Phase III Cat-PAD Study

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.