The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:September 21, 2018
End Date:October 2019

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A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3%
or ARQ-151 cream 0.15% or vehicle cream is applied once daily for 84 days to subjects with
chronic plaque psoriasis involving between 2 and 20% body surface area.


Inclusion Criteria:

- Participants legally competent to sign and give informed consent

- Males and females ages 18 years and older (inclusive)

- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined
by the Investigator

- Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at
Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
agree to use at least one form of highly effective contraception throughout the trial.

- In good health as judged by the Investigator, based on medical history, physical
examination, serum chemistry labs, hematology values, and urinalysis.

- Subjects are considered reliable and capable of adhering to the Protocol and visit
schedule, according to the judgment of the Investigator.

Exclusion Criteria:

- Planned excessive exposure of treated area(s) to either natural or artificial sunlight
or tanning bed.

- Females who are pregnant, wishing to become pregnant during the study, or are
breast-feeding.

- Previous treatment with ARQ-151 or its active ingredient

- Subjects with any serious medical condition or laboratory abnormality that would
prevent study participation or place the subject at significant risk, as determined by
the Investigator.

- Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation
of study medication.

- Subjects who are unable to communicate, read or understand the local language, or who
display another condition, which in the Investigator's opinion, makes them unsuitable
for clinical study participation.
We found this trial at
20
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Beverly Hills, California 90212
1176
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Beverly Hills, CA
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Bexley, Ohio 43209
814
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Clinton Township, Michigan 48038
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Clinton Township, MI
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College Station, Texas 77845
499
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College Station, TX
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Detroit, Michigan 48202
841
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Detroit, MI
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Fridley, Minnesota 55432
558
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Fridley, MN
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High Point, North Carolina 27262
853
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High Point, NC
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Houston, Texas 77004
569
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Houston, TX
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Louisville, Kentucky 40217
657
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Louisville, KY
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Miami, Florida 33144
1321
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Miami, FL
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New York, New York 10029
1225
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New York, NY
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Norfolk, Virginia 23502
1182
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Northridge, California 91324
1180
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Northridge, CA
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Pittsburgh, Pennsylvania 15213
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San Antonio, Texas 78213
576
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San Diego, California 92123
1142
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Sanford, Florida 32771
1136
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Santa Monica, California 90403
1182
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Santa Monica, CA
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Surrey, British Columbia
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Webster, Texas 77598
588
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Webster, TX
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