Clinical trial • Phase III • Musculoskeletal|Immunology

surovatamig for Rheumatoid arthritis|Systemic lupus erythematosus

Phase III trial of surovatamig for Rheumatoid arthritis|Systemic lupus erythematosus. 33 participants.

Overview

Trial Therapeutic Area
Musculoskeletal|Immunology
Trial Disease
Rheumatoid arthritis|Systemic lupus erythematosus
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
15-10-2025
First CTIS Authorization Date
03-02-2026

Trial design

Phase III trial across 11 sites in Belgium, Germany, Spain.

Target Sample Size
33

Eligibility

Recruits 33 Vulnerable populations selected; no details on consent or assent handling available in source..

Vulnerable Population
Vulnerable populations selected; no details on consent or assent handling available in source.

Recruitment

Planned Sample Size
33
Recruitment Window Months
27

Geography

Total Number Of Sites
11
Total Number Of Participants
15

Belgium

Earliest CTIS Part Ii Submission Date
20-01-2026
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
20
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Department of rheumatology
Principal Investigator Name
Clio Ribbens
Principal Investigator Email
Clio.Ribbens@chuliege.be
Contact Person Name
Clio Ribbens
Contact Person Email
Clio.Ribbens@chuliege.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Department of immunology, allergology and rheumatology
Principal Investigator Name
Margot Van Mechelen
Principal Investigator Email
margot.vanmechelen@uza.be
Contact Person Name
Margot Van Mechelen
Contact Person Email
margot.vanmechelen@uza.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Department of rheumatology
Principal Investigator Name
Alla Ishchenko
Principal Investigator Email
alla.ishchenko@zas.be
Contact Person Name
Alla Ishchenko
Contact Person Email
alla.ishchenko@zas.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Department of rheumatology
Principal Investigator Name
Alla Ishchenko
Principal Investigator Email
alla.ishchenko@zas.be
Contact Person Name
Alla Ishchenko
Contact Person Email
alla.ishchenko@zas.be

Germany

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
1
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik IV Sektion Rheumatologie und klinische Immunologie–Studienambu
Principal Investigator Name
Hendrik Schulze-Koops
Principal Investigator Email
Hendrik.Schulze-Koops@med.uni-muenchen.de
Contact Person Name
Hendrik Schulze-Koops
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin III Rheumazentrum (G-BA-Kriterien) sowie Sektion Rheumatologie und Osteol
Principal Investigator Name
Alexander Pfeil
Principal Investigator Email
alexander.pfeil@med.uni-jena.de
Contact Person Name
Alexander Pfeil
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Med. Klinik und Poliklinik Nephrology
Principal Investigator Name
Julia Weinmann-Menke
Principal Investigator Email
julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann-Menke
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Rheumatology
Principal Investigator Name
Valentin Schäfer
Principal Investigator Email
Valentin.Schaefer@ukbonn.de
Contact Person Name
Valentin Schäfer
Contact Person Email
Valentin.Schaefer@ukbonn.de

Spain

Earliest CTIS Part Ii Submission Date
29-10-2025
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
100
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Rheumatology
Principal Investigator Name
Hye Sang Park
Principal Investigator Email
hsang@santpau.cat
Contact Person Name
Hye Sang Park
Contact Person Email
hsang@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Rheumatology
Principal Investigator Name
Francisco Javier Bachiller Corral
Principal Investigator Email
fbachiller@salud.madrid.org
Contact Person Name
Francisco Javier Bachiller Corral
Contact Person Email
fbachiller@salud.madrid.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Rheumatology
Principal Investigator Name
Alejandro Escudero Contreras
Principal Investigator Email
alexcudero@hotmail.com
Contact Person Name
Alejandro Escudero Contreras
Contact Person Email
alexcudero@hotmail.com

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
surovatamig

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