Clinical trial • Phase I • Immunology

ABO21009 for Rheumatoid arthritis

Phase I trial of ABO21009 for Rheumatoid arthritis. Placebo-controlled. 78 participants.

Overview

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

Key dates

Initial CTIS Submission Date
16-12-2024
First CTIS Authorization Date
31-01-2025

Trial design

Placebo-controlled Phase I trial across 4 sites in Netherlands, Belgium, Germany.

Comparator
Placebo
Target Sample Size
78

Recruitment

Planned Sample Size
78
Recruitment Window Months
31

Geography

Total Number Of Sites
4
Total Number Of Participants
78

Netherlands

Earliest CTIS Part Ii Submission Date
30-01-2025
Latest Decision Or Authorization Date
31-01-2025
Processing Time Days
1
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Centre for Human Drug Research
Department Name
Immunology
Contact Person Name
Matthijs Moerland
Contact Person Email
clintrials@chdr.nl

Belgium

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
14-08-2025
Processing Time Days
20
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
rheumatology
Contact Person Name
Clio Ribbens
Contact Person Email
clio.ribbens@chuliege.be

Germany

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
15
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP
Contact Person Name
Frank Behrens
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Department of Medicine 3 – Rheumatology and Immunology
Contact Person Name
Georg Schett
Contact Person Email
Georg.Schett@uk-erlangen.de

Sponsor

Primary sponsor

Full Name
Aboleris Holdco
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
ABO21009

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