Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAY121 | Experimental | All enrolled patients will receive RAY121 multiple dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAY121 | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence, severity, and causal relationship of AEs | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| RAY121 concentration | Serum RAY121 concentration | Baseline to Week 52 |
| Change from baseline in active C1s | Concentration of active C1s will be measured and assessed against baseline values |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co.Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Westmead Hospital |
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to Week 52 |
| Change from baseline in total C1s | Concentration of total C1s will be measured and assessed against baseline values | Baseline to Week 52 |
| Change from baseline in complement activity (classical pathway) | Level of complement activity (classical pathway) will be measured and assessed against baseline values | Baseline to Week 52 |
| Anti-RAY121 antibodies | Titer of anti-RAY121 antibodies | Baseline to Week 52 |
| Sydney |
| New South Wales |
| 2145 |
| Australia |
| Campbelltown Public Hospital | Sydney | New South Wales | 2560 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Box Hill Hospital | Melbourne | Victoria | 3128 | Australia |
| AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie | Vienna | 1090 | Austria |
| Diagnostic Consultation Center CONVEX EOOD | Sofia | Sofia City Province | 1202 | Bulgaria |
| "SHATHD" EAD Sofia | Sofia | Sofia City Province | 1756 | Bulgaria |
| UMHAT "Prof. Dr. St. Kirkovich", AD | Stara Zagora | Stara Zagora Province | 6003 | Bulgaria |
| DiIEX Recherche Sherbrooke, Inc | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Clinical Hospital Center "Sestre Milosrdnice" | Zagreb | City of Zagreb | 10000 | Croatia |
| University hospital centre Zagreb | Zagreb | City of Zagreb | 10000 | Croatia |
| Specialty Hospital Medico | Rijeka | Primorje-Gorski Kotar County | 51000 | Croatia |
| Sanatorium Profesora Arenbergera | Prague | Prague | 11000 | Czechia |
| Hopital Lapeyronie,Service d'Immuno Rhumatologie | Montpellier | Occitanie | 34295 | France |
| AP-HP Hôpital Universitaire Pitié Salpêtrière | Paris | Île-de-France Region | 75013 | France |
| Universitaetsklinikum Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie | Sachsen | Bundesländer | 1307 | Germany |
| Universitaetsmedizin Goettingen | Göttingen | Göttingen District | 3075 | Germany |
| Universitaetsklinikum Schleswig Holstein - Campus Luebeck, Klinik f Dermatologie, Allergologie u Venerologie | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | Csongrád-Csanád County | 6720 | Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST | Meldola | Forlì-Cesena Province | 47014 | Italy |
| Istituto Clinico Humanitas | Milan | Milan Province | 20089 | Italy |
| Ospedale San Giovanni Bosco | Torino | Turin Province | 10154 | Italy |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-0808 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano | Osaka | 586-8521 | Japan |
| Kindai University Hospital | Sakai | Osaka | 589-8511 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Institute of Science Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| National Center of Neurology and Psychiatry | Kodaira | Tokyo | 187-8551 | Japan |
| National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo | 152-8902 | Japan |
| Toho University Omori Medical Center | Ōta-ku | Tokyo | 134-8540 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| University Medical Centre Groningen UMCG | Groningen | Groningen Province | 9713 GZ | Netherlands |
| UMC Utrecht | Utrecht | Utrecht Province | 3584 CX | Netherlands |
| Sorlandet sykehus Kristiansand | Kristiansand | Agder County | 4604 | Norway |
| Stavanger Universitetssjukehus | Stavanger | Rogaland County | 4011 | Norway |
| Institute Reumatologii I'm. Eleonory Reicher | Warsaw | Masovian Voivodeship | 02-637 | Poland |
| Centro Clinico Academico Braga | Braga | Braga District | 471-243 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | Vila Nova de Gaia | Porto District | 4434-502 | Portugal |
| Centrul Medical Monza SRL | Bucharest | Bucharest Municipality | 400015 | Romania |
| Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N. | Cluj-Napoca | Cluj | 11658 | Romania |
| Clinica Universidad de Navarra | Pamplona | Community of Madrid & Navarre | 28027 | Spain |
| Hospital Universitario Ramon y Cajal, Servicio de Reumatologia | Madrid | Madrid | 28034 | Spain |
| Hospital Universitario 12 de October | Madrid | Madrid | 28041 | Spain |
| Hospital Universitari Vall d'Hebron, Internal Medicine Dept. | Barcelona | Province of Barcelona and Catalonia | 08035 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Province Of Córdoba | 14004 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Province Of Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | 46026 | Spain |
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
| Taichung Veterans General Hospital | Taipei | 407219 | Taiwan |
| Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital | Ankara | Ankara | 06200 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty | Istanbul | Istanbul | 34093 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| D010391 | Pemphigoid, Bullous |
| D001528 | Behcet Syndrome |
| D003882 | Dermatomyositis |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D017445 | Skin Diseases, Vascular |
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided