NCT00729508

Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Circassia Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic subjects following challenge to cat allergen in an environmental exposure chamber (EEC).

Detailed description

This study is designed as a multicentre, randomised, double-blind, placebo-controlled study of 4 treatment regimens in up to 120 cat allergic subjects. A total of 24 subjects will be randomised into each treatment group. Each subject will undergo screening up to 4 weeks before treatment. Baseline challenge will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days a week before the first administration of Cat-PAD or placebo. Treatment will be administered as intradermal injections into the flexor surface of alternate forearms. There are 5 treatment regimens involving administration of Cat-PAD or placebo. Post-treatment challenge (PTC) will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days 18 weeks after the first administration of study medication.

Conditions

• Cat Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Cat-PAD	Cat-PAD dose 2X 4 administrations 2 weeks apart
BIOLOGICAL	Cat-PAD	Cat-PAD dose 1X 4 administrations 2 weeks apart
BIOLOGICAL	Cat-PAD	Cat-PAD dose 1X 4 administrations 4 weeks apart
BIOLOGICAL	Cat-PAD	Cat-PAD dose 1X 8 administrations 2 weeks apart
BIOLOGICAL	Cat-PAD	Placebo

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-08-07
• Last updated: 2009-07-08

Locations

1 site across 1 country: Canada