Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04119050

Active Not RecruitingPhase 2, Phase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Warm Autoimmune Hemolytic Anemia

Interventions: M281, Placebo

Countries: United States, Brazil, China, Czechia, Egypt, France, Germany, Greece

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (171)
  • Fountain Valley, California, United States
  • Los Angeles, California, United States
  • Riverside, California, United States
  • Whittier, California, United States
  • Aurora, Colorado, United States
  • Cooper City, Florida, United States
  • Gainesville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • St. Petersburg, Florida, United States
  • Chicago, Illinois, United States
  • Merriam, Kansas, United States
  • New Orleans, Louisiana, United States
  • Detroit, Michigan, United States
  • Kansas City, Missouri, United States
  • Lake Success, New York, United States
  • Lake Success, New York, United States
  • Nyack, New York, United States
  • Durham, North Carolina, United States
  • Greenville, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Salt Lake City, Utah, United States
  • Tacoma, Washington, United States
  • Madison, Wisconsin, United States
  • Botucatu, Brazil
  • + 141 more on CT.gov