Trial Search Results

A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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 AD who are candidates for systemic therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AbbVie

Stanford Investigator(s):

Intervention(s):

  • Drug: Upadacitinib
  • Drug: Placebo for Upadacitinib

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

   - Active moderate to severe AD 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 AD

   - Documented history (within 6 months prior to Baseline) of inadequate response to
   topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
   systemic treatment for AD or for whom topical treatments are otherwise medically
   inadvisable due to side effects or safety risks

Exclusion Criteria:

   - Prior exposure to any Janus kinase (JAK) inhibitor

   - Unable or unwilling to discontinue current 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