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

Completed · Phase 4 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04033367

Run by

Sanofi

People needed

188

Starts

2019-08-22

Expected to finish

2021-10-06

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants, male or female 18 years or older,
• with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance.
• had applied skin emollients (moisturizers) at least 7 days before screening.
• had applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening.
• willed and able to comply with all clinic visits and study-related procedures.
• provided signed informed consent.

You may not qualify if…

• Participants excluded from the study:
• with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids.
• at Baseline, presence of any conditions listed as criteria for study drug discontinuation.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number :8400012 — North Little Rock, Arkansas, United States
• Investigational Site Number :8400002 — Redwood City, California, United States
• Investigational Site Number :8400001 — Rolling Hills Estates, California, United States
• Investigational Site Number :8400013 — Colorado Springs, Colorado, United States
• Investigational Site Number :8400005 — Denver, Colorado, United States
• Investigational Site Number :8400003 — Sarasota, Florida, United States
• Investigational Site Number :8400007 — Medford, Oregon, United States
• Investigational Site Number :8400008 — Charleston, South Carolina, United States
• Investigational Site Number :0360006 — Phillip, Australian Capital Territory, Australia
• Investigational Site Number :0360001 — Kogarah, New South Wales, Australia
• Investigational Site Number :0360007 — Woolloongabba, Queensland, Australia
• Investigational Site Number :0360003 — Carlton, Victoria, Australia
• Investigational Site Number :2500001 — Brest, France
• Investigational Site Number :2500003 — Nantes, France
• Investigational Site Number :2500002 — Paris, France
• Investigational Site Number :2500006 — Toulouse, France
• Investigational Site Number :2760005 — Bad Bentheim, Germany
• Investigational Site Number :2760002 — Frankfurt am Main, Germany
• Investigational Site Number :2760006 — Friedrichshafen, Germany
• Investigational Site Number :2760001 — Göttingen, Germany
• Investigational Site Number :2760004 — Münster, Germany
• Investigational Site Number :3760005 — Afula, Israel
• Investigational Site Number :3760003 — Jerusalem, Israel
• Investigational Site Number :3800005 — Rozzano, Milano, Italy
• Investigational Site Number :3800006 — Perugia, Italy

Full record on ClinicalTrials.gov

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