NCT04502862

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Study duration per participant was approximately 16 weeks and up to 29 weeks including up to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment follow-up period or until the participant switched to commercialized dupilumab (or other biologic product), whichever came first.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	SAR231893	Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Timeline

• Start date: 2020-08-10
• Primary completion: 2023-10-03
• Completion: 2023-11-10
• First posted: 2020-08-06
• Last updated: 2024-12-06
• Results posted: 2024-11-26

Locations

55 sites across 11 countries: United States, Argentina, Canada, Germany, Italy, Netherlands, Portugal, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study