Clinical Trial: A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia

U.S., July 26 -- ClinicalTrials.gov registry received information related to the study (NCT07086976) titled 'A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia' on July 17.

Brief Summary: This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants >= 18 years of age with a confirmed diagnosis of primary wAIHA.

Following a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib...