NCT03738423

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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to- Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (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 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

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	REGN3500	Administered subcutaneous (SC)
DRUG	REGN3500-Matching Placebo	Administered subcutaneous (SC)

Timeline

• Start date: 2018-11-13
• Primary completion: 2020-03-13
• Completion: 2020-07-24
• First posted: 2018-11-13
• Last updated: 2022-06-10
• Results posted: 2022-06-10

Locations

89 sites across 11 countries: United States, Australia, Canada, Czechia, Germany, Hungary, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study