Study identifier:CAT-354-0603
ClinicalTrials.gov identifier:NCT00640016
EudraCT identifier:2007-002090-31
CTIS identifier:N/A
A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354
asthma
Phase 2
No
-
All
14
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2016 by MedImmune, LLC
MedImmune, LLC
Cambridge Antibody Technology, PRA International
To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled asthma.
This is a randomized, stratified, double-blind, placebo-controlled, multicenter, multinational study in subjects with uncontrolled asthma despite optimal treatment. Following confirmation of eligibility, subjects will be randomly assigned on Day 0, to 1 of 4 dose groups 1 mg/kg CAT-354, 5 mg/kg CAT-354, 10 mg/kg CAT or Placebo to match all doses of CAT-354. Doses of the assigned treatment will be administered on three occasions 28 days apart. Subjects will be assessed for efficacy, including airway hyper-responsiveness (AHR), safety, pharmacokinetic, pharmacodynamics and immunogenicity until Day 84 post-first dose.
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56. | Other: Placebo Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56. Other Name: Tralokinumab |
Experimental: CAT-354 1 mg/kg CAT-354 1 milligram per kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. | Biological/Vaccine: CAT-354 1 mg/kg CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. Other Name: Tralokinumab |
Experimental: CAT-354 5 mg/kg CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. | Biological/Vaccine: CAT-354 5 mg/kg CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. Other Name: Tralokinumab |
Experimental: CAT-354 10 mg/kg CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56 | Other: CAT-354 10 mg/kg CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56. |
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