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

Recruiting now · Phase 1

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

In brief

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 facts

Study ID

NCT06371417

Run by

Chugai Pharmaceutical

People needed

144

Starts

2024-08-19

Expected to finish

2027-06-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of anaphylaxis or hypersensitivity to a biologic agent
• Active infection requiring systemic antiviral, antibiotics or antifungal
• Planned surgery during the study
• Pregnant or breastfeeding, or intending to become pregnant
• Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study
• Clinically significant ECG abnormalities
• Illicit drug or alcohol abuse
• Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)
• Positive for hepatitis B surface antigen
• Positive for hepatitis C virus antibody
• Positive for human immunodeficiency virus antibody
• Evidence of current infection with tuberculosis
• History of cancer within 5 years
• Treatment with investigational therapy within 28 days or 5 half-lives
• Previous and current treatment with anti-C1s antibody at any time
• Other complement inhibitors within 3 months
• Patients who receive any treatments which fall into the Prohibited Therapy Criteria
• Patients with an elevated alanine aminotransferase or aspartate aminotransferase > 1.5 × ULN in combination with an elevated total bilirubin > 1.5 × ULN
• APS cohort:
• 1) APS associated with other systemic autoimmune disease
• 2) Acute thrombosis (arterial or venous acute thrombosis diagnosis) within 30 days before screening
• 3) Patients with thrombotic APS without any anticoagulation treatment
• 4) Treatment with prohibited medications
• BP cohort:
• ・ 1) Initiation of treatment with or increase in the dose of systemic or topical corticosteroid within 2 weeks

Where it is running

• Semmelweis Egyetem — Budapest, Hungary (enrolling)
• IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST — Meldola, Forlì-Cesena Province, Italy (enrolling)
• Hopital Lapeyronie,Service d'Immuno Rhumatologie — Montpellier, Occitanie, France (enrolling)
• Immanuel Klinik Rudersdorf — Rüdersdorf, Brandenburg, Germany (enrolling)
• University of California-Irvine — Orange, California, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• DIEX Recherche Sherbrooke Inc. — Sherbrooke, Quebec, Canada (enrolling)
• Clinical Hospital Center "Sestre Milosrdnice" — Zagreb, City of Zagreb, Croatia (enrolling)
• AP-HP Hôpital Universitaire Pitié Salpêtrière — Paris, Île-de-France Region, France (enrolling)
• Nerve and Muscle Center of Texas — Houston, Texas, United States (enrolling)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
• Westmead Hospital — Sydney, New South Wales, Australia (enrolling)
• Campbelltown Public Hospital — Sydney, New South Wales, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Box Hill Hospital — Melbourne, Victoria, Australia (enrolling)
• University of Pennsylvania, Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• UMHAT Sv Ivan Rilski EAD — Sofia, Sofia City Province, Bulgaria (enrolling)
• Austin Neuromuscular Center — Austin, Texas, United States (enrolling)
• Universtity of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• University of Alberta Hospital - Department of Anesthesiology and Pain Medicine — Edmonton, Alberta, Canada (enrolling)
• University of Alberta Hospital - Dermatology — Edmonton, Alberta, Canada (enrolling)
• The Royal Institution for the Advancement of Learning/McGill University — Montreal, Quebec, Canada (enrolling)
• Centre de Rhumatologie de l'Est du Quebec — Rimouski, Quebec, Canada (enrolling)
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (enrolling)

Full record on ClinicalTrials.gov

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