Intestinal Ultrasound Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease:a Prospective Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Crohn's disease (CD) is a chronic non-specific intestinal inflammatory disease with incompletely clarified etiology, which can involve multiple organs and systems , and is prone to severe complications such as intestinal obstruction, perforation, and fistula.Currently, the main therapeutic drugs for CD include aminosalicylates, glucocorticoids, immunosuppressants, biological agents, etc. With the development of medical technology, biological agents have begun to be applied to moderate-to-severe Crohn's disease, providing new treatment options for patients with moderate-to-severe Crohn's disease. Guselkumab is a selective inhibitor of the interleukin-23 (IL-23) p19 subunit.The GALAXI2 and GALAXI3 studies demonstrated that guselkumab can better achieve the therapeutic goal of mucosal healing. The clinical remission rates of guselkumab at week 12 were 47.1% and 47.1%, respectively, and the endoscopic response rates were 37.7% and 36.2%, respectively . Intestinal ultrasound lUsnoninvasive, reproducible, convenient, and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making process.The 2019 ECCO-ESGAR guidelines recommend intestinalultrasound for disease monitoring in patients with CD. There are no validated indicators to predict the efficacy of guselkumab treatment in patients with moderate-to-severe CD in the currently available studies. Currently, there are no national orinternational studies in which intestinal ultrasound predicts the efficacy of guselkumab therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to guselkumab in CD patients, with the aiproviding evidence to guide the development of individualized treatment plans.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ Age ≥ 18 years and ≤ 80 years;

• Patients with newly diagnosed or relapsed moderate to severe Crohn's disease;

• Guselkumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound;

• No history of abdominal surgery;

• Clearly understand, voluntarily participate in the study, and sign an informed consent form.

Locations
Other Locations
China
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Li Tian
f3tianli@outlook.com
0731-13574843423
Backup
Yuwei Wu
wywer0612@163.com
0731-13308466056
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Leads: The Third Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov