An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

NCT07528040 | Not Yet Recruiting

• 1 other identifier: SHSY-IEC-6.0/26K44/P01
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.

Conditions

Crohn's Disease (CD)

Keywords

IBD

Outcome Measures

Primary Outcomes (1)

• Endoscopic recurrence rate at Wk 24

  The primary objective of this study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of CD in participants after surgery

  From enrollment to Week 24

Secondary Outcomes (4)

• Clinical remission without recurrence at Wk24/Wk48

  From enrollment to Wk48

• Endoscopic recurrence at Wk48

  From enrollment to Wk48

• Endoscopic remission at Wk24/48

  From enrollment to Wk48

• Safety profile

  From enrollment to Wk48

Study Arms (1)

Gulselkumab after surgery

The target population is male or female participants (minimum age 18) with a diagnosis of CD who have had a qualifying surgery (eg, ileocolonic resection) at most 3months before enrolled. Participants will be excluded if they have a short segment of bowel affected (ie,less than 10 cm) for fibrostenotic disease and they had their first surgery more than 10 years after diagnosis of CD. There is no requirement that participants have failed prior biologics.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab is an IL23 p19 subunit antagonist that binds to IL-23 with high affinity and potency and also binds to the CD64 receptor (high affinity Fcγ receptor 1) on the surface of human inflammatory monocytes, which enables it to neutralize IL-23 at its predominant source of production, potentially enriching the presence of guselkumab in the inflamed tissue microenvironment.GALAXI and GRAVITI studies have demonstrated that Guselkumab treatment was both safe and effective for induction and maintenance of remission is patients with moderate to severely active CD. No study is about the efficacy of IL-23is in POCD

Gulselkumab after surgery

Eligibility Criteria

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

Study Population

The target population is male or female participants (minimum age 18) with a diagnosis of CD who have had a qualifying surgery (eg, ileocolonic resection) at most 3months before enrolled. Participants will be excluded if they have a short segment of bowel affected (ie,less than 10 cm) for fibrostenotic disease and they had their first surgery more than 10 years after diagnosis of CD. There is no requirement that participants have failed prior biologics.

You may qualify if:

• Patients≥ 18，
• Have a documented diagnosis of moderate to severe CD
• Have undergone an ileocolonic surgical resection

You may not qualify if:

• Has complications of CD, such as short bowel syndrome Currently has or is suspected to have an abscess
• Active infection
• Currently has a malignancy or has a history of malignancy within 5 years

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Study Sites (1)

Shanghai 10th People's Hospital, Tongji University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Xiaolei Wang

CONTACT

+86 13817267967; xlwang2006@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)