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)
- How long the study runs
- Study runs about 88 months (dates as stated)
- About the drug or intervention
- Guselkumab — drug: Guselkumab will be administered as subcutaneous injection.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 3 Years and over
- Who
- All
- Number of participants
- 196
- Started
- 2024-10-29
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for crohns disease
- • Phase3 - 196 participants
- • The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA)
Who can take part?
- • Ages 3 Years and over
- • Diagnosed with crohns disease
Where?
- • Sheffield - Sheffield Children's Hospital
- • Stoke-on-Trent - Royal Stoke University Hospital
- • Stoke-on-Trent - Haywood Hospital
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 long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
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: 3 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ completed the dosing planned in the primary pediatric guselkumab study
- ✓ received benefit from continued guselkumab therapy in the opinion of the investigator
- ✓ for, the study and is willing to allow the child to participate in the study
What the study is looking for
- ✓Must have completed the dosing planned in the primary pediatric guselkumab study
- ✓Must have received benefit from continued guselkumab therapy in the opinion of the investigator
Who cannot take part
- ✗Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed...
- ✗Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for...
- ✗Are pregnant, nursing, or planning pregnancy or fathering a child
- ✗Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
See the full criteria
Where Is This Study? (3 UK sites)
Sheffield Children's Hospital
Sheffield S10 2TH, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
Haywood Hospital
Stoke-on-Trent ST6 7AG, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
