Trials / Recruiting
RecruitingNCT06371417
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Antiphospholipid Syndrome (APS)
- Bullous Pemphigoid (BP)
- Behçet's Syndrome (BS)
- Dermatomyositis (DM)
- Immune-mediated Necrotizing Myopathy (IMNM)
- Immune Thrombocytopenia (ITP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RAY121 | Injection |
Timeline
- Start date
- 2024-08-19
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2024-04-17
- Last updated
- 2026-04-02
Locations
69 sites across 20 countries: United States, Australia, Austria, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Portugal, Romania, Spain, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06371417. Inclusion in this directory is not an endorsement.