CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 202 enrolled
Drug / intervention
SAR231893 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04502862
NCT04502862Phase 4Completed
CompareCT.gov

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

Sanofi·interventional·Posted Aug 6, 2020·Updated Dec 6, 2024

In Brief

A Phase 4 clinical trial evaluating SAR231893 and Placebo for Asthma. Completed, enrolled 202 participants across 55 sites in 11 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Germany, Italy, Netherlands, Portugal, Russia, Spain, Ukraine, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 6, 2020
Enrollment StartAug 10, 2020
Primary CompletionOct 3, 2023
Study CompletionNov 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.9 years ago

Interventions

SAR231893drug

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Placebodrug

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous