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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (6 UK sites)
Royal Hospital for Sick Children
Glasgow G51 4TF, United Kingdom
Great Ormond Street Hospital
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Nowgen Centre, Research and Innovation
Manchester M13 9WL, United Kingdom
Royal Manchester Children's Hospital
Manchester M13 9WL, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Sheffield Children's Hospital
Sheffield S10 2TH, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
