A Prospective, Open-Label, Randomized Controlled Study of Risankizumab (an IL-23 Inhibitor) for the Treatment of Fibrostenotic Crohn's Disease

Official 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 Affiliated Hospital of Wenzhou Medical University. The primary aim of this research is to evaluate the efficacy and safety of ustekinumab, an IL-23 inhibitor, for patients with fibrostenotic Crohn's disease (CD) who have failed standard treatments. The study is a prospective, open-label, randomized controlled trial involving 260 participants across three major hospitals: the First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province, and the Second Affiliated Hospital of Wenzhou Medical University. The participants are divided into two groups: one receiving ustekinumab and the other receiving a placebo. The study is designed to assess whether ustekinumab can improve clinical outcomes and reduce fibrosis progression in patients with fibrotic CD. The study involves a comprehensive assessment of participants, including clinical history, physical examination, laboratory tests, and imaging studies. Key inclusion criteria include age between 18-80 years, confirmed diagnosis of fibrostenic CD, and failure of conventional or biological therapies. Participants are excluded if they are under 18, pregnant, breastfeeding, or have certain medical conditions that could interfere with the study. The primary endpoint of the study is a clinical-imaging composite endpoint, which includes imaging assessment of bowel wall thickness and clinical symptoms. Secondary endpoints include safety, tolerability, and various functional and quality of life indicators. The study also explores the potential of ustekinumab to modulate immune responses and fibrosis-related biomarkers. The study is expected to run from October 2025 to October 2028, with follow-up visits scheduled at regular intervals. The results will provide valuable insights into the potential of ustek

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 80 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 260 participants

Study Arms

• ustekinumab (ACTIVE_COMPARATOR)
  Ustekinumab group (induction phase with intravenous equivalent doses at weeks 0 and 8, maintenance phase with 90 mg subcutaneously every 8 weeks)
• risankizumab (EXPERIMENTAL)
  Risankizumab group (induction phase with intravenous 600 mg at weeks 0, 4, and 8, maintenance phase with 360 mg subcutaneously every 8 weeks)

Interventions

• DRUG: Ustekinumab — Ustekinumab group (induction phase with intravenous equivalent doses at weeks 0 and 8, maintenance phase with 90 mg subcutaneously every 8 weeks)
• DRUG: Risankizumab — Risankizumab group (induction phase with intravenous 600 mg at weeks 0, 4, and 8, maintenance phase with 360 mg subcutaneously every 8 weeks)

Primary Outcomes

• Radiological Composite Endpoint (up to 24 weeks)

Eligibility Criteria

Inclusion Criteria:

\- Here's the translation of the provided criteria into English:

1. Age between 18 and 80 years old, with no gender restrictions.
2. Voluntarily sign an informed consent form.
3. 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;
4. Clinical manifestations of intestinal obstruction or sub-obstruction.
5. Insufficient efficacy, intolerance, or contraindications to conventional or biological agents (azathioprine, 6-mercaptopurine, methotrexate, TNF-α inhibitors, etc.).
6. Plan to receive treatment with risankizumab or ustekinumab for the first time.
7. 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 Criteria:

* Here is the translation of the exclusion criteria into English:

  1. Age less than 18 or greater than 80 years old.
  2. Refusal or inability to sign the informed consent form.
  3. Absence of symptoms of fibrostenotic Crohn's disease, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain.
  4. Prior stenting and/or dilation treatment for stenosis (within less than 1 year).
  5. Pregnancy, lactation, or planning to conceive.
  6. Inaccessible endoscopy or presence of clinical conditions incompatible with endoscopy.
  7. Presence of abscesses, fistulas, or active complex strictures (not limited to the strictured segment).
  8. Stenosis length of 10 cm or greater, or more than 2 strictures in a single intestinal segment.
  9. Severe coagulation dysfunction (platelet count \< 50,000; INR \> 1.5).
  10. Presence of end-stage organ failure, positive for Human Immunodeficiency Virus, uncontrolled infections, or a history of malignant tumors within the past 5 years.
  11. Having received or started treatment with risankizumab or ustekinumab.
  12. Investigator determines other conditions that make participation in this clinical study unsuitable.

Contact Information

• Fang Director Wu, Doctor — CONTACT
  Phone: +86 13857709707
  Email: wufang@wmu.edu.cn

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