# A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

> **NCT03842189** · PHASE2 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 25 (actual)

## Conditions studied

- Hemolytic Disease of the Fetus and Newborn

## Interventions

- **DRUG:** M281

## Key facts

- **NCT ID:** NCT03842189
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-04-05
- **Primary completion:** 2024-08-05
- **Final completion:** 2024-08-05
- **Target enrollment:** 25 (ACTUAL)
- **Last updated:** 2026-03-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03842189

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03842189, "A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT03842189. Licensed CC0.

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