Back to resultsA Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
Primary Purpose
Ulcerative Colitis (UC)
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Placebo
IBI112
IBI112
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis (UC)
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;
Sites / Locations
- First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
IBI112 dose 1
IBI112 dose 2
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
Clinical Remission at Week 12
Clinical remission per modified Mayo score
Secondary Outcome Measures
Clinical Response at Week 12
Clinical response per modified Mayo score.
Symptomatic Remission at Week 12
Symptomatic remission per stool frequency and rectal bleeding subscores.
Endoscopic Healing at Week 12
Endoscopic healing per endoscopy subscore.
Histo-Endoscopic Mucosal Healing at Week 12
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Clinical Response at Week 44
Clinical response per modified Mayo score.
Symptomatic Remission at Week 44
Symptomatic remission per stool frequency and rectal bleeding subscores.
Endoscopic Healing at Week 44
Endoscopic healing per endoscopy subscore.
Histo-Endoscopic Mucosal Healing at Week 44
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Clinical Remission at Week at Week 44
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
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
Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 44
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
Full Information
NCT ID
NCT05377580
First Posted
May 6, 2022
Last Updated
September 20, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05377580
Brief Title
A Study to Evaluate IBI112 in the Treatment of 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
IBI112 dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
IBI112 dose 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo IV or SC
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
Participants will receive IBI112 IV or SC
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
Participants will receive IBI112 IV or SC
Primary Outcome Measure Information:
Title
Clinical Remission at Week 12
Description
Clinical remission per modified Mayo score
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Clinical Response at Week 12
Description
Clinical response per modified Mayo score.
Time Frame
week 12
Title
Symptomatic Remission at Week 12
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
week 12
Title
Endoscopic Healing at Week 12
Description
Endoscopic healing per endoscopy subscore.
Time Frame
week 12
Title
Histo-Endoscopic Mucosal Healing at Week 12
Description
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Time Frame
week 12
Title
Clinical Response at Week 44
Description
Clinical response per modified Mayo score.
Time Frame
week 44
Title
Symptomatic Remission at Week 44
Description
Symptomatic remission per stool frequency and rectal bleeding subscores.
Time Frame
week 44
Title
Endoscopic Healing at Week 44
Description
Endoscopic healing per endoscopy subscore.
Time Frame
week 44
Title
Histo-Endoscopic Mucosal Healing at Week 44
Description
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Time Frame
week 44
Title
Clinical Remission at Week at Week 44
Description
Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
Time Frame
week 44
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Description
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
Time Frame
week 12
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 44
Description
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
Time Frame
week 44
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhu Chen
Phone
020-87755766-8189
Email
chenminhu@vip.163.com
Facility Information:
Facility Name
First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minhu Chen
Phone
020-87755766-8189
Email
chenminhu@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
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