A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:November 14, 2018
End Date:March 16, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial)

The purpose of this study is to assess ZPL389 efficacy and safety in subjects with moderate
to severe atopic dermatitis.


Inclusion Criteria:

- Subjects must give a written, signed and dated informed consent

- Chronic atopic dermatitis present for at least 1 year before Baseline

- Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.

- Documented recent history (within 6 months before the screening visit) of inadequate
response to treatment with topical medications or for whom topical treatments are
otherwise medically inadvisable

- Candidate for systemic treatment

Exclusion Criteria:

- Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis
disease activity

- Use of other investigational drugs within 5 half-lives of enrollment, or within 30
days or until the expected pharmacodynamic effect has returned to baseline, whichever
is longer.

- History of hypersensitivity to any of the study drug constituents or to drugs of
similar chemical classes.

- Participation in prior ZPL389 studies
We found this trial at
19
sites
Tampa, Florida 33613
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Birmingham, Alabama 35209
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Centennial, Colorado 80112
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Fairborn, Ohio 45324
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Fairborn, OH
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Greer, South Carolina 29651
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Greer, SC
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Houston, Texas 77030
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Houston, TX
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Louisville, Kentucky 40202
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Louisville, KY
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Norfolk, Virginia 23507
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Norfolk, VA
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Omaha, Nebraska 68144
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Omaha, NE
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Oregon City, Oregon 97045
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Oregon City, OR
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Owensboro, Kentucky 42301
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Pembroke Pines, Florida 33024
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Pflugerville, Texas 78660
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Pflugerville, TX
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Saint Louis, Missouri 63128
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Saint Louis, MO
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Diego, California 92123
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San Diego, CA
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Verona, New Jersey 07044
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Verona, NJ
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Waterloo, Ontario
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Waterloo,
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West Jordan, Utah 84088
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West Jordan, UT
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