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NCT Number: NCT06710470

A 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Bristol-Meyers Squibb

Lawrenceville, New Jersey, 08648, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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