A Phase I Study to Evaluate PK, Efficacy and Safety of CT-P13 SC in Patients With Active CD and UC
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Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, PK and safety between CT-P13 SC and CT-P13 IV in patients with active CD or active UC.
Condition or disease
Crohn's DiseaseUlcerative Colitis
A new subcutaneous infliximab formulation is being developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD or active UC.
An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
Actual Study Start Date
September 12, 2016
Estimated Primary Completion Date
February 23, 2019
Estimated Study Completion Date
September 28, 2019
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient has a active Crohn's disease with a score on the Crohn's disease activity index score between 220 and 450 points.
Patient has a active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points.
Patient who has previously received a biological agent for the treatment of CD and UC and/or a TNFα inhibitor for the treatment of other disease
Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product