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
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Markham | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Peterborough | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Windsor | Canada | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Kozni ambulance Kutna Hora, s.r.o. Coordinator of this site? Confirm its status | Kutná Hora | Czechia | Completed |
| Krajska zdravotni a.s. Coordinator of this site? Confirm its status | Usti Nad Labem | Czechia | Completed |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Completed |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Kaposvár | Hungary | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Miskolc | Hungary | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Szolnok | Hungary | Unknown status |
| NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Pro Familia Altera Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Provita Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Dermedic Jacek Zdybski Coordinator of this site? Confirm its status | Ostrowiec Świętokrzyski | Poland | Completed |
| Clinical Research Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| High-Med Przychodnia Specjalistyczna Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Centennial | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Forest Hills | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Gahanna | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Regeneron Investigational site Coordinator of this site? Confirm its status | Mission Viejo | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Plainfield | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Plymouth | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Rolling Hills Estates | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Sandy Springs | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Regeneron Investigational Site Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.