Phase 1 Study of SAR448501DR-0201 for Safety and Activity in Adults With Select Autoimmune Rheumatic Diseases Including SLE and RA

What this Trial Is About

Researchers are evaluating SAR448501DR-0201 in adults with select autoimmune rheumatic diseases, including systemic lupus erythematosus SLE and rheumatoid arthritis RA. This open-label, phase 1 study aims to find optimal doses by studying safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial clinical responses. The study is sponsored by Sanofi and involves patients who meet specific disease activity and treatment history criteria. Participants will receive SAR448501 for up to 71 days, with multiple dose levels tested across different cohorts. Following treatment, a 42-week follow-up period will monitor participants, and if needed, visits will continue every 4 weeks until their blood B cells return to near-normal levels. This multi-ascending dose design allows careful observation of effects at increasing doses. Throughout the approximately 13-month participation, individuals will undergo screening, treatment, and extended follow-up. Assessments include monitoring adverse events, pharmacokinetic parameters, anti-drug antibodies, and clinical responses. Safety evaluations cover treatment-emergent adverse events and clinically significant abnormalities up to one year after treatment. Participants will have regular visits and blood tests to track progress and safety.

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases