Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
101
Countries
2
Sites
9
Active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
Key facts
- Sponsor
- CRISPR Therapeutics 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
- 2 Dec 2025 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518528-54-00
- WHO UTN
- U1111-1315-1975
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 100000004859 |
| 21.0 | LLT | 10042953 | Systemic sclerosis | 10028395 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CRISPR Therapeutics AG
- Sponsor organisation
- CRISPR Therapeutics AG
- Address
- Baarerstrasse 14
- City
- Zug
- Postcode
- 6300
- Country
- Switzerland
Scientific contact point
- Organisation
- CRISPR Therapeutics AG
- Contact name
- Medical Affairs
Public contact point
- Organisation
- CRISPR Therapeutics AG
- Contact name
- Medical Affairs
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 17 | 5 |
| Spain | Authorised, recruiting | 21 | 4 |
| Rest of world
United States
|
— | 63 | — |
Investigational sites
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
-, Sandhoefer Allee 1, Niederrad, Frankfurt Am Main
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
University Hospital Cologne AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Augsburg
II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Hospital Universitario Reina Sofia
Rheumatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Clinica Universidad De Navarra
Rheumatology, Pio XII Etorbidea 36, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Rheumatology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario De Valencia
Internal Medicine, Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| Germany | 2025-12-02 | 2026-01-21 | |||
| Spain | 2026-02-02 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Germany | Acceptable 2025-04-09
|
2025-04-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-30 | Germany | Acceptable | 2025-05-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-14 | Germany | Acceptable 2025-09-09
|
2025-09-26 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-10-07 | Acceptable 2025-09-09
|
2025-12-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-10 | Germany | Acceptable | 2025-11-21 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-21 | Germany | Acceptable | 2026-01-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-26 | Germany | Acceptable 2026-04-20
|
2026-04-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-05-08 | Acceptable | 2026-06-16 |