Clinical trial • Phase I • Immunology|Rare Disease

CTX112 for Systemic lupus erythematosus (SLE) | Systemic sclerosis | Idiopathic inflammatory myopathy (IIM)

Phase I trial of CTX112 for Systemic lupus erythematosus (SLE) | Systemic sclerosis | Idiopathic inflammatory myopathy (IIM). 63 participants.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Systemic lupus erythematosus (SLE) | Systemic sclerosis | Idiopathic inflammatory myopathy (IIM)
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
20-12-2024
First CTIS Authorization Date
14-04-2025

Trial design

Phase I trial across 8 sites in Germany, Spain.

Target Sample Size
63

Recruitment

Planned Sample Size
63
Recruitment Window Months
61

Geography

Total Number Of Sites
8
Total Number Of Participants
38

Germany

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
427
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
-
Contact Person Name
Frank Behrens
Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin I
Contact Person Name
Philipp Köhler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Contact Person Name
Christian Schultze-Florey
Site Name
Universitaetsklinikum Augsburg
Department Name
II. Medizinische Klinik
Contact Person Name
Christoph Schmid
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik und Poliklinik
Contact Person Name
Eva Wagner-Drouet
Contact Person Email
Eva.Wagner@unimedizin-mainz.de

Spain

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
161
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Rheumatology
Contact Person Name
Maria Angeles Aguirre Zamorano
Site Name
Clinica Universidad De Navarra
Department Name
Rheumatology
Contact Person Name
Enrique Ornilla Laraundogoitia
Contact Person Email
eornilla@unav.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Rheumatology
Contact Person Name
Elena Alonso Blanco Morales
Contact Person Email
elenaabm@hotmail.com

Sponsor

Primary sponsor

Full Name
CRISPR Therapeutics AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
CTX112

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