NCT05377580

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 ulcerative colitis

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	Period 1 IBI112 Placebo	Intravenous Injection
DRUG	Period 2 IBI112 dose 3	Subcutaneous injections
DRUG	Period 1 IBI112 dose 1	Intravenous Injection
DRUG	Period 1 IBI112 dose 2	Intravenous Injection
DRUG	Period 2 IBI112 dose 4	Intravenous Injection
DRUG	Period 2 IBI112 Placebo	Subcutaneous injections

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-21
• Completion: 2025-08-07
• First posted: 2022-05-17
• Last updated: 2025-11-19

Locations

1 site across 1 country: China