A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Recruiting now
Conditions studied: Colitis, Ulcerative
In brief
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.
Key facts
- Study ID
- NCT07302360
- Run by
- Xian-Janssen Pharmaceutical Ltd.
- People needed
- 200
- Starts
- 2025-12-11
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Peking Union Medical College Hospital — Beijing, China (enrolling)
- Peking University People's Hospital — Beijing, China (enrolling)
- Changzhou No 2 Peoples Hospital — Changzhou, China (enrolling)
- The First Affiliated Hospital Sun Yat-Sen University — Guangzhou, China (enrolling)
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (enrolling)
- The Second Affiliated Hospital of Zhejiang University — Hangzhou, China (enrolling)
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China (enrolling)
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing, China (enrolling)
- The Second Hospital of Hebei Medical University — Shijiazhuang, China (enrolling)
- Tianjin Medical University General Hospital — Tianjin, China (enrolling)
Full record on ClinicalTrials.gov
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