Clinical trial • Phase III • Immunology | Dermatology | Rare Disease

BIMEKIZUMAB for Palmoplantar pustulosis

Phase III trial of BIMEKIZUMAB for Palmoplantar pustulosis.

Overview

Trial Therapeutic Area
Immunology | Dermatology | Rare Disease
Trial Disease
Palmoplantar pustulosis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
06-08-2025
First CTIS Authorization Date
02-12-2025

Trial design

Randomised, open-label, placebo (placebo matching test. 0.9% sodium chloride solution for injection (unauthorized)) as comparator; active investigational product bimzelx (bimekizumab) available as 160 mg solution for injection in pre-filled syringe and 320 mg solution for injection in pre-filled pen. dosing schedule not specified in the available data.-controlled Phase III trial across 59 sites in Czechia, Denmark, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (Placebo matching test. 0.9% sodium chloride solution for injection (unauthorized)) as comparator; active investigational product Bimzelx (bimekizumab) available as 160 mg solution for injection in pre-filled syringe and 320 mg solution for injection in pre-filled pen. Dosing schedule not specified in the available data.
Target Sample Size
180

Eligibility

Recruits 180 No vulnerable populations selected; participants must be adults (≥18) and provide informed consent. No assent process or vulnerable-population consent procedures are described..

Vulnerable Population
No vulnerable populations selected; participants must be adults (≥18) and provide informed consent. No assent process or vulnerable-population consent procedures are described.

Inclusion criteria

  • {"criterion_text":"-Participant must be at least 18 years of age inclusive, at the time of signing the informed consent form (ICF).\n-Participant must have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit.\n-Participant must have Palmoplantar Pustulosis Area Severity Index (PPPASI) ≥12 at the Screening Visit and Baseline Visit.\n-Participant must have palmoplantar pustulosis- Investigator Global Assessment (PPP-IGA) ≥3 at the Screening Visit and Baseline Visit.\n-Participant must have pustules on the palms of the hands and/or soles of the feet (at the Screening Visit and Baseline Visit), defined as pustule severity ≥2 in at least 1 region and having more than 5 active white- yellow pustules across all regions.\n-Participant must be a candidate for systemic therapy or phototherapy."}

Exclusion criteria

  • {"criterion_text":"-Participant has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score.\n-Participant has palmoplantar PSO (plaque PSO on palms/soles).\n-Participant has the following: guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema, chronic hand eczema, or folliculitis.\n-Participant has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or TNF inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis).\n-Participant has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP.\n-Participant is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit.\n-Participant is taking or has ever taken an IL-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16","definition_or_measurement_approach":"Response measured by the Investigator Global Assessment for palmoplantar pustulosis (PPP-IGA); PPP-IGA 0/1 response assessed at Week 16."}

Secondary endpoints

  • {"endpoint_text":"-Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16","definition_or_measurement_approach":"PPPASI50 response (50% improvement in PPPASI) assessed at Week 16."}
  • {"endpoint_text":"-PPPASI75 response at Week 16","definition_or_measurement_approach":"PPPASI75 response (75% improvement in PPPASI) assessed at Week 16."}
  • {"endpoint_text":"-PPPASI90 response at Week 16","definition_or_measurement_approach":"PPPASI90 response (90% improvement in PPPASI) assessed at Week 16."}
  • {"endpoint_text":"-PPPASI50 response at Week 8","definition_or_measurement_approach":"PPPASI50 response assessed at Week 8."}
  • {"endpoint_text":"-PPP-IGA 0/1 response at Week 8","definition_or_measurement_approach":"PPP-IGA 0/1 response assessed at Week 8 by Investigator Global Assessment."}
  • {"endpoint_text":"-Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16","definition_or_measurement_approach":"Change from baseline in DLQI total score measured at Week 16."}
  • {"endpoint_text":"-Change from Baseline in Numerical Rating Scale (NRS) – PPP Pain score in the palmoplantar areas at Week 16","definition_or_measurement_approach":"Change from baseline in NRS PPP pain score in palmoplantar areas measured at Week 16."}
  • {"endpoint_text":"-Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period","definition_or_measurement_approach":"Incidence of TEAEs recorded from baseline through end of Safety Follow-up period (as reported in safety data collection)."}
  • {"endpoint_text":"-Incidence of serious TEAEs from Baseline to the end of the SFU Period","definition_or_measurement_approach":"Incidence of serious TEAEs recorded from baseline through end of Safety Follow-up period."}
  • {"endpoint_text":"-Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period","definition_or_measurement_approach":"Incidence of TEAEs that led to permanent discontinuation of study treatment from baseline through end of Safety Follow-up period."}

Recruitment

Planned Sample Size
180
Recruitment Window Months
40
Consent Approach
Participants are adults (≥18) who provide informed consent. Subject information and informed consent forms are provided per country/language (documents available for CZ, DK, FR, IT, ES, DE, HU, PL as listed). No assent procedures or vulnerable-population consent processes are described. Sponsor public contact: UCB Cares (UCBCares@ucb.com).

Geography

Total Number Of Sites
59
Total Number Of Participants
190

Czechia

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
32
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. - Kozni oddeleni
Department Name
40881: Kozni oddeleni
Principal Investigator Name
Olga Filipovska
Principal Investigator Email
olga.filipovska@kzcr.eu
Contact Person Name
Olga Filipovska
Contact Person Email
olga.filipovska@kzcr.eu
Site Name
Fakultni Nemocnice Plzen
Department Name
40748:Dermatovenerologicka klinika
Principal Investigator Name
Petra Cetkovska
Principal Investigator Email
cetkovska@fnplzen.cz
Contact Person Name
Petra Cetkovska
Contact Person Email
cetkovska@fnplzen.cz

Denmark

Earliest CTIS Part Ii Submission Date
19-11-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
13
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Gentofte Hospital
Department Name
40886: Dermato-allergologisk afdeling
Principal Investigator Name
Lone Skov
Principal Investigator Email
lone.skov.02@regionh.dk
Contact Person Name
Lone Skov
Contact Person Email
lone.skov.02@regionh.dk

France

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
18
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Hospital Edouard Herriot
Department Name
40067:Service de Dermatologie
Principal Investigator Name
Denis Jullien
Principal Investigator Email
denis.jullien@chu-lyon.fr
Contact Person Name
Denis Jullien
Contact Person Email
denis.jullien@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
40320: Service de Dermatologie
Principal Investigator Name
Charles Cassius
Principal Investigator Email
charles.cassius@aphp.fr
Contact Person Name
Charles Cassius
Contact Person Email
charles.cassius@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
40874: Service de Dermatologie
Principal Investigator Name
Thierry Passeron
Principal Investigator Email
passeron.t@chu-nice.fr
Contact Person Name
Thierry Passeron
Contact Person Email
passeron.t@chu-nice.fr
Site Name
Du Docteur Ruer S.E.L.A.R.L.
Department Name
40882
Principal Investigator Name
Mireille Ruer-Mulard
Principal Investigator Email
ruerdoc@gmail.com
Contact Person Name
Mireille Ruer-Mulard
Contact Person Email
ruerdoc@gmail.com
Site Name
HIA Sainte Anne
Department Name
40874: Service de Dermatologie
Principal Investigator Name
Thierry Boye
Principal Investigator Email
thierry.boye@yahoo.fr
Contact Person Name
Thierry Boye
Contact Person Email
thierry.boye@yahoo.fr
Site Name
Hopital Saint Joseph
Department Name
40883:Pôle de Recherche Clinique Pluridisciplinaire et Service de Dermatologie
Principal Investigator Name
Nathalie Quiles-Tsimaratos
Principal Investigator Email
nquiles@hopital-saint-joseph.fr
Contact Person Name
Nathalie Quiles-Tsimaratos
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
40286:Service de Dermatologie
Principal Investigator Name
Carle PAUL
Principal Investigator Email
paul.c@chu-toulouse.fr
Contact Person Name
Carle PAUL
Contact Person Email
paul.c@chu-toulouse.fr

Italy

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
41
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
40448:Unità di Dermatologia Clinica
Principal Investigator Name
Franco Rongioletti
Principal Investigator Email
franco.rongioletti@me.com
Contact Person Name
Franco Rongioletti
Contact Person Email
franco.rongioletti@me.com
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
40816:UO Dermatologia
Principal Investigator Name
Francesco Tonon
Principal Investigator Email
f.tonon@unibs.it
Contact Person Name
Francesco Tonon
Contact Person Email
f.tonon@unibs.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
40210: Clinica Dermatologica
Principal Investigator Name
Simone Ribero
Principal Investigator Email
simone.ribero@unito.it
Contact Person Name
Simone Ribero
Contact Person Email
simone.ribero@unito.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
40567:Dermatologia
Principal Investigator Name
Ketty Peris
Principal Investigator Email
ketty.peris@unicatt.it
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
40830: UO Dermatologia
Principal Investigator Name
Antonio Costanzo
Principal Investigator Email
antonio.costanzo@hunimed.eu
Contact Person Name
Antonio Costanzo
Contact Person Email
antonio.costanzo@hunimed.eu

Spain

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
36
Number Of Sites
11
Number Of Participants
10

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
40889: Dermatología
Principal Investigator Name
Enrique Herrera Acosta
Principal Investigator Email
eherreraacosta@gmail.com
Contact Person Name
Enrique Herrera Acosta
Contact Person Email
eherreraacosta@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
40266: Dermatología
Principal Investigator Name
José Manuel Carrascosa Carrillo
Principal Investigator Email
jmcarrascosac.germanstrias@gencat.ca
Contact Person Name
José Manuel Carrascosa Carrillo
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
40879: Dermatologia
Principal Investigator Name
Manuel Ginarte Val
Principal Investigator Email
javier.ginarte.val@sergas.es
Contact Person Name
Manuel Ginarte Val
Contact Person Email
javier.ginarte.val@sergas.es
Site Name
Hospital De Manises
Department Name
40297: Dermatología
Principal Investigator Name
Antonio Martorell Calatayud
Principal Investigator Email
antmarto@hotmail.com
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
antmarto@hotmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
40230: Dermatología
Principal Investigator Name
Antonio Sahuquillo Torralba
Principal Investigator Email
saucodos@gmail.com
Contact Person Name
Antonio Sahuquillo Torralba
Contact Person Email
saucodos@gmail.com
Site Name
Hospital Del Mar
Department Name
40890: Dermatologia
Principal Investigator Name
Marta Ferrán Farrés
Principal Investigator Email
mferran@imim.es
Contact Person Name
Marta Ferrán Farrés
Contact Person Email
mferran@imim.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
40750: Dermatología
Principal Investigator Name
Isabel Belinchón Romero
Principal Investigator Email
belinchon_isa@gva.es
Contact Person Name
Isabel Belinchón Romero
Contact Person Email
belinchon_isa@gva.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
40159: Dermatology
Principal Investigator Name
Anna López Ferrer
Principal Investigator Email
ALopezFe@santpau.cat
Contact Person Name
Anna López Ferrer
Contact Person Email
ALopezFe@santpau.cat
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
40868: Dermatología
Principal Investigator Name
Jorge Magdaleno-Tapial
Principal Investigator Email
jormagta@gmail.com
Contact Person Name
Jorge Magdaleno-Tapial
Contact Person Email
jormagta@gmail.com
Site Name
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Department Name
40888: Dermatología
Principal Investigator Name
Alvaro Gonzalez Cantero
Principal Investigator Email
alvarogc261893@hotmail.com
Contact Person Name
Alvaro Gonzalez Cantero
Contact Person Email
alvarogc261893@hotmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
40885: Dermatología
Principal Investigator Name
Ricardo Ruiz Villaverde
Contact Person Name
Ricardo Ruiz Villaverde

Germany

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
23
Number Of Sites
15
Number Of Participants
64

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
40023: Hautklinik – Studienambulanz
Principal Investigator Name
Michael Sticherling
Principal Investigator Email
michael.sticherling@uk-erlangen.de
Contact Person Name
Michael Sticherling
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
40747: Dermatology
Principal Investigator Name
Joanna Wegner
Principal Investigator Email
joanna.wegner@unimedizin-mainz.de
Contact Person Name
Joanna Wegner
Site Name
Rostock University Medical Center
Department Name
40366:Klinik und Poliklinik für Dermatologie und Venerologie
Principal Investigator Name
Alexander Thiem
Principal Investigator Email
alexander.thiem@med.uni-rostock.de
Contact Person Name
Alexander Thiem
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
40515: Alliance Headquarters
Principal Investigator Name
Sonja-Christine Molin
Principal Investigator Email
sonja-christine.molin@charite.de
Contact Person Name
Sonja-Christine Molin
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
40249: Dermatologie/Allergologie
Principal Investigator Name
Sascha Gerdes
Principal Investigator Email
Sascha.Gerdes@uksh.de
Contact Person Name
Sascha Gerdes
Contact Person Email
Sascha.Gerdes@uksh.de
Site Name
Universitaet Muenster
Department Name
40177: Hautklinik
Principal Investigator Name
Nina Magnolo
Principal Investigator Email
nina.magnolo@ukmuenster.de
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Klinikum Bielefeld gGmbH
Department Name
40891: Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Katharina Kreutzer
Principal Investigator Email
katharina.kreutzer@klinikumbielefeld.de
Contact Person Name
Katharina Kreutzer
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
40740:Dermatology
Principal Investigator Name
Athanasios Tsianakas
Principal Investigator Email
a.tsianakas@fk-bentheim.de
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Hautaerztliche Gemeinschaftspraxis Dres. med. Petri & Moecklinghoff
Department Name
40875
Principal Investigator Name
Maximilian Petri
Principal Investigator Email
maximilianpetri@gmx.de
Contact Person Name
Maximilian Petri
Contact Person Email
maximilianpetri@gmx.de
Site Name
Goethe University Frankfurt
Department Name
40287: Dermatology
Principal Investigator Name
Andreas Pinter
Principal Investigator Email
andreas.pinter@unimedizin-ffm.de
Contact Person Name
Andreas Pinter
Site Name
Universitaetsmedizin Goettingen
Department Name
40866: Dermatology
Principal Investigator Name
Rotraut Moessner
Principal Investigator Email
rotraut.moessner@med.uni-goettingen.de
Contact Person Name
Rotraut Moessner
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
40892:CCIM
Principal Investigator Name
Diamant Thaci
Principal Investigator Email
diamant.thaci@uksh.de
Contact Person Name
Diamant Thaci
Contact Person Email
diamant.thaci@uksh.de
Site Name
Technische Universitaet Dresden
Department Name
40356: Klinik und Poliklinik für Dermatologie
Principal Investigator Name
Stefan Beissert
Principal Investigator Email
Stefan.beissert@ukdd.de
Contact Person Name
Stefan Beissert
Contact Person Email
Stefan.beissert@ukdd.de
Site Name
Dr. Niesmann And Dr. Othlinghaus GbR
Department Name
40893: Hautzentrum im Jahrhunderthaus
Principal Investigator Name
Johannes Niesmann
Principal Investigator Email
niesmann@niesmann-othlinghaus.de
Contact Person Name
Johannes Niesmann
Site Name
Universitaetsklinikum Essen AöR
Department Name
40134: Hautklinik
Principal Investigator Name
Wiebke Sondermann
Principal Investigator Email
wiebke.sondermann@uk-essen.de
Contact Person Name
Wiebke Sondermann
Contact Person Email
wiebke.sondermann@uk-essen.de

Hungary

Earliest CTIS Part Ii Submission Date
30-09-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
72
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Semmelweis University
Department Name
40203:Dermatology
Principal Investigator Name
Péter Holló
Principal Investigator Email
titkarsag.bor@semmelweis.hu
Contact Person Name
Péter Holló
Contact Person Email
titkarsag.bor@semmelweis.hu
Site Name
Derma-B Kft.
Department Name
40895: Dermatology
Principal Investigator Name
Emese Herédi
Principal Investigator Email
emeseheredi@gmail.com
Contact Person Name
Emese Herédi
Contact Person Email
emeseheredi@gmail.com
Site Name
DermaMed Research Kft.
Department Name
40894: Dermatology
Principal Investigator Name
Piroska Dosa
Principal Investigator Email
dermamed.research@gmail.com
Contact Person Name
Piroska Dosa
Contact Person Email
dermamed.research@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
30-10-2025
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
48
Number Of Sites
15
Number Of Participants
68

Sites

Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Department Name
40334: Dermatology
Principal Investigator Name
Jacek Szepietowski
Principal Investigator Email
jacek.szepietowski.work@gmail.com
Contact Person Name
Jacek Szepietowski
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
40743: Dermatology
Principal Investigator Name
Tadeusz Debniak
Principal Investigator Email
debniak@twojaprzychodnia.com
Contact Person Name
Tadeusz Debniak
Contact Person Email
debniak@twojaprzychodnia.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
40788: Dermatology
Principal Investigator Name
Malgorzata Plocka
Principal Investigator Email
malgorzata.plocka@mics.medicover.com
Contact Person Name
Malgorzata Plocka
Site Name
Dermmedica Sp. z o.o.
Department Name
40862: Dermatology
Principal Investigator Name
Jolanta Weglowska
Principal Investigator Email
jolanta.weglowska@dermmedica.pl
Contact Person Name
Jolanta Weglowska
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Department Name
40625: Dermatology
Principal Investigator Name
Andrzej Kaszuba
Principal Investigator Email
andrzej.kaszuba@dermed.com.pl
Contact Person Name
Andrzej Kaszuba
Contact Person Email
andrzej.kaszuba@dermed.com.pl
Site Name
Royalderm Agnieszka Nawrocka
Department Name
40876: Dermatology
Principal Investigator Name
Witold Owczarek
Principal Investigator Email
witold.owczarek@dermedicus.pl
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl
Site Name
Solumed Centrum Medyczne Sp. z o.o.
Department Name
40757: Dermatology
Principal Investigator Name
Kinga Adamska
Principal Investigator Email
kingabyczkowska@gmail.com
Contact Person Name
Kinga Adamska
Contact Person Email
kingabyczkowska@gmail.com
Site Name
Etg Warszawa Sp. z o.o.
Department Name
40604: Dermatology
Principal Investigator Name
Maria Zegadlo-Mylik
Principal Investigator Email
m.zegadlomylik@etg-network.com
Contact Person Name
Maria Zegadlo-Mylik
Contact Person Email
m.zegadlomylik@etg-network.com
Site Name
Miedzyleski Szpital Specjalistyczny W Warszawie
Department Name
40867:Oddzial Dermatologii Doroslych
Principal Investigator Name
Ewelina Bialo-Wojcicka
Principal Investigator Email
ewelbialo@poczta.onet.pl
Contact Person Name
Ewelina Bialo-Wojcicka
Contact Person Email
ewelbialo@poczta.onet.pl
Site Name
Specderm Poznanska Sp. j.
Department Name
40626: Dermatology
Principal Investigator Name
Maria Poznanska
Principal Investigator Email
specderm@gmail.com
Contact Person Name
Maria Poznanska
Contact Person Email
specderm@gmail.com
Site Name
Dermedic Iwona Zdybska
Department Name
40877: Dermatology
Principal Investigator Name
Beata Polkowska-Pruszynska
Principal Investigator Email
beata.polkowska@zdybski.pl
Contact Person Name
Beata Polkowska-Pruszynska
Contact Person Email
beata.polkowska@zdybski.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
40396:Oddzial Dermatologii i Dermatologii Onkologicznej
Principal Investigator Name
Adam Reich
Principal Investigator Email
adi_medicalis@go2.pl
Contact Person Name
Adam Reich
Contact Person Email
adi_medicalis@go2.pl
Site Name
Pro Familia Altera Sp. z o.o.
Department Name
40878: Dermatology
Principal Investigator Name
Ewa Sygula
Principal Investigator Email
esyg@wp.pl
Contact Person Name
Ewa Sygula
Contact Person Email
esyg@wp.pl
Site Name
Medelis Badania Kliniczne Sp. z o.o.
Department Name
40092: Dermatology
Principal Investigator Name
Karolina Pelka
Principal Investigator Email
pelkakarola@gmail.com
Contact Person Name
Karolina Pelka
Contact Person Email
pelkakarola@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Department Name
40637: Dermatology
Principal Investigator Name
Aleksandra Okuniewska
Principal Investigator Email
a.okuniewska@pihouse.pl
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@pihouse.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
4g Clinical LLC
Responsibilities
3
Name
Parexel International Limited
Responsibilities
On site monitoring (HU); Unblinded Monitoring (all EU countries); On site monitoring (CZE, DEU, DNK, ESP, FRA, ITA, POL)
Name
Icon Clinical Research Limited
Responsibilities
On Site Monitoring (CZE, DEU, DNK, ESP, FRA, ITA, POL); On Site Monitoring (CZE, DEU, DNK, ESP, FRA, ITA, POL); On Site Monitoring (CZE, DEU, DNK, ESP, FRA, ITA, POL)
Name
PPD
Responsibilities
4
Name
Bioagilytix Labs LLC
Responsibilities
4

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"On site monitoring (HU)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"On Site Monitoring (CZE, DEU, DNK, ESP, FRA, ITA, POL)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"Unblinded Monitoring (all EU countries)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"On site monitoring (HU)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"Unblinded Monitoring (all EU countries)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"On Site Monitoring (CZE, DEU, DNK, ESP, FRA, ITA, POL)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD","duties_or_roles":"4","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"11","organisation_type":"Patient organisation/association"}
  • {"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":"AG Mednet Inc.","duties_or_roles":"Adjudication services","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quantificare S.A","duties_or_roles":"Imaging services","organisation_type":"Health care"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Bimzelx 320 mg solution for injection in pre-filled pen
Active Substance
BIMEKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised
Investigational Product Name
Bimzelx 160 mg solution for injection in pre-filled syringe
Active Substance
BIMEKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised
Investigational Product Name
Placebo matching test. 0.9% sodium chloride solution for injection (unauthorized).
Modality
Other
Authorisation Status
Unauthorised

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