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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT07545317
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IL-23 inhibitor — DRUG
    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.
  • TNF inhibitors — DRUG
    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.

Study Details

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

Key Dates

First listed
Apr 22, 2026
Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
665 participants (estimated)

Arms

  • Arm: IL-23 Inhibitor Cohort
    Adults with active Crohn's disease who initiate treatment with an IL-23 inhibitor, including guselkumab or risankizumab, in routine clinical practice. This is the primary prospective cohort of the study and will be used to evaluate the effectiveness and safety of IL-23 inhibitors. A bio-naive subgroup within this cohort will be included in a nested comparative analysis with a concurrent prospective TNF inhibitor cohort.
  • Arm: TNF Inhibitor Comparative Cohort
    Bio-naive adults with active Crohn's disease who initiate treatment with a TNF inhibitor in routine clinical practice and are prospectively followed during the same study period. This is a concurrent prospective comparative cohort enrolled specifically for the nested comparative analysis with the bio-naive subgroup of the IL-23 inhibitor cohort.

Primary Outcome Measure

Clinical Remission Rate [ Time Frame: Week 12 ]

Central Contacts

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