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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 76 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4. - Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Upadacitinib 30 mg QD 		Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
  • Biological: Upadacitinib
    Extended release tablet
    Other names:
    • ABT-494
    • RINVOQ®
  • Drug: Placebo to dupilumab
    Placebo administered as a subcutaneous injection
Experimental
Dupilumab 300 mg EOW 		Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.
  • Biological: Dupilumab
    Dupilumab is administered as a subcutaneous (SC) injection
    Other names:
    • Dupixent®
  • Drug: Placebo to upadacitinib
    Tablet

More Details

Status
Completed
Sponsor
AbbVie

Study Contact

Detailed Description

The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks. Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.