A Study to Assess Deucravacitinib Safety in Pregnancy

Bristol-Myers Squibb (BMS)

Status

Enrolling

Conditions

Psoriasis (PsO)

Treatments

Drug: Deucravacitinib

Drug: Other systemic treatments for PsO

Study type

Observational

Funder types

Industry

Identifiers

NCT07017699

IM011-1111

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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