Intestinal ultrasound predicts guselkumab response in moderate-to-severe Crohn's disease

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

This project will test whether intestinal ultrasound can help predict if guselkumab will work for adults with moderate-to-severe Crohn's disease.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Third Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: Guselkumab
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07034664 on ClinicalTrials.gov

What this trial studies

This is a prospective observational study enrolling adults with newly diagnosed or relapsed moderate-to-severe Crohn's disease who are starting guselkumab. Participants will have baseline intestinal ultrasound (IUS) and endoscopy within one month before beginning guselkumab, and imaging features will be recorded. Clinical and endoscopic outcomes after guselkumab treatment will be tracked and compared to baseline IUS findings to identify predictive ultrasound markers. The goal is to determine whether noninvasive IUS features correlate with subsequent treatment response.

Who should consider this trial

Good fit: Adults aged 18–80 with newly diagnosed or relapsed moderate-to-severe Crohn's disease who plan to start guselkumab within one month and have no history of abdominal surgery are ideal candidates.

Not a fit: Patients with contraindications to guselkumab (active infections, severe liver dysfunction, allergy), those with extensive colectomy or planned colectomy, or those who cannot undergo contrast ultrasound may not benefit from participation.

Why it matters

Potential benefit: If successful, clinicians could use a noninvasive ultrasound scan to predict who is likely to benefit from guselkumab and tailor treatment earlier.

How similar studies have performed: Previous randomized trials (GALAXI2 and GALAXI3) have shown guselkumab achieves meaningful clinical remission and endoscopic response, while using IUS specifically as a predictor of biologic response remains relatively novel.

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.

Where this trial is running

Changsha, Hunan

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Li Tian

Conditions Crohn' s Disease; Guselkumab; Intestinal Ultrasound; Predictor