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

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: Deucravacitinib; Drug: Systemic psoriasis medications; Other: No systemic medications

• Registration Number: NCT06710470
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-02
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2027-01-31
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 833

Inclusion Criteria

• Maternal age 15 through 50 years at date of conception
• Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
• Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
• Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy

Exclusion Criteria

• Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Deucravacitinib	Participants exposed to deucravacitinib for the full pregnancy duration
Cohort 2	Deucravacitinib	Participants exposed to deucravacitinib for the first trimester
Cohort 3	Deucravacitinib	Participants exposed to deucravacitinib for the first 20 weeks of gestation
Cohort 4	Systemic psoriasis medications	Participants exposed to other systemic psoriasis medications for the full pregnancy duration
Cohort 5	Systemic psoriasis medications	Participants exposed to other systemic psoriasis medications for the first trimester
Cohort 6	Systemic psoriasis medications	Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
Cohort 7	No systemic medications	Participants not exposed to any systemic medications for the full pregnancy duration
Cohort 8	No systemic medications	Participants not exposed to any systemic medications during the first trimester
Cohort 9	No systemic medications	Participants not exposed to any systemic medications during the first 20 weeks of gestation

Primary Outcome Measures

Name	Time	Method
Number of infants born with Major Congenital Malformations (MCMs)	Up to 12 months after birth or date of health plan disenrollment	MCMs defined as a structural abnormality with surgical, medical, or cosmetic importance (excluding chromosomal abnormalities or physiological features due to complications of prematurity, such as cryptorchidism, inguinal hernia, or isolated patent ductus arteriosus in infants born less than 37 weeks of gestation)

Secondary Outcome Measures

Name	Time	Method
Pregnancy outcomes	Up to 9 months or date of health plan disenrollment	Incidence of the following pregnancy outcomes: spontaneous abortion, induced abortion, ectopic pregnancy, stillbirth, pre-eclampsia, eclampsia and gestational diabetes
Infant outcomes	Up to 12 months after birth or date of health plan disenrollment	Incidence of the following infant outcomes: small for gestational age, large for gestational age, low birthweight, preterm birth, serious or opportunistic infections, postnatal growth deficiency, infant developmental deficiency, neonatal hospitalization, and infant/neonatal/perinatal death

Trial Locations

Locations (1)

Bristol-Meyers Squibb; 🇺🇸 Lawrenceville, New Jersey, United States