drugset / Trial / NCT03738423

Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT03738423

Phase 2 Terminated 129 enrolled Regeneron Pharmaceuticals Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: * Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD * Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD * Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD

Timeline

Start
2018-11-13
Primary completion
2020-03-13
Completion
2020-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Itepekimab Monoclonal antibody Subcutaneous

Indications