NCT03736967

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	REGN3500	Administered subcutaneous (SC) every 2 weeks (q2w)
DRUG	Dupilumab	Administered SC q2w
DRUG	REGN3500 + Dupilumab Combo	Administered SC q2w
DRUG	Placebo	Administered SC q2w

Timeline

• Start date: 2018-11-12
• Primary completion: 2020-03-13
• Completion: 2020-07-28
• First posted: 2018-11-09
• Last updated: 2021-11-01
• Results posted: 2021-11-01

Locations

66 sites across 7 countries: United States, Belgium, Czechia, Germany, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study