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

CompletedPhase 4

Sponsor: Sanofi

Conditions: Atopic Dermatitis

Interventions: Dupilumab, Placebo

Countries: United States, Australia, France, Germany, Israel, Italy, Spain, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

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.

Exclusion criteria:

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.

Locations (42)

North Little Rock, Arkansas, United States
Redwood City, California, United States
Rolling Hills Estates, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Sarasota, Florida, United States
Medford, Oregon, United States
Charleston, South Carolina, United States
Phillip, Australian Capital Territory, Australia
Kogarah, New South Wales, Australia
Woolloongabba, Queensland, Australia
Carlton, Victoria, Australia
Brest, France
Nantes, France
Paris, France
Toulouse, France
Bad Bentheim, Germany
Frankfurt am Main, Germany
Friedrichshafen, Germany
Göttingen, Germany
Münster, Germany
Afula, Israel
Jerusalem, Israel
Rozzano, Milano, Italy
Perugia, Italy
Pisa, Italy
Reggio Calabria, Italy
Roma, Italy
Siena, Italy
Granada, Andalusia, Spain
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