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

NCT ID: NCT03392168

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-11
• Study Completion Date: 2018-05-02

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 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).

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, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream was applied once a day for 28 days to participants with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Participants were adult (≥18 years old) males or females with chronic plaque psoriasis.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 - ARQ-151 cream 0.5%

Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s)

Group Type: EXPERIMENTAL

ARQ-151 cream 0.5%

Intervention Type: DRUG

0.5% active concentration

Cohort 2 - ARQ-151 cream 0.5%

ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA

Group Type: EXPERIMENTAL

ARQ-151 cream 0.5%

Intervention Type: DRUG

0.5% active concentration

Cohort 2 - ARQ-151 cream 0.15%

ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA

Group Type: EXPERIMENTAL

ARQ-151 cream 0.15%

Intervention Type: DRUG

0.15% active concentration

Cohort 2 - ARQ-151 vehicle cream

Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA

Group Type: PLACEBO_COMPARATOR

ARQ-151 vehicle cream

Intervention Type: DRUG

Vehicle cream

Interventions

ARQ-151 cream 0.5%

0.5% active concentration

Intervention Type: DRUG

ARQ-151 cream 0.15%

0.15% active concentration

Intervention Type: DRUG

ARQ-151 vehicle cream

Vehicle cream

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Berk, M.D.

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics, Inc.

Locations

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

Countries

United States; Canada

References

Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.

Reference Type: DERIVED

PMID: 36422852 (View on PubMed)

Papp KA, Gooderham M, Droege M, Merritt C, Osborne DW, Berk DR, Thurston AW, Smith VH, Welgus H. Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study. J Drugs Dermatol. 2020 Aug 1;19(8):734-740. doi: 10.36849/JDD.2020.5370.

Reference Type: DERIVED

PMID: 32845114 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-151-101

Identifier Type: -

Identifier Source: org_study_id