IL-23 inhibitors for adults with active Crohn's disease in routine care
Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study
This project will see if IL-23 blockers like guselkumab or risankizumab help adults with active Crohn's disease and are safe when used in everyday clinical practice.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 665 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | guselkumab, risankizumab, vedolizumab, ustekinumab, mirikizumab, radiation, methotrexate |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07545317 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter observational cohort follows adults with active Crohn's disease who start IL-23 inhibitor therapy (guselkumab or risankizumab) as part of routine care. Treatment choice is made by the treating physician rather than by random assignment, and participants are enrolled consecutively and followed according to a common protocol. A nested concurrent cohort of biologic‑naive patients initiating TNF inhibitors is included to support comparative analyses between bio‑naive groups. Outcomes include clinical remission at Week 12, endoscopic, biomarker and imaging measures, and safety during induction and maintenance periods.
Who should consider this trial
Good fit: Adults aged 18–75 with active Crohn's disease and objective evidence of intestinal inflammation who are planning to start an IL-23 inhibitor (or, for the comparator cohort, a TNF inhibitor) in routine clinical practice.
Not a fit: People under 18, those without objective inflammatory findings, or patients who have previously received IL-23 inhibitors are unlikely to be eligible or benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help clinicians understand how well IL-23 inhibitors induce remission and their safety profile in everyday Crohn's care.
How similar studies have performed: Randomized phase 2/3 trials have demonstrated efficacy of IL-23 inhibitors in Crohn's disease, but real-world observational evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 to 75 years 2. Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and/or histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria 3. 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 4. Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors 5. 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 6. 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 7. Able to understand the study procedures, provide written informed consent, and comply with follow-up and biospecimen collection requirements 8. Additional criteria for the concurrent prospective TNF inhibitor cohort used in the nested comparative analysis: (1) Participants must be bio-naive, defined as no prior exposure to any biologic agent (including TNF inhibitors, vedolizumab, ustekinumab, etc.) or targeted small-molecule therapy (such as JAK inhibitors), (2) Participants must also meet Inclusion Criteria 1, 2, 3, 6, and 7 above, (3) Participants must be planned to initiate TNF inhibitor therapy in routine clinical practice Exclusion Criteria: 1. Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents 2. 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 3. Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction 4. 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 5. Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence 6. Pregnancy, breastfeeding, or planned pregnancy during the study period 7. 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 8. Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial
Where this trial is running
Guangzhou, Guangdong
- The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Wei Wang, MD — The Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Wei Wang, MD & PhD
- Email: weiwang0303@gmail.com
- Phone: +86-020-82514458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.