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Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

CompletedPhase 3

Sponsor: AbbVie

Conditions: Atopic Dermatitis

Interventions: Placebo for Upadacitinib, Upadacitinib

Countries: United States, Argentina, Australia, Bosnia and Herzegovina, Bulgaria, Canada, China, Colombia

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and \< 18 years of age
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
* Active moderate to severe AD defined by:

  * Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
  * Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
  * ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
  * Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
* Candidate for systemic therapy or have recently required systemic therapy for AD
* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
* Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor
* Unable or unwilling to discontinue current atopic dermatitis 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 (180)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Bakersfield, California, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Newport Beach, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Luis Obispo, California, United States
Stanford, California, United States
Walnut Creek, California, United States
Shelton, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Lake City, Florida, United States
Margate, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Ormond Beach, Florida, United States
Sunrise, Florida, United States
West Palm Beach, Florida, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Covington, Louisiana, United States
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