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

Clinical Trial ID: NCT04033367

Description

Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult patients 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

Duration per participant is up to 28 weeks.


Criteria

Inclusion criteria : Participants, male or female 18 years or older, - with diagnosed chronic atopic dermatitis (AD), demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance - having applied skin emollients (moisturizers) at least 7 days before screening - having applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening - willing and able to comply with all clinic visits and study-related procedures - providing 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 may present unreasonable risk to patients or interfere with study assessment, or any severe concomitant illness(es) that would adversely affect the patient'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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  • Start Date

    2019-08-22

  • Last Updated

    2019-08-28

  • Sponsor

    Regeneron Pharmaceuticals

  • Condition Name

    Atopic Dermatitis

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