Summary

for people ages 12-75 (full criteria)
at UC Irvine
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 Dermatitis Upadacitinib Dermatitis, Atopic Dermatitis Eczema Topical corticosteroids (TCS)

Eligibility

You can join if…

Open to people ages 12-75

  • Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years of age
  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline Visit
  • 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
  • Documented history of inadequate response to topical corticosteroids or topical calcineurin inhibitor OR documented systemic treatment for AD within 6 months prior to Baseline Visit

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# 200902 accepting new patients
    Irvine California 92697-1385 United States
  • Mosaic Dermatology /ID# 200553 accepting new patients
    Santa Monica California 90404 United States
  • Therapeutics Clinical Research /ID# 200593 accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved.
ID
NCT03568318
Phase
Phase 3
Study Type
Interventional
Last Updated