Actively Recruiting

FEMALE
Healthy Volunteers
NCT07017699

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

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of California San Diego

La Jolla, California, United States, 92037

Actively Recruiting

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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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