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, Older Adult)
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