Clinical trial • Phase III • Immunology

BIMEKIZUMAB for Psoriatic arthritis

Phase III trial of BIMEKIZUMAB for Psoriatic arthritis. open-label, none/not specified-controlled. 471 participants.

Overview

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

Key dates

Initial CTIS Submission Date
07-06-2024
First CTIS Authorization Date
11-07-2024

Trial design

open-label, none/not specified-controlled Phase III trial in Germany, Italy, Spain and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
471
Trial Duration For Participant
980

Eligibility

Recruits 471 No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial population limited to adults; informed consent obtained from each adult participant. Multiple subject information and informed consent form documents are provided (languages and country-specific versions present in the dossier), no assent procedures for minors are indicated..

Pregnancy Exclusion
Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Trial population limited to adults; informed consent obtained from each adult participant. Multiple subject information and informed consent form documents are provided (languages and country-specific versions present in the dossier), no assent procedures for minors are indicated.

Inclusion criteria

  • {"criterion_text":"- In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study\n- Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria\n- Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception"}

Exclusion criteria

  • {"criterion_text":"- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)\n- Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator\n- Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1.\tIncidence of treatment-emergent adverse events (TEAEs) during the study\n- 2.\tIncidence of treatment-emergent serious adverse events (SAEs) during the study","definition_or_measurement_approach":"Measured as the incidence (counts and rates) of TEAEs and of treatment-emergent SAEs reported during the study period."}

Secondary endpoints

  • {"endpoint_text":"- TEAEs leading to withdrawal from investigational medicinal product (IMP) during the study","definition_or_measurement_approach":"Measured as incidence of TEAEs resulting in withdrawal from IMP during the study."}
  • {"endpoint_text":"- American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR20 response at Week 24 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR20 response at Week 52 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR20 response at Week 140 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 50% improvement (ACR50) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR50 response at Week 24 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 50% improvement (ACR50) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR50 response at Week 52 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 50% improvement (ACR50) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR50 response at Week 140 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 70% improvement (ACR70) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR70 response at Week 24 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 70% improvement (ACR70) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR70 response at Week 52 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- American College of Rheumatology 70% improvement (ACR70) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as ACR70 response at Week 140 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Psoriasis Area Severity Index 75 (PASI75) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as PASI75 response at Week 24 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Psoriasis Area Severity Index 75 (PASI75) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as PASI75 response at Week 52 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Psoriasis Area Severity Index 75 (PASI75) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as PASI75 response at Week 140 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Psoriasis Area Severity Index 90 (PASI90) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as PASI90 response at Week 24 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Psoriasis Area Severity Index 90 (PASI90) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as PASI90 response at Week 52 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Psoriasis Area Severity Index 90 (PASI90) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as PASI90 response at Week 140 using the baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 24 from the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as IGA score 0 or 1 with ≥2-grade reduction at Week 24 versus baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 52 from the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as IGA score 0 or 1 with ≥2-grade reduction at Week 52 versus baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction at Week 140 from the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as IGA score 0 or 1 with ≥2-grade reduction at Week 140 versus baseline from PA0010 or PA0011."}
  • {"endpoint_text":"- Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as LEI-defined enthesitis-free status at Week 24 in the subgroup with enthesitis at baseline."}
  • {"endpoint_text":"- Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as LEI-defined enthesitis-free status at Week 52 in the subgroup with enthesitis at baseline."}
  • {"endpoint_text":"- Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as LEI-defined enthesitis-free status at Week 140 in the subgroup with enthesitis at baseline."}
  • {"endpoint_text":"- Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 24 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as SPARCC index-defined enthesitis-free status at Week 24 in the subgroup with enthesitis at baseline."}
  • {"endpoint_text":"- Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 52 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as SPARCC index-defined enthesitis-free status at Week 52 in the subgroup with enthesitis at baseline."}
  • {"endpoint_text":"- Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 140 in PA0012 using the subgroup of subjects with enthesitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as SPARCC index-defined enthesitis-free status at Week 140 in the subgroup with enthesitis at baseline."}
  • {"endpoint_text":"- Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 24 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as LDI-defined dactylitis-free status at Week 24 in the subgroup with dactylitis at baseline."}
  • {"endpoint_text":"- Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 52 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as LDI-defined dactylitis-free status at Week 52 in the subgroup with dactylitis at baseline."}
  • {"endpoint_text":"- Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 140 in PA0012 using the subgroup of subjects with dactylitis at the Baseline of PA0010 or PA0011","definition_or_measurement_approach":"Measured as LDI-defined dactylitis-free status at Week 140 in the subgroup with dactylitis at baseline."}

Recruitment

Registry Or Advocacy Recruitment
True, Center For Information And Study On Clinical Research Participation Inc.
Planned Sample Size
471
Recruitment Window Months
78
Consent Approach
Informed consent obtained from each adult participant. Subject information and informed consent form documents are provided (country- and language-specific versions present in the dossier, e.g. Hungarian, Czech, French, English versions listed). No assent for minors is indicated; consent is provided by the participant themselves (adult population).

Geography

Total Number Of Sites
39
Total Number Of Participants
741

Germany

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
15
Number Of Sites
10
Number Of Participants
103

Sites

Site Name
Universitaetsklinikum Leipzig AöR
Department Name
#40078: Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
Contact Person Name
Ulf Wagner
Site Name
Centrum fuer innovative Diagnostik und Therapie Rheumatologie/Immunologie c i r i GmbH
Department Name
#40117: nap
Contact Person Name
Frank Behrens
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
#40027: nap
Contact Person Name
Xenofon Baraliakos
Site Name
Rheumazentrum Ratingen
Department Name
#40026: Studienambulanz GbR
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
#40029: HRF II-Hamburger Rheuma Forschungszentrum II
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Praxis Mario Sutowicz
Department Name
#40076: nap
Contact Person Name
Mario Sutowicz
Contact Person Email
sutowicz@gmx.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
#40023: Rheumatologie und Klinische Immunologie
Contact Person Name
Andreas Wirsching
Site Name
Praxis für klinische Studien und Praxis für Orthopädie
Department Name
#40071: nap
Contact Person Name
Georg Dahmen
Contact Person Email
georg.dahmen@pfct.de
Site Name
Prof. Dr. med. Gunther Neeck MVZ GmbH
Department Name
#40074: Rheumazentrum
Contact Person Name
Gunther Neeck
Site Name
Rheumatologische Schwerpunktpraxis
Department Name
#40025: nap
Contact Person Name
Jan Brandt-Jürgens
Contact Person Email
jan.brandt-juergens@charite.de

Italy

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
27
Number Of Sites
1
Number Of Participants
18

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
#40086: Reumatologia
Contact Person Name
Carlo Salvarani
Contact Person Email
carlo.salvarani@ausl.re.it

Spain

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
15
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
#40101: Servicio de reumatologia
Contact Person Name
Jordi Gratacos Masmitja
Contact Person Email
jgratacosmas@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
#40106: Reumatología
Contact Person Name
Elena Alonso Blanco-Morales
Contact Person Email
elenaabm@hotmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
#40104: Reumatología
Contact Person Name
Antonio Mera Varela
Contact Person Email
antonio.mera.varela@sergas.es
Site Name
Hospital General Universitario Reina Sofia
Department Name
#40105: Reumatologia
Contact Person Name
Maria López Montilla
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
#40099: Reumatología
Contact Person Name
José Pego Reigosa
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
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
Complexo Hospitalario Universitario A Coruna
Department Name
#40045: Reumatologia e Immunologia
Contact Person Name
Francisco Blanco Garcia
Contact Person Email
fblagar@sergas.es

Poland

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
18
Number Of Sites
7
Number Of Participants
420

Sites

Site Name
Centrum Medyczne Amed Sp. z o.o.
Department Name
#40041: nap
Contact Person Name
Agnieszka Jurek - Urbanowska
Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
#40091: nap
Contact Person Name
Malgorzata Miakisz
Contact Person Email
miakisz@twojaprzychodnia.com
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Department Name
#40095: nap
Contact Person Name
Jerzy Swierkot
Contact Person Email
Jurekswierkot0@poczta.onet.pl
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Department Name
#40038: nap
Contact Person Name
Jan Brzezicki
Contact Person Email
janisb@poczta.onet.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
#40098: nap
Contact Person Name
Anna Zubrzycka - Sienkiewicz
Contact Person Email
annazub1@wp.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
Department Name
#40039: nap
Contact Person Name
Piotr Wiland
Contact Person Email
pwiland1@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
#40097: nap
Contact Person Name
Agnieszka Zielinska

Belgium

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
15
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
UZ Leuven
Department Name
#40002: Reumatologie
Contact Person Name
Kurt de Vlam
Contact Person Email
kurt.devlam@uzleuven.be
Site Name
CHU Helora
Department Name
#40059: Rhumatologie
Contact Person Name
Marc Léon
Contact Person Email
marc.leon@hap.be
Site Name
Reumaclinic
Department Name
#40003: Reumatologie
Contact Person Name
Johan Vanhoof
Contact Person Email
johan@vanhoofjohan.be

France

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
11-07-2024
Processing Time Days
14
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
University Hospitals Pitie Salpetriere Charles Foix
Department Name
#40019: Service de Rhumatologie
Contact Person Name
Bruno Fautrel
Contact Person Email
bruno.fautrel@aphp.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
#40068: Rhumatologie
Contact Person Name
Philippe Goupille

Hungary

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
26-09-2024
Processing Time Days
91
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
#40083: Reumatologiai Osztaly
Contact Person Name
Ilona Ujfalussy
Contact Person Email
ujfalussylona@gmail.com
Site Name
University Of Debrecen
Department Name
#40032: Reumatológiai Klinika, Reumatológia, Reuma-Farmakológia
Contact Person Name
Nora Bodnar
Contact Person Email
drbodnarnora@gmail.com
Site Name
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
Department Name
#40079: Mozgasszervi Rehabil. Osztaly
Contact Person Name
Eva Mike
Contact Person Email
mikezsuzsa@yahoo.com

Czechia

Earliest CTIS Part Ii Submission Date
27-06-2024
Latest Decision Or Authorization Date
16-01-2025
Processing Time Days
203
Number Of Sites
5
Number Of Participants
100

Sites

Site Name
Pratia Prague s.r.o.
Department Name
#40015: nap
Contact Person Name
Martina Machkova
Contact Person Email
martina.machkova@ccrprague.com
Site Name
Affidea Praha s.r.o.
Department Name
#40013: nap
Contact Person Name
Jan Rosa
Contact Person Email
rosaj@affidea-praha.cz
Site Name
Revmatologie s.r.o.
Department Name
#40065: nap
Contact Person Name
Leona Prochazkova
Site Name
PV-Medical s.r.o.
Department Name
#40012: nap
Contact Person Name
Petr Vitek
Contact Person Email
pv.medical@seznam.cz
Site Name
Pratia Pardubice a.s.
Department Name
#40009
Contact Person Name
Marcela Svobodova
Contact Person Email
joz.svo@centrum.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
Parexel International Corp.
Responsibilities
Project Management, Clinical Operations, Data Management, Medical Monitoring, Regulatory, Clinical Logistics, safety reporting, Clinical Site Agreements, Vendor Management
Name
Bioclinica Inc.
Responsibilities
eCOA collection; ECG collection
Name
Perceptive Informatics Inc.
Responsibilities
Medical Imaging
Name
Pharmaceutical Product Development LLC
Name
Icon (Lr) Limited

Third parties

  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"sponsorDuties code 11","organisation_type":"Patient organisation/association"}
  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"sponsorDuties code 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code 15; value: eCOA collection","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties code 15; value: Medical Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Project Management, Clinical Operations, Data Management, Medical Monitoring, Regulatory, Clinical Logistics, safety reporting, Clinical Site Agreements, Vendor Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syner-G Biopharma Group LLC","duties_or_roles":"sponsorDuties code 11","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc. (additional entry)","duties_or_roles":"sponsorDuties code 15; value: ECG collection","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc. (additional entry)","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"sponsorDuties code 15; value: Site Training","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code 15; value: Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties code 15; value: Long Term Sample Storage","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
bimekizumab
Active Substance
BIMEKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised (prodAuthStatus=1)
Maximum Dose
160 mg

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