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SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

NCT04033367 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-09-17

Study results available
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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.

Conditions

Interventions

DRUG

Dupilumab

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2021-10-06
Completion
2021-10-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Israel
  • Italy
  • Spain
  • Switzerland
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033367 on ClinicalTrials.gov