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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
October 6, 2014
February 7, 2017
September 2014
November 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02260986 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to week 16 ]
  • Proportion of patients with improvement (reduction) of Pruritus NRS ≥3 from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  • Proportion of patients with an IGA 0-1at week 52 [ Time Frame: At week 52 ]
  • Proportion of patients with an EASI-75 response at week 52 [ Time Frame: At week 52 ]
  • Change from baseline to week 16 in percent Body surface area of involvement of atopic dermatitis (BSA) [ Time Frame: At week 16 ]
  • Change in "SCORing Atopic Dermatitis" (SCORAD) from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  • Change from baseline to week 16 in global individual AD signs (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 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) of Pruritus NRS ≥3 from baseline to week 52 [ Time Frame: Baseline to week 52 ]
  • Percent change from baseline to week 52 in Pruritus NRS [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 52 in percent BSA [ Time Frame: Baseline to week 52 ]
  • Change in SCORAD from baseline to week 52 [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 52 in global individual AD signs (erythema, infiltration/papulation, excoriations, lichenification) [ Time Frame: Baseline to week 52 ]
  • Change from baseline to week 2 in pruritus NRS [ Time Frame: Baseline to week 2 ]
    NOTE: Time frame in protocol is baseline to week 2. Should it be week 52?
  • Incidence of skin-infections requiring systemic treatment from baseline through week 56 [ Time Frame: Baseline through week 56 ]
  • Number of flares through week 52 [ Time Frame: Baseline through week 52 ]
  • Incidence of serious treatment-emergent adverse events (TEAEs) from baseline through week 56 [ Time Frame: Baseline through week 56 ]
  • Incidence of TEAEs leading to study drug discontinuation from baseline through week 56 [ Time Frame: Baseline through week 56 ]
Not Provided
Not Provided
 
Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Patients With Moderate-to-Severe Atopic Dermatitis
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
The purpose is to demonstrate efficacy and long term safety of dupilumab in combination with topical corticosteroids in patients with moderate to severe AD.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: dupilumab
    Other Names:
    • REGN668
    • SAR231893
  • Drug: placebo
  • Experimental: dosing regimen 1
    Participants in this group will receive dupilumab according to dosing regimen 1.
    Intervention: Drug: dupilumab
  • Experimental: dosing regimen 2
    Participants in this group will receive dupilumab according to dosing regimen 2.
    Intervention: Drug: dupilumab
  • Experimental: Matching placebo
    Patients will receive SC matching placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
739
October 2016
November 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Romania,   Spain,   United Kingdom,   United States
France,   Germany,   Latvia,   Russian Federation,   Taiwan
 
NCT02260986
R668-AD-1224
Yes
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP