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Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
NCT06371417 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG RAY121
Study Locations (20)
New South Wales
- Royal Prince Alfred Hospital — Camperdown
- Westmead Hospital — Sydney
- Campbelltown Public Hospital — Sydney
New York
- Northwell Health, LLC PRIME — Lake Success
- Hospital for Special Surgery — New York
Texas
- Amarillo Center for Clinical Research — Amarillo
- Nerve and Muscle Center of Texas — Houston
Victoria
- The Alfred Hospital — Melbourne
- Box Hill Hospital — Melbourne
Sofia City Province
- Diagnostic Consultation Center CONVEX EOOD — Sofia
- "SHATHD" EAD Sofia — Sofia
Alberta
- University of Alberta Hospital - Department of Anesthesiology and Pain Medicine — Edmonton
- University of Alberta Hospital - Dermatology — Edmonton
California
- University of California-Irvine — Orange
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06371417
The ClinicalTrials.gov registry entry for NCT06371417 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chugai Pharmaceutical, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Immune Thrombocytopenia (ITP) appearing as the primary indexed condition, and to 1 intervention — of which RAY121 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06371417 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New South Wales, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06371417 about?
NCT06371417 is a clinical study titled "Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)". 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 antiphospholipi...
What is the current status of trial NCT06371417?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2024-08-19. Estimated completion is 2026-06-30.
What conditions does trial NCT06371417 study?
This clinical trial studies the following conditions: Immune Thrombocytopenia (ITP), Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06371417?
The interventions under investigation include: RAY121 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06371417?
This trial is sponsored by Chugai Pharmaceutical, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06371417 being conducted?
This trial has 20 study locations across California, Maryland, New York, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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