Cat Allergy Clinical Trial
Official title:
An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.
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 investigate the safety of Cat-PAD administered as increasing single doses.
This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
NCT01383590 -
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
|
Phase 1 | |
Completed |
NCT01383603 -
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array 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 |
NCT01033344 -
Cat-PAD Exposure Chamber Study
|
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 |