Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 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), Investigator's Global Assessment (IGA), Body Surface Area (BSA) and pruritus.
  • 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
Participants administered with upadacitinib
Participants are administered with upadacitinib from baseline to week 24 and placebo pre-filled syringe at baseline visit (2 injections) followed by an injection every other week until week 22
  • Drug: Upadacitinib (ABT-494)
    Upadacitinib is administered orally
    Other names:
    • ABT-494
  • Drug: Placebo
    Placebo pre-filled syringe is as administered subcutaneous (SC) injections
Experimental
Participants administered with dupilumab
Participants are administered with dupilumab (2 injections) at baseline followed by one every other week until week 22 and placebo tablets daily from baseline to week 24
  • Drug: Dupilumab
    Dupilumab is administered as a subcutaneous (SC) injection
  • Drug: Placebo
    Placebo tablets are administered orally

Recruiting Locations

Montefiore Medical Center - Moses Campus /ID# 209647
Bronx, New York 10467-2401

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

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.