Clinical trial NCT07017699: A Study to Assess Deucravacitinib Safety in Pregnancy
Official title: The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis (PsO)
Keywords: Psoriasis (PsO)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 900
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include pregnant women participating in the The Organization of Teratology Information Specialists (OTIS) pregnancy registry in the US or Canada

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of major congenital malformations among infants
timeFrame: 1-year post pregnancy outcome
Secondary outcomes:
measure: Number of other pregnancy and infant outcomes
timeFrame: 1-year post pregnancy outcome
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: