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Recruiting NCT07017699

A Study to Assess Deucravacitinib Safety in Pregnancy

— Observational Psoriasis (PsO)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deucravacitinib, Other systemic treatments for PsO.
Who it may be relevant to
Registry conditions: Psoriasis (PsO). Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Deucravacitinib
    According to product label
  • Drug Other systemic treatments for PsO
    According to product label

Primary outcome measures

  • Number of major congenital malformations among infants [Time frame: 1-year post pregnancy outcome]
Secondary outcome measures (1)
  • Number of other pregnancy and infant outcomes [Time frame: 1-year post pregnancy outcome]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California San Diego — La Jolla

Identifiers

NCT: NCT07017699 · IM011-1111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗