Clinical Trials in Italy / 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 Italy tracker
Condition(s) studied
Antiphospholipid Syndrome (APS)Bullous Pemphigoid (BP)Behçet's Syndrome (BS)Dermatomyositis (DM)Immune-mediated Necrotizing Myopathy (IMNM)Immune Thrombocytopenia (ITP)
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
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)
- Adverse events (AEs) — Baseline to Week 52
Incidence, severity, and causal relationship of AEs
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
Prospective Multiethnic Validation of the Behçet's Syndrome Overall Damage Index (BODI)
Active, not recruiting
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 Italy