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

Study Overview
=================
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

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

Conditions
-----------------
Ulcerative Colitis (UC)

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: IBI112
* Drug: IBI112


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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: Exclusion Criteria: 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will receive placebo in intravenously (IV) in Induction period. Subsequent study treatment will be determined by the participant's clinical response status at Week 12 | Drug: Placebo<br>* Participants will receive placebo IV or SC<br>|
| Experimental: IBI112 dose 1<br>Participants will receive IBI112 dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. | Drug: IBI112<br>* Participants will receive IBI112 IV or SC<br>|
| Experimental: IBI112 dose 2<br>Participants will receive IBI112 dose 2 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. | Drug: IBI112<br>* Participants will receive IBI112 IV or SC<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission at Week 12 | Clinical remission per modified Mayo score | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response at Week 12 | Clinical response per modified Mayo score. | week 12 | 
| Symptomatic Remission at Week 12 | Symptomatic remission per stool frequency and rectal bleeding subscores. | week 12 | 
| Endoscopic Healing at Week 12 | Endoscopic healing per endoscopy subscore. | week 12 | 
| Histo-Endoscopic Mucosal Healing at Week 12 | Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. | week 12 | 
| Clinical Response at Week 52 | Clinical response per modified Mayo score. | week 52 | 
| Symptomatic Remission at Week 52 | Symptomatic remission per stool frequency and rectal bleeding subscores. | week 52 | 
| Endoscopic Healing at Week 52 | Endoscopic healing per endoscopy subscore. | week 52 | 
| Histo-Endoscopic Mucosal Healing at Week 52 | Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. | week 52 | 
| Clinical Remission at Week at Week 52 | Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. | week 52 | 
| 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 |