A Study to Assess Deucravacitinib Safety in Pregnancy
ConditionPsoriasis (PsO)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorBristol-Myers Squibb
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Deucravacitinib
DrugAccording to product label
Other systemic treatments for PsO
DrugAccording to product label
Treatment groups
900 Participants
are divided into 3 treatment groupsGroup A: Deucravacitinib Cohort1 intervention
Group B: Other Systemic Treatment Cohort1 intervention
Group C: Unexposed Cohort0 interventions
Trial outcomes
Primary outcomes
1
Number of major congenital malformations among infants
Time frame
1-year post pregnancy outcomeSecondary outcomes
1
Number of other pregnancy and infant outcomes
Other pregnancy and infant outcomes include: * Minor congenital malformations, * Small for gestational age * Small for age postnatal growth at 1 year of age * Serious or opportunistic infections * Neonatal hospitalization * Infant deaths * Neonatal deaths * Perinatal deaths * Spontaneous abortions * Stillbirths * Elective terminations/abortions * Preterm deliveries * Preeclampsia/eclampsia * Gestational hypertension
Time frame
1-year post pregnancy outcomeSponsors and contacts
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Source ClinicalTrials.gov