A Study to Assess Deucravacitinib Safety in Pregnancy

Part of paid clinical trials in La Jolla, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07017699
Status
Recruiting
Apply to this trial

Conditions

  • Psoriasis (PsO)

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Deucravacitinib — DRUG
    According to product label
  • Other systemic treatments for PsO — DRUG
    According to product label

Study Details

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.

Key Dates

Start date
Mar 21, 2025
Status verified
Jun 2025
Primary completion
Apr 1, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
900 participants (estimated)

Arms

  • Arm: Deucravacitinib Cohort
    Pregnant participants with psoriasis exposed to deucravacitinib treatment
  • Arm: Other Systemic Treatment Cohort
    Pregnant participants with psoriasis exposed to other systemic treatments for PsO
  • Arm: Unexposed Cohort
    Pregnant participants without psoriasis or any other autoimmune diseases

Primary Outcome Measure

Number of major congenital malformations among infants [ Time Frame: 1-year post pregnancy outcome ]

Central Contacts

  • BMS Study Connect Contact Center www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92037
www.mothertobaby.org/ongoing-study/sotyktu-deucravacitinib/ The Organization of Teratology Information Specialists (OTIS)
[email protected]
877-311-8972
[email protected]
858-246-1741

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CA

Related Studies