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

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ClinicalTrials.gov Identifier: NCT03392168
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Arcutis, Inc.

Brief Summary:
This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo 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).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: ARQ-151 cream 0.5% Drug: ARQ-151 cream 0.15% Drug: ARQ-151 cream placebo Phase 1 Phase 2

Detailed Description:
There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (≥18 years old) males or females with chronic plaque psoriasis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Cohort 1 is open label. Cohort 2 is double blind.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : April 26, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Cohort 1 - PK and Safety
Open Label ARQ-151 cream 0.5%
Drug: ARQ-151 cream 0.5%
0.5% active concentration

Active Comparator: Cohort 2 - ARQ-151 cream 0.5%
Blinded
Drug: ARQ-151 cream 0.5%
0.5% active concentration

Active Comparator: Cohort 2 - ARQ-151 cream 0.15%
Blinded
Drug: ARQ-151 cream 0.15%
0.15% active concentration

Placebo Comparator: Cohort 2 - ARQ-151 cream placebo
Blinded
Drug: ARQ-151 cream placebo
Cream vehicle




Primary Outcome Measures :
  1. 4 Week TPSS x TPA [ Time Frame: 4 weeks ]
    Difference in mean percent change from baseline at week 4 in the product of: [Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA)] (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.


Secondary Outcome Measures :
  1. 1, 2, 3 Week TPSS x TPA [ Time Frame: 1, 2, and 3 weeks ]
    Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.

  2. TPSS [ Time Frame: 1, 2, 3, and 4 weeks ]
    Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.

  3. TPA [ Time Frame: 1, 2, 3, and 4 weeks ]
    Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female subjects aged ≥18 years
  • In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).
  • In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 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.
  • Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.
  • Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392168


Locations
United States, California
Mosaic Dermatology
Santa Monica, California, United States, 90403
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
Canada, Ontario
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
Research by ICLS
Oakville, Ontario, Canada, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research Inc.
Windsor, Ontario, Canada, N8W 1E6
Sponsors and Collaborators
Arcutis, Inc.
Investigators
Study Director: Howard Welgus, M.D. Arcutis, Inc.

Responsible Party: Arcutis, Inc.
ClinicalTrials.gov Identifier: NCT03392168     History of Changes
Other Study ID Numbers: ARQ-151-101
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

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

Keywords provided by Arcutis, Inc.:
Psoriasis
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases