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Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

NCT06371417 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-07-22

No results posted yet for this 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

  • Antiphospholipid Syndrome (APS)
  • Bullous Pemphigoid (BP)
  • Behçet's Syndrome (BS)
  • Dermatomyositis (DM)
  • Immune-mediated Necrotizing Myopathy (IMNM)
  • Immune Thrombocytopenia (ITP)

Interventions

DRUG

RAY121

Injection

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371417 on ClinicalTrials.gov