Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/28/2018 |
Start Date: | December 11, 2017 |
End Date: | May 2, 2018 |
A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis
This study is designed to assess the safety and pharmacokinetics (PK) of a single dose
application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will
also assess the safety, PK and efficacy of different doses and multiple applications of
ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28
days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis
(Cohort 2).
application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will
also assess the safety, PK and efficacy of different doses and multiple applications of
ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28
days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis
(Cohort 2).
There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream
applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a
parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151
cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5%
to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects
will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (≥18 years
old) males or females with chronic plaque psoriasis.
applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a
parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151
cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5%
to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects
will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (≥18 years
old) males or females with chronic plaque psoriasis.
Inclusion Criteria:
- Adult male and female subjects aged ≥18 years
- In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding
the face, scalp, intertriginous areas, palms and soles).
- In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis
and at least one target plaque, of at least 9 cm2 in size with a TPSS ≥4 (excluding
the face, scalp, intertriginous areas, palms and soles).
- Women of childbearing potential must have a negative urine pregnancy test at Screening
and agree to use birth control throughout the trial.
- In good health as judged by the Investigator, based on medical history, physical
examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values,
and urinalysis.
- Subjects agree not to have prolonged sun exposure during the course of the study.
Tanning bed use is not allowed.
- Subjects are competent to sign and give informed consent and considered reliable and
capable of adhering to the Protocol and visit schedule.
Exclusion Criteria:
- Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or
palmo-plantar psoriasis) or with drug-induced psoriasis
- Evidence of skin conditions other than psoriasis that would interfere with evaluation
of the effect of the study medication.
- Pregnant or lactating women or women planning to become pregnant during the study and
/ or within 28 days following the last dose of study medication
- Known allergies to excipients in ARQ-151 cream
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or
inhibitors for two weeks prior to the baseline visit and during the study period.
- Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and
during the study.
- Subjects who cannot discontinue systemic therapies and/or topical therapies for the
treatment of psoriasis.
- Subjects with a history of chronic alcohol or drug abuse in past 6 months.
- History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock
or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.
- Current or a history of cancer within 5 years with the exception of fully excised skin
basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the
cervix.
- Subjects with active infection that requires oral or intravenous administration of
antibiotics, antifungal or antiviral agents.
- Subjects who are unable to communicate, read or understand language, or who display
another condition which makes them unsuitable for clinical study participation.
We found this trial at
2
sites
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