A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Recruiting · NCT07310095 · Interventional (participants receive a specific treatment) · Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Guselkumab (GUS)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed.
- The First Affiliated Hospital Sun Yat sen University - Guangzhou, China
- The Sixth Affiliated Hospital Sun Yat sen University - Guangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou, China
- The First Affiliated Hospital of Anhui Medical University - Hefei, China
- Ruijin Hospital - Shanghai, China