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
2133
mi
from 91732
Tampa, FL
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Birmingham, Alabama 35209
1785
mi
from 91732
Birmingham, AL
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Centennial, Colorado 80112
820
mi
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Centennial, CO
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Fairborn, Ohio 45324
1906
mi
from 91732
Fairborn, OH
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Greer, South Carolina 29651
2027
mi
from 91732
Greer, SC
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
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Norfolk, Virginia 23507
2335
mi
from 91732
Norfolk, VA
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Omaha, Nebraska 68144
1291
mi
from 91732
Omaha, NE
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Oregon City, Oregon 97045
816
mi
from 91732
Oregon City, OR
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Owensboro, Kentucky 42301
1736
mi
from 91732
Owensboro, KY
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Pembroke Pines, Florida 33024
2313
mi
from 91732
Pembroke Pines, FL
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Pflugerville, Texas 78660
1215
mi
from 91732
Pflugerville, TX
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Saint Louis, Missouri 63128
1562
mi
from 91732
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...
1187
mi
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San Antonio, TX
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San Diego, California 92123
100
mi
from 91732
San Diego, CA
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Verona, New Jersey 07044
2420
mi
from 91732
Verona, NJ
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Waterloo, Ontario
?
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Waterloo,
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West Jordan, Utah 84088
559
mi
from 91732
West Jordan, UT
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