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

NCT04033367 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: LPS154972018-004705-26U1111-1223-4147
• Study Type: interventional
• Target: 188
• Locations: 10 countries
• Sites: 42

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12

  Sleep quality NRS was used to assess the quality of the participant's previous night's sleep. It was collected on a 11-point scale ranged from 0 (worst possible sleep) to 10 (best possible sleep), where higher score indicated better outcome. Percent change from Baseline in sleep quality NRS at Week 12 was reported in this outcome measure.

  Baseline, Week 12

Secondary Outcomes (14)

• DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12

  Baseline, Week 12

• DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12

  Baseline, Week 12

• DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12

  Baseline, Week 12

• 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

  Baseline, Week 12

• DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12

  Baseline, Week 12

Study Arms (2)

Dupilumab/Dupilumab

EXPERIMENTAL

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.

Drug: Dupilumab

Placebo/Dupilumab

PLACEBO COMPARATOR

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.

Drug: Dupilumab; Drug: Placebo

Interventions

Dupilumab DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: SAR231893

Dupilumab/Dupilumab; Placebo/Dupilumab

Placebo DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo/Dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (42)

Investigational Site Number :8400012

North Little Rock, Arkansas, 72117, United States

Location

Investigational Site Number :8400002

Redwood City, California, 94063, United States

Location

Investigational Site Number :8400001

Rolling Hills Estates, California, 90274, United States

Location

Investigational Site Number :8400013

Colorado Springs, Colorado, 80907, United States

Location

Investigational Site Number :8400005

Denver, Colorado, 80230, United States

Location

Investigational Site Number :8400003

Sarasota, Florida, 34239, United States

Location

Investigational Site Number :8400007

Medford, Oregon, 97504, United States

Location

Investigational Site Number :8400008

Charleston, South Carolina, 29407, United States

Location

Investigational Site Number :0360006

Phillip, Australian Capital Territory, 2606, Australia

Location

Investigational Site Number :0360001

Kogarah, New South Wales, 2217, Australia

Location

Investigational Site Number :0360007

Woolloongabba, Queensland, 4102, Australia

Location

Investigational Site Number :0360003

Carlton, Victoria, 3053, Australia

Location

Investigational Site Number :2500001

Brest, 29200, France

Location

Investigational Site Number :2500003

Nantes, 44093, France

Location

Investigational Site Number :2500002

Paris, 75014, France

Location

Investigational Site Number :2500006

Toulouse, 31059, France

Location

Investigational Site Number :2760005

Bad Bentheim, 48455, Germany

Location

Investigational Site Number :2760002

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number :2760006

Friedrichshafen, 88045, Germany

Location

Investigational Site Number :2760001

Göttingen, 37075, Germany

Location

Investigational Site Number :2760004

Münster, 48149, Germany

Location

Investigational Site Number :3760005

Afula, 18101, Israel

Location

Investigational Site Number :3760003

Jerusalem, 91120, Israel

Location

Investigational Site Number :3800005

Rozzano, Milano, 20089, Italy

Location

Investigational Site Number :3800006

Perugia, 06129, Italy

Location

Investigational Site Number :3800001

Pisa, 56126, Italy

Location

Investigational Site Number :3800004

Reggio Calabria, 86100, Italy

Location

Investigational Site Number :3800002

Roma, 168, Italy

Location

Investigational Site Number :3800003

Siena, 53100, Italy

Location

Investigational Site Number :7240004

Granada, Andalusia, 18016, Spain

Location

Investigational Site Number :7240001

Barcelona / Sabadell, Castille and León, 08208, Spain

Location

Investigational Site Number :7240003

Manises, Valencia, 46940, Spain

Location

Investigational Site Number :7240006

Córdoba, 14004, Spain

Location

Investigational Site Number :7240008

Madrid, 28007, Spain

Location

Investigational Site Number :7240010

Madrid, 28922, Spain

Location

Investigational Site Number :7240005

Seville, 41013, Spain

Location

Investigational Site Number :7240002

Valencia, 46026, Spain

Location

Investigational Site Number :7560001

Bern, 3010, Switzerland

Location

Investigational Site Number :7840002

Abu Dhabi, 46713, United Arab Emirates

Location

Investigational Site Number :7840001

Dubai, United Arab Emirates

Location

Investigational Site Number :8260002

Dudley, Birmingham, DY1 2HQ, United Kingdom

Location

Investigational Site Number :8260004

Edinburgh, Edinburgh, City of, EH16 4SA, United Kingdom

Location

Related Links

• LPS15497 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 26, 2019
• Study Start: August 22, 2019
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: September 17, 2025
• Results First Posted: November 2, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); DE (5); IT (6); US (8); FR (4); CH (1); AE (2); GB (2); ES (8); IL (2)