Clinical trial • Phase I • Musculoskeletal

Clinical trial in Rheumatoid arthritis

Phase I trial for Rheumatoid arthritis. open-label, none/not specified-controlled. 46 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
11-12-2024
First CTIS Authorization Date
11-04-2025

Trial design

open-label, none/not specified-controlled Phase I trial across 10 sites in Germany, Italy, Poland.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
46

Eligibility

Recruits 46 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling available in the provided record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling available in the provided record.

Recruitment

Planned Sample Size
46
Recruitment Window Months
51

Geography

Total Number Of Sites
10
Total Number Of Participants
46

Germany

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
372
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 3 – Rheumatologie und Immunologie
Contact Person Name
Ricardo Grieshaber-Boyer
Contact Person Email
Ricardo.grieshaber@fau.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Hämatologie, Onkologie und Rheumatologie Innere Medizin V
Contact Person Name
Hanns-Martin Lorenz

Italy

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
381
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Rheumatology
Contact Person Name
Maria Antonietta D’Agostino
Site Name
Humanitas Mirasole S.p.A.
Department Name
Division of Rheumatology and Clinical Immunology
Contact Person Name
Elisa Gremese
Contact Person Email
elisa.gremese@hunimed.eu
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Rheumatology
Contact Person Name
Francesco Ciccia

Poland

Earliest CTIS Part Ii Submission Date
23-04-2026
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
13
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Med Polonia Sp. z o.o.
Contact Person Name
Maria Jaraczewska-Baumann
Site Name
Malopolskie Centrum Kliniczne
Department Name
CWBK
Contact Person Name
Ewa Zimmer-Satora
Contact Person Email
biuro@mck-krakow.pl
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
CWBK
Contact Person Name
Brygida Kwiatkowska
Contact Person Email
cwbk@spartanska.pl
Site Name
Biokinetica S.A.
Department Name
CWBK
Contact Person Name
Malgorzata Gryka-Marton
Contact Person Email
marta.jeka@medicover.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Contact Person Name
Malgorzata Gryka-Marton
Contact Person Email
marta.jeka@medicover.com

Sponsor

Primary sponsor

Full Name
Cullinan Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

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