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

NCT07487480 | Recruiting

• 1 other identifier: 研2025-1623
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  52weeks

Interventions

Observation OTHER

observation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Observation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Shurong Hu, PhD

CONTACT

008619857407061; hushurong@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)