Clinical Trials Logo

Clinical Trial Summary

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy.

This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.


Clinical Trial Description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01033344
Study type Interventional
Source Circassia Limited
Contact
Status Completed
Phase Phase 2
Start date January 2010
Completion date September 2010

See also
  Status Clinical Trial Phase
Terminated NCT02959073 - Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients N/A
Completed NCT00987909 - Exposure Chamber Trial With Cat Immunotherapy Phase 2
Completed NCT01383603 - Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis Phase 1
Completed NCT01383590 - Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis Phase 1
Completed NCT01003301 - The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge Phase 2
Completed NCT02311413 - A Randomized Prospective Clinical Trial of Fel d 1 Peptide Immunotherapy Phase 2
Completed NCT02237196 - Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy Phase 1/Phase 2
Completed NCT02399579 - Evaluation of a New Self-Assessed, Home-Based Symptom Score Test in Cat Allergic Patients N/A
Terminated NCT01292070 - Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy Phase 0
Completed NCT00867906 - Safety of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects With Controlled Asthma Phase 2
Completed NCT04435678 - Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens N/A
Completed NCT00685711 - Safety of Cat-PAD in Cat Allergic Subjects Phase 1/Phase 2
Completed NCT02040844 - Phase III Cat-PAD Follow-on Study Phase 3
Completed NCT01604018 - An Optional Two Year Follow Up Study to Study CP005A N/A
Completed NCT01272323 - Cat-PAD Follow on Study N/A
Completed NCT03838731 - Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge Phase 2
Completed NCT00729508 - Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects Phase 2
Recruiting NCT05331170 - Viral Mucosal Reprogramming Phase 2