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ENROLLING BY INVITATION
NCT06723106
PHASE1

Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)

Sponsor: Chugai Pharmaceutical

View on ClinicalTrials.gov

Summary

This is a long-term extension trial of RAY121 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).

Official title: Phase 1b Open-label, Long-term Extension Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW-LTE Trial)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-12-09

Completion Date

2027-04-30

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

RAY121

Injection

Locations (58)

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

"SHATHD" EAD Sofia

Sofia, Sofia City Province, Bulgaria

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

Stara Zagora, Stara Zagora Province, Bulgaria

DiIEX 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

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

Tohoku University Hospital

Sendai, Miyagi, Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

Kindai University Hospital

Sakai, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Okayama University Hospital

Okayama, 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

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)