About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Guselkumab (GUS)