NCT07017699RecruitingNot Applicable
The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
Bristol-Myers Squibb1 site in 1 country900 target enrollmentStarted: March 21, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Number of major congenital malformations among infants
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Cohort 1: Deucravacitinib-exposed cohort
- •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
- •Cohort 2: PsO Disease-matched unexposed comparator cohort
- •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
- •Cohort 3: Non-disease unexposed comparator cohort
- •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 Criteria
- •Cohort 1: Deucravacitinib-exposed cohort
- •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
- •Cohort 2: Disease-matched unexposed comparator cohort
- •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
- •Cohort 3: Non-disease unexposed comparator cohort
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Deucravacitinib Cohort
Pregnant participants with psoriasis exposed to deucravacitinib treatment
Intervention: Deucravacitinib (Drug)
Other Systemic Treatment Cohort
Pregnant participants with psoriasis exposed to other systemic treatments for PsO
Intervention: Other systemic treatments for PsO (Drug)
Outcomes
Primary Outcomes
Number of major congenital malformations among infants
Time Frame: 1-year post pregnancy outcome
Secondary Outcomes
- Number of other pregnancy and infant outcomes(1-year post pregnancy outcome)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their OffspringPsoriasisNCT06710470Bristol-Myers Squibb833
Recruiting
Not Applicable
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®InsomniaNCT06498128Idorsia Pharmaceuticals Ltd.785
Completed
Phase 2
Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)Repeated IVF FailureNCT01978561Nora Therapeutics, Inc.40
Completed
Not Applicable
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV SurveillanceRespiratory Syncytial Virus InfectionsNCT03614676GlaxoSmithKline4,493
Recruiting
Not Applicable
Dengvaxia US Pregnancy RegistryDengue Virus InfectionNCT04486638Sanofi Pasteur, a Sanofi Company500