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

Summary

The primary objective is to evaluate the prophylactic efficacy of REGN1908-1909 (anti-Fel d 1) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a Controlled Cat Allergen Challenge-induced early asthmatic response (EAR) assessed by measures of lung function (FEV1) compared to placebo-treated patients. Secondary Efficacy Objectives: * To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat, in the prevention of a Controlled Cat Allergen Challenge-induced: Allergic rhinitis and Ocular symptoms * To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure to cat allergen, measured as a product of minute ventilation and time, required to induce EAR in a Controlled Cat Allergen Challenge as compared to placebo patients Secondary Safety Objective: * To evaluate the safety and tolerability of REGN1908-1909 vs. placebo in patients with cat allergen-triggered asthma

Timeline

Start

2019-02-12

Primary completion

2019-12-21

Completion

2020-04-06

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs REGN1908-1909 600 mg; p = 0.0083; Hazard Ratio (HR) 0.36 (95% CI 0.17 to 0.77); Cox Proportional Hazard NCT03838731 ↗

paper Single-dose REGN1908/1909 significantly prevented reductions in FEV1 on days 8, 29, 57, and 85. PMID 35934082 ↗

release “the Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints.” regeneron.com ↗

release “REGN1908-1909 in cat-allergic patients with mild asthma. The trial met the primary endpoint of preventing early asthma reactions (EAR,” regeneron.com ↗

Publications

• de Blay FJ, Gherasim A, Domis N, Meier P, Shawki F, Wang CQ, Orengo JM, DeVeaux M, Ramesh D, Jalbert JJ, Kamal MA, Abdallah H, Dingman R, Perlee L, Weinreich DM, Herman G, Yancopoulos GD, O'Brien MP. REGN1908/1909 prevented cat allergen-induced early asthmatic responses in an environmental exposure unit. J Allergy Clin Immunol. 2022 Dec;150(6):1437-1446. doi: 10.1016/j.jaci.2022.06.025. Epub 2022 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Freneslerbart	Monoclonal antibody	—	Subcutaneous
Subject	REGN1908-1909	Monoclonal antibody	—	Subcutaneous

Indications