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

Inclusion Criteria:

• Male and female participants with a documented (confirmed) diagnosis of primarywAIHA for at least 3 months.

• Participants who have previously failed to maintain a sustained response aftertreatment with CS (CS-resistance [defined as failure to obtain hemoglobin responsewithin 3 weeks on at least 1 mg/kg or 60 mg prednisone or equivalent per day],CS-dependent wAIHA [defined as need to continue on prednisone or equivalent at adose of >10 mg/day to maintain a response]), or are intolerant or ineligible to CS (defined as with contraindications, pre-existing medical conditions or CS-relatedcomplications that may render CS intolerant or ineligible per the best clinicaljudgement of the investigators).

• Participants with Eastern Cooperative Oncology Group (ECOG) performance status Grade 2 or lower.

• Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• Participants with clinically significant medical history or ongoing chronic illnessthat would jeopardize the safety of the participant or compromise the quality of thedata derived from his or her participation in the study as determined by theInvestigator.

• Participants with medical history of lymphoma, leukemia, or any malignancy withinthe past 5 years except for basal cell or squamous epithelial carcinomas of the skinthat have been resected with no evidence of metastatic disease for the past 3 years.

• Participants with symptomatic herpes zoster within 3 months prior to screening.

• Participants with secondary wAIHA from any cause including drugs, Evans Syndrome,lymphoproliferative disorders (low count monoclonal B-cell lymphocytosis isallowed), infectious or autoimmune disease, or active hematologic malignancies.Participants with positive antinuclear antibodies but without a definitive diagnosisof an autoimmune disease are allowed.

• Participants with history of myelodysplastic syndrome.

• Participants with uncontrolled or active HBV infection or Active HCV infection.

• HIV infection.

• Participants with history of solid organ transplant.

• Participants with a history of active or latent tuberculosis (TB).

• Concurrent treatment with other experimental/investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to treatment start. Participants whopreviously received treatment with BTK inhibitors for wAIHA before Day 1 (randomization) are not eligible.

• Sensitivity to any of the study interventions, or components thereof, or drug orother allergy that, in the opinion of the Investigator, contraindicatesparticipation in the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.