A Study to Assess Deucravacitinib Safety in Pregnancy

NCT07017699 | Recruiting FDA Drug

• 1 other identifier: IM011-1111
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists \[OTIS\]) who were exposed to deucravacitinib.

Conditions

Psoriasis (PsO)

Keywords

Psoriasis (PsO)

Outcome Measures

Primary Outcomes (1)

• Number of major congenital malformations among infants

  1-year post pregnancy outcome

Secondary Outcomes (1)

• Number of other pregnancy and infant outcomes

  1-year post pregnancy outcome

Study Arms (3)

Deucravacitinib Cohort

Pregnant participants with psoriasis exposed to deucravacitinib treatment

Drug: Deucravacitinib

Other Systemic Treatment Cohort

Pregnant participants with psoriasis exposed to other systemic treatments for PsO

Drug: Other systemic treatments for PsO

Unexposed Cohort

Pregnant participants without psoriasis or any other autoimmune diseases

Interventions

Deucravacitinib DRUG

According to product label

Deucravacitinib Cohort

Other systemic treatments for PsO DRUG

According to product label

Other Systemic Treatment Cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant women participating in the The Organization of Teratology Information Specialists (OTIS) pregnancy registry in the US or Canada

You may qualify if:

• Cohort 1: Deucravacitinib-exposed cohort
• Currently pregnant during the enrollment period
• Diagnosed with psoriasis (PsO) validated by medical records when possible
• Exposure to deucravacitinib for any number of days, at any dose, and at any time from 2 days prior to date of conception (DOC) to the end of pregnancy
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
• Cohort 2: PsO Disease-matched unexposed comparator cohort
• Currently pregnant during the enrollment period
• Diagnosed with PsO validated by medical records when possible
• May be exposed to systemic treatments for PsO
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
• Cohort 3: Non-disease unexposed comparator cohort
• Currently pregnant during the enrollment period
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants

You may not qualify if:

• Cohort 1: Deucravacitinib-exposed cohort
• Pregnant women who have enrolled in this cohort study with a previous pregnancy
• Pregnant women who have used deucravacitinib for an indication other than PsO
• Women who do not have exposure to deucravacitinib anytime from 2 days prior to DOC to the end of pregnancy
• Women who have exposure to another oral tyrosine kinase 2 (TYK2) inhibitor or any oral Janus kinase (JAK) inhibitor from within 5 half-lives of DOC to the end of pregnancy
• Women who have exposure to methotrexate or an oral retinoid
• Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
• Results of a diagnostic test are positive for an major congenital malformation(s) (MCM) prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
• Cohort 2: Disease-matched unexposed comparator cohort
• Pregnant women who have enrolled in this cohort study with a previous pregnancy
• Women who have exposure to deucravacitinib or any other oral TYK2 inhibitor except deucravacitinib, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
• Women who have exposure to methotrexate or an oral retinoid
• Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
• Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
• Cohort 3: Non-disease unexposed comparator cohort

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)