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ClinicalTrial.gov Identifier : NCT03738397

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

    Status Recruiting
    Related Conditions
    Atopic Dermatitis

Enrollment Details

650 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M16-046

Brief summary

Top

This is a phase 3, randomized, multi-center study that will evaluate upadacitinib versus dupilumab in adults (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The study is comprised of a 35-day screening period, a 24-week blinded treatment period, and a 12-week follow-up period.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 75 Years

Canada: 13

0
Calgary, AB
1
Calgary, AB
2
Surrey, BC
3
Surrey, BC
4
Vancouver, BC
5
Ajax, ON
6
London, ON
7
Markham, ON
8
Mississauga, ON
9
Toronto, ON
10
Waterloo, ON
11
Quebec, QC
12
St-Jerome, QC
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Study Design

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.
    • Participant is a candidate for systemic therapy or has recently required systemic therapy for AD.
    • Participant has prior exposure to Janus Kinase (JAK) inhibitor.
    • Participant has prior exposure to dupilumab.
    • Participant is unable or unwilling to discontinue current AD treatments prior to the study.
    • Participant has requirement of prohibited medications during the study.
    • Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
    • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

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