Risankizumab for Fibrostenotic Crohn's Disease Treatment

Sponsor
First Affiliated Hospital of Wenzhou Medical University
Study ID
NCT07177118
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 ustekinumab as a novel treatment for fibrotic CD, offering a new therapeutic option for patients who do not respond to existing treatments. This research is crucial because fibrotic CD is a severe and progressive disease with limited treatment options. Ustekinumab, by targeting the IL-23 pathway, may offer a more effective and targeted approach to manage this condition. The study's findings could significantly impact clinical practice and improve patient outcomes. For more detailed information, please refer to the study protocol document titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study" dated September 2, 2025. For further inquiries, contact the principal investigators Dr. Wu Fang or Dr. Wu Xiaoli at the First Affiliated Hospital of Wenzhou Medical University.

Key Dates

Start date
Oct 20, 2025
Status verified
Sep 2025
Primary completion
Jun 20, 2028
Completion
Oct 20, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ustekinumab
    Ustekinumab group (induction phase with intravenous equivalent doses at weeks 0 and 8, maintenance phase with 90 mg subcutaneously every 8 weeks)
  • Experimental: 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 Outcome Measure

Radiological Composite Endpoint [ Time Frame: up to 24 weeks ]

Central Contacts

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