A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

  • STATUS
    Not Recruiting
  • sponsor
    Circassia Ltd.
Updated on 21 April 2022

Summary

A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

Description

A randomized, double-blind, superiority, multiple dose, placebo-controlled, parallel group, multi-centre, field study.

A minimum of 1182 subjects will be randomized into the study, 394 in each of 2 active treatment groups and placebo group, at a ratio of 1:1:1. Subjects will be stratified in each of the treatment groups according to asthma status and according to age, such that a target of 20%-30% of subjects are adolescent (12-17 years) and 70%-80% of subjects are adults (18-65 years). Subjects who withdraw may be replaced.

Subjects aged 12-65 years, with a documented history of moderate to severe allergic rhinoconjunctivitis only or allergic rhinoconjunctivitis plus GINA Step 1 controlled asthma on exposure to cats for at least 2 years.

Details
Condition Allergy
Clinical Study IdentifierTX137586
SponsorCircassia Ltd.
Last Modified on21 April 2022

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