A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
Phase: PHASE2
Conditions: Psoriasis
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study 
to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants with 
Moderate-to-Severe Psoriasis 
NCT Number: NCT05730725 
Document Date (Date in which document was last revised): 29 Mar 2023 

Page:
1
Protocol Number:
IM032041
Date:
14-Oct-2022
Revised Date:
29-Mar-2023
CLINICAL PROTOCOL IM032041
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study 
to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants with 
Moderate-to-Severe Psoriasis
Compound: BMS-986322
Brief Title:
Multiple Dose Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and 
Tolerability of BMS-986322 in Participants with Moderate-to-Severe Psoriasis
Protocol Amendment Number 01
Medical Monitor Name and Contact Information:
Clinical Trial Physician – Medical Monitor
Bristol-Myers Squibb Company
556 Morris Ave
Summit, NJ 07901
Phone: 
email: 
24-hr Emergency Telephone Number
USA: 1-866-470-2267
International: +1-248-844-7390
Sponsor Name and Legal Registered Address:
Bristol-Myers Squibb Company
Route 206 & Province Line Road
Lawrenceville, NJ 08543
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
1-2-1 Otemachi, Chiyoda-ku
Tokyo, 100-0004, Japan
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REGULATORY AGENCY IDENTIFIER NUMBER(S)
IND: 145913
EU CT: 2023-504848-34-00
UTN: U1111‐1282‐3606
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company (BMS) and its global affiliates. By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS-sponsored 
study. Any permitted disclosures will be made only on a confidential “need to know” basis 
within your organization or to your Independent Ethics Committee(s). Any other use, 
copying, disclosure or dissemination of this information is strictly prohibited unless expressly 
authorized in writing by BMS. Any supplemental information (eg, amendments) that may 
be added to this document is also confidential and proprietary to BMS and must be kept in 
confidence in the same manner as the contents of this document. Any person who receives 
this document without due authorization from BMS is requested to return it to BMS or 
promptly destroy it. References to BMS in this protocol may apply to partners to which BMS 
has transferred obligations (eg, a Contract Research Organization [CRO]).  
© 2023 Bristol-Myers Squibb Company
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DOCUMENT HISTORY
Document
Date of Issue
Summary of Changes
Protocol 
Amendment 01
29-Mar-2023
The purpose of Protocol Amendment 01 is to update the European 
Union Clinical Trial number for this study.
Original Protocol
14-Oct-2022
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OVERALL RATIONALE FOR PROTOCOL AMENDMENT 01:
The purpose of Protocol Amendment 01 is to update the European Union (EU) Clinical Trial (CT) 
number for this study and Sponsor address in Japan.
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01
Section 
Number & 
Title
Description of Change
Brief Rationale
Title Page
Updated the EU CT number and 
the Sponsor address in Japan.
Administrative changes.
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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
DOCUMENT HISTORY .............................................................................................. 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 01: ............................ 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 01 ................ 
TABLE OF CONTENTS .............................................................................................. 
1 PROTOCOL SUMMARY ......................................................................................... 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
3 INTRODUCTION ..................................................................................................... 
3.1 Study Rationale ................................................................................................. 
3.2 Background ....................................................................................................... 
3.3 Benefit/Risk Assessment .................................................................................. 
3.3.1 Risk Assessment ....................................................................................... 
3.3.1.1 Coronavirus Disease 2019-related Risks and Risk Mitigation 
Measures ............................................................................................... 
3.3.1.2 General COVID-19-related Risk Mitigation Measures .................. 
3.3.2 Benefit Assessment ................................................................................... 
3.3.3 Overall Benefit/Risk Conclusion .............................................................. 
4 OBJECTIVES AND ENDPOINTS ........................................................................... 
5 STUDY DESIGN....................................................................................................... 
5.1 Overall Design .................................................................................................. 
5.1.1 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 ........................................................................................ 
6.4 Screen Failures .................................................................................................. 
6.4.1 Re-testing During Screening .................................................................... 
7 STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ....................... 
7.1 Study Interventions Administered .................................................................... 
7.2 Assignment to Study Intervention .................................................................... 
7.3 Blinding............................................................................................................. 
7.4 Dosage Modification ......................................................................................... 
7.5 Preparation/Handling/Storage/Accountability .................................................. 
7.6 Study Intervention Compliance ........................................................................ 
7.7 Concomitant Therapy........................................................................................ 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
7.7.2 Other Restrictions and Precautions ......................................................... 
7.8 Continued Access to Study Intervention After the End of the Study ............... 
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8 DISCONTINUATION CRITERIA ........................................................................... 
 
8.1 Discontinuation of Study Intervention .............................................................. 
 
8.1.1 Post-study Intervention Study Follow-up................................................. 
 
8.2 Discontinuation From the Study ....................................................................... 
 
8.2.1 Individual Discontinuation Criteria ........................................................ 
 
8.2.2 Study Termination for Unexpectedly Unfavorable Risk/Benefit Balance 
 
8.3 Lost to Follow-up .............................................................................................. 
 
9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
 
9.1 Efficacy Assessments ........................................................................................ 
 
9.1.1 Efficacy Assessment for the Study ............................................................ 
 
 ......................................................................... 
 
9.1.3 Psoriasis Area and Severity Index (PASI) ............................................... 
 
................... 
 
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................... 
 
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................... 
 
9.2 Adverse Events ................................................................................................. 
 
9.2.1 Period and Frequency for Collecting AE and SAE Information ............. 
 
9.2.2 Method of Detecting AEs and SAEs ......................................................... 
 
9.2.3 Follow-up of AEs and SAEs ..................................................................... 
 
9.2.4 Regulatory Reporting Requirements for SAEs ......................................... 
 
9.2.5 Pregnancy ................................................................................................ 
 
9.2.6 Laboratory Test Result Abnormalities ..................................................... 
 
9.2.7 Potential Drug-induced Liver Injury ....................................................... 
 
9.2.8 Other Safety Considerations .................................................................... 
 
9.3 Overdose ........................................................................................................... 
 
9.4 Safety ................................................................................................................ 
 
9.4.1 Physical Examinations ............................................................................. 
 
9.4.2 Tuberculosis Screening and Chest X-Ray ................................................ 
 
9.4.3 Electrocardiograms ................................................................................. 
 
 
 
 
 
 
 
9.4.7 Vital Signs ................................................................................................ 
 
9.4.8 Clinical Safety Laboratory Assessments .................................................. 
 
 .............................................................................................. 
 
9.6 Immunogenicity Assessments ........................................................................... 
 
 
 
 
 
 
 
9.8 Optional Future Research ................................................................................. 
 
9.9 Other Assessments ............................................................................................ 
 
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9.10 Health Economics OR Medical Resource Utilization and Health Economics
........................................................................................................................... 
 
10 STATISTICAL CONSIDERATIONS .................................................................... 
 
10.1 Statistical Hypotheses ..................................................................................... 
 
10.2 Sample Size Determination ............................................................................. 
 
10.3 Analysis Sets ................................................................................................... 
 
10.4 Statistical Analyses ......................................................................................... 
 
10.4.1 General Considerations ......................................................................... 
 
10.4.2 Planned Analyses ................................................................................... 
 
10.4.3 Primary Endpoint(s) .............................................................................. 
 
10.4.4 Secondary Endpoint(s) ........................................................................... 
 
 ........................................................................ 
 
10.4.6 Other Safety Analyses ............................................................................ 
 
 ....................................................................................... 
 
 ............................................................................................. 
 
11 REFERENCES ........................................................................................................ 
 
12 APPENDICES ......................................................................................................... 
 
APPENDIX 1 ABBREVIATIONS............................................................................... 
 
APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. 
 
APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW-UP, AND REPORTING ....................................................................... 
 
APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION ..................................................................... 
 
APPENDIX 5 PSORIASIS AREA AND SEVERITY INDEX (PASI) ....................... 
 
 
 
 
 
 
 
 
 
APPENDIX 14 ADME GENE LIST (FROM HTTP://PHARMAADME.ORG) ........ 
 
 
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1
PROTOCOL SUMMARY
Protocol Title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to 
Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants with Moderate-to-Severe 
Psoriasis
Brief Title: 
Multiple Dose Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and 
Tolerability of BMS-986322 in Participants with Moderate-to-Severe Psoriasis
Rationale:
Tyrosine kinase 2 (TYK2) catalyzes the phosphorylation of signal transducer and activator of 
transcription (STAT) proteins downstream of the receptors for the p40-containing cytokines
interleukin (IL)-12 and IL-23 as well as the Type I interferon (IFN) receptor, resulting in the 
activation of STAT-dependent transcription and functional responses specific for these receptors.
TYK2-dependent receptors are distinct from those dependent on the Janus kinase (JAK)1/JAK3 
(eg, receptors for IL-2, IL-15), JAK1/JAK2 pair (eg, IL-6, IFN), or JAK2/JAK2 (eg, 
erythropoietin, thrombopoietin, granulocyte macrophage colony-stimulating factor). A selective 
TYK2 inhibitor is expected to have a differentiated profile from inhibitors of other JAK family 
kinases.
IL-23 is critical in the expansion and survival of pathogenic TH17 cells as well as the induction of 
innate lymphoid cells in autoimmunity. Thus, IL-23 supports the production of key 
proinflammatory cytokines by TH17 cells including IL-17 and IL-22, which are effector molecules 
important for the pathogenesis of immune-mediated conditions such as psoriasis (PsO) and 
spondyloarthritidies. The receptor signaling pathways regulated by TYK2 play key roles in several 
immune-mediated disorders. IL-12 is essential for TH1 cell development and drives the production 
of IFN, a major effector molecule in dermatologic autoimmune disorders such as alopecia areata 
and vitiligo. 
Type I IFNs impact many cell types and pathways important in autoimmunity including dendritic 
cell maturation and expression of major histocompatibility complex and costimulation molecules, 
B cell differentiation and antibody production, as well as T cell survival. All Type I IFNs act 
through a common receptor dependent on TYK2 signaling. Type I IFNs have also been implicated 
in the pathogenesis of PsO (including flares), dermatomyositis, interferonopathies, and systemic 
sclerosis.
In summary, inhibition of TYK2 impacts PsO through its effects on the IL-23/TH17/TH22 axis, 
IL-12-mediated TH1 functions, and Type I IFN-driven modulation of a number of immune 
activities.
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Objectives and Endpoints:
Objectives
Endpoints
Primary

To compare BMS-986322 with placebo on 
achieving a 75% reduction in PASI score 
(PASI-75)

Proportion of participants achieving
PASI-75 at 
Week 12

To assess the safety and tolerability of 
BMS-986322

Type and frequency of TEAEs, SAEs, and TEAEs 
leading to treatment discontinuation

Severity and causal relationship of TEAEs

Change from baseline and incidence of marked 
abnormalities in clinical laboratory tests, 12-lead ECG, 
vital signs, and physical examination
Secondary

To compare BMS-986322 with placebo on 
achieving an sPGA score of 0 (“cleared”) or 1 
(“minimal”)

Proportion of participants achieving sPGA score of 0 or 
1 at Week 12

To compare BMS-986322 with placebo on 
achieving a 50% reduction in PASI score 
(PASI-50)

Proportion of participants achieving PASI-50 at 
Week 12

To compare BMS-986322 with placebo on 
achieving a 90% reduction in PASI score 
(PASI-90)

Proportion of participants achieving PASI-90
at 
Week 12

To compare BMS-986322 with placebo on 
achieving a 100% reduction in PASI score 
(PASI-100)

Proportion of participants achieving PASI-100 at 
Week 12

To compare BMS-986322 with placebo on 
achievement of PASI-50, -75, -90, and -100 
over time

Proportion of participants achieving PASI-50, -75, -90, 
and -100 at various time points from baseline through 
Week 12

To compare BMS-986322 with placebo on 
improvement 
of 
continuous 
PASI 
measurements over time

Change from baseline in PASI score at various time 
points from baseline through Week 12 

To assess Cmax, AUC(TAU), Tmax, and 
trough concentrations of BMS-986322

BMS-986322 trough concentrations at various time 
points through Week 12

BMS-986322 Cmax, AUC(TAU), and Tmax on Day 15
Abbreviations: AUC(TAU), area under the plasma concentration-time curve over the dosing interval; Cmax, 
maximum observed plasma concentration; ECG, electrocardiogram; PASI, Psoriasis Area and Severity Index; SAE, 
serious adverse event; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse event; Tmax, 
time of maximum observed plasma concentration.
Overall Design:
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, parallel group,
multiple oral dose Phase 2 study of BMS-986322 in participants with moderate-to-severe PsO. 
Participants will be randomly assigned to receive BMS-986322 (16 mg once daily [QD], 32 mg 
QD, or 64 mg QD) or placebo. Participants will undergo screening evaluations to determine 
eligibility within 
 days prior to administration of study intervention. 
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This will be an outpatient study. Participants will receive BMS-986322 and/or placebo tablets to 
be taken at home. Participants will be provided by the Investigator Site with enough tablets to 
cover the treatment interval between study visits beginning on Study Day . Additional tablets 
covering the treatment interval between study visits should be supplied by the Investigator Site 
during each applicable follow-up visit. At follow-up visits (Days 
), doses of 
BMS-986322 and/or placebo tablets will be administered in the clinic.  
Participants will report to the clinic for study visits on Study Days 
, and 
for an Early Termination (ET) visit if needed.  
Number of Participants:
Approximately 120 participants will be randomized and treated. 
Assuming a screen failure rate of about 20%, it is estimated that approximately 150 screened 
participants will be required to achieve the planned 120 treated participants.
Study Population:
Key Inclusion Criteria:

Type of Participant and Target Disease Characteristics

Male and female participants with a diagnosis of plaque PsO for ≥ 6 months. 

Body mass index 18 to 40 kg/m2 and total body weight > 50 kg (110 lbs).

Deemed by Investigator to be eligible for phototherapy or systemic therapy.

Psoriatic plaques must cover ≥ 10% of body surface area at baseline.
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
Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global 
Assessment (sPGA) ≥ 3 at baseline.

Willing to discontinue topical and/or systemic therapies, with the exception of topical 
emollients and low potency topical steroids (rescue) prior to dosing.

Age of Participant 

Participant must be 18 to 70 years of age inclusive at the time of signing the informed 
consent form.
Key Exclusion Criteria:

Target Disease Exceptions

Diagnosis of non-plaque PsO (guttate, inverse, pustular, erythrodermic). 

Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions 
that are commonly associated with PsO for which a participant requires current systemic 
(oral, 
subcutaneous, 
or 
intravenous) 
(including 
corticosteroids, 
biologics) 
immunosuppressant medical treatment. Certain therapies such as non-steroidal 
anti-inflammatory drugs may be permitted but should be discussed with the Sponsor
Medical Monitor prior to determination of participant eligibility.
Intervention Groups and Duration:
Participants will be randomly assigned to receive BMS-986322 (16 mg QD, 32 mg QD, or 64 mg 
QD) or placebo. Participants will undergo screening evaluations to determine eligibility within 
days prior to administration of study intervention. 
Study Intervention: 
Study Intervention for IM032-041
Intervention Name
Unit Dose Strength(s)
IP/IMP/Non-IP/
Non-IMP/AxMP
BMS-986322-01
 mg
IMP Blinded
Placebo to Match BMS-986322-01
N/A
IMP Blinded
Abbreviations: AxMP, Auxiliary Medicinal Product; IMP, Investigational Medicinal Product; IP, Investigational 
Product; N/A, not applicable.
Statistical Methods:
Approximately 120 participants will be randomized in a 1:1:1:1 ratio to receive BMS-986322 
(16 mg PO QD, 32 mg PO QD, or 64 mg PO QD) or placebo. Randomization will be stratified by 
use of previous treatment with a biologic (yes/no). Assuming a screen failure rate of about 20%, it 
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is estimated that approximately 150 screened participants will be required to achieve the planned 
120 treated participants.
The primary objective of this study is to evaluate the response rate in PASI-75 after 12 weeks of 
treatment with BMS-986322. The response rate in PASI-75 is defined as the proportion of 
participants with moderate-to-severe PsO experiencing a 75% improvement (reduction from 
baseline) in PASI score at Week 12 (Day 85) and will be evaluated on the Full Analysis Set. 
The safety and tolerability of BMS-986322 will be assessed by the type, frequency, relationship, 
severity, and seriousness of treatment-emergent adverse events (AEs), clinical laboratory tests, 
12-lead electrocardiogram (ECG), vital signs, and physical examination (PE). Treatment-emergent 
AEs and study intervention-related AEs and SAEs will be summarized using counts and 
percentages of participants experiencing the event as well as the number of events by system organ 
class, preferred term, and treatment group. PE findings, vital signs, clinical laboratory test results, 
and ECG test results will be summarized using descriptive summary statistics for continuous 
variables and frequency distributions (counts and percentages) for categorical variables. All safety 
analyses will be performed on the Safety Analysis Set.
Data Monitoring Committee: Yes
An Independent Data Monitoring Committee will be used in the study.
Other Committee: No
Other committees will not be used in this study. 
Brief Summary:
The purpose of this study is to compare the proportion of moderate-to-severe PsO participants 
achieving PASI-75 score (≥75% reduction from baseline in PASI) between treatment and placebo 
groups at Week 12. Study details include the following:
Study Duration: 16 weeks
Study Intervention Duration: 12 weeks
Study Visit Frequency: Participants will report to the clinic for study visits on study Days 
 
, and, if applicable, Early Termination.
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2
SCHEDULE OF ACTIVITIES
The schedule of activities are outlined in Table 2-1 (Screening Procedural Outline), Table 2-2
(
 Follow-up Procedural Outline), 
 
 
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Table 2-1:
Screening Procedural Outline
Procedure
Screening
Notes
Eligibility Assessments
Informed Consent
X
A participant is considered enrolled only when a protocol-specific informed 
consent is signed; informed consent must be obtained prior to performing any 
screening procedures. 
Inclusion/Exclusion Criteria
X
See Section 6.
Medical History
X
All medical history relevant to disease under study. Include findings from PE. 
Include any toxicities or allergy related to previous treatments. See Section 6.2
Exclusion Criteria for complete eligibility criteria associated with medical 
history.
Psoriasis-related History
X
Includes scalp symptoms, PsA/joint pain, nail involvement, palmoplantar 
involvement, genital involvement, history of other forms of psoriasis. See 
Section 3.
Demographics
X
Some data may be collected via electronic device. See Section 3.
Safety Assessments
Complete PE
X
See Section 9.4.1.
Physical Measurements 
X
Includes height, weight, and BMI.
Vital Signs
X
Includes (ear or oral) body temperature, respiratory rate, seated blood pressure, 
and seated heart rate. Blood pressure and heart rate should be measured after the 
participant has been resting quietly for at least 5 minutes. 
Prior/Concomitant Medication Use
X
Concomitant medications should be reviewed and updated at each visit. See 
Section 7.7.
12-lead ECG
X
12-lead ECGs should be recorded after the participant has been supine for at 
least 5 minutes. A single ECG will be collected. See Section 9.4.3.
Chest X-ray
X
Chest x-ray is required if not already performed within 6 months of obtaining 
written informed consent or if documentation is not on file. See Section 9.4.2.
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Table 2-1:
Screening Procedural Outline
Procedure
Screening
Notes
Laboratory Tests
Hematology
X
Complete blood count with differential. Participants are required to fast for at 
least 8 hours prior to the collection of specimens for clinical laboratory tests. 
See Section 9.4.8.
Chemistry
X
Participants are required to fast for at least 8 hours prior to the collection of 
specimens for clinical laboratory tests. See Section 9.4.8.
Creatinine Clearance
X
At screening only. See Section 9.4.8.
Serology
X
Serum for hepatitis C antibody, HBsAg, anti-hepatitis B core antibody, 
anti-HBsAb, HIV-1 and -2 antibody (HIV viral RNA or p24 antigen, if 
needed) at screening only. See Section 9.4.8.
Urinalysis
X
Participants are required to fast for at least 8 hours prior to the collection of 
specimens for clinical laboratory tests. See Section 9.4.8.
Test for Drugs of Abuse
X
Urine or serum. See Section 9.4.8.
Tuberculosis Test (Interferon-gamma Release Assay)
X
In accordance with BMS standard testing at screening only. See Section 9.4.2. 
Pregnancy Test (Serum)
X
Female participant only (see Appendix 4). Serum (minimum sensitivity 
equivalent units 25 IU/L or equivalent units of hCG) to be done at screening 
visit. The participant must be excluded from participation if the serum 
pregnancy result is positive.
FSH
X
If needed to document postmenopausal status, as defined in Appendix 4, at 
screening only.
Females under the age of 55 years must have a serum FSH level > 40 mIU/mL 
to confirm menopause.
SARS-CoV-2 testing
X
PCR testing and other measures (eg, antibody testing, social distancing, 
temperature readings, personal protective equipment) that may be required by 
the site will be implemented.
Efficacy Assessments
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Table 2-1:
Screening Procedural Outline
Procedure
Screening
Notes
PASI 
X
See Section 9.1.3 and Appendix 5 for an illustrative example.
AE Reporting
Monitor for AEs and SAEs
X
All AEs and SAEs must be collected from the date of participant’s written consent 
until 30 days following discontinuation of dosing or participant’s participation in 
the study if the last scheduled visit occurs at a later time. See Section 9.2 and 
Appendix 3.
Abbreviations: AE, adverse event; BMI, body mass index; BMS, Bristol-Myers Squibb Company; 
; ECG, electrocardiogram; FSH, 
follicle-stimulating hormone; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; hCG, human chorionic gonadotropin; HIV, human 
immunodeficiency virus; 
; PASI, Psoriasis Area and Severity Index; PCR, polymerase chain reaction; PE, physical examination; PsA, 
psoriatic arthritis; 
; RNA, ribonucleic acid; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory 
syndrome coronavirus 2; 
. 
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Table 2-2:
 Follow-up Procedural Outline
Procedurea
Follow-up 
Visit
Notes
Safety Assessments
Complete PE
X
X
X
X
X
X
X
See Section 9.4.1.
Weight
X
X
X
X
X
Vital Signs
X
X
X
X
X
X
X
Includes (ear or oral) body 
temperature, respiratory rate, seated 
blood pressure, and heart rate. 
Blood pressure and heart rate should 
be measured after the participant 
has been resting quietly for at least 
5 minutes.
12-lead ECG
X
X
X
X
X
X
X
12-lead ECGs should be recorded 
after the participant has been supine 
for at least 5 minutes. A single ECG 
will be collected. See Section 9.4.3.
Concomitant Medication Use
Continuously
Concomitant medications should be 
reviewed and updated at each visit. 
See Section 7.7.
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Table 2-2:
 Follow-up Procedural Outline
Procedurea
Follow-up 
Visit
Notes
Laboratory Tests
Hematology
Xb
X
X
X
X
X
X
Including complete blood count 
with differential. Participants are 
required to fast for at least 8 hours 
prior to the collection of specimens 
for clinical laboratory tests on Day 
, and ET. See 
Section 9.4.8.
Chemistry
Xb
X
X
X
X
X
X
Participants are required to fast for 
at least 8 hours prior to the 
collection of specimens for clinical 
laboratory tests on Day 
, 
and ET. Fasting glucose and fasting 
C-peptide will only be taken on 
fasting days (Day 
, and 
ET). See Section 9.4.8.
hsCRP
Xb
X
X
X
Participants are required to fast for 
at least 8 hours prior to the 
collection of specimens for clinical
laboratory tests on Day 
, 
and ET. See Section 9.4.8.
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Table 2-2:
 Follow-up Procedural Outline
Procedurea
Follow-up 
Visit
Notes
Fasting Lipid Panel
Xb
X
Participants are required to fast for 
at least 8 hours prior to the 
collection of specimens for clinical 
laboratory tests on Day 
, 
and ET. See Section 9.4.8.
Urinalysis
Xb
X
X
X
X
X
X
Participants are required to fast for 
at least 8 hours prior to the 
collection of specimens for clinical 
laboratory tests on Day 
, 
and ET. See Section 9.4.8.
Test for Drugs of Abuse
Xb
Urine or serum. See Section 9.4.8.
Pregnancy Test (Urine)
Xb
X
X
X
X
All women must have a negative 
pregnancy test prior to dosing on 
Day .
AE Reporting
Monitor for AEs and SAEs
Continuously
All AEs and SAEs must be 
collected from the date of 
participant’s written consent until 
30 days following discontinuation 
of dosing or participant’s 
participation in the study if the last 
scheduled visit occurs at a later 
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Table 2-2:
 Follow-up Procedural Outline
Procedurea
Follow-up 
Visit
Notes
time. See Section 9.2 and Appendix 
3.
Efficacy Assessments
PASI 
X
X
X
X
X
X
X
See Section 9.1.3 and Appendix 5
for an illustrative example.
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Table 2-2:
 Follow-up Procedural Outline
Procedurea
Follow-up 
Visit
Notes
Study Intervention
Randomization via IRT
X
See Section 7.2.
Dispense Study Intervention
X
X
X
BMS-986322 QD or Placebo QD 
(see Section 7).
Study Intervention Compliance
X
X
X
X
X
See Section 7.6.
a In the event that multiple procedures are required at a single time point, the following is the order in which the procedures should be performed, from first to 
last: 
, safety (ECG), safety (vital signs), 
, 
, safety (clinical laboratory assessments).
b Sample to be taken at predose.
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Abbreviations: AE, adverse event; 
; ECG, electrocardiogram; ET, Early Termination; hsCRP, 
high-sensitivity C-reactive protein; 
 IRT, Interactive Response Technology;
; PASI, Psoriasis 
Area and Severity Index;
; PE, physical examination; 
 
 
; 
; QD, once daily; SAE, serious adverse event; 
 
.
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In the event that multiple procedures are required at a single time point, the following is the order 
in which the procedures should be performed, from first to last: 

Safety (electrocardiogram [ECG])

Safety (vital signs)

Pharmacokinetic (PK) sampling

Safety (clinical laboratory assessments)
When vital signs measurement or ECG recording coincide with a blood collection, they should 
preferably be performed before the blood collection, whenever possible. It is expected that every 
effort be made to collect PK samples at the times indicated in the protocol. However, for flexibility 
in PK sampling, the following windows serve as a guideline for PK sample collection:
To ensure PK 
 samples can be collected on time, the ECG and vital signs may be obtained 
± 15 minutes from the nominal postdose time point. Clinical laboratory samples may be obtained 
± 15 minutes from the nominal postdose time point. 
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3
INTRODUCTION
BMS-986322 is an oral tyrosine kinase 2 (TYK2) inhibitor with a highly selective mechanism of 
action that has the potential to safely and effectively treat a broad spectrum of immune-mediated 
diseases. TYK2 activates intracellular signal transducer and activator of transcription 
(STAT)-dependent transcription and functional responses downstream of receptors for critical 
immune mediators, such as interleukin (IL)-12, IL-23, and Type I interferons (IFNs).1,2,3 These 
immune and inflammatory signaling pathways are critical in the pathophysiology of various
immune-mediated diseases including psoriasis (PsO), lupus, spondyloarthritis, inflammatory 
bowel disease (IBD), dermatomyositis, and Type I interferonopathies.4,5,6,7,8,9
A comprehensive in vitro and in vivo characterization of BMS-986322 has been established and 
supports the testing of BMS-986322 in humans. 
 
 
 
 
 
 
 
 
 
 
A detailed description of the chemistry, pharmacology, efficacy, and safety of BMS-986322 is 
provided in the Investigator’s Brochure (IB).10
PsO is a chronic inflammatory skin disorder, characterized primarily by erythematous scaly 
plaques, that affects up to 3% of the general population. Men and women are equally affected, and 
it can present at any age.11,12 Several studies have observed a bimodal distribution of PsO onset 
with the first peak ranging from 15 to 22 years of age, and the second peak ranging from 55 to 
60 years of age.13,14,15 The most common form of PsO (58% to 97%) is plaque PsO (PsO vulgaris), 
with less common forms being guttate, pustular, inverse (flexural), and erythrodermic PsO. The 
disease can have a fluctuating relapsing course with flares that may be induced by factors such as 
infections, trauma, smoking, and stress.13 PsO can involve skin in any part of the body; particularly 
disabling is the involvement of specific anatomic regions, such as hands and feet (palmoplantar), 
face, scalp, and nails. The scalp is the most commonly affected region of the body in PsO, involved 
in about 80% of PsO cases.16 Scalp PsO represents one of the ‘special sites,’ given its 
difficult-to-treat nature and disproportionate impact on quality of life. PsO in general has a 
profound impact on quality of life and can lead to psychological, social, and economic 
consequences, especially in moderate-to-severe disease.17,18 Additionally, scalp disease in 
particular is associated with pain, itching, and bleeding. It has been shown to be associated with a 
disproportionate impact on quality of life with significant impact on psychosocial impairment. 
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Effective management of scalp PsO is essential to improving a participant’s quality of life.16 The 
presence of hair and unacceptable cosmetic appeal of topical therapy are barriers to compliance 
and satisfaction with the currently available topical interventions. Topical regimens can be 
complex and are highly dependent on participant preference. Additionally, some participants with 
severe scalp disease may have minimal body involvement and, hence, may not receive systemic 
therapy indicated for moderate-to-severe chronic plaque PsO.16,19,20
Interventions include topical preparations (eg, corticosteroids, vitamin D analogues, calcineurin 
inhibitors, salicylic acid, urea, and coal tar), phototherapy modalities (including broad-band and 
narrow band ultraviolet B), and systemic therapies. In moderate-to-severe disease, systemic 
interventions are usually needed and may include oral agents (retinoids, methotrexate, 
cyclosporine, and apremilast) or injectables (eg, biologics such as tumor necrosis factor [TNF] 
inhibitors etanercept, infliximab, and adalimumab) anti-IL-12/23p40 antibody (ustekinumab), 
IL-17 antagonists (secukinumab, ixekizumab, and brodalumab), and anti–IL-23p19 antibody 
(guselkumab, tildrakizumab and risankizumab). Many of these interventions are associated with 
increased risk of adverse events (AEs) such as hepatotoxicity and neutropenia (methotrexate),21
nephrotoxicity (cyclosporine),22 depression and weight loss (apremilast),23 serious infections 
(cytokine inhibitors),24,25,26,27 and candidiasis and Crohn’s disease (IL-17 antagonists).27, 28, 29
Although effective therapeutic options are available, undertreatment or nontreatment of PsO has 
been reported in up to half of surveyed participants (based on absence of intervention and/or 
dissatisfaction with intervention).30 Only guselkumab, secukinumab, and apremilast have efficacy 
data for scalp PsO included in their Food and Drug Administration (FDA) label.23,27,31 Scalp PsO 
presents considerable intervention challenges for the patient and practitioner. PsO of this site also 
contributes to a significant burden on participant quality of life.16
3.1
Study Rationale
TYK2 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 these receptors.
TYK2-dependent receptors are distinct from those dependent on the Janus kinase (JAK)1/JAK3 
(eg, receptors for IL-2, IL-15), JAK1/JAK2 pair (eg, IL-6, IFN), or JAK2/JAK2 (eg, 
erythropoietin, thrombopoietin, granulocyte macrophage colony-stimulating factor). A selective 
TYK2 inhibitor is expected to have a differentiated profile from inhibitors of other JAK family 
kinases.
IL-23 is critical in the expansion and survival of pathogenic TH17 cells as well as the induction of 
innate lymphoid cells in autoimmunity.32,33 Thus, IL-23 supports the production of key 
proinflammatory cytokines by TH17 cells including IL-17 and IL-22, which are effector molecules 
important for the pathogenesis of immune-mediated conditions such as PsO
and 
spondyloarthritidies. The receptor signaling pathways regulated by TYK2 play key roles in several 
immune-mediated disorders. IL-12 is essential for TH1 cell development and drives the production 
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of IFN, a major effector molecule in dermatologic autoimmune disorders such as alopecia areata 
and vitiligo.34
Type I IFNs impact many cell types and pathways important in autoimmunity including dendritic 
cell maturation and expression of major histocompatibility complex and costimulation molecules, 
B cell differentiation and antibody production, as well as T cell survival.35,36,37,38,39 All Type I 
IFNs act through a common receptor dependent on TYK2 signaling. Type I IFNs have also been 
implicated in the pathogenesis of PsO (including flares), dermatomyositis, interferonopathies, and 
systemic sclerosis.40,41,42,43,44
Monoclonal antibodies directed against either the p19 subunit of IL-23 or the p40 subunit it shares 
with IL-12 have been clinically validated in autoimmune diseases including PsO, psoriatic arthritis 
(PsA), and Crohn’s disease.4,5 For example, ustekinumab (anti-p40 antibody) is approved for the 
treatment of plaque PsO and PsA and produces a 75% reduction in Psoriasis Area and Severity 
Index (PASI) score (PASI-75) at 12 weeks in approximately 70% of PsO participants versus < 5% 
of placebo control participants.45
Similarly, deucravacitinib, another selective TYK2 inhibitor, was highly effective in the treatment 
of PsO based on results of recently completed 52-week, randomized, Phase 3, placebo-controlled 
studies of deucravacitinib (BMS-986165) 6 mg daily versus placebo and apremilast 30 mg twice 
daily (BID) (POETYK PSO-1 and PSO-2).46,47 In these 2 Phase 3 studies, in addition to achieving 
both co-primary clinical efficacy endpoints (PASI-75 and static Physician’s Global Assessment
[sPGA] 0/1), deucravacitinib also improved DLQI scores. More deucravacitinib-treated 
participants achieved ≥ 4-point improvement on DLQI meaningful change threshold (MCT ≥ 4) at 
Week 16 versus placebo-treated and apremilast-treated participants in PSO-1 (77.6% vs 43.4% 
and 68.8%, respectively) and PSO-2 (78.6% vs 44.9% and 69.3%).
Deucravacitinib, an oral, first in class, selective TYK2 inhibitor, has been approved by the US 
FDA for treating adults with moderate-to-severe plaque PsO who are candidates for systemic 
therapy or phototherapy.
In summary, inhibition of TYK2 impacts PsO through its effects on the IL-23/TH17/TH22 axis, 
IL-12-mediated TH1 functions, and Type I IFN-driven modulation of a number of immune 
activities.
3.2
Background
BMS-986322 binds to the pseudokinase domain of TYK2, stabilizing an inhibitory interaction 
between the pseudokinase and catalytic domains of the enzyme, the result of which is blockade of 
TYK2-mediated functions in vitro and in vivo. The compound is potent and highly selective, 
blocking responses in human cells induced by IL-12, IL-23, and Type I IFNs, including signal 
transduction, STAT-dependent gene transcription, and functional responses.
A detailed description of the chemistry, pharmacology, efficacy, and safety of BMS-986322 is 
provided in the IB.10
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3.3
Benefit/Risk Assessment
At this early stage in the development of BMS-986322 for the treatment of patients with PsO, 
assessment of benefit and risk rely on nonclinical data and clinical study experience in healthy 
volunteers. The proposed dosing regimens reflect correlations between exposures, target 
engagement, and measures of efficacy in preclinical disease models, safety margins calculated 
from preclinical toxicology studies, and PK parameters as well as safety and tolerability results 
from a Phase 1 FIH study. 
In the FIH Study IM032007, BMS-986322 was effective in inhibiting in vivo TYK2 activity. 
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3.3.1
Risk Assessment
Inhibition of TYK2-dependent immune responses by BMS-986322 has the potential to increase
the risk of infections in humans. TYK2 inhibition affects multiple cytokine pathways (including
IL-12, IL-23, and Type I IFN).
As BMS-986322 is a potential immunosuppressant and in line with standard practice for
immunosuppressive therapies, the current study has been designed with study visits that allow for 
close monitoring and with inclusion/exclusion criteria aimed at minimizing the risk for serious 
infections.
As with any modulator of the immune system, there is a theoretical risk of increased malignancy
with BMS-986322. BMS-986322 was not found to be genotoxic during in vitro and in vivo 
preclinical studies. Carcinogenicity studies with BMS-986322 have not yet been conducted.
3.3.1.1
Coronavirus Disease 2019-related Risks and Risk Mitigation Measures 
Whether BMS-986322 increases the risk for contracting severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) infection or increases the severity or duration of symptoms is 
currently unknown due to insufficient clinical data. This unknown risk must be considered when 
enrolling a participant. 
Participants with recent or acute infections will have the start of intervention delayed or be 
excluded as defined in Section 6. If a participant has a confirmed SARS-CoV-2 infection while on 
study intervention, dose discontinuation is required as described in Section 8.1. 
The study includes several features to mitigate this risk of BMS-986322 exposure during active 
SARS-CoV-2 infection:
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
The study entry criteria that exclude participants with recent or active infections (see Section 
6.2).

The clinical research unit has implemented standard monitoring and prevention control 
measures for risk mitigation.

The protocol implements SARS-CoV-2 testing (see Section 2), as stipulated by the clinical site 
at which the study is being conducted, in order to prevent participants who are shedding the 
virus from entering into the research unit and from being dosed with BMS-986322.
3.3.1.2
General COVID-19-related Risk Mitigation Measures
General risk mitigation against COVID-19 will be implemented in accordance with clinical 
research site’s monitoring and prevention control procedures and relevant governmental and 
Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-associated requirements. 
Such measures aim to minimize the prevalence and transmission of SARS-CoV-2 among site staff 
and participants, and include distancing, sanitization, testing, and the use of personal protective 
equipment. The risk mitigation measures are part of the research site’s generic informed consent 
and, when and where applicable, may be amended based on emerging guidance. 
3.3.2
Benefit Assessment
Inhibition of TYK2 is expected to provide therapeutic benefit for participants with PsO for 
multiple reasons: 1) Many of the pathways in the TYK2 signaling cascade (IL-23 and the 
downstream mediators IL-17 and IL-22; IFNα) are involved in the pathogenesis of PsO.48
2) Biologic agents targeting the IL-17, IL-23p19, and IL-12/23 p40 pathways have been approved 
for and are highly efficacious in the treatment of PsO. Further, participants with PsO may sustain 
a durable therapeutic response after repeated dosing with BMS-986322. A recent study using only 
a single dose of a monoclonal antibody targeting the IL-23 p19 subunit resulted in rapid and 
sustained response for up to 66 weeks in participants with moderate-to-severe PsO.49 Similarly, 
deucravacitinib, another selective TYK2 inhibitor, was highly effective in the treatment of 
PsO.46,47
Based on its mechanism of action as an inhibitor of TYK2-mediated signaling pathways 
downstream of well-characterized pharmaceutical targets for the treatment of PsO, the p19 subunit 
of IL-23 or the p40 subunit it shares with IL-12, and the demonstration of extended inhibition of 
IL-23 signaling in healthy participants (clinical study IM0032007), it is likely that participants
with moderate-to-severe PsO will benefit from the treatment with BMS-986322.
3.3.3
Overall Benefit/Risk Conclusion
In summary, existing preclinical data (see the IB10 or toxicology data) and clinical experience in 
healthy participants in combination with the design and doses selected for the current Phase 2 
study indicate an overall favorable benefit/risk assessment of investigating BMS-986322 as an oral 
treatment of participants with moderate-to-severe PsO.
More detailed information about the known and expected benefits and risks and reasonably 
anticipated AEs of BMS-986322 may be found in the IB.10
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4
OBJECTIVES AND ENDPOINTS
To examine the effects of BMS-986322 16 mg, 32 mg, and 64 mg, when orally (PO) administered
once daily (QD), compared with placebo, after 12 weeks of treatment in participants with 
moderate-to-severe PsO, the following objectives and endpoints as outlined in Table 4-1 will be 
assessed.
Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
Primary

To compare BMS-986322 with placebo on 
achieving a 75% reduction in PASI score 
(PASI-75)

Proportion of participants
achieving
PASI-75 at 
Week 12

To assess the safety and tolerability of 
BMS-986322

Type and frequency of TEAEs, SAEs, and TEAEs 
leading to treatment discontinuation

Severity and causal relationship of TEAEs

Change from
baseline and incidence of marked
abnormalities in clinical laboratory tests, 12-lead ECG, 
vital signs, and physical examination
Secondary

To compare BMS-986322 with placebo on 
achieving an sPGA score of 0 (“cleared”) or 1 
(“minimal”)

Proportion of participants achieving sPGA score of 0 or 
1 at Week 12

To compare BMS-986322 with placebo on 
achieving a 50% reduction in PASI score 
(PASI-50)

Proportion of
participants achieving
PASI-50 at 
Week 12

To compare BMS-986322 with placebo on 
achieving a 90% reduction in PASI score 
(PASI-90)

Proportion of participants achieving
PASI-90 at 
Week 12

To compare BMS-986322 with placebo on 
achieving a 100% reduction in PASI score 
(PASI-100)

Proportion of participants achieving PASI-100 at 
Week 12

To compare BMS-986322 with placebo on 
achievement of PASI-50, -75, -90, and -100 
over time

Proportion of participants achieving PASI-50, -75, -90, 
and -100 at various time points from baseline through 
Week 12

To compare BMS-986322 with placebo on 
improvement 
of 
continuous 
PASI 
measurements over time

Change from baseline in PASI score at various time
points from baseline through Week 12 

To assess Cmax, AUC(TAU), Tmax, and 
trough concentrations of BMS-986322

BMS-986322 trough concentrations at various time
points through Week 12

BMS-986322 Cmax, AUC(TAU), and Tmax on Day 15
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Table 4-1:
Objectives and Endpoints
Objectives
Endpoints
Abbreviations: AUC(TAU), area under the plasma concentration-time curve over the dosing interval;
 
 Cmax, maximum observed plasma concentration;
; ECG, 
electrocardiogram; 
 PASI, Psoriasis Area and Severity Index; 
 
 
; 
;
; SAE, serious adverse event; sPGA, 
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static Physician’s Global Assessment; TEAE, treatment-emergent adverse event; Tmax, time of maximum observed 
plasma concentration.
5
STUDY DESIGN
5.1
Overall Design
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, parallel group,
multiple oral dose Phase 2 study of BMS-986322 in participants with moderate-to-severe PsO.
Participants will be randomly assigned to receive BMS-986322 (16 mg QD, 32 mg QD, or 64 mg 
QD) or placebo. Participants will undergo screening evaluations to determine eligibility within 
days prior to administration of study intervention. 
This will be an outpatient study. Participants will receive BMS-986322 and/or placebo tablets to 
be taken at home. Participants will be provided by the Investigator Site with enough tablets to 
cover the treatment interval between study visits beginning on Study Day . Additional tablets 
covering the treatment interval between study visits should be supplied by the Investigator Site 
during each applicable follow-up visit. At follow-up visits (Days 
), doses of 
BMS-986322 and/or placebo tablets will be administered in the clinic (see Section 2). 
Participants will report to the clinic for study visits on Study Days 
 and 
for an Early Termination (ET) visit if needed. 
Physical examinations (PEs), clinical disease activity assessments (PASI, 
, sPGA), vital sign measurements, PK evaluations, clinical laboratory evaluations, 
ECG, 
 
 
evaluations will be performed at selected times throughout the dosing 
interval. AEs will be recorded and assessed by the Investigator (or designee as documented in the 
Delegation of Authority) at study visits and throughout the study period. Participants will be 
required to return to the clinic for additional (unscheduled) safety follow-up visits as deemed 
necessary by the investigator. 
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5.1.1
Data Monitoring Committee and Other Committees
The Independent Data Monitoring Committee (IDMC) charter will describe the procedures related 
to the committee operations in greater detail.
An IDMC will be established to monitor data on an ongoing basis to ensure the continuing safety 
of participants enrolled in this study, to ensure the integrity of the blinded nature of the study, 
 
. An IDMC charter will be developed that will specify the roles 
and responsibilities of the members and interim decision rules. Sponsor Steering Committee will 
receive and act on the recommendations from the IDMC. A firewall will be established to ensure 
the maintenance of the study blind for the Sponsor, the investigational site staff, and study 
participants and their study partners.
Data summaries and listings will be provided to the IDMC to facilitate their safety assessment at 
the regularly scheduled times and on an ad hoc basis if needed. The safety review includes SAEs
and events of special interest, focusing on early signal detection. Further details on the frequency, 
content, and methods of data reports to the IDMC will be outlined in the IDMC Charter along with 
the processes and procedures the committee will follow.
5.2
Number of Participants
Approximately 120 participants will be randomized and treated. 
Assuming a screen failure rate of about 20%, it is estimated that approximately 150 screened
participants will be required to achieve the planned 120 treated participants.
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5.3
End of Study Definition
The start of the study is defined as the first participant’s first visit.
The primary completion date is defined as the date on which the last data point is collected for the 
study’s primary endpoint. If the study has multiple primary endpoints, the primary completion date 
is the date on which the last data point is collected for the last primary endpoint.
End of study is defined as the last participant’s last visit.
A participant is considered to have completed the study if he/she has completed all periods of the 
study including the last procedure/assessment shown in the Schedule of Activities.
5.4
Scientific Rationale for Study Design
The proposed Phase 2 study in participants with PsO is being conducted to provide safety data and 
evidence of clinical efficacy of BMS-986322 in a relevant disease population,
 
 Psoriasis is an ideal 
condition to evaluate the safety and efficacy of the TYK2 inhibitor BMS-986322 for multiple 
reasons. 1) Many of the pathways in the TYK2 signaling cascade (IFNα, IL-12/-23, and the 
downstream mediators IL-17 and IL-22) have been implicated in psoriatic disease pathogenesis. 
2) Biologic agents targeting the IL-17, IL-23p19, and IL-12/-23 p40 pathways are currently 
available and highly effective in the treatment of PsO. 3) The use of deucravacitinib, another 
selective TYK2 inhibitor, was highly effective in the treatment of moderate-to-severe PsO.46,47,52
4) Psoriasis is a prevalent systemic inflammatory condition, yet some patients remain untreated or 
undertreated. This allows for evaluation of drug safety and efficacy without interactions from 
multiple background therapies. 
 
 
Deucravacitinib, an oral, first in class, selective TYK2 inhibitor, has been approved by the US 
FDA for treating adults with moderate-to-severe plaque PsO who are candidates for systemic 
therapy or phototherapy.
In this study, data will be collected from participants such as race, ethnicity, sexual orientation, 
and gender/gender they identify with. Participation in the main study is not contingent upon 
providing responses to race, ethnicity, sexual orientation, or gender identity questions.
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6
STUDY POPULATION
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted.
6.1
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1) Signed Written Informed Consent
a) Participants must have signed and dated an IRB-/IEC-approved written informed consent 
form (ICF) in accordance with regulatory, local, and institutional guidelines. This must be 
obtained before the performance of any protocol-related procedures that are not part of 
normal patient care.
2) Type of Participant and Target Disease Characteristics
a) Male and female participants with a diagnosis of plaque PsO for ≥ 6 months.
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b) Body mass index (BMI) 18 to 40 kg/m2 and total body weight > 50 kg (110 lbs).
c) Deemed by Investigator to be eligible for phototherapy or systemic therapy.
d) Psoriatic plaques must cover ≥ 10% of BSA at baseline.
e) PASI score ≥ 12 and sPGA ≥ 3 at baseline.
f)
Willing to discontinue topical and/or systemic therapies, with the exception of topical 
emollients and low potency topical steroids (rescue) prior to dosing.
3) Age of Participant
a) Participant must be 18 to 70 years of age inclusive at the time of signing the ICF.
4) Reproductive Status

Investigators shall counsel women of childbearing potential (WOCBP) (as defined in 
Appendix 4) participants, and male participants who are sexually active with WOCBP, on the 
importance of pregnancy prevention and the implications of an unexpected pregnancy.

The investigator shall evaluate the effectiveness of the contraceptive method in relationship to 
the first dose of study intervention.

Local laws and regulations may require the use of alternative and/or additional contraception 
methods.
a) Female Participants: 
i)
Female participants must have documented proof that they are not of childbearing 
potential.
(1) Women who are not of childbearing potential (as defined in Appendix 4) are 
exempt from contraceptive requirements. 
ii) WOCBP must have a negative highly sensitive serum pregnancy test (minimum 
sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 
hours prior to the start of study intervention.

Additional requirements for pregnancy testing during and after study intervention are in 
Section 2: Schedule of Activities.

The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to potentially decrease the risk for inclusion of a woman with an undetected 
pregnancy.
iii) WOCBP and male participants who are sexually active with WOCBP must agree to 
follow instructions for method(s) of contraception as described below and included in 
the ICF.

WOCBP are not permitted to use hormonal contraception methods alone as a highly effective 
method (as described in Appendix 4).
iv) A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least 1 of the following conditions applies:
(1) Is not a WOCBP 
OR
(2) Is a WOCBP and using at least a non-hormonal contraceptive method that is 
highly effective (ie, intrauterine device), AND another highly effective user 
independent method (ie, vasectomized partner, sexual abstinence), or a less than 
highly effective non-hormonal contraceptive method (ie, male or female condom, 
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diaphragm with spermicide, cervical cap with spermicide, vaginal sponge 
spermicide) during the intervention period and for at least 5 days after the last 
dose of study intervention and agrees not to donate eggs (ova, oocytes) for the 
purpose of reproduction for the same period. Definitions are provided in 
Appendix 4.
b) Male Participants:
i)
Azoospermic males are not exempt from contraceptive requirements and will be 
required to always use a latex or other synthetic condom during any sexual activity 
(eg, vaginal, anal, oral) with WOCBP, even if the participant has undergone a 
successful vasectomy or if the partner is pregnant.
ii) Male participants will be required to always use a latex or other synthetic condom 
during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participant 
has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. 
Male participants should continue to use a condom during the intervention period and 
for at least 5 days after the last dose of study intervention. 
iii) Female partners of male participants should be advised to use a highly effective method
of contraception during the intervention period and for at least 5 days after the last dose 
of study intervention for the male participant.
iv) Male participants with a pregnant or breastfeeding partner must agree to remain 
abstinent from sexual activity or use a male condom during any sexual activity 
(eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, 
during the intervention period and for at least 5 days after the last dose of study 
intervention.
v) Male participants must refrain from donating sperm during the intervention period and 
for at least 5 days after the last dose of study intervention.
vi) Breastfeeding partners of male participants should be advised to consult their health 
care provider about using appropriate highly effective contraception during the time 
the male participant is required to use condoms.
6.2
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1) Target Disease Exceptions
a) Diagnosis of non-plaque PsO (guttate, inverse, pustular, erythrodermic). 
b) Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions 
that are commonly associated with PsO for which a participant requires current systemic 
(oral, subcutaneous, or intravenous [IV]) (including corticosteroids, biologics) 
immunosuppressant medical treatment. Certain therapies such as non-steroidal 
anti-inflammatory drugs may be permitted but should be discussed with the Sponsor
Medical Monitor prior to determination of participant eligibility.
2) Infectious/Immune-related Exclusions
a) History or evidence of active infection and/or febrile illness within 7 days of screening (eg, 
bronchopulmonary, urinary, gastrointestinal, etc).
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b) History of serious bacterial, fungal, or viral infections that led to hospitalization and IV 
antibiotic treatment within 90 days prior to screening, or any recent serious infection 
requiring antibiotic treatment within 30 days of Study Day .
c) History of administration of live vaccines within 60 days prior to Day , or plans to receive 
a live vaccine during the study, or within 60 days after completing study intervention.
d) Immunization with non-live vaccines (including COVID-19) within 1 month prior to 
dosing or planning to receive immunization with a non-live vaccine within 21 days 
following dosing.
e) Has a history of an infected joint prosthesis or has received antibiotics for a suspected 
infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
f)
Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated 
on PE and/or medical history within 2 months of administration of study intervention).
g) History of disseminated or complicated herpes zoster infection (including, but not limited 
to, multi-dermatomal involvement, ophthalmic zoster, central nervous system 
involvement, or post-herpetic neuralgia).
h) Positive hepatitis B virus (HBV) surface antigen (HBsAg) or HBV DNA by polymerase 
chain reaction (PCR).
i)
Positive hepatitis-C virus (HCV) antibody.
j)
Active COVID-19 infection as documented by a positive SARS-CoV-2 antigenic test or 
PCR test prior to dosing, regardless of signs or symptoms, and post-acute SARS-CoV-2
infection sequelae that may be configured as chronic medical illness (as in Exclusion 
Criterion 4a).
3) Participants with any history or risk for tuberculosis (TB), specifically participants with
the following:
a) Current clinical radiographic or laboratory evidence of active TB.
b) History of active TB up to 10 years, unless there is documentation that prior anti-TB 
treatment was appropriate in duration and type according to current World Health 
Organization Guidelines.
c) Latent TB defined as Positive Quantiferon G or other diagnostic test in the absence of 
clinical manifestations, unless participant has received at least 1 month of treatment with 
isoniazid, or other agents recommended by local Health Authority guidelines, and an 
interferon gamma release assay (IGRA) test (eg, Quantiferon G or T-spot) is negative 
before Day .
d) Any history of known or suspected congenital or acquired immunodeficiency state or 
condition that would compromise the participant’s immune status (eg, history of 
splenectomy, primary immunodeficiency, human immunodeficiency virus [HIV] infection, 
etc).
4) Medical History and Concurrent Diseases
a) Any significant acute or chronic medical illness.
b) Any major surgery (ie, requiring anesthesia, intubation and penetration in body cavities) 
within 4 weeks of study intervention administration.
c) Blood transfusion within 4 weeks of study intervention administration.
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d) Recent (within 6 months of study intervention administration) drug or alcohol abuse as 
determined by the Investigator. 
e) Any major illness/condition or evidence of an unstable clinical condition (eg, renal, 
hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active 
infection/infectious illness) that, in the Investigator’s judgment will substantially increase 
the risk to the participant if he or she participates in the study.
f)
Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable 
angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the 
last 3 months. 
g) Class III or IV congestive heart failure by New York Heart Association Criteria.
h) Has been hospitalized in the past 3 months for asthma, ever required intubation for 
treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or
required more than one short-term (≤ 2 weeks) course of oral corticosteroids for asthma 
within the previous 6 months.
i)
History of cancer (solid organ or hematologic including myelodysplastic syndrome) or 
lymphoproliferative disease within the previous 5 years (other than resected cutaneous 
basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence).
j)
Inability to tolerate oral medication.
k) Inability to be venipunctured and/or tolerate venous access.
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u) Is currently receiving lithium, antimalarials, or has received lithium, antimalarials within 
4 weeks of the first administration of study intervention.
5) Reproductive Status
a) Women who are breastfeeding.
b) Women who have a positive serum pregnancy test result at screening.
6) Prior/Concomitant Therapy
a) Inability to comply with restrictions and prohibited treatments as listed in Section 7.7: 
Concomitant Therapy.
7) Physical and Laboratory Test Findings
a) Evidence of organ dysfunction or any clinically significant deviation from normal in PE, 
vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the 
target population.
b) Urinalysis findings suspicious of infection (eg, pyuria, bacteriuria) in a non-contaminated 
sample collected at screening. Participants may be rescreened and if deemed eligible, may 
be randomized within 14 days of completing an appropriate course of antibiotic treatment 
for urinary tract infection.
c) Chest x-ray findings suspicious of infection at screening. Participants may be rescreened if 
deemed eligible and may be randomized within 
 days of completing an appropriate 
course of antibiotic treatment for pulmonary infection.
d) Leukopenia defined as absolute white blood cell count < 3000/mm3 within 
 days of 
dosing with study intervention on Day .
e) Lymphopenia defined as absolute lymphocyte count < 500/mm3 within 
 days of dosing 
with study intervention on Day .
f)
Neutropenia defined as absolute neutrophil count < 1000/mm3 within 
 days of dosing 
with study intervention on Day .
g) Moderate-to-severe thrombocytopenia defined as platelet count < 100,000/mm3 within 
days of dosing with study intervention on Day .
h) Moderate-to-severe anemia defined as hemoglobin < 9 g/dL within 
 days of dosing with 
study intervention on Day .
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i)
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3× upper limit 
of normal (ULN) within 
 days of dosing with study intervention on Day . 
j)
Total, unconjugated, and/or conjugated bilirubin > 1.5× ULN within 
 days of dosing 
with study intervention on Day . 
k) Any other significant laboratory or procedure abnormalities that, in the opinion of the 
Investigator, might place the participant at unacceptable risk for participation in this study.
l)
Positive blood screen for hepatitis C antibody, HBsAg, or HIV-1 and -2 antibody.
8) Allergies and Adverse Drug Reactions
a) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
9) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific 
circumstances and only in countries where local regulations permit, a person who has been 
imprisoned may be included or permitted to continue as a participant. Strict conditions 
apply, and Sponsor approval is required.)
b) Inability to comply with restrictions as listed in Section 6.3: Lifestyle Restrictions.
c) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness.
d) Participation in another clinical trial concurrent with this study.
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
participants and that the results of the study can be used. It is imperative that participants fully 
meet all eligibility criteria.
6.3
Lifestyle Restrictions
Participants are advised to protect against sun exposure through sun avoidance, use of protective 
clothing (long sleeves, pants, hats, etc), and use of sunscreen from at least 1 week prior to the first 
dose of study intervention until the safety follow-up visit. Participants should avoid excessive sun 
exposure or use of tanning booths or other ultraviolet light sources and avoid risks that are known 
to provoke flare of psoriasis.
6.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized in the study/included in the analysis population. 
A minimal set of screen failure information is required to ensure transparent reporting of screen 
failure participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) 
publishing 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 adverse events (SAEs) that occurred following consent.
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6.4.1
Re-testing During Screening
This study permits the re-enrollment of a participant who has discontinued the study as a screen
failure (ie, participant has not been randomized/has not been treated). If re-enrolled, the participant
must be re-consented.
Re-testing of laboratory parameters and/or other assessments within any single screening or lead-in
period will be permitted once (in addition to any parameters that require a confirmatory value).
The most current result prior to randomization is the value by which study inclusion will be 
assessed because it represents the participant’s most current clinical state.
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 Sponsor Medical Monitor may be needed to identify whether repeat testing of any 
particular parameter is clinically relevant.
7
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study intervention is defined as any investigational intervention(s), marketed product(s), placebo,
procedure(s), or medical device intended to be administered to a study participant according to the 
study protocol.
Study intervention includes both Investigational [Medicinal] Product (IP/IMP) and 
Non-investigational/Auxiliary [Medicinal] Product (Non-IP/Non-IMP/AxMP) as indicated in
Table 7.1-1.
An IP, also known as an IMP in some regions, is defined as a pharmaceutical form of an active 
substance or placebo being tested or used as a reference in a clinical study, including products 
already with a marketing authorization but used or assembled (formulated or packaged) differently 
from the authorized form, used for an unauthorized indication, or when used to gain further 
information about the authorized form.
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis may be considered Non-
IMPs/AxMPs.
7.1
Study Interventions Administered
Participants will receive BMS-986322 and/or placebo tablets to be taken at home. Participants will 
be provided by the Investigator Site with enough tablets to cover the treatment interval between 
study visits beginning on Study Day . Additional tablets covering the treatment interval between 
study visits should be supplied by the Investigator Site during each applicable follow-up visit. At 
follow-up visits (Days 
), doses of BMS-986322 and/or placebo tablets will be 
administered in the clinic (see Section 2).
In the morning of visits on Days 
(Table 2-2), each participant will receive a 
single oral dose of BMS-986322 and/or placebo at approximately 9:00 AM. Participants will be 
required to fast for at least 8 hours prior to study visit on Days 
.
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At the time of dosing, 240 mL of water will be administered to the participant along with his/her 
dose of study intervention. The time of dose administration will be called “0” hour.
Table 7.1-1:
Study Intervention(s) Administered
Type/
Intervention 
Name/Dose 
Formulation
Unit Dose 
Strength(s)
IMP/Non-IMP/AxMP
Blinded or 
Open-label Use
Sourcing
Packaging 
and Labeling
Current/
Former 
Name(s) 
or 
Alias(es)
Storage 
Conditions
(Per Label)
BMS-
986322-01
 mg
IMP Blinded
Provided 
centrally 
by the 
Sponsor
Study 
interventions 
will be 
provided in 
bottles 
 
 
 
 
 
BMS-
986322-
01
Refer to the 
label on the 
container 
and/or 
Pharmacy 
Manual.
Placebo to 
Match BMS-
986322-01
N/A
IMP Blinded
Provided 
centrally 
by the 
Sponsor
Study 
interventions 
will be 
provided in 
bottles
 
 
 
 
 
BMS-
986322-
01
Refer to the 
label on the 
container 
and/or 
Pharmacy 
Manual.
Abbreviations: AxMP, Auxiliary Medicinal Product; IMP, Investigational Medicinal Product; N/A, not applicable.
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Table 7.1-2:
Study Arm(s)
Arm Title/
Arm Type
Route of Administration
Placebo
Oral
16 mg BMS-986322
Oral
32 mg BMS-986322
Oral
64 mg BMS-986322
Oral
The BMS-986322 tablets (active or placebo) are provided in a kit 
 
 
 
 
 
 
 
 
 
 
7.2
Assignment to Study Intervention
All participants will be centrally randomized using Interactive Response Technology (IRT).
Before the study is initiated, each user will receive log-in information and directions on how to 
access the IRT.
During the screening visit, the investigative site will call into the enrollment option of the IRT
designated by Bristol-Myers Squibb Company (BMS) for assignment of a participant number that 
will be unique across all sites. Enrolled participants, including those not dosed, will be assigned 
sequential participant numbers starting with 
 Sequential 
numbering may restart at 
 for each participating site as the distinct participant identification 
number (PID) will ultimately be composed of the site number and participant number. For 
example, the first participant screened (ie, enrolled) at site number  will have a PID of 
 
. 
Once it is determined that the participant meets the eligibility criteria following the screening visit, 
the investigative site will call the IRT to randomize the participant. Randomization numbers will 
be assigned prior to dosing. Participants will be randomized to receive either BMS-986322 at one 
of the doses being evaluated (16 mg PO QD, 32 mg PO QD, 64 mg PO QD) or placebo according 
to a computer-generated randomization scheme prepared by an IRT Manager within the Drug 
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Supply Management Department of BMS Research and Development. Randomization will be 
stratified by previous treatment with a biologic (yes/no). Block randomization with fixed block 
size per stratum will be employed in this study.
Study intervention will be dispensed at the study visits listed in the Schedule of Activities 
(Section 2).
Participants will not be replaced if they are discontinued from the study secondary to an AE unless 
the AE can be determined to be unrelated to treatment. If a participant is replaced after dosing,
then the replacement participant will be assigned the original participant’s number plus 
. The 
replacement participant will receive the same treatment as the participant being replaced, but a 
new randomization number will be assigned to him/her. For example, Participant
 would be 
replaced by Participant data 
.
7.3
Blinding
This is a randomized, double-blind, placebo-controlled study. Blinded intervention assignments 
will be managed using IRT. IP supply will be controlled by IRT at each visit. Access to treatment 
codes will be restricted from all site and Sponsor personnel and participants prior to database lock 
for the final analysis with exceptions as specified below. Treatment codes may be shared with sites 
and participants after finalization of the CSR.
Randomization schedules will be shipped directly to a pharmacist or other individual(s) who will 
be responsible for the dispensing of blinded study intervention. This (these) individual(s) will be 
unblinded to study intervention identification but will not be involved in any other aspect of study 
conduct. The randomization schedules will be maintained in a secure location with access limited 
to authorized personnel.
Blinding of study intervention assignment is critical to the integrity of this clinical study. However, 
in the event of a medical emergency or pregnancy in an individual participant in which knowledge 
of the IP is critical to the participant’s management, the blind for that participant may be broken 
by the investigator. The participant’s safety takes priority over any other considerations in 
determining whether a treatment assignment should be unblinded.
Before breaking the blind of an individual participant’s treatment, the investigator should 
determine that the unblinded information is necessary (ie, that it will alter the participant’s 
immediate management). In many cases, particularly when the emergency is clearly not related to 
the IP, the problem may be properly managed by assuming that the participant is receiving the IP. 
It is highly desirable that the decision to unblind treatment assignment be discussed with the 
Medical Monitor, but the investigator always has ultimate authority for the decision to unblind. 
The actual task of unblinding can be delegated by the investigator to a designee assigned the task
on the Delegation of Authority. The Principal Investigator or appointed designee should only 
perform the emergency unblinding after the decision to unblind the participant has been 
documented.
For this study, the method of unblinding for emergency purposes is IRT.
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In cases of accidental unblinding, contact the Medical Monitor and ensure every attempt is made 
to minimize additional disclosure and the impact of unblinding.
Any request to unblind a participant for non-emergency purposes should be discussed with the 
Medical Monitor.
If a participant is unblinded for any reason, the participant will be discontinued from study 
intervention.
In case of an emergency, the investigator(s) has unrestricted access to randomization information 
via the IRT system and is capable of breaking the blind through the IRT system without prior 
approval from the Sponsor. Following the unblinding, the investigator shall notify the Sponsor 
Medical Monitor or designee that the unblinding took place as soon as possible.
A scientist in the Non-clinical Disposition and Bioanalysis department or the Sponsor (and/or a 
designee in the external bioanalytical laboratory) will be unblinded to the randomized treatment 
assignments to minimize unnecessary bioanalytical analysis of samples. Any results shared by the 
Non-clinical Disposition and Bioanalysis group with the Sponsor’s study team will be blinded to 
ensure integrity of the study.
Blind break (IRT)
The IRT will be programmed with blind-breaking instructions. In case of an 
emergency, the investigator has the sole responsibility for determining whether
unblinding of a participant’s intervention assignment is warranted. Participant safety 
must always be the first consideration in making such a determination. If the 
investigator decides that unblinding is warranted, the investigator should make every 
effort to contact the Sponsor prior to unblinding a participant’s intervention 
assignment unless doing so could delay emergency treatment of the participant. If a 
participant’s intervention assignment is unblinded, the Sponsor must be notified 
within 24 hours after breaking the blind. The date and reason that the blind was 
broken must be recorded in the source documentation and CRF, as applicable.
Blinded study with 
unblinded site 
pharmacist who is 
dispensing drug
Participants will be randomly assigned in a 1:1:1:1 ratio to receive study intervention. 
Investigators will remain blinded to each participant’s assigned study intervention 
throughout the study. To maintain this blind, an otherwise uninvolved third party will 
be responsible for the reconstitution and dispensation of all study intervention and 
will endeavor to ensure that there are no differences in time taken to dispense study 
intervention following randomization.
This third party will instruct the participant to avoid discussing the taste, dosing 
frequency, or packaging of the study intervention with the investigator.
In the event of a Quality Assurance audit, the auditor(s) will be allowed access to 
unblinded study intervention records at the site(s) to verify that 
randomization/dispensing has been done accurately.
Abbreviations: CRF, Case Report Form; IRT, Interactive Response Technology.
7.4
Dosage Modification
There is no provision for dose modification of study intervention. If a participant interrupts 
intervention due to an AE, study intervention can be restarted in consultation with the Sponsor 
Medical Monitor or designee.
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7.5
Preparation/Handling/Storage/Accountability
The IP/Non-IMP/AxMP must be stored in a secure area according to local regulations. It is the 
responsibility of the investigator, or designee where permitted, to ensure that IP/IMP/Non-
IMP/AxMP is only dispensed to study participants. The IP/IMP/Non-IMP/AxMP must be 
dispensed only from official study sites by authorized personnel according to local regulations.
The product storage manager should ensure that the study intervention is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by the Sponsor. If 
concerns regarding the quality or appearance of the study intervention arise, the study intervention
should not be dispensed, and the Sponsor should be contacted immediately.
Study intervention not supplied by the Sponsor will be stored in accordance with the package 
insert.
IP/IMP/Non-IMP/AxMP documentation (whether supplied by the Sponsor or not) must be 
maintained and must include all processes required to ensure the drug is accurately administered. 
This includes documentation of drug storage, administration and, as applicable, storage 
temperatures, reconstitution, and use of required processes (eg, required diluents, administration 
sets).

The investigator or designee must confirm that 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.

Only participants enrolled in the study may receive study intervention, and only authorized site 
staff may supply, prepare, or administer study intervention. 

All study intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access 
limited to the investigator and authorized site staff.

The investigator, institution, head of the medical institution (where applicable), or authorized 
site staff is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition of records).

Further guidance and information for the final disposition of unused study interventions are 
provided in the Pharmacy Manual.
7.6
Study Intervention Compliance
When participants self-administer study intervention(s) at home, compliance with study 
intervention will be assessed at each visit. Compliance will be assessed by direct questioning, 
counting returned tablets, etc during the site visits and documented in the source documents and 
relevant form. Deviation(s) from the prescribed dosage regimen should be recorded in the Case 
Report Form (CRF).
A record of the quantity of BMS-986322/placebo dispensed to and administered by each 
participant must be maintained and reconciled with study intervention and compliance records. 
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Intervention start and stop dates, including dates for intervention delays and/or dose reductions, 
will also be recorded in the CRF.
7.7
Concomitant Therapy
7.7.1
Prohibited and/or Restricted Treatments
Prohibited and/or restricted medications taken prior to study intervention administration in the 
study are described below in Table 7.7.1-1. Medications taken within 4 weeks prior to study 
intervention administration must be recorded on the CRF.
Table 7.7.1-1:
Prohibited and/or Restricted Treatments
Prohibited Treatments
Washout Period 
(Before Randomization)
Lithium, antimalarials
4 weeks
Metformin or statins
Restrict dose of metformin to 
500 mg twice a day or 850 mg 
once a day with plasma lactate 
monitoring or switch to other 
glucose-lowering agents; 
restrict dose of statins as 
follows: 
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Table 7.7.1-1:
Prohibited and/or Restricted Treatments
Prohibited Treatments
Washout Period 
(Before Randomization)
atorvastatin (≤ 20 mg) 
rosuvastatin (≤ 10 mg) 
simvastatin (≤ 20 mg) 
Pravastatin (≤ 20 mg) 
lovastatin (≤ 20 mg) 
Fluvastatin (≤ 40 mg) 
pitavastatin (≤ 2 mg)
Abbreviations: 
; 
 
Therefore, drugs that are sensitive substrates of these transporters are 
recommended to be used with caution or their dose restricted for the duration of the study. 
Additional references54,55 and individual drug labels should be referred to for further information 
on PK drug-drug interactions.
In addition, the use of concomitant medications (prescription, over-the-counter) should be limited 
during the study unless they are prescribed by the investigator for treatment of specific clinical 
events and after consultation with the Sponsor Medical Monitor. Any changes to or new 
concomitant therapies must be recorded on the CRF.
The use of herbal products is prohibited during and up to 30 days after the completion of the study.
7.7.2
Other Restrictions and Precautions
See Section 6.3 for details regarding sun exposure restrictions.
7.8
Continued Access to Study Intervention After the End of the Study
At the end of the study, the Sponsor will not continue to provide Sponsor-supplied study 
intervention to participants/investigators unless the Sponsor chooses to extend the study. The 
investigator should ensure that the participant receives appropriate standard of care to treat the 
condition under study.
The Sponsor reserves the right to terminate access to Sponsor-supplied study intervention if any 
of the following occur: a) the study is terminated due to safety concerns; b) the development of 
BMS-986322 is terminated for other reasons, including, but not limited to, lack of efficacy and/or 
not meeting the study objectives; or c) the participant can obtain medication from a 
government-sponsored or other health program. In all cases, the Sponsor will follow local 
regulations.
8
DISCONTINUATION CRITERIA
Discontinuation of specific sites or of the study as a whole is detailed in Appendix 2.
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8.1
Discontinuation of Study Intervention
Participants MUST discontinue IP/IMP (and Non-IMP/AxMP at the discretion of the investigator) 
for any of the following reasons:

Participant’s request to stop study intervention. Participants who request to discontinue study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by the participant 
to provide this information.

Any clinical AE, laboratory test result 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 the Sponsor.

Loss of ability to freely provide consent through imprisonment or involuntary incarceration for 
treatment of either a psychiatric or physical illness (eg, infectious disease). (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 
Sponsor approval is required.)

Significant noncompliance with protocol (eg, procedures, assessments, medications, etc). The
investigator should discuss such issues with the Sponsor Medical Monitor.

Any current evidence of SARS-CoV-2 infection.

If a participant is unblinded for any reason.

Permanent discontinuation of the study intervention for abnormal liver tests should be 
considered by the Investigator when a participant meets one of the conditions outlined in 
Section 9.2.7 or if the Investigator believes that it is in best interest of the participant.

Pregnancy (see Section 9.2.5).
Refer to the Section 2: Schedule of Activities for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed.
All participants who discontinue study intervention should comply with protocol-specified 
follow-up procedures as outlined in Section 2: Schedule of Activities. The only exception to this 
requirement is when a participant withdraws consent for all study procedures, including post-
treatment study follow-up, or loses the ability to consent freely (eg, is imprisoned or involuntarily 
incarcerated for the treatment of either a psychiatric or physical illness).
If study intervention is discontinued prior to the participant’s completion of the study, the reason 
for the discontinuation must be documented in the participant’s medical records per local 
regulatory requirements in each region/country and entered on the appropriate CRF page.
8.1.1
Post-study Intervention Study Follow-up
Participants who discontinue study intervention may continue to be followed.
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8.2
Discontinuation From the Study
Participants who request to discontinue study intervention will remain in the study and must 
continue to be followed for protocol-specified follow-up procedures. The only exception to this is 
when a participant specifically withdraws consent for any further contact with him/her or persons 
previously authorized by the participant to provide this information. 

Participants should notify the investigator of the decision to withdraw consent from future 
follow-up.

The withdrawal of consent should be explained in detail in the medical records by the 
investigator as to whether the withdrawal is from further treatment with study intervention only 
or also from study procedures and/or post-treatment study follow-up, and entered on the 
appropriate CRF page.

In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law.

If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
8.2.1
Individual Discontinuation Criteria

A participant may withdraw completely from the study at any time at his/her own request, or 
may be withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. This is expected to be uncommon. Stopping study 
intervention is not considered withdrawal from the study.

At the time of discontinuing from the study, if possible, an ET visit should be conducted, as 
shown in the Schedule of Activities. See the Schedule of Activities (Section 2) for data to be 
collected at the time of study discontinuation and follow-up and for any further evaluations 
that need to be completed.

The participant will be permanently discontinued from both the study intervention and the 
study at that time. No follow-up visit will be performed where a participant withdraws consent.

If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.
8.2.2
Study Termination for Unexpectedly Unfavorable Risk/Benefit Balance
The DMC will evaluate the risk/benefit profile of the study on an ongoing basis. This evaluation 
will be based on all available unblinded data with particular attention to: (1) AEs or other safety 
trends in this or any other clinical study of BMS-986322 whose character, severity, and/or 
frequency suggest that participants would be exposed to an unreasonable and significant risk of 
illness or injury; (2) new nonclinical data suggesting unreasonable and significant risk of illness 
or injury. In addition, the Sponsor will evaluate the blinded data on an ongoing basis for 
unexpected/unusual safety findings/signals and increases in PsO disease activity and/or 
discontinuations not anticipated in a clinical trial of similar participant populations. Any concerns 
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will be escalated promptly to the DMC for further evaluation.
 
 
If such evaluation suggests that the risk/benefit profile of the study or an individual dose group has 
become unfavorable to the study participants, the Sponsor will pause enrollment and/or dosing 
until further assessment of data and interaction with the appropriate Health Auhtority(ies) can take 
place on potential actions. Such actions may include, but are not limited to, study continuation 
without change, continuation with modification, or termination of the study.
8.3
Lost to Follow-up
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:

All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant.

Lost to follow-up is defined by the inability to reach the participant after a minimum 
of 3 documented phone calls, faxes, or emails, as well as lack of response by participant
to 1 registered mail letter. All attempts should be documented in the participant’s 
medical records.

If the investigator’s use of a third-party representative to assist in the follow-up portion of the 
study has been included in the participant’s informed consent, then the investigator may use a 
Sponsor-retained third-party representative to assist site staff with obtaining the participant’s 
contact information or other public vital status data, such as public health registries and 
databases, 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, 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.

If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death.
9
STUDY ASSESSMENTS AND PROCEDURES

Study procedures and timing are summarized in the Schedule of Activities, see Section 2. 

Protocol waivers or exemptions are not allowed.

All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine whether the participant should continue or discontinue 
treatment.

Adherence to the study design requirements, including those specified in the Schedule of 
Activities (see Section 2), is essential and required for study conduct.

All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria before randomization. The investigator will maintain a 
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screening log to record details of all participants screened and to confirm eligibility or record 
reasons for screening failure, as applicable.

Procedures conducted as part of the participant’s routine clinical management (eg, complete 
blood count) and obtained before signing of informed consent may be utilized for screening or 
baseline purposes provided the procedure meets the protocol-defined criteria and has been 
performed within the time frame defined in the Schedule of Activities, see Section 2.

For several assessments, appropriate training will be provided to investigators and designated 
personnel at sites. Only those individuals trained and certified to perform these assessments 
will be performing them during the study.

Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples.

As part of the online questionnaire, the study sponsor may collect and use information about 
the gender that participants identify with, sexual orientation, and intersex status. At the 
conclusion of the study, summaries of this information, including information already collected 
about race, ethnicity, and gender, across all study participants will be developed to understand 
the populations that participated in the study. In addition, in the future, this data may be 
combined with data from other BMS studies to conduct subsequent research on how the disease 
or treatment impacts certain populations. Answering the questions about the gender you 
identify with, sexual orientation, and intersex status is voluntary, and participants are not 
required to answer these questions in the questionnaire to take part in this clinical study.
9.1
Efficacy Assessments
9.1.1
Efficacy Assessment for the Study
Every effort must be made to ensure that the same evaluator(s) complete the assessment for each 
participant. If the evaluator(s) is/are unable to complete the evaluation, then a qualified individual 
with overlapping experience may perform the evaluation. Documentation of who performed the 
evaluation is to be recorded in source documents. Assessments are to be performed at 
approximately the same time of day throughout the duration of the study. 
Baseline assessments must be performed per protocol (standard of care assessments may not be 
used for baseline). Procedures not specified in the protocol that are part of standard care may be 
performed if they do not interfere with study procedures; any data arising from such procedures 
are not to be reported in the electronic CRF (eCRF).
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9.1.3
Psoriasis Area and Severity Index (PASI)
The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions 
(each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and 
legs to top of buttocks).59 The PASI produces a numeric score that can range from 0 to 72, with 
higher PASI scores denoting more severe disease activity. PASI can also be used to assess response 
to treatment. The PASI-50 is the proportion of participants who experience at least a 50% 
improvement in PASI score as compared with baseline value. The PASI-75, PASI-90, and 
PASI-100 are defined similarly. BMS will host a training session prior to initiation of the study to 
demonstrate proper PASI scoring. PASI assessments should be performed by a dermatologist or 
appropriately trained investigator who is experienced in the assessment of PsO patients (see 
Appendix 5 for an illustrative example).
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9.2
Adverse Events
The definitions of an AE or SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver or a surrogate).
The investigator and any qualified designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE and remain responsible for following up 
on AEs that are serious, considered related to the study intervention or the study, or that caused 
the participant to discontinue before completing the study. 
Refer to Appendix 3 for SAE reporting.
9.2.1
Period and Frequency for Collecting AE and SAE Information
All AEs and SAEs must be collected from the time of signing the consent, including those thought 
to be associated with protocol-specified procedures and until 30 days following discontinuation of 
dosing.
The investigator must report any SAE that occurs after these periods and that is believed to be 
related to a study intervention or protocol-specified procedure (eg, a follow-up 
).

All SAEs will be recorded and reported to the Sponsor or designee, promptly and not to exceed
24 hours of awareness of the event , as indicated in Appendix 3. 

The investigator will submit any updated SAE data to the Sponsor or designee within 24 hours
of updated information being available.
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
However, if the investigator learns of any SAE, including a death, at any time after a participant 
has been discharged from the study, and he/she considers the event reasonably related to the study 
intervention or study participation, the investigator must promptly notify the Sponsor.
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in Appendix 3.
9.2.2
Method of Detecting AEs and SAEs
AEs can be spontaneously reported or elicited during open-ended questioning, examination, or 
evaluation of a participant. Care should be taken not to introduce bias when collecting AEs and/or 
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SAEs. Inquiry about specific AEs should be guided by clinical judgment in the context of known 
AEs, when appropriate for the program or protocol.
9.2.3
Follow-up of AEs and SAEs

Non-serious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3).

Follow-up is also required for non-serious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate.

All identified non-serious AEs must be recorded and described on the non-serious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory test result abnormalities that are reported/identified during the study.
All SAEs will be followed until resolution, until the condition stabilizes, until the event is 
otherwise explained, or until the participant is lost to follow-up (as defined in Section 8.3: Lost to 
Follow-up).
Further information on follow-up procedures is given in Appendix 3.
9.2.4
Regulatory Reporting Requirements for SAEs

Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met.

An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the Investigator’s Brochure and will notify the IRB/IEC, if appropriate, according to local 
requirements.
The Sponsor or designee must report AEs to regulatory authorities and ethics committees 
according to local applicable laws and regulations. A suspected, unexpected serious adverse 
reaction (SUSAR) is a subset of SAEs and must be reported to the appropriate regulatory 
authorities and investigators following local and global guidelines and requirements.
9.2.5
Pregnancy
This section is not applicable for women not of childbearing potential.
If, following initiation of the study intervention, it is discovered that a participant is pregnant or 
may have been pregnant at the time of study intervention exposure, including at least 5 days after 
study intervention administration, the investigator must immediately notify the Sponsor Medical 
Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form to the 
Sponsor designee within 24 hours of awareness of the event and in accordance with SAE reporting 
procedures described in Appendix 3.
In all cases, the study intervention will be discontinued in an appropriate manner (eg, dose tapering 
if necessary for participant safety).
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Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form. Protocol-required procedures for study discontinuation and follow-up must be 
performed.
Any pregnancy that occurs in a female partner of a male participant at the time of study 
intervention exposure, including at least 5 days after study intervention administration, should be 
reported to the Sponsor or designee. 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 and recorded on the 
Pregnancy Surveillance Form.
If any sexual activity involving penile intercourse (eg, vaginal, anal, oral) has occurred between a 
male participant and a pregnant partner(s) without the use of a condom during and for at least
5 days after study intervention administration, the information should be reported to the Sponsor 
or designee, even if the male participant has undergone a successful vasectomy.
9.2.6
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the Adverse Events –
Non-serious and Serious Events CRF page. 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 requires the participant to have study intervention
discontinued or interrupted

Any laboratory test result abnormality that requires the participant to receive specific 
corrective therapy
It is expected that, wherever possible, the clinical rather than the laboratory term will be used by 
the reporting investigator (eg, anemia vs low hemoglobin value).
9.2.7
Potential Drug-induced Liver Injury
Wherever possible, timely confirmation of initial liver-related laboratory test result abnormalities 
should occur prior to the reporting of a potential drug-induced liver injury (DILI) event. All 
occurrences of potential DILIs meeting the defined criteria must be reported as SAEs (see Section 
9.2: Adverse Events and Appendix 3: ADVERSE EVENTS AND SERIOUS ADVERSE 
EVENTS: DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW-UP, AND REPORTING for reporting details).
A potential DILI is defined as follows: 

Aminotransferase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) 
elevation > 3× upper limit of normal (ULN)
AND
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
Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase)
AND

No other immediately apparent possible causes of aminotransferase elevation and 
hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute 
liver disease, or the administration of other drug(s) known to be hepatotoxic
9.2.8
Other Safety Considerations
Any significant worsening of conditions noted during interim or final physical examinations, ECG, 
radiographic imaging, or any other potential safety assessment required or not required by the 
protocol should also be recorded as a non-serious AE or SAE, as appropriate, and reported 
accordingly.
9.3
Overdose
 
. Overdoses that meet the regulatory definition of an SAE will be reported 
as SAEs (see Appendix 3).
9.4
Safety
Planned time points for all safety assessments are listed in Section 2: Schedule of Activities.
9.4.1
Physical Examinations
A complete PE will be obtained at specified time points as outlined in Section 2: Schedule of 
Activities. The complete PE will consist of evaluation of the following systems: general, head, 
eyes, ears, nose, throat, neck, cardiovascular, lungs, abdominal, extremities, neurologic, 
psychiatric, skin, and musculoskeletal. Complete PEs may be performed by a Doctor of Medicine, 
Doctor of Osteopathy, Physician’s Assistant, or a Nurse Practitioner.
9.4.2
Tuberculosis Screening and Chest X-Ray
A chest x-ray and PE are considered part of the process to assess a participant’s eligibility as 
outlined in Section 6. Chest x-ray at the screening visit is required if not already performed within 
6 months of obtaining written informed consent or if documentation is not on file.
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®, QuantiFERON®), preferably performed centrally. 
If unable to obtain central lab results (eg, repeated test due to indeterminate result), an IGRA test 
could be obtained locally, after consultation with the Sponsor Medical Monitor.
Participants with a positive screening test will not be eligible for the study unless they have
completed at least 1 month of treatment for latent TB prior to dosing of study intervention, and the
participant has a negative chest x-ray done at screening that reveals no evidence of active TB and 
a negative IGRA test (Quantiferon or T-spot) is confirmed prior to Day .
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9.4.3
Electrocardiograms
12-lead ECGs should be collected at times specified in Table 2-1 and Table 2-2. All scheduled 
ECGs should be performed after the participant has rested quietly for at least 5 minutes in a supine 
position. When the timing of the measurements coincides with a blood collection, the ECG should 
be obtained prior to the nominal time of the blood collection, blood pressure, and pulse rate.
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9.4.7
Vital Signs
Refer to Section 2: Schedule of Activities.
9.4.8
Clinical Safety Laboratory Assessments

Investigators must document their review of each laboratory safety report.
Participants should fast for at least 8 hours prior to sample collection at screening, on Day 
 
, and ET only. A central/local laboratory will perform the analyses and will provide reference 
ranges for these tests.
Table 9.4.8-1:
Clinical Laboratory Assessments
Hematology
Hemoglobin
Hematocrit
Total leukocyte count, including differential
Platelet count
Chemistry
Aspartate aminotransferase
Alanine aminotransferase 
Total bilirubin
Direct bilirubin
Alkaline phosphatase
Lactate dehydrogenase 
Creatinine
Blood urea nitrogen or serum urea
Uric acid
Fasting glucose (Day 
, and ET only)
Fasting C-peptide (Day 
, and ET only)
Total protein
Albumin
Sodium
Potassium
Chloride
Calcium
Phosphorus
Magnesium
Creatine kinase
Creatinine clearance – screening only
Fasting Lipid Panel
Total C (mg/dL, mmol/L)
Reflex testing will occur for direct LDL-C if TG > 400 mg/dL (4.52 mmol/L)
HDL-C (mg/dL, mmol/L)
TG (mg/dL, mmol/L)
Note: A participant should be fasting at least 8 hours (Day 
, and ET only).
Urinalysis
Protein
Glucose
Blood
Leukocyte esterase
Specific gravity
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Table 9.4.8-1:
Clinical Laboratory Assessments
pH
Microscopic examination of the sediment if blood, protein, or leukocytes esterase are positive on the dipstick
Serology
Serum for hepatitis C antibody, HBsAg, anti-hepatitis B core antibody, anti-HBsAb, HIV-1 and -2 antibody (HIV 
viral RNA or p24 antigen, if needed). At screening only.
Other Analyses
Test for drugs of abuse (urine or serum) (screening and predose on Day )
Pregnancy test (women only: serum at screening, urine at Days 
)
Follicle stimulating hormone (screening only for women only)
hsCRP - abnormalities in hsCRP levels present at baseline do not necessarily warrant participant exclusion. 
Please discuss with the Sponsor Medical Monitor.
Tuberculosis test (at screening only)
Abbreviations: ET, early termination; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; 
HDL-C, high-density lipoprotein cholesterol; HIV, human immunodeficiency virus; hsCRP, high sensitivity 
C-reactive protein; 
; LDL-C, low-density lipoprotein cholesterol; RNA, ribonucleic acid; 
 
; TG, triglycerides.
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9.6
Immunogenicity Assessments 
Not applicable.
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9.8
Optional Future Research
This protocol will include residual sample storage for optional future research, from consented 
participants only,
:
Samples kept for future research will be stored at the Sponsor-designated storage facility.
The manager of these samples will ensure that they are properly used throughout their usable life 
and will destroy the samples at the end of the scheduled storage period, no longer than 20 years
after the end of the study or the maximum period allowed by applicable law.
Samples will be stored in a coded fashion, and no researcher will have access to the key. The key 
will be securely held by the investigator at the clinical site, so there is no direct ability for a 
researcher to connect a sample to a specific individual.
Further details of sample collection and processing will be provided to the site in the Laboratory
Manual.
9.9
Other Assessments
Not applicable.
9.10
Health Economics OR Medical Resource Utilization and Health 
Economics
Health economics/medical resource utilization and health economics parameters will not be 
evaluated in this study.
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10
STATISTICAL CONSIDERATIONS
10.1
Statistical Hypotheses
The primary efficacy hypothesis of this study stipulates that the proportion of participants with 
moderate-to-severe PsO achieving a 75% reduction in PASI score from baseline after 12 weeks of 
treatment with BMS-986322 will be higher than after 12 weeks of treatment with placebo.
10.2
Sample Size Determination
The sample size calculation is driven by several considerations.
The first consideration is to compare the response rate in PASI-75, the proportion of participants 
with moderate-to-severe PsO experiencing a 75% improvement (reduction from baseline) in PASI 
score from baseline after 12 weeks, between BMS-986322 and placebo arms. With a 2-sided, 
2-sample Fisher’s exact test at a significant level of 5%, a sample size of 
 participants per arm 
will provide at least 99% power to detect a 60% increase in the PASI-75 response rate in an active 
arm (ie, 70% response rate) compared to placebo assuming the response rate is 10% in the placebo 
arm after 12 weeks of treatment. The second consideration is to assess the response rate in PASI-75 
in active dose arms. With a probability of at least 99%, data from 
 treated participants per active 
arm will produce a 2-sided 95% exact confidence interval (CI) with a margin of error (half-width) 
of at most 18.8%. In addition, administration of BMS-986322 to 
 participants in each active 
treatment group provides approximately 26%, 79%, and 96% probability of observing at least one 
occurrence of any treatment-emergent AE that would occur with 1%, 5%, or 10% incidence rate,
respectively.
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Therefore, approximately 120 participants will be randomized in a 1:1:1:1 ratio to receive 
BMS-986322 (16 mg PO QD, 32 mg PO QD, or 64 mg PO QD) or placebo. Randomization will 
be stratified by use of previous treatment with a biologic (yes/no). Assuming a screen failure rate 
of about 20%, it is estimated that approximately 150 screened participants will be required to 
achieve the planned 120 treated participants.
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10.3
Analysis Sets
For the purposes of analysis, the following populations are defined:
Population
Description
All Enrolled 
Participants 
All participants who have agreed to participate in a clinical study following completion 
of the informed consent process, unless otherwise specified by the protocol.
All Randomized 
Participants
All participants who were randomized using IRT. 
Full Analysis Set
All participants who were randomized and have received at least one dose of study 
intervention. This population will be used for efficacy analyses and will be analyzed as 
per randomized treatment.
Per Protocol 
Population
All participants who were randomized and have no relevant protocol deviation. The 
primary efficacy analysis will be repeated using this population if there are more than 
10% of participants with relevant protocol deviations. Participants will be analyzed as 
per randomized treatment.
Safety Population
All participants who were randomized and have received at least one dose of study 
intervention. This population will be used for safety analyses and will be analyzed as per 
actual treatment received.
Abbreviation: IRT, Interactive Response Technology.
10.4
Statistical Analyses
The SAP will be developed and finalized prior to final database lock and subsequent unblinding, 
and it will include a more technical and detailed description of the statistical analyses described in 
this section. This section is a summary of the planned statistical analyses of the most important 
endpoints, including primary and key secondary endpoints.
A description of the participant population will be included in the CSR, including subgroups of 
age, gender, gender identity, race, and other study-specific populations and demographic 
characteristics. A description of participant disposition will also be included in the CSR.
Participant characteristics and/or demographic data may be pooled across studies for future 
analysis.
10.4.1
General Considerations
Categorical variables will be summarized using counts and percentages of participants falling into 
each category by treatment group and visit, as applicable. Continuous variables will be 
summarized using number of participants, mean, standard deviation, median, lower quartile, upper 
quartile, minimum, and maximum by treatment group and visit, as applicable and unless otherwise 
specified. Descriptive summaries of PK data will additionally include geometric mean and 
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arithmetic percentage coefficient of variation (%CV). Tmax and similar parameters will be 
described by median, minimum, and maximum statistics. Change from baseline will be derived as 
difference of the observed value to its corresponding baseline value, where baseline is defined as 
the last non-missing observation prior to first administration of any study intervention and will be 
presented by descriptive summary statistics. Details on statistical considerations will be included 
in the SAP.
10.4.2
Planned Analyses
 
The final analysis will be conducted after conclusion of the study (ie, when the last participant has 
completed the study as defined in Section 5.3) and final database lock has occurred.
10.4.3
Primary Endpoint(s)
The primary objective of this study is to evaluate the response rate in PASI-75 after 12 weeks of 
treatment with BMS-986322. The response rate in PASI-75 is defined as the proportion of 
participants with moderate-to-severe PsO experiencing a 75% improvement (reduction from 
baseline) in PASI score at Week 12 (Day 85) and will be evaluated on the Full Analysis Set. 
The safety and tolerability of BMS-986322 will be assessed by the type, frequency, relationship, 
severity, and seriousness of treatment-emergent AEs, clinical laboratory tests, 12-lead ECG, vital 
signs, and PE. Treatment-emergent AEs and study intervention-related AEs and SAEs will be 
summarized using counts and percentages of participants experiencing the event as well as the 
number of events by system organ class, preferred term, and treatment group. PE findings, vital 
signs, clinical laboratory test results, and ECG test results will be summarized using descriptive 
summary statistics for continuous variables and frequency distributions (counts and percentages) 
for categorical variables. All safety analyses will be performed on the Safety Analysis Set. An 
overview of primary efficacy and safety endpoints is given in Table 10.4.3-1.
Table 10.4.3-1:
Primary Efficacy and Safety Endpoints
Primary Endpoint
Description
Time Frame
Achievement of PASI-75
At least 75% improvement in PASI 
score as compared to baseline, ie, 
percent change from baseline less 
than or equal to -75%
Week 12
Incidence of TEAEs
Type and frequency of TEAEs, 
SAEs, and TEAEs leading to 
treatment discontinuation
Severity and causal relationship of 
TEAEs
30 days after last dose of study 
intervention or date of last 
follow-up, whichever is later
Clinical laboratory tests
Change from baseline and 
incidence of marked abnormalities
30 days after last dose of study 
intervention or date of last 
follow-up, whichever is later
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Table 10.4.3-1:
Primary Efficacy and Safety Endpoints
Primary Endpoint
Description
Time Frame
12-lead ECG
Change from baseline and 
incidence of abnormal findings
30 days after last dose of study 
intervention or date of last 
follow-up, whichever is later
Vital signs
Change from baseline and 
incidence of marked abnormalities
30 days after last dose of study 
intervention or date of last 
follow-up, whichever is later
Physical examination
Change from baseline (weight), and 
incidence of abnormal findings
30 days after last dose of study 
intervention or date of last 
follow-up, whichever is later
Abbreviations: ECG, electrocardiogram; PASI, Psoriasis Area and Severity Index; SAE, serious adverse event; TEAE, 
treatment-emergent adverse event.
To compare the response rates between each treatment group and placebo, the achievement of 
PASI-75 at Week 12 will be analyzed by 2-sample Fisher’s exact test or Chi-square test based on 
the observed counts. Fisher’s exact test will be employed if at least one cell count is smaller than 
5. If a participant discontinues from the study prior to Week 12 but has available PASI assessment 
at the ET visit, the record will be included into the statistical analysis if the ET visit occurred after 
at least 
Otherwise, participants without evaluable 
response due to missing PASI scores at baseline and/or Week 12 will be imputed as non-responder 
for analysis. The number of participants with imputed response will be provided per treatment 
group. The absolute count and proportion of participants with moderate-to-severe PsO achieving 
PASI-75 at Week 12 along with corresponding 2-sided 95% asymptotic and Clopper-Pearson exact 
CIs will be provided for each treatment group. Table 10.4.3-2 provides a summary of the primary 
estimand.
Table 10.4.3-2:
Primary Estimand
Estimand attribute
Primary definition
Treatment
BMS-986322 16 mg QD vs Placebo
BMS-986322 32 mg QD vs Placebo
BMS-986322 64 mg QD vs Placebo
Population
Adult male and female participants with 
moderate-to-severe PsO with or without previous use 
of biologics
Endpoint
Percent change from baseline in PASI score ≤ -75% at 
Week 12 (yes/no)
Intercurrent event
Event
Strategy
Rationale
Participant 
discontinuation prior to 
Week 12
To provide a conservative 
estimate of the treatment 
effect assuming early 
discontinuation due to 
deterioration of disease
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Table 10.4.3-2:
Primary Estimand
Estimand attribute
Primary definition
Population-level 
summary
Proportion of participants achieving PASI-75 at Week 
12
Abbreviations: 
; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; QD, once daily.
The unstratified odds ratio versus placebo and the difference in the response rates (unstratified risk 
difference), their associated 2-sided 95% CIs, and p-value from Fisher’s exact test or Chi-square 
test will be provided. There will be no adjustment for multiplicity. All comparisons will be 
performed in a pre-specified hierarchical procedure starting from the highest dose arm to the lowest 
dose arm. If a comparison is not significant at level 0.05, all p-values in subsequent comparisons 
will be considered nominal. As a supportive analysis, the primary efficacy endpoint will be 
analyzed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor 
prior use of biologics (yes/no) to compare each BMS-986322 treatment group versus placebo. The 
2-sided p-values from the CMH test, the adjusted difference in response rates (stratified risk 
difference) using the weighted average of the treatment differences across the strata with the CMH 
weights, along with the associated 2-sided 95% CIs using a normal approximation to the weighted 
average will be provided.
A Cochran-Armitage trend test will be performed to assess a positive trend between treatment 
groups of BMS-986322 and PASI-75 response rates at Week 12.
As a secondary analysis of the primary endpoint, a logistic regression model analysis will be 
performed to evaluate the impact of treatment on PASI-75 at Week 12, with treatment group, age, 
gender, weight, BMI, baseline PASI score, and prior use of biologics (yes/no) as covariates, if 
applicable. Similar to above, PASI scores observed at ET visits 
 will be included into the 
analysis. Otherwise, missing observations at Week 12 will not be imputed for analysis. Adjusted 
odds ratios for each treatment group versus placebo will be provided along with associated 2-sided 
95% CIs. Details of the tests and models as well as further analyses of the primary endpoint will 
be given in the SAP.
Primary safety endpoints will be analyzed by observed incidence and percentage as well as 
descriptive summary statistics of observed value and change from baseline per treatment group 
and visit, as applicable. Further details will be given in the SAP.
10.4.4
Secondary Endpoint(s)
The statistical analysis of dichotomous secondary endpoints, such as achievement of PASI-50, 90, 
and 100, and achievement of sPGA score of 0 or 1 at Week 12 will in general follow the primary 
endpoint analysis. To assess dichotomous endpoints over time, a repeated measures logistic 
regression model analysis will be performed using a generalized estimating equations model.
Continuous secondary endpoints, such as continuous PASI score and BMS-986322 Cmax, 
AUC(TAU), Tmax, and trough concentrations, will be presented by descriptive summary statistics 
of value and change from baseline by treatment group and time point, as applicable per parameter. 
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A mixed model for repeated measurements (MMRM) will be employed to assess PASI scores over 
time. Further details of secondary endpoint analyses including covariates used for model 
adjustment will be given in the SAP.
10.4.6
Other Safety Analyses
Other safety analyses not covered in Section 10.4.3 will be described in the SAP.
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APPENDICES
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APPENDIX 1
ABBREVIATIONS
Term
Definition
AE
adverse event
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUC(TAU)
area under the plasma concentration-time curve over the dosing interval
BMI
body mass index
BMS
Bristol-Myers Squibb Company
BSA
body surface area
CI
confidence interval
Cmax
maximum observed concentration
CMH
Cochran-Mantel-Haenszel
COVID-19
coronavirus disease 2019
CRF
Case Report Form, paper or electronic
CSR
clinical study report
DLQI
Dermatology Life Quality Index
DNA
deoxyribonucleic acid
ECG
electrocardiogram
eCRF
electronic Case Report Form
ET
Early Termination
FDA
Food and Drug Administration
FIH
first-in-human
FSH
follicle-stimulating hormone
HBsAb
hepatitis B surface antibody
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
hCG
human chorionic gonadotropin
HCV
hepatitis C virus
HIV
human immunodeficiency virus
hsCRP
high-sensitivity C-reactive protein
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Term
Definition
IBD
inflammatory bowel disease
ICF
informed consent form
ICH
International Council for Harmonisation 
IDMC
Independent Data Monitoring Committee
IEC
Independent Ethics Committee
IFN
interferon
IGRA
interferon gamma release assay
IL
interleukin
IMP
Investigational Medicinal Product
IND
Investigational New Drug 
IP
Investigational Product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IV
intravenous(ly)
JAK
Janus kinase
MMRM
mixed model for repeated measurements
PASI
Psoriasis Area and Severity Index
PCR
polymerase chain reaction
PE
physical examination
PID
participant identification number
PK
pharmacokinetic(s)
PO
orally
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Term
Definition
PsA
psoriatic arthritis
PsO
psoriasis
RNA
ribonucleic acid
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SAE
serious adverse event
SAP
statistical analysis plan
sPGA
static Physician’s Global Assessment
STAT
signal transducer and activator of transcription
TB
tuberculosis
TEAE
treatment-emergent adverse event
TYK2
tyrosine kinase 2
ULN
upper limit of normal
WOCBP
women of childbearing potential
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APPENDIX 2
STUDY GOVERNANCE CONSIDERATIONS
The terms “participant” and “subject” refer to a person who has consented to participate in the 
clinical research study. Typically, the term “participant” is used in the protocol and the term
“subject” is used in the Case Report Form (CRF).
REGULATORY AND ETHICAL CONSIDERATIONS
This study will be conducted in accordance with:

Consensus ethical principles derived from international guidelines, including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS)
international ethical guidelines

Applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP)
guidelines

Applicable laws, regulations, and requirements
The study will be conducted in compliance with the protocol. The protocol,
any 
revisions/amendments,
and the participant informed consent form (ICF) will receive 
approval/favorable 
opinion 
by 
the 
Institutional 
Review 
Board/Independent 
Ethics 
Committee (IRB/IEC), and regulatory authorities according to applicable regulations prior to 
initiation of the study.
All potential serious breaches must be reported to the Sponsor or designee immediately. A 
potential serious breach is defined as a quality issue (eg, protocol deviation) that is likely to affect, 
to a significant degree, 1 or more of the following: (1) the rights, physical safety, or mental integrity 
of 1 or more participants; (2) the scientific value of the clinical trial (eg, reliability and robustness 
of generated data). Items (1) or (2) can be associated with either GCP regulation(s) or trial 
protocol(s).
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks.
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, Investigator’s Brochure, product labeling information, ICF, 
participant recruitment materials (eg, advertisements), and any other written information to be 
provided to participants.
The investigator, Sponsor, or designee should provide the IRB/IEC with reports, updates, and other 
information (eg, expedited safety reports, amendments, administrative letters) annually, or more 
frequently, in accordance with regulatory requirements or institution procedures.
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 (US) Code of Federal Regulations, Title 21, Part 50 (21CFR50)

European Union (EU) Directive 2001/20/EC

European Regulation 536/2014 for clinical studies (if applicable)

European Medical Device Regulation 2017/745 for clinical device research (if applicable)

the IRB/IEC

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, by the local Health Authority), except where necessary to eliminate an immediate 
hazard(s) to study participants. 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s), the deviation or change will be submitted as soon 
as possible to the following:

IRB/IEC

Regulatory authority(ies), if applicable according to 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, by the local Health Authority must be sent to Bristol-Myers 
Squibb Company (BMS).
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the ICF must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from participants 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new participants prior to enrollment.
FINANCIAL DISCLOSURE
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information, in accordance with regulations, to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate Health Authorities. Investigators 
are responsible for providing information on financial interests during the study and for 1 year 
after completion of the study.
INFORMED CONSENT PROCESS
Investigators must ensure that participants are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which they volunteer to 
participate. 
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The Sponsor or designee will provide the investigator with an appropriate sample ICF, which will 
include all elements required by the ICH GCP, and applicable regulatory requirements. The sample 
ICF will adhere to the ethical principles that have their origin in the Declaration of Helsinki.
The investigator or his/her representative must:

Obtain IRB/IEC written approval/favorable opinion of the written ICF and any other 
information to be provided to the participant prior to the beginning of the study and after any 
revisions are completed for new information.

Provide a copy of the ICF and written information about the study in the language in which 
the participant is proficient prior to clinical study participation. The language must be 
nontechnical and easily understood. 

Explain the nature of the study to the participant and answer all questions regarding the study.

Inform the participant that his/her participation is voluntary. The participant will be required 
to sign a statement of informed consent that meets the requirements of 21 CFR Part 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 the participant to inquire about the details of the study.

Obtain an ICF signed and personally dated by the participant and by the person who conducted 
the informed consent discussion. 

Include a statement in the participant’s medical record that written informed consent was 
obtained before the 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 the participant to the most current version of the ICF(s) during his/her participation.

Revise the ICF whenever important new information becomes available that is relevant to the 
participant’s consent. The investigator, or a person designated by the investigator, should fully 
inform the participant of all pertinent aspects of the study and of any new information relevant 
to the participant’s willingness to continue participation in the study. This communication 
should be documented. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the participant’s signed 
ICF, and, in the US, the participant’s signed HIPAA authorization.
The ICF must also include a statement that BMS and local and foreign regulatory authorities have 
direct access to participant records. 
The rights, safety, and well-being of the study participants are the most important considerations 
and should prevail over interests of science and society.
BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
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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.
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
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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 Case Report Form (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.

Definition of what constitutes source data and its origin can be found in the source data location 
list/map or equivalent document.
The investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original, and attributable, whether the data are handwritten on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical records/electronic health 
records, adverse event (AE) tracking/reporting, protocol-required assessments, and/or drug 
accountability records.
When paper records from such systems are used in place of an electronic format to perform 
regulated activities, such paper records should be certified copies. A certified copy consists of a 
copy of original information that has been verified, as indicated by a dated signature, as an exact 
copy having all of the same attributes and information as the original. 
STUDY INTERVENTION RECORDS
Records for study intervention (whether supplied by BMS, its vendors, or the site) must 
substantiate study intervention integrity and traceability from receipt, preparation, administration, 
and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority.
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If
Then
Supplied by BMS (or its 
vendors)
Records or logs must comply with applicable regulations and 
guidelines and should include the following:

amount received and placed in storage area

amount currently in storage area

label identification number or batch number

amount dispensed to and returned by each participant, 
including unique participant identifiers

amount transferred to another area/site for dispensing or 
storage

non-study disposition (eg, lost, wasted) 

amount destroyed at study site, if applicable

amount returned to BMS

retain samples for 
bioavailability/bioequivalence/biocomparability, if applicable 

dates and initials of person responsible for Investigational 
Product dispensing/accountability per the Delegation of 
Authority Form
Sourced by site and not 
supplied by BMS or its 
vendors 
(examples 
include 
Investigational 
Product sourced from the 
site’s 
stock 
or 
commercial supply or a 
specialty pharmacy)
The investigator or designee accepts responsibility for documenting 
traceability and study intervention integrity in accordance with 
requirements applicable under law and the standard operating 
procedures/standards of the sourcing pharmacy
BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements.
CASE REPORT FORMS
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the 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 test result 
abnormalities that are reported or identified during the study.
For sites using the Sponsor or designee electronic data capture (EDC) tool, eCRFs will be prepared 
for all data collection fields except for fields specific to serious adverse events (SAEs) and 
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pregnancy, which will be reported on the electronic SAE form and Pregnancy Surveillance Form, 
respectively. If the electronic SAE form is not available, a paper SAE form can be used. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF and SAE/pregnancy CRFs must be promptly reviewed, signed, and dated by 
the investigator or qualified physician who is a sub-investigator and who is delegated this task on 
the Delegation of Authority Form. Sub-investigators in Japan may not be delegated the CRF 
approval task. The investigator must retain a copy of the CRFs, including records of the changes 
and corrections.
Each individual electronically signing eCRFs must meet Sponsor or designee training 
requirements and must only access the BMS EDC tool using the unique user account provided by 
the Sponsor or designee. User accounts are not to be shared or reassigned to other individuals.
MONITORING
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of non-compliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan.
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site, they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable.
Certain CRF pages and/or electronic files may serve as source documents.
In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to CRFs, source documents, other study files, 
and study facilities. BMS audit reports will be kept confidential.
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee. 
RECORDS RETENTION
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or its designee, whichever is longer. 
The investigator (or head of the study site in Japan) must contact BMS prior to destroying any 
records associated with the study.
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BMS or its designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed.
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed-upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or its designee. 
RETURN OF STUDY INTERVENTION
For this study, study interventions (those supplied by BMS or a vendor or sourced by the 
investigator), such as partially used study intervention containers, vials, and syringes, may be 
destroyed on site. 
If
Then
Study interventions supplied by 
BMS (including its vendors)
Any unused study interventions supplied by BMS can only 
be destroyed after being inspected and reconciled by the 
responsible Study Monitor,
unless study intervention
containers must be immediately destroyed as required for 
safety or to meet local regulations (eg, cytotoxic or biologic
agents).
Partially used study interventions and/or empty containers 
may 
be 
destroyed 
after 
proper reconciliation 
and 
documentation. However, unused Investigational Medicinal 
Product must be reconciled by the site monitor/clinical 
research associate prior to destruction.
If study interventions will be returned, the return will be 
arranged by the responsible study monitor.
Study interventions sourced by 
site, not supplied by BMS (or its 
vendors; eg, study interventions 
sourced from the site’s stock or 
commercial 
supply 
or 
a 
specialty pharmacy)
It is the investigator’s or designee’s responsibility to dispose 
of all containers according to the institutional guidelines 
and procedures.
It is the investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met:

On-site disposal practices must not expose humans to risks from the drug.

On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances.
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
Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s standard operating procedures and a copy provided to BMS upon request.

Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal (eg, incinerator, licensed sanitary landfill, or licensed waste-disposal 
vendor) must be documented.

Accountability and disposal records are complete, up-to-date, and available for the 
Study Monitor to review throughout the clinical trial period.
It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers.
If conditions for destruction cannot be met, the responsible Study Monitor will make arrangements 
for return of study interventions provided by BMS (or its vendors). Destruction of non-study 
interventions sourced by the site, not supplied by BMS, is solely the responsibility of the 
investigator or designee.
STUDY AND SITE CLOSURE
The Sponsor/designee reserves the right to close the study site or to terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies have 
been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the Sponsor or investigator may include, but are 
not limited to, the following:
For study termination:

Discontinuation of further study intervention development
For site termination:

Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local Health Authorities, the Sponsor’s procedures, or GCP guidelines

Inadequate or no recruitment (evaluated after a reasonable amount of time) of participants by 
the investigator
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should ensure 
appropriate participant therapy and/or follow-up.
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DISSEMINATION OF CLINICAL STUDY DATA
To benefit potential study participants, patients, health care 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 per regulatory and BMS 
requirements. BMS will post study information on local, national, or regional databases in 
compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases.
In the European Union (EU, the summary of results and summary for laypersons will be submitted
within 1 year  of the end of trial in the EU/European Economic Area and third countries.
CLINICAL STUDY REPORT
A Signatory Investigator must be selected to sign the Clinical Study Report (CSR). 
For each CSR related to this protocol, the following criteria will be used to select the Signatory 
Investigator:

Participant recruitment (eg, among the top quartile of enrollers)

Regional representation (eg, among top quartile of enrollers from a specified region or country)
SCIENTIFIC PUBLICATIONS
The data collected during this study are confidential and proprietary to the Sponsor or designee. 
Any publications or abstracts arising from this study must adhere to the publication requirements 
set forth in the Clinical Trial Agreement (CTAg) governing [study site or investigator] 
participation in the study. These requirements include, but are not limited to, submitting proposed 
publications to the Sponsor or designee at the earliest practicable time prior to submission or 
presentation and otherwise within the period set forth in the CTAg.
Scientific publications (such as abstracts, congress podium presentations and posters, and 
manuscripts) of the study results will be a collaborative effort between the study Sponsor and the 
external authors. No public presentation or publication of any interim results may be made by any 
Principal Investigator, sub-investigator, or any other member of the study staff without the prior 
written consent of the Sponsor.
Authorship of publications at the Sponsor is aligned with the criteria of the International 
Committee of Medical Journal Editors (ICMJE; www.icmje.org). Authorship selection is based on 
significant contributions to the study (ie, ICMJE criterion #1). Authors must meet all 4 ICMJE 
criteria for authorship:
1) Substantial intellectual contribution to the conception or design of the work; or the acquisition 
of data (ie, evaluable participants with quality data), analysis, or interpretation of data for the 
work (eg, problem solving, advice, evaluation, insights, and conclusion)
2) Drafting the work or revising it critically for important intellectual content
3) Final approval of the version to be published
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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 the 
Sponsor for authorship of the primary publication. Sub-investigators will generally not be 
considered for authorship in the primary publication. Geographic representation will also be 
considered.
Authors will be listed by order of significant contributions (highest to lowest), with the exception 
of the last author. Authors in first and last position have provided the most significant contributions 
to the work. 
For secondary analyses and related publications, author list and author order may vary from 
primary to reflect additional contributions.
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APPENDIX 3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING
ADVERSE EVENTS
Adverse Event Definition:
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a 
pre-existing medical condition occurring in a clinical investigation participant after signing of 
informed consent, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
test result), symptom, or disease temporally associated with the study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, electrocardiograms, radiological scans, vital sign 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal laboratory test 
results or other safety assessment findings 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 
the condition may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator), 
should not be reported as an AE/serious adverse event (SAE) unless it is an intentional 
overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae and should specify “intentional overdose” as the 
verbatim term.
Events NOT Meeting the AE Definition

Medical or surgical procedure (eg, endoscopy, appendectomy); the condition that leads to 
the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
DEFINITION OF SAE
If an event is not an AE per the definition above, then it cannot be an SAE, even if serious 
conditions are met.
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SERIOUS ADVERSE EVENTS
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at 
any dose:
Results in death.
Is life threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event that 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 department or other hospital department < 24 hours that does not 
result in admission (unless considered an important medical or life-threatening event).

Elective surgery that was planned prior to signing consent.

Admissions per protocol for a planned medical/surgical procedure.

Routine health assessment requiring admission for baseline/trending
of health 
status (eg, routine colonoscopy).

Medical/surgical admission other than to remedy ill health and planned prior to enrollment
in the study. Appropriate documentation is required in these cases.

Admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason).

Admission for administration of anticancer therapy in the absence of any other 
SAEs (applies to oncology protocols).
Results in persistent or significant disability/incapacity.
Is a congenital anomaly/birth defect.
Is an important medical event (defined as a medical event[s] that may not be immediately life
threatening or results in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above). Examples 
of such events include, but are not limited to, intensive treatment in an emergency department 
or at home for allergic bronchospasm and blood dyscrasias or convulsions that do not result in 
hospitalization. Potential drug-induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.7: Potential Drug-induced Liver Injury of the protocol for the 
definition of a potential DILI.) 
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Pregnancy and DILI must follow the same transmission timing and processes to BMS as those 
used for SAEs. (See Section 9.2.5: Pregnancy of the protocol for reporting pregnancies.)
EVALUATING AES AND SAES
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration,
will be considered and investigated.

The investigator will also consult the Investigator’s Brochure and/or product information for 
marketed products, in his/her assessment.

For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to the Sponsor.

The investigator may change his/her opinion of causality in light of follow-up information 
and send an SAE follow-up report with the updated causality assessment.

The causality assessment is 1 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 pre-defined 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 intervention or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or the designee) using the same procedure used for transmitting the initial SAE report.
All AEs/SAEs must be followed to resolution or stabilization.
REPORTING OF SAES TO SPONSOR OR DESIGNEE

SAEs, whether related or not related to study intervention, and pregnancies must be reported 
to BMS (or the designee) promptly and not to exceed 24 hours of awareness of the event.

SAEs must be recorded on the SAE Report Form.

The required method for SAE data reporting is through the electronic Case Report 
Form (eCRF).

The paper SAE Report Form is intended only as a back-up option when the electronic 
data capture system is unavailable/not functioning for transmission of the eCRF to BMS 
(or the designee).
In this case, the paper form is transmitted via email or confirmed fax transmission.
When paper forms are used, the original paper forms are to remain on site.

Pregnancies must be recorded on paper Pregnancy Surveillance Forms and transmitted via 
email or confirmed fax transmission.
SAE Email Address: worldwide.safety@BMS.com
SAE Fax Number: Will be provided by local site monitor.
SAE Telephone Contact (required for SAE and pregnancy reporting): Will be provided by 
local site monitor.
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APPENDIX 4
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION
Appendix 4 provides general information and definitions related to Women of Childbearing 
Potential (WOCBP) 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: Inclusion Criteria of the protocol. Only the contraception 
methods as described in Section 6.1: Inclusion Criteria of the protocol are acceptable for this study.
DEFINITIONS
Women of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy.
Women in the following categories are not considered WOCBP:

Premenarchal

Pre-menopausal 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.

Post-menopausal female

A post-menopausal state is defined as 12 months of amenorrhea in a woman over the age 
of 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 to obtain a physiologic FSH level. The 
duration of the washout period is a function of the type of HRT used. Suggested guidelines for the 
duration of the washout periods for HRT types are presented below. Investigators should use their 
judgment in checking serum FSH levels. 

1-week minimum for vaginal hormonal products (rings, creams, gels)

4-week minimum for transdermal products

8-week minimum for oral products
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Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the woman can be considered 
postmenopausal.
End of Relevant Systemic Exposure
End of relevant systemic exposure is the time point at which the study intervention (Investigational 
Medicinal Product [IP/IMP] and other study interventions ie, Non-IMP/AxMP required for study)
or any active major metabolites have decreased to a concentration that is no longer considered 
relevant for human teratogenicity or fetotoxicity. This should be evaluated in context of safety 
margins from the no-observed-adverse-effect level or the time required for 5 half-lives of the study 
intervention 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 in which 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 in which 
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 in which hormonal contraception is permitted by the study protocol.)b

Intrauterine device.
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
Intrauterine system (IUS). (This method of contraception can only be used by WOCBP 
participants in studies in which 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.
Male participants will be required to always use a latex or other synthetic condom during any 
sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participants have undergone a 
successful vasectomy or if their partner is pregnant or breastfeeding.

Sexual abstinence.
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study intervention. 
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant.

Continuous abstinence must begin at least 30 days prior to initiation of study therapy.

It is not necessary to use any other method of contraception when complete abstinence 
is elected.

WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2 of the protocol.

Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participant chooses to forego complete abstinence.

Periodic abstinence (including, but not limited to, calendar, symptothermal, post-ovulation 
methods), withdrawal (coitus interruptus), spermicides only, and lactation amenorrhea 
method (LAM) are not acceptable methods of contraception for this study.
NOTES: 
a Typical use failure rates may differ from failure rates when contraceptive methods are used consistently and 
correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for 
participants in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study intervention, which may reduce the 
efficacy of the contraceptive method. Hormonal contraception is permissible only when there is sufficient 
evidence that the Investigational Medicinal Product and other study medications will not alter hormonal 
exposures such that contraception would be ineffective or result in increased exposures that could be potentially 
hazardous. In this case, alternative methods of contraception should be utilized. For information specific to 
this study regarding permissibility of hormonal contraception, refer to Section 6.1: Inclusion Criteria and 
Section 7.7.1: Prohibited and/or Restricted Treatments of the protocol.
c IUSs are acceptable methods of contraception in the absence of definitive drug interaction studies when hormone 
exposures from intrauterine devices do not alter contraception effectiveness. For information specific to this 
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study regarding permissibility of hormonal contraception, refer to Section 6.1: Inclusion Criteria and 
Section 7.7.1: Prohibited and/or Restricted Treatments of the protocol.
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 in which hormonal contraception is prohibited.)
Unacceptable Methods of Contraception

Periodic abstinence (calendar, symptothermal, post-ovulation methods).

Withdrawal (coitus interruptus).

Spermicide only.

LAM.
COLLECTION OF PREGNANCY INFORMATION
Guidance for collection of pregnancy information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.5: Pregnancy of the protocol and Appendix 3.
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APPENDIX 5
PSORIASIS AREA AND SEVERITY INDEX (PASI)
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APPENDIX 14
ADME GENE LIST (FROM HTTP://PHARMAADME.ORG)
CORE ADME GENE LIST
Gene Symbol
Full Gene Name
Class
ABCB1
ATP-binding cassette, subfamily B (MDR/TAP), member 
1
Transporter
ABCC2
ATP-binding cassette, subfamily C (CFTR/MRP), member 
2
Transporter
ABCG2
ATP-binding cassette, subfamily 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
GSTA1
glutathione S-transferase A1
Phase II
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, 1 A, phenol-preferring, 
member 1
Phase II
TPMT
thiopurine S-methyltransferase,
Phase II
UGT1A1
UDP glucuronosyltransferase 1 family, polypeptide A1
Phase II
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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
EXTENDED ADME GENE LIST
Rank
Gene Symbol
Full Gene Name
Class
7
ABCB8
ATP-binding cassette, subfamily B (MDR/TAP), 
member 8
Transporter
7
ABCC12
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 12
Transporter
7
ABCC3
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 3
Transporter
7
ABCC4
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 4
Transporter
7
AHR
aryl hydrocarbon receptor
Modifier
7
ALDH4A1
aldehyde dehydrogenase 4 family, member A1
Phase I
7
ALDH5A1
aldehyde dehydrogenase 5 family, member A1
Phase I
7
ALDH6A1
aldehyde dehydrogenase 6 family, member A1
Phase I
7
CES1
carboxylesterase 1 (monocyte/macrophage serine 
esterase 1)
Phase I
7
CES2
carboxylesterase 2 (intestine, liver)
Phase I
7
CYP7A1
cytochrome P450, family 7, subfamily A, 
polypeptide 1
Phase I
7
EPHX1
epoxide hydrolase 1, microsomal (xenobiotic)
Phase I
7
FMO3
flavin containing monooxygenase 3
Phase I
7
GSTA1
glutathione S-transferase A1
Phase II
7
GSTA2
glutathione S-transferase A2
Phase II
7
GSTA3
glutathione S-transferase A3
Phase II
7
GSTA4
glutathione S-transferase A4
Phase II
7
GSTA5
glutathione S-transferase A5
Phase II
7
GSTM2
glutathione S-transferase M2 (muscle), glutathione 
S-transferase M4
Phase II
7
GSTM3
glutathione S-transferase M3 (brain)
Phase II
7
GSTM4
glutathione S-transferase M4
Phase II
7
GSTO1
glutathione S-transferase omega 1, glutathione S-
transferase omega 2
Phase II
7
GSTO2
glutathione S-transferase omega 2
Phase II
7
GSTT2
glutathione S-transferase theta 2
Phase II
7
SLC10A1
solute carrier family 10 (sodium/bile acid 
cotransporter family), member 1
Transporter
7
SLC15A1
solute carrier family 15 (oligopeptide transporter),
member 1
Transporter
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Rank
Gene Symbol
Full Gene Name
Class
7
SLC22A11
solute carrier family 22 (organic anion/cation 
transporter), member 11
Transporter
7
SLC22A8
solute carrier family 22 (organic anion transporter), 
member 8
Transporter
7
SLC7A5
solute carrier family 7 (cationic amino acid 
transporter, y+ system), member 5
Transporter
7
SLCO1A2
solute carrier organic anion transporter family, 
member 1A2
Transporter
7
SLCO2B1
solute carrier organic anion transporter family, 
member 2B1
Transporter
7
SULT1A2
sulfotransferase family, cytosolic, 1 A, phenol-
preferring, member 2
Phase II
7
SULT1A3
sulfotransferase family, cytosolic, 1 A, phenol-
preferring, member 3
Phase II
7
SULT1B1
sulfotransferase family, cytosolic, 1B, member 1
Phase II
7
UGT1A3
UDP glucuronosyltransferase 1 family, polypeptide 
A3
Phase II
7
UGT1A6
UDP glucuronosyltransferase 1 family, polypeptide 
A6
Phase II
7
UGT1A7
UDP glucuronosyltransferase 1 family, polypeptide 
A7
Phase II
7
UGT1A8
UDP glucuronosyltransferase 1 family, polypeptide 
A8
Phase II
7
UGT1A9
UDP glucuronosyltransferase 1 family, polypeptide 
A9
Phase II
7
UGT2A1
UDP glucuronosyltransferase 2 family, polypeptide 
A1
Phase II
7
UGT2B11
UDP glucuronosyltransferase 2 family, polypeptide 
B11
Phase II
7
UGT2B28
UDP glucuronosyltransferase 2 family, polypeptide 
B28
Phase II
7
UGT2B4
UDP glucuronosyltransferase 2 family, polypeptide 
B4
Phase II
6
ABCA1
ATP-binding cassette, subfamily A (ABC1), 
member 1
Transporter
6
ABCA4
ATP-binding cassette, subfamily A (ABC1), 
member 4
Transporter
6
ABCB11
ATP-binding cassette, subfamily B (MDR/TAP), 
member 11
Transporter
6
ABCB4
ATP-binding cassette, subfamily B (MDR/TAP), 
member 4
Transporter
6
ABCB5
ATP-binding cassette, subfamily B (MDR/TAP), 
member 5
Transporter
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Rank
Gene Symbol
Full Gene Name
Class
6
ABCB6
ATP-binding cassette, subfamily B (MDR/TAP), 
member 6
Transporter
6
ABCB7
ATP-binding cassette, subfamily B (MDR/TAP), 
member 7
Transporter
6
ABCC1
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 1
Transporter
6
ABCC10
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 10
Transporter
6
ABCC11
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 11
Transporter
6
ABCC5
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 5
Transporter
6
ABCC6
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 6
Transporter
6
ABCC8
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 8
Transporter
6
ABCC9
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 9
Transporter
6
ABCG1
ATP-binding cassette, subfamily G (WHITE), 
member 1
Transporter
6
ADH1A
alcohol dehydrogenase 1 A (class I), alpha 
polypeptide
Phase I
6
ADH1B
alcohol dehydrogenase IB (class I), beta 
polypeptide
Phase I
6
ADH1C
alcohol dehydrogenase 1C (class I), gamma 
polypeptide
Phase I
6
ADH4
alcohol dehydrogenase 4 (class II), pi polypeptide
Phase I
6
ADH5
alcohol dehydrogenase 5 (class III), chi 
polypeptide, methionyl aminopeptidase 1
Phase I
6
ADH6
alcohol dehydrogenase 6 (class V)
Phase I
6
ADH7
alcohol dehydrogenase 7 (class IV), mu or sigma 
polypeptide
Phase I
6
ALDH1A1
aldehyde dehydrogenase 1 family, member A1
Phase I
6
ALDH1A2
aldehyde dehydrogenase 1 family, member A2
Phase I
6
ALDH1A3
aldehyde dehydrogenase 1 family, member A3
Phase I
6
ALDH1B1
aldehyde dehydrogenase 1 family, member B1
Phase I
6
ALDH2
aldehyde dehydrogenase 2 family (mitochondrial)
Phase I
6
ALDH3A1
aldehyde dehydrogenase 3 family, memberA1
Phase I
6
ALDH3A2
aldehyde dehydrogenase 3 family, member A2
Phase I
6
ALDH3B1
aldehyde dehydrogenase 3 family, member B1
Phase I
6
ALDH3B2
aldehyde dehydrogenase 3 family, member B2
Phase I
6
ALDH7A1
aldehyde dehydrogenase 7 family, member A1
Phase I
Protocol Amendment No.: 01
Date: 29-Mar-2023
115
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
6
ALDH8A1
aldehyde dehydrogenase 8 family, member A1
Phase I
6
ALDH9A1
aldehyde dehydrogenase 9 family, member A1
Phase I
6
AOX1
aldehyde oxidase 1
Phase I
6
ARNT
aryl hydrocarbon receptor nuclear translocator
Modifier
6
CBR1
carbonyl reductase 1
Phase I
6
CBR3
carbonyl reductase 3
Phase I
6
CDA
cytidine deaminase
Modifier
6
CYB5R3
cytochrome b5 reductase 3
Phase I
6
CYP11A1
cytochrome P450, family 11, subfamily A, 
polypeptide 1
Phase I
6
CYP11B1
cytochrome P450, family 11, subfamily B, 
polypeptide 1
Phase I
6
CYP11B2
cytochrome P450, family 11, subfamily B, 
polypeptide 2
Phase I
6
CYP17A1
cytochrome P450, family 17, subfamily A, 
polypeptide 1
Phase I
6
CYP1B1
cytochrome P450, family 1, subfamily B, 
polypeptide 1
Phase I
6
CYP20A1
cytochrome P450, family 20, subfamily A, 
polypeptide 1
Phase I
6
CYP20A1
cytochrome P450, family 20, subfamily A, 
polypeptide 1
Phase I
6
CYP21A2
cytochrome P450, family 21, subfamily A, 
polypeptide 2
Phase I
6
CYP24A1
cytochrome P450, family 24, subfamily A, 
polypeptide 1
Phase I
6
CYP26A1
cytochrome P450, family 26, subfamily A, 
polypeptide 1
Phase I
6
CYP27A1
cytochrome P450, family 27, subfamily A, 
polypeptide 1
Phase I
6
CYP2A13
cytochrome P450, family 2, subfamily A, 
polypeptide 13
Phase I
6
CYP2A7
cytochrome P450, family 2, subfamily A, 
polypeptide 7
Phase I
6
CYP2C18
cytochrome P450, family 2, subfamily C, 
polypeptide 18
Phase I
6
CYP2F1
cytochrome P450, family 2, subfamily F, 
polypeptide 1
Phase I
6
CYP2J2
cytochrome P450, family 2, subfamily J, 
polypeptide 2
Phase I
6
CYP39A1
cytochrome P450, family 39, subfamily A, 
polypeptide 1
Phase I
Protocol Amendment No.: 01
Date: 29-Mar-2023
116
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
6
CYP3A43
cytochrome P450, family 3, subfamily A, 
polypeptide 43
Phase I
6
CYP3A7
cytochrome P450, family 3, subfamily A, 
polypeptide 7
Phase I
6
CYP4B1
cytochrome P450, family 4, subfamily B, 
polypeptide 1
Phase I
6
CYP4F11
cytochrome P450, family 4, subfamily F, 
polypeptide 11
Phase I
6
CYP51A1
cytochrome P450, family 51, subfamily A, 
polypeptide 1
Phase I
6
EPHX2
epoxide hydrolase 2, cytoplasmic
Phase I
6
FMO1
flavin containing monooxygenase 1
Phase I
6
FMO2
flavin containing monooxygenase 2
Phase I
6
FMO4
flavin containing monooxygenase 4
Phase I
6
FMO5
flavin containing monooxygenase 5
Phase I
6
GPX2
glutathione peroxidase 2 (gastrointestinal)
Phase I
6
GPX3
glutathione peroxidase 3 (plasma)
Phase I
6
GPX7
glutathione peroxidase 7
Phase I
6
GSR
glutathione reductase
Phase I
6
GSTK1
glutathione S-transferase kappa 1
Phase II
6
GSTM5
glutathione S-transferase M5
Phase II
6
GSTZ1
glutathione transferase zeta 1 (maleylacetoacetate 
isomerase)
Phase II
6
NNMT
nicotinamide N-methyltransferase
Phase II
6
NR1I2
nuclear receptor subfamily 1, group I, member 2
Modifier
6
NR1I3
nuclear receptor subfamily 1, group I, member 3
Modifier
6
PNMT
phenylethanolamine N-methyltransferase
Phase II
6
PON1
paraoxonase 1
Phase I
6
PON2
paraoxonase 2
Phase I
6
PON3
paraoxonase 3
Phase I
6
POR
P450 (cytochrome) oxidoreductase
Modifier
6
PPARD
peroxisome proliferative activated receptor, delta
Modifier
6
PPARG
peroxisome proliferative activated receptor, gamma
Modifier
6
RXRA
retinoid X receptor, alpha
Modifier
6
SLC10A2
solute carrier family 10 (sodium/bile acid 
cotransporter family), member 2
Transporter
6
SLC13A1
solute carrier family 13 (sodium/sulfate 
symporters), member 1
Transporter
6
SLC13A2
solute carrier family 13 (sodium-dependent 
dicarboxylate transporter), member 2
Transporter
Protocol Amendment No.: 01
Date: 29-Mar-2023
117
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
6
SLC13A3
solute carrier family 13 (sodium-dependent 
dicarboxylate transporter), member 3
Transporter
6
SLC16A1
solute carrier family 16 (monocarboxylic acid 
Transporter), member 1
Transporter
6
SLC19A1
solute carrier family 19 (folate transporter), 
member 1
Transporter
6
SLC22A10
solute carrier family 22 (organic anion/cation 
transporter), member 10
Transporter
6
SLC22A12
solute carrier family 22 (organic anion/cation 
transporter), member 12
Transporter
6
SLC22A13
solute carrier family 22 (organic cation transporter),
member 13
Transporter
6
SLC22A14
solute carrier family 22 (organic cation transporter), 
member 14
Transporter
6
SLC22A15
solute carrier family 22 (organic cation transporter), 
member 15
Transporter
6
SLC22A16
solute carrier family 22 (organic cation transporter), 
member 16
Transporter
6
SLC22A17
solute carrier family 22 (organic cation transporter), 
member 17
Transporter
6
SLC22A18
solute carrier family 22 (organic cation transporter), 
member 18
Transporter
6
SLC22A18AS
solute carrier family 22 (organic cation transporter), 
member 18 antisense
Transporter
6
SLC22A3
solute carrier family 22 (extraneuronal monoamine 
transporter), member 3
Transporter
6
SLC22A4
solute carrier family 22 (organic cation transporter), 
member 4
Transporter
6
SLC22A5
solute carrier family 22 (organic cation transporter), 
member 5
Transporter
6
SLC22A7
solute carrier family 22 (organic anion transporter), 
member 7
Transporter
6
SLC22A9
solute carrier family 22 (organic anion/cation 
transporter), member 9
Transporter
6
SLC27A1
solute carrier family 27 (fatty acid transporter), 
member 1
Transporter
6
SLC28A1
solute carrier family 28 (sodium-coupled 
nucleoside transporter), member 1
Transporter
6
SLC28A2
solute carrier family 28 (sodium-coupled 
nucleoside transporter), member 2
Transporter
6
SLC28A3
solute carrier family 28 (sodium-coupled 
nucleoside transporter), member 3
Transporter
6
SLC29A1
solute carrier family 29 (nucleoside Transporter), 
member 1
Transporter
Protocol Amendment No.: 01
Date: 29-Mar-2023
118
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
6
SLC29A2
solute carrier family 29 (nucleoside Transporter), 
member 2
Transporter
6
SLC2A4
solute carrier family 2 (facilitated glucose 
transporter), member 4
Transporter
6
SLC2A5
solute carrier family 2 (facilitated glucose/fructose 
transporter), member 5
Transporter
6
SLC5A6
solute carrier family 5 (sodium-dependent vitamin 
transporter)
Transporter
6
SLC6A6
solute carrier family 6 (neurotransmitter 
transporter, taurine), member 6
Transporter
6
SLC7A8
solute carrier family 7 (cationic amino acid 
transporter, y+ system), member 8
Transporter
6
SLCO1C1
solute carrier organic anion transporter family, 
member 1C1
Transporter
6
SLCO2A1
solute carrier organic anion transporter family, 
member 2A1
Transporter
6
SLCO3A1
solute carrier organic anion transporter family, 
member 3A1
Transporter
6
SLCO4A1
solute carrier organic anion transporter family, 
member 4A1
Transporter
6
SLCO4C1
solute carrier organic anion transporter family, 
member 4C1
Transporter
6
SLCO5A1
solute carrier organic anion transporter family, 
member 5A1
Transporter
6
SLCO6A1
solute carrier organic anion transporter family, 
member 6A1
Transporter
6
SULT1C1
sulfotransferase family, cytosolic, 1C, member 1
Phase II
6
SULT1C2
sulfotransferase family, cytosolic, 1C, member 2
Phase II
6
SULT1E1
sulfotransferase family 1E, estrogen-preferring, 
member 1
Phase II
6
SULT2A1
sulfotransferase family, cytosolic, 2 A, DHEA 
preferring, member 1
Phase II
6
SULT2B1
sulfotransferase family, cytosolic, 2B, member 1
Phase II
6
TAP1
transporter 1, ATP-binding cassette, subfamily B 
(MDR/TAP)
Transporter
6
UGT1A10
UDP glucuronosyltransferase 1 family, polypeptide 
A10
Phase II
6
UGT1A4
UDP glucuronosyltransferase 1 family, polypeptide 
A4
Phase II
6
UGT1A5
UDP glucuronosyltransferase 1 family, polypeptide 
A5
Phase II
6
UGT2B10
UDP glucuronosyltransferase 2 family, polypeptide 
B10
Phase II
Protocol Amendment No.: 01
Date: 29-Mar-2023
119
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
5
ABCC13
ATP-binding cassette, subfamily C (CFTR/MRP), 
member 13
Transporter
5
ARSA
arylsulfatase A
Modifier
5
CAT
catalase
Modifier
5
CHST8
carbohydrate (N-acetylgalactosamine 4-0) 
sulfotransferase 8
Phase II
5
CYP19A1
cytochrome P450, family 19, subfamily A, 
polypeptide 1
Phase I
5
CYP26C1
cytochrome P450, family 26, subfamily C, 
polypeptide 1
Phase I
5
CYP27B1
cytochrome P450, family 27, subfamily B, 
polypeptide 1
Phase I
5
CYP2R1
cytochrome P450, family 2, subfamily R, 
polypeptide 1
Phase I
5
CYP2S1
cytochrome P450, family 2, subfamily S, 
polypeptide 1
Phase I
5
CYP46A1
cytochrome P450, family 46, subfamily A, 
polypeptide 1
Phase I
5
CYP4A11
cytochrome P450, family 4, subfamily A, 
polypeptide 11
Phase I
5
CYP4F12
cytochrome P450, family 4, subfamily F, 
polypeptide 12
Phase I
5
CYP4F2
cytochrome P450, family 4, subfamily F, 
polypeptide 2
Phase I
5
CYP4F3
cytochrome P450, family 4, subfamily F, 
polypeptide 3
Phase I
5
CYP4F8
cytochrome P450, family 4, subfamily F, 
polypeptide 8
Phase I
5
CYP4Z1
cytochrome P450, family 4, subfamily Z, 
polypeptide 1
Phase I
5
CYP7B1
cytochrome P450, family 7, subfamily B, 
polypeptide 1
Phase I
5
CYP8B1
cytochrome P450, family 8, subfamily B, 
polypeptide 1
Phase I
5
DHRS13
dehydrogenase/reductase (SDR family) member 13
Phase I
5
DHRS2
dehydrogenase/reductase (SDR family) member 2
Phase I
5
GPX1
glutathione peroxidase 1
Phase I
5
GPX4
glutathione peroxidase 4 (phospholipid 
hydroperoxidase)
Phase I
5
GPX5
glutathione peroxidase 5 (epididymal androgen-
related protein)
Phase I
5
GPX6
glutathione peroxidase 6 (olfactory)
Phase I
5
GSS
glutathione synthetase
Phase I
Protocol Amendment No.: 01
Date: 29-Mar-2023
120
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
5
GSTCD
glutathione S-transferase, C-terminal domain 
containing
Phase II
5
HNF4A
hepatocyte nuclear factor 4, alpha
Modifier
5
HNMT
histamine N-methyltransferase
Phase II
5
HSD11B1
hydroxysteroid (17-beta) dehydrogenase 11
Phase I
5
HSD17B11
hydroxysteroid (17-beta) dehydrogenase 11
Phase I
5
HSD17B14
hydroxysteroid (17-beta) dehydrogenase 14
Phase I
5
LOC731356
similar to dehydrogenase/reductase (SDR family) 
member 4 like 2
Phase I
5
MGST1
microsomal glutathione S-transferase 1
Phase II
5
MGST2
microsomal glutathione S-transferase 2
Phase II
5
MGST3
microsomal glutathione S-transferase 3
Phase II
5
MPO
myeloperoxidase
Modifier
5
NOS1
nitric oxide synthase 1 (neuronal)
Phase I
5
NOS2A
nitric oxide synthase 2 A (inducible, hepatocytes)
Phase I
5
NOS3
nitric oxide synthase 3 (endothelial cell)
Phase I
5
PPARA
peroxisome proliferator-activated receptor alpha
Modifier
5
SERPINA7
serpin peptidase inhibitor, clade A (alpha-1 
antiproteinase, antitrypsin), member 7
Modifier
5
SLC7A7
solute carrier family 7 (cationic amino acid 
transporter, y+ system), member 7
Transporter
5
SOD1
superoxide dismutase 1, soluble (amyotrophic 
lateral sclerosis 1 (adult))
Modifier
5
SOD2
superoxide dismutase 2, mitochondrial
Modifier
5
SOD3
superoxide dismutase 3, extracellular precursor
Modifier
5
SULF1
sulfatase 1
Phase I
5
SULT4A1
sulfotransferase family 4 A, member 1
Phase II
5
TAP2
transporter 2, ATP-binding cassette, subfamily B 
(MDR/TAP)
Transporter
5
UGT8
UDP glycosyltransferase 8 (UDP-galactose 
ceramide galactosyltransferase)
Phase II
5
XDH
xanthine dehydrogenase
Phase I
4
ADHFE1
alcohol dehydrogenase, iron containing, 1
Phase I
4
CHST1
carbohydrate (keratan sulfate Gal-6) 
sulfotransferase 1
Phase II
4
CHST10
carbohydrate sulfotransferase 10
Phase II
4
CHST11
carbohydrate (chondroitin 4) sulfotransferase 11
Phase II
4
CHST12
carbohydrate (chondroitin 4) sulfotransferase 12
Phase II
4
CHST13
carbohydrate (chondroitin 4) sulfotransferase 13
Phase II
4
CHST2
carbohydrate (N-acetylglucosamine-6-O) 
sulfotransferase 2
Phase II
Protocol Amendment No.: 01
Date: 29-Mar-2023
121
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
4
CHST3
carbohydrate (chondroitin 6) sulfotransferase 3
Phase II
4
CHST4
carbohydrate (N-acetylglucosamine 6-O) 
sulfotransferase 4
Phase II
4
CHST5
carbohydrate (N-acetylglucosamine 6-O) 
sulfotransferase 5
Phase II
4
CHST6
carbohydrate (N-acetylglucosamine 6-O)
sulfotransferase 6
Phase II
4
CHST7
carbohydrate (N-acetylglucosamine 6-O) 
sulfotransferase 7
Phase II
4
CHST9
carbohydrate (N-acetylgalactosamine 4-0) 
sulfotransferase 9
Phase II
4
CYP2D7P1
cytochrome P450, family 2, subfamily D, 
polypeptide 7 pseudogene 1
Phase I
4
DDO
D-aspartate oxidase
Phase I
4
DHRS1
dehydrogenase/reductase (SDR family) member 1
Phase I
4
DHRS12
dehydrogenase/reductase (SDR family) member 12
Phase I
4
DHRS3
dehydrogenase/reductase (SDR family) member 3
Phase I
4
DHRS4
dehydrogenase/reductase (SDR family) member 4
Phase I
4
DHRS4L1
dehydrogenase/reductase (SDR family) member 4 
like 1
Phase I
4
DHRS4L2
dehydrogenase/reductase (SDR family) member 4 
like 2
Phase I
4
DHRS7
dehydrogenase/reductase (SDR family) member 7
Phase I
4
DHRS7B
dehydrogenase/reductase (SDR family) member 7B
Phase I
4
DHRS7C
dehydrogenase/reductase (SDR family) member 7C
Phase I
4
DHRS9
dehydrogenase/reductase (SDR family) member 9
Phase I
4
DHRSX
dehydrogenase/reductase (SDR family) X-linked
Phase I
4
DPEP1
dipeptidase 1 (renal)
Phase I
4
FMO6P
flavin containing monooxygenase 6
Phase I
4
HAGH
hydroxyacylglutathione hydrolase
Phase I
4
IAPP
islet amyloid polypeptide
Modifier
4
KCNJ11
potassium inwardly-rectifying channel, subfamily J, 
member 11
Modifier
4
LOC728667
similar to dehydrogenase/reductase (SDR family) 
member 2 isoform 1
Phase I
4
LOC731931
similar to dehydrogenase/reductase (SDR family) 
member 2 isoform 1
Phase I
4
MAT1A
methionine adenosyltransferase I, alpha
Modifier
4
METAP1
methionyl aminopeptidase 1
Phase I
4
PDE3A
phosphodiesterase 3A, cGMP-inhibited
Phase I
4
PDE3B
phosphodiesterase 3B, cGMP-inhibited
Phase I
Protocol Amendment No.: 01
Date: 29-Mar-2023
122
2.0
Approved
930193109
2.0
v
Approved
1.0
v

Clinical Protocol
IM032041
BMS-986322
TYK2 inhibitor
Rank
Gene Symbol
Full Gene Name
Class
4
PLGLB1
plasminogen-like B1
Phase I
3
ATP7A
ATPase, Cu++ transporting, alpha polypeptide 
(Menkes syndrome)
Modifier
3
ATP7B
ATPase, Cu++ transporting, beta polypeptide
Modifier
3
CFTR
cystic fibrosis transmembrane conductance 
regulator
Modifier
Protocol Amendment No.: 01
Date: 29-Mar-2023
123
2.0
Approved
930193109
2.0
v
Approved
1.0
v