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



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:2/17/2019
Start Date:October 25, 2016
End Date:January 31, 2019

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A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects With Moderate to Severe Atopic Dermatitis

This is an 88-week Phase 2b, randomized, double-blind, parallel-group, placebo-controlled
multicenter study to evaluate the safety and efficacy of ABT-494 (upadacitinib) in adult
subjects with moderate to severe atopic dermatitis. In Period 1, subjects will be randomized
in a 1:1:1:1 ratio to one of four treatment groups.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- Prior exposure to any systemic or topical 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.

- 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.
We found this trial at
12
sites
Boston, Massachusetts 02111
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Arlington, TX
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Atlanta, GA
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Dallas, TX
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East Windsor, New Jersey 08520
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East Windsor, NJ
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Houston, TX
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New York, NY
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Pittsburgh, Pennsylvania 15260
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Pittsburgh, PA
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601 Elmwood Avenue
Rochester, New York 14642
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Rochester, NY
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Rockville, Maryland 20850
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Rockville, MD
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15 Santa Rosa Street
San Luis Obispo, California 93405
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San Luis Obispo, CA
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4915 Ehrlich Road
Tampa, Florida 33624
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Tampa, FL
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