Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
This is a parallel group, double blind, vehicle-controlled study in which roflumilast cream 0.05% or 0.15% or vehicle is applied QD x 28 days to adolescent and adult subjects with atopic dermatitis. A subset of subjects will have serial PK testing, which will include the first few adolescents and adults enrolled in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast Cream 0.05% | Active Comparator | Participants apply roflumilast cream 0.05% QD for 28 days. |
|
| Roflumilast Cream 0.15% | Active Comparator | Participants apply roflumilast cream 0.15% QD for 28 days. |
|
| Vehicle Cream | Placebo Comparator | Participants apply vehicle cream QD for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Cream 0.05% | Drug | Roflumilast 0.05% cream for topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 | The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in EASI Total Score | The LS mean (SD) percentage change from baseline in EASI Total Score at Weeks 1, 2, and 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
Evidence of skin conditions other than AD (atopic dermatitis) 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.
Known allergies to excipients in ARQ-151 cream.
Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.
Known or suspected:
Previous treatment with ARQ-151.
Subjects with a history of chronic alcohol or drug abuse in past 6 months.
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 with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Site 25 | Scottsdale | Arizona | 85254 | United States | ||
| Arcutis Clinical Site 01 |
Not provided
Adolescent (12 to 17 years of age) and adult (≥18 years of age) male and female participants with mild to moderate atopic dermatitis (AD) were enrolled at 3 study sites in Canada and 19 sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast Cream 0.05% | Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application |
| FG001 | Roflumilast Cream 0.15% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2019 | Oct 17, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Roflumilast Cream 0.15% | Drug | Roflumilast 0.15% cream for topical application |
|
|
| Vehicle Cream | Drug | Inactive vehicle cream matched to roflumilast cream for topical application. |
|
| Baseline and Weeks 1, 2, and 4 |
| Mean Change From Baseline in EASI Total Score at Weeks 1 and 2 | The LS mean (SD) change from baseline in EASI Total Score at Weeks 1 and 2 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Baseline and Weeks 1 and 2 |
| Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50) | The number of participants with a decrease of at least 50% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Baseline and Weeks 1, 2, and 4 |
| Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) | The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Baseline and Weeks 1, 2, and 4 |
| Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90) | The number of participants with a decrease of at least 90% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases. | Baseline and Weeks 1, 2, and 4 |
| Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100) | The number of participants with a decrease of 100% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases. | Baseline and Weeks 1, 2, and 4 |
| Mean Change From Baseline in Body Surface Area (BSA) Involvement | The LS mean (SE) change from baseline in BSA involvement at Weeks 1, 2, and 4 is presented. The BSA affected by AD was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. Negative scores indicate improvement of symptoms, whereas positive scores indicate worsening. | Baseline and Weeks 1, 2, and 4 |
| Worse Itch Numerical Rating Score (WI-NRS) Score Change | The LS mean (SE) change from baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity. | Baseline and Weeks 1, 2, and 4 |
| Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score | The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity. | Baseline and Weeks 1, 2, and 4 |
| San Diego |
| California |
| 92123 |
| United States |
| Arcutis Clinical Site 19 | Hialeah | Florida | 33016 | United States |
| Arcutis Clinical Site 18 | Miami | Florida | 33174 | United States |
| Arcutis Clinical Site 17 | Sanford | Florida | 32771 | United States |
| Arcutis Clinical Site 16 | Boise | Idaho | 83713 | United States |
| Arcutis Clinical Site 12 | Indianapolis | Indiana | 46250 | United States |
| Arcutis Clinical Site 13 | Plainfield | Indiana | 46168 | United States |
| Arcutis Clinical Site 15 | Metairie | Louisiana | 70006 | United States |
| Arcutis Clinical Site 03 | Fridley | Minnesota | 55432 | United States |
| Arcutis Clinical Site 02 | High Point | North Carolina | 27262 | United States |
| Arcutis Clinical Site 08 | Bexley | Ohio | 43209 | United States |
| Arcutis Clinical Site 23 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Clinical Site 20 | Murfreesboro | Tennessee | 37130 | United States |
| Arcutis Clinical Site 09 | College Station | Texas | 77845 | United States |
| Arcutis Clinical Site 04 | San Antonio | Texas | 78213 | United States |
| Arcutis Clinical Site 21 | Richmond | Virginia | 23224 | United States |
| Arcutis Clinical Site 14 | Cobourg | Ontario | K9A 4J9 | Canada |
| Arcutis Clinical Site 10 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Arcutis Clinical Site 06 | Montreal | Quebec | H2K 4L5 | Canada |
Participants apply roflumilast cream 0.15% QD for 28 days.
Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application
| FG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast Cream 0.05% | Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application |
| BG001 | Roflumilast Cream 0.15% | Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application |
| BG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Eczema Area and Severity Index (EASI) Score | The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Baseline Body Surface Area (BSA) Score | The percentage of BSA affected by AD is determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. All AD lesions on a subject were treated including the face, trunk, genitals/skin folds, or limbs (excluding the scalp); the palms and soles were treated but were not counted towards any measurements of BSA. | Mean | Standard Deviation | percentage of body surface area |
| ||||||||||||||
| Baseline Worst Itch Numerical Rating Scale (WI-NRS) Score | The WI-NRS is a simple, single item scale to assess the participant-reported severity of this symptom, 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 |
|
| 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 | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 | The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | All randomized participants with data are included. | Posted | Least Squares Mean | Standard Deviation | score on a scale | Baseline and Week 4 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in EASI Total Score | The LS mean (SD) percentage change from baseline in EASI Total Score at Weeks 1, 2, and 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | All randomized participants with data are included. | Posted | Least Squares Mean | Standard Deviation | percent change | Baseline and Weeks 1, 2, and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in EASI Total Score at Weeks 1 and 2 | The LS mean (SD) change from baseline in EASI Total Score at Weeks 1 and 2 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | All randomized participants with data are included. | Posted | Least Squares Mean | Standard Deviation | score on a scale | Baseline and Weeks 1 and 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50) | The number of participants with a decrease of at least 50% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | All randomized participants with ≥1 post-baseline assessment are included (last observation carried forward [LOCF] used for missing data after Week 1). | Posted | Count of Participants | Participants | Baseline and Weeks 1, 2, and 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75) | The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. | All randomized participants with ≥1 post-baseline assessment are included (LOCF used for missing data after Week 1). | Posted | Count of Participants | Participants | Baseline and Weeks 1, 2, and 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90) | The number of participants with a decrease of at least 90% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases. | All randomized participants with ≥1 post-baseline assessment are included (LOCF used for missing data after Week 1). | Posted | Count of Participants | Participants | Baseline and Weeks 1, 2, and 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100) | The number of participants with a decrease of 100% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases. | All randomized participants with ≥1 post-baseline assessment are included (LOCF used for missing data after Week 1). | Posted | Count of Participants | Participants | Baseline and Weeks 1, 2, and 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Body Surface Area (BSA) Involvement | The LS mean (SE) change from baseline in BSA involvement at Weeks 1, 2, and 4 is presented. The BSA affected by AD was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. Negative scores indicate improvement of symptoms, whereas positive scores indicate worsening. | All randomized participants with data are included. | Posted | Least Squares Mean | Standard Error | percentage of BSA affected | Baseline and Weeks 1, 2, and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Worse Itch Numerical Rating Score (WI-NRS) Score Change | The LS mean (SE) change from baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity. | All randomized participants with data are included. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Weeks 1, 2, and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score | The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity. | All randomized participants with data are included. | Posted | Count of Participants | Participants | Baseline and Weeks 1, 2, and 4 |
|
Up to 32 days
All participants who received ≥1 dose of study intervention are included.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Roflumilast Cream 0.05% | Participants apply roflumilast cream 0.05% QD for 28 days. Roflumilast Cream 0.05%: Roflumilast 0.05% cream for topical application | 0 | 46 | 1 | 46 | 0 | 46 |
| EG001 | Roflumilast Cream 0.15% | Participants apply roflumilast cream 0.15% QD for 28 days. Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application | 0 | 45 | 0 | 45 | 0 | 45 |
| EG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. | 0 | 45 | 0 | 45 | 0 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traumatic spinal cord compression | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
Not provided
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 | Nov 25, 2019 | Oct 17, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
| Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream | MMRM | Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate. | 0.097 | LS Mean Difference vs Vehicle | -1.60 | 2-Sided | 95 | -3.382 | 0.178 | Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate. | Superiority |
Participants apply vehicle cream QD for 28 days.
Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
|
|
|
Participants apply vehicle cream QD for 28 days.
Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application.
|
|
|
| OG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. |
|
|
|
| OG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. |
|
|
|
Participants apply roflumilast cream 0.15% QD for 28 days.
Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application
| OG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. |
|
|
|
Participants apply roflumilast cream 0.15% QD for 28 days.
Roflumilast Cream 0.15%: Roflumilast 0.15% cream for topical application
| OG002 | Vehicle Cream | Participants apply vehicle cream QD for 28 days. Vehicle Cream: Inactive vehicle cream matched to roflumilast cream for topical application. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|