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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014