Last updated 9 days ago
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
90 patients around the world
Available in Brazil, Argentina
Sanofi
3Research sites
90Patients around the world
This study is for people with
Anemia
Warm Autoimmune Hemolytic Anemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male and female participants with a confirmed diagnosis of primary wAIHA for at least 3 months.Participants who have previously failed to maintain a sustained response after treatment with CS.CS-resistance defined as failure to obtain hemoglobin response within 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 a dose of >10 mg/day to maintain a response.Participants who are intolerant or ineligible to CS defined as with contraindications, pre-existing medical conditions or CS-related complications that may render CS intolerant or ineligible per the best clinical judgement 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 regulations regarding the methods of contraception for those participating in clinical studies.
- Participants with 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.Participants with symptomatic herpes zoster within 3 months prior to screening.Participants with secondary wAIHA from any cause including drugs, Evans Syndrome, lymphoproliferative disorders.Participants with positive antinuclear antibodies but without a definitive diagnosis of 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 who previously received treatment with BTK inhibitors for wAIHA before Day 1 are not eligible.Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
Sites
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Hospital das Clínicas da FMUSP - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Recruiting
StudyLUMINA 3
SponsorSanofi
Study typeInterventional
Conditions
Warm Autoimmune Hemolytic Anemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07086976
