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Clinical Trials in Taiwan / NCT06723106
Enrolling by invitation Phase 1

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

NCT06723106 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 1
Started
2024-12-09
Last updated
2026-07-17

Condition(s) studied

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

Investigational drug(s) / intervention(s)

RAY121 →

RAY121: Injection

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent form 2. Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses 3. Ability to comply with the study protocol, in the investigator's judgment 4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of RAY121 5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: 1. History of anaphylaxis or hypersensitivity to a biologic agent 2. Known active infection with encapsuled bacteria 3. History of Neisseria meningitidis infection 4. Planned surgery 5. Pregnant or breastfeeding, or intending to become pregnant 6. Clinically significant electrocardiogram abnormalities 7. Illicit drug or alcohol abuse 8. Known or suspected immune deficiency 9. Treatment with investigational therapy other than RAY121 10. Vaccination with a live vaccine within 4 weeks

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Camperdown New South Wales
Westmead Hospital Sydney New South Wales
Campbelltown Public Hospital Sydney New South Wales
The Alfred Hospital Melbourne Victoria
Box Hill Hospital Melbourne Victoria
AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie Vienna Austria
Diagnostic Consultation Center CONVEX EOOD Sofia Sofia City Province
"SHATHD" EAD Sofia Sofia Sofia City Province
UMHAT "Prof. Dr. St. Kirkovich", AD Stara Zagora Stara Zagora Province
DiIEX Recherche Sherbrooke, Inc Sherbrooke Quebec
Clinical Hospital Center "Sestre Milosrdnice" Zagreb City of Zagreb
University hospital centre Zagreb Zagreb City of Zagreb
Specialty Hospital Medico Rijeka Primorje-Gorski Kotar County
Sanatorium Profesora Arenbergera Prague Prague
Hopital Lapeyronie,Service d'Immuno Rhumatologie Montpellier Occitanie
AP-HP Hôpital Universitaire Pitié Salpêtrière Paris Île-de-France Region
Universitaetsklinikum Tuebingen Tübingen Baden-Wurttemberg
Universitaetsklinikum Erlangen Erlangen Bavaria
Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie Sachsen Bundesländer
Universitaetsmedizin Goettingen Göttingen Göttingen District
Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie Lübeck Schleswig-Holstein
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged Csongrád-Csanád County
Semmelweis Egyetem Budapest Hungary
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST Meldola Forlì-Cesena Province
Istituto Clinico Humanitas Milan Milan Province
Ospedale San Giovanni Bosco Torino Turin Province
Hokkaido University Hospital Sapporo Hokkaido
Hyogo Prefectural Harima-Himeji General Medical Center Himeji Hyōgo
Tokai University Hospital Isehara Kanagawa
Tohoku University Hospital Sendai Miyagi
Tohoku Medical and Pharmaceutical University Hospital Sendai Miyagi
National Hospital Organization Osaka Minami Medical Center Kawachi-Nagano Osaka
Kindai University Hospital Sakai Osaka
The University of Osaka Hospital Suita Osaka
Hamamatsu University Hospital Hamamatsu Shizuoka
Institute of Science Tokyo Hospital Bunkyo-ku Tokyo
National Center of Neurology and Psychiatry Kodaira Tokyo
National Hospital Organization Tokyo Medical Center Meguro-ku Tokyo
Toho University Omori Medical Center Ōta-ku Tokyo
National Hospital Organization Kyushu Medical Center Fukuoka Japan

+ 22 more sites — see the full list on the official registry below.

More Chugai Pharmaceutical trials in Taiwan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06723106 on ClinicalTrials.gov ↗ ← All trials in Taiwan