A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02407756
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age). The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).

Key Dates

Start date
Mar 31, 2015
Status verified
Nov 2020
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
78 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cohort 1 will receive dupilumab dosing regimen 1
  • Experimental: Cohort 2
    Cohort 2 will receive dupilumab dosing regimen 2

Primary Outcome Measure

Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration [ Time Frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50 ]

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