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

Phase 2

Active, not recruiting

• Conditions: Ulcerative Colitis (UC)
• Interventions: Drug: Period 2 IBI112 dose 4; Drug: Period 1 IBI112 Placebo; Drug: Period 2 IBI112 dose 3; Drug: Period 1 IBI112 dose 2; Drug: Period 2 IBI112 Placebo; Drug: Period 1 IBI112 dose 1

• Registration Number: NCT05377580
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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 ulcerative colitis

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-15
• Study First Posted: 2022-05-17
• Study Start: 2022-07-01
• Primary Completion: 2024-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Period 2 IBI112 dose 4	Period 2 IBI112 dose 4	-
Period 1 IBI112 Placebo	Period 1 IBI112 Placebo	-
Period 2 IBI112 dose 3	Period 2 IBI112 dose 3	-
Period 2 IBI112 dose 3	Period 2 IBI112 Placebo	-
Period 1 IBI112 dose 2	Period 1 IBI112 dose 2	-
Period 2 IBI112 Placebo	Period 2 IBI112 Placebo	-
Period 1 IBI112 dose 1	Period 1 IBI112 Placebo	-
Period 1 IBI112 dose 1	Period 1 IBI112 dose 1	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC)	week 12	Percentage of subjects who achieved clinical remission at week 12.

Secondary Outcome Measures

Name	Time	Method
The proportion of participants achieving a clinical response at Week 12.	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.
The proportion of participants achieving symptomatic relief at Week 12.	week 12	Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
The proportion of participants achieving endoscopic remission at Week 12.	week 12	Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score.
The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period.	week 52
The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period.	week 52
The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period.	week 52
The proportion of participants achieving mucosal healing at Week 12.	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.
The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.	week 52
The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period.	week 52
The change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.	Week 12, Week 52，Weeks 24 and 64
The change from baseline in the 36-item Short Form Health Survey (SF-36) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period.	Week 12, Week 52，Weeks 24 and 64

Trial Locations

Locations (1)

First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China