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Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

NCT03054428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2019-07-23

Study results available
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Summary

The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.

Conditions

  • Moderate-to-Severe Atopic Dermatitis
  • Dermatitis, Dermatitis Atopic
  • Eczema, Skin Diseases, Skin
  • Diseases Genetic, Genetic
  • Diseases Inborn, Skin
  • Disease, Eczematous Skin
  • Hypersensitivity, Immediate
  • Hypersensitivity, Immune System Diseases
  • Dermatitis, Atopic

Interventions

DRUG

Dupilumab

Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.

DRUG

Placebo

Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2018-04-04
Completion
2018-06-05
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT03054428 on ClinicalTrials.gov