Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
392
Countries
6
Sites
42
CCI
Key facts
- Sponsor
- UCB Biopharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 7 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-522782-30-00
- WHO UTN
- U1111-1325-3322
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
CCI
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10071400 | Axial spondyloarthritis | 100000004859 |
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UCB Biopharma
- Sponsor organisation
- UCB Biopharma
- Address
- Researchdreef 60
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Public contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Locations
6 EU/EEA countries · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 33 | 6 |
| Croatia | Authorised, recruitment pending | 12 | 3 |
| Czechia | Ongoing, recruiting | 17 | 5 |
| Germany | Ongoing, recruiting | 18 | 6 |
| Poland | Ongoing, recruiting | 203 | 19 |
| Slovakia | Authorised, recruitment pending | 10 | 3 |
| Rest of world
United States
|
— | 99 | — |
Investigational sites
Outpatient Clinic For Individual Practice For Specialized Medical Assistance In Rheumatology Dr. Gergana Rumenova Avramova EOOD
#201, Ulitsa Dragota 6, Floor 1 Office 2 Room 1 And 2, Plovdiv
Medical Center Excelsior OOD
#206, Jk Geo Milev, Ulitsa Nikolay Kopernik 9, Sofia
University Multiprofile Hospital For Active Treatment Kaspela EOOD
#202: Clinic of Rheumatology, Zapaden District, Sofia Str 64, Plovdiv
Medical Center Medconsult Pleven OOD
#205: Rheumatology, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
DCC V Plovdiv EOOD
#203: Rheumatology, Trakia District, Ulitsa Siedinenie 42, Plovdiv
Medical Center Medconsult Pleven OOD
#204, Ulitsa Tirgovska 12, 5500, Lovech
Klinicki Bolnicki Centar Osijek
#502: Immunology, Ulica Josipa Huttlera 4, 31000, Osijek
Specijalna Bolnica Medico
#503: Immunology, Agaticeva 8, 51000, Rijeka
KBC Split
#501: Immunology, Spinciceva 1, 21000, Split
L.K.N. Arthrocentrum s.r.o.
#703, Na Valech 1, 748 01, Hlucin
MEDICAL PLUS Research s.r.o.
#702, Obchodni 1507, 686 01, Uherske Hradiste
Artroscan s.r.o.
#704: Rheumatology, Trebovicka 5114/106, Trebovice, Ostrava
Affidea Praha s.r.o.
#701, Sustova 1930/2, Chodov, Prague 11
Resme s.r.o.
#705, Mendlovo namesti 157/1, 603 00, Brno
Studienambulanz Rheumazentrum Ratingen GbR
#302, Calor-Emag-Strasse 3, Zentrum, Ratingen
Rheumatologische Schwerpunktpraxis
#305, Bundesallee 104-105, Friedenau, Berlin
Studienteam Lahn-Dill-Siegerland GbR
#306, Schanzenfeldstrasse 12, 35578, Wetzlar
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
#301: Rheumatology, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
#303, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
#304, Chariteplatz 1, Mitte, Berlin
Medicover Integrated Clinical Services Sp. z o.o.
#409: MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
#413: Twoja Przychodnia Nowosolskie Centrum Medyczne, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Nzoz Bif-Med
#404, ul. Zeromskiego 18, 41-902, Bytom
Centrum Medyczne All-Med Badania Kliniczne
#412: Centrum Medyczne All-Med Badania Kliniczne, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
#411, Ul. Marcelinska 92, 60-324, Poznan
Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki
#420: Rheumatology, Pl. Sw. Macieja 8, 50-244, Wroclaw
Rheuma Medicus Sp. z o.o.
#414, Ul. Pruszkowska 6, 02-118, Warsaw
Ai Centrum Medyczne Sp. z o.o.
#408: Ai Centrum Medyczne Sp. z o.o. S.K., Ul. Swietojanska 1, 61-113, Poznan
Reumed Sp. z o.o.
410:Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Medyczne Centrum Hetmanska
#406: Medyczne Centrum Hetmanska, ul. Hetmanska 55/1, 60-218, Poznan
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
#407: Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik, Ul. Wiejska 81, 15-351, Bialystok
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
#417: ETYKA Ośrodek Badań Klinicznych, Ul. 1 Maja 13 C, 10-117, Olsztyn
Clinicmed Daniluk Nowak Sp. k.
#418: Rheumatology, Ul. Stoleczna 7/200, 15-879, Bialystok
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
#401: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska, Ul. Studzienna 35-36/a, 82-300, Elblag
Innova Clinic Sp. z o.o.
#415: Rheumatology, Ul. Mlodziezowa 31 N, 09-100, Plonsk
Medicover Integrated Clinical Services Sp. z o.o.
#416: MICS Centrum Medyczne Torun, Ul. Stefana Batorego 18-22, 87-100, Torun
Klinika Reuma Park Sp. z o.o. S.K.
#405, Aleja Wilanowska 333, 02-665, Warsaw
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
#419: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Santa Sp. z o.o.
#402, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Zazabie s.r.o.
#601, Hlavna 38/70, Stare Mesto, Kosice - Stare Mesto
Artromac N.O.
#602, Toryska 275/1, Zapad, Kosice
Narodny Ustav Reumatickych Chorob
#603, Nabrezie Ivana Krasku 4782/4, 921 01, Piestany
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2026-04-16 | 2026-04-16 | |||
| Czechia | 2026-05-11 | 2026-05-11 | |||
| Germany | 2026-04-07 | 2026-04-07 | |||
| Poland | 2026-04-07 | 2026-04-07 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-06 | Slovakia | Acceptable 2026-03-16
|
2026-03-16 |