Deucravacitinib safety during pregnancy.
The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
This project will see if taking deucravacitinib during pregnancy affects pregnancy and baby outcomes for people with psoriasis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Sex | Female |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | Deucravacitinib, methotrexate |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07017699 on ClinicalTrials.gov |
What this trial studies
This observational registry enrolls pregnant people with psoriasis through the North American OTIS registry to capture pregnancy and infant outcomes after exposure to deucravacitinib. Participants are followed in three cohorts: those exposed to deucravacitinib from two days before conception through pregnancy, a disease-matched psoriasis cohort not exposed to deucravacitinib (which may include other systemic treatments), and a non-disease unexposed comparator cohort. Data collection includes structured interviews, medical record review, and dysmorphology examinations of live-born infants. The study is sponsored by Bristol-Myers Squibb and coordinated at participating centers including UC San Diego.
Who should consider this trial
Good fit: Pregnant people with a diagnosis of psoriasis who were exposed to deucravacitinib from two days before conception through the end of pregnancy and who can complete interviews, release medical records, and permit infant examinations.
Not a fit: People who are not pregnant, do not have psoriasis, or who cannot provide medical records or consent to infant exams are unlikely to gain direct benefit from the exposure-specific safety findings.
Why it matters
Potential benefit: If results show no increased risk, the findings could give clearer safety information to help pregnant people and clinicians make treatment decisions about deucravacitinib.
How similar studies have performed: Pregnancy registries have previously provided useful safety data for other systemic psoriasis treatments, but this is among the first focused analyses examining deucravacitinib exposure in pregnancy.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
La Jolla, California
- University of California San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.