Phase III Cat-PAD Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:12 - 65
Updated:6/17/2018
Start Date:October 2012

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A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

The purpose of this study is to compare the treatment effect of two treatment regimens of
Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue
medication usage and Quality of Life.


Inclusion Criteria

- Male or female, aged 12-65 years.

- Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.

- Subjects may optionally also have GINA Step 1 controlled asthma.

- Positive skin prick test to cat hair.

- Cat dander specific IgE ≥0.35 kU/L.

Exclusion Criteria

- Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or
Steps 2 to 5.

- FEV1 <80% of predicted.

- Clinically significant confounding symptoms of allergy to seasonal allergens during
the final evaluation period.

- Skin prick test 5 mm greater than the negative control to perennial allergens or
animal dander (other than cat) which cannot be avoided during the study.

- Significant symptoms of another clinically relevant illness that is likely to affect
scoring of rhinoconjunctivitis symptoms.

- Clinically relevant abnormalities detected on physical examination.

- History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
We found this trial at
53
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