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
Unknown
Trial ID
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 | |
---|---|---|---|---|
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 |