Clinical trial • Phase III • Immunology

bimekizumab for Axial spondyloarthritis | Psoriatic arthritis

Phase III trial of bimekizumab for Axial spondyloarthritis | Psoriatic arthritis. 293 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Axial spondyloarthritis | Psoriatic arthritis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
06-11-2025
First CTIS Authorization Date
16-03-2026

Trial design

Phase III trial across 42 sites in Croatia, Bulgaria, Czechia and others.

Target Sample Size
293
Trial Duration For Participant
1187

Eligibility

Recruits 293 Vulnerable population selected (isVulnerablePopulationSelected = true) — no further details on consent/assent handling are provided in the available documents..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true) — no further details on consent/assent handling are provided in the available documents.

Recruitment

Planned Sample Size
293
Recruitment Window Months
38
Consent Approach
Not specified in the available records; no details on who provides consent, age-specific documents, assent, or languages available.

Geography

Total Number Of Sites
42
Total Number Of Participants
293

Croatia

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
35
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Specijalna Bolnica Medico
Department Name
#503: Immunology
Contact Person Name
Marija Rogoznica Pavlovic
Contact Person Email
marija.rogoznica@gmail.com
Site Name
KBC Split
Department Name
#501: Immunology
Contact Person Name
Daniela Marasovic-Krstulovic
Contact Person Email
dmaraskrst@kbsplit.hr
Site Name
Klinicki Bolnicki Centar Osijek
Department Name
#502: Immunology
Contact Person Name
Jasminka Milas-Ahic
Contact Person Email
jmilasahic@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
45
Number Of Sites
6
Number Of Participants
33

Sites

Site Name
DCC V Plovdiv EOOD
Department Name
#203: Rheumatology
Contact Person Name
Melita Encheva
Contact Person Email
melita.encheva@gmail.com
Site Name
Medical Center Medconsult Pleven OOD
Department Name
#205: Rheumatology
Contact Person Name
Krasimira Tsoneva
Contact Person Email
dr.krasimira.tsoneva@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
#202: Clinic of Rheumatology
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com
Site Name
Medical Center Medconsult Pleven OOD
Department Name
#204
Contact Person Name
Dimitar Nikolov
Contact Person Email
dnikolov_mclovech@abv.bg
Site Name
Medical Center Excelsior OOD
Department Name
#206
Contact Person Name
Daniela Bichovska
Contact Person Email
ivdan@abv.bg
Site Name
Outpatient Clinic For Individual Practice For Specialized Medical Assistance In Rheumatology Dr. Gergana Rumenova Avramova EOOD
Department Name
#201
Contact Person Name
Gergana Avramova
Contact Person Email
gergana_avramova@abv.bg

Czechia

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
34
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Artroscan s.r.o.
Department Name
#704: Rheumatology
Contact Person Name
Ladislav Bortlik
Contact Person Email
bor-med@volny.cz
Site Name
Affidea Praha s.r.o.
Department Name
#701
Contact Person Name
Jan Rosa
Contact Person Email
rosaj@affidea-praha.cz
Site Name
L.K.N. Arthrocentrum s.r.o.
Department Name
#703
Contact Person Name
Libor Novosad
Contact Person Email
libor.novosad@email.cz
Site Name
MEDICAL PLUS Research s.r.o.
Department Name
#702
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
Resme s.r.o.
Department Name
#705
Contact Person Name
Martina Dvorakova
Contact Person Email
martina@revmatologie.xyz

Germany

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
28
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
#304
Contact Person Name
David Simon
Contact Person Email
david.simon@charite.de
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
#301: Rheumatology
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
#303
Contact Person Name
Frank Behrens
Site Name
Rheumatologische Schwerpunktpraxis
Department Name
#305
Contact Person Name
Jan Brandt-Juergens
Contact Person Email
jan.brandt-juergens@charite.de
Site Name
Studienambulanz Rheumazentrum Ratingen GbR
Department Name
#302
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
Studienteam Lahn-Dill-Siegerland GbR
Department Name
#306
Contact Person Name
Mirko Steinmueller
Contact Person Email
mirko.steinmueller@web.de

Poland

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
35
Number Of Sites
19
Number Of Participants
203

Sites

Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
#412: Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name
Grazyna Pulka
Contact Person Email
pulkaallmed@gmail.com
Site Name
Rheuma Medicus Sp. z o.o.
Department Name
#414
Contact Person Name
Robert Rupinski
Contact Person Email
rupinski@mp.pl
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Department Name
#401: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Contact Person Name
Jan Brzezicki
Contact Person Email
janisb@poczta.onet.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
#416: MICS Centrum Medyczne Torun
Contact Person Name
Slawomir Jeka
Contact Person Email
s.jeka@wp.pl
Site Name
Santa Sp. z o.o.
Department Name
#402
Contact Person Name
Tomasz Budlewski
Contact Person Email
tomasz.budlewski@somed.pl
Site Name
Reumed Sp. z o.o.
Department Name
410:Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
Contact Person Name
Dariusz Chudzik
Contact Person Email
dariuszbchudzik@wp.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
#419: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Contact Person Name
Rafal Wojciechowski
Contact Person Email
r.wojciechowski@wp.eu
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
#409: MICS Centrum Medyczne Warszawa
Contact Person Name
Agnieszka Zielinska
Site Name
Nzoz Bif-Med
Department Name
#404
Contact Person Name
Hanna Mastalerz
Contact Person Email
hannamastalerz@wp.pl
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Department Name
#417: ETYKA Ośrodek Badań Klinicznych
Contact Person Name
Magdalena Krajewska-Wlodarczyk
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
#405
Contact Person Name
Anna Zubrzycka - Sienkiewicz
Contact Person Email
annazub1@wp.pl
Site Name
Medyczne Centrum Hetmanska
Department Name
#406: Medyczne Centrum Hetmanska
Contact Person Name
Piotr Leszczynski
Site Name
Ai Centrum Medyczne Sp. z o.o.
Department Name
#408: Ai Centrum Medyczne Sp. z o.o. S.K.
Contact Person Name
Anna Rychlewska-Hanczewska
Contact Person Email
a.hanczewska@wp.pl
Site Name
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Department Name
#407: Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Contact Person Name
Artur Racewicz
Contact Person Email
racart@poczta.onet.pl
Site Name
Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki
Department Name
#420: Rheumatology
Contact Person Name
Marek Zawadzki
Contact Person Email
mareklek.9@wp.pl
Site Name
Innova Clinic Sp. z o.o.
Department Name
#415: Rheumatology
Contact Person Name
Tomasz Wysocki
Contact Person Email
t.wysocki@innova-clinic.pl
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Department Name
#411
Contact Person Name
Agata Wytyk - Nowak
Contact Person Email
wytyk@twojaprzychodnia.com
Site Name
Clinicmed Daniluk Nowak Sp. k.
Department Name
#418: Rheumatology
Contact Person Name
Stefan Daniluk
Contact Person Email
daniluk@clinicmed.pl
Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
#413: Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Malgorzata Miakisz
Contact Person Email
miakisz@twojaprzychodnia.com

Slovakia

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
27
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Artromac N.O.
Department Name
#602
Contact Person Name
Michaele Zarikova
Contact Person Email
m.zarikova@gmail.com
Site Name
Zazabie s.r.o.
Department Name
#601
Contact Person Name
Juraj Semancik
Contact Person Email
zazabie.sro@gmail.com
Site Name
Narodny Ustav Reumatickych Chorob
Department Name
#603
Contact Person Name
Olga Lukacova
Contact Person Email
olga.lukacova@nurch.sk

Sponsor

Primary sponsor

Full Name
UCB Biopharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
bimekizumab
Active Substance
bimekizumab
Modality
Monoclonal antibody

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