Bullous Pemphigoid Clinical Trials

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

Status: Recruiting
Location: See all (76) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ ・ 3) Cancer-associated myositis

⁃ ・ 4) Significant muscle damage

⁃ ・ 5) Past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease

⁃ ・ 6) Severe respiratory muscle weakness

⁃ ・ 7) Severe bulbar palsy

⁃ ・ 8) Treatment with prohibited medications

• ITP cohort:

⁃ ・ 1) Secondary ITP

⁃ ・ 2) Clinical diagnosis or history of Myelodysplastic Syndrome or autoimmune hemolytic anemia

⁃ ・ 3) History of venous or arterial thrombosis within 12 months

⁃ ・ 4) Patients who experienced major bleeding within 4 weeks

‣ 5\) Treatment with prohibited medications

‣ 6\) Any laboratory test results meet either of the following criteria at screening:

• Hemoglobin \<10 g/dL

∙ Thyroid-stimulating hormone \>= 10 μIU/mL

Locations
United States
California
University of California-Irvine
RECRUITING
Orange
Maryland
Johns Hopkins University
RECRUITING
Baltimore
North Carolina
Universtity of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Northwell Health, LLC PRIME
WITHDRAWN
Lake Success
Hospital for Special Surgery
WITHDRAWN
New York
Ohio
Ohio State University
WITHDRAWN
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania, Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
Texas
Amarillo Center for Clinical Research
WITHDRAWN
Amarillo
Austin Neuromuscular Center
RECRUITING
Austin
Nerve and Muscle Center of Texas
RECRUITING
Houston
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Box Hill Hospital
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Campbelltown Public Hospital
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Sydney
Austria
AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie
WITHDRAWN
Vienna
Bulgaria
Diagnostic Consultation Center CONVEX EOOD
WITHDRAWN
Sofia
SHATHD EAD Sofia
NOT_YET_RECRUITING
Sofia
UMHAT Sv Ivan Rilski EAD
RECRUITING
Sofia
UMHAT Prof. Dr. St. Kirkovich, AD
NOT_YET_RECRUITING
Stara Zagora
Canada
University of Alberta Hospital - Department of Anesthesiology and Pain Medicine
RECRUITING
Edmonton
University of Alberta Hospital - Dermatology
RECRUITING
Edmonton
The Royal Institution for the Advancement of Learning/McGill University
RECRUITING
Montreal
Centre de Rhumatologie de l'Est du Quebec
RECRUITING
Rimouski
DIEX Recherche Sherbrooke Inc.
RECRUITING
Sherbrooke
Croatia
Specialty Hospital Medico
WITHDRAWN
Rijeka
Clinical Hospital Center Sestre Milosrdnice
RECRUITING
Zagreb
University hospital centre Zagreb
NOT_YET_RECRUITING
Zagreb
France
Hopital Lapeyronie,Service d'Immuno Rhumatologie
RECRUITING
Montpellier
AP-HP Hôpital Universitaire Pitié Salpêtrière
RECRUITING
Paris
Germany
Universitaetsklinikum Erlangen
NOT_YET_RECRUITING
Erlangen
Universitaetsmedizin Goettingen
WITHDRAWN
Göttingen
Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie
WITHDRAWN
Lübeck
Immanuel Klinik Rudersdorf
RECRUITING
Rüdersdorf
Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
NOT_YET_RECRUITING
Sachsen
Universitaetsklinikum Tuebingen
NOT_YET_RECRUITING
Tübingen
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
NOT_YET_RECRUITING
Szeged
Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori - IRST
RECRUITING
Meldola
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Milan
Ospedale San Giovanni Bosco
WITHDRAWN
Torino
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō-ku
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Hyogo Prefectural Harima-Himeji General Medical Center
RECRUITING
Himeji
Tokai University Hospital
RECRUITING
Isehara
National Center of Neurology and Psychiatry
RECRUITING
Kodaira
Okayama University Hospital
RECRUITING
Okayama
Toho University Omori Medical Center
RECRUITING
Ōta-ku
Kindai University Hospital
RECRUITING
Sakai
Hokkaido University Hospital
RECRUITING
Sapporo
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING
Sendai
Tohoku University Hospital
RECRUITING
Sendai
The University of Osaka Hospital
RECRUITING
Suita
Toyama University Hospital
NOT_YET_RECRUITING
Toyama
Netherlands
University Medical Centre Groningen UMCG
RECRUITING
Groningen
UMC Utrecht
RECRUITING
Utrecht
Norway
Sykehuset Ostfold Fredrikstad
NOT_YET_RECRUITING
Fredrikstad
Sorlandet sykehus Kristiansand
RECRUITING
Kristiansand
Stavanger Universitetssjukehus
RECRUITING
Stavanger
Poland
Institute Reumatologii I'm. Eleonory Reicher
RECRUITING
Warsaw
Portugal
Centro Clinico Academico Braga
NOT_YET_RECRUITING
Braga
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
NOT_YET_RECRUITING
Vila Nova De Gaia
Romania
Centrul Medical Monza SRL
RECRUITING
Bucharest
Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.
RECRUITING
Cluj-napoca
Spain
Hospital Universitari Vall d'Hebron, Internal Medicine Dept.
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Universitario 12 de October
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal, Servicio de Reumatologia
NOT_YET_RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
WITHDRAWN
Valencia
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Taichung Veterans General Hospital
RECRUITING
Taipei
Turkey
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
WITHDRAWN
Ankara
Istanbul University Istanbul Medical Faculty
WITHDRAWN
Istanbul
Contact Information
Primary
Clinical trials information
clinical-trials@chugai-pharm.co.jp
only use Email
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 144
Treatments
Experimental: RAY121
All enrolled patients will receive RAY121 multiple dose
Sponsors
Leads: Chugai Pharmaceutical

This content was sourced from clinicaltrials.gov