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This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-151 cream 0.3% | Experimental | Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-151 cream 0.3% | Drug | ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of ARQ-151 Cream 0.3% | Plasma levels of circulating roflumilast were determined at 2 points in the study. | Predose on Days 14 and 28 |
| Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study. | Predose on Days 14 and 28 |
| Number of Participants With ≥1 Adverse Event (AE) | The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. | Up to 28 days |
| Number of Participants With Application Site Reactions | The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product. | Baseline (Day 1), Day 7, and Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Site 503 | Mountain Brook | Alabama | 35223 | United States | ||
| Arcutis Clinical Site 504 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40862624 | Derived | Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. Pediatr Dermatol. 2026 Jan-Feb;43(1):105-108. doi: 10.1111/pde.70013. Epub 2025 Aug 27. |
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Pediatric participants 6-11 years of age were enrolled at 17 study sites in the United States, Canada, and the Dominican Republic.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARQ-151 Cream 0.3% | Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks |
| 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 | Jan 22, 2021 | Nov 2, 2023 |
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| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Arcutis Clinical Site 509 | Fountain Valley | California | 92708 | United States |
| Arcutis Site 518 | Los Angeles | California | 90017 | United States |
| Arcutis Clinical Site 508 | Los Angeles | California | 90057 | United States |
| Arcutis Clinical Site 511 | Rancho Santa Margarita | California | 92688 | United States |
| Arcutis Clinical Site 510 | Boca Raton | Florida | 33428 | United States |
| Arcutis Clinical Site 502 | Coral Gables | Florida | 33146 | United States |
| Arcutis Clinical Site 513 | Delray Beach | Florida | 33484 | United States |
| Arcutis Clinical Site 501 | Hialeah | Florida | 33016 | United States |
| Arcutis Clinical Site 507 | Miami | Florida | 33155 | United States |
| Arcutis Clinical Site 527 | West Lafayette | Indiana | 47906 | United States |
| Arcutis Clinical Site 506 | Arlington | Texas | 76001 | United States |
| Arcutis Clinical Site 519 | Frisco | Texas | 75034 | United States |
| Arcutis Clinical Site 505 | Houston | Texas | 77030 | United States |
| Arcutis Clinical Site 521 | Toronto | Ontario | MG5-1X8 | Canada |
| Arcutis Clinical Site 530 | Santo Domingo | Dominican Republic |
| COMPLETED | Seven of the 20 participants who completed the study are continuing in study ARQ-151-306. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ARQ-151 Cream 0.3% | Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks |
| 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 | Plasma Concentration of ARQ-151 Cream 0.3% | Plasma levels of circulating roflumilast were determined at 2 points in the study. | Participants with data available are included. | Posted | Mean | Standard Deviation | ng/mL | Predose on Days 14 and 28 |
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| Primary | Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study. | Participants with data available are included. | Posted | Mean | Standard Deviation | ng/mL | Predose on Days 14 and 28 |
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| ||||||||||||||||||||||||||||
| Primary | Number of Participants With ≥1 Adverse Event (AE) | The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. | All treated participants are included. | Posted | Count of Participants | Participants | Up to 28 days |
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| Primary | Number of Participants With Application Site Reactions | The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product. | All treated participants are included. | Posted | Count of Participants | Participants | Baseline (Day 1), Day 7, and Day 14 |
|
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Up to 28 days
All treated participants 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 | ARQ-151 Cream 0.3% | Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks | 0 | 20 | 0 | 20 | 4 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Candida infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Application site pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Perineal pain | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Perineal erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | 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 | Mar 2, 2022 | Nov 2, 2023 | 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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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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| Unknown or Not Reported |
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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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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 14 |
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| Day 28 |
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