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NCT02612454CompletedPhase 3

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

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
880 (actual)
First submitted
11 Nov 2015
Start date
15 Oct 2015
Primary completion date
9 Oct 2026
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT02612454
EU CT number
2023-509425-53-00
EudraCT number
2015-001396-40

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 880
  • From 15 Oct 2015 to the primary completion date, 9 Oct 2026
  • 72 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient
  • Participants, who during the participation in a prior Dupilumab study, developed an AE 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 that continued treatment with study drug may present an unreasonable risk for the patient
  • Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
  • Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
  • Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
  • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study
  • Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study
  • Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol.
    • Note: Other protocol defined Inclusion / Exclusion criteria may apply

Other illness

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

Other

  • PFP Sub-study Only:
  • Switched dupilumab doses within the past 12 weeks

Who the study is looking for

  • Participated in a prior dupilumab study in pediatric participants with AD and adequately completed the visits and assessments required for both the treatment and follow-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-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol

Age in the registry: 6 months to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (72)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Regeneron Investigational Site
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CalgaryCanadaUnknown status
Regeneron Investigational Site
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MarkhamCanadaUnknown status
Regeneron Investigational Site
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MontrealCanadaUnknown status
Regeneron Investigational Site
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OttawaCanadaUnknown status
Regeneron Investigational Site
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PeterboroughCanadaUnknown status
Regeneron Investigational Site
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SurreyCanadaUnknown status
Regeneron Investigational Site
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WaterlooCanadaUnknown status
Regeneron Investigational Site
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WindsorCanadaUnknown status
Regeneron Investigational Site
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WinnipegCanadaUnknown status
Kozni ambulance Kutna Hora, s.r.o.
Coordinator of this site? Confirm its status
Kutná HoraCzechiaCompleted
Krajska zdravotni a.s.
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Usti Nad LabemCzechiaCompleted
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyCompleted
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyCompleted
Universitaetsklinikum Muenster AöR
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MuensterGermanyCompleted
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyCompleted
Regeneron Investigational Site
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LondonUnited KingdomUnknown status
Regeneron Investigational Site
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ManchesterUnited KingdomUnknown status
Regeneron Investigational Site
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SheffieldUnited KingdomUnknown status
Regeneron Investigational Site
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KaposvárHungaryUnknown status
Regeneron Investigational Site
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MiskolcHungaryUnknown status
Regeneron Investigational Site
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SzegedHungaryUnknown status
Regeneron Investigational Site
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SzolnokHungaryUnknown status
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
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BialystokPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandCompleted
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
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CracowPolandCompleted
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandCompleted
Pro Familia Altera Sp. z o.o.
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KatowicePolandCompleted
Provita Sp z o o
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KatowicePolandCompleted
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandCompleted
Dermedic Jacek Zdybski
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Ostrowiec ŚwiętokrzyskiPolandCompleted
Clinical Research Group Sp. z o.o.
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WarsawPolandCompleted
High-Med Przychodnia Specjalistyczna
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WarszawaPolandCompleted
Regeneron Investigational Site
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BakersfieldUnited StatesUnknown status
Regeneron Investigational Site
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BellaireUnited StatesUnknown status
Regeneron Investigational Site
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BirminghamUnited StatesUnknown status
Regeneron Investigational Site
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BostonUnited StatesUnknown status
Regeneron Investigational Site
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CentennialUnited StatesUnknown status
Regeneron Investigational Site
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CharlestonUnited StatesUnknown status
Regeneron Investigational Site
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ChicagoUnited StatesUnknown status
Regeneron Investigational Site
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ColumbusUnited StatesUnknown status
Regeneron Investigational Site
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Coral GablesUnited StatesUnknown status
Regeneron Investigational Site
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Forest HillsUnited StatesUnknown status
Regeneron Investigational Site
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Fort WorthUnited StatesUnknown status
Regeneron Investigational Site
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GahannaUnited StatesUnknown status
Regeneron Investigational Site
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GilbertUnited StatesUnknown status
Regeneron Investigational Site
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Long BeachUnited StatesUnknown status
Regeneron Investigational Site
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Los AngelesUnited StatesUnknown status
Regeneron Investigational Site
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MaconUnited StatesUnknown status
Regeneron Investigational site
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Mission ViejoUnited StatesUnknown status
Regeneron Investigational Site
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New YorkUnited StatesUnknown status
Regeneron Investigational Site
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NorfolkUnited StatesUnknown status
Regeneron Investigational Site
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North CharlestonUnited StatesUnknown status
Regeneron Investigational Site
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OrangeUnited StatesUnknown status
Regeneron Investigational Site
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Palo AltoUnited StatesUnknown status
Regeneron Investigational Site
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PhiladelphiaUnited StatesUnknown status
Regeneron Investigational Site
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PlainfieldUnited StatesUnknown status
Regeneron Investigational Site
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PlymouthUnited StatesUnknown status
Regeneron Investigational Site
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PortlandUnited StatesUnknown status
Regeneron Investigational Site
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RochesterUnited StatesUnknown status
Regeneron Investigational Site
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RockvilleUnited StatesUnknown status
Regeneron Investigational Site
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Rolling Hills EstatesUnited StatesUnknown status
Regeneron Investigational Site
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San AntonioUnited StatesUnknown status
Regeneron Investigational Site
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San DiegoUnited StatesUnknown status
Regeneron Investigational Site
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Sandy SpringsUnited StatesUnknown status
Regeneron Investigational Site
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SeattleUnited StatesUnknown status
Regeneron Investigational Site
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SkokieUnited StatesUnknown status
Regeneron Investigational Site
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St LouisUnited StatesUnknown status
Regeneron Investigational Site
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TampaUnited StatesUnknown status
Regeneron Investigational Site
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Washington D.C.United StatesUnknown status
Regeneron Investigational Site
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.