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NCT07034664
IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
trial in Crohn's Disease in 50 participants. Currently enrolling.
30 July 2027
Quick facts
| Lead sponsor | The Third Xiangya Hospital of Central South University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 16 June 2025 |
| Primary completion | 30 July 2027 |
| Estimated completion | 30 September 2027 |
| Sites | 1 location across China |
Conditions studied
- Crohn's Disease — all drugs for Crohn's Disease →
- Guselkumab — all drugs for Guselkumab →
- Intestinal Ultrasound — all drugs for Intestinal Ultrasound →
- Predictor — all drugs for Predictor →
Sponsor
The Third Xiangya Hospital of Central South University
Who can join
Adults 18 to 80, any sex, with Crohn's Disease or Guselkumab. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other The Third Xiangya Hospital of Central South University trials
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- NCT07039097 — A Multicenter, Prospective, Randomized, Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resectio · NA · recruiting
- NCT07093294 — Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter · recruiting
- NCT07093502 — Establishment of a Classification System and Postoperative Risk Warning Model for Patients Undergoing Bariatric Metaboli · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07034664 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Third Xiangya Hospital of Central South University
- Last refreshed: 24 June 2025
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