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NCT06710470Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 29 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
833 (estimated)
First submitted
26 Nov 2024
Start date
2 Aug 2024
Primary completion date
31 Jan 2027
Lead sponsor
Bristol-Myers Squibb
Diseases
Psoriasis
NCT number
NCT06710470

What you commit to

  • Study type: Observational
  • Planned participants: 833
  • From 2 Aug 2024 to the primary completion date, 31 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Who the study is looking for

  • 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

Age in the registry: 15 years to 50 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bristol-Meyers Squibb
Coordinator of this site? Confirm its status
LawrencevilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.