Safety of Cat-PAD in Cat Allergic Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Cat Allergy
• Intervention / Treatment: Biological: Cat-PAD

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-10117
    • Allergy-Centre-Charité

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo intradermal n = 2 with each dose level of Cat-PAD.	Biological: Cat-PAD; single, escalating dose intradermal and subcutaneous injections of Cat-PAD
Experimental: 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.	Biological: Cat-PAD; single, escalating dose intradermal and subcutaneous injections of Cat-PAD
Placebo Comparator: 3; Placebo subcutaneous n = 2 with each dose level of Cat-PAD.	Biological: Cat-PAD; single, escalating dose intradermal and subcutaneous injections of Cat-PAD
Experimental: 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.	Biological: Cat-PAD; single, escalating dose intradermal and subcutaneous injections of Cat-PAD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Circassia Limited
• Investigators: Principal Investigator: Margitta Worm, MD Professor, Allergy-Centre-Charité

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): August 6, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Immunotherapy; Cat allergy; Cat-PAD
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CP001