Paediatric Safety Study in Cat-PAD

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

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

Details

• Lead Sponsor: Circassia Limited
• Collaborator: inVentiv Health Clinical

Criteria

• Inclusion Criteria

• Male or female, aged 5-12 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 relevant abnormalities detected on physical examination.

• History of severe drug allergy, severe angioedema or anaphylactic reaction to food.