MOM-M281-006, M281
Research type
Research Study
Full title
Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study
IRAS ID
250648
Contact name
Frederick Chen
Contact email
Sponsor organisation
Momenta Pharmaceuticals, Inc.
Eudract number
2019-000720-17
Duration of Study in the UK
1 years, 7 months, 29 days
Research summary
Warm autoimmune hemolytic anemia(wAIHA)is a rare disease that affects the red blood cells and causes anemia. It is considered an autoimmune disorder because the body’s natural defenses destroy healthy tissue(red blood cells)by autoantibodies for unknown reasons. The process leads to premature destruction of healthy red blood cells and low levels of circulating red blood cells causing anemia. Anemia may cause fatigue, a pale skin color, yellowing of the skin and whites of the eyes jaundice, and enlargement of the spleen and liver.M281,an investigative drug, is designed to block a receptor called FcRn, a receptor that is involved in recycling of antibodies. Blocking this receptor results in a reduction of the antibodies that cause warm autoimmune hemolytic anemia and may potentially treat the disease. M281 has been tested in animals and also in healthy human participants for safety evaluation. The purpose of this study is to determine whether M281 is safe in the treatment of this disease, along with the standard treatment.M281 is an experimental drug developed by Momenta Pharmaceuticals. It is expected that approximately 90 participants with wAIHA will be enrolled in this study each receiving 24 weeks of study treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1582
Date of REC Opinion
31 Oct 2019
REC opinion
Further Information Favourable Opinion