Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
100
Countries
6
Sites
16
Systemic Sclerosis
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physical Phenomena [G01], Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Respiratory Tract Diseases [C08], Phenomena and Processes [G] - Immune System Phenomena [G13]
- Trial duration
- 27 Jun 2022 → 11 Jul 2025
- Decision date (initial)
- 2024-02-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502981-26-00
- EudraCT number
- 2021-004578-68
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10042953 | Systemic sclerosis | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4990
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
6 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 4 | 1 |
| France | Ended | 14 | 7 |
| Germany | Ended | 4 | 1 |
| Poland | Ended | 14 | 2 |
| Portugal | Ended | 4 | 2 |
| Spain | Ended | 12 | 3 |
| Rest of world
Mexico, Israel, Argentina, United States, Serbia, United Kingdom
|
— | 48 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Service de médecine interne et immunologie clinique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Toulouse
Service de Médecine Interne et immunologie clinique, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
Service de Rhumatologie, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Bordeaux
Service de Rhumatologie, 12 ème étage, Place Amelie Raba Leon, 33000, Bordeaux
Les Hopitaux Universitaires De Strasbourg
Service d’immunologie clinique, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Service de médecine vasculaire Boulevard de la Chantourne, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Assistance Publique Hopitaux De Paris
Service de Médecine Interne, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Medical Center - University Of Freiburg
Clinic of Rheumatology and Clinical Immunology, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Reumed Sp. z o.o.
Zespół Poradni Specjalistycznych REUMED, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Unidade Local De Saude De Almada-Seixal E.P.E.
Rheumatology, Avenida Torrado Da Silva, 2805-267, Almada
Unidade Local De Saude De Coimbra E.P.E.
Rheumatology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitari Vall D Hebron
Systemic Autoimmune Diseases, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital De La Santa Creu I Sant Pau
Rheumatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
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 | 2022-11-25 | 2023-08-31 | 2024-04-18 | ||
| France | 2022-10-03 | 2023-03-30 | 2024-06-28 | ||
| Germany | 2023-02-23 | 2024-05-07 | |||
| Poland | 2022-10-05 | 2022-12-21 | 2024-06-05 | ||
| Portugal | 2023-03-26 | 2025-01-09 | 2023-08-23 | 2024-06-19 | |
| Spain | 2022-06-27 | 2022-12-19 | 2024-04-23 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Spain | Acceptable 2024-02-19
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-09 | Spain | Acceptable 2024-10-01
|
2024-10-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-31 | Spain | Acceptable 2025-01-16
|
2025-01-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-27 | Spain | Acceptable 2025-01-16
|
2025-03-27 |