Safety of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects With Controlled Asthma

Phase 2

Completed

• Conditions: Cat Allergy
• Interventions: Biological: Cat-PAD; Biological: Placebo

• Registration Number: NCT00867906
• Lead Sponsor: Circassia Limited

Brief 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 evaluate the safety and tolerability of multiple doses of Cat-PAD in controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation Test.

Detailed Description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis and controlled asthma. The efficacy of Cat-PAD will also be explored in these subjects using the EPSR, LPSR, CPT, and levels of cat specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.

Three cohorts will be studied, depending on the treatment used to control the subject's asthma:Cohort 1 - inhaled salbutamol only, Cohort 2 - inhaled corticosteroid only, Cohort 3 - inhaled corticosteroid plus a LABA

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to either 3 nmol Cat-PAD or placebo. Treatments will be administered every 2 weeks (±2 days) for 14 week

In Period 3, Post Treatment Challenge consist of a single visit 24-28 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-05
• Last Update Posted: 2010-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Cat-PAD	Asthmatics using salbutamol only, subjects to receive either Cat-PAD or placebo comparator
Cohort 1	Placebo	Asthmatics using salbutamol only, subjects to receive either Cat-PAD or placebo comparator
Cohort 2	Cat-PAD	Asthmatics using inhaled corticosteroid, subjects to receive either Cat-PAD or placebo comparator
Cohort 2	Placebo	Asthmatics using inhaled corticosteroid, subjects to receive either Cat-PAD or placebo comparator
Cohort 3	Cat-PAD	Asthmatics using inhaled corticosteroid and LABA, subjects to receive either Cat-PAD or placebo comparator
Cohort 3	Placebo	Asthmatics using inhaled corticosteroid and LABA, subjects to receive either Cat-PAD or placebo comparator

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of multiple intradermal injections of Cat-PAD in cat allergic subjects with controlled asthma	28 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo	28 weeks
Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo	28 weeks
Mean change from baseline in CPT score at PTC after Cat-PAD injection compared to placebo	28 weeks
Mean change from baseline in concentration of cat specific IgE at PTC after Cat-PAD injection compared to placebo	28 weeks

Trial Locations

Locations (1)

Alpha Medical Research; 🇨🇦 Mississauga, Toronto, Ontario, Canada