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

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

Recruiting
18 years and older
All
Phase 4

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Overview

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

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

Study details
    Crohn Disease

NCT07310095

Xian-Janssen Pharmaceutical Ltd.

13 May 2026

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