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

April 7, 2026 updated by: Xiaolei Wang, Shanghai 10th People's Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-labeled, single arm, non-interventional, prospective, descriptive study, planned to include postoperative CD patients. After ileocolonic surgical resection, the patients who are treated with GUS will be enrolled in this study. The period is 48 weeks. The primary endpoint is Endoscopic recurrence （modified Rutgeerts score ≥ i2b）at Wk 24. IA is planned to be conducted when 30% of the enrolled patients have finished 24wk follow up. The Secondary endpoint are Clinical remission without recurrence（CDAI < 150）at Wk24/Wk48;Endoscopic recurrence at Wk48 (modified Rutgeerts score ≥ i2b);Endoscopic remission（SES-CD≤3）at Wk24/48;Safety profile. Exploratory endpoint includes histologic score (Geboes scale/RHI/GHAS) at Wk24/48 ileocolonoscopy; time to endoscopic recurrence; time to recurrence of symptoms; endoscopic recurrence rate at Wk24/48(POCER)

Study Type

Observational

Enrollment (Estimated)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Shanghai 10th People's Hospital, Tongji University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic recurrence rate at Wk 24
Time Frame: From enrollment to Week 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission without recurrence at Wk24/Wk48
Time Frame: From enrollment to Wk48
Clinical remission without recurrence (defined as CDAI < 150) at Wk24/Wk48
From enrollment to Wk48
Endoscopic recurrence at Wk48
Time Frame: From enrollment to Wk48
Endoscopic recurrence at Wk48 (defined as modified Rutgeerts score ≥ i2b)
From enrollment to Wk48
Endoscopic remission at Wk24/48
Time Frame: From enrollment to Wk48
Endoscopic remission (defined as SES-CD≤3) at Wk24/48;
From enrollment to Wk48
Safety profile
Time Frame: From enrollment to Wk48
To explore the real-world safety profile of Guselkumab in this patient type
From enrollment to Wk48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Collaborators

Xian-Janssen Pharmaceutical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSY-IEC-6.0/26K44/P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease (CD)

Clinical Trials on Guselkumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe