Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.

July 21, 2026 updated by: Second Affiliated Hospital of Wenzhou Medical University
In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound changes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yi Jiang, Doctor of Medicine
  • Phone Number: +8613676715542
  • Email: wzjiangyi@yeah.net

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325026
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study employs a prospective consecutive enrollment design to include patients with moderate-to-severe active ulcerative colitis who excepts guselkumab treatment at our center based on clinical indications. The inclusion and exclusion criteria are as previously stated.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Diagnosis of ulcerative colitis is established based on clinical manifestations, laboratory findings, colonoscopy, radiological imaging (CT or ultrasound), and histopathological examination.
  3. Presence of moderate-to-severe disease activity, defined as a modified Mayo score (MMS) ≥ 5 points, accompanied by a rectal bleeding subscore (RBS) ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2.
  4. Inadequate response or intolerance to at least one conventional therapy (5-aminosalicylates, corticosteroids, or immunosuppressants), as assessed by the investigator according to clinical practice.
  5. Based on the research cohort requirements, the GUS real-world cohort may include patients who are biologic-naive, have failed first-line therapy, or have failed multiple lines of therapy.
  6. Availability of baseline data for disease activity assessment, including symptom scores (partial Mayo score or PRO2), endoscopic evaluation (MES), biochemical markers (C-reactive protein or fecal calprotectin), or imaging parameters (CT or intestinal ultrasonography).
  7. Patients enrolled in the prospective GUS cohort are required to provide written informed consent voluntarily.

Exclusion Criteria:

  1. Diagnosed with other intestinal diseases, such as Crohn's disease, intestinal tuberculosis, infectious colitis, ischemic colitis or other chronic intestinal inflammatory diseases;
  2. If there is an active intestinal infection, and the fecal culture or pathogen test shows positive within 8 weeks before the study (including Clostridium difficile, cytomegalovirus, etc.), and the re-examination turns negative without any signs of persistent infection, a re-evaluation can be conducted.
  3. Combined with severe infections, malignant tumors, severe liver and kidney dysfunction, or accompanied by active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, and Graves' disease that may interfere with disease assessment
  4. Those who have undergone total colorectal resection or stoma surgery in the past and whose disease activity cannot be evaluated, or are expected to undergo major intestinal surgery during the study period;
  5. Has had a severe allergic reaction to monoclonal antibodies;
  6. During pregnancy or lactation (can be recorded as an independent cohort but not included in the primary analysis);
  7. Severe absence of baseline and follow-up data makes it impossible to determine efficacy or safety.
  8. Currently participating in other interventional clinical trials that may interfere with the results of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Guselkumab treatment group
Drug: Guselkumab
All the patients receive GUS (IV) 200 mg induction therapy at weeks 0, 4, and 8, and who met the criteria for clinical symptom remission, biochemical remission, and improvement in intestinal ultrasound based on the clinical assessment at week 12, proceeded to receive GUS (SC) 100 mg every 8 weeks as maintenance therapy. Patients who did not meet the above criteria received GUS (SC) 200 mg every 4 weeks as maintenance therapy. At week 24, based on clinical and endoscopic evaluations, patients who achieved endoscopic remission were switched to GUS (SC) 100 mg every 8 weeks for maintenance, while those who did not achieve endoscopic remission continued to receive GUS (SC) 200 mg every 4 weeks for maintenance treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
48-week endoscopic remission
Time Frame: 48 weeks
Assessment was performed using the Mayo endoscopic subscore: endoscopic response was defined as a decrease in the Mayo endoscopic subscore by at least 1 point from baseline or a score of ≤1; endoscopic remission was defined as a Mayo endoscopic subscore of 0. For patients who completed the 48-week treatment, we evaluate endoscopic scores, and calculate the number/proportion of patients achieving endoscopic remission.
48 weeks
48-week histological remission
Time Frame: 48 weeks
We apply the Geboes score, and histological remission is defined as a Geboes score ≤ 2B.0. The Nancy Histological Index (NHI) is assessed concurrently, with histological remission defined as an NHI = 0 (indicating no active inflammation). We performed Histological scoring for patients who complete the 48-week treatment course, and evaluate the number/proportion of patients achieving histological remission.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-week clinical remission
Time Frame: 12 weeks
Clinical remission in UC is assessed using the partial Mayo score (pMayo) or PRO2. It's defined as either a pMayo score ≤ 2 with no individual subscore > 1, or meeting the symptomatic remission criteria of PRO2 (indicating improvement in both stool frequency and rectal bleeding scores to the mild or normal range).
12 weeks
12-week biochemical remission
Time Frame: 12 weeks
  1. CRP normalization (≤5 mg/L) or reduction by ≥50% from baseline.
  2. Fecal calprotectin (FC) reduction to <250 μg/g or reduction by ≥50% from baseline.
12 weeks
12-week intestinal ultrasound response
Time Frame: 12 weeks
Response to intestinal ultrasound (IUS) was defined as meeting both of the following criteria: 1) a decrease in bowel wall thickness (BWT) by ≥25% or a reduction of ≥1 mm from baseline; and 2) a reduction in blood flow signal (Limberg score) by ≥1 grade.
12 weeks
24-week and 48-week intestinal ultrasound response
Time Frame: 24 weeks; 48 weeks
Intestinal ultrasound (IUS) remission was defined as meeting both of the following criteria: 1) bowel wall thickness (BWT) ≤ 3 mm; and 2) no detectable blood flow signal (Limberg grade 0).
24 weeks; 48 weeks
24-week endoscopic response and remission
Time Frame: 24 weeks
Endoscopic response in UC was defined as a Mayo Endoscopic Score (MES) reduction of ≥1 point from baseline or a score of ≤1. Endoscopic remission was defined as an MES of 0.
24 weeks
24-week and 48-week Corticosteroid-free remission rate
Time Frame: 24 weeks; 48 weeks
Corticosteroid-free remission, a core treatment target recommended by the STRIDE-II guidelines, reflects a patient's ability to maintain clinical remission without the aid of systemic glucocorticoids. It is defined as achieving clinical remission at the assessment timepoint without the use of oral or intravenous glucocorticoids for at least 12 weeks prior to assessment. The proportion of UC patients achieving corticosteroid-free remission was documented to evaluate the sustainability and steroid-sparing capacity of the treatment.
24 weeks; 48 weeks
48-week drug persistence rate
Time Frame: 48 weeks
Drug persistence rate is defined as the proportion of patients who continue to receive a given drug after initiation of treatment. It reflects the tolerability, adherence, and long-term benefit of the therapy, and serves as a core indicator in real-world evidence (RWE) studies. Patients who discontinue treatment due to objective non-medical reasons (e.g., relocation, change of healthcare system) may be excluded in sensitivity analyses.
48 weeks
Hospitalization and surgery rates at week 48
Time Frame: 48 weeks
  1. Incidence of hospitalizations due to inadequate disease control and cumulative length of hospital stay.
  2. Incidence and timing of intestinal resection or related surgeries performed due to disease activity or complications.
48 weeks
Impact of Prior Biologic Exposure on Efficacy
Time Frame: Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48.
The clinical, endoscopic, intestinal ultrasound (IUS), and biochemical improvements were compared between biologic-naïve patients and patients with prior biologic therapy failure or intolerance. This analysis aimed to determine if previous biologic exposure influences treatment outcomes.
Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48.
Inflammatory Bowel Disease Questionnaire (IBD-Q) scores at week 48
Time Frame: 48 weeks
  1. A total score increase of ≥16 points from baseline is considered a clinically significant improvement.
  2. Restoration to a normal or near-normal level (score ≥ 170) from an active disease state is considered achievement of quality of life remission.
48 weeks
Exploratory Study (Comparing the Efficacy of GUS and VDZ)
Time Frame: Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48
Patients with ulcerative colitis (UC) who had previously received vedolizumab (VDZ) treatment and had complete baseline and follow-up data were retrospectively enrolled from our center. Propensity score matching analysis was performed to compare the effects of GUS and VDZ on multidimensional outcomes in moderate-to-severe UC in a real-world setting, including clinical response and remission, endoscopic remission, histological remission, and treatment persistence.
Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Collaborators

Xian-Janssen Pharmaceutical Ltd.

Investigators

  • Principal Investigator: Yi Jiang, Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2025-01-232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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