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Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)

NCT06371417•Chugai Pharmaceutical

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•* Persistently positive anticardiolipin (aCL) immunoglobulin G (IgG) isotype
•* Persistently positive anti-beta-2 glycoprotein-1 (aβ2GPI) IgG isotype
+41 more criteria

Exclusion Criteria

•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)
•9. Positive for hepatitis B surface antigen
•10. Positive for hepatitis C virus antibody
+49 more criteria

Locations (67)

University of California-Irvine

Orange, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Northwell Health, LLC PRIME

Lake Success, New York, United States

Hospital for Special Surgery

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Nerve and Muscle Center of Texas

Houston, Texas, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Key Dates

Start Date

August 19, 2024

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

May 20, 2025

Enrollment

144

ESTIMATED participants

Conditions

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

Interventions

RAY121

DRUG

Contacts

Clinical trials information

CONTACT

only use Email clinical-trials@chugai-pharm.co.jp

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases

Hematological Disorders in EHPVO Patients

DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study

OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs