Phase 1b Study of RAY121 Injection for Treating Various Immunological Diseases Including APS, BP, BS, DM, IMNM, and ITP

What this Trial Is About

Researchers are evaluating RAY121, an inhibitor of the classical complement pathway, in a Phase 1b basket trial involving patients with various immunological diseases including antiphospholipid syndrome, bullous pemphigoid, Behets syndrome, dermatomyositis, immune-mediated necrotizing myopathy, and immune thrombocytopenia. This study aims to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of multiple doses of RAY121 in these patient populations. All enrolled patients will receive multiple doses of RAY121 administered by injection. The study is designed as a single-group trial where participants receive the experimental treatment without comparison to placebo or other interventions. Treatment monitoring and assessments will continue up to 32 weeks following the baseline visit to evaluate the effects and behavior of the drug in the body. Participants will be involved in regular assessments including monitoring for adverse events, measurement of drug concentration and activity, complement pathway activity, and antibody formation against RAY121 from baseline through week 32. The study includes safety evaluations and collection of pharmacokinetic and pharmacodynamic data to understand how the drug works and is tolerated over time. The total participation duration may last up to 32 weeks with ongoing monitoring throughout this period.

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)