Safety of Cat-PAD in Cat Allergic Subjects

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 investigate the safety of Cat-PAD administered as increasing single doses.

Detailed Description
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This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.

Official Title
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An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.

Conditions
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Cat Allergy

Intervention / Treatment
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* Biological: Cat-PAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year. Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm. Exclusion Criteria: Subjects with asthma falling under GINA(2006) classification 2 (partly controlled) and 3 (uncontrolled). A history of anaphylaxis to cat allergen. Subjects with a cat specific IgE >100 kU/L. Subjects with an FEV1 <80% of normal. Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm. Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season. Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever. Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria. Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). Subjects being treated with beta-blockers

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: 1<br>Placebo intradermal n = 2 with each dose level of Cat-PAD. | Biological: Cat-PAD<br>* single, escalating dose intradermal and subcutaneous injections of Cat-PAD<br>|
| Experimental: 2<br>Intradermal injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 12 nmol may be administered to an additional cohort of 6 subjects. | Biological: Cat-PAD<br>* single, escalating dose intradermal and subcutaneous injections of Cat-PAD<br>|
| Placebo Comparator: 3<br>Placebo subcutaneous n = 2 with each dose level of Cat-PAD. | Biological: Cat-PAD<br>* single, escalating dose intradermal and subcutaneous injections of Cat-PAD<br>|
| Experimental: 4<br>Subcutaneous injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12, 20 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 20 nmol may be administered to an additional cohort of 6 subjects. | Biological: Cat-PAD<br>* single, escalating dose intradermal and subcutaneous injections of Cat-PAD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of Cat-PAD |  | 0, 7, 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen. |  | Day 21 | 

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