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Clinical Trials in Italy / NCT04119050
Active, not recruiting Phase 2/3

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

NCT04119050 · tracked via the Priya Life Science Italy 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)

M281 →Placebo

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
No
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)

FacilityCityRegionStatus
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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A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Recruiting
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A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Active, not recruiting

Other trials for the same condition

A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre) Active, not recruiting
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab 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 Italy