Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
63
Countries
5
Sites
11
Systemic Lupus Erythematosus (SLE)
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
- 11 Oct 2023 → ongoing
- Decision date (initial)
- 2024-08-09
- 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
Systemic Lupus Erythematosus (SLE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
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
5 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 3 | 2 |
| Germany | Ongoing, recruitment ended | 12 | 2 |
| Netherlands | Ongoing, recruitment ended | 8 | 1 |
| Poland | Ongoing, recruitment ended | 6 | 3 |
| Spain | Ongoing, recruitment ended | 6 | 3 |
| Rest of world
Colombia, Thailand, Peru, Malaysia, United Kingdom, Taiwan, Mexico, South Africa
|
— | 28 | — |
Investigational sites
Hopitaux Universitaires Pitie Salpetriere
Internal medicine, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Montpellier
Internal medicine, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Universitaetsklinikum Duesseldorf AöR
Clinic for Rheumatology, Moorenstrasse 5, Bilk, Duesseldorf
Charite Research Organisation GmbH
Rheumatology and Clinical Immunology, Chariteplatz 1, Mitte, Berlin
Centre for Human Drug Research
-, Zernikedreef 8, 2333 CL, Leiden
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Centrum Wsparcia Badań Klinicznych, Ulica Szaserow 128, 04-141, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Dluga 1/2, 61-848, Poznan
Centrum Medyczne Damiana Holding Sp. z o.o.
MICS Centrum Medyczne Damiana, Wałbrzyska, Ul. Walbrzyska 46, 02-739, Warsaw
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 |
|---|---|---|---|---|---|
| France | 2024-10-18 | 2026-01-22 | 2026-05-27 | ||
| Germany | 2024-01-23 | 2024-03-21 | 2026-05-27 | ||
| Netherlands | 2023-10-11 | 2023-12-01 | 2026-05-27 | ||
| Poland | 2023-11-22 | 2024-10-29 | 2026-05-27 | ||
| Spain | 2023-10-18 | 2024-01-11 | 2026-05-27 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-04 | Netherlands | Acceptable with conditions 2023-08-28
|
2023-08-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-13 | Netherlands | Acceptable with conditions 2023-08-28
|
2023-09-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-19 | Acceptable with conditions | 2023-11-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-16 | Netherlands | Acceptable 2024-04-02
|
2024-04-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-03 | Netherlands | Acceptable 2024-04-02
|
2024-05-03 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-05-17 | Acceptable 2024-04-02
|
2024-08-09 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-16 | Netherlands | Acceptable 2024-04-02
|
2024-09-16 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-10 | Netherlands | Acceptable 2024-12-09
|
2024-12-10 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-10 | Netherlands | Acceptable 2024-12-09
|
2025-01-10 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-01-23 | Netherlands | Acceptable 2024-12-09
|
2025-01-23 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-07 | Acceptable | 2025-03-06 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-07 | Acceptable | 2025-03-12 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-02-07 | Acceptable | 2025-03-18 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-07 | Acceptable | 2025-03-14 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-07 | Netherlands | Acceptable | 2025-02-24 |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-06-05 | Netherlands | Acceptable 2025-09-08
|
2025-09-09 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-21 | Netherlands | Acceptable 2025-09-08
|
2025-10-21 |
| 18 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-14 | Netherlands | Acceptable 2026-01-13
|
2026-01-13 |
| 19 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-04-20 | Netherlands | Acceptable 2026-06-01
|
2026-06-01 |