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

NCT07545317 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 665

Last updated 2026-04-22

No results posted yet for this study

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

Conditions

Interventions

DRUG

IL-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.

DRUG

TNF 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.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Wei Wang, MD · The Sixth Affiliated Hospital, Sun Yat-sen University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545317 on ClinicalTrials.gov