A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
Status
Active, not recruiting
Conditions
Psoriasis
Treatments
Drug: Deucravacitinib
Other: No systemic medications
Drug: Systemic psoriasis medications
Details and patient eligibility
About
This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.
Enrollment
833 estimated patients
Sex
Female
Ages
15 to 50 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Maternal age 15 through 50 years at date of conception
- Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
- Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy
Exclusion criteria
• Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window
Trial design
833 participants in 9 patient groups
Cohort 1
Description:
Participants exposed to deucravacitinib for the full pregnancy duration
Treatment:
Drug: Deucravacitinib
Cohort 2
Description:
Participants exposed to deucravacitinib for the first trimester
Treatment:
Drug: Deucravacitinib
Cohort 3
Description:
Participants exposed to deucravacitinib for the first 20 weeks of gestation
Treatment:
Drug: Deucravacitinib
Cohort 4
Description:
Participants exposed to other systemic psoriasis medications for the full pregnancy duration
Treatment:
Drug: Systemic psoriasis medications
Cohort 5
Description:
Participants exposed to other systemic psoriasis medications for the first trimester
Treatment:
Drug: Systemic psoriasis medications
Cohort 6
Description:
Participants exposed to other systemic psoriasis medications for the first 20 weeks of gestation
Treatment:
Drug: Systemic psoriasis medications
Cohort 7
Description:
Participants not exposed to any systemic medications for the full pregnancy duration
Treatment:
Other: No systemic medications
Cohort 8
Description:
Participants not exposed to any systemic medications during the first trimester
Treatment:
Other: No systemic medications
Cohort 9
Description:
Participants not exposed to any systemic medications during the first 20 weeks of gestation
Treatment:
Other: No systemic medications
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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