Back to resultsCT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
CT-P13 SC (Infliximab)
Placebo SC
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Patient is male or female aged 18 to 75 years, inclusive.
- Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points
Exclusion Criteria:
- Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
- Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives
Sites / Locations
- Centrum Zdrowia MDM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CT-P13 SC
Placebo SC
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Patients Achieving Clinical Remission at Week 54
Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score.
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Secondary Outcome Measures
Percentage Patients Achieving Clinical Response at Week 54
Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved.
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54
Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04205643
Brief Title
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Official Title
A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
548 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P13 SC
Arm Type
Experimental
Arm Title
Placebo SC
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CT-P13 SC (Infliximab)
Intervention Description
Subcutaneous injection of CT-P13 SC
Intervention Type
Other
Intervention Name(s)
Placebo SC
Intervention Description
Subcutaneous injection of Placebo SC
Primary Outcome Measure Information:
Title
Percentage of Patients Achieving Clinical Remission at Week 54
Description
Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score.
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Time Frame
Week 54
Secondary Outcome Measure Information:
Title
Percentage Patients Achieving Clinical Response at Week 54
Description
Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
Time Frame
Week 54
Title
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
Description
Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved.
Time Frame
Week 54
Title
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54
Description
Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Time Frame
Week 54
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:
Patient is male or female aged 18 to 75 years, inclusive.
Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points
Exclusion Criteria:
Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives
Facility Information:
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
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