg) are to be excluded 
from the study (interpretation unclear)
Please refer to the below “Interpretation of Hepatitis B Serologic Test Results” provided by the 
Department of Health and Human Services, Centers for Disease Control and Prevention.
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APPENDIX 25
CORE AND EXTENDED ADME GENE LIST
Appendix 25 is not applicable per Protocol Amendment 02.
Core ADME Gene List:
Gene Symbol
Full Gene Name
Class
ABCB1
ATP-binding cassette, sub-family B (MDR/TAP), member 1
Transporter
ABCC2
ATP-binding cassette, sub-family C (CFTR/MRP), member 2
Transporter
ABCG2
ATP-binding cassette, sub-family G (WHITE), member 2
Transporter
CYP1A1
cytochrome P450, family 1, subfamily A, polypeptide 1
Phase I
CYP1A2
cytochrome P450, family 1, subfamily A, polypeptide 2
Phase I
CYP2A6
cytochrome P450, family 2, subfamily A, polypeptide 6
Phase I
CYP2B6
cytochrome P450, family 2, subfamily B, polypeptide 6
Phase I
CYP2C19
cytochrome P450, family 2, subfamily C, polypeptide 19
Phase I
CYP2C8
cytochrome P450, family 2, subfamily C, polypeptide 8
Phase I
CYP2C9
cytochrome P450, family 2, subfamily C, polypeptide 9
Phase I
CYP2D6
cytochrome P450, family 2, subfamily D, polypeptide 6
Phase I
CYP2E1
cytochrome P450, family 2, subfamily E, polypeptide 1
Phase I
CYP3A4
cytochrome P450, family 3, subfamily A, polypeptide 4
Phase I
CYP3A5
cytochrome P450, family 3, subfamily A, polypeptide 5
Phase I
DPYD
dihydropyrimidine dehydrogenase
Phase I
GSTM1
glutathione S-transferase M1
Phase II
GSTP1
glutathione S-transferase pi
Phase II
GSTT1
glutathione S-transferase theta 1
Phase II
NAT1
N-acetyltransferase 1 (arylamine N-acetyltransferase)
Phase II
NAT2
N-acetyltransferase 2 (arylamine N-acetyltransferase)
Phase II
SLC15A2
solute carrier family 15 (H+/peptide transporter), member 2
Transporter
SLC22A1
solute carrier family 22 (organic cation transporter), member 1
Transporter
SLC22A2
solute carrier family 22 (organic cation transporter), member 2
Transporter
SLC22A6
solute carrier family 22 (organic anion transporter), member 6
Transporter
SLCO1B1
solute carrier organic anion transporter family, member 1B1
Transporter
SLCO1B3
solute carrier organic anion transporter family, member 1B3
Transporter
SULT1A1
sulfotransferase family, cytosolic, 1A, phenol-preferring, member 1
Phase II
TPMT
thiopurine S-methyltransferase,
Phase II
UGT1A1
UDP glucuronosyltransferase 1 family, polypeptide A1
Phase II
UGT2B15
UDP glucuronosyltransferase 2 family, polypeptide B15
Phase II
UGT2B17
UDP glucuronosyltransferase 2 family, polypeptide B17
Phase II
UGT2B7
UDP glucuronosyltransferase 2 family, polypeptide B7
Phase II
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Extended ADME Gene List:
Gene Symbol
Full Gene Name
Class
ABCB8
ATP-binding cassette, sub-family B (MDR/TAP), member 8
Transporter
ABCC12
ATP-binding cassette, sub-family C (CFTR/MRP), member 12
Transporter
ABCC3
ATP-binding cassette, sub-family C (CFTR/MRP), member 3
Transporter
ABCC4
ATP-binding cassette, sub-family C (CFTR/MRP), member 4
Transporter
AHR
aryl hydrocarbon receptor
Modifier
ALDH4A1
aldehyde dehydrogenase 4 family, member A1
Phase I
ALDH5A1
aldehyde dehydrogenase 5 family, member A1
Phase I
ALDH6A1
aldehyde dehydrogenase 6 family, member A1
Phase I
CES1
carboxylesterase 1 (monocyte/macrophage serine esterase 1)
Phase I
CES2
carboxylesterase 2 (intestine, liver)
Phase I
CYP7A1
cytochrome P450, family 7, subfamily A, polypeptide 1
Phase I
EPHX1
epoxide hydrolase 1, microsomal (xenobiotic)
Phase I
FMO3
flavin containing monooxygenase 3
Phase I
GSTA1
glutathione S-transferase A1
Phase II
GSTA2
glutathione S-transferase A2
Phase II
GSTA3
glutathione S-transferase A3
Phase II
GSTA4
glutathione S-transferase A4
Phase II
GSTA5
glutathione S-transferase A5
Phase II
GSTM2
glutathione S-transferase M2 (muscle),glutathione S-transferase M4
Phase II
GSTM3
glutathione S-transferase M3 (brain)
Phase II
GSTM4
glutathione S-transferase M4
Phase II
GSTO1
glutathione S-transferase omega 1,glutathione S-transferase omega 2
Phase II
GSTO2
glutathione S-transferase omega 2
Phase II
GSTT2
glutathione S-transferase theta 2
Phase II
SLC10A1
solute carrier family 10 (sodium/bile acid cotransporter family), 
member 1
Transporter
SLC15A1
solute carrier family 15 (oligopeptide transporter), member 1
Transporter
SLC22A11
solute carrier family 22 (organic anion/cation transporter), member 11
Transporter
SLC22A8
solute carrier family 22 (organic anion transporter), member 8
Transporter
SLC7A5
solute carrier family 7 (cationic amino acid transporter, y+ system), 
member 5
Transporter
SLCO1A2
solute carrier organic anion transporter family, member 1A2
Transporter
SLCO2B1
solute carrier organic anion transporter family, member 2B1
Transporter
SULT1A2
sulfotransferase family, cytosolic, 1A, phenol-preferring, member 2
Phase II
SULT1A3
sulfotransferase family, cytosolic, 1A, phenol-preferring, member 3
Phase II
SULT1B1
sulfotransferase family, cytosolic, 1B, member 1
Phase II
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Gene Symbol
Full Gene Name
Class
UGT1A3
UDP glucuronosyltransferase 1 family, polypeptide A3
Phase II
UGT1A6
UDP glucuronosyltransferase 1 family, polypeptide A6
Phase II
UGT1A7
UDP glucuronosyltransferase 1 family, polypeptide A7
Phase II
UGT1A8
UDP glucuronosyltransferase 1 family, polypeptide A8
Phase II
UGT1A9
UDP glucuronosyltransferase 1 family, polypeptide A9
Phase II
UGT2A1
UDP glucuronosyltransferase 2 family, polypeptide A1
Phase II
UGT2B11
UDP glucuronosyltransferase 2 family, polypeptide B11
Phase II
UGT2B28
UDP glucuronosyltransferase 2 family, polypeptide B28
Phase II
UGT2B4
UDP glucuronosyltransferase 2 family, polypeptide B4
Phase II
ABCA1
ATP-binding cassette, sub-family A (ABC1), member 1
Transporter
ABCA4
ATP-binding cassette, sub-family A (ABC1), member 4
Transporter
ABCB11
ATP-binding cassette, sub-family B (MDR/TAP), member 11
Transporter
ABCB4
ATP-binding cassette, sub-family B (MDR/TAP), member 4
Transporter
ABCB5
ATP-binding cassette, sub-family B (MDR/TAP), member 5
Transporter
ABCB6
ATP-binding cassette, sub-family B (MDR/TAP), member 6
Transporter
ABCB7
ATP-binding cassette, sub-family B (MDR/TAP), member 7
Transporter
ABCC1
ATP-binding cassette, sub-family C (CFTR/MRP), member 1
Transporter
ABCC10
ATP-binding cassette, sub-family C (CFTR/MRP), member 10
Transporter
ABCC11
ATP-binding cassette, sub-family C (CFTR/MRP), member 11
Transporter
ABCC5
ATP-binding cassette, sub-family C (CFTR/MRP), member 5
Transporter
ABCC6
ATP-binding cassette, sub-family C (CFTR/MRP), member 6
Transporter
ABCC8
ATP-binding cassette, sub-family C (CFTR/MRP), member 8
Transporter
ABCC9
ATP-binding cassette, sub-family C (CFTR/MRP), member 9
Transporter
ABCG1
ATP-binding cassette, sub-family G (WHITE), member 1
Transporter
ADH1A
alcohol dehydrogenase 1A (class I), alpha polypeptide
Phase I
ADH1B
alcohol dehydrogenase IB (class I), beta polypeptide
Phase I
ADH1C
alcohol dehydrogenase 1C (class I), gamma polypeptide
Phase I
ADH4
alcohol dehydrogenase 4 (class II), pi polypeptide
Phase I
ADH5
alcohol dehydrogenase 5 (class III), chi polypeptide,methionyl 
aminopeptidase 1
Phase I
ADH6
alcohol dehydrogenase 6 (class V)
Phase I
ADH7
alcohol dehydrogenase 7 (class IV), mu or sigma polypeptide
Phase I
ALDH1A1
aldehyde dehydrogenase 1 family, member A1
Phase I
ALDH1A2
aldehyde dehydrogenase 1 family, member A2
Phase I
ALDH1A3
aldehyde dehydrogenase 1 family, member A3
Phase I
ALDH1B1
aldehyde dehydrogenase 1 family, member B1
Phase I
ALDH2
aldehyde dehydrogenase 2 family (mitochondrial)
Phase I
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Gene Symbol
Full Gene Name
Class
ALDH3A1
aldehyde dehydrogenase 3 family, memberA1
Phase I
ALDH3A2
aldehyde dehydrogenase 3 family, member A2
Phase I
ALDH3B1
aldehyde dehydrogenase 3 family, member B1
Phase I
ALDH3B2
aldehyde dehydrogenase 3 family, member B2
Phase I
ALDH7A1
aldehyde dehydrogenase 7 family, member A1
Phase I
ALDH8A1
aldehyde dehydrogenase 8 family, member A1
Phase I
ALDH9A1
aldehyde dehydrogenase 9 family, member A1
Phase I
AOX1
aldehyde oxidase 1
Phase I
ARNT
aryl hydrocarbon receptor nuclear translocator
Modifier
CBR1
carbonyl reductase 1
Phase I
CBR3
carbonyl reductase 3
Phase I
CDA
cytidine deaminase
Modifier
CYB5R3
cytochrome b5 reductase 3
Phase I
CYP11A1
cytochrome P450, family 11, subfamily A, polypeptide 1
Phase I
CYP11B1
cytochrome P450, family 11, subfamily B, polypeptide 1
Phase I
CYP11B2
cytochrome P450, family 11, subfamily B, polypeptide 2
Phase I
CYP17A1
cytochrome P450, family 17, subfamily A, polypeptide 1
Phase I
CYP1B1
cytochrome P450, family 1, subfamily B, polypeptide 1
Phase I
CYP20A1
cytochrome P450, family 20, subfamily A, polypeptide 1
Phase I
CYP20A1
cytochrome P450, family 20, subfamily A, polypeptide 1
Phase I
CYP21A2
cytochrome P450, family 21, subfamily A, polypeptide 2
Phase I
CYP24A1
cytochrome P450, family 24, subfamily A, polypeptide 1
Phase I
CYP26A1
cytochrome P450, family 26, subfamily A, polypeptide 1
Phase I
CYP27A1
cytochrome P450, family 27, subfamily A, polypeptide 1
Phase I
CYP2A13
cytochrome P450, family 2, subfamily A, polypeptide 13
Phase I
CYP2A7
cytochrome P450, family 2, subfamily A, polypeptide 7
Phase I
CYP2C18
cytochrome P450, family 2, subfamily C, polypeptide 18
Phase I
CYP2F1
cytochrome P450, family 2, subfamily F, polypeptide 1
Phase I
CYP2J2
cytochrome P450, family 2, subfamily J, polypeptide 2
Phase I
CYP39A1
cytochrome P450, family 39, subfamily A, polypeptide 1
Phase I
CYP3A43
cytochrome P450, family 3, subfamily A, polypeptide 43
Phase I
CYP3A7
cytochrome P450, family 3, subfamily A, polypeptide 7
Phase I
CYP4B1
cytochrome P450, family 4, subfamily B, polypeptide 1
Phase I
CYP4F11
cytochrome P450, family 4, subfamily F, polypeptide 11
Phase I
CYP51A1
cytochrome P450, family 51, subfamily A, polypeptide 1
Phase I
EPHX2
epoxide hydrolase 2, cytoplasmic
Phase I
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Gene Symbol
Full Gene Name
Class
FMO1
flavin containing monooxygenase 1
Phase I
FMO2
flavin containing monooxygenase 2
Phase I
FMO4
flavin containing monooxygenase 4
Phase I
FMO5
flavin containing monooxygenase 5
Phase I
GPX2
glutathione peroxidase 2 (gastrointestinal)
Phase I
GPX3
glutathione peroxidase 3 (plasma)
Phase I
GPX7
glutathione peroxidase 7
Phase I
GSR
glutathione reductase
Phase I
GSTK1
glutathione S-transferase kappa 1
Phase II
GSTM5
glutathione S-transferase M5
Phase II
GSTZ1
glutathione transferase zeta 1 (maleylacetoacetate isomerase)
Phase II
NNMT
nicotinamide N-methyltransferase
Phase II
NR1I2
nuclear receptor subfamily 1, group I, member 2
Modifier
NR1I3
nuclear receptor subfamily 1, group I, member 3
Modifier
PNMT
phenylethanolamine N-methyltransferase
Phase II
PON1
paraoxonase 1
Phase I
PON2
paraoxonase 2
Phase I
PON3
paraoxonase 3
Phase I
POR
P450 (cytochrome) oxidoreductase
Modifier
PPARD
peroxisome proliferative activated receptor, delta
Modifier
PPARG
peroxisome proliferative activated receptor, gamma
Modifier
RXRA
retinoid X receptor, alpha
Modifier
SLC10A2
solute carrier family 10 (sodium/bile acid cotransporter family), 
member 2
Transporter
SLC13A1
solute carrier family 13 (sodium/sulfate symporters), member 1
Transporter
SLC13A2
solute carrier family 13 (sodium-dependent dicarboxylate transporter), 
member 2
Transporter
SLC13A3
solute carrier family 13 (sodium-dependent dicarboxylate transporter), 
member 3
Transporter
SLC16A1
solute carrier family 16 (monocarboxylic acid Transporter), member 1
Transporter
SLC19A1
solute carrier family 19 (folate transporter), member 1
Transporter
SLC22A10
solute carrier family 22 (organic anion/cation transporter), member 10
Transporter
SLC22A12
solute carrier family 22 (organic anion/cation transporter), member 12
Transporter
SLC22A13
solute carrier family 22 (organic cation transporter), member 13
Transporter
SLC22A14
solute carrier family 22 (organic cation transporter), member 14
Transporter
SLC22A15
solute carrier family 22 (organic cation transporter), member 15
Transporter
SLC22A16
solute carrier family 22 (organic cation transporter), member 16
Transporter
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Gene Symbol
Full Gene Name
Class
SLC22A17
solute carrier family 22 (organic cation transporter), member 17
Transporter
SLC22A18
solute carrier family 22 (organic cation transporter), member 18
Transporter
SLC22A18AS
solute carrier family 22 (organic cation transporter), member 18 
antisense
Transporter
SLC22A3
solute carrier family 22 (extraneuronal monoamine transporter), 
member 3
Transporter
SLC22A4
solute carrier family 22 (organic cation transporter), member 4
Transporter
SLC22A5
solute carrier family 22 (organic cation transporter), member 5
Transporter
SLC22A7
solute carrier family 22 (organic anion transporter), member 7
Transporter
SLC22A9
solute carrier family 22 (organic anion/cation transporter), member 9
Transporter
SLC27A1
solute carrier family 27 (fatty acid transporter), member 1
Transporter
SLC28A1
solute carrier family 28 (sodium-coupled nucleoside transporter), 
member 1
Transporter
SLC28A2
solute carrier family 28 (sodium-coupled nucleoside transporter), 
member 2
Transporter
SLC28A3
solute carrier family 28 (sodium-coupled nucleoside transporter), 
member 3
Transporter
SLC29A1
solute carrier family 29 (nucleoside Transporter), member 1
Transporter
SLC29A2
solute carrier family 29 (nucleoside Transporter), member 2
Transporter
SLC2A4
solute carrier family 2 (facilitated glucose transporter), member 4
Transporter
SLC2A5
solute carrier family 2 (facilitated glucose/fructose transporter), member 
5
Transporter
SLC5A6
solute carrier family 5 (sodium-dependent vitamin transporter)
Transporter
SLC6A6
solute carrier family 6 (neurotransmitter transporter, taurine), member 6 Transporter
SLC7A8
solute carrier family 7 (cationic amino acid transporter, y+ system), 
member 8
Transporter
SLCO1C1
solute carrier organic anion transporter family, member 1C1
Transporter
SLCO2A1
solute carrier organic anion transporter family, member 2A1
Transporter
SLCO3A1
solute carrier organic anion transporter family, member 3A1
Transporter
SLCO4A1
solute carrier organic anion transporter family, member 4A1
Transporter
SLCO4C1
solute carrier organic anion transporter family, member 4C1
Transporter
SLCO5A1
solute carrier organic anion transporter family, member 5A1
Transporter
SLCO6A1
solute carrier organic anion transporter family, member 6A1
Transporter
SULT1C1
sulfotransferase family, cytosolic, 1C, member 1
Phase II
SULT1C2
sulfotransferase family, cytosolic, 1C, member 2
Phase II
SULT1E1
sulfotransferase family 1E, estrogen-preferring, member 1
Phase II
SULT2A1
sulfotransferase family, cytosolic, 2A, DHEA preferring, member 1
Phase II
SULT2B1
sulfotransferase family, cytosolic, 2B, member 1
Phase II
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Gene Symbol
Full Gene Name
Class
TAP1
transporter 1, ATP-binding cassette, sub-family B (MDR/TAP)
Transporter
UGT1A10
UDP glucuronosyltransferase 1 family, polypeptide A10
Phase II
UGT1A4
UDP glucuronosyltransferase 1 family, polypeptide A4
Phase II
UGT1A5
UDP glucuronosyltransferase 1 family, polypeptide A5
Phase II
UGT2B10
UDP glucuronosyltransferase 2 family, polypeptide B10
Phase II
ABCC13
ATP-binding cassette, sub-family C (CFTR/MRP), member 13
Transporter
ARSA
arylsulfatase A
Modifier
CAT
catalase
Modifier
CHST8
carbohydrate (N-acetylgalactosamine 4-0) sulfotransferase 8
Phase II
CYP19A1
cytochrome P450, family 19, subfamily A, polypeptide 1
Phase I
CYP26C1
cytochrome P450, family 26, subfamily C, polypeptide 1
Phase I
CYP27B1
cytochrome P450, family 27, subfamily B, polypeptide 1
Phase I
CYP2R1
cytochrome P450, family 2, subfamily R, polypeptide 1
Phase I
CYP2S1
cytochrome P450, family 2, subfamily S, polypeptide 1
Phase I
CYP46A1
cytochrome P450, family 46, subfamily A, polypeptide 1
Phase I
CYP4A11
cytochrome P450, family 4, subfamily A, polypeptide 11
Phase I
CYP4F12
cytochrome P450, family 4, subfamily F, polypeptide 12
Phase I
CYP4F2
cytochrome P450, family 4, subfamily F, polypeptide 2
Phase I
CYP4F3
cytochrome P450, family 4, subfamily F, polypeptide 3
Phase I
CYP4F8
cytochrome P450, family 4, subfamily F, polypeptide 8
Phase I
CYP4Z1
cytochrome P450, family 4, subfamily Z, polypeptide 1
Phase I
CYP7B1
cytochrome P450, family 7, subfamily B, polypeptide 1
Phase I
CYP8B1
cytochrome P450, family 8, subfamily B, polypeptide 1
Phase I
DHRS13
dehydrogenase/reductase (SDR family) member 13
Phase I
DHRS2
dehydrogenase/reductase (SDR family) member 2
Phase I
GPX1
glutathione peroxidase 1
Phase I
GPX4
glutathione peroxidase 4 (phospholipid hydroperoxidase)
Phase I
GPX5
glutathione peroxidase 5 (epididymal androgen-related protein)
Phase I
GPX6
glutathione peroxidase 6 (olfactory)
Phase I
GSS
glutathione synthetase
Phase I
GSTCD
glutathione S-transferase, C-terminal domain containing
Phase II
HNF4A
hepatocyte nuclear factor 4, alpha
Modifier
HNMT
histamine N-methyltransferase
Phase II
HSD11B1
hydroxysteroid (17-beta) dehydrogenase 11
Phase I
HSD17B11
hydroxysteroid (17-beta) dehydrogenase 11
Phase I
HSD17B14
hydroxysteroid (17-beta) dehydrogenase 14
Phase I
Protocol Amendment No.: 02
Date: 15-Apr-2022
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930158569
3.0
v
Approved
1.0
v

Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Gene Symbol
Full Gene Name
Class
LOC731356
similar to dehydrogenase/reductase (SDR family) member 4 like 2
Phase I
MGST1
microsomal glutathione S-transferase 1
Phase II
MGST2
microsomal glutathione S-transferase 2
Phase II
MGST3
microsomal glutathione S-transferase 3
Phase II
MPO
myeloperoxidase
Modifier
NOS1
nitric oxide synthase 1 (neuronal)
Phase I
NOS2A
nitric oxide synthase 2A (inducible, hepatocytes)
Phase I
NOS3
nitric oxide synthase 3 (endothelial cell)
Phase I
PPARA
peroxisome proliferator-activated receptor alpha
Modifier
SERPINA7
serpin peptidase inhibitor, clade A (alpha-1 antiproteinase, antitrypsin), 
member 7
Modifier
SLC7A7
solute carrier family 7 (cationic amino acid transporter, y+ system), 
member 7
Transporter
SOD1
superoxide dismutase 1, soluble (amyotrophic lateral sclerosis 1 (adult)) Modifier
SOD2
superoxide dismutase 2, mitochondrial
Modifier
SOD3
superoxide dismutase 3, extracellular precursor
Modifier
SULF1
sulfatase 1
Phase I
SULT4A1
sulfotransferase family 4A, member 1
Phase II
TAP2
transporter 2, ATP-binding cassette, sub-family B (MDR/TAP)
Transporter
UGT8
UDP glycosyltransferase 8 (UDP-galactose ceramide 
galactosyltransferase)
Phase II
XDH
xanthine dehydrogenase
Phase I
ADHFE1
alcohol dehydrogenase, iron containing, 1
Phase I
CHST1
carbohydrate (keratan sulfate Gal-6) sulfotransferase 1
Phase II
CHST10
carbohydrate sulfotransferase 10
Phase II
CHST11
carbohydrate (chondroitin 4) sulfotransferase 11
Phase II
CHST12
carbohydrate (chondroitin 4) sulfotransferase 12
Phase II
CHST13
carbohydrate (chondroitin 4) sulfotransferase 13
Phase II
CHST2
carbohydrate (N-acetylglucosamine-6-O) sulfotransferase 2
Phase II
CHST3
carbohydrate (chondroitin 6) sulfotransferase 3
Phase II
CHST4
carbohydrate (N-acetylglucosamine 6-O) sulfotransferase 4
Phase II
CHST5
carbohydrate (N-acetylglucosamine 6-O) sulfotransferase 5
Phase II
CHST6
carbohydrate (N-acetylglucosamine 6-O) sulfotransferase 6
Phase II
CHST7
carbohydrate (N-acetylglucosamine 6-O) sulfotransferase 7
Phase II
CHST9
carbohydrate (N-acetylgalactosamine 4-0) sulfotransferase 9
Phase II
CYP2D7P1
cytochrome P450, family 2, subfamily D, polypeptide 7 pseudogene 1
Phase I
DDO
D-aspartate oxidase
Phase I
Protocol Amendment No.: 02
Date: 15-Apr-2022
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3.0
Approved
930158569
3.0
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Approved
1.0
v

Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Gene Symbol
Full Gene Name
Class
DHRS1
dehydrogenase/reductase (SDR family) member 1
Phase I
DHRS12
dehydrogenase/reductase (SDR family) member 12
Phase I
DHRS3
dehydrogenase/reductase (SDR family) member 3
Phase I
DHRS4
dehydrogenase/reductase (SDR family) member 4
Phase I
DHRS4L1
dehydrogenase/reductase (SDR family) member 4 like 1
Phase I
DHRS4L2
dehydrogenase/reductase (SDR family) member 4 like 2
Phase I
DHRS7
dehydrogenase/reductase (SDR family) member 7
Phase I
DHRS7B
dehydrogenase/reductase (SDR family) member 7B
Phase I
DHRS7C
dehydrogenase/reductase (SDR family) member 7C
Phase I
DHRS9
dehydrogenase/reductase (SDR family) member 9
Phase I
DHRSX
dehydrogenase/reductase (SDR family) X-linked
Phase I
DPEP1
dipeptidase 1 (renal)
Phase I
FMO6P
flavin containing monooxygenase 6
Phase I
HAGH
hydroxyacylglutathione hydrolase
Phase I
IAPP
islet amyloid polypeptide
Modifier
KCNJ11
potassium inwardly-rectifying channel, subfamily J, member 11
Modifier
LOC728667
similar to dehydrogenase/reductase (SDR family) member 2 isoform 1
Phase I
LOC731931
similar to dehydrogenase/reductase (SDR family) member 2 isoform 1
Phase I
MAT1A
methionine adenosyltransferase I, alpha
Modifier
METAP1
methionyl aminopeptidase 1
Phase I
PDE3A
phosphodiesterase 3A, cGMP-inhibited
Phase I
PDE3B
phosphodiesterase 3B, cGMP-inhibited
Phase I
PLGLB1
plasminogen-like B1
Phase I
ATP7A
ATPase, Cu++ transporting, alpha polypeptide (Menkes syndrome)
Modifier
ATP7B
ATPase, Cu++ transporting, beta polypeptide
Modifier
CFTR
cystic fibrosis transmembrane conductance regulator
Modifier
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
APPENDIX 26
 DISCOID LUPUS CLASSIFICATION CRITERIA
Instructions:
The investigator should identify the 
presence or absence of each candidate 
morphological characteristic for DLE once 
at screening visit and a second time at 
baseline visit. 
The clinical features and the points-based 
system should be scored according to 
Table 3 and recorded.
Assign the appropriate score for each 
feature that is observed for the participant 
at the visit. Only one location score, 
either the conchal bowl or head and 
neck can be applied. Tally up the points 
to generate a total score.
Note: A maximum score of 8 points can be 
given.
Source: Elman SA, Joyce C, Braudis K, et al. Creation and validation of classification criteria for discoid lupus erythematosus. JAMA Dermatol. 2020 Jun 
17;156(8):1-6.
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
APPENDIX 27
PROTOCOL AMENDMENT SUMMARY OF CHANGE HISTORY
Overall Rationale for Revised Protocol 01, 01-Dec-2020
The rationale for the IM011-132 protocol revision 01:
 
4) An unscheduled visit for participants experiencing flare outside of visit window has been 
added, along with assessments to be completed at that visit.
In addition, minor clarifications and corrections have been made throughout. This revised protocol 
also incorporates changes from Administrative Letter 01.
Summary of Key Changes for Revised Protocol 01
Section Number & Title
Description of Change
Brief Rationale
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Summary of Key Changes for Revised Protocol 01
Section Number & Title
Description of Change
Brief Rationale
Section 2, Table 2-2: 
Placebo-Controlled 
Treatment Period Outline Up 
to Week 16; Table 2-3: 
Active Treatment Period 
Activities and Assessments 
(IM011132); Section 4:
Table 4-1 Objectives and 
Endpoints; 


DLQI 
 
 
Assessments 
have 
been 
removed.

DLQI Appendix replaced 
.

 
Appendix 
replaced 
.

has 
been 
replaced 
 due to 
licensing complications. 
These 
assessments 
combined will provide 
comparable information 

DLQI has been replaced 
to 
support 
qualification of CLASI 
. 
Section 2, Table 2-2: 
Placebo-Controlled 
Treatment Period Outline Up 
to Week 16; Table 2-3: 
Active Treatment Period 
Activities and Assessments 
(IM011132); 
.

Added 
that 
participants 
should come to the site for 
an 
unscheduled 
visit. 
Details 
regarding 
assessments 
at 
an 
unscheduled visit 
.

 
the participant  must come 
to an unscheduled visit for 
verification of meeting 
the oral 
corticosteroid 
rescue therapy criteria. 


Table 9.2.1: Time Period and 
Frequency for Collecting AE 
and SAE Information; 

Revised to reflect collection 
and follow-up of SARS-
CoV-2 events with AE 
collection.

Clarified that all AEs 
related to SARS-CoV-2 
should be followed until 
Protocol Amendment No.: 02
Date: 15-Apr-2022
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Clinical Protocol
IM011132
BMS-986165
Deucravacitinib
Summary of Key Changes for Revised Protocol 01
Section Number & Title
Description of Change
Brief Rationale
Section 9.2.3: Follow-up of 
AEs and SAEs.
resolution as an SAE or 
an AE of special interest. 
All

Minor 
formatting 
and 
typographical corrections.

Minor, therefore have not 
been summarized.
Protocol Amendment No.: 02
Date: 15-Apr-2022
170
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930158569
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