RecruitingNCT07545317

Real-World Study of IL-23 Inhibitors in Active Crohn's Disease

Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

665 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IL-23 inhibitor and a drug called TNF inhibitors for people with crohn's disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIL-23 inhibitor

Participants in this observational study receive IL-23 inhibitor therapy as part of routine clinical care, including guselkumab or risankizumab according to local practice and physician judgment. Treatment is not assigned by the study protocol. This drug exposure is the primary focus of the study for evaluation of effectiveness and safety in active Crohn's disease.

DRUGTNF inhibitors

Participants in the comparative cohort receive TNF inhibitor therapy as part of routine clinical care, including infliximab or adalimumab according to local practice and physician judgment. Treatment is not assigned by the study protocol. This drug exposure is included for the concurrent prospective comparative cohort used in the nested comparative analysis.


Locations(1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT07545317


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