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

NCT06710470 | Active Not Recruiting FDA Drug

• 1 other identifier: IM011-201
• Study Type: observational
• Target: 833
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of infants born with Major Congenital Malformations (MCMs)

  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)

  Up to 12 months after birth or date of health plan disenrollment

Secondary Outcomes (2)

• Pregnancy outcomes

  Up to 9 months or date of health plan disenrollment

• Infant outcomes

  Up to 12 months after birth or date of health plan disenrollment

Study Arms (9)

Cohort 1

Participants exposed to deucravacitinib for the full pregnancy duration

Drug: Deucravacitinib

Cohort 2

Participants exposed to deucravacitinib for the first trimester

Drug: Deucravacitinib

Cohort 3

Participants exposed to deucravacitinib for the first 20 weeks of gestation

Drug: Deucravacitinib

Cohort 4

Participants exposed to other systemic psoriasis medications for the full pregnancy duration

Drug: Systemic psoriasis medications

Cohort 5

Participants exposed to other systemic psoriasis medications for the first trimester

Drug: Systemic psoriasis medications

Cohort 6

Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation

Drug: Systemic psoriasis medications

Cohort 7

Participants not exposed to any systemic medications for the full pregnancy duration

Other: No systemic medications

Cohort 8

Participants not exposed to any systemic medications during the first trimester

Other: No systemic medications

Cohort 9

Participants not exposed to any systemic medications during the first 20 weeks of gestation

Other: No systemic medications

Interventions

Deucravacitinib DRUG

As per product label

Cohort 1; Cohort 2; Cohort 3

Systemic psoriasis medications DRUG

As per product label

Cohort 4; Cohort 5; Cohort 6

No systemic medications OTHER

Participants not exposed to any systemic medications

Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include women aged 15 through 50 years with psoriasis who become pregnant (based on their estimated date of conception) from 09-Sep-2022 through 31-Oct-2026 that have been identified in the Optum Research Database (ORD).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol-Meyers Squibb

Lawrenceville, New Jersey, 08648, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2029
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)