A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI112 in Patients With Moderate to Severe Active Ulcerative Colitis

  • End date
    Jun 30, 2025
  • participants needed
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 14 October 2022


To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.


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 ulcerative colitis

Condition Ulcerative Colitis (UC)
Treatment Placebo, IBI112
Clinical Study IdentifierNCT05377580
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on14 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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