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This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-154 foam 0.3% | Experimental | active |
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| ARQ foam VehicleRQ-154 foam Vehicle | Placebo Comparator | placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast foam 0.3% | Drug | experimental |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale | The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8 | The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Biotherapeutics Clinical Site 71 | Rogers | Arkansas | 72758 | United States | ||
| Arcutis Biotherapeutics Clinical Site 72 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast Foam 0.3% | Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. |
| FG001 | Vehicle Foam |
| 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 10, 2020 | Aug 11, 2022 |
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| Vehicle foam | Drug | experimental |
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| Week 8 |
| Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only. | Baseline and Weeks 2, 4, 8 |
| Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. | Baseline and Weeks 4 and 8 |
| Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score | The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only. | Up to 8 weeks |
| Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75) | The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. | Week 8 |
| Number of Participants Achieving PSSI-90 | The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. | Baseline and Week 8 |
| Fremont |
| California |
| 94538 |
| United States |
| Arcutis Biotherapeutics Clinical Site 85 | San Diego | California | 92123 | United States |
| Arcutis Biotherapeutics Clinical Site 21 | Cromwell | Connecticut | 06416 | United States |
| Arcutis Biotherapeutics Clinical Site 91 | Boynton Beach | Florida | 33437 | United States |
| Arcutis Biotherapeutics Clinical Site 20 | Coral Gables | Florida | 33134 | United States |
| Arcutis Biotherapeutics Clinical Site 88 | Miami | Florida | 33144 | United States |
| Arcutis Biotherapeutics Clinical Site 90 | Miami | Florida | 33714 | United States |
| Arcutis Biotherapeutics Clinical Site 83 | Sweetwater | Florida | 33172 | United States |
| Arcutis Biotherapeutics Clinical Site 99 | Rolling Meadows | Illinois | 60008 | United States |
| Arcutis Biotherapeutics Clinical Site 78 | Indianapolis | Indiana | 46250 | United States |
| Arcutis Biotherapeutics Clinical Site 95 | Plainfield | Indiana | 46168 | United States |
| Arcutis Biotherapeutics Clinical Site 77 | Louisville | Kentucky | 40217 | United States |
| Arcutis Biotherapeutics Clinical Site 79 | Covington | Louisiana | 70433 | United States |
| Arcutis Biotherapeutics Clinical Site 94 | Metairie | Louisiana | 70006 | United States |
| Arcutis Biotherapeutics Clinical Site 73 | Fridley | Minnesota | 55432 | United States |
| Arcutis Biotherapeutics Clinical Site 84 | Saint Joseph | Missouri | 64506 | United States |
| Arcutis Biotherapeutics Clinical Site 98 | Portsmouth | New Hampshire | 03801 | United States |
| Arcutis Biotherapeutics Clinical Site 87 | High Point | North Carolina | 27262 | United States |
| Arcutis Biotherapeutics Clinical Site 96 | Bexley | Ohio | 43209 | United States |
| Arcutis Biotherapeutics Clinical Site 82 | Portland | Oregon | 97210 | United States |
| Arcutis Biotherapeutics Clinical Site 80 | Broomall | Pennsylvania | 19008 | United States |
| Arcutis Biotherapeutics Clinical Site 97 | Murfreesboro | Tennessee | 37130 | United States |
| Arcutis Biotherapeutics Site 70 | Arlington | Texas | 76011 | United States |
| Arcutis Biotherapeutics Clinical Site 76 | Austin | Texas | 78759 | United States |
| Arcutis Biotherapeutics Clinical Site 86 | College Station | Texas | 77845 | United States |
| Arcutis Biotherapeutics Clinical Site 74 | Houston | Texas | 77056 | United States |
| Arcutis Biotherapeutics Clinical Site 89 | Pflugerville | Texas | 78660 | United States |
| Arcutis Biotherapeutics Clinical Site 93 | San Antonio | Texas | 78213 | United States |
| Arcutis Biotherapeutics Clinical Site 81 | Norfolk | Virginia | 23502 | United States |
| Arcutis Biotherapeutics Clinical Site 75 | Richmond | Virginia | 23220 | United States |
| Arcutis Biotherapeutics Clinical Site 51 | Kogarah | New South Wales | 2217 | Australia |
| Arcutis Biotherapeutics Clinical Site 52 | Westmead | New South Wales | 2145 | Australia |
| Arcutis Biotherapeutics Clinical Site 54 | Hectorville | South Australia | 5073 | Australia |
| Arcutis Biotherapeutics Clinical Site 50 | East Melbourne | Victoria | 3002 | Australia |
| Arcutis Biotherapeutics Clinical Site 11 | Pleven | 5800 | Bulgaria |
| Arcutis Biotherapeutics Clinical Site 13 | Sevlievo | 5402 | Bulgaria |
| Arcutis Biotherapeutics Clinical Site 14 | Sofia | 1592 | Bulgaria |
| Arcutis Biotherapeutics Clinical Site 10 | Sofia | 1606 | Bulgaria |
| Arcutis Biotherapeutics Clinical Site 12 | Stara Zagora | 6003 | Bulgaria |
| Arcutis Biotherapeutics Clinical Site 64 | Calgary | Alberta | T1Y0B4 | Canada |
| Arcutis Biotherapeutics Clinical Site 61 | Barrie | Ontario | L4M 7G1 | Canada |
| Arcutis Biotherapeutics Clinical Site 60 | London | Ontario | N6H5L5 | Canada |
| Arcutis Biotherapeutics Clinical Site 62 | Peterborough | Ontario | K9J 5K2 | Canada |
| Arcutis Biotherapeutics Clinical Site 63 | Waterloo | Ontario | N2J 1C4 | Canada |
| Arcutis Biotherapeutics Clinical Site 66 | Montreal | Quebec | H2X 2V1 | Canada |
| Arcutis Biotherapeutics Clinical Site 65 | Westmount | Quebec | H3Z 2S6 | Canada |
Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast Foam 0.3% | Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. |
| BG001 | Vehicle Foam | Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| Scalp Investigator Global Assessment (S-IGA) Baseline Score | The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. | Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments. | Count of Participants | Participants |
| ||||||||||||||
| Psoriasis Scalp Severity Index (PSSI) Baseline Score | The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. | Two participants did not have a baseline PSSI assessment. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Body Investigator Global Assessment (B-IGA) Baseline Score | The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. | Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments. | Count of Participants | Participants |
| ||||||||||||||
| Scalp Itch Numeric Rating Scale (SI-NRS) Baseline Score | The SI-NRS is a simple, single item scale to assess the participant-reported severity of scalp itch, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Psoriasis Symptom Diary (PSD) Total Baseline Score | The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. | Mean | Standard Deviation | units 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 Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale | The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. | All randomized participants with S-IGA score at baseline ≥2 and data available are included. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8 | The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. | All randomized participants with data available and baseline B-IGA score ≥2 are included. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score | The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only. | All randomized participants with baseline SI-NRS score ≥4 with data available are included. | Posted | Count of Participants | Participants | Baseline and Weeks 2, 4, 8 |
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| Secondary | Change From Baseline in Psoriasis Symptoms Diary (PSD) Score | The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. | All randomized participants are included, with multiple imputation used for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Weeks 4 and 8 |
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| Secondary | Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score | The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only. | All randomized participants are included. | Posted | Median | 95% Confidence Interval | days | Up to 8 weeks |
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| Secondary | Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75) | The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. | All randomized participants with data available are included. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants Achieving PSSI-90 | The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. | All randomized participants with data available are included. | Posted | Count of Participants | Participants | Baseline and Week 8 |
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Up to 9 weeks
All participants who received ≥1 dose of study intervention 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 | Roflumilast Foam 0.3% | Participants applied roflumilast foam 0.3% QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. | 0 | 198 | 1 | 198 | 0 | 198 |
| EG001 | Vehicle Foam | Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment. | 0 | 104 | 0 | 104 | 0 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Testicular torsion | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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The Sponsor is supportive of publishing clinical trial findings. Any form of publication that is derived from this study must be submitted to Arcutis, Inc. for review and approval. 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 | Dec 9, 2020 | Sep 15, 2022 | SAP_002.pdf |
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| 1 - almost clear |
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| 2 - mild |
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| 3 - moderate |
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| 4 - severe |
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| 1 - almost clear |
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| 2 - mild |
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| 3 - moderate |
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| 4 - severe |
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