drugset / Trial / NCT03736967

Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT03736967

Phase 2 Terminated 206 enrolled Regeneron Pharmaceuticals Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD). Secondary Objectives are to: * Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD * Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD * Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD

Timeline

Start
2018-11-12
Primary completion
2020-03-13
Completion
2020-07-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody Subcutaneous
Subject Itepekimab Monoclonal antibody Subcutaneous

Indications