Real-World Study of IL-23 Inhibitors in Active Crohn's Disease
Summary
ClinicalTrials.gov registry entry for NCT07545317, a prospective observational study evaluating IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The study will assess clinical remission at Week 12 and track endoscopic, biomarker, imaging, and safety outcomes through Week 52. A nested comparative analysis will compare bio-naive participants on IL-23 inhibitors with a concurrent cohort on TNF inhibitors.
“The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice.”
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What changed
This ClinicalTrials.gov registry entry documents a prospective observational study (NCT07545317) examining IL-23 inhibitors in adults with active Crohn's disease under real-world conditions. The study will track clinical remission at Week 12, along with endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment through Week 52. A nested comparative analysis will evaluate bio-naive participants on IL-23 inhibitors against a concurrent cohort on TNF inhibitors.
Affected parties—pharmaceutical manufacturers developing IL-23 inhibitors, clinical investigators, and healthcare providers treating Crohn's disease patients—should note this registry entry for awareness of ongoing real-world evidence generation. The study does not impose regulatory obligations but may inform future label expansions or comparative effectiveness claims.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Real-World Study of IL-23 Inhibitors in Active Crohn's Disease
Observational NCT07545317 Kind: OBSERVATIONAL Apr 22, 2026
Abstract
The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are:
- What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?
- What are the clinical, endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment?
This is not a head-to-head randomized study. Treatments are selected by treating physicians as part of routine clinical care. For a nested comparative analysis, bio-naive participants treated with IL-23 inhibitors will be compared with a concurrent prospective cohort of bio-naive participants treated with TNF inhibitors to evaluate comparative effectiveness and safety.
Participants will:
- Receive treatment chosen by their treating physicians as part of routine clinical care, including IL-23 inhibitors or TNF inhibitors
- Attend study follow-up visits during induction and maintenance, including assessments at baseline, Week 12 and Week 52
- Undergo routine clinical evaluations, which may include symptom assessment, laboratory tests, endoscopy, and imaging, as available
- Be monitored for adverse events and treatment changes during the study
- Optionally provide blood, stool, and other available samples for exploratory biomarker, microbiome, metabolomic, and other multi-omics analyses related to treatment response
Conditions: Crohn's Disease
Interventions: IL-23 inhibitor, TNF inhibitors
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