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
1 other identifier
interventional
150
1 country
1
Brief Summary
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2025
CompletedNovember 19, 2025
November 1, 2025
2 years
May 6, 2022
November 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
week 12
Secondary Outcomes (11)
The proportion of participants achieving a clinical response at Week 12.
week 12
The proportion of participants achieving symptomatic relief at Week 12.
week 12
The proportion of participants achieving endoscopic remission at Week 12.
week 12
The proportion of participants achieving mucosal healing at Week 12.
week 12
The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period.
week 52
- +6 more secondary outcomes
Study Arms (6)
Period 2 IBI112 dose 4
EXPERIMENTALPeriod 1 IBI112 Placebo
PLACEBO COMPARATORPeriod 2 IBI112 dose 3
EXPERIMENTALPeriod 1 IBI112 dose 2
EXPERIMENTALPeriod 2 IBI112 Placebo
PLACEBO COMPARATORPeriod 1 IBI112 dose 1
EXPERIMENTALInterventions
Intravenous Injection
Subcutaneous injections
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 17, 2022
Study Start
July 1, 2022
Primary Completion
June 21, 2024
Study Completion
August 7, 2025
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share