A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients With Allergic Rhinitis Who Live With a Cat to Assess the Efficacy and Safety of Anti-Fel d 1 Antibodies During Natural Cat Exposure in the Home

  • STATUS
    Recruiting
  • End date
    Jun 11, 2024
  • participants needed
    630
  • sponsor
    Regeneron Pharmaceuticals
Updated on 20 September 2022
Investigator
Clinical Trials Administrator
Primary Contact
Kingston Health Science Centre (0.6 mi away) Contact
+90 other location

Summary

The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure.

The Secondary Objectives are:

  • To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS
  • To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S])
  • To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen
  • To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W)
  • To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen
  • To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma
  • To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma
  • To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo
  • To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo
  • To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations
  • To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909
  • To assess the immunogenicity of REGN1908 and REGN1909

Details
Condition Allergic Rhinitis Due to Cat Allergy
Treatment Matching Placebo, REGN1908-1909
Clinical Study IdentifierNCT04981717
SponsorRegeneron Pharmaceuticals
Last Modified on20 September 2022

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