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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00685711
Other study ID # CP001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 20, 2008
Last updated August 5, 2008
Start date January 2008
Est. completion date July 2008

Study information

Verified date August 2008
Source Circassia Limited
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Allergy-Centre-Charité Berlin

Sponsors (1)

Lead Sponsor Collaborator
Circassia Limited

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of Cat-PAD 0, 7, 21 days Yes
Secondary Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen. Day 21 No
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