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NCT04173442 · ClinicalTrials.gov registry record
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
A clinical trial, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- 581
- Enrollment target
NCT04173442: Completed study, sponsored by Regeneron Pharmaceuticals.
NCT04173442 is a clinical trial that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 581 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04173442 has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- 581 participants
- Enrollment target
Study 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.
Primary Outcome
Defined and classified using the Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
Interventions
- DRUG dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2025-11-04 |
What the finished NCT04173442 record still lists
NCT04173442 is an observational study that tracks outcomes without assigning an intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which dupilumab is the first listed.
NCT04173442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04173442 about?
NCT04173442 is a clinical study titled "Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy". 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 majo...
What is the current status of trial NCT04173442?
This trial is currently completed. The enrollment target is 581 participants. The study started on 2018-10-24. Estimated completion is 2025-11-04.
What interventions are being tested in trial NCT04173442?
The interventions under investigation include: dupilumab (DRUG).
Who is sponsoring clinical trial NCT04173442?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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