Status:
NOT_YET_RECRUITING
Risankizumab for Fibrostenotic Crohn's Disease Treatment
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Taizhou Hospital
Second Affiliated Hospital of Wenzhou Medical University
Conditions:
Crohn Disease
Crohn Disease and Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study, titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study," is conducted by researchers from the First Affil...
Detailed Description
Summary of the plan Project Name: Prospective, Open-label, Randomized Controlled Study on the Treatment of Fibrostenosing Crohn's Disease with IL-23 Inhibitor Ruxolitinib Research purpose Main purpo...
Eligibility Criteria
Inclusion
- \- Here's the translation of the provided criteria into English:
- Age between 18 and 80 years old, with no gender restrictions.
- Voluntarily sign an informed consent form.
- Diagnosed with fibrostenosing Crohn's disease by endoscopy and histology, and meet the following criteria:
- Presence of symptoms indicating fibrostenosis, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain;
- Endoscopic or radiological confirmation of new fibrotic stenosis (not caused by previous dilation/stenting);
- The length of stenosis is less than 10 cm, and there are no more than 2 stenoses in a single intestinal segment;
- Clinical manifestations of intestinal obstruction or sub-obstruction.
- Insufficient efficacy, intolerance, or contraindications to conventional or biological agents (azathioprine, 6-mercaptopurine, methotrexate, TNF-α inhibitors, etc.).
- Plan to receive treatment with risankizumab or ustekinumab for the first time.
- Have not previously used risankizumab or ustekinumab; if other biological agents have been used, they have been discontinued for at least the specified washout period (TNF-α inhibitors ≥8 weeks).
Exclusion
- Here is the translation of the exclusion criteria into English:
- Age less than 18 or greater than 80 years old.
- Refusal or inability to sign the informed consent form.
- Absence of symptoms of fibrostenotic Crohn's disease, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain.
- Prior stenting and/or dilation treatment for stenosis (within less than 1 year).
- Pregnancy, lactation, or planning to conceive.
- Inaccessible endoscopy or presence of clinical conditions incompatible with endoscopy.
- Presence of abscesses, fistulas, or active complex strictures (not limited to the strictured segment).
- Stenosis length of 10 cm or greater, or more than 2 strictures in a single intestinal segment.
- Severe coagulation dysfunction (platelet count \< 50,000; INR \> 1.5).
- Presence of end-stage organ failure, positive for Human Immunodeficiency Virus, uncontrolled infections, or a history of malignant tumors within the past 5 years.
- Having received or started treatment with risankizumab or ustekinumab.
- Investigator determines other conditions that make participation in this clinical study unsuitable.
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2028
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT07177118
Start Date
October 20 2025
End Date
October 20 2028
Last Update
September 16 2025
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