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| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
| Cetero Research, San Antonio | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Solution resembling active solution but without peptides |
|
| Group 1 | Experimental | Cat-PAD dose group 1 |
|
| Group 2 | Experimental | Cat-PAD Dose group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Intradermal injection 1x8 administrations 2 weeks apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Rhinoconjunctivitis Symptom Score | 0 and 18-22 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scores for ocular and nasal symptoms | 0 and 18-22 weeks after start of treatment | |
| Acoustic Rhinometry | 0 and 18-22 weeks after start of treatment | |
| Cat Specific IgE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepen Patel, MD, CCF | Cetero Research, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Mississauga | Ontario | L4W 1N2 | Canada |
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| Cat-PAD |
| Biological |
Intradermal injection 1x8 administrations 2 weeks apart |
|
| Cat-PAD | Biological | Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo |
|
| At 0 weeks and at follow up |
| Adverse Events | During study |