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A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

NCT03738397 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2024-03-15

Study results available
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Summary

This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Conditions

Interventions

BIOLOGICAL

Upadacitinib

Extended release tablet

BIOLOGICAL

Dupilumab

Dupilumab is administered as a subcutaneous (SC) injection

DRUG

Placebo to dupilumab

Placebo administered as a subcutaneous injection

DRUG

Placebo to upadacitinib

Tablet

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2020-08-27
Completion
2020-12-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Croatia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Singapore
  • Spain
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

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 NCT03738397 on ClinicalTrials.gov