Phase II HDM-SPIRE Safety and Efficacy Study

Inclusion Criteria:

- Male or female, aged 18-65 years.

- Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.

- Mean TRSS ≥10

- Positive skin prick test to Der p and Der f.

- Dep p and Der f specific IgE ≥0.7 kU/L

Exclusion Criteria:

- Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3
(www.ginasthma.org)or higher treatment

- FEV1 <80% of predicted.

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

- 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.