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

NCT07310095 · tracked via the Priya Life Science China tracker

Sponsor

Xian-Janssen Pharmaceutical Ltd.

Phase

Phase 4

Started

2025-12-30

Last updated

2026-08-27

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Guselkumab (GUS)

Guselkumab (GUS): Guselkumab will be administered intravenously or by subcutaneous injection.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 * Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks * 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: * Received UST dose optimization or multiple intravenous therapy in maintenance phase * 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

Primary outcome measure(s)

Percentage of Participants Achieving Clinical Remission At Week 48 — At Week 48
Clinical remission is defined as less than (\<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

Trial sites (5)

Facility	City	Region	Status
The First Affiliated Hospital Sun Yat sen University	Guangzhou	China	Recruiting
The Sixth Affiliated Hospital Sun Yat sen University	Guangzhou	China	Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	China	Recruiting
The First Affiliated Hospital of Anhui Medical University	Hefei	China	Recruiting
Ruijin Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07310095 on ClinicalTrials.gov ↗ ← All trials in China