A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

Summary

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: * To evaluate the effect of dupilumab on additional participant reported sleep outcomes * To evaluate the effect of dupilumab on objective sleep assessment * To evaluate the effect of dupilumab on asthma symptoms * To evaluate the effect of dupilumab on lung function * To evaluate the safety of dupilumab

Timeline

Start

2020-08-10

Primary completion

2023-10-03

Completion

2023-11-10

Publications

• Maspero JF, Gupta A, Schmidt O, Perez de Llano LA, Martinez Moragon E, Knolle M, Pfeffer PE, Ricciardolo FL, van der Sar-van der Brugge S, Lopes C, Ostrovskyy M, Dobrianskyi D, Cole J, Wachtel A, Zhang M, Berthou B, Gall R, Awad H. Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Moderate-to-Severe Asthma, Type 2 Inflammation, and Nocturnal Awakenings: The MORPHEO Randomized Controlled Trial. J Investig Allergol Clin Immunol. 2026 Jun 29:0. doi: 10.18176/jiaci.1160. Online ahead of print.

Drugs

Indications