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

NCT07034664 | Recruiting

• 1 other identifier: fu3tianli6
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease; Guselkumab; Intestinal Ultrasound; Predictor

Outcome Measures

Primary Outcomes (1)

• Bowel wall thickness(BWT)

  BWT is measured by intestinal ultrasound. BWT≤3mm means that CD is in quiescent, \>3mm means CD is active

  follow-up time of about 56weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the Third Xiangya Hospital of Central South University, patients with newly diagnosed or relapsed moderate to severe Crohn's disease treated with Guselkumab will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Central Study Contacts

Li Tian

CONTACT

0731-13574843423; f3tianli@outlook.com

Yuwei Wu

CONTACT

0731-13308466056; wywer0612@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Li Tian,MD[fu3tianli]

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)