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

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

6 Months - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Weight-tiered dosing administered subcutaneous (SC)

Study Details

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

Key Dates

Start date

Oct 15, 2015

Status verified

May 2026

Primary completion

Oct 7, 2026

Completion

Oct 7, 2026

Study Design

Enrollment

880 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Body weight ≥60 kg
  Administered every two weeks (Q2W)
• Experimental: Body weight 30 kg to <60 kg
  Administered Q2W
• Experimental: Body weight 15 kg to <30 kg
  Administered every 4 weeks (Q4W)
• Experimental: Body weight 5 kg to <15 kg
  Administered Q4W

Primary Outcome Measure

Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit [ Time Frame: Baseline up to week 272 ]

Locations (40)

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