A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis

NCT07302360 | Recruiting

• 1 other identifier: CNTO1959UCO4003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Response at Week 12

  Clinical response is defined as a decrease from baseline in the partial Mayo score by \>= 30 percent (%) and \>= 2 points, with either a \>=1 decrease from baseline in rectal bleeding subscore (RBS) or an RBS of 0 or 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.

  At Week 12

Secondary Outcomes (21)

• Percentage of Participants Achieving Clinical Response at Week 24 and Week 48

  At Week 24 and Week 48

• Percentage of Participants Achieving Symptomatic Response at Week 2

  At Week 2

• Mean Change from Baseline in Stool Frequency Subscore (SFS) Over Week 2

  From Baseline to Week 2

• Mean Change from Baseline in RBS Over Week 2

  From Baseline to Week 2

• Percentage of Participants Achieving Clinical Remission at Week 12, Week 24 and Week 48

  At Week 12, Week 24 and Week 48

Study Arms (1)

Guselkumab: Moderate to Severe Ulcerative Colitis (UC)

Participants with confirmed diagnosis of moderate-to-severe UC treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected and observed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible Chinese participants with moderate-to-severe UC who are bio-naive will be consecutively enrolled in this study.

You may qualify if:

• Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\>=) 2; c) Mayo rectal bleeding subscore (RBS) \>= 1 at baseline
• Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
• Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
• Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements

You may not qualify if:

• Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
• Contraindicated to guselkumab per the label
• Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
• Participants who will be receiving guselkumab therapy combined with a second advanced therapy
• Participants with a history of colectomy and/or pouch

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, 050000, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)