Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
144
Countries
14
Sites
43
Immune-mediated necrotizing myopathy
Key facts
- Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 28 Mar 2025 → ongoing
- Decision date (initial)
- 2025-02-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Immune-mediated necrotizing myopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012503 | Dermatomyositis | 100000004858 |
| 20.0 | PT | 10034277 | Pemphigoid | 100000004858 |
| 20.0 | PT | 10004213 | Behcet's syndrome | 100000004866 |
| 23.0 | LLT | 10083567 | Immune-mediated thrombocytopenia | 10005329 |
| 22.1 | PT | 10083073 | Immune-mediated myositis | 100000004859 |
| 23.0 | LLT | 10083567 | Immune-mediated thrombocytopenia | 10005329 |
| 20.0 | PT | 10002817 | Antiphospholipid syndrome | 100000004851 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chugai Pharmaceutical Co. Ltd.
- Sponsor organisation
- Chugai Pharmaceutical Co. Ltd.
- Address
- 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Chuo-ku
- City
- Chuo
- Postcode
- 103-8324
- Country
- Japan
Scientific contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Public contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Locations
14 EU/EEA countries · 43 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 4 | 1 |
| Bulgaria | Authorised, recruiting | 6 | 3 |
| Croatia | Authorised, recruitment pending | 6 | 6 |
| Czechia | Authorised, recruitment pending | 2 | 1 |
| France | Ongoing, recruiting | 10 | 2 |
| Germany | Authorised, recruitment pending | 9 | 6 |
| Hungary | Authorised, recruitment pending | 7 | 2 |
| Italy | Authorised, recruitment pending | 2 | 3 |
| Netherlands | Authorised, recruitment pending | 6 | 2 |
| Norway | Ongoing, recruiting | 2 | 3 |
| Poland | Ongoing, recruiting | 4 | 1 |
| Portugal | Authorised, recruitment pending | 3 | 2 |
| Romania | Ongoing, recruiting | 7 | 2 |
| Spain | Authorised, recruitment pending | 10 | 9 |
| Rest of world
Taiwan, Turkey, Australia, Canada, Japan
|
— | 66 | — |
Investigational sites
Medical University Of Vienna
Department of Clinical Pharmacology, Waehringer Guertel 18-20, Alsergrund, Vienna
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Rheumatology, Ulitsa Urvich 13, 1612, Sofia
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Clinic of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Department of Clinical Hematology, Ulitsa General Stoletov 2, 6003, Stara Zagora
Specijalna Bolnica Medico
Clinical pharmacology, Agaticeva 8, 51000, Rijeka
Klinicki bolnicki centar Sestre milosrdnice
Dermatovenerology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
KBC Zagreb
Immunodermatology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Specijalna Bolnica Medico
Rheumatology, Agaticeva 8, 51000, Rijeka
Specijalna Bolnica Medico
Hematology, Agaticeva 8, 51000, Rijeka
Specijalna Bolnica Medico
Dermatology and Venerology, Agaticeva 8, 51000, Rijeka
Fakultni Nemocnice Kralovske Vinohrady
Dermatovenerologická klinika, Srobarova 1150/50, Vinohrady, Prague
Centre Hospitalier Universitaire De Montpellier
Rheumatology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopitaux Universitaires Pitie Salpetriere
Internal Medicine and Clinical Immunology, 47 To 83 Boulevard De L Hopital, 75013, Paris
Immanuel Klinik Ruedersdorf
Neurologie, Seebad 82, 15562, Rüdersdorf
Universitaetsklinikum Tuebingen AöR
Hautklinik, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitaetsmedizin Goettingen
Klinik für Neurologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Erlangen AöR
Hautklinik, Ulmenweg 18, Innenstadt, Erlangen
Technische Universitaet Dresden
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Schleswig-Holstein AöR
Institut für Entzündungsmedizin, Ratzeburger Allee 160, 23538, Luebeck
Semmelweis University
Belgyógyászati és Onkológiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
University Of Szeged
Szent-Györgyi Albert Klinikai Központ, Klinikai Farmakológiai Központ Fázis I. Vizsgálóhely, Koranyi Fasor 6, 6720, Szeged
Humanitas Mirasole S.p.A.
Dermatology, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia ed Ematologia Clinica e Sperimentale, Via Piero Maroncelli 40, 47014, Meldola
Ospedale San Giovanni Bosco
SCdU Nefrologia e Dialisi, Piazza Del Donatore Di Sangue 3, 10154, Turin
Universitair Medisch Centrum Groningen
Dermatology, Hanzeplein 1, 9713 GZ, Groningen
Universitair Medisch Centrum Utrecht
Haematology, Heidelberglaan 100, 3584 CX, Utrecht
Helse Stavanger HF
Rheumatology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Sorlandet Sykehus HF
Rheumatology, Egsveien 100, 4615, Kristiansand S
Sykehuset Oestfold HF Kalnes
Hematology, Kalnesveien 300, 1714, Graalum
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Unidade Local De Saude De Gaia/Espinho E.P.E.
Rheumatology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
CCAB Centro Clinico Academico Braga Associacao
Rheumatology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Arensia Clinics S.R.L.
Internal Medicine, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Internal Medicine, Strada Republicii 34-36, 400015, Cluj-Napoca
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Internal Medicine, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Reina Sofia
Rheumatology, Avenida Menendez Pidal S/n, 14004, Cordoba
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Rheumatology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Ramon Y Cajal
Rheumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2026-04-14 | ||||
| France | 2025-04-02 | 2025-04-29 | |||
| Norway | 2026-03-06 | 2026-03-26 | |||
| Poland | 2025-04-02 | 2025-10-02 | |||
| Romania | 2025-03-28 | 2025-08-25 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Austria | Acceptable 2025-02-10
|
2025-02-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-20 | Acceptable 2025-02-10
|
2025-02-20 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-25 | Acceptable 2025-02-10
|
2025-02-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-03 | Acceptable | 2025-03-27 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | Acceptable | 2025-03-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-06 | Austria | Acceptable 2025-07-16
|
2025-07-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-09 | Acceptable 2025-07-16
|
2025-09-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-03 | Acceptable | 2025-11-11 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-11 | Austria | Acceptable | 2026-02-11 |