Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)

Chugai Pharmaceutical

Summary

This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

Eligibility

Age range: 18–85 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Signed informed consent form 2. Age \>= 18 and \<=75 at the time of signing informed consent form (except for BP; Age \>=18 and \<= 85 with Karnofsky score \>= 60% at screening) 3. Ability to comply with the study protocol 4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods 5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm 6. APS cohort: Established primary APS…

Interventions

Drug
RAY121
Injection

Locations (69)

University of California-Irvine
Orange, California
Johns Hopkins University
Baltimore, Maryland
Northwell Health, LLC PRIME
Lake Success, New York
Hospital for Special Surgery
New York, New York
Universtity of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Ohio State University
Columbus, Ohio