NCT00640016

A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma

A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled asthma.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Placebo	Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
BIOLOGICAL	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.
BIOLOGICAL	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	CAT-354 10 mg/kg	CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-03-20
• Last updated: 2017-01-31
• Results posted: 2017-01-31

Locations

41 sites across 5 countries: Australia, Germany, Netherlands, Poland, United Kingdom