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

NCT07545317 | Recruiting

• 1 other identifier: 2026ZSLYEC-203
• Study Type: observational
• Target: 665
• Locations: 1 country
• Sites: 1

Brief 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

Crohn's Disease

Keywords

Crohn's disease; IL-23 inhibitor; TNF inhibitor; Bio-naive; Real-world study; Observational cohort; Clinical remission; Endoscopic remission

Outcome Measures

Primary Outcomes (1)

• Clinical Remission Rate

  Proportion of participants achieving clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score \<150.

  Week 12

Secondary Outcomes (14)

• Clinical Response Rate

  Weeks 12 and 52

• Endoscopic Remission Rate

  Weeks 12 and 48

• Endoscopic Response Rate

  Weeks 12 and 52

• Corticosteroid-Free Clinical Remission Rate

  Weeks 12 and 52

• Corticosteroid-Free Endoscopic Remission Rate

  Weeks 12 and 52

Other Outcomes (1)

• Integrated Multi-Omics Features Associated With Treatment Response

  Baseline, Week 12, and Week 52

Study Arms (2)

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.

Drug: IL-23 inhibitor

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.

Drug: TNF inhibitors

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.

IL-23 Inhibitor Cohort

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.

TNF Inhibitor Comparative Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with active Crohn's disease consecutively enrolled from participating centers in routine clinical practice. The main study population is a prospective multicenter cohort of patients initiating IL-23 inhibitor therapy, including guselkumab or risankizumab. A concurrent prospective cohort of bio-naive patients initiating TNF inhibitor therapy will also be enrolled for a nested comparative analysis. Participants must have objective evidence of active disease and satisfy protocol-defined eligibility criteria.

You may qualify if:

• Age 18 to 75 years
• Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and/or histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria
• Active Crohn's disease with a baseline Crohn's Disease Activity Index (CDAI) score of 150 to 450, and at least one of the following objective inflammatory findings: (1) Endoscopic activity within 1 month before enrollment, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \>=6 for ileocolonic or colonic disease, or SES-CD \>=4 for isolated ileal disease, (2) Active intestinal inflammation on bowel ultrasound, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), (3) Serum C-reactive protein (CRP) above the upper limit of normal, (4) Fecal calprotectin (FC) \>=250 ug/g
• Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors
• Prior treatment history for the IL-23 inhibitor cohort may include biologic-naive or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted
• If receiving concomitant medications, doses should be stable for at least 2 to 4 weeks before enrollment, including oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid
• Able to understand the study procedures, provide written informed consent, and comply with follow-up and biospecimen collection requirements

You may not qualify if:

• Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents
• Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis
• Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction
• Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe/recurrent infection history
• Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence
• Pregnancy, breastfeeding, or planned pregnancy during the study period
• Severe systemic disease or other condition that, in the investigator's judgment, makes participation unsuitable, including severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence
• Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Optional biospecimens include peripheral blood (serum, plasma, and when available PBMCs), stool samples for microbiome and metabolomic analyses, and clinically available intestinal mucosal or tissue samples. Samples may be collected at baseline, Week 12, and selected follow-up visits for exploratory biomarker, microbiome, metabolomic, and other translational analyses related to treatment response and safety.

MeSH Terms

Conditions

Crohn Disease

Interventions

Tumor Necrosis Factor Inhibitors

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Inflammatory Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Wei Wang, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Wang, MD & PhD

CONTACT

+86-020-82514458; weiwang0303@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)