Resumen

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

Edad: 18 años o más

Gender: All

Fecha de inicio: 08/15/2019

Fecha de finalización principal (estimada): 02/02/2025

Fecha estimada de finalización del estudio: 04/01/2028

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

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.

Criterios de elegibilidad

Edad: 18 años o más

Gender: All

Acepta voluntarios sanos: No

Criterios de inclusión:

* 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