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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033344
Other study ID # CP005
Secondary ID
Status Completed
Phase Phase 2
First received December 15, 2009
Last updated September 30, 2010
Start date January 2010
Est. completion date September 2010

Study information

Verified date September 2010
Source Circassia Limited
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
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 look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.


Description:

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Male or female, aged 18-65 years

- Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)

- Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control

- Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

- "Partly controlled" and "uncontrolled" asthma

- History of anaphylaxis to cat allergen

- FEV1 of less than 70% of predicted

- Subjects who cannot tolerate baseline challenge in the EEC

- Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs

- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

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:
Placebo
Intradermal injection 1x8 administrations 2 weeks apart
Cat-PAD
Intradermal injection 1x8 administrations 2 weeks apart
Cat-PAD
Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo

Locations

Country Name City State
Canada Cetero Research Mississauga Ontario

Sponsors (3)

Lead Sponsor Collaborator
Circassia Limited Adiga Life Sciences, Inc., Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Rhinoconjunctivitis Symptom Score 0 and 18-22 weeks after start of treatment No
Secondary Symptom scores for ocular and nasal symptoms 0 and 18-22 weeks after start of treatment No
Secondary Acoustic Rhinometry 0 and 18-22 weeks after start of treatment No
Secondary Cat Specific IgE At 0 weeks and at follow up No
Secondary Adverse Events During study Yes
See also
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