Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease

Condition studied

Sickle Cell Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Number and percentage of subjects with Treatment Emergent Adverse Events (TEAEs), overall and by severity, seriousness and relationship to Investigational Product (IP), Number and percentage of subjects with Adverse Events of Special Interest (AESIs), Clinically relevant changes from baseline in laboratory assessments and vital signs

Endpoint detail

From the first dose of anumigilimab through Week 65: • Serum anumigilimab, During the 52-week Maintenance Period: • Annualized rate of Vaso-occlusive crisis (VOC) (medical facility)