Purpose

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy.

Condition

Eligibility

Eligible Ages
Between 12 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Active moderate to severe atopic dermatitis defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
  • Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis.

Exclusion Criteria

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
  • Requirement of prohibited medications during the study
  • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
  • Female subject 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
Arm A
Upadacitinib Dose A is administered once daily.
  • Drug: Upadacitinib
    It is administered orally.
    Other names:
    • ABT-494
Experimental
Arm B
Upadacitinib Dose B is administered once daily.
  • Drug: Upadacitinib
    It is administered orally.
    Other names:
    • ABT-494
Experimental
Arm C
Placebo administered once daily followed by Upadacitinib Dose A once daily.
  • Drug: Upadacitinib
    It is administered orally.
    Other names:
    • ABT-494
  • Drug: Placebo for Upadacitinib
    It is administered orally.
Experimental
Arm D
Placebo administered once daily followed by Upadacitinib Dose B once daily.
  • Drug: Upadacitinib
    It is administered orally.
    Other names:
    • ABT-494
  • Drug: Placebo for Upadacitinib
    It is administered orally.

Recruiting Locations

Montefiore Medical Center /ID# 200456
Bronx, New York 10461

More Details

NCT ID
NCT03569293
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.