Clinical trial • Phase III • Musculoskeletal | Dermatology | Immunology

BIMEKIZUMAB for Psoriatic arthritis

Phase III trial of BIMEKIZUMAB for Psoriatic arthritis.

Overview

Trial Therapeutic Area
Musculoskeletal | Dermatology | Immunology
Trial Disease
Psoriatic arthritis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-07-2024
First CTIS Authorization Date
08-11-2024

Trial design

Randomised, risankizumab (skyrizi) 150 mg solution for injection in pre-filled syringe, subcutaneous (comparator). placebo matching test and comparator: 0.9% sodium chloride solution for injection (unauthorised). dose schedules not specified in the ctis metadata provided.-controlled Phase III trial in Germany, Czechia, Hungary and others.

Randomised
Yes
Comparator
Risankizumab (Skyrizi) 150 mg solution for injection in pre-filled syringe, subcutaneous (comparator). Placebo matching test and comparator: 0.9% sodium chloride solution for injection (unauthorised). Dose schedules not specified in the CTIS metadata provided.
Target Sample Size
132
Trial Duration For Participant
730

Eligibility

Recruits 132 No vulnerable populations selected; trial enrols adult participants only. Informed consent is required from adult participants; no assent processes for minors are mentioned in the documentation..

Pregnancy Exclusion
• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study.
Vulnerable Population
No vulnerable populations selected; trial enrols adult participants only. Informed consent is required from adult participants; no assent processes for minors are mentioned in the documentation.

Inclusion criteria

  • {"criterion_text":"- •\tStudy participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).\n- •\tStudy participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each). \n- •\tStudy participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).\n- •\tStudy participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)\n- •\tStudy participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either: -\texperienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or -\tbeen intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)."}

Exclusion criteria

  • {"criterion_text":"- •\tStudy participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.\n- •\tFemale subjects who are breastfeeding, pregnant, or plan to become pregnant during the study.\n- •\tSubject has an active infection or a history of recent serious infections.\n- •\tSubject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.\n- •\tStudy participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis. \n- •\tStudy participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn’s disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.\n- •\tStudy participants with fibromyalgia or osteoarthritis symptoms that in the Investigator’s opinion would have potential to interfere with efficacy assessments.\n- •\tSubject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.\n- •\tSubject has a history of chronic alcohol or drug abuse within 6 months prior to Screening.\n- •\tStudy participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.\n- •\tStudy participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit or is taking or has taken weight management medications without meeting the mandatory dose stability period/washout period relative to the Baseline visit.\n- •\tStudy participant is taking or has taken janus kinase (JAK) inhibitor.\n- •\tStudy participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor.\n- •\tStudy participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- American College of Rheumatology 50 (ACR50) at Week 16","definition_or_measurement_approach":"American College of Rheumatology 50 (ACR50) at Week 16 — measured as the ACR50 response at Week 16 (as stated in the primary endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- •\tMinimal Disease Activity (MDA) at Week 16\n- •\tComposite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline\n- •\tTreatment-emergent adverse events (TEAEs)\n- •\tTreatment-emergent serious AEs\n- •\tTEAEs leading to withdrawal from investigational medicinal product (IMP)\n- • American College of Rheumatology 50 (ACR50) at Week 4","definition_or_measurement_approach":"MDA at Week 16 — Minimal Disease Activity at Week 16 (as stated). Composite ACR50+PASI100 at Week 16 — evaluated in subgroup with PSO ≥3% BSA at baseline. TEAEs/serious AEs/TEAEs leading to withdrawal — recorded treatment-emergent adverse events during the study. ACR50 at Week 4 — ACR50 response measured at Week 4."}

Recruitment

Registry Or Advocacy Recruitment
True, Center For Information And Study On Clinical Research Participation Inc.
Digital Remote Recruitment
True, digital outreach and patient recruitment activities are described (Splash Clinical LLC - 'Patient Recruitment and digital outreach'); online repositories and digital materials are used (Longboat Clinical Limited).
Planned Sample Size
132
Recruitment Window Months
19
Consent Approach
Informed consent obtained from adult participants; subject information and informed consent forms available in multiple language versions (examples in CTIS documents: German, Czech, Hungarian, Spanish, Polish, Bulgarian, English). No assent for minors is described (trial enrols adults). Contact for public inquiries: UCB Cares (UCBCares@ucb.com).

Methods

  • Patient recruitment and digital outreach provided by Splash Clinical LLC (digital channels and outreach materials mentioned in third-party duties).
  • Online repository of study related documents and tasks (Longboat Clinical Limited) to support recruitment logistics and document access.
  • Use of local recruitment materials and posters as indicated by multiple country-specific recruitment arrangement documents (titles listed in CTIS document set).
  • Rater trainings and site support (WCG Clinical Inc. provided rater trainings for TJC/SJC + PASI trainings and certifications) to support consistent site assessments during recruitment.

Geography

Total Number Of Sites
76
Total Number Of Participants
418

Germany

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
234
Number Of Sites
12
Number Of Participants
19

Sites

Site Name
Studienambulanz Rheumazentrum Ratingen GbR
Department Name
#40800;
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
#40138; Medizinische Klinik und Poliklinik III
Contact Person Name
Valentin Schäfer
Contact Person Email
valentin.schaefer@ukbonn.de
Site Name
Kerckhoff-Klinik GmbH
Department Name
#40073; Rheumatologie
Contact Person Name
Philipp Klemm
Contact Person Email
p.klemm@kerckhoff-klinik.de
Site Name
Rheumatologische Schwerpunktpraxis
Department Name
#40025
Contact Person Name
Jan Brandt-Jürgens
Contact Person Email
jan.brandt-juergens@charite.de
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
#40367
Contact Person Name
Frank Behrens
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
#40810
Contact Person Name
Ioana Andreica
Site Name
University Hospital Cologne AöR
Department Name
#40808; Innere Medizin I
Contact Person Name
Philipp Köhler
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
#40724; Medizinische Klinik und Poliklinik IV - Rheumatologie
Contact Person Name
Hendrik Schulze-Koops
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#40515; Gastroenterologie, Infektiologie, Rheumathologie
Contact Person Name
Hildrun Haibel
Contact Person Email
hildrun.haibel@charite.de
Site Name
Medical Center - University Of Freiburg
Department Name
#40072; Klinik für Rheumatologie und Klinische Immunologie
Contact Person Name
Stephanie Finzel
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
#40029; Rheumatology
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
#40814; Onkologie, Hämatologie, Klinische Immunologie, Rheumatologie und Pulmologie
Contact Person Name
Joerg Henes

Czechia

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
11-06-2025
Processing Time Days
226
Number Of Sites
8
Number Of Participants
88

Sites

Site Name
Medical Plus s.r.o.
Department Name
#40010
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
PV Medical Services s.r.o.
Department Name
#40012
Contact Person Name
Petr Vitek
Contact Person Email
pv.medical@seznam.cz
Site Name
Vesalion s.r.o.
Department Name
#40802
Contact Person Name
Libor Novosad
Contact Person Email
libor.novosad@email.cz
Site Name
Revmatologicky Ustav
Department Name
#40066
Contact Person Name
Jakub Zavada
Contact Person Email
zavada@revma.cz
Site Name
MUDr. Zuzana Stejfova
Department Name
#40801
Contact Person Name
Zuzana Stejfova
Contact Person Email
stejfova.zuzana@seznam.cz
Site Name
CCR Ostrava s.r.o.
Department Name
#40062
Contact Person Name
Sylva Brtnikova
Contact Person Email
sylva.brtnikova@ccrostrava.com
Site Name
Revmatologie s.r.o.
Department Name
#40065
Contact Person Name
Petr Nemec
Contact Person Email
revmatologie.nemec@seznam.cz
Site Name
PV Medical Services s.r.o. (additional site)
Department Name
#40012
Contact Person Name
Petr Vitek
Contact Person Email
pv.medical@seznam.cz

Hungary

Earliest CTIS Part Ii Submission Date
29-10-2024
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
233
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Qualiclinic Kft.
Department Name
40081
Contact Person Name
Istvan Szombati
Contact Person Email
i.szombati@qclinic.hu
Site Name
University Of Szeged
Department Name
40031: Reumatologiai es Immunologiai Klinika
Contact Person Name
Attila Balog
Contact Person Email
balog.attila@med.u-szeged.hu
Site Name
Vasarhelyi Sarkanyfu Kft.
Department Name
40809
Contact Person Name
Eva Balazs
Contact Person Email
jimbies@gmail.hu
Site Name
Revita Kft.
Department Name
40804
Contact Person Name
Marta Megyaszai
Contact Person Email
m.megyaszai@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
227
Number Of Sites
31
Number Of Participants
252

Sites

Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
40502: Centrum Medyczne Plejady
Contact Person Name
Alicja Wloch
Contact Person Email
alawloch@interia.pl
Site Name
Reumed Sp. z o.o.
Department Name
40037: Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
Contact Person Name
Dariusz Chudzik
Contact Person Email
dariuszbchudzik@wp.pl
Site Name
Provita Sp. z o.o.
Department Name
40795: Centrum Medyczne Angelius Provita
Contact Person Name
Magdalena Wloch - Targonska
Contact Person Email
wloch.magdalena@gmail.com
Site Name
NZOZ Lecznica Mak Med s.c.
Department Name
40483: NZOZ Lecznica MAK-MED S.C.
Contact Person Name
Marek Krogulec
Contact Person Email
marekkrogulec@wp.pl
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Department Name
40792: Małopolskie Badania Kliniczne
Contact Person Name
Bogdan Batko
Contact Person Email
b.batko@mbk.clinic
Site Name
Rheuma Medicus Sp. z o.o.
Department Name
40094: Rheuma Medicus
Contact Person Name
Maria Rell-Bakalarska
Contact Person Email
rell-bakalarska@wp.pl
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
40092: Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name
Grazyna Pulka
Contact Person Email
pulkaallmed@gmail.com
Site Name
Etg Warszawa Sp. z o.o.
Department Name
40604: ETG Warszawa
Contact Person Name
Anna Rowinska - Osuch
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
40798: MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Katarzyna Kolossa
Contact Person Email
k.kolossa@naszlekarz.pl
Site Name
Centrum Medyczne Oporow
Department Name
40043: Centrum Medyczne Oporow
Contact Person Name
Maria Misterska - Skora
Contact Person Email
maria.misterska@cmoporow.pl
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
40394: Centrum Wsparcia Badan Klinicznych
Contact Person Name
Brygida Kwiatkowska
Contact Person Email
kwiatkowskabrygida@gmail.com
Site Name
Medyczne Centrum Hetmanska Piotr Leszczynski
Contact Person Name
Piotr Leszczynski
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
40797: Centrum Medyczne Reuma Park
Contact Person Name
Anna Zubrzycka - Sienkiewicz
Contact Person Email
annazub1@wp.pl
Site Name
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
Department Name
40824: Nova Reuma Domysławska i Rusiłowicz Społka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Contact Person Name
Izabela Domyslawska
Contact Person Email
izadomyslawska@o2.pl
Site Name
Ai Centrum Medyczne Sp. z o.o. S.K.
Department Name
40807: Ai Centrum Medyczne Sp. z o.o. S.K.
Contact Person Name
Anna Rychlewska-Hanczewska
Contact Person Email
a.hanczewska@wp.pl
Site Name
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
Department Name
40539: REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
Contact Person Name
Jakub Trefler
Contact Person Email
jatrefler@gmail.com
Site Name
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Department Name
40791: Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Contact Person Name
Artur Racewicz
Contact Person Email
artur.racewicz@gmail.com
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Department Name
40038: 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
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
40091: Twoja Przychodnia Nowosolskie Centrum Medyczne
Contact Person Name
Malgorzata Miakisz
Contact Person Email
miakisz@twojaprzychodnia.com
Site Name
Rcmed Oddzial Sochaczew
Department Name
40790: RCMed Oddzial Sochaczew
Contact Person Name
Monika Wronisz
Contact Person Email
monika.wronisz@rcmed.com.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
Department Name
40805: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
Contact Person Name
Piotr Wiland
Contact Person Email
pwiland1@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
40793: MICS Centrum Medyczne Warszawa
Contact Person Name
Agnieszka Zielinska
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
40788: MICS Centrum Medyczne Toruń
Contact Person Name
Slawomir Jeka
Contact Person Email
s.jeka@wp.pl
Site Name
Clinicmed Daniluk Nowak Sp. k.
Department Name
40789: ClinicMed Daniluk, Nowak Sp. k.
Contact Person Name
Stefan Daniluk
Contact Person Email
daniluk@clinicmed.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
40119: Klinika Reumatologii i Układowych Chorob Tkanki Lacznej
Contact Person Name
Rafal Wojciechowski
Contact Person Email
r.wojciechowski@wp.eu
Site Name
Novamed Robert Koteras
Contact Person Name
Grazyna Jaworska - Gorna
Contact Person Email
gjaworska@opolemed.com
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Department Name
40796: ETYKA Osrodek Badan Klinicznych
Contact Person Name
Magdalena Krajewska-Wlodarczyk
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Department Name
40095: WroMedica I. Bielicka A Strzalkowska s.c.
Contact Person Name
Jerzy Swierkot
Contact Person Email
Jurekswierkot0@poczta.onet.pl
Site Name
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu
Department Name
40484: Klinika Reumatologii, Rehabilitacji i Chorob Wewnetrznych
Contact Person Name
Wlodzimierz Samborski
Contact Person Email
samborskiw@tlen.pl
Site Name
Pratia S.A.
Department Name
40490: Pratia MCM Krakow
Contact Person Name
Mariusz Korkosz
Contact Person Email
mariusz.korkosz@pratia.com
Site Name
Prywatna Praktyka Lekarska Prof. dr hab.med. Pawel Hrycaj
Department Name
40090: Prywatna Praktyka Lekarska prof. dr hab. med. Paweł Hrycaj
Contact Person Name
Pawel Hrycaj
Contact Person Email
pawel.hrycaj@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
01-11-2024
Latest Decision Or Authorization Date
13-08-2025
Processing Time Days
286
Number Of Sites
12
Number Of Participants
27

Sites

Site Name
Medical Center Teodora EOOD
Department Name
#40656; rheumatology office
Contact Person Name
Margarita Velkova
Contact Person Email
dr_margarita_velkova@mail.bg
Site Name
Medical Center Hera EOOD
Department Name
#40314; Rheumatology Office
Contact Person Name
Sarita Kostova
Contact Person Email
sarita.kostova@gmail.com
Site Name
Medical Center Excelsior OOD
Department Name
#40811
Contact Person Name
Tsvetanka Petranova
Contact Person Email
dr_petranova@yahoo.com
Site Name
Dkc Fokus-5 Lzip OOD
Department Name
#40822
Contact Person Name
Rumen Stoilov
Contact Person Email
rmstoilov@abv.bg
Site Name
Medical Center Artmed Ltd.
Department Name
#40820
Contact Person Name
Mariela Geneva-Popova
Contact Person Email
genevapopova@yahoo.com
Site Name
Diagnostic Consulting Center XVII Sofia Ltd.
Department Name
#40819; Rheumatology
Contact Person Name
Rodina Nestorova-Licheva
Contact Person Email
rodina_usd@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
#40006: Clinic of Rheumatology
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com
Site Name
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Department Name
#40818: Internal medicine department
Contact Person Name
Asen Atanasov
Contact Person Email
assen_a@abv.bg
Site Name
Outpatient Clinic For Individual Practice For Specialized Medical Assistance In Rheumatology Dr. Gergana Rumenova Avramova EOOD
Department Name
#40813
Contact Person Name
Gergana Avramova
Contact Person Email
gergana_avramova@yahoo.com
Site Name
Dkc 1 Ruse EOOD
Department Name
#40823; ІV Therapeutically department
Contact Person Name
Nadezhda Kapandjieva
Contact Person Email
nely_kap@abv.bg
Site Name
Medical Center Medconsult Pleven OOD
Department Name
#40313; Rheumatology
Contact Person Name
Krasimira Tsoneva
Contact Person Email
dr.krasimira.tsoneva@abv.bg
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Department Name
#40380
Contact Person Name
Delina Ivanova
Contact Person Email
dr.ivanova@hotmail.com

Spain

Earliest CTIS Part Ii Submission Date
01-11-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
535
Number Of Sites
9
Number Of Participants
10

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
40753: Reumatología
Contact Person Name
Eva Maria Perez Pampin
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Parc Tauli Hospital Universitari
Department Name
40803: Reumatología
Contact Person Name
Maria Llop Vilaltella
Contact Person Email
mllop.parctauli@gmail.com
Site Name
Hospital Universitario Basurto
Department Name
40269: Reumatología
Contact Person Name
Maria García Vivar
Site Name
Hospital Universitario 12 De Octubre
Department Name
40231: Reumatología
Contact Person Name
Beatriz Joven Ibáñez
Contact Person Email
beatrizjoven@hotmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
40806: Reumatologia e Immunologia
Contact Person Name
Francisco Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
40799: Reumatología
Contact Person Name
Juan Miguel Sanchez Burson
Contact Person Email
reujsb@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
40266: Reumatología
Contact Person Name
Maria Aparicio Espinar
Site Name
Hospital Universitario Regional De Malaga
Department Name
40102: Reumatología
Contact Person Name
Antonio Fernández Nebro
Contact Person Email
afnebro@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
40049: Reumatología
Contact Person Name
Jose Javier Perez Venegas
Contact Person Email
perez.venegas@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Clinical Operations, Clinical Logistics
Name
Icon Clinical Research Limited
Name
WCG Clinical Inc.
Responsibilities
Rater trainings for the sites(for TJC/SJC + PASI trainings and certifications)
Name
Drug Development Solutions Limited
Name
4g Clinical LLC

Third parties

  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Online repository of study related documents and tasks","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Splash Clinical LLC","duties_or_roles":"Patient Recruitment and digital outreach","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syner-G Biopharma Group LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Rater trainings for the sites(for TJC/SJC + PASI trainings and certifications)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quantificare","duties_or_roles":"Photography","organisation_type":"Health care"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long Term Sample Storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"","organisation_type":"Patient organisation/association"}
  • {"country":"Japan","full_name":"Mediford Corp.","duties_or_roles":"T-spot test","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Clinical Operations, Clinical Logistics","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Splash Clinical LLC (additional entry)","duties_or_roles":"Patient Recruitment and digital outreach","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
bimekizumab
Active Substance
BIMEKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
No marketing authorisation indicated in CTIS product entry (prodAuthStatus: 1)
Maximum Dose
320 mg (maxTotalDoseAmount)
Investigational Product Name
Skyrizi 150 mg solution for injection in pre-filled syringe (risankizumab)
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Marketing authorisation: EU/1/19/1361/003 (prodAuthStatus: 2)
Maximum Dose
150 mg (maxTotalDoseAmount)
Investigational Product Name
Placebo matching test and comparator (0.9% sodium chloride solution for injection)
Modality
Other
Authorisation Status
Unauthorized (described as unauthorized in product name)

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