Actively Recruiting
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Led by Xian-Janssen Pharmaceutical Ltd. · Updated on 2026-05-08
78
Participants Needed
5
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, defined by baseline Crohn's Disease Activity Index (CDAI) score >= 220 and either mean daily stool frequency count >= 4 or mean daily abdominal pain score >= 2
- Received at least two doses of ustekinumab (6 mg/kg intravenous induction followed by 90 mg subcutaneous at week 8) as per instruction manual
- Initially responded to ustekinumab induction therapy but then lost response
- Receiving ustekinumab treatment during screening as first or second line biologic
You will not qualify if you...
- Responded well to ustekinumab treatment in a dosing regimen not aligned with approved recommended dosing (e.g., multiple intravenous inductions)
- Requires urgent surgical or endoscopic intervention, or elective surgery within 2 months due to Crohn's disease
- Currently enrolled in another interventional clinical study
- Has complications of Crohn's disease such as symptomatic strictures, stenoses, or short gut syndrome
- Has or is suspected to have an abscess
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China, 510060
Actively Recruiting
2
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, China, 510655
Actively Recruiting
3
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China, 310018
Actively Recruiting
4
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230022
Actively Recruiting
5
Ruijin Hospital
Shanghai, China, 200031
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here