A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Phase: PHASE4
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
A Phase IV, Open-label, Single-group, Single-dose Study 
Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating 
Female Participants 
 
NCT Number: NCT06476834 
Document Date (Date in which document was last revised): 03 May 2024 
 
 
 

Page: 1 
Protocol Number: IM0111123 
Date: 03-May-2024 
CLINICAL PROTOCOL IM0111123 
A Phase IV, Open-label, Single-group, Single-dose Study 
Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating 
Female Participants 
Compound: BMS-986165 
Brief Title: Deucravacitinib Concentrations in the Breast Milk and Plasma of Lactating Females 
Medical Monitor Name and Contact Information:  
 
Clinical Trial Physician – Medical Monitor 
Bristol-Myers Squibb Company 
1000 Sierra Point Parkway 
Brisbane, CA 94005 
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 
Princeton, NJ 08543 
REGULATORY AGENCY IDENTIFIER NUMBER 
IND: 131,993 
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Date: 03-May-2024 
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This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company (BMS) and its global affiliates. By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS-sponsored 
study. Any permitted disclosures will be made only on a confidential “need to know” basis 
within your organization or to your Independent Ethics Committee(s). Any other use, 
copying, disclosure or dissemination of this information is strictly prohibited unless expressly 
authorized in writing by BMS. Any supplemental information (eg, amendments) that may 
be added to this document is also confidential and proprietary to BMS and must be kept in 
confidence in the same manner as the contents of this document. Any person who receives 
this document without due authorization from BMS is requested to return it to BMS or 
promptly destroy it. References to BMS in this protocol may apply to partners to which BMS 
has transferred obligations (eg, a Contract Research Organization).   
© 2023 Bristol-Myers Squibb Company 
 
 
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DOCUMENT HISTORY 
Document 
Date of Issue 
Summary of Changes 
Original Protocol 
03-May-2024 
Not applicable. 
 
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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
DOCUMENT HISTORY .................................................................................................................3 
TABLE OF CONTENTS .................................................................................................................4 
1 
PROTOCOL SUMMARY ............................................................................................7 
2 
SCHEDULE OF ACTIVITIES ..................................................................................10 
3 
INTRODUCTION ......................................................................................................17 
3.1 
Study Rationale ...........................................................................................................17 
3.2 
Background .................................................................................................................18 
3.2.1 
Reproductive and Developmental Toxicity and Lactation ..........................................18 
3.2.2 
Clinical Studies ...........................................................................................................18 
3.3 
Benefit/Risk Assessment ............................................................................................19 
3.3.1 
Risk Assessment ..........................................................................................................19 
3.3.2 
Benefit Assessment ......................................................................................................23 
3.3.3 
Overall General COVID-19-related Risk Mitigation Measures ................................23 
3.3.4 
Overall Benefit/Risk Conclusion .................................................................................23 
4 
OBJECTIVES AND ENDPOINTS ............................................................................24 
5 
STUDY DESIGN .......................................................................................................25 
5.1 
Overall Design ............................................................................................................25 
5.1.1 
Data Monitoring Committee and Other Committees ..................................................26 
5.2 
Number of Participants ...............................................................................................26 
5.3 
End of Study Definition ..............................................................................................26 
5.4 
Scientific Rationale for Study Design ........................................................................26 
............................................................27 
............................................................27 
6 
STUDY POPULATION .............................................................................................27 
6.1 
Inclusion Criteria ........................................................................................................27 
6.2 
Exclusion Criteria .......................................................................................................29 
6.3 
Lifestyle Restrictions ..................................................................................................31 
6.3.1 
Meals and Dietary Restrictions ..................................................................................32 
6.3.2 
Caffeine, Alcohol, and Tobacco ..................................................................................32 
6.3.3 
Activity ........................................................................................................................32 
6.4 
Screen Failures ............................................................................................................32 
6.4.1 
Re-testing During Screening .......................................................................................32 
7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ........................33 
7.1 
Study Interventions Administered ..............................................................................33 
7.2 
Assignment to Study Intervention ..............................................................................34 
7.3 
Blinding ......................................................................................................................34 
7.4 
Dosage Modification ..................................................................................................34 
7.5 
Preparation/Handling/Storage/Accountability ............................................................34 
7.6 
Study Intervention Compliance ..................................................................................35 
7.7 
Concomitant Therapy .................................................................................................35 
7.7.1 
Prohibited and/or Restricted Treatments ...................................................................35 
7.7.2 
Permitted Treatments ..................................................................................................36 
7.8 
Continued Access to Study Intervention After the End of the Study .........................36 
8 
DISCONTINUATION CRITERIA ............................................................................36 
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8.1 
Discontinuation of Study Intervention ........................................................................36 
8.1.1 
Study Stopping Criteria ..............................................................................................37 
8.1.2 
Post-study Intervention Study Follow-up ...................................................................37 
8.2 
Discontinuation From the Study .................................................................................37 
8.2.1 
Individual Discontinuation Criteria ...........................................................................38 
8.3 
Lost to Follow-up .......................................................................................................38 
9 
STUDY ASSESSMENTS AND PROCEDURES ......................................................39 
9.1 
Efficacy Assessments .................................................................................................39 
9.2 
Adverse Events ...........................................................................................................39 
9.2.1 
Period and Frequency for Collecting AE and SAE Information ................................39 
9.2.2 
Method of Detecting AEs and SAEs ............................................................................40 
9.2.3 
Follow-up of AEs and SAEs ........................................................................................40 
9.2.4 
Regulatory Reporting Requirements for SAEs ...........................................................40 
9.2.5 
Pregnancy ...................................................................................................................41 
9.2.6 
Laboratory Test Result Abnormalities ........................................................................41 
9.2.7 
Potential Drug-induced Liver Injury ..........................................................................41 
9.2.8 
Other Safety Considerations .......................................................................................42 
9.3 
Overdose .....................................................................................................................42 
9.4 
Safety ..........................................................................................................................42 
9.4.1 
Physical Examinations ................................................................................................42 
9.4.2 
Vital Signs ...................................................................................................................43 
9.4.3 
Electrocardiograms ....................................................................................................43 
9.4.4 
Clinical Safety Laboratory Assessments .....................................................................43 
9.4.5 
Breastfeeding Questionnaire ......................................................................................44 
9.4.6 
Instructions for Storage of Breast Milk ......................................................................44 
9.5 
Pharmacokinetics ........................................................................................................45 
9.5.1 
Milk and Plasma Collection and Processing ..............................................................45 
9.6 
Immunogenicity Assessments ....................................................................................46 
9.7 
Biomarkers ..................................................................................................................46 
 
 ...........................................................................................46 
9.9 
Other Assessments ......................................................................................................46 
9.10 
Health Economics OR Medical Resource Utilization and Health Economics ...........46 
10 
STATISTICAL CONSIDERATIONS .......................................................................47 
10.1 
Statistical Hypotheses .................................................................................................47 
10.2 
Sample Size Determination ........................................................................................47 
10.3 
Analysis Sets ...............................................................................................................47 
10.4 
Statistical Analyses .....................................................................................................47 
10.4.1 
General Considerations ..............................................................................................47 
10.4.2 
Primary Endpoint(s) ...................................................................................................48 
10.4.3 
Secondary Endpoint(s) ................................................................................................49 
 
 .............................................................................................50 
10.4.5 
Pharmacokinetic Analyses ..........................................................................................50 
 
 ............................................................................................................50 
10.5 
Interim Analyses .........................................................................................................50 
11 
REFERENCES ...........................................................................................................51 
12 
APPENDICES ............................................................................................................52 
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APPENDIX 1 
ABBREVIATIONS ............................................................................................53 
APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS ...............................................56 
APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING .......................................67 
APPENDIX 4 
INDIVIDUALS OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION .......................................................71 
APPENDIX 5 
BREASTFEEDING QUESTIONNAIRE… .......................................................75
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1 
PROTOCOL SUMMARY 
Protocol Title:  
A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib 
Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants 
Brief Title:  
Deucravacitinib Concentrations in the Breast Milk and Plasma of Females 
Rationale: 
A milk-only clinical study for deucravacitinib in lactating females 
 
 to assess the concentrations 
of deucravacitinib in breast milk. 
To date, no data are available on the presence of deucravacitinib in human milk. 
The purpose of this study is to determine the pharmacokinetics (PK) of deucravacitinib and its 
major active metabolite, BMT-153261, in the breast milk of healthy lactating female participants 
following a single oral administration of deucravacitinib. Knowledge of the PK of deucravacitinib 
and BMT-153261 in breast milk is relevant for potential exposure to breast fed infants and the 
appropriate labeling of the product for the treatment of plaque psoriasis and future approved 
indications.  
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
To assess the PK of deucravacitinib and its major 
active metabolite (BMT-153261) in breast milk of 
healthy lactating females 
• 
Milk Cmax 
• 
Milk Tmax 
• 
Milk AUC(0-24) 
• 
Milk AUC(INF) 
• 
Milk Cavg 
• 
Milk AR(24) 
• 
Milk AR 
• 
M/P 
To estimate dose in infants 
• 
Estimated daily infant dose 
• 
Relative infant dose 
Secondary 
To assess the PK of deucravacitinib and its major 
active metabolite (BMT-153261) in plasma of 
healthy lactating females  
• 
Plasma Cmax  
• 
Plasma AUC(INF) 
• 
Plasma AUC(0-24) 
• 
Plasma AUC(0-T) 
• 
Plasma Tmax 
• 
Plasma Cavg 
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Objectives 
Endpoints 
To evaluate the safety and tolerability of 
deucravacitinib and its major active metabolite 
(BMT-153261) in healthy lactating females 
• 
Incidence, 
severity, 
and 
relationship 
of 
treatment-emergent adverse events; and clinically 
significant changes in clinical laboratory tests 
(hematology and chemistry), vital signs, physical 
examinations, and electrocardiograms 
Abbreviations: AR, total amount recovered in milk; AR(24), amount recovered in milk within 24 hours of dosing; 
AUC(0-24), area under the plasma or milk concentration-time curve from time zero to 24 hours; AUC(0-T), area 
under the plasma concentration-time curve from time zero to time of last quantifiable concentration; AUC(INF), area 
under the plasma or milk concentration-time curve from time zero extrapolated to infinite time; Cavg, average plasma 
or milk concentration; Cmax, maximum observed plasma or milk concentration; M/P, milk-plasma ratio; PK, 
pharmacokinetics; Tmax, time of maximum observed plasma or milk concentration. 
Overall Design: 
This is an open-label, single-group, nonrandomized, single-dose, postmarketing study that will 
enroll healthy lactating adult female participants. 
• Participants will undergo screening evaluations to determine eligibility within 35 days prior to 
administration of study intervention. Participants will be offered consultations with a certified 
lactation consultant from screening until approximately 30 days post dose. 
• On Day -1, participants will be admitted to the clinical research unit (CRU) to ensure sufficient 
time to complete baseline assessments and to confirm eligibility as needed.  
• On Day 1, all participants will receive a single 9-mg oral dose of study intervention. Study 
assessments and procedures will be performed during the on-treatment period (Days 1 to 4). 
Milk and plasma samples will be collected up to 72 hours post dose for PK analysis.   
• On Day 4, participants will be discharged from the CRU following completion of the required 
study procedures. Participants can resume breastfeeding (or pumping milk for infant 
consumption) after CRU discharge (beginning 72 hours post dose).  
• On Day 10 (± 2 days) and Day 30 (± 2 days), the site staff will contact each participant via 
phone follow-up to inquire about concomitant medications and procedures, nonserious adverse 
events, and serious adverse events.  
Study Design Schema: 
 
Abbreviations: CRU, clinical research unit; PK, pharmacokinetic. 
 
Number of Participants: 
Approximately 8 healthy lactating female adult participants are planned to receive study 
intervention.  
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Study Population: 
Eligible participants must be 18 to 45 years of age, inclusive, have well-established lactation, and 
can produce stable breast milk product. Participants must be willing to exclusively pump breast 
milk for the 72-hour post-dose period of milk collection during CRU confinement, and not to 
breastfeed or provide milk to their infant until after CRU discharge (beginning 72 hours post dose). 
Study Duration and Study Intervention Duration: 
The approximate study duration will be up to 67 days (including a 35-day screening period, a 4-day 
treatment period, and safety follow-up phone calls on Day 10 [± 2 days] and Day 30 [± 2 days]). 
In addition, participants will be offered consultations with a certified lactation consultant from 
screening until approximately 30 days post dose.  
Study intervention will be administered as a single oral dose to all participants on Day 1. 
Study Intervention: 
Study Intervention 
Intervention Name 
Unit Dose Strength(s) 
IMP/ 
Non-IMP/AxMP  
Deucravacitinib tablet 
IMP 
Abbreviations: AxMP, Auxiliary Medicinal Product; IMP, Investigational Medicinal Product.  
 
Statistical Methods: 
No prospective hypotheses are being formally evaluated. 
 
 
Data Monitoring Committee: No  
A Data Monitoring Committee will not be used in the study. 
Other Committee: No  
Other review committees will not be used in the study.
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2 
SCHEDULE OF ACTIVITIES 
Study assessments and procedures for screening and on treatment are presented in Table 2-1 and 
Table 2-2. 
 
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Table 2-1: 
Screening Procedural Outline (IM0111123) 
Procedure 
Screening 
Notes 
Days -35 to -2 
Day -1 
CRU Visit 
X 
X 
Admission to CRU 
X 
Eligibility Assessments and Procedures 
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 
X 
Demography 
X 
Medical History 
X 
X 
Include any toxicities or allergies related to previous treatments. 
Include clinically significant findings from the PE. 
Gestational and Postpartum History 
X 
Includes maternal age at delivery, length of time postpartum, and stage of lactation. 
Breastfeeding Questionnaire 
X 
See Section 9.4.5 and Appendix 5. Includes previous experience with breastfeeding, 
frequency of breastfeeding, duration of breastfeeding, estimated volume of milk 
production, and use of formula supplementation. 
Smoking History 
X 
Record history for the past 6 months prior to screening. 
Provide Electric Milk Pump 
X 
X 
Site staff will provide instructions for use of milk pump and offer certified lactation 
consultation for additional guidance if needed. 
Offer Certified Lactation Consultation 
X 
X 
Verification of Breast Milk Expression 
X 
X 
To be done anytime during screening to determine if the participant can produce 
stable milk product (defined per Inclusion Criterion 2c [Section 6.1]). 
Provide Instructions for Storage of 
Breast Milk 
X 
See Section 9.4.6. Participants will be provided instructions on how to store their 
breast milk in order to ensure a sufficient supply of food for the infant (during the 
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Table 2-1: 
Screening Procedural Outline (IM0111123) 
Procedure 
Screening 
Notes 
Days -35 to -2 
Day -1 
time the participant must temporarily discontinue breastfeeding due to their study 
participation). 
Safety Assessments and Procedures 
Complete PE 
X 
 
Any clinically significant findings from the screening PE(s) will be recorded as 
medical history in the participant’s medical records and on the appropriate CRF. Refer 
to Section 9.4.1. 
Physical Measurements 
X 
X 
Includes height, weight, and BMI. Height and BMI will be measured at the first 
screening visit (Days -35 to -2) only.  
Vital Signs 
X 
X 
Includes oral or tympanic body temperature, respiratory rate, blood pressure, and heart 
rate. Blood pressure and heart rate should be measured after the participant has been 
resting quietly in the supine position for at least 5 min.  
Single 12-lead ECG 
X 
 
ECG should be recorded after the participant has been supine for at least 5 min. 
Prior and Concomitant Medications 
and Procedures 
X 
X 
Includes prescription, over-the-counter medications, vitamins, and herbal 
supplements.  
See Section 7.7 for prohibited and/or restricted treatments and permitted treatments. 
Laboratory Tests 
See Section 9.4.4 and Table 9.4.4-1 for a detailed list of clinical laboratory 
assessments. 
Clinical Laboratory Assessments: 
Hematology, Chemistry, and Urinalysis 
X 
X 
Participants are required to fast for at least 10 hours prior to the collection of 
specimens for clinical laboratory tests.  
Serum Pregnancy Test (All 
Participants) 
X 
X 
 
Serology 
X 
 
Includes hepatitis C antibody, hepatitis B surface antigen, and HIV-1 and HIV-2 
antibody. 
Drugs of Abuse Test (Urine)  
X 
X 
Screen for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, 
and cannabinoids. 
Cotinine Test (Urine) 
X 
X 
Screen for smoking. 
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Table 2-1: 
Screening Procedural Outline (IM0111123) 
Procedure 
Screening 
Notes 
Days -35 to -2 
Day -1 
Alcohol Test (Urine or Breath) 
X 
X 
 
QuantiFERON® TB Gold Plus Test or 
equivalent 
X 
 
A documented negative result within 1 month prior to Day -1 from a healthcare 
provider/facility is acceptable.  
AE Reporting 
Monitor for Nonserious and Serious 
AEs 
X 
X 
All AEs and SAEs must be collected from the date of the participant’s written consent 
during screening. See Section 9.2.1 for further details. 
Abbreviations: AE, adverse event; BMI, body mass index; CRF, Case Report Form; CRU, clinical research unit; ECG, electrocardiogram; HIV, human 
immunodeficiency virus; min, minute(s); PE, physical examination; SAE, serious adverse event; TB, tuberculosis.  
 
 
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Table 2-2: 
On-treatment Procedural Outline (IM0111123) 
Procedure 
Day 1 
(Predose) 
Day 1 
Day 2 
Day 3 
Day 4/ 
Early 
Termination 
Day 10 
±2 days 
Follow-up 
Day 30  
±2 days 
Follow-up 
Notes 
Confinement in CRU 
X 
X 
X 
X 
X 
 
 
 
Discharge from CRU 
 
 
 
 
X 
 
 
 
Phone Call 
 
 
 
 
 
X 
X 
 
Safety Assessments and Procedures 
Complete PE 
 
 
 
 
X 
 
 
Refer to Section 9.4.1. 
Targeted PE 
X 
 
 
 
 
 
 
Refer to Section 9.4.1. 
Vital Signs 
X 
X 
 
 
X 
 
 
Refer to VS in Table 2-1 for details. 
On Day 1, VS will be conducted at 
predose (up to 90 min prior to dosing), 
approximately 2 hours post dose, and 
prior to discharge on Day 4/ET. 
Single 12-lead ECG 
X 
 
 
 
X 
 
 
ECG should be recorded after the 
participant has been supine for at least 
5 min. On Day 1, ECG will be 
conducted at predose (up to 90 min 
prior to dosing) and prior to discharge 
on Day 4/ET. 
Concomitant Medications 
and Procedures 
X 
X 
X 
X 
X 
X 
X 
Refer to Section 7.7 for prohibited 
and/or restricted treatments. 
Offer Certified Lactation 
Consultation 
X 
X 
X 
X 
X 
X 
X 
Lactation consultation will be available 
for approximately 30 days post dose 
(Section 9.4.6). 
Breastfeeding 
Questionnaire 
 
 
 
 
 
X 
 
See Section 9.4.5 and Appendix 5. 
Includes participant-reported effects on 
milk production before (ie, screening) 
and after discontinuation (ie, CRU 
discharge) of study intervention. 
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Table 2-2: 
On-treatment Procedural Outline (IM0111123) 
Procedure 
Day 1 
(Predose) 
Day 1 
Day 2 
Day 3 
Day 4/ 
Early 
Termination 
Day 10 
±2 days 
Follow-up 
Day 30  
±2 days 
Follow-up 
Notes 
AE Reporting 
Monitor for Nonserious 
and Serious AEs 
X 
X 
X 
X 
X 
X 
X 
All AEs and SAEs must be collected 
from the date of participant’s written 
consent until 30 days post dose (or 
until ET, if the participant was not 
dosed). 
Laboratory Tests 
See Section 9.4.4 and Table 9.4.4-1 for 
a detailed list of clinical laboratory 
assessments. 
Clinical Laboratory 
Assessments: 
Hematology, Chemistry, 
and Urinalysis 
 
 
X 
 
X 
 
 
Participants are required to fast for at 
least 10 hours prior to the collection of 
specimens for clinical laboratory tests. 
Serum Pregnancy Test (All 
Participants) 
 
 
 
 
X 
 
 
 
PK Assessments 
PK Milk and Plasma 
Collections 
. 
Refer to Section 9.5.1 for details. 
Study Intervention 
Administer 
Deucravacitinib 
 
X 
 
 
 
 
 
 
Abbreviations: AE, adverse event; CRU, clinical research unit; ECG, electrocardiogram; ET, early termination; min, minute(s); PE, physical examination; PK, 
pharmacokinetic; SAE, serious adverse event; VS, vital signs.  
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In the event that multiple procedures are required at a single post-dose time point, the following is 
the order in which the procedures should be performed to ensure that the pharmacokinetic (PK) 
samples are collected as close as possible to the nominal time point: 
• Safety (vital signs measurements) 
• Safety (single 12-lead electrocardiogram [ECG]) 
• PK sampling 
• Safety (clinical laboratory tests) 
 
Note: Safety assessments in response to adverse events (AEs) are not impacted by this priority list.  
 
 For more 
information, refer to Section 9.5: Pharmacokinetics. Further details of milk and plasma sample 
collection, processing, and shipping will be provided to the site in the laboratory/procedure 
manual. 
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3 
INTRODUCTION 
Deucravacitinib (BMS-986165) is an inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member 
of the Janus kinase (JAK) family. Deucravacitinib binds to the regulatory domain of TYK2, 
stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the 
enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its 
downstream activation of signal transducers and activators of transcription (STATs). JAK kinases, 
including TYK2, function as pairs of homo- or heterodimers in the JAK-STAT pathways. 
TYK2-dependent receptors (eg, receptors for Type I interferons [IFNs], interleukin [IL]-10, IL-12, 
IL-23) are distinct from those highly dependent on JAK1/JAK3 (eg, receptors for IL-2, IL-15, 
IL-6) or JAK2 (eg, erythropoietin, thrombopoietin, granulocyte macrophage colony-stimulating 
factor); a TYK2 inhibitor would be expected to have a highly differentiated profile from inhibitors 
of other JAK family kinases. The TYK2-dependent pathways and the cytokine networks they 
modulate (eg, IL-17, IL-22, IFNγ) have been implicated in the pathophysiology of multiple 
immune-mediated diseases including psoriasis, lupus, spondyloarthritides, dermatomyositis, and 
Type I interferonopathies.  
Deucravacitinib is approved by the United States (US) Food and Drug Administration (FDA) for 
the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic 
therapy or phototherapy. Deucravacitinib is also being developed as an oral treatment for other 
inflammatory diseases such as psoriatic arthritis and systemic lupus erythematosus.1 
3.1 
Study Rationale 
Psoriasis is a chronic inflammatory skin disorder, characterized primarily by erythematous scaly 
plaques, that affects up to 3% of the general population. In the US adult population, it is estimated 
that more than 7.5 million adults 20 years or older have psoriasis. This suggest that psoriasis 
remains one of the most common immune-mediated diseases affecting US adults.2 Men and 
women are equally affected, and it can present at any age.3,4 Several studies have observed a 
bimodal distribution of psoriasis onset, with the first peak ranging from 15 to 22 years of age and 
the second peak ranging from 55 to 60 years of age.5,6,7  
Roughly 50% of patients with psoriasis are women, and in more than 75% of cases, onset of 
psoriasis occurs at 40 years or younger, indicating many patients will be affected during their 
reproductive years.8,9  It is anticipated that deucravacitinib will be administered to lactating 
females of reproductive age in clinical practice. 
A milk-only clinical study for deucravacitinib in lactating females 
 
 to assess the concentrations of deucravacitinib in breast milk. 
To date, no data are available on the presence of deucravacitinib in human milk. 
The purpose of this study is to determine the PK of deucravacitinib and its major active metabolite, 
BMT-153261, in the breast milk of healthy lactating female participants following a single oral 
administration of deucravacitinib. Breastfeeding (or providing milk for infant consumption) will 
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be discontinued from dosing through 72 hours post dose (CRU discharge) so that the participants’ 
infants are not exposed to deucravacitinib. 
Knowledge of the PK of deucravacitinib and its major active metabolite BMT-153261 in breast 
milk is relevant for potential exposure to breast fed infants and the appropriate labeling of the 
product for the treatment of plaque psoriasis and future approved indications. 
3.2 
Background 
A detailed description of the chemistry, pharmacology, efficacy, and safety of deucravacitinib 
from nonclinical and clinical studies is provided in the Investigator’s Brochure (IB)10 and package 
insert.1 
3.2.1 
Reproductive and Developmental Toxicity and Lactation 
Deucravacitinib was administered orally during the period of organogenesis at doses of 5, 15, or 
75 mg/kg/day in rats and 1, 3, or 10 mg/kg/day in rabbits. Deucravacitinib was neither 
embryolethal nor teratogenic at the highest doses tested in either species. These doses resulted in 
maternal exposures (area under the concentration-time curve [AUC]) that were approximately 
266 times (rat) or 91 times (rabbit) the exposure at the recommended human dose. 
In a pre- and post-natal development study in rats, deucravacitinib was administered from 
Gestation Day 6 through Lactation Day 20, at doses of 5, 15, or 50 mg/kg/day. At 50 mg/kg/day, 
pup body weights were reduced, relative to control values, during the preweaning period; during 
postweaning, their weights caught up and were comparable to those in control offspring by 
Postnatal Days 73 or 35 in males and females, respectively. There were no additional adverse 
findings in the F1 offspring, nor in F2 intrauterine survival. Maternal exposures at 50 mg/kg/day 
were approximately 110 times the recommended human dose.  
A single oral dose of 5 mg/kg radiolabeled deucravacitinib was administered to lactating 
(Postpartum Days 8 to 12) rats. Deucravacitinib and/or its metabolites were present in the milk of 
lactating rats, with milk-to-plasma concentration ratios of 2.7 (at 0.5 hours post dose) to 30.9 (at 
12 hours post dose), then declining to 16.6 (at 24 hours post dose). Concentrations of radioactivity 
in milk were below the limit of quantitation after 48 hours post dose.11 
3.2.2 
Clinical Studies 
The clinical development program for deucravacitinib as of 22-May-2023 consists of studies in 
healthy participants, participants with renal or hepatic insufficiency, and participants with 
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psoriasis, psoriatic arthritis, discoid lupus erythematosus/subacute cutaneous lupus erythematosus, 
systemic lupus erythematosus, lupus nephritis, and alopecia areata. 
In healthy participants, there are 27 completed Phase 1 studies of deucravacitinib. Details for these 
studies are provided in the IB.10 
3.3 
Benefit/Risk Assessment 
Because this study will enroll healthy participants and not patients, there is no direct benefit to 
participants except for a baseline assessment of their health. Deucravacitinib had an overall 
acceptable safety profile when investigated in Study IM011002 with healthy participants at single 
doses up to 40 mg and multiple doses up to 24 mg/day (12 mg twice daily) for 14 days. 
The most common drug-related AE in healthy participants was acneiform skin reactions, which 
were observed at higher doses across Phase 1 studies with deucravacitinib. They appeared to be 
dose related with the highest incidence at the 12 mg twice daily dose (24 mg/day). These reactions 
were mild or moderate, nonserious, reversible, and managed with topical treatment when required. 
All events requiring treatment responded appropriately and rarely resulted in discontinuation of 
study intervention. There were no signs or symptoms of circulatory or respiratory impairment and 
no suggestion of systemic hypersensitivity associated with skin reactions. 
To mitigate and monitor for potential risk of immunomodulatory effects of TYK2 inhibition during 
the study, the exclusion criteria have been designed to prevent potential participants at risk for 
infection from participating, and participants will be monitored in clinic for a 4-day washout period 
prior to discharge from the clinical research unit (CRU). 
More detailed information about the known and expected benefits and risks and reasonably 
anticipated AEs of deucravacitinib may be found in the IB10 and package insert4. 
3.3.1 
Risk Assessment 
Table 3.3.1-1: 
Risk Assessment 
Potential Risk of 
Clinical Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention: deucravacitinib 
Exposure of infants to 
deucravacitinib due to 
excretion of 
deucravacitinib into 
breast milk 
IB Sections 7.3.3  
SOTYKTU® USPI Section 8.2 
Breastfeeding (or providing milk for infant 
consumption) will be discontinued from 
dosing through 72 hours post dose until 
CRU discharge (72 hours post dose) so 
that infants are exposed to a minimal 
amount of deucravacitinib. 
Hypersensitivity 
IB Section 7.1.2.3, 
SOTYKTU® USPI Section 5.1 
Participants with a history of allergy to 
deucravacitinib (or related compounds) or 
of any significant drug allergy will be 
excluded. 
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Table 3.3.1-1: 
Risk Assessment 
Potential Risk of 
Clinical Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Skin events 
IB Sections 7.1 and 7.1.2.3 
The totality of the clinical data shows 
that treatment with deucravacitinib is 
associated with folliculitis and acne. 
These skin events were not severe or 
serious, resolved spontaneously or with 
topical or oral antimicrobial treatments, 
and rarely led to treatment 
discontinuation. The events appeared to 
be dose related, with the highest 
incidence at the 12-mg dose twice daily.  
Participants will be administered a single 
dose of 9 mg deucravacitinib only and will 
be monitored for any skin-related AEs that 
develop. 
Malignancy 
IB Section 7.1.2.2, 
SOTYKTU® USPI Section 5.4 
Based on the available clinical data and 
the relevant epidemiology for 
malignancy and specifically lymphoma, 
there does not appear to be a clear 
association with deucravacitinib 
exposure. However, the potential role of 
deucravacitinib in the development of 
malignancies is unknown and will 
continue to be monitored in studies with 
deucravacitinib. 
Participants will be administered a single 
dose of 9 mg deucravacitinib only and will 
be monitored for any malignancy-related 
AEs that develop. 
Participants with a known malignancy will 
be excluded. 
Infection 
IB Section 7.1.2.1,  
SOTYKTU® USPI Sections 2.1, 5.2, and 
5.3 
Based on its mechanism of action, 
deucravacitinib may increase the risk of 
infections, yet broad immunosuppressive 
effects are not expected. 
The study has been designed with 
exclusion criteria aimed at minimizing the 
risk for serious and acute infections. 
Excluding participants with the following: 
• 
Active herpes infection  
• 
Clinically significant history or known 
presence of acute, recurrent, or 
chronic bacterial, fungal, or viral 
infection  
• 
History or risk for tuberculosis  
• 
Positive screen for hepatitis C 
antibody, hepatitis B surface antigen, 
or HIV-1 and HIV-2 antibody 
Participants will be domiciled up to 
72 hours post dose to allow for close 
monitoring of participants’ safety 
throughout the duration of the study.  
Participants will be evaluated for 
tuberculosis prior to study drug 
intervention. 
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Table 3.3.1-1: 
Risk Assessment 
Potential Risk of 
Clinical Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Cardiovascular risk 
IB Section 7.1.2.4 
SOTYKTU® USPI Section 5.8 
Excluding participants with the following: 
• 
Presence or history of any clinically 
relevant abnormality, condition, or 
disease (such as cardiovascular or 
pulmonary diseases) which places the 
participant at an unacceptable risk if 
participating in the study  
• 
Any of the following on 12-lead ECG 
prior to study intervention 
administration, confirmed by repeat: 
PR ≥ 210 msec, QRS ≥ 120 msec, 
QT ≥ 500 msec, QTcF ≥ 470 msec.  
• 
Persistent or intermittent complete 
bundle branch block, incomplete 
bundle branch block, or 
intraventricular conduction delay with 
QRS > 120 msec  
• 
Clinically significant vital signs 
examination results outside the normal 
reference range prior to study 
intervention administration, confirmed 
by repeat. 
Rhabdomyolysis and 
elevated creatine 
phosphokinase 
IB Section 7.1.3,  
SOTYKTU® USPI Section 5.5 
Participants are instructed to refrain from 
strenuous exercise and contact sports from 
at least 2 days prior to Day -1 until CRU 
discharge. 
Liver injury 
SOTYKTU® USPI Section 5.6 
Excluding participants with the following: 
• 
Presence or history of any clinically 
relevant abnormality, condition, or 
disease (such as liver disease or 
abnormal liver function tests) which 
places the participant at an 
unacceptable risk if participating in 
the study  
• 
History of biliary disorders, including 
Gilbert’s syndrome or Dubin-Johnson 
disease. 
Renal injury 
SOTYKTU® USPI Section 6.1 
Requiring that participants have normal 
renal function at screening.  
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Table 3.3.1-1: 
Risk Assessment 
Potential Risk of 
Clinical Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Fetal risk 
IB Section 7.3.2,  
SOTYKTU® USPI Section 8.1 
Excluding individuals who are pregnant, 
are planning to become pregnant during 
the course of the study, or are of 
childbearing potential and not using an 
effective contraceptive method.  
Pregnancy testing throughout the study. 
Drug-drug interaction 
with broader 
transporter/enzyme 
inducers/inhibitors 
IB Section 7.3.1, 
SOTYKTU® USPI Section 12.1 
Dedicated drug interaction studies 
confirmed that deucravacitinib does not 
have clinically meaningful impact on the 
exposure of coadministered drugs. No 
drug interactions are anticipated with 
substrates of major CYPs, UGTs, or 
transporters. Coadministered drugs do 
not have a clinically meaningful effect 
on deucravacitinib exposure. 
Restricting consumption of any nutrients 
or food products known to modulate 
CYP450 enzyme activity (eg, grapefruit or 
grapefruit juice, pomelo juice, star fruit, or 
Seville [blood] orange products).  
Excluding current smokers, as well as 
those who have stopped smoking less than 
6 months prior to administration of study 
intervention. 
Other 
Immunizations 
SOTYKTU® USPI Section 5.7 
Receipt of any live vaccinations is 
prohibited within 60 days before 
screening, while on study, and for 30 days 
after last study intervention administration. 
Coronavirus disease 
2019 (COVID-19)-
associated risks  
The ongoing COVID-19 pandemic is a 
risk that needs to be considered by the 
site investigator. Based on its mechanism 
of action, deucravacitinib may increase 
the risk of infections, including 
COVID-19.  
Participants with recent acute infection 
with SARS-CoV-2 are excluded in this 
clinical trial.  
Local measures at the CRU to limit the 
risk of infection with SARS-CoV-2, as 
applicable. 
Early Cessation of 
Breastfeeding 
The interruption of breastfeeding for the 
study may inadvertently contribute to 
early cessation of breastfeeding.  
A certified lactation consultant will be 
available for consultations from screening 
throughout the participant’s study 
participation (up until approximately 
30 days post dose) in order to support the 
participant’s breastfeeding routine and 
return to breastfeeding after study 
completion. 
Informed consent form will detail the risks 
and benefits of breastfeeding. 
Participants will be provided instructions 
at screening on how to store their breast 
milk in order to ensure a sufficient supply 
of food for the infant during the time the 
participant must temporarily discontinue 
breastfeeding. 
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Table 3.3.1-1: 
Risk Assessment 
Potential Risk of 
Clinical Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Procedures 
ECG: Application of 
electrodes  
Adhesive electrodes placed on 
participants’ chests and limbs during 
ECG procedures may cause some local 
irritation and may be uncomfortable to 
remove. 
Participants will be closely monitored by 
site personnel and action may be taken to 
ensure any local irritation does not persist. 
Blood sample 
collection 
Collecting a blood sample from a vein 
may cause pain, bruising, swelling, light 
headedness, fainting, and very rarely clot 
formation, nerve damage, and/or 
infection at the site of the needle stick.  
Participants will be closely monitored by 
site personnel during and after blood 
draws.  
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; CRU, clinical research unit; CYP, 
cytochrome P450; ECG, electrocardiogram; HIV, human immunodeficiency virus; IB, Investigator’s Brochure; QTcF, 
QT interval corrected for heart rate using Fridericia’s formula; SARS-CoV-2, severe acute respiratory syndrome 
coronavirus-2; UGT, uridine diphosphate glucuronosyltransferase; USPI, United States prescribing information.  
3.3.2 
Benefit Assessment 
This study will provide data for future lactating females treated with deucravacitinib who decide 
to provide breast milk to their infants.  
3.3.3 
Overall General COVID-19-related Risk Mitigation Measures 
General risk mitigation against COVID-19 will be implemented in accordance with the 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 severe acute respiratory syndrome 
coronavirus-2 (SARS-CoV-2) amongst site staff and participants, and may include distancing, 
sanitization, testing, and the use of personal protective equipment. The risk mitigation measures 
are part of the site’s generic informed consent and, when and where applicable, will be amended 
based on emerging guidance. The informed consent form (ICF) and any other documentation 
regarding these general measures are independent of this protocol and will be entered into this 
study’s trial master file if used for participants in this study. 
3.3.4 
Overall Benefit/Risk Conclusion 
Given the safety and tolerability profile of deucravacitinib, a single dose of the study intervention 
is deemed to be safe and well tolerated in healthy populations. The overall risk to the participants 
in this study is deemed to be low and acceptable. Therefore, the Sponsor considers that it is 
medically acceptable to conduct a study of the PK of deucravacitinib in the breast milk of healthy 
lactating females to determine whether deucravacitinib can be safely taken by lactating females. 
The Sponsor will evaluate the benefit/risk profile of the study on an ongoing basis. This evaluation 
will be based on all available data, with particular attention to (i) AEs or other safety trends in this 
or any other clinical study of deucravacitinib whose character, severity, and/or frequency suggest 
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that participants would be exposed to an unreasonable and significant risk of illness or injury; 
(ii) new nonclinical data suggesting unreasonable and significant risk of illness or injury. 
If such evaluation suggests that the benefit/risk profile of the study has become unfavorable to 
participants, the Sponsor will pause enrollment and/or treatment until further evaluation of data, 
and interaction with the appropriate Health Authority(ies) can take place on potential actions. Such 
actions may include (but are not limited to) study continuation, substantial amendment, or 
termination of the study. 
4 
OBJECTIVES AND ENDPOINTS 
Table 4-1: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To assess the PK of deucravacitinib and its major 
active metabolite (BMT-153261) in breast milk of 
healthy lactating females  
• 
Milk Cmax 
• 
Milk Tmax 
• 
Milk AUC(0-24)  
• 
Milk AUC(INF) 
• 
Milk Cavg 
• 
Milk AR(24) 
• 
Milk AR 
• 
M/P 
To estimate dose in infants 
• 
Estimated daily infant dose 
• 
Relative infant dose 
Secondary 
To assess the PK of deucravacitinib and its major 
active metabolite (BMT-153261) in plasma of 
healthy lactating females 
• 
Plasma Cmax  
• 
Plasma AUC(INF) 
• 
Plasma AUC(0-24) 
• 
Plasma AUC(0-T) 
• 
Plasma Tmax 
• 
Plasma Cavg 
To evaluate the safety and tolerability of 
deucravacitinib and its major active metabolite 
(BMT-153261) in healthy lactating females 
• 
Incidence, severity, and relationship of TEAEs; and 
clinically significant changes in clinical laboratory tests 
(hematology and chemistry), vital signs, physical 
examinations, and ECGs 
Abbreviations: AR, total amount recovered in milk; AR(24), amount recovered in milk within 24 hours of dosing; 
AUC(0-24), area under the plasma or milk concentration-time curve from time zero to 24 hours; AUC(0-T), area 
under the plasma concentration-time curve from time zero to time of last quantifiable concentration; AUC(INF), area 
under the plasma or milk concentration-time curve from time zero extrapolated to infinite time; Cavg, average plasma 
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or milk concentration; Cmax, maximum observed plasma or milk concentration; ECG, electrocardiogram; 
 
; M/P, milk-plasma ratio; PK, pharmacokinetics; TEAE, treatment-emergent adverse event; Tmax, 
time of maximum observed plasma or milk concentration. 
5 
STUDY DESIGN 
5.1 
Overall Design 
This is an open-label, single-group, nonrandomized, single-dose, postmarketing study that will 
enroll healthy lactating adult female participants. 
Participants will undergo screening evaluations to determine eligibility within 35 days prior to 
administration of study intervention. Screening assessments to determine eligibility are shown in 
Table 2-1. Participants may be rescreened once (refer to Section 6.4.1). Participants will be offered 
consultations with a certified lactation consultant from screening until approximately 30 days post 
dose. 
On Day -1, participants will be admitted to the CRU to ensure sufficient time to complete baseline 
assessments and to confirm eligibility as needed.  
On Day 1, all participants will receive a single 9-mg oral dose of study intervention. Study 
assessments and procedures that will be performed during the on-treatment period (Days 1 to 4) 
are shown in Table 2-2. Milk and plasma samples will be collected up to 72 hours post dose for 
PK analysis. Less than 500 mL of blood will be drawn from each participant during the study. 
During the domiciling period at the CRU, mother-infant visits will be provided as needed on a 
case-by-case basis. The visits will be supervised by the site staff to ensure that no breastfeeding 
takes place during the visits. 
On Day 4, participants will be discharged from the CRU following completion of the required 
study procedures. Participants can resume breastfeeding (or pumping milk for infant consumption) 
after CRU discharge (beginning 72 hours post dose).  
On Day 10 (± 2 days) and Day 30 (± 2 days), the site staff will contact each participant via phone 
follow-up to inquire about concomitant medications and procedures, nonserious AEs, and serious 
AEs (SAEs). 
The total study duration will be up to approximately 67 days (including a 35-day screening period, 
a 4-day treatment period, and safety follow-up phone calls on Day 10 [± 2 days] and Day 30 
[± 2 days]). In addition, participants will be offered a certified lactation consultant from screening 
until approximately 30 days post dose.   
The study design schema is presented in Figure 5.1-1. 
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Figure 5.1-1: 
Study Design Schema 
 
Abbreviations: CRU, clinical research unit; PK, pharmacokinetic. 
5.1.1 
Data Monitoring Committee and Other Committees 
A Data Monitoring Committee or other review committee will not be used in the study.   
5.2 
Number of Participants 
Approximately 8 healthy lactating female adult participants are planned to receive study 
intervention. 
 
 
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 she has completed the last procedure 
shown in the Schedule of Activities. 
5.4 
Scientific Rationale for Study Design 
This study aims to determine the PK of deucravacitinib and its major active metabolite, 
BMT-153261, in breast milk in healthy lactating female participants following a single oral 
administration of deucravacitinib.  
An open-label study design is appropriate since the primary endpoint (PK of deucravacitinib and 
BMT-153261 in milk) is objective. 
Deucravacitinib was studied in multiple animal studies and clinical studies. Deucravacitinib was 
safe in multiple studies in healthy participants at single doses up to 40 mg and multiple doses up 
to 24 mg/day for up to 14 days. Further, the PK of deucravacitinib and its active metabolite, 
BMT-153261, were comparable between healthy participants and participants with psoriasis. 
Population PK indicated comparable clearance (11.3 L/h vs 10.0 L/h) and volume of central 
compartment in multi-compartment model (90.2 L vs 108 L) in healthy participants and 
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participants with psoriasis, respectively. Therefore, it is appropriate to enroll healthy lactating 
female participants in this study.  
PK samples of milk and plasma will be collected predose and post dose up to 72 hours. Although 
the half-life (T-HALF) of deucravacitinib is approximately 
 and it is expected that all 
deucravacitinib would be cleared within 5× T-HALF (approximately 
, or sooner due to 
the milk expression), this study will collect samples up to 72 hours post dose. This extra caution 
will ensure that a minimum amount of deucravacitinib is left in the body at the time of discharge.  
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 
Participants must have signed and dated an IRB/IEC-approved written ICF in accordance with 
regulatory, local, and institutional guidelines. This must be obtained before the performance 
of any protocol-related procedures that are not part of normal patient care. 
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2) Type of Participant and Target Disease Characteristics 
a) Healthy female participants without, in the opinion of the investigator, clinically significant 
deviation from normal in medical history, physical examination, ECGs, vital signs, and 
clinical laboratory determinations. 
b) Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg 
(110 lb), at screening. Given participants are postpartum, BMI accommodation up to 
35.0 kg/m2 may be expected. 
c) Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk 
product (ie, approximately 3 oz per 3 hours at screening) using the methods required for 
the study. 
Note: Lactating participants who are planning to wean their infants independent of study 
participation will be allowed to participate in the study, provided that these participants 
have not yet started the process of weaning and will maintain an adequate supply of breast 
milk by breastfeeding and/or pumping prior to study intervention administration.  
d) Is willing to exclusively pump breast milk for the 72-hour post dose period of milk 
collection during CRU confinement, and not to breastfeed or provide milk to infant until 
after CRU discharge (72 hours post dose). 
3) Age of Participant  
Participant must be 18 to 45 years of age, inclusive, at the time of signing the ICF. 
4) Reproductive Status 
• The investigator or designee shall counsel individuals of childbearing potential (IOCBPs) 
participants (as defined in Appendix 4) (as assigned at birth) on the importance of pregnancy 
prevention and the implications of an unexpected pregnancy. 
• The investigator or designee 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 (as assigned at birth) participants: 
i) IOCBP 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 administration of study intervention. 
• Additional requirements for pregnancy testing during and after study intervention are 
in the Schedule of Activities in Section 2. 
• 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. 
ii) IOCBP must agree to follow instructions for method(s) of contraception as described 
below and included in the ICF. 
• IOCBP are permitted to use hormonal contraception methods (as described in 
Appendix 4). 
iii) A female participant (as assigned at birth) is eligible to participate if she is not pregnant, 
and at least 1 of the following conditions applies: 
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(1) Is not a IOCBP  
OR 
(2) Is a IOCBP and using a contraceptive method as described in Appendix 4 during 
the intervention period (at a minimum until 3 days after the last dose of study 
intervention). 
6.2 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1) Medical Conditions 
a) Presence or history of any clinically relevant abnormality, condition, or disease (such as 
liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) 
that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or 
elimination of the study intervention, that would prevent the participant from participating 
in the study, or which places the participant at unacceptable risk if she were to participate 
in the study. 
b) Current or recent (within 3 months of study intervention administration) clinically 
significant gastrointestinal disease that, in the opinion of the investigator, could impact 
upon the absorption of study intervention. 
c) Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which 
are considered clinically significant by the investigator and/or, in the investigator’s 
opinion, may significantly impact breastfeeding or collection of milk from one or both 
breasts. 
d) History of biliary disorders, including Gilbert’s syndrome or Dubin-Johnson disease, 
except for isolated gallbladder issues, which are not by themselves exclusionary. 
e) Active herpes infection, including herpes simplex 1 and 2, or herpes zoster. 
f) Clinically significant history or known presence of acute, recurrent, or chronic bacterial, 
fungal, or viral infection (eg, pneumonia, septicemia) within 3 months prior to screening. 
For nonsevere upper respiratory viral infection associated with cold season (ie, the common 
cold), participants will only be excluded if it has occurred within 1 month prior to screening 
or is present at screening (a history of recurrent urinary tract infections is not exclusionary; 
however, infection must not be present at screening). 
g) Any history or risk for tuberculosis (TB), specifically participants with: 
i) current clinical, radiographic, or laboratory evidence of active TB. 
ii) history of active TB unless there is documentation that the prior anti-TB treatment was 
appropriate in duration and type. 
iii) latent TB that has not been successfully treated; a QuantiFERON Gold Plus test or 
equivalent at screening or within 1 month prior to Day -1 from a healthcare 
provider/facility is acceptable as long as there is documentation of a negative result. 
h) Known malignancy. 
i) Any clinically significant symptoms of coronavirus disease 2019 (COVID-19) in the last 
4 weeks, including, but not limited to, fever, new and persistent cough, breathlessness, or 
loss of taste or smell, as per the judgement of the investigator. 
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2) Reproductive Status 
a) Individuals who are pregnant, are planning to become pregnant during the course of the 
study, or are of childbearing potential and not using an effective contraceptive method. 
3) Prior/Concomitant Therapy 
a) Prior exposure to deucravacitinib, JAK inhibitors, or related compounds.  
b) Exposure to any investigational drug or placebo within 4 weeks or 5 half-lives (if known), 
whichever is longer, prior to study intervention administration.  
c) Use of any prescription drugs or over-the-counter acid controllers within 4 weeks or 
5 half-lives (if known), whichever is longer, prior to study intervention administration, 
except those medications cleared by the Sponsor Medical Monitor. 
d) Use of any other drugs, including over-the-counter medications and herbal preparations, 
within 1 week prior to study intervention administration, except those medications cleared 
by the Sponsor Medical Monitor. 
e) Receipt of any vaccination or plans for vaccination with any live vaccine within 60 days 
before screening, during the course of the study, or 30 days after last study intervention 
administration. The use of inactivated seasonal influenza vaccines (eg, Fluzone®) and 
non-live COVID-19 vaccines will be permitted on the study without restriction.  
f) Inability to comply with restrictions and prohibited treatments as listed in Section 7.7. 
4) Physical and Laboratory Test Findings 
a) Evidence of organ dysfunction or any clinically significant deviation from normal in 
physical examination, vital signs, ECG, or clinical laboratory determinations beyond what 
is consistent with the target population (ie, healthy adult females). 
b) Any significant deviation from the following on 12-lead ECG prior to study intervention 
administration, confirmed by repeat: 
i) PR ≥ 210 msec 
ii) QRS ≥ 120 msec 
iii) QT ≥ 500 msec 
iv) QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥ 470 msec 
c) Persistent or intermittent complete bundle branch block, incomplete bundle branch block, 
or intraventricular conduction delay with QRS > 120 msec. 
d) Clinically significant vital signs examination results outside the normal reference range 
prior to study intervention administration, confirmed by repeat; normal ranges are:  
i) Heart rate 40 to 100 bpm,  
ii) Systolic blood pressure 90 to 140 mmHg,  
iii) Diastolic blood pressure 50 to 90 mmHg. 
e) Positive urine screen for drugs of abuse, urine cotinine, or alcohol breath or urine test. 
f) Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or human 
immunodeficiency virus (HIV)-1 and HIV-2 antibody.  
g) 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 
(see Table 9.4.4-1 for laboratory parameters).  
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5) Allergies and Adverse Drug Reactions 
a) History of allergy or hypersensitivity to deucravacitinib, JAK inhibitors, or related 
compounds. 
b) History of any significant drug allergy or adverse reaction (such as anaphylaxis or 
hepatotoxicity). 
c) Presence or history of clinically significant allergy requiring treatment, as judged by the 
investigator. Seasonal pollen allergies are allowed unless they are active.  
6) Other Exclusion Criteria 
a) Currently breastfeeding a pre-term infant, a sick infant, or any other infant for whom it is 
medically advised for the mother to continue breastfeeding. 
b) Prisoners or participants who are involuntarily incarcerated.  
c) Inability to comply with restrictions as listed in Section 6.3: Lifestyle Restrictions. 
d) Currently smoke, as well as those who have stopped smoking less than 6 months prior to 
administration of study intervention. This includes participants using electronic cigarettes, 
vaporizers, or nicotine-containing products, such as tobacco for chewing, nicotine patches, 
nicotine lozenges, or nicotine gum.  
e) Participation in an interventional clinical trial of an investigational agent concurrent with 
this study. 
f) Inability to tolerate oral medication. 
g) Any major surgery within 4 weeks of study intervention administration. 
h) Any gastrointestinal surgery, including cholecystectomy, that could impact the absorption 
of study intervention. 
i) Donation of blood to a blood bank or in a clinical study (except at a screening visit) greater 
than 400 mL within 4 weeks of study intervention administration (within 2 weeks for 
plasma only) until end of study. 
j) Blood transfusion within 4 weeks of study intervention administration until end of study. 
k) Inability to be venipunctured and/or tolerate venous access. 
l) Recent (within 6 months of study intervention administration) drug or alcohol abuse as 
defined in the current version of the Diagnostic and Statistical Manual of Mental Disorders 
Diagnostic Criteria for Drug and Alcohol Abuse. 
m) Any other sound medical, psychiatric, and/or social reason as determined by the 
investigator. 
n) Participants who are Sponsor or study site employees, or immediate family members of a 
study site or Sponsor employee.  
6.3 
Lifestyle Restrictions 
In addition to the eligibility criteria at screening (Sections 6.1 and 6.2), participants are required 
to adhere to the following restrictions during the study.  
The lifestyle restrictions listed in Sections 6.3.1, 6.3.2, and 6.3.3 are not exclusion criteria; if 
noncompliance occurs, following discussion between the investigator and medical monitor, a 
protocol deviation may be completed and the participant may be allowed to participate in the study. 
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6.3.1 
Meals and Dietary Restrictions 
• To avoid false positive drug screen results, participants should refrain from consuming 
any foods containing poppy seeds within 48 hours (2 days) prior to screening and CRU 
admission on Day -1. 
• From at least 7 days prior to study intervention administration on Day 1 until CRU discharge 
on Day 4, participants should not consume any nutrients or food products known to modulate 
CYP450 enzyme activity (eg, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville 
[blood] orange products). 
• Participants are required to fast (nothing to eat or drink except water) for 10 hours prior to the 
collection of specimens for clinical laboratory tests.  
6.3.2 
Caffeine, Alcohol, and Tobacco 
• Participants are not permitted to consume caffeine-containing beverages for 3 days prior 
to Day -1 until CRU discharge on Day 4. 
• Participants are not permitted to consume alcohol-containing beverages from 3 days prior 
to Day -1 until CRU discharge on Day 4. 
• Participants are not permitted to smoke or use electronic cigarettes, vaporizers, or any 
tobacco/nicotine-containing products for 6 months prior to study intervention administration 
on Day 1 until CRU discharge on Day 4. 
6.3.3 
Activity 
• Participants are to refrain from strenuous exercise and contact sports from at least 2 days prior 
to Day -1 until CRU discharge on Day 4. 
• Participants are required to remain in the CRU from admission on Day -1 until discharge on 
Day 4.  
6.4 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently entered in the study/included in the analysis population.  
A minimal set of 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 SAEs that occurred following consent. 
6.4.1 
Re-testing During Screening 
Participant re-enrollment: This study permits the 1-time 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 once within any single screening or 
lead-in period will be permitted (in addition to any parameters that require a confirmatory value). 
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The most current result prior to administration of study intervention 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 required during Screening may be repeated to 
identify all possible well-qualified participants. Consultation with the Medical Monitor may be 
needed to identify whether repeat testing of a parameter is clinically relevant. 
7 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
Study interventions are defined as all pre-specified, investigational interventions, marketed 
products, placebos, procedures, or medical devices intended to be administered to study 
participants according to the study protocol. 
Study intervention includes Investigational [Medicinal] Product (IP/IMP) 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/Auxiliary Medicinal Products (AxMPs). Not applicable for this study. 
7.1 
Study Interventions Administered 
In the morning on Day 1, each participant will receive a single oral 9-mg dose of deucravacitinib 
. 
At the time of dosing, 240 mL of water will be administered to the participant along with her dose 
of study intervention. The time of dose administration will be called “0” hour. 
Restrictions related to food and fluid intake are described in Section 6.3. 
Table 7.1-1: 
Study Intervention 
Type/ 
Intervention 
Name/ 
Dose Formulation 
Unit Dose 
Strength(s) 
IMP/Non-IMP/ 
AxMP 
Blinded or 
Open-label Use 
Current/ 
Former 
Name(s) or 
Alias(es) 
Deucravacitinib 
tablet 
 
IMP 
BMS-986165 
Deucravacitinib 
tablet 
 
IMP 
BMS-986165 
SOTYKTU® 
Abbreviations: AxMP, Auxiliary Medicinal Product; IMP, Investigational Medicinal Product. 
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7.2 
Assignment to Study Intervention 
Enrolled participants, including those not dosed, will be assigned sequential participant numbers 
starting with 
. Those enrolled participants meeting 
inclusion and exclusion criteria will be eligible to be dosed. 
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 study intervention. The Sponsor may replace 
participants for other reasons.  
7.3 
Blinding 
This is a nonrandomized, open-label study. Blinding procedures are not applicable. 
7.4 
Dosage Modification 
Not applicable.  
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. 
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• 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 Appendix 2. 
 
7.6 
Study Intervention Compliance 
When the individual dose for a participant is prepared from a bulk supply, the preparation of the 
dose will be confirmed by a second member of the study site staff. Study intervention will be 
administered in the CRU. After administration of deucravacitinib, an examination of the oral cavity 
is required to verify that a participant has swallowed a tablet. Since multiple tablets are 
administered as part of a single dose, the mouth check should be performed after the final tablet 
has been taken. The participant should drink the entire amount of water given to swallow the 
tablets. 
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. Medications taken within 4 weeks or 5 half-lives (if known), whichever 
is longer, prior to study intervention administration must be recorded on the Case Report Form 
(CRF). 
• Prior exposure to deucravacitinib, JAK inhibitors, or related compounds. 
• Exposure to any investigational drug or placebo within 4 weeks or 5 half-lives (if known), 
whichever is longer, prior to study intervention administration. 
• Use of any prescription drugs or over-the-counter acid controllers within 4 weeks or 
5 half-lives (if known), whichever is longer, prior to study intervention administration, except 
those medications cleared by the Sponsor Medical Monitor. 
• Use of any other drugs, including over-the-counter medications and herbal preparations, within 
1 week prior to study intervention administration, except those medications cleared by the 
Sponsor Medical Monitor. 
• Receipt of any vaccination or plans for vaccination with any live vaccine within 60 days before 
screening, during the course of the study, or 30 days after last study intervention 
administration. The use of inactivated seasonal influenza vaccines (eg, Fluzone®) and non-live 
COVID-19 vaccines will be permitted on the study without restriction.  
 
Other than hormonal contraception and those mentioned in Section 7.7.2, no concomitant 
medications (prescription, over-the-counter, or herbal) are to be administered during the study 
unless they are prescribed for treatment of specific clinical events. Any concomitant therapies must 
be recorded on the CRF. 
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The investigator should contact and confirm agreement with the Sponsor Medical Monitor (and 
acknowledgement from the contract research organization Medical Monitor) prior to the 
administration of any concomitant medications. 
7.7.2 
Permitted Treatments 
Permitted treatments, if needed, may be given 4 hours post dose. 
• Acetaminophen (paracetamol), when given according to the package insert, may be used as a 
mild analgesic at the discretion of the investigator. 
• Prune juice may be given to help alleviate constipation or to facilitate a bowel movement 
during the CRU domiciling period. 
• Use of a standard dose of vitamins (including pre/post-natal vitamins) during the study will be 
allowed. 
 
7.8 
Continued Access to Study Intervention After the End of the Study 
This is a healthy volunteer PK study. The purpose is not to treat any condition. Therefore, study 
intervention will not be provided to participants after the end of the 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 
deucravacitinib is terminated for other reasons, including, but not limited to, lack of efficacy and/or 
not meeting the study objectives. 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. 
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. 
• Any clinical AE, laboratory test result abnormality, or intercurrent illness that, 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 the study. Strict conditions apply, and 
Sponsor approval is required.) 
• Pregnancy (refer to Section 9.2.5). 
• Significant noncompliance with protocol (eg, procedures, assessments, medications, etc). The 
investigator should discuss such issues with the Medical Monitor. 
• At the discretion of the investigator for any other reason. 
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Refer to the Schedule of Activities in Section 2 for data to be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed. 
All participants who discontinue study intervention should comply with protocol-specified 
follow-up procedures as outlined in the Section 2: Schedule of Activities for an end of 
treatment/early termination visit. The only exception 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 
Study Stopping Criteria  
Dosing of new participants will pause if either of the following criteria are met: 
• Two participants experience an SAE or severe AE that is assessed as related to deucravacitinib 
by the investigator. 
• The investigator or Sponsor assesses for any reason that further dosing may pose an 
unacceptable risk to study participants. 
 
If either of the above criteria are met, the investigator and Sponsor will perform a review of 
available data, and the overall risk of continuing the study will be assessed. Upon conclusion of 
the review, one of the following decisions will be taken: (1) to continue with the study as planned; 
(2) to continue the study with adjustments to the study plan, which may include modified selection 
criteria, additional safety monitoring measures, etc; or (3) to terminate the study. 
8.1.2 
Post-study Intervention Study Follow-up 
Participants who discontinue study intervention may continue to be followed. 
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 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. 
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• If 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 
• Participants may withdraw completely from the study at any time at her own request or may 
be withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. Stopping study intervention is not considered 
withdrawal from the study. 
• At the time of discontinuing from the study, if possible, an early termination visit should be 
conducted, as shown in the Section 2: Schedule of Activities. See the Schedule of Activities 
for data to be collected at the time of study discontinuation and follow-up, if applicable, 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. 
• 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. 
 
To ensure a sufficient number of completers, the participant may be replaced if they discontinue 
during the study (see Section 5.2 and Section 7.2). 
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.  
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• 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 Section 2: Schedule of Activities.  
• Protocol waivers or exemptions are not allowed. 
• All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine whether the participant should continue or discontinue 
the study. 
• Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria before CRU admission and/or administration of study 
intervention. The investigator will maintain a screening log to record details of all participants 
screened and to confirm eligibility or record reasons for screening failure, as applicable. 
Participants may be rescreened once. 
• Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples. 
 
9.1 
Efficacy Assessments 
Not applicable. 
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 post dose or early 
termination (if the participant was not dosed). 
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 skin biopsy). 
• 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.  
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• The investigator will submit any updated SAE data to the Sponsor or designee promptly and 
not to exceed 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 
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 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3). 
• Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study intervention and for those present at the end of study intervention as appropriate. 
• All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory 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). 
Further information on follow-up procedures is given in Appendix 3. 
9.2.4 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
product under clinical investigation are met. 
• An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the IB and will notify the IRB/IEC, if appropriate, according to local requirements. 
 
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. 
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9.2.5 
Pregnancy 
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 5 half-lives of study 
intervention 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. Pregnancy 
reporting must follow the same transmission timing and processes to BMS as those used for SAEs, 
in accordance with 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). 
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. 
9.2.6 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the Adverse Events – 
Nonserious 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 and Appendix 3 for reporting details). 
A potential DILI is defined as follows:  
• Aminotransferase (ALT or AST) elevation > 3× 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 nonserious AE or SAE, as appropriate, and reported 
accordingly. 
9.3 
Overdose 
An overdose is defined as the accidental or intentional administration of any dose of a product that 
is considered both excessive and medically important. Overdoses that meet the regulatory 
definition of an SAE will be reported as SAEs (see Appendix 3). 
In the event of an overdose, the investigator should: 
• Contact the Medical Monitor immediately. 
• Closely monitor the participant for AEs/SAEs and laboratory test result abnormalities until 
study intervention can no longer be detected systemically (at least 4 days). 
• Obtain a plasma sample for PK analysis within 4 days from the date of the dose of study 
intervention if requested by the Sponsor Medical Monitor (determined on a case-by-case 
basis). 
• Document the quantity of the excess dose as well as the duration of the overdosing in the CRF. 
 
9.4 
Safety 
Planned time points for all safety assessments are listed in the Schedule of Activities in Section 2. 
9.4.1 
Physical Examinations 
A complete PE will include an evaluation of the heart, lungs, head and neck, abdomen, skin, breasts 
(screening only), and extremities, as well as a check for visual or neurologic symptoms.  
At a minimum, a targeted PE will include an evaluation of the skin and mucus membranes, a 
symptom-oriented evaluation, and a check for any previously noted abnormalities.   
The PE may be performed by a Doctor of Medicine or someone who is authorized to perform the 
examinations by training and has been delegated this task by the investigator.  
Refer to Schedule of Activities in Section 2. 
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9.4.2 
Vital Signs 
Refer to Schedule of Activities in Section 2. 
9.4.3 
Electrocardiograms 
Refer to Schedule of Activities in Section 2. 
9.4.4 
Clinical Safety Laboratory Assessments 
Investigators must document their review of each laboratory safety report. 
Central and local laboratories may perform the analyses and will provide reference ranges for these 
tests. 
Results of clinical laboratory tests (including serum pregnancy test, serology, and QuantiFERON® 
TB Gold Test [or equivalent]) performed at screening must be available and reviewed prior to 
dosing. 
Table 9.4.4-1: 
Clinical Laboratory Assessments 
Hematology 
Hemoglobin 
Hematocrit 
Total leukocyte count, including differential 
Platelet count 
Red blood cell count 
Basophils 
Eosinophils 
Monocytes 
Neutrophils 
Lymphocytes 
Chemistry 
Aspartate aminotransferase 
Alanine aminotransferase  
Total bilirubin 
Direct bilirubin 
Alkaline phosphatase 
Lactate dehydrogenase  
Creatinine 
Blood urea nitrogen or serum urea 
Uric acid  
Glucose 
Total protein 
Albumin 
Sodium 
Potassium 
Chloride 
Calcium 
Phosphorus 
Magnesium 
Creatine kinase 
eGFR using CKD-EPI (screening only) 
Urinalysis 
Protein 
Glucose 
Blood 
Leukocyte esterase 
Specific gravity 
pH 
Microscopic examination of the sediment if blood, protein, or leukocytes esterase are positive on the dipstick 
Serology  
Serum for hepatitis C antibody, hepatitis B surface antigen, HIV-1 and HIV-2 antibody 
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Table 9.4.4-1: 
Clinical Laboratory Assessments 
TB testing (QuantiFERON-TB Gold Plus or equivalent)  
Other Analyses 
Drugs of abuse test (urine) 
Cotinine tests (urine) 
Alcohol test (urine or breath) 
Pregnancy test (serum) (all participants)  
Abbreviations: CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; eGFR, estimated glomerular 
filtration rate; HIV, human immunodeficiency virus; TB, tuberculosis. 
 
9.4.5 
Breastfeeding Questionnaire 
At screening and Day 10, designated site staff will ask participants questions about their 
breastfeeding history, current breastfeeding practices (eg, frequency of breastfeeding [including 
pumping], duration of breast feeds, estimated volume of milk production [if information is 
available], use of formula supplementation), and intentions for continuing breastfeeding after the 
study.  
The questionnaire will include previous and current experience with breastfeeding as well as 
participant-reported effects on milk production before (ie, screening) and after discontinuation (ie, 
CRU discharge) of study intervention (Appendix 5). 
9.4.6 
Instructions for Storage of Breast Milk 
Participants will be provided instructions on how to store their breast milk in order to ensure a 
sufficient supply of food for the infant during the time the participant must temporarily discontinue 
breastfeeding. If sufficient pumped breastmilk is not available, alternative infant nutrition 
(previously stored breastmilk or infant formula) can be suggested for feeding the infant until after 
CRU discharge (beginning 72 hours post dose). 
A certified lactation consultant will be available for consultations from screening throughout the 
participant’s study participation (up until approximately 30 days post dose) in order to support the 
participant’s breastfeeding routine and return to breastfeeding. 
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9.5 
Pharmacokinetics 
Pharmacokinetics of deucravacitinib (BMS-986165) and its major active metabolite, 
BMT-153261, will be derived from plasma and breast milk concentration-time data. 
The PK parameters to be assessed for breast milk and plasma include the following: 
Cmax 
Maximum observed plasma or milk concentration 
Tmax 
Time of maximum observed plasma or milk concentration 
AUC(0-T) 
Area under the plasma concentration-time curve from time zero to time of last 
quantifiable concentration 
AUC(INF) 
Area under the plasma or milk concentration-time curve from time zero extrapolated 
to infinite time 
AUC(0-24) 
Area under the plasma or milk concentration-time curve from time zero to 24 hours 
Cavg 
Average plasma or milk concentration 
AR(24) 
Amount recovered in milk within 24 hours of dosing 
AR 
Total amount recovered in milk 
M/P 
Milk-plasma ratio, calculated as milk AUC(0-24)/plasma AUC(0-24) 
Daily Infant Dose 
Total deucravacitinib consumed by the infant per day (estimated) 
Relative Infant Dose 
The percent of the weight-adjusted maternal deucravacitinib dosage consumed in 
breast milk over 24 hours (estimated) 
 
Individual participant PK parameter values will be derived by noncompartmental methods by a 
validated PK analysis program. Actual times will be used for the analyses.  
9.5.1 
Milk and Plasma Collection and Processing 
 
 
Both breasts should be pumped such that they are completely emptied with each milk expression 
and within -25 minutes of the end of the scheduled collection time. 
Multiple milk expressions within each collection interval are allowed if needed. All milk collected 
within each collection interval will be pooled. The total volume of the breast milk expressed during 
each collection interval will be recorded. 
It is expected that every effort be made to collect the PK plasma samples at the times indicated in 
the PK sampling schedule
. 
The following time windows serve as a guideline for PK plasma sample collections: 
• All predose samples should be taken within 
 prior to dosing 
• 
 for samples collected 
 post dose  
• 
 for all samples drawn 
.  
 
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Concentration analyses for deucravacitinib and BMT-153261 will be performed by validated 
bioanalytical method(s).  
Bioanalytical samples designated for assessments (eg, immunogenicity, PK, or biomarker) from 
the same collection time point may be used interchangeably for analyses, if required (including, 
but not limited to, insufficient volume for complement assessment to follow-up on suspected 
immunogenicity-related AEs, etc).  
Additionally, residual bioanalytical samples will be archived for up to 
 after the end of the 
study or the maximum period allowed by applicable law and 
 
 
 
.    
Detailed instructions for PK milk and plasma collection, labeling, processing, storage, and 
shipping will be provided to the site in the laboratory/procedure manual. 
9.6 
Immunogenicity Assessments 
Not applicable. 
9.7 
Biomarkers 
Not applicable. 
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 
No prospective hypotheses are being formally evaluated. 
10.2 
Sample Size Determination 
Approximately 8 healthy lactating female adult participants are planned to receive study 
intervention. 
 
 
 
10.3 
Analysis Sets 
For the purposes of analysis, the following populations are defined: 
Population 
Description 
Enrolled  
All participants who have agreed to participate in a clinical study following completion of the 
informed consent process, unless otherwise specified by the protocol. 
Pharmacokinetic 
(PK) 
All participants who received the single dose of study intervention and have any available 
concentration-time datum.  
Evaluable PK 
All participants in the PK population who have adequate PK profiles or have at least 1 
evaluable PK parameter.  
Participants with any missing milk sample collection within 24 hours post dose will be 
excluded from the milk PK evaluable analysis population. 
Safety 
All participants who received the single dose of study intervention.  
 
10.4 
Statistical Analyses 
The statistical analysis plan (SAP) will be developed and finalized before database lock and 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 primary and secondary 
endpoints. 
10.4.1 
General Considerations 
All statistical analyses will be performed using SAS® (SAS Institute, Cary, NC, US).  
In general, summary statistics (n [number of available measurements], arithmetic mean, standard 
deviation, median, minimum, and maximum) for quantitative variables and frequency tables for 
qualitative data will be presented. Any deviations from this general approach will be outlined in 
the SAP. 
The PK population will be used for all PK-related listings. The Evaluable PK population will be 
used for all PK parameter summaries and statistical analyses. All safety analyses will be performed 
using the Safety population. 
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10.4.2 
Primary Endpoint(s) 
The primary endpoints are defined in Table 10.4.2-1. 
Table 10.4.2-1: 
Primary Endpoints 
Primary Endpoint 
Description 
Time Frame 
Milk PK – Cmax 
Maximum observed milk concentration for 
deucravacitinib and its major active metabolite BMT-
153261 
Up to 72 hours 
Milk PK – Tmax 
Time of milk Cmax for deucravacitinib and its major 
active metabolite BMT-153261 
Up to 72 hours 
Milk PK – AUC(0-24) 
Area under the milk concentration-time curve from 
time zero to 24 hours for deucravacitinib and its 
major active metabolite BMT-153261 
Up to 72 hours 
Milk PK – AUC(INF) 
Area under the milk concentration-time curve from 
time zero extrapolated to infinite time for 
deucravacitinib and its major active metabolite BMT-
153261 
Up to 72 hours 
Milk PK – Cavg 
Average milk concentration. The milk Cavg for 
deucravacitinib and its major active metabolite BMT-
153261 to be calculated as AUC(INF) divided by 24, 
assuming AUC(INF) after a single dose represents 
steady-state AUC(TAU) (TAU = 24 hours)  
Up to 72 hours 
Milk PK – AR(24) 
Amount recovered in milk within 24 hours of dosing 
for deucravacitinib and its major active metabolite 
BMT-153261 
Up to 72 hours 
Milk PK – AR 
Total amount recovered in milk for deucravacitinib 
and its major active metabolite BMT-153261 
Up to 72 hours 
M/P 
Milk-plasma ratio for both deucravacitinib and its 
major active metabolite BMT-153261, calculated as 
milk AUC(0-24)/plasma AUC(0-24) 
Up to 72 hours 
Daily Infant Dose 
Total deucravacitinib consumed by the infant per 
day, as estimated below: 
Estimated Daily Infant Dosage (mg/kg/day) = Mean 
M/P multiplied by the average maternal plasma 
concentration (Cavg) multiplied by 200 mL/kg/day 
Up to 72 hours 
Relative Infant Dose 
The percent of the weight-adjusted maternal 
deucravacitinib dosage consumed in breast milk over 
24 hours. As calculated below: 
Relative Infant Dose = Infant Dosage 
(mg/kg/day)/Maternal Dosage (mg/kg/day) 
multiplied by 100 
Up to 72 hours 
Abbreviations: AR, total amount recovered in milk; AR(24), amount recovered in milk within 24 hours of dosing; 
AUC(0-24), area under the milk concentration-time curve from time zero to 24 hours; AUC(INF), area under the milk 
concentration-time curve from time zero extrapolated to infinite time; AUC(TAU), area under the milk 
concentration-time curve within a dosing interval; Cavg, average plasma or milk concentration; Cmax, maximum 
observed milk concentration; M/P, milk-plasma ratio; PK, pharmacokinetics; Tmax, time of maximum observed milk 
concentration. 
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10.4.3 
Secondary Endpoint(s) 
The secondary endpoints are defined in Table 10.4.3-1. 
Table 10.4.3-1: 
Secondary Endpoints 
Secondary Endpoint 
Description 
Time Frame 
Plasma PK – Cmax 
Maximum observed plasma concentration 
for deucravacitinib and its major active 
metabolite BMT-153261 
Up to 72 hours 
Plasma PK – AUC(0-24) 
Area under the plasma concentration-time 
curve from time 0 to 24 hours for 
deucravacitinib and its major active 
metabolite BMT-153261 
Up to 72 hours 
Plasma PK – AUC(INF) 
Area under the plasma concentration-time 
curve from time zero extrapolated to infinite 
time for deucravacitinib and its major active 
metabolite BMT-153261 
Up to 72 hours 
Plasma PK – AUC(0-T) 
Area under the plasma concentration-time 
curve from time 0 to last quantifiable 
concentration for deucravacitinib and its 
major active metabolite BMT-153261 
Up to 72 hours 
Plasma PK – Tmax 
Time of plasma Cmax for deucravacitinib 
and its major active metabolite 
BMT-153261 
Up to 72 hours 
Plasma PK – Cavg 
Average maternal plasma concentration. 
The plasma Cavg for deucravacitinib and its 
major active metabolite BMT-153261 to be 
calculated as AUC(INF) divided by 24, 
assuming AUC(INF) after a single dose 
represents steady-state AUC(TAU) 
(TAU = 24 hours) 
Up to 72 hours 
Safety 
Incidence, severity, and relationship of 
TEAEs; and clinically significant changes in 
clinical laboratory tests (hematology and 
chemistry), vital signs, physical 
examinations, and ECGs 
Up to 30 days 
Abbreviations: AUC(0-24), area under the plasma concentration-time curve from time zero to 24 hours; AUC(0-T), 
area under the plasma concentration-time curve from time zero to time of last quantifiable concentration; AUC(INF), 
area under the plasma concentration-time curve from time zero extrapolated to infinite time; AUC(TAU), area under 
the milk concentration-time curve within a dosing interval; Cavg, average plasma concentration; Cmax, maximum 
observed plasma concentration; ECG, electrocardiogram; PK, pharmacokinetics; TEAE, treatment-emergent adverse 
event; Tmax, time of maximum observed plasma concentration. 
 
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10.4.5 
Pharmacokinetic Analyses 
Individual milk and plasma PK concentrations will be listed and summarized by study day and 
nominal collection time for deucravacitinib and its major active metabolite BMT-153261, where 
appropriate. Plots of individual and mean milk and plasma concentrations versus time will be 
provided. 
All individual milk and plasma PK parameters will be listed for deucravacitinib and its major 
active metabolite BMT-153261, where appropriate. Summary statistics will be tabulated for each 
PK parameter as appropriate. Geometric means and geometric coefficients of variation will be 
presented for milk and plasma Cmax, AUCs, and Cavg, milk AR, and M/P. Medians and ranges 
will be presented for milk and plasma Tmax. Daily and relative infant dose will be reported.  
Further details will be provided in the SAP. 
10.5 
Interim Analyses 
Not applicable. 
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11 
REFERENCES 
1. SOTYKTU® (deucravacitinib) tablets, for oral use; prescribing information. Bristol Myers 
Squibb, 2022. Available from: https://packageinserts.bms.com/pi/pi_sotyktu.pdf 
2. Armstrong AW, Mehta MD, Schupp CW, et al. Psoriasis Prevalence in Adults in the United 
States. JAMA Dermatol 2021;157:940-6.  
3. Parisi R, Symmons DP, Griffiths CE, et al. Global epidemiology of psoriasis: a systematic 
review of incidence and prevalence. J Invest Dermatol 2013;133:377-85. 
4. Kupetsky EA, Keller M. Psoriasis vulgaris: an evidence-based guide for primary care. J Am 
Board Fam Med 2013;26(6):787-801. 
5. World Health Organization. Global report on psoriasis. WHO 2016. 
6. Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality 
of life. Ann Rheum Dis 2005;64(Suppl II):ii18-ii23. 
7. Queiro R, Tejón P, Alonso S, et al. Age at disease onset: a key factor for understanding 
psoriatic disease. Rheumatology (Oxford) 2014;53:1178-85. 
8. Gottlieb AB, Ryan C, Murase JE. Clinical considerations for the management of psoriasis in 
women. Int J Womens Dermatol 2019;5:141-50.  
9. Lima XT, Janakiraman V, Hughes MD, et al. The impact of psoriasis on pregnancy 
outcomes. J Invest Dermatol 2012;132:85-91.  
10. Deucravacitinib (BMS-986165) Bristol-Myers Squibb Company. Investigator’s Brochure 
Version 10.0, 08-Sep-2023. Document Control No. 930090873. 
11. Placental Transfer, Lacteal Excretion, and Tissue Distribution of Radioactivity in Pregnant 
Female Rats and Tissue Distribution of Radioactivity in Male and Non-Pregnant Female Rats 
Following Oral Administration of [14C]BMS-986165; (Study NCPK580). Bristol-Myers 
Squibb Company; 2019. Document Control No. 930144804. 
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12 
APPENDICES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX 1 
ABBREVIATIONS 
Term 
Definition 
 
 
AE 
adverse event 
ALT 
alanine aminotransferase 
AR(24) 
amount recovered in milk within 24 hours of dosing 
AR 
total amount recovered in milk 
AST 
aspartate aminotransferase 
AUC 
area under the concentration-time curve 
AUC(0-T) 
area under the plasma concentration-time curve from time zero to time of 
last quantifiable concentration  
AUC(INF) 
area under the plasma or milk concentration-time curve from time zero 
extrapolated to infinite time  
AUC(0-24) 
area under the plasma or milk concentration-time curve from time zero to 
24 hours 
AUC(TAU) 
area under the milk concentration-time curve within a dosing interval 
AxMP 
Auxiliary Medicinal Product 
BMI 
body mass index 
BMS 
Bristol-Myers Squibb Company 
Cavg 
average plasma or milk concentration 
CFR 
Code of Federal Regulations  
CIOMS 
Council for International Organizations of Medical Sciences 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
Cmax 
maximum observed plasma or milk concentration 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
coronavirus disease 2019 
CRF 
Case Report Form, paper or electronic 
CRU 
clinical research unit 
CSR 
Clinical Study Report 
CTAg 
Clinical Trial Agreement 
CYP 
cytochrome P450 
DILI 
drug-induced liver injury 
ECG 
electrocardiogram 
eCRF 
electronic Case Report Form 
EDC 
electronic data capture 
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Term 
Definition 
ET 
early termination 
eGFR 
estimated glomerular filtration rate 
FDA 
US Food and Drug Administration 
FSH 
follicle-stimulating hormone 
 
 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IFN 
interferon 
IL 
interleukin 
IMP 
Investigational Medicinal Product 
IOCBP 
individual of childbearing potential 
IP 
Investigational Product 
IRB 
Institutional Review Board 
JAK 
Janus kinase 
min 
minute(s) 
M/P 
milk-plasma ratio, calculated as milk AUC(0-24)/plasma AUC(0-24) 
PE 
physical examination 
PK 
pharmacokinetic(s) 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus-2 
STAT 
signal transducer and activator of transcription 
SUSAR 
suspected unexpected adverse reaction 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
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Term 
Definition 
T-HALF 
half-life 
Tmax 
time of maximum observed plasma or milk concentration 
TYK2 
tyrosine kinase 2 
UGT 
uridine glucuronyl transferase 
ULN 
upper limit of normal 
US 
United States 
USPI 
United States prescribing information 
VS 
vital signs 
 
 
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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
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 (IRB)/Independent Ethics 
Committee (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: 
• ICH guidelines 
• United States (US) Code of Federal Regulations (CFR), Title 21, Part 50 (21CFR50) 
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• European Regulation 536/2014 for clinical studies (if applicable) 
• European Medical Device Regulation 2017/745 for clinical device research 
• 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. 
To honor this commitment and to evaluate population-specific signals, data on race and ethnicity 
data will be collected for this trial. A participant’s race/ethnicity should be self-reported to the 
local study team and not assumed. These data will be documented by the study team in the 
electronic Case Report Form (eCRF), where permissible by local guidance, and will not be used 
as determinants of participant eligibility and/or continuation in the clinical trial. These data will be 
protected consistent with all other data collected during this trial. 
RECRUITMENT STRATEGY 
A participant engagement and recruitment program using continuous multi-channel marketing 
campaigns will be developed in cooperation with the site and will focus on assessing  drop-out 
risks and the feasibility of the study schedule with the participants.   
Throughout this process, the length of time the participant must temporarily discontinue 
breastfeeding after dosing is detailed, along with encouraging participants to pump and store 
sufficient breastmilk prior to study check-in.  In order to support the participant’s breastfeeding 
routine and return to breastfeeding upon study completion, a certified lactation consultant will be 
available from screening throughout the participant’s study participation (up until approximately 
30 days post dose); utilization of this study resource also promotes study participation and 
retention. Participants will be encouraged by site staff to utilize this resource throughout the study 
as needed. 
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY 
BMS collects and processes personal data of study participants, patients, health care providers, 
and researchers for biopharmaceutical research and development to advance innovative, 
high-quality medicines that address the medical needs of patients. BMS ensures the privacy, 
protection, and confidentiality of such personal data to comply with applicable laws. To achieve 
these goals, BMS has internal policies that indicate measures and controls for processing personal 
data. BMS adheres to these standards to ensure that collection and processing of personal data are 
limited and proportionate to the purpose for which BMS collects such personal data. This purpose 
is clearly and unambiguously notified to the individual at the time of collection of personal data. In 
the true spirit of science, BMS is dedicated to sharing clinical trial information and data with 
participants, medical/research communities, the media, policy makers, and the general public. This 
is done in a manner that safeguards participant privacy and informed consent while respecting the 
integrity of national regulatory systems. Clinical trial data, health-related research, and 
pharmacovigilance activities on key-coded health data transferred by BMS across national borders 
is done in compliance with the relevant data protection laws in the country and GCP requirements. 
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BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of 
its processing.  
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data. 
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyber attacks and other 
unauthorized attempts to access personal data. These standards also aid in mitigating possible 
adverse effects. Furthermore, BMS Information Technology has defined 6 principles to protect our 
digital resources and information:  
1) Responsibilities of Information Technology Personnel 
2) Securing the BMS Digital Infrastructure 
3) Identity and Access Management 
4) External Partner Connections 
5) Cyber Threat Detection and Response 
6) Internal Cyber Incident Investigation 
 
SOURCE DOCUMENTS 
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site. 
Data reported on the Case Report Form (CRF) or entered in the 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. 
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Such systems may include, but are not limited to, electronic medical records/electronic health 
records, adverse event (AE) tracking/reporting, protocol-required assessments, and/or drug 
accountability records. 
When paper records from such systems are used in place of an electronic format to perform 
regulated activities, such paper records should be certified copies. A certified copy consists of a 
copy of original information that has been verified, as indicated by a dated signature, as an exact 
copy having all of the same attributes and information as the original.  
STUDY INTERVENTION RECORDS 
Records for study intervention (whether supplied by BMS, its vendors, or the site) must 
substantiate study intervention integrity and traceability from receipt, preparation, administration, 
and through destruction or return. Records must be made available for review at the request of 
BMS/designee or a Health Authority. 
If 
Then 
Supplied by BMS (or its 
vendors) 
Records or logs must comply with applicable regulations and 
guidelines and should include 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 
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BMS or its designee will provide forms to facilitate inventory control if the investigational site 
does not have an established system that meets these requirements. 
CASE REPORT FORMS 
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 CRF. 
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 
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 who signs eCRFs electronically 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 
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with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable. 
In addition, the study may be evaluated by the Sponsor or designee internal auditors and 
government inspectors who must be allowed access to CRFs, source documents, other study files, 
and study facilities. BMS audit reports will be kept confidential. 
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities 
and promptly forward copies of inspection reports to the Sponsor or designee.  
RECORDS RETENTION 
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or its designee, whichever is longer. 
The investigator (or head of the study site in Japan) must contact BMS prior to destroying any 
records associated with the study. 
BMS or its designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed. 
If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed-upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or its designee.  
Records collected throughout the study will be stored in the BMS clinical data management system 
for a duration of the life of the product plus 25 years. 
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. 
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If 
Then 
If study interventions will be returned, the return will be 
arranged by the responsible study monitor. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal of study interventions, 
provided that procedures for proper disposal have been established according to applicable federal, 
state, local, and institutional guidelines and procedures, and provided that appropriate records of 
disposal are kept. The following minimal standards must be met: 
• On-site disposal practices must not expose humans to risks from the drug. 
• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
• Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s standard operating procedures and a copy provided to BMS upon request. 
• Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal (eg, incinerator, licensed sanitary landfill, or licensed waste-disposal 
vendor) must be documented. 
• Accountability and disposal records are complete, up-to-date, and available for the 
Study Monitor to review throughout the clinical 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 
 
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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. 
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. 
CLINICAL STUDY REPORT 
A Signatory Investigator must be selected to sign the Clinical Study Report (CSR).  
For this single-site protocol, the Principal Investigator for the site will sign the CSR.  
SCIENTIFIC PUBLICATIONS 
The data collected during this study are confidential and proprietary to the Sponsor or designee. 
Any publications or abstracts arising from this study must adhere to the publication requirements 
set forth in the CTAg governing study site or investigator participation in the study. These 
requirements include, but are not limited to, submitting proposed publications to the Sponsor or 
designee at the earliest practicable time prior to submission or presentation and otherwise within 
the 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: 
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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 
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 
An SAE is defined as any untoward medical occurrence that, at any dose: 
Results in death. 
Is life threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event that hypothetically might have caused death if it were 
more severe). 
Requires inpatient hospitalization or causes prolongation of existing hospitalization 
(see NOTE below). 
NOTES: The following hospitalizations are not considered SAEs in BMS clinical studies:  
A visit to the emergency department or other hospital department that does not result in 
admission. These visits should be evaluated for an occurrence of 1 of the other serious outcomes 
that would qualify as an SAE. 
 
• 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 1 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 promptly and 
not to exceed 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 paper SAE Report Form. 
− The paper form is transmitted via email or confirmed fax transmission. 
− 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 reporting contact information will be provided locally. 
 
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APPENDIX 4 
INDIVIDUALS OF CHILDBEARING POTENTIAL DEFINITIONS 
AND METHODS OF CONTRACEPTION 
Appendix 4 provides general information and definitions related to individuals of childbearing 
potential (IOCBPs) 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 contraceptive 
methods as described in Section 6.1: Inclusion Criteria of the protocol are acceptable for this study. 
DEFINITIONS 
Individuals of Childbearing Potential (IOCBP) 
An individual is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Individuals in the following categories are not considered IOCBP: 
• Premenarchal 
• Pre-menopausal individual with 1 of the following: 
− Hysterectomy 
− Bilateral salpingectomy 
− Bilateral oophorectomy 
• Postmenopausal individual 
 
A postmenopausal state is defined as 12 months of amenorrhea in an individual over the age of 
45 years in the absence of other biological or physiological causes. In addition, individuals under 
the age of 55 years must have a serum follicle-stimulating hormone (FSH) level > 40 mIU/mL to 
confirm menopause. 
Note: Individuals 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 when checking serum FSH levels.  
• 1-week minimum for vaginal hormonal products (rings, creams, gels) 
• 4-week minimum for transdermal products 
• 8-week minimum for oral products 
 
Other parenteral products may require washout periods as long as 6 months. If the serum FSH 
level is > 40 mIU/mL at any time during the washout period, the individual can be considered 
postmenopausal. 
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End of Relevant Systemic Exposure 
End of relevant systemic exposure is the time point at which the study intervention (Investigational 
Medicinal Product [IMP] and other study interventions ie, Non-IMP/Auxiliary Medicinal Product 
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 the 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 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 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 Contraceptive 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 
participants in studies in which hormonal contraception is permitted by the study protocol.)b 
• Intrauterine device. 
• Intrauterine system. (This method of contraception can only be used by participants in 
studies in which hormonal contraception is permitted by the study protocol.)b,c 
• Bilateral tubal occlusion. 
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• Vasectomized partner.  
Having a vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole male sexual partner of the IOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective contraceptive method should be used. 
• Sexual abstinence.  
Sexual abstinence is considered a highly effective contraceptive 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. 
• IOCBP 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 IOCBP 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 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 Intrauterine systems are acceptable methods of contraception in the absence of definitive drug interaction studies 
when hormone exposures from intrauterine devices do not alter contraception effectiveness. 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. 
 
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. 
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• 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 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. 
• Lactational amenorrhea method. 
 
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 
BREASTFEEDING QUESTIONNAIRE 
Screening Visit (Days -35 to -2) 
1. Does the participant breastfeed and/or pump? 
__ Breastfeed  __ Pump  __ Breastfeed and pump 
2. Frequency (how many times does the participant pump/feed per day): ______ 
2a. Average duration of feeds (pumping):  
Left breast  _____ min   Right breast  _____ min 
2b. Average volume of breast milk per feeding/pumping session (if known): ______ 
2c. Average duration of feeds (breastfeeding):  
Left breast  _____ min   Right breast  _____ min 
3. Does the participant give their infant any formula for supplementation? ___ yes   ___ no 
3a. If yes, how often? (Choose one) 
__ Less than 25% of the time  __ 25% of the time  __ 50% of the time  __ 75% of the time 
4. Does the participant intend to continue breastfeeding after the study period? ___ yes  ___ no 
5. Does the participant plan on weaning their infant from breastfeeding following participation in 
the study? ___ yes  ___ no 
6. Was the participant encouraged to have stored breastmilk available for feeding their infant for 
the duration of the required study period? ___ yes  ___ no 
7. How does the participant feel like their breast milk production is going? (Choose one) 
___ 1-Very Poor  ___ 2-Poor  ___ 3-Acceptable  ___ 4-Good  ___ 5-Very Good 
8. Confirm the participant was offered a lactation consultant to be available from screening until 
approximately 30 days post dose. ___ yes  ___ no 
9. Does the participant wish to speak with a lactation consultant? ___ yes ___ no  
(if yes, notify lactation consultant for scheduling) 
 
Safety Follow-up Phone Call (Day 10) 
1. How does the participant feel like their breast milk production is going? (Choose one) 
___ 1-Very Poor  ___ 2-Poor  ___ 3-Acceptable  ___ 4-Good  ___ 5-Very Good 
2. After the participant took the study drug, how was their milk production? 
___ Same as before  ___ Less than before  ___ More than before  
3. Does the participant give their infant any formula for supplementation? ___ yes  ___ no 
3a. If yes, how often? (Choose one) 
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__ Less than 25% of the time  __ 25% of the time  __ 50% of the time    __75% of the time 
4. Were there any problems with re-initiating breastfeeding?  ___ yes  ___ no 
 
4a. If yes, please specify_______________________________________ 
5. Confirm the participant was offered a lactation consultant to be available from screening until 
approximately 30 days post dose.  ___ yes  ___ no 
6. Does the participant wish to speak with a lactation consultant? ___ yes ___ no 
(if yes, notify lactation consultant for scheduling) 
 
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