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Study to Assess the Long-term...

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: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-15

Study Completion Date

2026-10-07

Brief Summary

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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

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Body weight ≥60 kg

Administered every two weeks (Q2W)

Group Type EXPERIMENTAL