Phase II HDM-SPIRE Safety and Efficacy Study

• Status: Completed
• Trial end date: 2017-04-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Circassia Limited
• Collaborator: Quintiles, Inc.

Criteria

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.