A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Recruiting

Trial ID: NCT03607422

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.

Official Title

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

Stanford Investigator(s)

Justin M Ko, MD, MBA
Justin M Ko, MD, MBA

Clinical Professor, Dermatology

Eligibility


Inclusion Criteria:

   - Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age

   - Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
   Baseline and subject meets Hanifin and Rajka criteria

   - Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16,
   validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA)
   affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating
   scale (NRS) score ≥ 4.

   - 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

Intervention(s):

drug: Upadacitinib

drug: Placebo for Upadacitinib

Recruiting

Contact Information

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