Safety of Cat-PAD in Cat Allergic Subjects

Circassia Limited88 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cat Allergy

Interventions

Cat-PADBIOLOGICAL

single, escalating dose intradermal and subcutaneous injections of Cat-PAD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Allergy-Centre-Charité

Berlin, Germany

Outcomes

Primary Outcomes

Safety and tolerability of Cat-PAD

Time frame: 0, 7, 21 days

Secondary Outcomes

Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.

Time frame: Day 21

Data from ClinicalTrials.gov

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