ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Patients and clinicians considering guselkumab for Crohn’s disease or ulcerative colitis may gain real-world evidence on how the drug performs across treatment lines and subgroups over up to 96 weeks. The study will measure remission, response, and steroid-free remission using standard clinical scores.
Who Should Pay Attention
Adults with moderate-to-severe CD or UC starting guselkumab; clinicians prescribing IL‑23 inhibitors; researchers interested in biologic real-world outcomes.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment220 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes a UK observational study enrolling adults with moderate-to-severe Crohn’s disease or ulcerative colitis who are starting guselkumab in routine clinical care.
The study will collect medical-record data (no study drug supplied) to evaluate real-world effectiveness through up to 96 weeks using HBI for Crohn’s and Partial Mayo Score for UC, and will track corticosteroid-free remission and clinical response.
The study will enroll about 220 participants, excludes prior exposure to IL-23 inhibitors (including guselkumab, risankizumab, mirikizumab) and patients with >4 prior advanced therapy lines; treatment decisions remain with the treating physician. Recruitment status is listed as "RECRUITING."
Keep In Mind
This is an observational, non-interventional study (no drug supplied) intended to collect routine clinical data; it is a trial registration and does not present results. Exclusion criteria bar prior IL‑23 exposure and certain heavily pretreated patients, which may affect generalizability.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorJanssen-Cilag Ltd.
Trial IDNCT07242248
Study typeObservational
Enrollment220 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 28, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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