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A Study to Assess Deucravacitinib Safety in Pregnancy

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the safety of deucravacitinib during pregnancy by tracking pregnancy and baby health. It includes pregnant people in a North American pregnancy registry who took this drug for psoriasis, plus comparison groups who did not take it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All groups: Be pregnant when you join.
  • All groups: Agree to interviews, sharing medical records, and an exam of your baby after birth to check for differences in body structure.
  • Drug-exposed group: Have psoriasis, a skin disease, confirmed by medical records when possible.
  • Drug-exposed group: Have taken deucravacitinib at any dose for any number of days, from 2 days before conception (when pregnancy begins) through the end of pregnancy.
  • Psoriasis comparison group: Have psoriasis, confirmed by medical records when possible. Treatments that work throughout the body may be allowed.
  • Other comparison group: Be pregnant without psoriasis or another autoimmune disease, where the immune system attacks the body.

Who can't join

  • All groups: You joined this study during an earlier pregnancy, or your current pregnancy ended before you joined.
  • All groups: Before joining, a diagnostic test showed a major birth defect. Other normal or abnormal prenatal test results do not rule you out unless they show a major birth defect.
  • Drug-exposed group: You took deucravacitinib for a condition other than psoriasis, or did not take it during the required time.
  • Drug-exposed group: You took another TYK2 inhibitor or any JAK inhibitor by mouth during the restricted period. These are medicines that block certain immune signals.
  • Both comparison groups: You took deucravacitinib, another TYK2 inhibitor, or any JAK inhibitor by mouth during the restricted period.
  • For the TYK2 and JAK drug rules, the restricted period starts before conception and lasts through pregnancy. The start depends on how long each drug takes to leave the body: 5 half-lives, or five rounds of its amount dropping by half.
  • Drug-exposed and psoriasis comparison groups: You took methotrexate or a retinoid medicine by mouth.
  • Other comparison group: You have psoriasis or another autoimmune disease, or had contact during pregnancy with something known or suspected to cause birth defects, as confirmed by the registry's research center.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA