RecruitingNCT07034664

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

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


Sponsor

The Third Xiangya Hospital of Central South University

Enrollment

50 participants

Start Date

Jun 16, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether intestinal ultrasound (a non-invasive scan of the bowel) can predict how well patients with moderate to severe Crohn's disease will respond to a drug called guselkumab — before they start treatment. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with or have relapsed moderate to severe Crohn's disease - Your doctor has recommended starting guselkumab within 1 month after your initial tests - You have not had previous abdominal surgery - You understand the study and are willing to sign informed consent **You may NOT be eligible if...** - You have a known allergy to guselkumab - You have active tuberculosis or other serious active infections - You have a history of extensive bowel removal surgery - You have severe liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT07034664


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