Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
75
Countries
7
Sites
18
Multiple Sclerosis (MS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Jun 2021 → ongoing
- Decision date (initial)
- 2024-03-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509357-31-00
- EudraCT number
- 2020-004122-33
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Multiple Sclerosis (MS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
7 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 9 | 2 |
| Germany | Ongoing, recruiting | 12 | 5 |
| Italy | Ongoing, recruiting | 3 | 2 |
| Poland | Ongoing, recruiting | 10 | 3 |
| Portugal | Ongoing, recruiting | 6 | 3 |
| Romania | Ongoing, recruiting | 13 | 2 |
| Spain | Ongoing, recruiting | 2 | 1 |
| Rest of world
Canada, Moldova, Republic of, Israel, Russian Federation, United States, Serbia
|
— | 20 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Universitaetsklinikum Ulm AöR
Dept. of Neurology, Oberer Eselsberg 45, Eselsberg, Ulm
Klinikum rechts der Isar der TU Muenchen AöR
Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
MS Center Dresden, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Muenster AöR
Klinik u. Poliklinik f. Neurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Tuebingen AöR
Dept. of Neurology, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Ospedale San Raffaele S.r.l.
Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla, Via Olgettina 60, 20132, Milan
IRCCS Foundation Istituto Neurologico Carlo Besta
U.O.C. Neurologia IV - Neuroimmunologia e Malattie Neuromuscolari, Via Giovanni Celoria 11, 20133, Milan
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Neurologiczny, Ul. 3 Maja 13/15, 41-800, Zabrze
Euromedis Sp. z o.o.
Centrum Medyczne EUROMEDIS, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Med Polonia Sp. z o.o.
NA, Obornicka 262, 60-693, Poznan
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Serviço de Neurologia, Rua Doutor Candido Pinho, 4520-211, Santa Maria Da Feira
CCAB Centro Clinico Academico Braga Associacao
Neurologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Sao Jose E.P.E.
Centro de Responsabilidade Integrada de Esclerose Múltipla, Rua Jose Antonio Serrano, 1150-199, Lisbon
Spitalul Clinic Judetean De Urgenta Cluj
Neurology, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Arensia Clinics S.R.L.
Neurology, Intrarea Tudor Stefan 38-40, 011658, Bucharest
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 |
|---|---|---|---|---|---|
| Belgium | 2021-06-01 | 2022-06-08 | |||
| Germany | 2021-09-30 | 2022-07-20 | |||
| Italy | 2021-10-14 | 2024-01-22 | |||
| Poland | 2021-07-14 | 2021-07-15 | |||
| Portugal | 2022-09-12 | 2022-12-14 | |||
| Romania | 2023-05-12 | 2023-06-08 | |||
| Spain | 2025-03-14 | 2025-03-26 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-22 | Germany | Acceptable 2024-03-14
|
2024-03-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-17 | Germany | Acceptable with conditions 2024-08-26
|
2024-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-16 | Germany | Acceptable 2024-11-18
|
2024-11-20 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-12-03 | Acceptable 2024-11-18
|
2025-02-24 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-14 | Acceptable 2024-11-18
|
2025-05-14 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-07 | Germany | Acceptable 2024-11-18
|
2025-07-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-18 | Germany | Acceptable 2024-11-18
|
2025-08-18 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-18 | Germany | Acceptable 2026-01-05
|
2026-01-07 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-12 | Germany | Acceptable 2026-01-05
|
2026-03-12 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-21 | Acceptable | 2026-05-07 |