Trial Search Results

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AbbVie

Intervention(s):

  • Drug: Upadacitinib
  • Drug: Placebo for Upadacitinib
  • Drug: Topical corticosteroids (TCS)

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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

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

Ages Eligible for Study

12 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting