Clinical trial • Phase III • Immunology

GUSELKUMAB for Ulcerative colitis

Phase III trial of GUSELKUMAB for Ulcerative colitis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Ulcerative colitis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
31-10-2023
First CTIS Authorization Date
04-03-2024

Trial design

Randomised, open-label, placebo (guselkumab 1 ml pfs placebo; guselkumab 2 ml pfs placebo; guselkumab 0.5 ml varioject placebo) (placebo-controlled maintenance comparison; specific dose/schedule details not stated in the ctis metadata). Phase III trial in Norway, Belgium, Portugal and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (Guselkumab 1 mL PFS Placebo; Guselkumab 2 mL PFS Placebo; Guselkumab 0.5 mL Varioject Placebo) (placebo-controlled maintenance comparison; specific dose/schedule details not stated in the CTIS metadata).
Target Sample Size
42
Trial Duration For Participant
392

Eligibility

Recruits 42 paediatric patients.

Vulnerable Population
Pediatric participants (ages 2 to <18 years) are included. Consent is provided by a parent or legal guardian; assent is obtained from children/adolescents as appropriate. Subject information sheets, parent/guardian informed consent forms, child assent and adolescent assent forms are prepared (country/language-specific versions are provided in participating countries).

Inclusion criteria

  • {"criterion_text":"- 1) 2 to <18 years of age, inclusive (at the time of the first administration of study intervention at Week 0).\n- 2) Weight ≥10 kg at the time of consent for screening.\n- 3) A pathology report ‌to support a documented diagnosis of UC must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.\n- 4) Moderately to severely active UC, defined by a baseline modified Mayo (without PGA) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore ≥2 as determined by a central review of the video of the endoscopy.\n- 5) Participant must: a. Have failed an advanced therapy, ie, have received treatment with 1 or more TNFα antagonist, vedolizumab, ozanimod, or JAK inhibitor, and have a documented history of failure to respond to or tolerate such treatment as defined in Appendix 16 and Appendix 19 OR b. Be naïve to advanced therapy (ie, TNFα antagonist, vedolizumab, ozanimod, or JAK inhibitor) or not have demonstrated a history of failure to respond to, or tolerate, advanced therapy and have a prior or current UC medication history that includes at least 1 of the following: 1) Inadequate response to or failure to tolerate current treatment with oral or IV corticosteroids, aminosalicylates, or immunomodulators as defined in Appendix 17 AND/OR 2) History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids, aminosalicylates, or immunomodulators AND/OR 3) History of corticosteroid dependence as defined in Appendix 17"}

Exclusion criteria

  • {"criterion_text":"- 1) Have severe colitis as evidenced by: a. Investigator judgment that the participant is likely to require a colectomy within 12 weeks of Week 0. OR b. Symptom complex at screening or Week 0 visit that includes at least 4 of the following: 1) Diarrhea with ≥6 bowel movements/day with macroscopic blood in stool 2) Focal severe or rebound abdominal tenderness 3) Persistent fever (≥37.5°C) for more than 5 days 4) Persistent tachycardia for more than 5 days 5) Anemia (hemoglobin <8.5 g/dL)\n- 2) Have UC limited to the rectum only or to <20 cm of the colon.\n- 3) Presence of a stoma.\n- 4) Presence or history of a fistula\n- 5) Have evidence of CD: a. Small intestinal or ileal disease by upper GI small bowel follow-through, ileocolonoscopy with histology, video capsule endoscopy, or magnetic resonance enterography. b. Noncaseating and non-mucin granulomas that are suggestive of a diagnosis of CD on colonoscopy. c. Skip lesions on colonoscopy including absolute rectal sparing, with a normal rectum both endoscopically and histologically. d. Perianal disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical remission (modified Mayo) at Week 56","definition_or_measurement_approach":"Assessed using the modified Mayo score (clinical remission measured at Week 56 using the modified Mayo scale)."}

Recruitment

Digital Remote Recruitment
True - digital/remote methods include social media posts (Facebook, Instagram, Twitter) and email outreach templates (doctor-to-patient / caregiver e-mail) as listed in recruitment materials.
Planned Sample Size
42
Recruitment Window Months
53
Consent Approach
Informed consent is obtained from a parent or legal guardian; age-appropriate assent is obtained from child and adolescent participants. Country- and language-specific subject information sheets, parent/guardian informed consent forms, child assent forms and adolescent assent forms are provided (examples in English, Norwegian, Dutch, French, Portuguese, Italian, Polish, Danish, Spanish and other local languages as indicated in the submitted ICF documents). A subject wallet card and pregnancy-specific information forms are also included where applicable.

Methods

  • Investigator/site recruitment (hospital/clinic pediatric gastroenterology clinics) as indicated by participating trial sites in each country.
  • Printed materials: brochures, brochure inserts, caregiver/patient posters, pediatric brochures, infographics (country-specific versions).
  • Direct email outreach: 'Dr to Patient' email templates and 'Caregiver-Dr to Patient Email' materials.
  • Social media posts: Facebook, Instagram, Twitter recruitment materials (country-specific versions).
  • Clinic-facing materials and physician referral materials (recruitment arrangements K1 documents for participating countries).

Geography

Total Number Of Sites
34
Total Number Of Participants
79

Norway

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
680
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Pediatrics and Neonatal Medicine
Contact Person Name
Leno Nymo Trulsen
Contact Person Email
post@unn.no
Site Name
Oslo University Hospital HF
Department Name
Pediatric Dep. Gastroenterology
Contact Person Name
Gøri Perminow
Contact Person Email
goeper@ous-hf.no
Site Name
Akershus University Hospital
Department Name
Dept. Paediatric and Adolescent Medicine
Contact Person Name
Christopher Inchley
Contact Person Email
inchley@ahus.no
Site Name
St. Olavs Hospital HF
Department Name
Department of Clinical and Molecular Medicine, and Childrens Clinic
Contact Person Name
Henrik Dollner
Contact Person Email
Henrik.dollner@ntnu.no

Belgium

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
685
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
UZ Brussel
Department Name
Kindergastro-enterologie, hepatologie en nutritie
Contact Person Name
Elisabeth De Greef
Contact Person Email
elisabeth.degreef@uzbrussel.be
Site Name
UZ Leuven
Department Name
Kindergastro-enterologie, hepatologie en nutritie
Contact Person Name
Ilse Hoffman
Contact Person Email
ilse.hoffman@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric Gastroenterology, 3K12D
Contact Person Name
Pauline Debruyne
Contact Person Email
pauline.debruyne@uzgent.be
Site Name
ISPPC CHU Charleroi
Department Name
Pédiatrie
Contact Person Name
Laurence Muyshont

Portugal

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
680
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Centro Hospitalar Universitario Sao Joao E.P.E.
Department Name
Pediatrics Service (Pediatric Gastroenterology Unit)
Contact Person Name
Eunice Trindade
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Pediatrics Service
Contact Person Name
Sara Azevedo
Contact Person Email
saravazevedo@gmail.com
Site Name
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Department Name
Pediatrics Service
Contact Person Name
Rosa Lima
Contact Person Email
rosalima@chporto.min-saude.pt

Italy

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
04-02-2026
Processing Time Days
726
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Department of Women's and Children's Health Pediatric Gastroenterology and Liver Unit
Contact Person Name
Salvatore Oliva
Contact Person Email
salvatore.oliva@uniroma1.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
U.O.C. Pediatria
Contact Person Name
Patrizia Alvisi
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Gastroenterologia e nutrizione
Contact Person Name
Matteo Bramuzzo
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
U.O.C. Pediatria Medica Unità di Gastroenterologia Pediatrica
Contact Person Name
Maria Teresa Illiceto
Contact Person Email
mariateresa.illiceto@asl.pe.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
U.O.C. Pediatria - Poliambulatorio Giovanni Paolo II
Contact Person Name
Maria Rosa Pastore
Contact Person Email
m.pastore@operapadrepio.it
Site Name
Bambino Gesu Childrens Hospital
Department Name
Clinical Trial Center Padiglione Salviati
Contact Person Name
Daniela Knafelz
Contact Person Email
daniela.knafelz@opbg.net
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Paediatric Hepatology Gastroenterology and Transplantation
Contact Person Name
Naire Sansotta
Contact Person Email
nsansotta@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOC Gastroenterologia e Nutrizione
Contact Person Name
Paolo Lionetti
Contact Person Email
paolo.lionetti@unifi.it
Site Name
Casa Sollievo Della Sofferenza (additional listing if duplicate)

Poland

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
699
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
WIP Warsaw IBD Point Profesor Kierkuś
Department Name
WIP Warsaw IBD Point Profesor Kierkus
Contact Person Name
Monika Meglicka
Contact Person Email
m.meglicka@wip.waw.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Klinika Pediatrii, Gastroenterologii, Alergologii i Żywienia Dzieci GUMed
Contact Person Name
Michał Brzeziński
Contact Person Email
brzezinski@gumed.edu.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatri
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
Korczowski Bartosz, Gabinet Lekarski
Department Name
Korczowski Bartosz, Gabinet Lekarski
Contact Person Name
Bartosz Korczowski Bartosz, Gabinet Lekarski
Contact Person Email
korczowski@op.pl

Denmark

Earliest CTIS Part Ii Submission Date
20-11-2023
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
763
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Region Hovedstaden
Department Name
Borne- og Unge klinik
Contact Person Name
Lars Folmer Hansen
Contact Person Email
lars.folmer.hansen@regionh.dk
Site Name
Aarhus Universitetshospital
Department Name
Boern og Unge Aarhus Universitetshospital
Contact Person Name
Helene Kvistgaard
Contact Person Email
helekvis@rm.dk

France

Earliest CTIS Part Ii Submission Date
11-12-2023
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
742
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Hospices Civils De Lyon
Department Name
Service de gastroenterologie, hepatologie et nutrition pediatriques
Contact Person Name
Remi DUCLAUX-LORAS
Contact Person Email
remi.duclaux-loras@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Unite de Gastroenterologie, Hepatologie et Nutrition Pediatriques, Pole Enfant
Contact Person Name
Delphine LEY
Contact Person Email
delphine.ley@chru-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Gastro-enterologie et nutrition pediatrique
Contact Person Name
Christine MARTINEZ VINSON
Site Name
Hopital Des Enfants
Department Name
Service de Gastroenterologie, Hepatologie, Nutrition et Maladies Hereditaires du Metabolisme
Contact Person Name
Emmanuel MAS
Contact Person Email
mas.e@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service de Pediatrie
Contact Person Name
Raphaelle MAUDINAS

Spain

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
11-01-2026
Processing Time Days
704
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Pediatric Gastroenterology
Contact Person Name
Diana García Tirado
Contact Person Email
dgarciat@tauli.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Gastroenterology
Contact Person Name
Ester Donat Aliaga
Contact Person Email
donat_est@gva.es
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric Gastroenterology
Contact Person Name
Laura Palomino Pérez
Contact Person Email
laura.palomino.perez@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties code 6 (clinical trial support functions as listed)
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties code 3
Name
Bioclinica Inc.
Responsibilities
Central Reading (sponsorDuties code 15)
Name
Iqvia Rds Inc.
Responsibilities
sponsorDuties code 5

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Reading (sponsorDuties code 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties code 5","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Guselkumab (PRD10890563) - SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL (PRD2827309)
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
Guselkumab- Solution for infusion- 10 mg/ml (PRD8913651)
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Investigational Product Name
Guselkumab (PRD10890564) - SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
Guselkumab 1 mL PFS Placebo
Modality
Other
Investigational Product Name
Guselkumab 2 mL PFS Placebo
Modality
Other
Investigational Product Name
Guselkumab 0.5 mL Varioject Placebo
Modality
Other

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