RECRUITING

A Study to Assess Deucravacitinib Safety in Pregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists \[OTIS\]) who were exposed to deucravacitinib.

Official Title

The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy

Quick Facts

Study Start:2025-03-21

Study Completion:2029-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07017699

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.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* 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
* 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Principal Investigator

Bristol Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

University of California San Diego

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2025-03-21

Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-03-21

Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

Psoriasis (PsO)

Additional Relevant MeSH Terms

Psoriasis (PsO)