Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2010-01-31
2010-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Solution resembling active solution but without peptides
Placebo
Intradermal injection 1x8 administrations 2 weeks apart
Group 1
Cat-PAD dose group 1
Cat-PAD
Intradermal injection 1x8 administrations 2 weeks apart
Group 2
Cat-PAD Dose group 2
Cat-PAD
Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Adiga Life Sciences, Inc.
INDUSTRY
Cetero Research, San Antonio
NETWORK
Circassia Limited
INDUSTRY
Responsible Party
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Circassia Ltd
Principal Investigators
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Deepen Patel, MD, CCF
Role: PRINCIPAL_INVESTIGATOR
Cetero Research, San Antonio
Locations
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Cetero Research
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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CP005
Identifier Type: -
Identifier Source: org_study_id