Actively Recruiting
A Study to Assess Deucravacitinib Safety in Pregnancy
Led by Bristol-Myers Squibb · Updated on 2025-06-12
900
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 (PsO) validated by medical records when possible (for cohorts 1 and 2)
- Exposure to deucravacitinib from 2 days prior to conception to end of pregnancy (cohort 1)
- Exposure to other systemic psoriasis treatments allowed (cohort 2)
- Agree to study conditions including interview schedule, medical record release, and infant dysmorphology exam
- Pregnant women without psoriasis but agreeing to study conditions (cohort 3)
You will not qualify if you...
- Previous participation in this cohort study with another pregnancy
- Use of deucravacitinib for conditions other than psoriasis (cohort 1)
- No exposure to deucravacitinib from 2 days prior to conception to end of pregnancy (cohort 1)
- Use of other oral TYK2 or JAK inhibitors within 5 half-lives of conception to end of pregnancy (cohorts 1 and 2)
- Use of methotrexate or oral retinoids
- Retrospective enrollment after pregnancy outcome is known
- Positive test results for major congenital malformations before enrollment
- Exposure to known, possible, or suspected human teratogens during pregnancy (cohort 3)
- Diagnosis of psoriasis or other autoimmune diseases (cohort 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
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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