Trials / Completed
CompletedNCT04033367
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Detailed description
Duration per participant was up to 28 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| DRUG | Placebo | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
Timeline
- Start date
- 2019-08-22
- Primary completion
- 2021-10-06
- Completion
- 2021-10-06
- First posted
- 2019-07-26
- Last updated
- 2025-09-17
- Results posted
- 2022-11-02
Locations
42 sites across 10 countries: United States, Australia, France, Germany, Israel, Italy, Spain, Switzerland, United Arab Emirates, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04033367. Inclusion in this directory is not an endorsement.