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

Launched by THE THIRD XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Jun 15, 2025

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ClinConnect Summary

This clinical trial is studying whether a simple, painless test called intestinal ultrasound can help predict how well a medicine called guselkumab will work for people with moderate to severe Crohn's disease. Crohn's disease is a long-lasting condition that causes inflammation in the digestive tract and can lead to serious problems like blockages or holes in the intestines. Guselkumab is a newer type of treatment that targets specific parts of the immune system to reduce inflammation and help heal the gut. The researchers want to see if intestinal ultrasound, which uses sound waves to create images of the intestines, can show early signs that the medicine is working, helping doctors make better treatment decisions.

People eligible for this study are adults between 18 and 80 years old who have moderate to severe Crohn’s disease, either newly diagnosed or experiencing a flare-up. They should not have had abdominal surgery and must be ready to start guselkumab treatment soon after joining the study. Participants will have an ultrasound and an endoscopy (a procedure to look inside the intestines) before starting the medicine, and then doctors will use these tools to monitor how well the treatment is working. This study is important because it could help personalize Crohn’s disease treatment, ensuring patients get the best care based on how their bodies respond early on. If you or a loved one fits these criteria and are interested, joining this study might offer access to new insights and close monitoring during treatment.

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Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Contraindications to Guselkumab: allergy, active tuberculosis or other active infections, and comorbidities such as severe liver dysfunction;
• • Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia;
• • Hypersensitivity to the components of SonoVue contrast media.