Trials / Recruiting
RecruitingNCT05912517
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nipocalimab | Nipocalimab will be administered as an intravenous infusion. |
| DRUG | Placebo | Placebo will be administered as an intravenous infusion. |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2027-08-05
- Completion
- 2029-10-08
- First posted
- 2023-06-22
- Last updated
- 2026-04-13
Locations
60 sites across 17 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05912517. Inclusion in this directory is not an endorsement.