Safety of Cat-PAD in Cat Allergic Subjects

NCT ID: NCT00685711

Last Updated: 2008-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-07-31

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.

Conditions

Cat Allergy

Keywords

Cat allergy; Immunotherapy; Cat-PAD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Placebo intradermal n = 2 with each dose level of Cat-PAD.

Group Type: PLACEBO_COMPARATOR

Cat-PAD

Intervention Type: BIOLOGICAL

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

2

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.

Group Type: EXPERIMENTAL

Cat-PAD

Intervention Type: BIOLOGICAL

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

3

Placebo subcutaneous n = 2 with each dose level of Cat-PAD.

Group Type: PLACEBO_COMPARATOR

Cat-PAD

Intervention Type: BIOLOGICAL

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

4

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.

Group Type: EXPERIMENTAL

Cat-PAD

Intervention Type: BIOLOGICAL

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

Interventions

Cat-PAD

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Circassia Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Circassia Limited

Principal Investigators

Margitta Worm, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Allergy-Centre-Charité

Locations

Allergy-Centre-Charité

Berlin, , Germany

Countries

Germany

Other Identifiers

CP001

Identifier Type: -

Identifier Source: org_study_id