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SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT04033367
Collaborator
Regeneron Pharmaceuticals (Industry)
186
Enrollment
42
Locations
2
Arms
25.5
Actual Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Duration per participant is up to 28 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
186 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 22, 2019
Actual Primary Completion Date :
Oct 6, 2021
Actual Study Completion Date :
Oct 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dupilumab

Dupilumab 300mg q2w

Drug: DUPILUMAB
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Names:
  • SAR231893

    		•
    Placebo Comparator: Placebo

    Matching placebo

    Drug: PLACEBO
    Pharmaceutical form: solution for injection Route of administration: subcutaneous

    Outcome Measures

    Primary Outcome Measures

    1. Percentage change from baseline to Week 12 in sleep quality numerical rating scale (NRS) [Baseline to Week 12]

      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

    Secondary Outcome Measures

    1. Change from baseline to Week 12 in sleep efficiency based on actigraphy data [Baseline to Week 12]

      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.

    2. Change from baseline to Week 12 in total sleep time based on actigraphy data [Baseline to Week 12]

      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.

    3. Change from baseline to Week 12 in wake after sleep onset based on actigraph data [Baseline to Week 12]

      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.

    4. Change from baseline to Week 12 in sleep latency based on actigraph data [Baseline to Week 12]

      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.

    5. Percent change from baseline to Week 12 in pruritus [Baseline to Week 12]

      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.

    6. Change from baseline to Week 12 in SCORing Atopic Dermatitis (SCORAD) total score [Baseline to Week 12]

      Absolute change from baseline to Week 12 in SCORAD total score.

    7. Change from baseline to Week 12 in SCORAD sleep Visual Analog Scale (VAS) subscore [Baseline to Week 12]

      Absolute change from baseline to Week 12 in SCORAD sleep VAS subscore.

    8. Change from baseline to Week 12 in Patient Oriented Eczema Measure (POEM) total score [Baseline to Week 12]

      Absolute change from baseline to Week 12 in POEM total score.

    9. EASI50 (50% reduction in Eczema Area and Severity Index score) at Week 12 [Baseline to Week 12]

      Proportion of patients with EASI50 (reduction of EASI score by ≥50% from baseline) at Week 12.

    10. EASI75 (75% reduction in Eczema Area and Severity Index score) at Week12 [Baseline to Week 12]

      Proportion of patients with EASI75 (reduction of EASI score by ≥75% from baseline) at Week 12.

    11. Change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score [Baseline to Week 12]

      Absolute change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score.

    12. Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short-Form 8a (SF8a) Total Score [Baseline to Week 12]

      Absolute change from baseline to Week 12 in PROMIS Sleep Related Impairment SF8a Total Score.

    13. Adverse events [From the signing of Informed consent up to Week 24]

      Incidence of adverse events reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number :8400012 North Little Rock Arkansas United States 72117
    2 Investigational Site Number :8400002 Redwood City California United States 94063
    3 Investigational Site Number :8400001 Rolling Hills Estates California United States 90274
    4 Investigational Site Number :8400013 Colorado Springs Colorado United States 80907
    5 Investigational Site Number :8400005 Denver Colorado United States 80230
    6 Investigational Site Number :8400003 Sarasota Florida United States 34239
    7 Investigational Site Number :8400007 Medford Oregon United States 97504
    8 Investigational Site Number :8400008 Charleston South Carolina United States 29407
    9 Investigational Site Number :0360006 Phillip Australian Capital Territory Australia 2606
    10 Investigational Site Number :0360001 Kogarah New South Wales Australia 2217
    11 Investigational Site Number :0360007 Woolloongabba Queensland Australia 4102
    12 Investigational Site Number :0360003 Carlton Victoria Australia 3053
    13 Investigational Site Number :2500001 Brest France 29200
    14 Investigational Site Number :2500003 Nantes France 44093
    15 Investigational Site Number :2500002 Paris France 75014
    16 Investigational Site Number :2500006 Toulouse France 31059
    17 Investigational Site Number :2760005 Bad Bentheim Germany 48455
    18 Investigational Site Number :2760002 Frankfurt am Main Germany 60590
    19 Investigational Site Number :2760006 Friedrichshafen Germany 88045
    20 Investigational Site Number :2760001 Göttingen Germany 37075
    21 Investigational Site Number :2760004 Münster Germany 48149
    22 Investigational Site Number :3760005 Afula Israel 18101
    23 Investigational Site Number :3760003 Jerusalem Israel 91120
    24 Investigational Site Number :3800005 Rozzano Milano Italy 20089
    25 Investigational Site Number :3800006 Perugia Italy 06129
    26 Investigational Site Number :3800001 Pisa Italy 56126
    27 Investigational Site Number :3800004 Reggio Calabria Italy 86100
    28 Investigational Site Number :3800002 Roma Italy 168
    29 Investigational Site Number :3800003 Siena Italy 53100
    30 Investigational Site Number :7240004 Granada Andalucia Spain 18016
    31 Investigational Site Number :7240001 Barcelona / Sabadell Castilla Y León Spain 08208
    32 Investigational Site Number :7240003 Manises Valencia Spain 46940
    33 Investigational Site Number :7240006 Córdoba Spain 14004
    34 Investigational Site Number :7240008 Madrid Spain 28007
    35 Investigational Site Number :7240010 Madrid Spain 28922
    36 Investigational Site Number :7240005 Sevilla Spain 41013
    37 Investigational Site Number :7240002 Valencia Spain 46026
    38 Investigational Site Number :7560001 Bern Switzerland 3010
    39 Investigational Site Number :7840002 Abu Dhabi United Arab Emirates 46713
    40 Investigational Site Number :7840001 Dubai United Arab Emirates
    41 Investigational Site Number :8260002 Dudley Birmingham United Kingdom DY1 2HQ
    42 Investigational Site Number :8260004 Edinburgh Edinburgh, City Of United Kingdom EH16 4SA

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04033367
    Other Study ID Numbers:
    • LPS15497
    • 2018-004705-26
    • U1111-1223-4147
    First Posted:
    Jul 26, 2019
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 7, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Apr 25, 2022