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Looking for participantsPhase3

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT05923073

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Guselkumab (drug), Guselkumab (drug)
How long the study runs
Study runs about 53 months (dates as stated)
About the drug or intervention
Guselkumab — drug: Guselkumab will be administered subcutaneously. · Guselkumab — drug: Guselkumab will be administered intravenously.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
2 Years to 17 Years
Who
All
Number of participants
120
Started
2024-03-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn's disease
  • • Phase3 - 120 participants
  • • The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12

Who can take part?

  • • Ages 2 Years to 17 Years
  • • Diagnosed with crohn's disease

Where?

  • • Glasgow - Royal Hospital for Sick Children
  • • London - Great Ormond Street Hospital
  • • Manchester - Nowgen Centre, Research and Innovation
  • • Manchester - Royal Manchester Children's Hospital
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

Crohn's Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity...

Who cannot take part

  • ✗Participants has complications of CD such as causing symptoms strictures or stenosis, short gut syndrome, or any other...
  • ✗Participants must not have an abscess
  • ✗Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within...
See the full criteria
Inclusion Criteria: * 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. * Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30) * 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) within 1 month of receiving study intervention at Week 0 * Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN) Exclusion Criteria: * 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. * Participants must not have an abscess * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline

Where Is This Study? (6 UK sites)

Royal Hospital for Sick Children

Glasgow G51 4TF, United Kingdom

Recruiting

Great Ormond Street Hospital

London WC1N 3JH, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

Nowgen Centre, Research and Innovation

Manchester M13 9WL, United Kingdom

COMPLETED

Royal Manchester Children's Hospital

Manchester M13 9WL, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting

Sheffield Children's Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09