CompletedPhase 2

A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis

China150 participantsStarted 2022-07-01

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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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 agent:

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;

What they're measuring

Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)

Timeframe: week 12

Trial details

NCT IDNCT05377580

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-21

View on ClinicalTrials.gov More Ulcerative Colitis (UC) trials