Summary

for people ages 12-75 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Keywords

Atopic DermatitisUpadacitinibDermatitisDermatitis, AtopicEczemaTopical corticosteroids (TCS)

Eligibility

You can join if…

Open to people ages 12-75

  • 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
  • Able to tolerate topical corticosteroids for atopic dermatitis lesions

You CAN'T join if...

  • 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

Locations

  • University of California Irvine /ID# 200902accepting new patients
    IrvineCalifornia92697-1385United States
  • Mosaic Dermatology /ID# 200553accepting new patients
    Santa MonicaCalifornia90404United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03568318
Phase
Phase 3
Study Type
Interventional
Last Updated