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

November 26, 2024 updated by: Bristol-Myers Squibb

Deucravacitinib Pregnancy Study: A Retrospective Observational Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

833

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Bristol-Meyers Squibb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Participants exposed to deucravacitinib for the full pregnancy duration
Drug: Deucravacitinib
As per product label
Cohort 2
Participants exposed to deucravacitinib for the first trimester
Drug: Deucravacitinib
As per product label
Cohort 3
Participants exposed to deucravacitinib for the first 20 weeks of gestation
Drug: Deucravacitinib
As per product label
Cohort 4
Participants exposed to other systemic psoriasis medications for the full pregnancy duration
Drug: Systemic psoriasis medications
As per product label
Cohort 5
Participants exposed to other systemic psoriasis medications for the first trimester
Drug: Systemic psoriasis medications
As per product label
Cohort 6
Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
Drug: Systemic psoriasis medications
As per product label
Cohort 7
Participants not exposed to any systemic medications for the full pregnancy duration
Other: No systemic medications
Participants not exposed to any systemic medications
Cohort 8
Participants not exposed to any systemic medications during the first trimester
Other: No systemic medications
Participants not exposed to any systemic medications
Cohort 9
Participants not exposed to any systemic medications during the first 20 weeks of gestation
Other: No systemic medications
Participants not exposed to any systemic medications

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy outcomes
Time Frame: 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
Up to 9 months or date of health plan disenrollment
Infant outcomes
Time Frame: 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
Up to 12 months after birth or date of health plan disenrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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