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

NCT03736967 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2021-11-01

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2020-03-13
Completion
2020-07-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Germany
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03736967 on ClinicalTrials.gov