A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab

NCT07487480 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Observational

Started

2025-02-10

Last updated

2026-03-23

Condition(s) studied

Inflamatory Bowel DiseaseInflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Investigational drug(s) / intervention(s)

Observation

Observation: observation

Study summary

This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and maintenance regimen over a total observation period of 52 weeks. The primary endpoint is the proportion of patients achieving clinical remission at Week 52. Secondary endpoints include clinical response, endoscopic improvement, biomarker normalization, quality of life assessment, and safety monitoring.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Age 18-75 years. * Diagnosis of Crohn's disease for at least 3 months. * Moderate to severe disease activity (CDAI 220-450). * Previous treatment with at least one standard dose of ustekinumab with documented: * Primary non-response, or Secondary loss of response, or Intolerance leading to discontinuation. * Willing and able to comply with all study visits and procedures. Exclusion Criteria: * Previous exposure to any anti-IL-23p19 therapy (including guselkumab). * Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess (\<8 weeks). * History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection. * Pregnancy, lactation, or planned pregnancy during the study period.

Primary outcome measure(s)

Proportion of patients achieving clinical remission (CDAI <150 or HBI <4) at Week 52. — 52weeks

Trial sites (1)

Facility	City	Region	Status
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07487480 on ClinicalTrials.gov ↗ ← All trials in China