A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

Part of paid clinical trials in Lawrenceville, New Jersey.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06710470
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Deucravacitinib — DRUG
    As per product label
  • Systemic psoriasis medications — DRUG
    As per product label
  • No systemic medications — OTHER
    Participants not exposed to any systemic medications

Study Details

This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.

Key Dates

Start date
Aug 2, 2024
Status verified
Nov 2024
Primary completion
Jan 31, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
833 participants (estimated)

Arms

  • Arm: Cohort 1
    Participants exposed to deucravacitinib for the full pregnancy duration
  • Arm: Cohort 2
    Participants exposed to deucravacitinib for the first trimester
  • Arm: Cohort 3
    Participants exposed to deucravacitinib for the first 20 weeks of gestation
  • Arm: Cohort 4
    Participants exposed to other systemic psoriasis medications for the full pregnancy duration
  • Arm: Cohort 5
    Participants exposed to other systemic psoriasis medications for the first trimester
  • Arm: Cohort 6
    Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
  • Arm: Cohort 7
    Participants not exposed to any systemic medications for the full pregnancy duration
  • Arm: Cohort 8
    Participants not exposed to any systemic medications during the first trimester
  • Arm: Cohort 9
    Participants not exposed to any systemic medications during the first 20 weeks of gestation

Primary Outcome Measure

Number of infants born with Major Congenital Malformations (MCMs) [ Time Frame: Up to 12 months after birth or date of health plan disenrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Bristol-Meyers SquibbLawrencevilleNew Jersey08648-

Find similar trials in Lawrenceville, NJ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Bristol-Meyers Squibb· Lawrenceville, NJ

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