Overview

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

Status:
Completed
Trial end date:
2021-10-06
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Antibodies, Monoclonal
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.