RecruitingPhase 1NCT06371417

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)


Sponsor

Chugai Pharmaceutical

Enrollment

144 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called RAY121 for people with antiphospholipid syndrome (aps), behçet's syndrome (bs), and other related conditions. The study is currently recruiting participants at 69 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRAY121

Injection


Locations(77)

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

Universtity of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 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

Austin Neuromuscular Center

Austin, Texas, United States

Nerve and Muscle Center of Texas

Houston, Texas, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Campbelltown Public Hospital

Sydney, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Box Hill Hospital

Melbourne, Victoria, Australia

AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie

Vienna, Austria

Diagnostic Consultation Center CONVEX EOOD

Sofia, Sofia City Province, Bulgaria

UMHAT Sv Ivan Rilski EAD

Sofia, Sofia City Province, Bulgaria

"SHATHD" EAD Sofia

Sofia, Sofia City Province, Bulgaria

UMHAT "Prof. Dr. St. Kirkovich", AD

Stara Zagora, Stara Zagora Province, Bulgaria

University of Alberta Hospital - Department of Anesthesiology and Pain Medicine

Edmonton, Alberta, Canada

University of Alberta Hospital - Dermatology

Edmonton, Alberta, Canada

The Royal Institution for the Advancement of Learning/McGill University

Montreal, Quebec, Canada

Centre de Rhumatologie de l'Est du Quebec

Rimouski, Quebec, Canada

DIEX Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Clinical Hospital Center "Sestre Milosrdnice"

Zagreb, City of Zagreb, Croatia

University hospital centre Zagreb

Zagreb, City of Zagreb, Croatia

Specialty Hospital Medico

Rijeka, Primorje-Gorski Kotar County, Croatia

Sanatorium Profesora Arenbergera

Prague, Prague, Czechia

Hopital Lapeyronie,Service d'Immuno Rhumatologie

Montpellier, Occitanie, France

AP-HP Hôpital Universitaire Pitié Salpêtrière

Paris, Île-de-France Region, France

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen

Erlangen, Bavaria, Germany

Immanuel Klinik Rudersdorf

Rüdersdorf, Brandenburg, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie

Sachsen, Bundesländer, Germany

Universitaetsmedizin Goettingen

Göttingen, Göttingen District, Germany

Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie

Lübeck, Schleswig-Holstein, Germany

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád-Csanád County, Hungary

Semmelweis Egyetem

Budapest, Hungary

IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

Meldola, Forlì-Cesena Province, Italy

Istituto Clinico Humanitas

Milan, Milan Province, Italy

Ospedale San Giovanni Bosco

Torino, Turin Province, Italy

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Hyōgo, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Kindai University Hospital

Sakai, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Okayama University Hospital

Okayama, Japan

Toyama University Hospital

Toyama, Japan

University Medical Centre Groningen UMCG

Groningen, Groningen Province, Netherlands

UMC Utrecht

Utrecht, Utrecht Province, Netherlands

Sorlandet sykehus Kristiansand

Kristiansand, Agder County, Norway

Stavanger Universitetssjukehus

Stavanger, Rogaland County, Norway

Sykehuset Ostfold Fredrikstad

Fredrikstad, Østfold fylke, Norway

Institute Reumatologii I'm. Eleonory Reicher

Warsaw, Masovian Voivodeship, Poland

Centro Clinico Academico Braga

Braga, Braga District, Portugal

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Vila Nova de Gaia, Porto District, Portugal

Centrul Medical Monza SRL

Bucharest, Bucharest Municipality, Romania

Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.

Cluj-Napoca, Cluj, Romania

Clinica Universidad de Navarra

Pamplona, Community of Madrid & Navarre, Spain

Hospital Universitario Ramon y Cajal, Servicio de Reumatologia

Madrid, Madrid, Spain

Hospital Universitario 12 de October

Madrid, Madrid, Spain

Hospital Universitari Vall d'Hebron, Internal Medicine Dept.

Barcelona, Province of Barcelona and Catalonia, Spain

Hospital Universitario Reina Sofia

Córdoba, Province Of Córdoba, Spain

Hospital Universitario Virgen del Rocio

Seville, Province Of Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taichung Veterans General Hospital

Taipei, Taiwan

Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, Istanbul, Turkey (Türkiye)

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NCT06371417


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