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

Sponsor
Shanghai 10th People's Hospital
Study ID
NCT07528040
Status
Not Yet Recruiting

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Conditions

  • Crohn's Disease (CD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
88 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Endoscopic recurrence rate at Wk 24 [ Time Frame: From enrollment to Week 24 ]

Central Contacts

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