A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXian-Janssen Pharmaceutical Ltd.

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)

Treatment groups

78 Participants
are divided into 1 treatment group