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

NCT03392168 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ARQ-151-101
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 8

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).

Conditions

Psoriasis

Keywords

Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2

  Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

  Baseline and Week 4

Secondary Outcomes (3)

• Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2

  Baseline and Weeks 1, 2 and 3

• Percent Change From Baseline in Total Plaque Severity Score in Cohort 2

  Baseline and Weeks 1, 2, 3, and 4

• Percent Change From Baseline in Target Plaque Area in Cohort 2

  Baseline and Weeks 1, 2, 3, and 4

Study Arms (4)

Cohort 1 - ARQ-151 cream 0.5%

EXPERIMENTAL

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

Drug: ARQ-151 cream 0.5%

Cohort 2 - ARQ-151 cream 0.5%

EXPERIMENTAL

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

Drug: ARQ-151 cream 0.5%

Cohort 2 - ARQ-151 cream 0.15%

EXPERIMENTAL

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

Drug: ARQ-151 cream 0.15%

Cohort 2 - ARQ-151 vehicle cream

PLACEBO COMPARATOR

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

Drug: ARQ-151 vehicle cream

Interventions

ARQ-151 cream 0.5% DRUG

0.5% active concentration

Cohort 1 - ARQ-151 cream 0.5%; Cohort 2 - ARQ-151 cream 0.5%

ARQ-151 cream 0.15% DRUG

0.15% active concentration

Cohort 2 - ARQ-151 cream 0.15%

ARQ-151 vehicle cream DRUG

Vehicle cream

Cohort 2 - ARQ-151 vehicle cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (8)

Mosaic Dermatology

Santa Monica, California, 90403, United States

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

Research by ICLS

Oakville, Ontario, L6J 7W5, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6, Canada

Location

Related Publications (2)

• 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.

  PMID: 36422852 DERIVED

• 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.

  PMID: 32845114 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Inquiry
• Organization: Arcutis

studyinquiry@arcutis.com

650-847-4115

Study Officials

• David Berk, M.D.

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cohort 1 was open label. Cohort 2 was double blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 5, 2018
• Study Start: December 11, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: August 4, 2022
• Results First Posted: July 8, 2021

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7); US (1)