Phase 4
Completed N=188
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Source: ClinicalTrials.gov NCT04033367 ↗Enrolled (actual)
188
Serious AEs
1.1%
Results posted
Nov 2022
Primary outcomePrimary: DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12 — -47.71; -32.98 percent change — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12 |
-47.71; -32.98 | <0.001 sig |
| SECONDARY DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12 |
-52.45; -23.29 | <0.001 sig |
| SECONDARY DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12 |
-37.78; -20.55 | <0.001 sig |
| SECONDARY DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12 |
-4.85; -2.31 | <0.001 sig |
| SECONDARY DB Period: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a (SF8a) Total T-Score at Week 12 |
-11.42; -7.77 | <0.001 sig |
| SECONDARY DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12 |
9.00; -6.36 | 0.297 |
| SECONDARY DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12 |
1.81; 1.53 | — |
| SECONDARY DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12 |
-6.79; -9.19 | — |
| SECONDARY DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12 |
-1.44; -3.37 | — |
| SECONDARY DB Period: Percentage of Participants With Eczema Area Severity Index-50 (EASI-50) (Greater Than or Equal to [>=] 50% Improvement From Baseline) at Week 12 |
89.0; 58.3 | — |
| SECONDARY DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12 |
60.6; 29.2 | — |
| SECONDARY DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12 |
-13.63; -4.44 | — |
| SECONDARY DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 |
-11.82; -7.54 | — |
| SECONDARY DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
72; 41; 2; 1 | — |
| SECONDARY Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
89; 46; 3; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04033367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.