Phase III Cat-PAD Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Circassia Limited
• Collaborators: inVentiv Health Clinical; Pharm-Olam International

Criteria

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.