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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: February 7, 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • Proportion of patients with IGA 0 or 1 and a reduction from baseline of ≥2 points at week 52 [ Time Frame: At week 52 ]
  • Proportion of patients with EASI-75 response at week 52 [ Time Frame: At week 52 ]
  • 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 ]
  • Percent change from baseline to week 52 in weekly average of peak daily Pruritus NRS [ Time Frame: Baseline to week 52 ]
  • Percent change in EASI score from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  • Change from baseline to week 16 in percent body surface area (BSA) [ Time Frame: At week 16 ]
  • Percent change in SCORing Atopic Dermatitis (SCORAD) from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  • Percent change from baseline to week 16 in global individual signs score (GISS) (erythema, infiltration/papulation, excoriations, lichenification) [ Time Frame: Baseline to week 16 ]
  • Change from baseline to week 16 in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to week 16 ]
  • Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ]
  • Change from baseline to week 16 in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to week 16 ]
  • Reduction in topical AD medication use through week 16 [ Time Frame: Baseline to week 16 ]
  • 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 ]
  • 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 ]
  • Percent change in EASI score from baseline to week 52 [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 52 in percent BSA [ Time Frame: Baseline to week 52 ]
  • Percent change in SCORAD from baseline to week 52 [ Time Frame: Baseline to week 52 ]
  • Percent change from baseline to week 52 in GISS (erythema, infiltration/papulation, excoriations, lichenification) [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 2 in weekly average of peak daily Pruritus NRS [ Time Frame: Baseline to week 2 ]
  • Change from baseline to week 52 in DLQI [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 52 in POEM [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 52 in HADS [ Time Frame: Baseline to week 52 ]
  • Number of flares through week 52 [ Time Frame: Baseline to week 52 ]
  • Incidence of skin-infection TEAEs requiring systemic treatment from baseline through week 56 [ Time Frame: Baseline to week 56 ]
  • Incidence of serious treatment-emergent adverse events (TEAEs) through week 56 [ Time Frame: Baseline to week 56 ]
  • Incidence of TEAEs leading to study drug discontinuation from baseline through week 56 [ Time Frame: Baseline to week 56 ]

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)
Sexes Eligible for Study:   All
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: February 7, 2017

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 March 27, 2017