Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
90
Countries
3
Sites
7
Moderate to Severe Asthma
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] - Immune System Diseases [C20]
- Trial duration
- 1 Mar 2024 → 14 Nov 2025
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Moderate to Severe Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
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
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 3 | 1 |
| Germany | Ended | 22 | 5 |
| Netherlands | Ended | 5 | 1 |
| Rest of world
United Kingdom, Canada
|
— | 60 | — |
Investigational sites
PAREXEL International GmbH
Early Phase Clinical Unit, Klinikum Westend Haus 31, Spandauer Damm 130, Berlin
IKF Pneumologie GmbH & Co. KG
Clinical research centre respiratory diseases, Stresemannallee 3, Sachsenhausen, Frankfurt Am Main
Velocity Clinical Research Germany GmbH
Location Luebeck, Sandstrasse 18, Innenstadt, Luebeck
IKF Pneumologie GmbH & Co. KG
Clinical research centre respiratory diseases, Haifa-Allee 24, Bretzenheim, Mainz
Velocity Clinical Research Germany GmbH
Location Ahrensburg, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
Universitair Medisch Centrum Groningen
Pulmonology, Hanzeplein 1, 9713 GZ, Groningen
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 | 2024-03-22 | 2025-11-13 | 2024-05-16 | 2025-09-15 | |
| Germany | 2024-03-01 | 2025-11-12 | 2024-03-11 | 2025-09-15 | |
| Netherlands | 2024-03-26 | 2025-11-06 | 2024-06-18 | 2025-09-15 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-21 | Germany | Acceptable 2024-01-19
|
2024-01-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-13 | Acceptable 2024-01-19
|
2024-02-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-23 | Germany | Acceptable 2024-07-19
|
2024-07-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-29 | Germany | Acceptable 2024-10-31
|
2024-10-31 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-06 | Germany | Acceptable 2024-10-31
|
2024-11-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-07 | Germany | Acceptable | 2024-12-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-14 | Acceptable | 2024-11-29 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-25 | Acceptable | 2024-12-09 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-05 | Germany | Acceptable | 2025-06-26 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-08 | Germany | Acceptable | 2025-07-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-08-21 | Germany | Acceptable | 2025-09-15 |