RecruitingPhase 4NCT07310095

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

Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab

Sponsor

Xian-Janssen Pharmaceutical Ltd.

Enrollment

78 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Crohn Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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