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Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Patients With Moderate-to-Severe Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02260986
First received: October 6, 2014
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
The purpose is to demonstrate efficacy and long term safety of dupilumab in combination with topical corticosteroids in patients with moderate to severe AD.

Condition Intervention Phase
Atopic Dermatitis
Drug: dupilumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients with both an Investigator's Global Assessment (IGA) 0 to 1 (on a 5-point scale) at week 16 and a reduction from baseline of ≥2 points at week 16 [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with EASI-75 response (reduction of EASI score by ≥75% from baseline) at week 16 [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 16 in in weekly average of peak daily Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥4 from baseline to week 16 [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Proportion of patients with IGA 0 or 1 and a reduction from baseline of ≥2 points at week 52 [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with EASI-75 response at week 52 [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥3 from baseline to week 16 [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 52 in weekly average of peak daily Pruritus NRS [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent change in EASI score from baseline to week 16 [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to week 16 in percent body surface area (BSA) [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
  • Percent change in SCORing Atopic Dermatitis (SCORAD) from baseline to week 16 [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 16 in global individual signs score (GISS) (erythema, infiltration/papulation, excoriations, lichenification) [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to week 16 in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Change from baseline to week 16 in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Reduction in topical AD medication use through week 16 [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
  • Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥3 from baseline to week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with improvement (reduction) in weekly average of peak daily Pruritus NRS ≥4 from baseline to week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent change in EASI score from baseline to week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Change from baseline to week 52 in percent BSA [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent change in SCORAD from baseline to week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline to week 52 in GISS (erythema, infiltration/papulation, excoriations, lichenification) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Change from baseline to week 2 in weekly average of peak daily Pruritus NRS [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]
  • Change from baseline to week 52 in DLQI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Change from baseline to week 52 in POEM [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Change from baseline to week 52 in HADS [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Number of flares through week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  • Incidence of skin-infection TEAEs requiring systemic treatment from baseline through week 56 [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: Yes ]
  • Incidence of serious treatment-emergent adverse events (TEAEs) through week 56 [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: Yes ]
  • Incidence of TEAEs leading to study drug discontinuation from baseline through week 56 [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: Yes ]

Enrollment: 739
Study Start Date: September 2014
Study Completion Date: October 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dosing regimen 1
Participants in this group will receive dupilumab according to dosing regimen 1.
Drug: dupilumab
Other Names:
  • REGN668
  • SAR231893
Experimental: dosing regimen 2
Participants in this group will receive dupilumab according to dosing regimen 2.
Drug: dupilumab
Other Names:
  • REGN668
  • SAR231893
Experimental: Matching placebo
Patients will receive SC matching placebo
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Chronic atopic dermatitis (AD) that has been present for at least 3 years before the screening visit
  2. Documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s).

Key Exclusion Criteria:

  1. Participation in a prior dupilumab clinical trial
  2. Important side effects of topical medication (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician
  3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 2 weeks of study treatment:

    1. Immunosuppressive/immunomodulating drugs (eg, systemic steroids, cyclosporine, mycophenolate-mofetil, Janus kinase inhibitors, IFN-γ, azathioprine, methotrexate, etc)
    2. Phototherapy for AD
  4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  5. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
  6. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit
  7. Active or acute infection requiring systemic treatment within 2 weeks before baseline visit
  8. Known or suspected history of immunosuppression
  9. Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study

Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02260986

  Show 149 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02260986     History of Changes
Other Study ID Numbers: R668-AD-1224 
Study First Received: October 6, 2014
Last Updated: November 2, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Korea: Ministry for Health and Welfare
Latvia: State Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 06, 2016