Status:
COMPLETED
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 dupilum...
Detailed Description
Duration per participant was up to 28 weeks.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04033367
Start Date
August 22 2019
End Date
October 6 2021
Last Update
September 17 2025
Active Locations (42)
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1
Investigational Site Number :8400012
North Little Rock, Arkansas, United States, 72117
2
Investigational Site Number :8400002
Redwood City, California, United States, 94063
3
Investigational Site Number :8400001
Rolling Hills Estates, California, United States, 90274
4
Investigational Site Number :8400013
Colorado Springs, Colorado, United States, 80907