RecruitingPsoriasis (PsO)
A Study to Assess Deucravacitinib Safety in Pregnancy
Eligible age
All ages
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Bristol-Myers Squibb
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
California
La Jolla
Source: ClinicalTrials.gov · NCT07017699 · last updated 2025-06-12