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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis); Inflamatory Bowel Disease
• Intervention / Treatment: Other: Observation

Detailed Description

Crohn's disease is a chronic, progressive, and disabling inflammatory bowel disease. Ustekinumab, a monoclonal antibody targeting the p40 subunit of IL-12/23, is an established treatment option. However, a significant proportion of patients experience primary non-response, secondary loss of response, or intolerance. Guselkumab is a fully human monoclonal antibody that selectively targets the p19 subunit of IL-23, a key cytokine in the Th17-mediated inflammatory pathway in CD. While guselkumab has demonstrated efficacy in biologic-naïve or TNF-antagonist failed CD patients, real-world prospective data in ustekinumab-experienced patients are limited. This study aims to fill this evidence gap by providing prospective observational data on the effectiveness and safety of guselkumab in this specific patient population.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Shurong Hu, PhD; Phone Number: 008619857407061; Email: hushurong@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Yan Chen; Phone Number: +86-571-87783777; Email: chenyan72_72@zju.edu.cn
      • Contact: Shurong HU; Phone Number: +86-571-87783777; Email: hushurong@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will receive guselkumab according to the following schedule:

Induction Phase (Weeks 0-12): Guselkumab 200 mg IV every 4 weeks (3 doses).

Maintenance Phase (Weeks 12-52): Guselkumab 100 mg SC every 8 weeks. Adjustments may be made based on clinical response and physician judgment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving clinical remission (CDAI <150 or HBI <4) at Week 52.	52weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 研2025-1623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No