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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04033367
Ethics application status
Date submitted
16/07/2019
Date registered
26/07/2019

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 - Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.

Placebo comparator: Placebo/Dupilumab - Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.


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
DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12
Timepoint [10] 0 0
Baseline, Week 12
Secondary outcome [11] 0 0
DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12
Timepoint [11] 0 0
Baseline, Week 12
Secondary outcome [12] 0 0
DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [13] 0 0
Baseline up to 14 days after last IMP administration (i.e., up to Week 12)
Secondary outcome [14] 0 0
Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [14] 0 0
Baseline up to 14 days after last IMP administration (i.e., up to Week 24)

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
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 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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/10/2021
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number :0360006 - Phillip
Recruitment hospital [2] 0 0
Investigational Site Number :0360001 - Kogarah
Recruitment hospital [3] 0 0
Investigational Site Number :0360007 - Woolloongabba
Recruitment hospital [4] 0 0
Investigational Site Number :0360003 - Carlton
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
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
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
France
State/province [7] 0 0
Brest
Country [8] 0 0
France
State/province [8] 0 0
Nantes
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Bentheim
Country [12] 0 0
Germany
State/province [12] 0 0
Frankfurt am Main
Country [13] 0 0
Germany
State/province [13] 0 0
Friedrichshafen
Country [14] 0 0
Germany
State/province [14] 0 0
Göttingen
Country [15] 0 0
Germany
State/province [15] 0 0
Münster
Country [16] 0 0
Israel
State/province [16] 0 0
Afula
Country [17] 0 0
Israel
State/province [17] 0 0
Jerusalem
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Perugia
Country [20] 0 0
Italy
State/province [20] 0 0
Pisa
Country [21] 0 0
Italy
State/province [21] 0 0
Reggio Calabria
Country [22] 0 0
Italy
State/province [22] 0 0
Roma
Country [23] 0 0
Italy
State/province [23] 0 0
Siena
Country [24] 0 0
Spain
State/province [24] 0 0
Andalucia
Country [25] 0 0
Spain
State/province [25] 0 0
Castilla Y León
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
Spain
State/province [27] 0 0
Córdoba
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Switzerland
State/province [30] 0 0
Bern
Country [31] 0 0
United Arab Emirates
State/province [31] 0 0
Abu Dhabi
Country [32] 0 0
United Arab Emirates
State/province [32] 0 0
Dubai
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Birmingham
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Edinburgh, City Of

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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04033367