Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Eligible age
18–85 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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).
Sponsor: Chugai Pharmaceutical
You may qualify if…
- ✓ 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 defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):
- ✓ Laboratory criteria (aPL profile)
- ✓ Persistently positive lupus anticoagulant (LA) test
You may not qualify if…
- ✕ 1. History of anaphylaxis or hypersensitivity to a biologic agent
- ✕ 2. Active infection requiring systemic antiviral, antibiotics or antifungal
- ✕ 3. Planned surgery during the study
- ✕ 4. Pregnant or breastfeeding, or intending to become pregnant
- ✕ 5. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study
- ✕ 6. Clinically significant ECG abnormalities
- ✕ 7. Illicit drug or alcohol abuse
- ✕ 8. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)
Where it's recruiting
Orange
Baltimore
Lake Success · New York
Chapel Hill
Columbus
Portland
Philadelphia
Amarillo · Austin · Houston
Source: ClinicalTrials.gov · NCT06371417 · last updated 2026-04-02