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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04033367




Registration number
NCT04033367
Ethics application status
Date submitted
16/07/2019
Date registered
26/07/2019
Date last updated
24/11/2020

Titles & IDs
Public title
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Scientific 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)
Secondary ID [1] 0 0
2018-004705-26
Secondary ID [2] 0 0
LPS15497
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DUPILUMAB
Treatment: Drugs - PLACEBO

Experimental: Dupilumab - Dupilumab 300mg q2w

Placebo Comparator: Placebo - Matching placebo


Treatment: Drugs: DUPILUMAB
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Treatment: Drugs: PLACEBO
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Change from baseline to Week 12 in sleep efficiency based on actigraphy data - Absolute change from baseline to Week 12 in sleep efficiency based on actigraph data. Sleep Efficiency is calculated as the proportion of time spent asleep vs total time in bed, expressed as a percentage. This is assessed daily and weekly average is used in the analysis.
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change from baseline to Week 12 in total sleep time based on actigraphy data - Absolute change from baseline to Week 12 in total sleep time based on actigraph data. Total sleep time is assessed daily; Weekly average is used in the analysis.
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Change from baseline to Week 12 in wake after sleep onset based on actigraph data - Absolute change from baseline to Week 12 in wake after sleep onset (WASO) based on actigraph data. WASO is assessed daily; Weekly average is used in the analysis.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Change from baseline to Week 12 in sleep latency based on actigraph data - Absolute change from baseline to Week 12 in sleep latency based on actigraph data. Sleep latency is assessed daily; weekly average is used in the analysis.
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Percent change from baseline to Week 12 in pruritus - Percentage change from baseline to Week 12 in pruritus. Pruritus is measured daily using a numerical rating scale; weekly average is used for the analysis.
Timepoint [5] 0 0
Baseline to Week 12
Secondary outcome [6] 0 0
Change from baseline to Week 12 in SCORing Atopic Dermatitis (SCORAD) total score - Absolute change from baseline to Week 12 in SCORAD total score.
Timepoint [6] 0 0
Baseline to Week 12
Secondary outcome [7] 0 0
Change from baseline to Week 12 in SCORAD sleep Visual Analog Scale (VAS) subscore - Absolute change from baseline to Week 12 in SCORAD sleep VAS subscore.
Timepoint [7] 0 0
Baseline to Week 12
Secondary outcome [8] 0 0
Change from baseline to Week 12 in Patient Oriented Eczema Measure (POEM) total score - Absolute change from baseline to Week 12 in POEM total score.
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
EASI50 (50% reduction in Eczema Area and Severity Index score) at Week 12 - Proportion of patients with EASI50 (reduction of EASI score by =50% from baseline) at Week 12.
Timepoint [9] 0 0
Baseline to Week 12
Secondary outcome [10] 0 0
EASI75 (75% reduction in Eczema Area and Severity Index score) at Week12 - Proportion of patients with EASI75 (reduction of EASI score by =75% from baseline) at Week 12.
Timepoint [10] 0 0
Baseline to Week 12
Secondary outcome [11] 0 0
Change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score - Absolute change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score.
Timepoint [11] 0 0
Baseline to Week 12
Secondary outcome [12] 0 0
Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short-Form 8a (SF8a) Total Score - Absolute change from baseline to Week 12 in PROMIS Sleep Related Impairment SF8a Total Score.
Timepoint [12] 0 0
Baseline to Week 12
Secondary outcome [13] 0 0
Adverse events - Incidence of adverse events reported.
Timepoint [13] 0 0
From the signing of Informed consent up to Week 24

Eligibility
Key inclusion criteria
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 emollients (moisturizers) at least 7 days before screening

- having applied medium potency topical corticosteroids (TCS) on all active AD lesions
at least 7 days before screening

- willing and able to comply with all clinic visits and study-related procedures

- providing signed informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0360003 - Carlton
Recruitment hospital [2] 0 0
Investigational Site Number 0360001 - Kogarah
Recruitment hospital [3] 0 0
Investigational Site Number 0360006 - Phillip
Recruitment hospital [4] 0 0
Investigational Site Number 0360007 - Woolloongabba
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2606 - Phillip
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
Mulhouse
Country [11] 0 0
France
State/province [11] 0 0
Nantes Cedex 01
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Germany
State/province [14] 0 0
Bad Bentheim
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt Am Main
Country [16] 0 0
Germany
State/province [16] 0 0
Friedrichshafen
Country [17] 0 0
Germany
State/province [17] 0 0
Göttingen
Country [18] 0 0
Germany
State/province [18] 0 0
Münster
Country [19] 0 0
Israel
State/province [19] 0 0
Afula
Country [20] 0 0
Israel
State/province [20] 0 0
Jerusalem
Country [21] 0 0
Israel
State/province [21] 0 0
Rehovot
Country [22] 0 0
Italy
State/province [22] 0 0
Reggio Calabria
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Italy
State/province [24] 0 0
Rozzano
Country [25] 0 0
Italy
State/province [25] 0 0
Siena
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona / Sabadell
Country [27] 0 0
Spain
State/province [27] 0 0
Córdoba
Country [28] 0 0
Spain
State/province [28] 0 0
Granada
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Sevilla
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Switzerland
State/province [32] 0 0
Bern
Country [33] 0 0
United Arab Emirates
State/province [33] 0 0
Abu Dhabi
Country [34] 0 0
United Arab Emirates
State/province [34] 0 0
United Arab Emirates
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Dudley
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To evaluate the effect of dupilumab on sleep quality in adult patients 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
Trial website
https://clinicaltrials.gov/show/NCT04033367
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04033367