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

August 2, 2022 updated by: Arcutis Biotherapeutics, Inc.

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 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-Ho Hong Medical Inc.
    • Ontario
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Oakville, Ontario, Canada, L6J 7W5
        • Research by ICLS
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Centre for Dermatology
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre for Dermatology
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research Inc.
      • Windsor, Ontario, Canada, N8W 1E6
        • XLR8 Medical Research Inc.
  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Mosaic Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 - ARQ-151 cream 0.5%
Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s)
Drug: ARQ-151 cream 0.5%
0.5% active concentration
Experimental: 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
Drug: ARQ-151 cream 0.5%
0.5% active concentration
Experimental: 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
Drug: ARQ-151 cream 0.15%
0.15% active concentration
Placebo Comparator: 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
Drug: ARQ-151 vehicle cream
Vehicle cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Time Frame: Baseline and Week 4
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Time Frame: Baseline and Weeks 1, 2 and 3
Difference in least squares mean percent change from baseline at Weeks 1, 2 and 3 in 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 Weeks 1, 2 and 3
Percent Change From Baseline in Total Plaque Severity Score in Cohort 2
Time Frame: Baseline and Weeks 1, 2, 3, and 4
Difference in least squares mean percent change from baseline at Weeks 1, 2, 3 and 4 in total plaque severity score (TPSS) 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 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. A negative percent change indicates improvement.
Baseline and Weeks 1, 2, 3, and 4
Percent Change From Baseline in Target Plaque Area in Cohort 2
Time Frame: Baseline and Weeks 1, 2, 3, and 4
Difference in least squares mean percent change from baseline at Weeks 1, 2, 3, and 4 in 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 TPA score as a covariate. Target plaque area (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 Weeks 1, 2, 3, and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcutis Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Berk, M.D., Arcutis Biotherapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARQ-151-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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