Cat Allergy
Conditions
Keywords
Cat allergy, Immunotherapy, Cat-PAD
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 investigate the safety of Cat-PAD administered as increasing single doses.
Detailed description
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.
Interventions
BIOLOGICALCat-PAD
single, escalating dose intradermal and subcutaneous injections of Cat-PAD
Sponsors
Circassia Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of Cat-PAD | 0, 7, 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen. | Day 21 |
Countries
Germany
Outcome results
None listed