Actively Recruiting
The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
Led by Bristol-Myers Squibb · Updated on 2025-06-12
900
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently pregnant during the enrollment period
- Diagnosed with psoriasis for deucravacitinib-exposed and psoriasis disease-matched cohorts, validated by medical records when possible
- Exposure to deucravacitinib any time from 2 days before conception to end of pregnancy for the deucravacitinib-exposed cohort
- Exposure to other systemic treatments for psoriasis allowed in the disease-matched cohort
- Agree to study conditions including interview schedule, release of medical records, and infant dysmorphology examination
- Pregnant without psoriasis or autoimmune diseases for non-disease unexposed cohort
- Agree to study conditions including interview schedule, release of medical records, and infant dysmorphology examination
You will not qualify if you...
- Previous pregnancy enrollment in this cohort study
- Use of deucravacitinib for conditions other than psoriasis
- No exposure to deucravacitinib from 2 days before conception to end of pregnancy for deucravacitinib cohort
- Exposure to other oral TYK2 or JAK inhibitors within 5 half-lives of conception to end of pregnancy
- Exposure to methotrexate or oral retinoids
- Retrospective enrollment after pregnancy outcome is known
- Positive diagnostic test for major congenital malformations prior to enrollment
- Exposure to known or suspected human teratogens during pregnancy (non-disease cohort)
- Diagnosis of psoriasis or other autoimmune diseases (non-disease cohort)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment through pregnancy until birth
Participants are observed during pregnancy to assess exposure to treatments and pregnancy outcomes.
Regular interviews and medical record reviews as scheduled
Duration - Up to 1 year post pregnancy outcome
Participants and their infants are monitored for up to 1 year post-pregnancy to assess infant outcomes including congenital malformations.
Scheduled infant dysmorphology examinations and follow-up interviews
Trial Site Locations
Total: 1 location
1
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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