NCT04119050

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

Detailed description

The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.

Conditions

• Warm Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	M281	M281 injection administered as intravenous infusion
DRUG	Placebo	Placebo administered as intravenous infusion

Timeline

• Start date: 2019-08-15
• Primary completion: 2025-02-02
• Completion: 2028-04-01
• First posted: 2019-10-08
• Last updated: 2026-04-13

Locations

171 sites across 19 countries: United States, Brazil, China, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Poland, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study