A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).

Key facts

Study ID

NCT02925117

Run by

AbbVie

People needed

167

Starts

2016-10-25

Expected to finish

2019-01-31

Last updated by the study team

2020-07-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.
• Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index (EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment (IGA) score ≥ 3 at the Baseline visit.
• Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
• Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline.

You may not qualify if…

• Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).
• Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.
• Prior exposure to dupilumab or exposure to systemic therapies for AD including corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.
• Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study.

Where it is running

• ForCare Clinical Research /ID# 157974 — Tampa, Florida, United States
• Advanced Medical Research /ID# 154516 — Sandy Springs, Georgia, United States
• DermAssociates /ID# 153584 — Rockville, Maryland, United States
• Tufts Medical Center /ID# 153586 — Boston, Massachusetts, United States
• Psoriasis Treatment Ctr NJ /ID# 153578 — East Windsor, New Jersey, United States
• Icahn School of Med Mt. Sinai /ID# 153582 — New York, New York, United States
• Univ Rochester Med Ctr /ID# 154477 — Rochester, New York, United States
• Arlington Research Center, Inc /ID# 154522 — Arlington, Texas, United States
• Modern Research Associates, PL /ID# 154487 — Dallas, Texas, United States
• Center for Clinical Studies /ID# 153589 — Houston, Texas, United States
• Woden Dermatology /ID# 157907 — Phillip, Australian Capital Territory, Australia
• St George Hospital /ID# 157908 — Kogarah, New South Wales, Australia
• Specialist Connect Pty Ltd /ID# 157909 — Woolloongabba, Queensland, Australia
• Skin Health Institute Inc /ID# 157906 — Carlton, Victoria, Australia
• Institute for Skin Advancement /ID# 153246 — Calgary, Alberta, Canada
• Dr. Chih-ho Hong Medical Inc. /ID# 153241 — Surrey, British Columbia, Canada
• Enverus Medical Research /ID# 153239 — Surrey, British Columbia, Canada
• CCA Medical Research /ID# 155817 — Ajax, Ontario, Canada
• Lynderm Research Inc. /ID# 153242 — Markham, Ontario, Canada
• Dermatology Ottawa Research Centre /ID# 153248 — Ottawa, Ontario, Canada
• K. Papp Clinical Research /ID# 153244 — Waterloo, Ontario, Canada
• Mehiläinen Neo /ID# 154960 — Turku, Southwest Finland, Finland
• Mikkeli Central Hospital /ID# 154959 — Mikkeli, Finland
• TFS Trial Form Support GmbH /ID# 155442 — Hamburg, Germany
• Fukuoka University Hospital /ID# 152714 — Fukuoka, Fukuoka, Japan

Full record on ClinicalTrials.gov

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