A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Recruiting now · Phase 4
Conditions studied: Crohn Disease
In brief
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
Key facts
- Study ID
- NCT07310095
- Run by
- Xian-Janssen Pharmaceutical Ltd.
- People needed
- 78
- Starts
- 2025-12-30
- Expected to finish
- 2027-11-15
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 and either mean daily stool frequency (SF) count >= 4 or mean daily abdominal pain (AP) score >=2
- Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram [mg]/kilogram [kg] intravenous [IV] followed by 90 mg subcutaneous [SC] at week 8) as the instruction manual
- Initially responded to UST induction therapy and then lose response to UST
- During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
You may not qualify if…
- Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)
- Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
- Is currently enrolled in an interventional clinical study
- Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
- Have a current or be suspected to have an abscess
Where it is running
- The First Affiliated Hospital Sun Yat sen University — Guangzhou, China (enrolling)
- The Sixth Affiliated Hospital Sun Yat sen University — Guangzhou, China (enrolling)
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China (enrolling)
- The First Affiliated Hospital of Anhui Medical University — Hefei, China (enrolling)
- Ruijin Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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