Clinical trial • Phase III • Immunology

GUSELKUMAB for Fistulizing perianal Crohn's disease

Phase III trial of GUSELKUMAB for Fistulizing perianal Crohn's disease.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Fistulizing perianal Crohn's disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
11-07-2024
First CTIS Authorization Date
13-08-2024

Trial design

Randomised, placebo (product names in registry: 'placebo to guselkumab', 'placebo to guselkumab solution for injection in pre-filled syringe -100 mg/ml', and 'placebo to guselkumab- solution for infusion- 10 mg/ml'). no dose or schedule for comparator explicitly stated in provided data.-controlled Phase III trial in Greece, Hungary, Czechia and others.

Randomised
Yes
Comparator
Placebo (product names in registry: 'Placebo to Guselkumab', 'Placebo to Guselkumab solution for injection in pre-filled syringe -100 mg/ml', and 'Placebo to Guselkumab- Solution for infusion- 10 mg/ml'). No dose or schedule for comparator explicitly stated in provided data.
Target Sample Size
90

Eligibility

Recruits 90 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (multiple adult ICFs and country-specific ICFs including 'Other Pregnant Partner' ICFs). Consent is obtained from adult participants; no assent/minor consent procedures are described in the provided data..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (multiple adult ICFs and country-specific ICFs including 'Other Pregnant Partner' ICFs). Consent is obtained from adult participants; no assent/minor consent procedures are described in the provided data.

Inclusion criteria

  • {"criterion_text":"- Aged 18 years or over\n- Diagnosis of Crohn's disease with a minimum duration of at least 3 months\n- At least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening MRI results\n- Has previously demonstrated lack of initial response, responded initially but then lost response with continued therapy, or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease. OR History of failure to respond to, or tolerate, at least 1 of the following therapies for the treatment of Crohn's disease: oral corticosteroids (including budesonide and beclomethasone dipropionate) or immunomodulators (AZA, 6-MP, MTX).\n- Had a history of failure to respond to, or tolerate, at least 1 of the following therapies for fistula treatment: antibiotics (ie, ciprofloxacin, metronidazole) and/or immunomodulators (AZA, 6-MP, MTX)."}

Exclusion criteria

  • {"criterion_text":"- Has a very severe luminal disease activity (defined as CDAI ≥350).\n- Has any of the following: - history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis, stoma or functioning ostomy. - colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus.\n- Has current complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude any fistula evaluation (both clinical and radiological) to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24","definition_or_measurement_approach":"Measured as the proportion of participants who achieve combined fistula remission at Week 24"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
90
Recruitment Window Months
51
Consent Approach
Informed consent is obtained from adult participants using main adult ICFs and country-specific ICFs. Subject information and consent forms (including optional genetic research ICFs and 'Other Pregnant Partner' ICFs) are available in multiple languages (English, Greek, Hungarian, Czech, Dutch, French, German, Italian, Polish, Portuguese, Spanish as evidenced by the published ICF and recruitment documents).

Methods

  • Country/site recruitment materials (study information brochures, participant study guides, welcome booklets) — patient-facing printed materials
  • Recruitment posters and flyers (country-specific versions listed)
  • Patient information and study information videos (patient information video PDFs listed)
  • Recruitment procedure descriptions and K1 recruitment procedures (country-specific K1 documents)
  • Site-based recruitment via participating hospitals/clinics (site lists provided)

Geography

Total Number Of Sites
59
Total Number Of Participants
190

Greece

Latest Decision Or Authorization Date
01-11-2024
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Hippokration Hospital
Department Name
#GR10007: 2nd Internal Medicine
Principal Investigator Name
Spilios Manolakopoulos
Principal Investigator Email
smanolak@med.uoa.gr
Contact Person Name
Spilios Manolakopoulos
Contact Person Email
smanolak@med.uoa.gr
Site Name
University General Hospital Of Heraklion
Department Name
#GR10004: Gastroenterology
Principal Investigator Name
Ioannis Koutroubakis
Principal Investigator Email
ikoutroub2@gmail.com
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroub2@gmail.com
Site Name
General University Hospital Of Patras
Department Name
#GR10002: Gastroenterology
Principal Investigator Name
Konstantinos Thomopoulos
Principal Investigator Email
kxthomo@hotmail.com
Contact Person Name
Konstantinos Thomopoulos
Contact Person Email
kxthomo@hotmail.com
Site Name
Alexandra Hospital
Department Name
#GR10008: Gastroenterology
Principal Investigator Name
Spyridon Michopoulos
Principal Investigator Email
michosp5@gmail.com
Contact Person Name
Spyridon Michopoulos
Contact Person Email
michosp5@gmail.com
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
#GR10006: B'propaedeutic Clinic of Internal Medicine
Principal Investigator Name
Olga Giouleme
Principal Investigator Email
olgagi@med.auth.gr
Contact Person Name
Olga Giouleme
Contact Person Email
olgagi@med.auth.gr
Site Name
Evangelismos S.A.
Department Name
#GR10005: Gastroenterology
Principal Investigator Name
Nikolaos Viazis
Principal Investigator Email
nikos.viazis@gmail.com
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
#GR10009: Gastroenterology
Principal Investigator Name
Andreas Kapsoritakis
Principal Investigator Email
kapsoritakis@med.uth.gr
Contact Person Name
Andreas Kapsoritakis
Contact Person Email
kapsoritakis@med.uth.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
#GR10003: 3rd University Clinic of Internal Medicine
Principal Investigator Name
Giorgos Bamias
Principal Investigator Email
gbamias@gmail.com
Contact Person Name
Giorgos Bamias
Contact Person Email
gbamias@gmail.com

Hungary

Latest Decision Or Authorization Date
14-08-2024
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
#HU10002 : Gasztroenterológia Osztály
Principal Investigator Name
Tibor Gyökeres
Principal Investigator Email
gyokereshonvedstudy@gmail.com
Contact Person Name
Tibor Gyökeres
Contact Person Email
gyokereshonvedstudy@gmail.com
Site Name
University Of Pecs
Department Name
#HU10005:'I. sz. Belgyógyászati Klinika
Principal Investigator Name
Patrícia Sarlós
Principal Investigator Email
sarlos.patricia@pte.hu
Contact Person Name
Patrícia Sarlós
Contact Person Email
sarlos.patricia@pte.hu
Site Name
Semmelweis University
Department Name
#HU10007:'Belgyógyászati és Onkológiai Klinika
Principal Investigator Name
Ákos Iliás
Principal Investigator Email
ilias.akos@med.semmelweis-univ.hu
Contact Person Name
Ákos Iliás
Site Name
University Of Szeged
Department Name
#HU10006 : Gasztroenterológiai Osztály
Principal Investigator Name
Tamás Molnár
Principal Investigator Email
molnar.tamas@med.u-szeged.hu
Contact Person Name
Tamás Molnár
Contact Person Email
molnar.tamas@med.u-szeged.hu
Site Name
Semmelweis University
Department Name
#HU10004 : Gasztroenterológiai Osztály
Principal Investigator Name
Miheller Pál
Principal Investigator Email
pmiheller@gmail.com
Contact Person Name
Miheller Pál
Contact Person Email
pmiheller@gmail.com
Site Name
Semmelweis University
Department Name
#HU10003:'Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Emese Mihály
Principal Investigator Email
emesemihaly@hotmail.com
Contact Person Name
Emese Mihály
Contact Person Email
emesemihaly@hotmail.com

Czechia

Latest Decision Or Authorization Date
14-08-2024
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Iscare a.s.
Department Name
CZ10002 : IBD a gastroenterologie
Principal Investigator Name
Milan Lukas
Principal Investigator Email
milan.lukas@email.cz
Contact Person Name
Milan Lukas
Contact Person Email
milan.lukas@email.cz
Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
CZ10001 : Gastroenterologicke oddeleni
Principal Investigator Name
Martin Bortlik
Principal Investigator Email
mbortlik@seznam.cz
Contact Person Name
Martin Bortlik
Contact Person Email
mbortlik@seznam.cz

Belgium

Latest Decision Or Authorization Date
13-08-2024
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
#BE10006: Gastro-Entérologie
Principal Investigator Name
Clara Caenepeel
Principal Investigator Email
Clara.Caenepeel@zol.be
Contact Person Name
Clara Caenepeel
Contact Person Email
Clara.Caenepeel@zol.be
Site Name
Hopital Erasme
Department Name
#BE10005: Gastro-Entérologie
Principal Investigator Name
Denis Franchimont
Principal Investigator Email
denis.franchimont@erasme.ulb.ac.be
Contact Person Name
Denis Franchimont
Site Name
Centre hospitalier universitaire de Liege
Department Name
#BE10003: Gastro-entérologie
Principal Investigator Name
Edouard Louis
Principal Investigator Email
edouard.louis@uliege.be
Contact Person Name
Edouard Louis
Contact Person Email
edouard.louis@uliege.be
Site Name
UZ Leuven
Department Name
#BE10004: Gastro-enterologie
Principal Investigator Name
Severine Vermeire
Principal Investigator Email
severine.vermeire@uzleuven.be
Contact Person Name
Severine Vermeire
Contact Person Email
severine.vermeire@uzleuven.be

Germany

Latest Decision Or Authorization Date
16-08-2024
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
#DE10006: Innere Medizin I
Principal Investigator Name
Stefan Schreiber
Principal Investigator Email
s.schreiber@mucosa.de
Contact Person Name
Stefan Schreiber
Contact Person Email
s.schreiber@mucosa.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#DE10005: Interdisziplinäres Stoffwechse
Principal Investigator Name
Christoph Jochum
Principal Investigator Email
christoph.jochum@charite.de
Contact Person Name
Christoph Jochum
Contact Person Email
christoph.jochum@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
#DE10009: Gastroenterologie, Endokrinolo
Principal Investigator Name
Jochen Klaus
Principal Investigator Email
jochen.klaus@uniklinik-ulm.de
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
#DE10001: Medizinische Klinik I
Principal Investigator Name
Irina Blumenstein
Principal Investigator Email
blumenstein@em.uni-frankfurt.de
Contact Person Name
Irina Blumenstein
Site Name
Universitat Heidelberg
Department Name
#DE10011: II. Medizinische Klinik
Principal Investigator Name
Wolfgang Reindl
Principal Investigator Email
wolfgang.reindl@umm.de
Contact Person Name
Wolfgang Reindl
Contact Person Email
wolfgang.reindl@umm.de

Netherlands

Latest Decision Or Authorization Date
14-08-2024
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
NL10011, Gastroenterology and Hepatology
Principal Investigator Name
Annemarie de Vries
Principal Investigator Email
a.c.devries@erasmusmc.nl
Contact Person Name
Annemarie de Vries
Contact Person Email
a.c.devries@erasmusmc.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
NL10010, Maag, darm en leverziekten
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
marjolijn.duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein
Site Name
Stichting Amsterdam UMC
Department Name
NL10003, Gastroenterology
Principal Investigator Name
Krisztina Gecse
Principal Investigator Email
k.b.gecse@amsterdamumc.nl
Contact Person Name
Krisztina Gecse
Contact Person Email
k.b.gecse@amsterdamumc.nl

Spain

Latest Decision Or Authorization Date
13-08-2024
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
#ES10009:Gastroenterology
Principal Investigator Name
Elena Ricart Gómez
Principal Investigator Email
ericart@clinic.cat
Contact Person Name
Elena Ricart Gómez
Contact Person Email
ericart@clinic.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
#ES10001:Aparato Digestivo
Principal Investigator Name
Federico Argüelles Arias
Principal Investigator Email
Digestivo.hvm.sspa@juntadeandalucia.es
Contact Person Name
Federico Argüelles Arias
Site Name
Hospital Universitario Miguel Servet
Department Name
#ES10008:Gastroenterology
Principal Investigator Name
Raquel Vicente Lidon
Principal Investigator Email
raquelvicentelidon@gmail.com
Contact Person Name
Raquel Vicente Lidon
Contact Person Email
raquelvicentelidon@gmail.com
Site Name
Hospital Universitario De La Princesa
Department Name
#ES10007:Aparato Digestivo
Principal Investigator Name
Javier Pérez Gisbert
Principal Investigator Email
javier.p.gisbert@gmail.com
Contact Person Name
Javier Pérez Gisbert
Contact Person Email
javier.p.gisbert@gmail.com
Site Name
Area Sanitaria De Ferrol
Department Name
#ES10004:Digestivo
Principal Investigator Name
Ana Echarri Piudo
Principal Investigator Email
ana.echarri.piudo@sergas.es
Contact Person Name
Ana Echarri Piudo
Contact Person Email
ana.echarri.piudo@sergas.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
#ES10011: Cirugía Colorretal y Digestiva
Principal Investigator Name
Maria Isabel Vera Mendoza
Principal Investigator Email
mariaisabel.vera@salud.madrid.org
Contact Person Name
Maria Isabel Vera Mendoza
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
#ES10010:Aparato Digestivo
Principal Investigator Name
David Busquets Casals
Principal Investigator Email
unitatinflamatoria.girona.ics@gencat.cat
Contact Person Name
David Busquets Casals
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
#ES10005:Aparato Digestivo
Principal Investigator Name
Vicent Hernández Ramírez
Contact Person Name
Vicent Hernández Ramírez

Poland

Latest Decision Or Authorization Date
29-08-2024
Number Of Sites
9
Number Of Participants
35

Sites

Site Name
Gastromed Sp. z o.o.
Department Name
#PL10006: Gastrology
Principal Investigator Name
Adam Kopon
Principal Investigator Email
adamkopon@interia.pl
Contact Person Name
Adam Kopon
Contact Person Email
adamkopon@interia.pl
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
#PL10002: Gastrology
Principal Investigator Name
Beata Gawdis - Wojnarska
Principal Investigator Email
gawdis@twojaprzychodnia.com
Contact Person Name
Beata Gawdis - Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Centrum Medyczne Oporow
Department Name
#PL10012: Gastrology
Principal Investigator Name
Radoslaw Kempinski
Principal Investigator Email
kempinski.wroclaw@gmail.com
Contact Person Name
Radoslaw Kempinski
Contact Person Email
kempinski.wroclaw@gmail.com
Site Name
Gastromed Kralisz Romatowski Stachurska Sp. j.
Department Name
#PL10009:gastrology
Principal Investigator Name
Jacek Romatowski
Principal Investigator Email
jromatowski@wp.pl
Contact Person Name
Jacek Romatowski
Contact Person Email
jromatowski@wp.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Department Name
#PL10001:Gastrology
Principal Investigator Name
Rafal Filip
Principal Investigator Email
r.s.filip@wp.pl
Contact Person Name
Rafal Filip
Contact Person Email
r.s.filip@wp.pl
Site Name
Promed P.Lach R.Glowacki Sp. j.
Department Name
#PL10007: gastrology
Principal Investigator Name
Danuta Owczarek
Principal Investigator Email
dowczarek@cmpromed.pl
Contact Person Name
Danuta Owczarek
Contact Person Email
dowczarek@cmpromed.pl
Site Name
Centrum Medyczne Med-Gastr Sp. z o.o.
Department Name
#PL10016: Gastrology
Principal Investigator Name
Arkadiusz Mamos
Principal Investigator Email
arkadiusz.mamos@medgastr.pl
Contact Person Name
Arkadiusz Mamos
Contact Person Email
arkadiusz.mamos@medgastr.pl
Site Name
Melita Medical Sp. z o.o.
Department Name
#PL10013:Gastrology
Principal Investigator Name
Jaroslaw Leszczyszyn
Principal Investigator Email
j.leszczyszyn@melitamedical.pl
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Medical Network Sp. z o.o.
Department Name
#PL10004: Gastrology
Principal Investigator Name
Jaroslaw Kierkus
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl

Italy

Latest Decision Or Authorization Date
02-09-2024
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
IT10010, UO Malattie Infiammatorie Croniche Intestinali
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
clinicaltrialsibd@humanitas.it
Contact Person Name
Alessandro Armuzzi
Contact Person Email
clinicaltrialsibd@humanitas.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
IT10004, UO Gastroenterologia, DAI Specialita' Mediche e Chirurgiche
Principal Investigator Name
Francesco Costa
Principal Investigator Email
fcosta@med.unipi.it
Contact Person Name
Francesco Costa
Contact Person Email
fcosta@med.unipi.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
IT10003, Gastroenterologia 1
Principal Investigator Name
Flavio Caprioli
Principal Investigator Email
flavio.caprioli@policlinico.mi.it
Contact Person Name
Flavio Caprioli
Site Name
Casa Sollievo Della Sofferenza
Department Name
IT1002, Gastroenterologia e Endoscopia Digestiva
Principal Investigator Name
Fabrizio Bossa
Principal Investigator Email
f.bossa@operapadrepio.it
Contact Person Name
Fabrizio Bossa
Contact Person Email
f.bossa@operapadrepio.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
IT10009, UOC CEMAD (Centro malattie apparato Digerente)
Principal Investigator Name
Franco Scaldaferri
Principal Investigator Email
franco.scaldaferri@policlinicogemelli.it
Contact Person Name
Franco Scaldaferri
Site Name
Azienda Socio Sanitaria Territoriale Rhodense
Department Name
IT10008, UOC Gastroenterologia e Endoscopia Digestiva
Principal Investigator Name
Simone Saibeni
Principal Investigator Email
saibo@tiscali.it
Contact Person Name
Simone Saibeni
Contact Person Email
saibo@tiscali.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
IT0005, UO Malattie Retto-Intestinali
Principal Investigator Name
Angela Variola
Principal Investigator Email
angela.variola@sacrocuore.it
Contact Person Name
Angela Variola
Contact Person Email
angela.variola@sacrocuore.it
Site Name
Azienda Ospedaliero Universitaria Pisana (additional listed site)
Department Name
IT10004, UO Gastroenterologia, DAI Specialita' Mediche e Chirurgiche
Principal Investigator Name
Francesco Costa
Principal Investigator Email
fcosta@med.unipi.it
Contact Person Name
Francesco Costa
Contact Person Email
fcosta@med.unipi.it

Portugal

Latest Decision Or Authorization Date
14-08-2024
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
PT10007: Unidade de Investigação Clínica
Principal Investigator Name
Bruno Arroja
Principal Investigator Email
brunoarroja@gmail.com
Contact Person Name
Bruno Arroja
Contact Person Email
brunoarroja@gmail.com
Site Name
Unidade Local de Saúde de São José, E. P. E.
Department Name
PT10002:Gastroenterologia
Principal Investigator Name
Jaime Ramos
Principal Investigator Email
Jaime.ramos@chlc.min-saude.pt
Contact Person Name
Jaime Ramos
Contact Person Email
Jaime.ramos@chlc.min-saude.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
PT10005: Gastroenterologia
Principal Investigator Name
Paula Lago
Principal Investigator Email
paulalago@netcabo.pt
Contact Person Name
Paula Lago
Contact Person Email
paulalago@netcabo.pt

France

Latest Decision Or Authorization Date
13-09-2024
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
FR10002: main office
Principal Investigator Name
Amandine Landemaine
Principal Investigator Email
amandine.landemaine@chu-rennes.fr
Contact Person Name
Amandine Landemaine
Site Name
CHRU De Nancy
Department Name
FR10004: Service d'Hépato-Gastroentérologie
Principal Investigator Name
Bénédicte Caron
Principal Investigator Email
b.caron@chru-nancy.fr
Contact Person Name
Bénédicte Caron
Contact Person Email
b.caron@chru-nancy.fr
Site Name
Hospices Civils De Lyon
Department Name
FR10003: Hépato-Gastroentérologie
Principal Investigator Name
Stéphane Nancey
Principal Investigator Email
stephane.nancey@chu-lyon.fr
Contact Person Name
Stéphane Nancey
Contact Person Email
stephane.nancey@chu-lyon.fr

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Responsibilities
[{"code":917572},{"code":917573}]
Name
Icon Clinical Research Limited
Responsibilities
[{"code":917574,"value":"eCOA translations"}]
Name
Parexel International (IRL) Limited
Responsibilities
[{"code":917580},{"code":917581},{"code":917582},{"code":917583}]
Name
IQVIA Limited
Responsibilities
[{"code":917571}]
Name
Medidata Solutions Inc.
Responsibilities
[{"code":917575}]
Name
SGS Belgium
Responsibilities
[{"code":917577},{"code":917578}]

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"code\":917575}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"[{\"code\":917577},{\"code\":917578}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"[{\"code\":917572},{\"code\":917573}]","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"[{\"code\":917585}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Exco Intouch Limited","duties_or_roles":"[{\"code\":917579}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"[{\"code\":917570,\"value\":\"Imaging\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"[{\"code\":917574,\"value\":\"eCOA translations\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[{\"code\":917571}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"[{\"code\":917580},{\"code\":917581},{\"code\":917582},{\"code\":917583}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"[{\"code\":917584}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"[{\"code\":917576}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Guselkumab
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE (also available as solution for infusion formulation)
Route
SUBCUTANEOUS USE / SOLUTION FOR INFUSION
Authorisation Status
Authorised
Investigational Product Name
Guselkumab - solution for infusion - 10 mg/ml
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
intravenous infusion (solution for infusion) - exact administration schedule not specified in provided data
Authorisation Status
Authorised
Investigational Product Name
Placebo to Guselkumab
Modality
Placebo
Investigational Product Name
Placebo to Guselkumab solution for injection in pre-filled syringe -100 mg/ml
Modality
Placebo

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