Cat-PAD Exposure Chamber Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cat Allergy

Intervention / Treatment
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* Biological: Placebo
* Biological: Cat-PAD
* Biological: Cat-PAD


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Solution resembling active solution but without peptides | Biological: Placebo<br>* Intradermal injection 1x8 administrations 2 weeks apart<br>|
| Experimental: Group 1<br>Cat-PAD dose group 1 | Biological: Cat-PAD<br>* Intradermal injection 1x8 administrations 2 weeks apart<br>|
| Experimental: Group 2<br>Cat-PAD Dose group 2 | Biological: Cat-PAD<br>* Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cat allergy, Rhinoconjunctivitis, Exposure chamber, Immunotherapy, Cat-PAD