Status:
COMPLETED
Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ef...
Detailed Description
There were 2 cohorts of participants. Cohort 1 was a single dose study of ARQ-151 0.5% cream applied to 25 cm\^2 of psoriatic plaque(s) in 8 psoriasis participants. Cohort 2 was a parallel group, doub...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03392168
Start Date
December 11 2017
End Date
May 2 2018
Last Update
August 4 2022
Active Locations (8)
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1
Mosaic Dermatology
Santa Monica, California, United States, 90403
2
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
3
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
4
Research by ICLS
Oakville, Ontario, Canada, L6J 7W5