Paediatric Safety Study in Cat-PAD

Phase 2

Completed

• Conditions: Rhinoconjunctivitis
• Interventions: Drug: Cat-PAD; Drug: Placebo

• Registration Number: NCT01921257
• Lead Sponsor: Circassia Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-17
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-13
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Disposition First Submitted: 2017-03-21
• Disposition First Submitted QC: 2017-03-22
• Disposition First Posted: 2017-03-23
• Results First Submitted: 2018-03-19
• Results First Submitted QC: 2018-03-19
• Results First Posted: 2018-04-17
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Placebo	Cat-PAD and Placebo
Treatment	Cat-PAD	Cat-PAD and Placebo

Primary Outcome Measures

Name	Time	Method
Number of Subjects With AEs	up to 36 weeks after start of treatment	To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to \<12 years.