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Clinical Trials in the UK / NCT02612454
Active, not recruiting Phase 3

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

NCT02612454 · tracked via the Priya Life Science UK tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2015-10-15
Last updated
2026-05-29

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Dupilumab

Dupilumab: Weight-tiered dosing administered subcutaneous (SC)

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

Sex
ALL
Min age
6 Months
Max age
17 Years
Healthy volunteers
No
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * Diagnosed active endoparasitic infections or at high risk of these infections * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect 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 3 injections 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 of screening into PFP sub-study, as defined in the protocol. Note: Other protocol defined Inclusion / Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (84)

FacilityCityRegionStatus
Regeneron Investigational Site Birmingham Alabama
Regeneron Investigational Site Gilbert Arizona
Regeneron Investigational Site Bakersfield California
Regeneron Investigational Site Long Beach California
Regeneron Investigational Site Los Angeles California
Regeneron Investigational site Mission Viejo California
Regeneron Investigational Site Orange California
Regeneron Investigational Site Palo Alto California
Regeneron Investigational Site Rolling Hills Estates California
Regeneron Investigational Site San Diego California
Regeneron Investigational Site Centennial Colorado
Regeneron Investigational Site Washington D.C. District of Columbia
Regeneron Investigational Site Coral Gables Florida
Regeneron Investigational Site Tampa Florida
Regeneron Investigational Site Tampa Florida
Regeneron Investigational Site Columbus Georgia
Regeneron Investigational Site Macon Georgia
Regeneron Investigational Site Sandy Springs Georgia
Regeneron Investigational Site Chicago Illinois
Regeneron Investigational Site Skokie Illinois
Regeneron Investigational site Plainfield Indiana
Regeneron Investigational Site Rockville Maryland
Regeneron Investigational Site Boston Massachusetts
Regeneron Investigational Site Boston Massachusetts
Regeneron Investigational Site Ypsilanti Michigan
Regeneron Investigational Site Plymouth Minnesota
Regeneron Investigational Site St Louis Missouri
Regeneron Investigational Site Forest Hills New York
Regeneron Investigational Site New York New York
Regeneron Investigational Site Rochester New York
Regeneron Investigational Site Gahanna Ohio
Regeneron Investigational Site Portland Oregon
Regeneron Investigational site Philadelphia Pennsylvania
Regeneron Investigational Site Charleston South Carolina
Regeneron Investigational Site North Charleston South Carolina
Regeneron Investigational Site Bellaire Texas
Regeneron Investigational Site Fort Worth Texas
Regeneron Investigational Site San Antonio Texas
Regeneron Investigational Site Norfolk Virginia
Regeneron Investigational Site Seattle Washington

+ 44 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

More Regeneron Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02612454 on ClinicalTrials.gov ↗ ← All trials in the UK