A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) (NCT07310095) | Clinical Trial Compass
RecruitingPhase 4
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
China78 participantsStarted 2025-12-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Percentage of Participants Achieving Clinical Remission At Week 48