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NCT06371417 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
A Phase 1 study of Immune Thrombocytopenia (ITP) and Antiphospholipid Syndrome (APS), sponsored by Chugai Pharmaceutical.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT06371417: Recruiting Phase 1 study of Immune Thrombocytopenia (ITP) and Antiphospholipid Syndrome (APS), sponsored by Chugai Pharmaceutical.
NCT06371417 is a Phase 1 study of Immune Thrombocytopenia (ITP) and Antiphospholipid Syndrome (APS) that is actively recruiting participants, run by Chugai Pharmaceutical. The registered enrollment target is 144 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06371417, a Phase 1 study of Immune Thrombocytopenia (ITP) and Antiphospholipid Syndrome (APS), is actively recruiting participants, sponsored by Chugai Pharmaceutical.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Incidence, severity, and causal relationship of AEs
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 |
What NCT06371417 shows while recruiting
NCT06371417 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher).
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.
NCT06371417 names 20 study sites across 13 states, led by New South Wales, New York, Texas.
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).
What interventions are being tested in trial NCT06371417?
The interventions under investigation include: RAY121 (DRUG).
Who is sponsoring clinical trial NCT06371417?
This trial is sponsored by Chugai Pharmaceutical, which has 17 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Immune Thrombocytopenia (ITP)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06371417's enrollment target sits among peer trials
144 394th of 2000 higher than 1,600 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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