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

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ClinicalTrials.gov Identifier: NCT04033367
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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
Atopic Dermatitis Drug: DUPILUMAB Drug: PLACEBO Phase 4

Detailed Description:
Duration per participant is up to 28 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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 : August 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Dupilumab 300mg q2w
Drug: DUPILUMAB
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: SAR231893

Placebo Comparator: Placebo
Matching placebo
Drug: PLACEBO
Pharmaceutical form: solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  1. Percentage change from baseline to Week 12 in sleep quality numerical rating scale (NRS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to Week 12 ]
    Absolute change from baseline to Week 12 in PROMIS Sleep Related Impairment SF8a Total Score.

  13. Adverse events [ Time Frame: From the signing of Informed consent up to Week 24 ]
    Incidence of adverse events reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033367


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, California
Investigational Site Number 8400001 Recruiting
Rolling Hills Estates, California, United States, 90274
United States, Colorado
Investigational Site Number 8400005 Recruiting
Denver, Colorado, United States, 80230
United States, Oregon
Investigational Site Number 8400007 Recruiting
Medford, Oregon, United States, 97504
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04033367     History of Changes
Other Study ID Numbers: LPS15497
2018-004705-26 ( EudraCT Number )
U1111-1223-4147 ( Other Identifier: UTN )
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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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:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs