Trials / Completed
CompletedNCT04173442
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 581 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women. The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dupilumab | Dupilumab cohort |
Timeline
- Start date
- 2018-10-24
- Primary completion
- 2025-11-04
- Completion
- 2025-11-04
- First posted
- 2019-11-22
- Last updated
- 2026-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04173442. Inclusion in this directory is not an endorsement.