Real-World check: does new IBD drug guselkumab deliver in the clinic?
NCT ID NCT07242248
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study tracks 220 adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting guselkumab, a biologic drug. Researchers will measure how many achieve remission (symptom control) and whether they can stop steroids. The goal is to see how well the drug works in real-world NHS clinics, not just in controlled trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician) * Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records * Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements Exclusion Criteria: * Contraindicated to guselkumab per the label * Is currently enrolled in an interventional clinical study * Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included * Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and /or small molecules) * Is unable to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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London North West University Healthcare NHS Trust
RECRUITINGHarrow, HA1 3UJ, United Kingdom
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Other studies related to the condition(s) this trial covers.
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