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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-151 cream 0.5% | Drug | 0.5% active concentration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, M.D. | Arcutis Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mosaic Dermatology | Santa Monica | California | 90403 | United States | ||
| Dr. Chih-ho Hong Medical Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36422852 | Derived | 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. | |
| 32845114 | 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. |
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The study was conducted in 7 centers in Canada and 1 center in the United States (US). There was a total of 91 unique participants; 6 participants who completed Cohort 1 also participated in Cohort 2, with 2 per treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - ARQ-151 Cream 0.5% | Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Cohort 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2018 | Apr 29, 2021 |
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Cohort 1 was open label. Cohort 2 was double blind.
| ARQ-151 cream 0.15% | Drug | 0.15% active concentration |
|
| ARQ-151 vehicle cream | Drug | Vehicle cream |
|
| Baseline and Weeks 1, 2 and 3 |
| Percent Change From Baseline in Total Plaque Severity Score in Cohort 2 | 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 | 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 |
| Surrey |
| British Columbia |
| V3R 6A7 |
| Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| Research by ICLS | Oakville | Ontario | L6J 7W5 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| The Centre for Dermatology | Richmond Hill | Ontario | L4B 1A5 | Canada |
| K. Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research Inc. | Windsor | Ontario | N8W 1E6 | Canada |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2: Cohort 2 |
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Baseline characteristics for Cohort 2 arms are shown for participants who were not in Cohort 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - ARQ-151 Cream 0.5% | Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s) |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified intent-to-treat (mITT) population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Week 4 |
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| Secondary | Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2 | 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. | The mITT population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Weeks 1, 2 and 3 |
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| Secondary | Percent Change From Baseline in Total Plaque Severity Score in Cohort 2 | 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. | The mITT population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Weeks 1, 2, 3, and 4 |
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| Secondary | Percent Change From Baseline in Target Plaque Area in Cohort 2 | 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. | The mITT population included all participants who were in the safety population for Cohort 2 with at least 1 postbaseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Weeks 1, 2, 3, and 4 |
|
Up to approximately 5 months
A treatment-emergent adverse event is an event that is temporally associated with administration of study product; events meeting this definition are those with a start date during or after administration of the first dose of study drug through the telephone follow-up in each cohort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - ARQ-151 Cream 0.5% | Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s) | 0 | 8 | 0 | 8 | 1 | 8 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 9 | 30 |
| EG002 | 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 | 0 | 28 | 0 | 28 | 5 | 28 |
| EG003 | 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 | 0 | 31 | 0 | 31 | 11 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Application site pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Candiduria | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Arcutis | 650-847-4115 | 5 | studyinquiry@arcutis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2018 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Other |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate. |
| Mixed Models Analysis |
| 0.0011 |
| Least squares mean difference |
| -27.8 |
| 2-Sided |
| 95 |
| -44.2 |
| -11.5 |
| Superiority |
| OG002 | 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 |
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Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA |
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Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA |
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