Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)

Inclusion Criteria: * Male and female patients with a confirmed diagnosis of primary wAIHA or systemic lupus erythematosus (SLE)-associated wAIHA (without other SLE-related manifestations apart from cutaneous and musculoskeletal manifestations) * Participants who have previously failed to maintain a sustained response after treatment with corticosteroids. * Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower. * Up-to-date vaccination status as per local guidelines. * Body mass index (BMI) \>17.5 and \<40 kg/m2 * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Core Part B * Evidence of treatment efficacy to rilzabrutinib as defined by achieving overall response during Part A. * Completion of Part A treatment period (24 weeks). Extended Part B * Completion of Core Part B period. Exclusion Criteria: * Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the participant or compromise the quality of the data derived from his or her participation in the study as determined by the Investigator. * Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years. * Secondary wAIHA from any cause including d…