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Deucravacitinib Safety in Pregnancy Study for Psoriasis

This study is looking at the safety of deucravacitinib (a drug that works by affecting TYROSINE KINASE, a protein involved in cell signaling) and other systemic treatments for psoriasis (a skin condition) during pregnancy. It aims to understand how these treatments affect pregnant individuals and their babies. You may be able to join if you are currently pregnant, have psoriasis, and have been exposed to deucravacitinib at any time from 2 days before conception until the end of your pregnancy. The main goal is to count the number of major birth defects in infants, measured up to one year after birth. This is an observational study, meaning researchers will collect information without giving you a specific treatment. The study plans to include 900 participants, but its current status is unclear.

Study design
This is an observational study that plans to enroll 900 pregnant women who have psoriasis and have been exposed to deucravacitinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Infants will be followed for one year after birth to check for major congenital malformations.

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NCT07017699

A Study to Assess Deucravacitinib Safety in Pregnancy

Recruiting
Not specifiedAll AgesObservational
Bristol-Myers Squibb
~900 participants
Updated 2025-06-12 on ClinicalTrials.gov
What's tested:DeucravacitinibOther systemic treatments for PsO

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of major congenital malformations among infants
Measured over 1-year post pregnancy outcome

Conditions

Psoriasis (PsO)

Explore related trials

Psoriasis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Bristol Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Currently pregnant during the enrollment period
Diagnosed with psoriasis (PsO) validated by medical records when possible
Exposure to deucravacitinib for any number of days, at any dose, and at any time from 2 days prior to date of conception (DOC) to the end of pregnancy
Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
Currently pregnant during the enrollment period
Diagnosed with PsO validated by medical records when possible
May be exposed to systemic treatments for PsO
Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants
Currently pregnant during the enrollment period
Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants

Exclusion

Pregnant women who have enrolled in this cohort study with a previous pregnancy
Pregnant women who have used deucravacitinib for an indication other than PsO
Women who do not have exposure to deucravacitinib anytime from 2 days prior to DOC to the end of pregnancy
Women who have exposure to another oral tyrosine kinase 2 (TYK2) inhibitor or any oral Janus kinase (JAK) inhibitor from within 5 half-lives of DOC to the end of pregnancy
Women who have exposure to methotrexate or an oral retinoid
Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
Results of a diagnostic test are positive for an major congenital malformation(s) (MCM) prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
Pregnant women who have enrolled in this cohort study with a previous pregnancy
Women who have exposure to deucravacitinib or any other oral TYK2 inhibitor except deucravacitinib, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
Women who have exposure to methotrexate or an oral retinoid
Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
Pregnant women who have enrolled in this cohort study with a previous pregnancy
Women who have had exposure to deucravacitinib or any other oral TYK2 inhibitor, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy
Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment)
Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM
Women exposed to a known, possible, or suspected human teratogen during pregnancy as confirmed by the OTIS Research Center (see Appendix 3 for list of known, possible, and suspected human teratogens)
Women who are diagnosed with PsO, or any other autoimmune disease

What this trial measures

  • Number of major congenital malformations among infants1-year post pregnancy outcome