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REGN1908-1909

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat

Ensayo de REGENERON PHARMACEUTICALS, INC. en Allergic Rhinitis Due to Cat Allergy (del registro, en inglés).

Fase

Fase 3

Estado

Interrumpido

Participantes

446

previstos

Centros

92

Fin del objetivo primario

ene 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Lack of efficacy».

Qué mide

Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo (Weeks 48 to 60) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04981717), actualizada en may 2024.