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SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Trial ID: NCT04033367
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.
A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
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.
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
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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