Cat-PAD Exposure Chamber Study

A Double-blind, Randomized, Placebo-controlled Study to Evaluate Two Treatment Regimens of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

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 look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.

Study Overview

• Status: Completed
• Conditions: Cat Allergy
• Intervention / Treatment: Biological: Placebo; Biological: Cat-PAD; Biological: Cat-PAD

Detailed Description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 18-65 years
• Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)
• Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control
• Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

• "Partly controlled" and "uncontrolled" asthma
• History of anaphylaxis to cat allergen
• FEV1 of less than 70% of predicted
• Subjects who cannot tolerate baseline challenge in the EEC
• Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
• A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Solution resembling active solution but without peptides	Biological: Placebo; Intradermal injection 1x8 administrations 2 weeks apart
EXPERIMENTAL: Group 1; Cat-PAD dose group 1	Biological: Cat-PAD; Intradermal injection 1x8 administrations 2 weeks apart; Biological: Cat-PAD; Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo
EXPERIMENTAL: Group 2; Cat-PAD Dose group 2	Biological: Cat-PAD; Intradermal injection 1x8 administrations 2 weeks apart; Biological: Cat-PAD; Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Rhinoconjunctivitis Symptom Score	0 and 18-22 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom scores for ocular and nasal symptoms	0 and 18-22 weeks after start of treatment
Acoustic Rhinometry	0 and 18-22 weeks after start of treatment
Cat Specific IgE	At 0 weeks and at follow up
Adverse Events	During study

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Cetero Research, San Antonio; Adiga Life Sciences, Inc.
• Investigators: Principal Investigator: Deepen Patel, MD, CCF, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (ESTIMATE): December 16, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 1, 2010
• Last Update Submitted That Met QC Criteria: September 30, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Immunotherapy; Rhinoconjunctivitis; Cat allergy; Cat-PAD; Exposure chamber
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CP005