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

Ulcerative Colitis (UC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377580
• Other study ID #: CIBI112B201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Minhu Chen
• Phone: 020-87755766-8189
• Email: chenminhu[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Intervention

Drug:
• Placebo
Participants will receive placebo IV or SC
• IBI112
Participants will receive IBI112 IV or SC
• IBI112
Participants will receive IBI112 IV or SC

Locations

Country	Name	City	State
China	First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission at Week 12	Clinical remission per modified Mayo score	week 12
Secondary	Clinical Response at Week 12	Clinical response per modified Mayo score.	week 12
Secondary	Symptomatic Remission at Week 12	Symptomatic remission per stool frequency and rectal bleeding subscores.	week 12
Secondary	Endoscopic Healing at Week 12	Endoscopic healing per endoscopy subscore.	week 12
Secondary	Histo-Endoscopic Mucosal Healing at Week 12	Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.	week 12
Secondary	Clinical Response at Week 52	Clinical response per modified Mayo score.	week 52
Secondary	Symptomatic Remission at Week 52	Symptomatic remission per stool frequency and rectal bleeding subscores.	week 52
Secondary	Endoscopic Healing at Week 52	Endoscopic healing per endoscopy subscore.	week 52
Secondary	Histo-Endoscopic Mucosal Healing at Week 52	Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.	week 52
Secondary	Clinical Remission at Week at Week 52	Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.	week 52
Secondary	Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at week 12 and week 52	IBDQ remission is defined as total IBDQ score greater than or equal to (>=) 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes	week 12 and week 52