Clinical trial NCT04033367: SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Official title: A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2019-07-26
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 12
measure: DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline up to 14 days after last IMP administration (i.e., up to Week 12)
measure: Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline up to 14 days after last IMP administration (i.e., up to Week 24)
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Investigational Site Number :8400012
state: Arkansas
city: Redwood City
country: United States
facility: Investigational Site Number :8400002
state: California
city: Rolling Hills Estates
country: United States
facility: Investigational Site Number :8400001
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number :8400013
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number :8400005
state: Colorado
city: Sarasota
country: United States
facility: Investigational Site Number :8400003
state: Florida
city: Medford
country: United States
facility: Investigational Site Number :8400007
state: Oregon
city: Charleston
country: United States
facility: Investigational Site Number :8400008
state: South Carolina
city: Phillip
country: Australia
facility: Investigational Site Number :0360006
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Investigational Site Number :0360001
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number :0360007
state: Queensland
city: Carlton
country: Australia
facility: Investigational Site Number :0360003
state: Victoria
city: Brest
country: France
facility: Investigational Site Number :2500001
city: Nantes
country: France
facility: Investigational Site Number :2500003
city: Paris
country: France
facility: Investigational Site Number :2500002
city: Toulouse
country: France
facility: Investigational Site Number :2500006
city: Bad Bentheim
country: Germany
facility: Investigational Site Number :2760005
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number :2760002
city: Friedrichshafen
country: Germany
facility: Investigational Site Number :2760006
city: Göttingen
country: Germany
facility: Investigational Site Number :2760001
city: Münster
country: Germany
facility: Investigational Site Number :2760004
city: Afula
country: Israel
facility: Investigational Site Number :3760005
city: Jerusalem
country: Israel
facility: Investigational Site Number :3760003
city: Rozzano
country: Italy
facility: Investigational Site Number :3800005
state: Milano
city: Perugia
country: Italy
facility: Investigational Site Number :3800006
city: Pisa
country: Italy
facility: Investigational Site Number :3800001
city: Reggio Calabria
country: Italy
facility: Investigational Site Number :3800004
city: Roma
country: Italy
facility: Investigational Site Number :3800002
city: Siena
country: Italy
facility: Investigational Site Number :3800003
city: Granada
country: Spain
facility: Investigational Site Number :7240004
state: Andalucia
city: Barcelona / Sabadell
country: Spain
facility: Investigational Site Number :7240001
state: Castilla Y León
city: Manises
country: Spain
facility: Investigational Site Number :7240003
state: Valencia
city: Córdoba
country: Spain
facility: Investigational Site Number :7240006
city: Madrid
country: Spain
facility: Investigational Site Number :7240008
city: Madrid
country: Spain
facility: Investigational Site Number :7240010
city: Sevilla
country: Spain
facility: Investigational Site Number :7240005
city: Valencia
country: Spain
facility: Investigational Site Number :7240002
city: Bern
country: Switzerland
facility: Investigational Site Number :7560001
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number :7840002
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number :7840001
city: Dudley
country: United Kingdom
facility: Investigational Site Number :8260002
state: Birmingham
city: Edinburgh
country: United Kingdom
facility: Investigational Site Number :8260004
state: Edinburgh, City Of
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: