SAR231893-LPS15497- Dupilumab effect on Sleep in AD patients”

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-004705-26-DE
• Lead Sponsor: Sanofi Aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-22
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 268

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 emolients (moisturizers) at least 7 days before randomization
- having applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before randomization
- willing and able to comply with all clinic visits and study-related procedures
- providing signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 253
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of dupilumab on sleep quality in adult patients with moderate to severe atopic dermatitis (AD);Secondary Objective: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation<br>To continue to assess the safety and tolerability throughout the study<br>;Primary end point(s): Percentage change from baseline to Week 12 in sleep quality numerical rating scale (NRS) : Percentage change from baseline to Week 12 in sleep quality. Sleep quality is measured daily using a numerical rating scale; weekly average is used for the analysis;Timepoint(s) of evaluation of this end point: Baseline to Week 12