← Back to Clinical Trials
Recruiting NCT07017699

A Study to Assess Deucravacitinib Safety in Pregnancy

Trial Parameters

Condition Psoriasis (PsO)
Sponsor Bristol-Myers Squibb
Study Type OBSERVATIONAL
Phase N/A
Enrollment 900
Sex FEMALE
Min Age N/A
Max Age N/A
Start Date 2025-03-21
Completion 2028-04-01
Interventions
DeucravacitinibOther systemic treatments for PsO

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.

Eligibility Criteria

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 p

Related Trials