Safety of Cat-PAD in Cat Allergic Subjects

This study has been completed.
Sponsor:
Information provided by:
Circassia Limited
ClinicalTrials.gov Identifier:
NCT00685711
First received: May 20, 2008
Last updated: August 5, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Cat Allergy
Biological: Cat-PAD
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Safety and tolerability of Cat-PAD [ Time Frame: 0, 7, 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685711

Locations
Germany
Allergy-Centre-Charité
Berlin, Germany, D-10117
Sponsors and Collaborators
Circassia Limited
Investigators
Principal Investigator: Margitta Worm, MD Professor Allergy-Centre-Charité
  More Information

No publications provided

Responsible Party: Rod Hafner, Circassia Limited
ClinicalTrials.gov Identifier: NCT00685711     History of Changes
Other Study ID Numbers: CP001
Study First Received: May 20, 2008
Last Updated: August 5, 2008
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Circassia Limited:
Cat allergy
Immunotherapy
Cat-PAD

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014