Actively Recruiting
Study on the Safety of Deucravacitinib During Pregnancy in Women with Psoriasis
Led by Bristol-Myers Squibb · Updated on 2025-06-12
900
Participants Needed
1
Research Sites
47 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to assess pregnancy and infant outcomes among pregnant women enrolled in a North American pregnancy registry who were exposed to deucravacitinib. The study focuses on pregnant participants with psoriasis treated with deucravacitinib, those with psoriasis treated with other systemic treatments, and pregnant women without psoriasis or autoimmune diseases. The goal is to understand safety during pregnancy by comparing these groups. Participants are divided into three groups those exposed to deucravacitinib, those exposed to other systemic treatments for psoriasis, and a group without psoriasis or autoimmune diseases. Exposure timing includes any deucravacitinib use from 2 days before conception to the end of pregnancy. The study involves collecting data through interviews, medical record reviews, and physical exams of infants born alive. Participants will be followed to measure the number of major congenital malformations and other pregnancy and infant outcomes up to one year after birth. The study includes interviews, release of medical records, and dysmorphology examinations of infants. The total participation duration spans the pregnancy period and one year postpartum, with ongoing monitoring to track safety and outcomes.
CONDITIONS
Brief Title
A Study to Assess Deucravacitinib Safety in Pregnancy
Research Team
B
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