Risankizumab for Fibrostenotic Crohn's Disease Treatment
Status:
NOT_YET_RECRUITING
Trial end date:
2028-10-20
Target enrollment:
Participant gender:
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 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.
Phase:
PHASE3
Details
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Collaborators:
Second Affiliated Hospital of Wenzhou Medical University Taizhou Hospital