Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Last updated: June 24, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Eczema (Atopic Dermatitis)

Allergy

Atopic Dermatitis

Treatment

Dupilumab

Clinical Study ID

NCT02612454
R668-AD-1434
2015-001396-40
  • Ages 6-17
  • All Genders

Study Summary

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.

The secondary objectives of the study are:

  • To assess the long-term efficacy of dupilumab in pediatric participants with AD

  • To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab

Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to <12 years of age with AD

Co-Primary Objectives are:

  • To evaluate the pharmacokinetic (PK) of dupilumab PFPs

  • To evaluate the safety of dupilumab PFPs

Secondary Objective is:

  • To evaluate the immunogenicity of dupilumab PFPs

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participated in a prior dupilumab study in pediatric participants with AD andadequately completed the visits and assessments required for both the treatment andfollow-up periods, as defined in the prior study protocol

  • PFP Sub-Study Only:

  • Age ≥2 to <12 years at time of screening

  • Body weight ≥5 kg and <60 kg at time of screening

  • Must have received the same dupilumab dose regimen to be used in the PFP sub-studyduring the previous 12 weeks in the main OLE study using the prefilled syringe, asdefined in the protocol

Exclusion

Key Exclusion Criteria:

  • Participants who, during their participation in a prior dupilumab study developed anadverse event (AE) or serious adverse event (SAE) deemed related to study drug whichcould indicate that continued treatment with study drug may present an unreasonablerisk for the patient

  • Participants, who during the participation in a prior Dupilumab study, developed anAE that was deemed related to study drug and led to study treatment discontinuation,which in the opinion of the investigator or medical monitor could indicate thatcontinued treatment with study drug may present an unreasonable risk for the patient

  • Treatment with an investigational drug, other than dupilumab, within 8 weeks orwithin 5 half-lives (if known), whichever is longer, before the baseline visit

  • Having used immunosuppressive/immunomodulating drugs within 4 weeks before thebaseline visit

  • Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit

  • Diagnosed active endoparasitic infections or at high risk of these infections

  • Severe concomitant illness(es) that, in the investigator's judgment, would adverselyaffect the participant's participation in the study

  • PFP Sub-study Only:

  • Poor compliance as defined by having missed 1 or more of the planned last 3injections in the main OLE study prior to entering the sub-study

  • Switched dupilumab doses within the past 12 weeks

  • Meet criteria for temporary/permanent discontinuation of study drug at time ofscreening into PFP sub-study, as defined in the protocol.

Note: Other protocol defined Inclusion / Exclusion criteria may apply

Study Design

Total Participants: 880
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase: 3
Study Start date:
October 15, 2015
Estimated Completion Date:
October 07, 2026

Connect with a study center

  • Regeneron Investigational Site

    Calgary, Alberta T2G 1B1
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Ottawa, Ontario K2C 2N3
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Regeneron Investigational Site

    Kutna Hora, 28401
    Czechia

    Site Not Available

  • Regeneron Investigational Site

    Prague, 10034
    Czechia

    Site Not Available

  • Regeneron Investigational Site

    Ústí Nad Labem, 40113
    Czechia

    Site Not Available

  • Regeneron Study Site

    Tuebingen, Baden-Wuerttemberg 72076
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Muenster, North Rhine-Westphal 48149
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Gera, 07548
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Hamburg, 22149
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Kiel,
    Germany

    Site Not Available

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    Luebeck,
    Germany

    Site Not Available

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    Lübeck,
    Germany

    Site Not Available

  • Regeneron Study Site

    Muenchen, 80802
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Munich, 80337
    Germany

    Site Not Available

  • Regeneron Investigational Site

    Szolnok, Jasz-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • Regeneron Investigational Site

    Kaposvar, 7400
    Hungary

    Site Not Available

  • Regeneron Investigational Site

    Miskolc, 3526
    Hungary

    Site Not Available

  • Regeneron Investigational Site

    Szeged, 6720
    Hungary

    Site Not Available

  • Regeneron Investigational Site

    Wroclaw, Dolnoslaskie 50368
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Wrocław, Dolnoslaskie 50-381
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Ostrowiec Świętokrzyski, Kielce 27-400
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Krakow, Malopolska 31-011
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Bialystok, 15-453
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Białystok, 15 453
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Chorzow, 41-500
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Gdańsk, 80-152
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Katowice, 40 611
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Kraków, 30 363
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Lodz, 90-265
    Poland

    Site Not Available

  • Regeneron Investigational Site

    Warszawa, 91-142
    Poland

    Site Not Available

  • Regeneron Investigational Site

    London, Greater London SE1 7EH
    United Kingdom

    Site Not Available

  • Regeneron Investigational Site

    Manchester, Lancashire M13 9WL
    United Kingdom

    Site Not Available

  • Regeneron Investigational Site

    Sheffield, South Yorkshire S10 2TH
    United Kingdom

    Site Not Available

  • Regeneron Investigational Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Regeneron Investigational Site

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Regeneron Investigational Site

    Fort Smith, Arkansas 72916-6103
    United States

    Site Not Available

  • Regeneron Investigational Site

    Bakersfield, California 93309
    United States

    Site Not Available

  • Regeneron Investigational Site

    Long Beach, California 90808
    United States

    Site Not Available

  • Regeneron Investigational Site

    Los Angeles, California 90027
    United States

    Site Not Available

  • Regeneron Investigational site

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Regeneron Investigational Site

    Orange, California 92868
    United States

    Site Not Available

  • Regeneron Investigational Site

    Palo Alto, California 92304
    United States

    Site Not Available

  • Regeneron Investigational Site

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Regeneron Investigational Site

    San Diego, California 92123
    United States

    Site Not Available

  • Regeneron Investigational Site

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Regeneron Investigational Site

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Regeneron Investigational Site

    Denver, Colorado 80220
    United States

    Site Not Available

  • Regeneron Investigational Site

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Regeneron Investigational Site

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Regeneron Investigational Site

    Tampa, Florida 33624
    United States

    Site Not Available

  • Regeneron Investigational Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Regeneron Investigational Site

    Macon, Georgia 31217
    United States

    Site Not Available

  • Regeneron Investigational Site

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Regeneron Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Regeneron Investigational Site

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Regeneron Investigational Site

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Regeneron Investigational Site

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Regeneron Investigational site

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Regeneron Investigational Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Regeneron Investigational Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Regeneron Investigational Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Regeneron Investigational Site

    Plymouth, Minnesota 55441
    United States

    Site Not Available

  • Regeneron Investigational Site

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Regeneron Investigational Site

    Corning, New York 14830
    United States

    Site Not Available

  • Regeneron Investigational Site

    Forest Hills, New York 11375
    United States

    Site Not Available

  • Regeneron Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • Regeneron Investigational Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Regeneron Investigational Site

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • Regeneron Investigational Site

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • Regeneron Investigational Site

    Tulsa, Oklahoma 74136-7028
    United States

    Site Not Available

  • Regeneron Investigational Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Regeneron Investigational site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Regeneron Investigational Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Regeneron Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Regeneron Investigational Site

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Regeneron Investigational Site

    Bellaire, Texas 77401-3505
    United States

    Site Not Available

  • Regeneron Investigational Site

    Fort Worth, Texas 76244
    United States

    Site Not Available

  • Regeneron Investigational Site

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Regeneron Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Regeneron Investigational Site

    Seattle, Washington 98105
    United States

    Site Not Available

  • Regeneron Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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