Actively Recruiting
Real-World Study of IL-23 Inhibitors in Active Crohn's Disease
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-04-22
665
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Real-World Study of IL-23 Inhibitors in Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosis of Crohn's disease based on clinical, endoscopic, imaging, or histopathology criteria
- Active Crohn's disease with a Crohn's Disease Activity Index (CDAI) score between 150 and 450
- At least one objective sign of intestinal inflammation within one month before enrollment, such as endoscopic activity (SES-CD ≥6 for ileocolonic or colonic disease, SES-CD ≥4 for isolated ileal disease), active inflammation on bowel ultrasound, CT enterography, or MR enterography, elevated C-reactive protein, or fecal calprotectin ≥250 ug/g
- Planned start of IL-23 inhibitor therapy (guselkumab or risankizumab) with no prior IL-23 inhibitor exposure
- Prior biologic treatments allowed except previous IL-23 inhibitors; prior TNF inhibitors, vedolizumab, or ustekinumab permitted
- Stable doses of concomitant medications such as corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid for at least 2 to 4 weeks before enrollment
- Ability to understand study procedures, provide written informed consent, and comply with follow-up and sample collection
- For the TNF inhibitor comparative cohort: bio-naive status with no prior biologic or targeted small-molecule therapy, meeting other inclusion criteria, and planned TNF inhibitor therapy start
You will not qualify if you...
- 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 could affect diagnosis, such as ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis
- Crohn's disease requiring urgent surgery or with severe complications like active bowel perforation, uncontrolled infected fistula, or complete bowel obstruction
- Active infection or high-risk infections including active or latent tuberculosis without prophylaxis, active hepatitis B or C, HIV infection, or history of severe or recurrent infections
- Current or past cancer except treated non-melanoma skin cancer or cervical carcinoma in situ without recurrence
- Pregnancy, breastfeeding, or planned pregnancy during the study
- Severe systemic diseases or conditions making participation unsuitable, including severe heart, liver, or kidney dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence
- Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
W
Wei Wang, MD & PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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