A Study to Assess Deucravacitinib Safety in Pregnancy

Recruiting

• Conditions: Psoriasis (PsO)
• Interventions: Drug: Deucravacitinib; Drug: Other systemic treatments for PsO

• Registration Number: NCT07017699
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-21
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2028-04-01
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

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

Exclusion Criteria

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

• Pregnant women who have enrolled in this cohort study with a previous pregnancy
• Women who have had exposure to deucravacitinib or any other oral TYK2 inhibitor, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
• 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
• Women exposed to a known, possible, or suspected human teratogen during pregnancy as confirmed by the OTIS Research Center (see Appendix 3 for list of known, possible, and suspected human teratogens)
• Women who are diagnosed with PsO, or any other autoimmune disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deucravacitinib Cohort	Deucravacitinib	Pregnant participants with psoriasis exposed to deucravacitinib treatment
Other Systemic Treatment Cohort	Other systemic treatments for PsO	Pregnant participants with psoriasis exposed to other systemic treatments for PsO

Primary Outcome Measures

Name	Time	Method
Number of major congenital malformations among infants	1-year post pregnancy outcome

Secondary Outcome Measures

Name	Time	Method
Number of other pregnancy and infant outcomes	1-year post pregnancy outcome	Other pregnancy and infant outcomes include: * Minor congenital malformations,; * Small for gestational age; * Small for age postnatal growth at 1 year of age; * Serious or opportunistic infections; * Neonatal hospitalization; * Infant deaths; * Neonatal deaths; * Perinatal deaths; * Spontaneous abortions; * Stillbirths; * Elective terminations/abortions; * Preterm deliveries; * Preeclampsia/eclampsia; * Gestational hypertension

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States