Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07034664

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

Led by The Third Xiangya Hospital of Central South University · Updated on 2025-06-24

50

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and older, up to 80 years
  • Patients with newly diagnosed or relapsed moderate to severe Crohn's disease
  • Proposed guselkumab therapy within 1 month after baseline endoscopy and intestinal ultrasound
  • No history of abdominal surgery
  • Understand and voluntarily agree to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Allergy or contraindications to guselkumab, active tuberculosis, or other active infections
  • Severe liver dysfunction or other serious comorbidities
  • History of extensive colectomy or planned colectomy soon
  • History of colonic mucosal dysplasia
  • Hypersensitivity to SonoVue contrast media components

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410000

Actively Recruiting

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Research Team

L

Li Tian

CONTACT

Y

Yuwei Wu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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