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

Description

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

Conditions

Warm Autoimmune Hemolytic Anemia

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Warm Autoimmune Hemolytic Anemia
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

MemorialCare Medical Group, Fountain Valley, California, United States, 92708

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Riverside

Compassionate Cancer Care, Riverside, California, United States, 92501

Whittier

American Institute of Research, Whittier, California, United States, 90603

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Cooper City

GNP Research, Cooper City, Florida, United States, 33024

Gainesville

University of Florida College of Medicine, Gainesville, Florida, United States, 32610

Jacksonville

21st Century Oncology, Jacksonville, Florida, United States, 32204

Miami Lakes

Lakes Research, Miami Lakes, Florida, United States, 33014

Orlando

AdventHealth Cancer Institute, Orlando, Florida, United States, 32804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2028-04-10