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NCT Number: NCT07528040

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

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.

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Key information

Conditions

Crohn's Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical remission without recurrence at Wk24/Wk48

    Time frame: From enrollment to Wk48

    Clinical remission without recurrence (defined as CDAI < 150) at Wk24/Wk48

  2. Endoscopic recurrence at Wk48

    Time frame: From enrollment to Wk48

    Endoscopic recurrence at Wk48 (defined as modified Rutgeerts score ≥ i2b)

  3. Endoscopic remission at Wk24/48

    Time frame: From enrollment to Wk48

    Endoscopic remission (defined as SES-CD≤3) at Wk24/48;

  4. Safety profile

    Time frame: From enrollment to Wk48

    To explore the real-world safety profile of Guselkumab in this patient type

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaolei Wang

CONTACT

[email protected]

+86 13817267967

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

Registry information

Acronym: POST-CD

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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