Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension.

ABSTRACT:

Background

Dupilumab (monoclonal antibody inhibiting IL-4/IL-13 signalling) is approved for use in adolescents aged ≥ 12 years with inadequately controlled moderate-to-severe atopic dermatitis (AD). Dupilumab significantly improved AD signs/symptoms in a 16-week, randomised, placebo-controlled phase III trial in adolescents (NCT03054428).

Objectives

To characterize the pharmacokinetics of dupilumab, and long-term safety and efficacy in adolescents.

Methods

This was a global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study with a phase III open-label extension (OLE) in adolescents with moderate-to-severe AD. In the phase IIa study, patients received one dupilumab dose (2 mg kg^-1 or 4 mg kg^-1 ) and 8 weeks of pharmacokin

SUBMITTER: Cork MJ 

PROVIDER: S-EPMC6972638 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature