Guselkumab in Moderate-to-Severe Ulcerative Colitis: Real-World Experience

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a real-world setting, this observational study evaluates the efficacy and safety of guselkumab for ulcerative colitis by looking at multiple outcomes, including clinical, biochemical, endoscopic, histologic, and imaging measures. Eligible adults with moderate-to-severe disease who have not fully responded to traditional therapies are followed to observe response and safety in routine practice. The study uses baseline disease activity data and ongoing assessments to describe how guselkumab performs outside of controlled trials. It is conducted at a single leading center in China with collaboration from a pharmaceutical partner.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yi Jiang — Second Affiliated Hospital of Wenzhou Medical University
• Study coordinator: Yi Jiang, Doctor of Medicine
• Email: wzjiangyi@yeah.net
• Phone: +8613676715542

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intestinal ultrasound predicts guselkumab response in moderate-to-severe Crohn's disease

  This project will test whether intestinal ultrasound can help predict if guselkumab will work for adults with moderate-to-severe Crohn's disease.

  Recruiting The Third Xiangya Hospital of Central South University · Changsha, Hunan · NCT07034664

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen Research & Development, LLC · Amiens · NCT07822529

• Colonic delivery of two antibodies to see if they reach the bloodstream in healthy people

  This early study tests whether guselkumab and adalimumab given directly into the colon can enter the body in healthy adults.

  Recruiting Phase 1 Surmount Services, Inc. · Maroochydore, Queensland · NCT07788807

• Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis in Remission

  This study tests whether a Mediterranean diet, with or without an 8-hour eating window, helps gut health and quality of life in adults with ulcerative colitis in remission.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT07752446

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

• BDHK-2009 safety test in healthy adults

  This early-stage test checks if BDHK-2009 tablets are safe and tolerable in healthy adults aged 18–55 compared with placebo.

  Recruiting Phase 1 Benethera (Shaoxing) Biotechnology Co., Ltd. · Hangzhou, Zhejiang · NCT07632573

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.