Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis

Completed · Phase 1/Phase 2

Conditions studied: Psoriasis

In brief

This study assessed the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) (Cohort 1). The study also assessed the safety, PK and efficacy of ARQ-151 cream 0.5% vs vehicle and ARQ-151 cream 0.15% vs vehicle 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).

Key facts

Study ID

NCT03392168

Run by

Arcutis Biotherapeutics, Inc.

People needed

91

Starts

2017-12-11

Expected to finish

2018-05-02

Last updated by the study team

2022-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male and female participants aged ≥18 years.
• In Cohort 1, participants must have at least 25 cm\^2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).
• In Cohort 2, participants must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm\^2 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.
• Participants agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.
• Participants are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.

You may not qualify if…

• Participants 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.
• Participants 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.
• Participants who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.
• Participants who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.
• Participants 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.
• Participants with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
• Participants who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.

Where it is running

• Mosaic Dermatology — Santa Monica, California, United States
• Dr. Chih-ho Hong Medical Inc. — Surrey, British Columbia, Canada
• Lynderm Research Inc. — Markham, Ontario, Canada
• Research by ICLS — Oakville, Ontario, Canada
• SKiN Centre for Dermatology — Peterborough, Ontario, Canada
• The Centre for Dermatology — Richmond Hill, Ontario, Canada
• K. Papp Clinical Research Inc. — Waterloo, Ontario, Canada
• XLR8 Medical Research Inc. — Windsor, Ontario, Canada

Full record on ClinicalTrials.gov

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