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

NCT03738423 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-06-10

Study results available
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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

Interventions

DRUG

REGN3500

Administered subcutaneous (SC)

DRUG

REGN3500-Matching Placebo

Administered subcutaneous (SC)

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
2018-11-13
Primary Completion
2020-03-13
Completion
2020-07-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Japan
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT03738423 on ClinicalTrials.gov