A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study
- Colitis, Ulcerative
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Enrolment target
- 200
- Started
- 11 December 2025
- Main results due
- 30 June 2028
- Study sites
- 10
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion criteria: * 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 Exclusion criteria: * 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(10)
Peking Union Medical College Hospital
Beijing, China
Recruiting
Peking University People's Hospital
Beijing, China
Recruiting
Changzhou No 2 Peoples Hospital
Changzhou, China
Recruiting
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, China
Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Recruiting
Tianjin Medical University General Hospital
Tianjin, China
Recruiting
Showing 10 of 10 sites. 10 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07302360. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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