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

Innovent Biologics (Suzhou) Co. Ltd.150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Ulcerative Colitis (UC)

Interventions

Period 1 IBI112 PlaceboDRUG

Intravenous Injection

Period 2 IBI112 dose 3DRUG

Subcutaneous injections

Period 1 IBI112 dose 1DRUG

Intravenous Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis; 2. Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2; 3. Subject must have received at least one prior treatment or first use of a biological agent: Exclusion Criteria: 1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease; 2. UC lesions were limited to rectum or involved colon \< 15cm; 3. Evidence of toxic hirschsprung's disease was found during screening; 4. History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;

Locations (1)

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Percentage of subjects who achieved clinical remission at week 12.

Time frame: week 12

Secondary Outcomes

The proportion of participants achieving a clinical response at Week 12.

Clinical response is defined as a relative decrease from baseline in the modified Mayo score of ≥30% and ≥2 points, along with a relative decrease in the rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1.

Time frame: week 12

The proportion of participants achieving symptomatic relief at Week 12.

Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.

Time frame: week 12

The proportion of participants achieving endoscopic remission at Week 12.

Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score.

Time frame: week 12

The proportion of participants achieving mucosal healing at Week 12.

Mucosal healing is defined as endoscopic remission, which means an endoscopic subscore of 0 or 1 within the modified Mayo score, and central Geboes histopathological index remission.

Time frame: week 12

The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.

Time frame: week 52

The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.

Data from ClinicalTrials.gov

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