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

NCT04119050 · tracked via the Priya Life Science China tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 2/3

Started

2019-08-15

Last updated

2026-08-31

Condition(s) studied

Warm Autoimmune Hemolytic Anemia

Investigational drug(s) / intervention(s)

M281Placebo

M281: M281 injection administered as intravenous infusion

Placebo: Placebo administered as intravenous infusion

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb) — Up to Week 20 of the double-blind period

Trial sites (171)

Facility	City	Region
MemorialCare Medical Group	Fountain Valley	California
University of Southern California	Los Angeles	California
Compassionate Cancer Care	Riverside	California
American Institute of Research	Whittier	California
University of Colorado Anschutz Medical Campus	Aurora	Colorado
GNP Research	Cooper City	Florida
University of Florida College of Medicine	Gainesville	Florida
21st Century Oncology	Jacksonville	Florida
Lakes Research	Miami Lakes	Florida
AdventHealth Cancer Institute	Orlando	Florida
Children's Research Institute	St. Petersburg	Florida
Rush University Medical Center	Chicago	Illinois
Alliance for Multispeciality Research	Merriam	Kansas
Tulane University School of Medicine	New Orleans	Louisiana
Henry Ford Medical Center	Detroit	Michigan
Research Medical Center	Kansas City	Missouri
Montefiore Medical Center	Lake Success	New York
Monter Cancer Center	Lake Success	New York
Hematology Oncology Associates of Rockland	Nyack	New York
Duke University Medical Center	Durham	North Carolina
East Carolina University	Greenville	North Carolina
Taussig Cancer Insititute Cleveland Clinic	Cleveland	Ohio
The Ohio State University- James Cancer Hospital	Columbus	Ohio
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
West Penn Hospital	Pittsburgh	Pennsylvania
University of Utah	Salt Lake City	Utah
Northwest Medical Specialists	Tacoma	Washington
University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
Hospital das Clínicas da Faculdade de Medicina de Botucatu	Botucatu	Brazil
Impar Servicos Hospitalares S/A - Hospital Brasilia	Brasília	Brazil
CTO Centro de Tratamento Oncologico Unidade Belem	Campinas	Brazil
Hospital Das Clinicas Da Universidade Federal De Goias	Goiânia	Brazil
Complexo Hospitalar de Niteroi	Niterói	Brazil
Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite	Recife	Brazil
Nucleo de Oncologia da Bahia	Salvador	Brazil
Hospital Sao Rafael	Salvador	Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia	Santo André	Brazil
Hospital Santa Marcelina	Santo André	Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base	São José do Rio Preto	Brazil

+ 131 more sites — see the full list on the official registry below.

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Other trials for the same condition

Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab Recruiting

Sirolimus in the Treatment of Refractory/Relapsed wAIHA Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04119050 on ClinicalTrials.gov ↗ ← All trials in China