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

Part of paid clinical trials in Orange, California.

Sponsor
Chugai Pharmaceutical
Study ID
NCT06371417
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • RAY121 — DRUG
    Injection

Study Details

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).

Key Dates

Start date
Aug 19, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RAY121
    All enrolled patients will receive RAY121 multiple dose

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: Baseline to Week 32 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California-IrvineOrangeCalifornia92868-
Johns Hopkins UniversityBaltimoreMaryland21224-
Northwell Health, LLC PRIMELake SuccessNew York11042-
Hospital for Special SurgeryNew YorkNew York10021-
Universtity of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Ohio State UniversityColumbusOhio43203-
Oregon Health & Science UniversityPortlandOregon97239-
University of Pennsylvania, Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
Amarillo Center for Clinical ResearchAmarilloTexas79124-
Austin Neuromuscular CenterAustinTexas78759-
Nerve and Muscle Center of TexasHoustonTexas77030-

Find similar trials in Orange, CA

By research site
University of California-Irvine· Orange, CAJohns Hopkins University· Baltimore, MDNorthwell Health, LLC PRIME· Lake Success, NYHospital for Special Surgery· New York, NYUniverstity of North Carolina at Chapel Hill· Chapel Hill, NCOhio State University· Columbus, OH

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