Efficacy and Safety of Dupilumab in Patients ≥12 to <18 Years of Age, With Moderate-to-Severe Atopic Dermatitis

Description

To demonstrate the efficacy of dupilumab as a monotherapy in patients ?12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD)

Study Start Date

April, 07 2017

Estimated Completion Date

July 2018

Interventions

  • Drug: Dupilumab
  • Drug: Placebo

Study ID

Regeneron Pharmaceuticals -- R668-AD-1526

Status

Recruiting

Trial ID

NCT03054428

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

240

Sponsor

Regeneron Pharmaceuticals

Inclusion Criteria

  • Male or female ?12 to <18 years of age at time of screening visit
  • Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
  • IGA ?3 at screening and baseline visit
  • EASI ?16 at the screening and baseline visit
  • Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ?4
  • ?10% body surface area (BSA) of AD involvement at the screening and baseline visits
  • With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable

Exclusion Criteria

  • Participation in a prior dupilumab clinical study
  • Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
  • Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
  • Body weight <30 kg at Baseline
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
  • Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
  • History of malignancy before the baseline visit
  • Diagnosed active endoparasitic infections or at high risk of these infections
  • Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug Other protocol-defined inclusion/exclusion criteria may apply

Gender

All

Ages

12 Years to 17 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (168)

Study Location Distance Name Phone Email
Harvard Medical School Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Harvard Medical School Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Harvard Medical School Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Harvard Medical School Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Harvard Medical School Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Harvard Medical School Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Tufts Medical Center Inc - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center Inc - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center Inc - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center Inc - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center Inc - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center Inc - Boston, Massachusetts 3.2 miles None None None
Forest Hills Dermatology Group - Forest Hills, New York 182.0 miles None None None
Forest Hills Dermatology Group - Forest Hills, New York 182.0 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
University of Rochester Medical Center - Rochester, New York 335.8 miles None None None
DermAssociates PC - Rockville, Maryland 391.1 miles None None None
DermAssociates PC - Rockville, Maryland 391.1 miles None None None
DermAssociates PC - Rockville, Maryland 391.1 miles None None None
DermAssociates PC - Rockville, Maryland 391.1 miles None None None
DermAssociates PC - Rockville, Maryland 391.1 miles None None None
DermAssociates PC - Rockville, Maryland 391.1 miles None None None
MedStar Washington Hospital Center - Washington, D.C., District of Columbia 393.8 miles None None None
MedStar Washington Hospital Center - Washington, D.C., District of Columbia 393.8 miles None None None
MedStar Washington Hospital Center - Washington, D.C., District of Columbia 393.8 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
Virginia Clinical Research Inc - Norfolk, Virginia 468.9 miles None None None
UNC Dermatology and Skin Cancer Center - Chapel Hill, North Carolina 619.9 miles None None None
UNC Dermatology and Skin Cancer Center - Chapel Hill, North Carolina 619.9 miles None None None
UNC Dermatology and Skin Cancer Center - Chapel Hill, North Carolina 619.9 miles None None None
UNC Dermatology and Skin Cancer Center - Chapel Hill, North Carolina 619.9 miles None None None
Dermatologists of Greater Columbus - Bexley, Ohio 638.5 miles None None None
Dermatologists of Greater Columbus - Bexley, Ohio 638.5 miles None None None
Dermatologists of Greater Columbus - Bexley, Ohio 638.5 miles None None None
Dermatologists of Greater Columbus - Bexley, Ohio 638.5 miles None None None
Dermatologists of Greater Columbus - Bexley, Ohio 638.5 miles None None None
Dermatologists of Greater Columbus - Bexley, Ohio 638.5 miles None None None
Office of Dr David Fivenson MD - Ann Arbor, Michigan 650.2 miles None None None
Office of Dr David Fivenson MD - Ann Arbor, Michigan 650.2 miles None None None
Office of Dr David Fivenson MD - Ann Arbor, Michigan 650.2 miles None None None
Office of Dr David Fivenson MD - Ann Arbor, Michigan 650.2 miles None None None
Office of Dr David Fivenson MD - Ann Arbor, Michigan 650.2 miles None None None
Office of Dr David Fivenson MD - Ann Arbor, Michigan 650.2 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
The Indiana Clinical Trials Center PC - Plainfield, Indiana 818.6 miles None None None
The Indiana Clinical Trials Center PC - Plainfield, Indiana 818.6 miles None None None
The Indiana Clinical Trials Center PC - Plainfield, Indiana 818.6 miles None None None
The Indiana Clinical Trials Center PC - Plainfield, Indiana 818.6 miles None None None
The Indiana Clinical Trials Center PC - Plainfield, Indiana 818.6 miles None None None
The Indiana Clinical Trials Center PC - Plainfield, Indiana 818.6 miles None None None
National Allergy and Asthma - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma - Charleston, South Carolina 822.5 miles None None None
National Allergy and Asthma - Charleston, South Carolina 822.5 miles None None None
Northwestern University Feinberg School of Medicine - Chicago, Illinois 847.9 miles None None None
Northwestern University Feinberg School of Medicine - Chicago, Illinois 847.9 miles None None None
Northwestern University Feinberg School of Medicine - Chicago, Illinois 847.9 miles None None None
Northwestern University Feinberg School of Medicine - Chicago, Illinois 847.9 miles None None None
Deaconess Clinic Inc - Evansville, Indiana 921.0 miles None None None
Deaconess Clinic Inc - Evansville, Indiana 921.0 miles None None None
Deaconess Clinic Inc - Evansville, Indiana 921.0 miles None None None
Deaconess Clinic Inc - Evansville, Indiana 921.0 miles None None None
Deaconess Clinic Inc - Evansville, Indiana 921.0 miles None None None
Deaconess Clinic Inc - Evansville, Indiana 921.0 miles None None None
Advanced Medical Research PC - Sandy Springs, Georgia 927.9 miles None None None
Advanced Medical Research PC - Sandy Springs, Georgia 927.9 miles None None None
Advanced Medical Research PC - Sandy Springs, Georgia 927.9 miles None None None
Advanced Medical Research PC - Sandy Springs, Georgia 927.9 miles None None None
Advanced Medical Research PC - Sandy Springs, Georgia 927.9 miles None None None
Advanced Medical Research PC - Sandy Springs, Georgia 927.9 miles None None None
Dermatologic Surgery Specialists PC - Macon, Georgia 947.5 miles None None None
Dermatologic Surgery Specialists PC - Macon, Georgia 947.5 miles None None None
Dermatologic Surgery Specialists PC - Macon, Georgia 947.5 miles None None None
Dermatologic Surgery Specialists PC - Macon, Georgia 947.5 miles None None None
Dermatologic Surgery Specialists PC - Macon, Georgia 947.5 miles None None None
Dermatologic Surgery Specialists PC - Macon, Georgia 947.5 miles None None None
Saint Louis University - Saint Louis, Missouri 1,039.5 miles None None None
Total Skin and Beauty Dermatology Center PC - Birmingham, Alabama 1,052.4 miles None None None
Total Skin and Beauty Dermatology Center PC - Birmingham, Alabama 1,052.4 miles None None None
Total Skin and Beauty Dermatology Center PC - Birmingham, Alabama 1,052.4 miles None None None
Total Skin and Beauty Dermatology Center PC - Birmingham, Alabama 1,052.4 miles None None None
Total Skin and Beauty Dermatology Center PC - Birmingham, Alabama 1,052.4 miles None None None
Total Skin and Beauty Dermatology Center PC - Birmingham, Alabama 1,052.4 miles None None None
Clinical Research Center of Alabama - Birmingham, Alabama 1,054.2 miles None None None
Clinical Research Institute - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute - Plymouth, Minnesota 1,129.6 miles None None None
Clinical Research Institute - Plymouth, Minnesota 1,129.6 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Forward Clinical Trials Inc - Tampa, Florida 1,179.8 miles None None None
Vital Prospects Clinical Research Institute PC - Tulsa, Oklahoma 1,396.7 miles None None None
Vital Prospects Clinical Research Institute PC - Tulsa, Oklahoma 1,396.7 miles None None None
Vital Prospects Clinical Research Institute PC - Tulsa, Oklahoma 1,396.7 miles None None None
Vital Prospects Clinical Research Institute PC - Tulsa, Oklahoma 1,396.7 miles None None None
Vital Prospects Clinical Research Institute PC - Tulsa, Oklahoma 1,396.7 miles None None None
Vital Prospects Clinical Research Institute PC - Tulsa, Oklahoma 1,396.7 miles None None None
Bellaire Dermatology Associates - Bellaire, Texas 1,612.9 miles None None None
Bellaire Dermatology Associates - Bellaire, Texas 1,612.9 miles None None None
Bellaire Dermatology Associates - Bellaire, Texas 1,612.9 miles None None None
Bellaire Dermatology Associates - Bellaire, Texas 1,612.9 miles None None None
Bellaire Dermatology Associates - Bellaire, Texas 1,612.9 miles None None None
Bellaire Dermatology Associates - Bellaire, Texas 1,612.9 miles None None None
Texas Dermatology and Laser Specialists - San Antonio, Texas 1,759.9 miles None None None
Immunoe International Research Center - Centennial, Colorado 1,764.5 miles None None None
Immunoe International Research Center - Centennial, Colorado 1,764.5 miles None None None
Arizona Allergy Immunology Research - Gilbert, Arizona 2,285.1 miles None None None
Arizona Allergy Immunology Research - Gilbert, Arizona 2,285.1 miles None None None
Arizona Allergy Immunology Research - Gilbert, Arizona 2,285.1 miles None None None
Arizona Allergy Immunology Research - Gilbert, Arizona 2,285.1 miles None None None
Arizona Allergy Immunology Research - Gilbert, Arizona 2,285.1 miles None None None
Arizona Allergy Immunology Research - Gilbert, Arizona 2,285.1 miles None None None
JDR Dermatology Research - Las Vegas, Nevada 2,385.6 miles None None None
JDR Dermatology Research - Las Vegas, Nevada 2,385.6 miles None None None
JDR Dermatology Research - Las Vegas, Nevada 2,385.6 miles None None None
JDR Dermatology Research - Las Vegas, Nevada 2,385.6 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Oregon Medical Research Center PC - Portland, Oregon 2,543.2 miles None None None
Oregon Medical Research Center PC - Portland, Oregon 2,543.2 miles None None None
Oregon Medical Research Center PC - Portland, Oregon 2,543.2 miles None None None
Oregon Medical Research Center PC - Portland, Oregon 2,543.2 miles None None None
Oregon Medical Research Center PC - Portland, Oregon 2,543.2 miles None None None
Oregon Medical Research Center PC - Portland, Oregon 2,543.2 miles None None None
Childrens Hospital of Orange County PSF - Orange, California 2,585.0 miles None None None
Childrens Hospital of Orange County PSF - Orange, California 2,585.0 miles None None None
Childrens Hospital of Orange County PSF - Orange, California 2,585.0 miles None None None
Childrens Hospital of Orange County PSF - Orange, California 2,585.0 miles None None None
Childrens Hospital of Orange County PSF - Orange, California 2,585.0 miles None None None
Childrens Hospital of Orange County PSF - Orange, California 2,585.0 miles None None None
Allergy and Asthma Care Center Long Beach - Long Beach, California 2,595.4 miles None None None
Allergy and Asthma Care Center Long Beach - Long Beach, California 2,595.4 miles None None None
Allergy and Asthma Care Center Long Beach - Long Beach, California 2,595.4 miles None None None
Allergy and Asthma Care Center Long Beach - Long Beach, California 2,595.4 miles None None None
Allergy and Asthma Care Center Long Beach - Long Beach, California 2,595.4 miles None None None
Allergy and Asthma Care Center Long Beach - Long Beach, California 2,595.4 miles None None None
Bakersfield Dermatology and Skin Cancer Medical Group - Bakersfield, California 2,597.8 miles None None None
Bakersfield Dermatology and Skin Cancer Medical Group - Bakersfield, California 2,597.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Peninsula Research Associates Inc - Rolling Hills Estates, California 2,610.8 miles None None None
Redwood Family Dermatology - Santa Rosa, California 2,695.0 miles None None None
Redwood Family Dermatology - Santa Rosa, California 2,695.0 miles None None None

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