NCT03345914 - Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD) | Biotech Hunter

Enrollment

367

Participants

Timeline

Start Date

November 17, 2017

Primary Completion Date

June 20, 2019

Study Completion Date

September 10, 2019

Conditions

Dermatitis, Atopic

Interventions

DRUG

Dupilumab

"Pharmaceutical form: Solution for injection in pre-filled syringe;~Route of administration: Subcutaneous (SC)"

DRUG

Matching Placebo

"Pharmaceutical form: Solution for injection;~Route of administration: Subcutaneous (SC)"

OTHER

Background Treatment: Topical Corticosteroids

All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.

OTHER

Background Treatment: Moisturizers

All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.

Trial Locations (61)

10029

Regeneron Research Site, New York

11375

Regeneron Research Site, Forest Hills

14620

Regeneron Research Site, Rochester

19104

Regeneron Research Site, Philadelphia

20850

Regeneron Research Site, Rockville

22149

Regeneron Research Site, Hamburg

23502

Regeneron Research Site, Norfolk

29420

Regeneron Research Site, North Charleston

29425

Regeneron Research Site, Charleston

30328

Regeneron Research Site, Sandy Springs

30363

Regeneron Research Site, Krakow

31217

Regeneron Research Site, Macon

33146

Regeneron Research Site, Coral Gables

33612

Regeneron Research Site, Tampa

33624

Regeneron Research Site, Tampa

35209

Regeneron Research Site, Birmingham

40113

Regeneron Research Site, Ústí nad Labem

40123

Regeneron Research Site, Katowice

43230

Regeneron Research Site, Gahanna

48149

Regeneron Research Site, Münster

48197

Regeneron Research Site, Ypsilanti

48455

Regeneron Research Site, Bad Bentheim

49074

Regeneron Research Site, Osnabrück

50381

Regeneron Research Site, Wroclaw

55402

Regeneron Research Site, Minneapolis

60611

Regeneron Research Site, Chicago

61761

Regeneron Research Site, Normal

63104

Regeneron Research Site, St Louis

77401

Regeneron Research Site, Bellaire

78218

Regeneron Research Site, San Antonio

80206

Regeneron Research Site, Denver

80337

Regeneron Research Site, Munich

85234

Regeneron Research Site, Gilbert

90274

Regeneron Research Site, Rolling Hills Estates

90808

Regeneron Research Site, Long Beach

92123

Regeneron Research Site, San Diego

92691

Regeneron Research Site, Mission Viejo

93309

Regeneron Research Site, Bakersfield

97239

Regeneron Research Site, Portland

98105

Regeneron Research Site, Seattle

T2G 1B1

Regeneron Research Site, Calgary

L3P 1X2

Regeneron Research Site, Markham

K9J 5K2

Regeneron Research Site, Peterborough

H3T 1C5

Regeneron Research Site, Montreal

284 01

Regeneron Research Site, Kutná Hora

01307

Regeneron Research Site, Dresden

07548

Regeneron Research Site, Gera

15-453

Regeneron Research Site, Bialystok

85-065

Regeneron Research Site, Bydgoszcz

80-152

Regeneron Research Site, Gdansk

40-611

Regeneron Research Site, Katowice

40-648

Regeneron Research Site, Katowice

90-265

Regeneron Research Site, Lodz

27-400

Regeneron Research Site, Świętokrzyskie

01-142

Regeneron Research Site, Warsaw

01-817

Regeneron Research Site, Warsaw

02-758

Regeneron Research Site, Warsaw

SE1 7EH

Regeneron Research Site, London

M13 9WL

Regeneron Research Site, Manchester

NE1 4LP

Regeneron Research Site, Newcastle upon Tyne

S10 2TH

Regeneron Research Site, Sheffield