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

NCT04119050 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-05-11

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

M281

M281 injection administered as intravenous infusion

DRUG

Placebo

Placebo administered as intravenous infusion

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2025-02-02
Completion
2028-04-01
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • China
  • Czechia
  • Egypt
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04119050 on ClinicalTrials.gov