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 |
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.
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
sites
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