CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 188 enrolled
Drug / intervention
Dupilumab +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/NCT04033367
NCT04033367Phase 4Completed
CompareCT.gov

A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

Sanofi·interventional·Posted Jul 26, 2019·Updated Sep 17, 2025

In Brief

A Phase 4 clinical trial evaluating Dupilumab and Placebo for Atopic Dermatitis. Completed, enrolled 188 participants across 42 sites in 10 countries.

Detailed Summary

Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesAustralia, France, Germany, Israel, Italy, Spain, Switzerland, United Arab Emirates, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 26, 2019
Enrollment StartAug 22, 2019
Primary CompletionOct 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago

Interventions

Dupilumabdrug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebodrug

Pharmaceutical form: solution for injection Route of administration: subcutaneous