Clinical trial • Phase III • Gastroenterology

GUSELKUMAB for Crohn's disease (moderately to severely active)

Phase III trial of GUSELKUMAB for Crohn's disease (moderately to severely active).

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease (moderately to severely active)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
19-07-2024
First CTIS Authorization Date
13-08-2024

Trial design

Randomised, placebo (placebo 0.5ml equivalent; placebo 1.0ml equivalent; placebo 2.0ml equivalent) as comparator arms; guselkumab active arms (formulations listed: solution for injection in pre-filled syringe and solution for infusion). dose and schedule not specified in the summary record.-controlled Phase III trial in Poland, Austria, Portugal and others.

Randomised
Yes
Comparator
Placebo (Placebo 0.5ml equivalent; Placebo 1.0ml equivalent; Placebo 2.0ml equivalent) as comparator arms; guselkumab active arms (formulations listed: solution for injection in pre-filled syringe and solution for infusion). Dose and schedule not specified in the summary record.
Target Sample Size
58
Trial Duration For Participant
364

Eligibility

Recruits 58 paediatric patients.

Vulnerable Population
Includes pediatric participants; assent and parental consent processes are documented with age-specific assent forms and parental informed consent forms (assent forms and parental ICFs are provided for age groups such as 2-5, 6-11, 12-17, and addenda for 'Turning 18'); specific parental and pregnant-partner ICF/addenda are included in documentation. Vulnerable population flag is selected in the trial record.

Inclusion criteria

  • {"criterion_text":"- Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria."}
  • {"criterion_text":"- Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [≥] 30)"}
  • {"criterion_text":"- Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) during screening into this study"}
  • {"criterion_text":"- Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor"}

Exclusion criteria

  • {"criterion_text":"- Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery."}
  • {"criterion_text":"- Participants must not have an abscess"}
  • {"criterion_text":"- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline"}
  • {"criterion_text":"- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical remission at Week 52 (defined as PCDAI score ≤10)","definition_or_measurement_approach":"Clinical remission defined as Pediatric Crohn's Disease Activity Index (PCDAI) score ≤10 at Week 52."}
  • {"endpoint_text":"- Endoscopic response (≥50% reduction from SES-CD score at baseline) at Week 52","definition_or_measurement_approach":"Endoscopic response defined as ≥50% reduction from baseline Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 52."}

Recruitment

Planned Sample Size
58
Recruitment Window Months
57
Consent Approach
Parental/legal guardian informed consent is required for minor participants; age‑appropriate assent forms are used (documented assent forms for age groups including 2-5 years, 6-11 years, 12-17 years). 'Turning 18' procedures and parental addenda are provided. Informed consent and assent documents are available in multiple language versions (examples in the dossier: English, French, Polish, Portuguese, Dutch, Spanish, Italian, Norwegian, German/Austria).

Geography

Total Number Of Sites
31
Total Number Of Participants
30

Poland

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
14-12-2025
Processing Time Days
499
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkuś
Contact Person Name
Monika Meglicka
Contact Person Email
m.meglicka@wip.waw.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Gastroenterologii, Hepatologii, Zaburzeń odżywiania i Pediatrii
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Centrum Medyczne Oporow
Contact Person Name
Radosław Kempiński
Site Name
Gabinet Lekarski Bartosz Korczowski
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl

Austria

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
500
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Pediatric Nephrology and Gastroenterology
Contact Person Name
Judith Pichler

Portugal

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
483
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Pediatria
Contact Person Name
Luís Rodrigues
Contact Person Email
luisnorterodrigues@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Pediatria
Contact Person Name
Filipa Neiva
Contact Person Email
ana.neiva@hb.min-saude.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Pediatria
Contact Person Name
Eunice Trindade
Contact Person Email
eunice_trindade@netcabo.pt

Norway

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
501
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Akershus University Hospital
Department Name
Cardiology
Contact Person Name
Christopher Inchley
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Doctor of Medicine
Contact Person Name
Lene Nymo Trulsen
Contact Person Email
lene.nymo.trulsen@unn.no
Site Name
Oslo University Hospital HF
Department Name
Doctor of Medicine
Contact Person Name
Gori Perminow
Contact Person Email
goeper@ous-hf.no
Site Name
St. Olavs Hospital HF
Department Name
Doctor of Medicine
Contact Person Name
Henrik Dollner
Contact Person Email
henrik.dollner@ntnu.no

Netherlands

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
539
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Erasmus Medisch Centrum 1
Department Name
Research Facility
Contact Person Name
Johanna Escher
Contact Person Email
j.escher@erasmusmc.nl

Spain

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
497
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Gastroenterology
Contact Person Name
Maria Isabel Iborra Colomino
Contact Person Email
marisaiborra@hotmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Pediatric Gastroenterology
Contact Person Name
Diana Garcia Tirado
Contact Person Email
dgarcia@tauli.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
Pediatric Gastroenterology
Contact Person Name
Rafael Gonzalez de Caldas Marchal

Belgium

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
537
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
UZ Leuven
Department Name
Pediatric gastroenterology
Contact Person Name
Ilse Hoffman
Contact Person Email
ilse.hoffman@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pediatric gastroenterology
Contact Person Name
Françoise Smets
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric gastroenterology
Contact Person Name
Saskia Vande Velde
Contact Person Email
saskia.vandevelde@uzgent.be
Site Name
UZ Brussel
Department Name
Pediatric gastroenterology
Contact Person Name
Elisabeth De Greef
Contact Person Email
elisabeth.degreef@uzbrussel.be

Italy

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
545
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
Pediatrics Unit
Contact Person Name
Enrico Felici
Contact Person Email
enrico.felici@ospedale.al.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
OU di Epatologia, Gastroenterologia e Nutrizione
Contact Person Name
Fiammetta Bracci
Contact Person Email
fiammetta.bracci@opbg.net
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Gastroenterologia ed Epotologia Pediatrica
Contact Person Name
Salvatore Oliva
Contact Person Email
salvatore.oliva@uniroma1.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
Pediatria
Contact Person Name
Patrizia Alvisi
Site Name
ASST Fatebenefratelli Sacco
Department Name
Gastroenterologia e Nutrizione
Contact Person Name
Lorenzo Norsa
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Gastroenterologia e Nutrizione
Contact Person Name
Paolo Lionetti
Contact Person Email
paolo.lionetti@unifi.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Epatologia e Gastroenterologia Pediatrica e dei Trapianti
Contact Person Name
Naire Sansotta
Contact Person Email
nsansotta@asst-pg23.it

France

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
495
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pediatric
Contact Person Name
Christine MARTINEZ VINSON
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Pediatric
Contact Person Name
Djamal-Dine DJEDDI
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pediatric
Contact Person Name
Frank RUEMMELE
Contact Person Email
frank.ruemmele@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pediatric
Contact Person Name
Delphine LEY
Contact Person Email
delphine.ley@chu-lille.fr

Sponsor

Primary sponsor

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

Contract research organisations

Name
Almac Clinical Technologies LLC
Name
Alimentiv Inc.
Responsibilities
Central Imaging reading and slide provision services
Name
Labcorp Central Laboratory Services LP
Responsibilities
Central Laboratory – sample collection and processing
Name
Signant Health Global LLC
Responsibilities
eCOA, ePRO - design and device provision
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central Laboratory – sample collection and processing
Name
IQVIA Limited

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Central Imaging reading and slide provision services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory – sample collection and processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA, ePRO - design and device provision","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory – sample collection and processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
Guselkumab
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
Guselkumab- Solution for infusion- 10 mg/ml
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
Guselkumab - solution for injection in pre-filled syringe
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
Authorised (prodAuthStatus=1)

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