Taking people in ChinaNo phase

Ultrasound scans to predict response to guselkumab in Crohn's disease

Tests whether intestinal ultrasound can predict response to guselkumab in adults with Crohn's disease.

Key facts

Who runs it: The Third Xiangya Hospital of Central South University
Where: Changsha, ChinaSee the site
Trial code: NCT07034664
Registry title: IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
Status: Recruiting
People taking part: 50 people, planned
Started: 16 Jun 2025
Expected to end: 30 Sept 2027
Type of study: Observational
Record updated: 24 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed or relapsed moderate to severe Crohn's disease who are planned to start guselkumab. It studies whether bowel ultrasound can predict how well guselkumab works.

Age: 18 to 80 years
Sex: All sexes can join.
Disease stage: Newly diagnosed or relapsed moderate to severe Crohn's disease.
Earlier treatment: No history of abdominal surgery. Guselkumab is planned within 1 month after the baseline endoscopy and intestinal ultrasound.

Main reasons for not taking part

Contraindications to guselkumab: allergy, active tuberculosis or other active infection, severe liver dysfunction
History of extensive colectomy or a colectomy planned soon
History of colonic mucosal dysplasia
Hypersensitivity to SonoVue contrast media

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in China

The Third Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Li Tian, doctorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.