Status:
COMPLETED
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
Detailed Description
This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerativ...
Eligibility Criteria
Inclusion
- Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis;
- Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2;
- Subject must have received at least one prior treatment or first use of a biological agent:
Exclusion
- Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease;
- UC lesions were limited to rectum or involved colon \< 15cm;
- Evidence of toxic hirschsprung's disease was found during screening;
- History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05377580
Start Date
July 1 2022
End Date
August 7 2025
Last Update
November 19 2025
Active Locations (1)
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1
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080