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: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.
Inclusion criteria:
Exclusion criteria:
São José do Rio Preto, 15090 000, Brazil
Wuhan, 430022, China
Budapest, 1097, Hungary
Gyõr, 9023, Hungary
Kiryat Tzanz, 4244916, Israel
Petach Tikvah, 49100, Israel
Iruma-gun, 350-0495, Japan
Kitakyusyu-Shi, 806-8501, Japan
Johor Bharu, 80100, Malaysia
Amsterdam, 1081 HV Amsterdam, Netherlands
Lodz, 93 510, Poland
Dnipro, 49102, Ukraine