- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205643
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
September 26, 2023 updated by: Celltrion
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
548
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Warszawa, Poland, 00-728
- Centrum Zdrowia MDM
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo SC
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Subcutaneous injection of Placebo SC
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Experimental: CT-P13 SC
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Subcutaneous injection of CT-P13 SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Achieving Clinical Remission at Week 54
Time Frame: 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. |
Week 54
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Patients Achieving Clinical Response at Week 54
Time Frame: 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.
|
Week 54
|
Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
Time Frame: 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.
|
Week 54
|
Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54
Time Frame: 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.
|
Week 54
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
July 7, 2022
Study Completion (Actual)
July 11, 2023
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 19, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Gastrointestinal Agents
- Dermatologic Agents
- Tumor Necrosis Factor Inhibitors
- Infliximab
Other Study ID Numbers
- CT-P13 3.7
- 2019-003849-15 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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