Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
101
Countries
2
Sites
8
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 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
| 21.0 | LLT | 10042953 | Systemic sclerosis | 10028395 |
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 · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 17 | 5 |
| Spain | Authorised, recruiting | 21 | 3 |
| 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
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
7 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 |