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This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.
Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201 (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in ARQ-151-201.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term Safety of Roflumilast | Other | Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug | Roflumilast cream 0.3% for topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs [TEAEs]) in ARQ-151-202 are presented. | Up to 52 weeks |
| Number of Participants Experiencing ≥1 Serious Adverse Event (SAE) | An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity. | Weeks 12, 24, 36, and 52 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in Study ARQ-151-201.
Subjects that use any Excluded Medications and Treatments
Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular psoriasis.
Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period.
Known or suspected:
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Site 35 | Beverly Hills | California | 90212 | United States | ||
| Arcutis Clinical Site 29 |
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Participants were recruited at 30 study sites in the United States and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Study 201 Participants | This arm consisted of participants who previously participated in Study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 12, 2019 | Jun 27, 2022 |
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Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)
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| Duration of Response in Participants Achieving 'Clear' IGA Score | The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented. | Up to 52 weeks |
| Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear' | The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity. | Weeks 12, 24, 36, and 52 |
| Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75) | The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. | Baseline and Weeks 12, 24, 36, and 52 |
| Northridge |
| California |
| 91324 |
| United States |
| Arcutis Clinical Site 28 | San Diego | California | 92123 | United States |
| Arcutis Clinical Site 27 | Santa Monica | California | 90403 | United States |
| Arcutis Clinical Site 12 | Miami | Florida | 33144 | United States |
| Arcutis Clinical Site 16 | Sanford | Florida | 32771 | United States |
| Arcutis Clinical Site 21 | Louisville | Kentucky | 40217 | United States |
| Arcutis Clinical Site 34 | Clinton Township | Michigan | 48038 | United States |
| Arcutis Clinical Site 33 | Detroit | Michigan | 48202 | United States |
| Arcutis Clinical Site 20 | Fridley | Minnesota | 55432 | United States |
| Arcutis Clinical Site 22 | New York | New York | 10029 | United States |
| Arcutis Clinical Site 14 | High Point | North Carolina | 27262 | United States |
| Arcutis Clinical Site 39 | Bexley | Ohio | 43209 | United States |
| Arcutis Clinical Site 15 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Clinical Site 19 | College Station | Texas | 77845 | United States |
| Arcutis Clinical Site 37 | Houston | Texas | 77004 | United States |
| Arcutis Clinical Site 13 | Houston | Texas | 77056 | United States |
| Arcutis Clinical Site 23 | San Antonio | Texas | 78213 | United States |
| Arcutis Clinical Site 24 | Webster | Texas | 77598 | United States |
| Arcutis Clinical Site 31 | Norfolk | Virginia | 23502 | United States |
| Arcutis Clinical Site 18 | Surrey | British Columbia | V3R 6A7 | Canada |
| Arcutis Clinical Site 11 | Surrey | British Columbia | V3V 0C6 | Canada |
| Arcutis Clinical Site 38 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Arcutis Clinical Site 10 | Ajax | Ontario | L1S 7K8 | Canada |
| Arcutis Clinical Site 25 | London | Ontario | N6H 5L5 | Canada |
| Arcutis Clinical Site 26 | Markham | Ontario | L3P 1X2 | Canada |
| Arcutis Clinical Site 32 | Oakville | Ontario | L6J 7W5 | Canada |
| Arcutis Clinical Site 17 | Peterborough | Ontario | K9J 5K2 | Canada |
| Arcutis Clinical Site 30 | Waterloo | Ontario | N2J 1C4 | Canada |
| Arcutis Clinical Site 36 | Windsor | Ontario | N8W 1E6 | Canada |
| FG001 | Cohort 2: Non-study 201 Participants | This arm consisted of participants who did not previously participate in Study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline was defined as the last observation prior to administration of ARQ-151 cream. Thus the baseline assessments for participants in Cohort 1 assigned to ARQ-151 cream occurred in the ARQ-151-201 study, whereas baseline occurred in this study (ARQ-151-202) for vehicle cream participants in the 201 study and Cohort 2 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Study 201 Participants | This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study. |
| BG001 | Cohort 2: Non-study 201 Participants | This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring. |
| BG002 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Modified Psoriasis Area Severity Index (mPASI) | The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. | One participant in Cohort 2 did not have a baseline mPASI assessment. | Mean | Standard Deviation | score on a scale |
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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 | Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs [TEAEs]) in ARQ-151-202 are presented. | All randomized participants who received ≥1 dose of study treatment are included. | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Primary | Number of Participants Experiencing ≥1 Serious Adverse Event (SAE) | An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. | All randomized participants who received ≥1 dose of study drug are included. | Posted | Count of Participants | Participants | Up to 52 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' | The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity. | All participants who received ≥1 dose of study drug and have data available at the relevant time points are included. | Posted | Count of Participants | Participants | Weeks 12, 24, 36, and 52 |
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| Secondary | Duration of Response in Participants Achieving 'Clear' IGA Score | The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented. | All participants who received ≥1 dose of study drug and achieved an IGA score of 'clear' are included. | Posted | Median | 95% Confidence Interval | weeks | Up to 52 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear' | The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity. | All participants who received ≥1 dose of study drug, have intertriginous area involvement, and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus I-IGA was not assessed in a subset of participants in Cohort 1. | Posted | Count of Participants | Participants | Weeks 12, 24, 36, and 52 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75) | The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. | All participants who received ≥1 dose of study drug and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus mPASI was not assessed in a subset of participants in Cohort 1. | Posted | Count of Participants | Participants | Baseline and Weeks 12, 24, 36, and 52 |
|
Up to 52 weeks
All participants who received ≥1 dose of study drug are included.
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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: Study 201 Participants | This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study. | 0 | 230 | 8 | 230 | 15 | 230 |
| EG001 | Cohort 2: Non-study 201 Participants | This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring. | 0 | 102 | 2 | 102 | 7 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Device failure | Product Issues | MedDRA 23.0 | Systematic Assessment |
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| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arcutis Medical Information | Arcutis Biotherapeutics | +1 (844) 692-6729 | medinfo@arcutis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2020 | Jun 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Multiple/Other |
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