Clinical trial

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

NCT04119050

Name

CR108987

Description

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

Trial arms

Trial start

2019-08-15

Estimated PCD

2025-03-20

Trial end

2028-04-10

Status

Recruiting

Phase

Early phase I

Treatment

M281

M281 injection administered as intravenous infusion

Arms:

M281 administered every 2 weeks (double-blind period), M281 administered every 2 weeks (open-label extension period), M281 administered every 4 weeks (double-blind period), M281 administered every 4 weeks (open-label extension period)

Other names:

Nipocalimab, JNJ-80202135

Placebo

Placebo administered as intravenous infusion

Arms:

M281 administered every 4 weeks (double-blind period), Placebo administered every 2 weeks (double-blind period)

Size

111

Primary endpoint

Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb)

Up to Week 20 of the double-blind period

Eligibility criteria

Inclusion criteria: * Participants greater than or equal to (\>=)18 years of age * Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible) * Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures Exclusion criteria: * Participants must not be pregnant or breastfeeding * Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate * Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 111, 'type': 'ESTIMATED'}}

Updated at

2024-03-27

1 organization

2 products

1 indication

Organization

Janssen Research & Development

Product

Placebo

Indication

Autoimmune Hemolytic Anemia

Product

M281