Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast Cream 0.15% | Experimental | Participants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks. |
|
| Vehicle Cream | Placebo Comparator | Participants with mild to moderate AD applied vehicle cream QD for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Cream 0.15% | Drug | Roflumilast Cream 0.15% - Active |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 57 | Montgomery | Alabama | 36117 | United States | ||
| Arcutis Clinical Site 34 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39292443 | Derived | Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121. |
Not provided
Not provided
Not provided
This study was conducted at 65 centers in the United States, Canada, and Poland.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Roflumilast Cream 0.15% | Participants with mild to moderate AD applied roflumilast cream 0.15% once daily (QD) for 4 weeks. |
| FG001 | Vehicle Cream | Participants with mild to moderate AD applied vehicle cream QD for 4 weeks. |
| 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 | Oct 19, 2020 | Aug 2, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle Cream | Drug | Cream - Vehicle |
|
| Week 4 |
| Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 4 |
| Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 2 |
| Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | Week 1 |
| Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 | The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. | Week 4 |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 4 |
| Achievement of vIGA-AD Success at Week 2 | The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 2 |
| Achievement of vIGA-AD Success at Week 1 | The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 1 |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 2 |
| Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | Week 1 |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Arcutis Clinical Site 58 | Little Rock | Arkansas | 72212 | United States |
| Arcutis Clinical Site 40 | Beverly Hills | California | 90212 | United States |
| Arcutis Clinical Site 06 | Encinitas | California | 92024 | United States |
| Arcutis Clinical Site 52 | Los Angeles | California | 90056 | United States |
| Arcutis Clinical Site 05 | San Diego | California | 92123 | United States |
| Arcutis Clinical Site 08 | San Francisco | California | 94132 | United States |
| Arcutis Clinical Site 62 | Thousand Oaks | California | 91320 | United States |
| Arcutis Clinical Site 30 | Coral Gables | Florida | 33134 | United States |
| Arcutis Clinical Site 04 | Jacksonville | Florida | 32256 | United States |
| Arcutis Clinical Site 15 | Largo | Florida | 33770 | United States |
| Arcutis Clinical Site 39 | Miami Lakes | Florida | 33014 | United States |
| Arcutis Clinical Site 38 | North Miami Beach | Florida | 33162 | United States |
| Arcutis Clinical Site 01 | Tampa | Florida | 33613 | United States |
| Arcutis Clinical Site 61 | Wellington | Florida | 33449 | United States |
| Arcutis Clinical Site 26 | Sandy Springs | Georgia | 30328 | United States |
| Arcutis Clinical Site 13 | Rolling Meadows | Illinois | 33770 | United States |
| Arcutis Clinical Site 48 | Clarksville | Indiana | 47129 | United States |
| Arcutis Clinical Site 02 | Indianapolis | Indiana | 46250 | United States |
| Arcutis Clinical Site 03 | Louisville | Kentucky | 40217 | United States |
| Arcutis Clinical Site 36 | Rockville | Maryland | 20850 | United States |
| Arcutis Clinical Site 55 | Auburn Hills | Michigan | 48326 | United States |
| Arcutis Clinical Site 54 | Bay City | Michigan | 48706 | United States |
| Arcutis Clinical Site 46 | Clarkston | Michigan | 48346 | United States |
| Arcutis Clinical Site 37 | Detroit | Michigan | 48202 | United States |
| Arcutis Clinical Site 10 | New Brighton | Minnesota | 55112 | United States |
| Arcutis Clinical Site 33 | Reno | Nevada | 89509 | United States |
| Arcutis Clinical Site 42 | East Windsor | New Jersey | 08520 | United States |
| Arcutis Clinical Site 17 | Gresham | Oregon | 97030 | United States |
| Arcutis Clinical Site 16 | Portland | Oregon | 97223 | United States |
| Arcutis Clinical Site 14 | Portland | Oregon | 97239 | United States |
| Arcutis Clinical Site 35 | Newtown Square | Pennsylvania | 19073 | United States |
| Arcutis Clinical Site 101 | Johnston | Rhode Island | 02919 | United States |
| Arcutis Clinical Site 31 | Murfreesboro | Tennessee | 37130 | United States |
| Arcutis Clinical Site 19 | Arlington | Texas | 76011 | United States |
| Arcutis Clinical Site 43 | Bellaire | Texas | 77401 | United States |
| Arcutis Clinical Site 27 | Houston | Texas | 77030 | United States |
| Arcutis Clinical Site 20 | Houston | Texas | 77056 | United States |
| Arcutis Clinical Site 28 | San Antonio | Texas | 78218 | United States |
| Arcutis Clinical Site 21 | South Jordan | Utah | 84095 | United States |
| Arcutis Clinical Site 12 | Spokane | Washington | 99202 | United States |
| Arcutis Clinical Site 41 | Calgary | Alberta | T2J 7E1 | Canada |
| Arcutis Clinical Site 29 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Arcutis Clinical Site 11 | Markham | Ontario | L3P 1X3 | Canada |
| Clinical Site 25 | Mississauga | Ontario | L5H 1G9 | Canada |
| Arcutis Clinical Site 32 | Peterborough | Ontario | K9J 5K2 | Canada |
| Arcutis Clinical Site 09 | Windsor | Ontario | N8W 1E6 | Canada |
| Arcutis Clinical Site 24 | Montreal | Quebec | H2X 2V1 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Roflumilast Cream 0.15% | Participants with mild to moderate AD applied roflumilast cream 0.15% once daily (QD) for 4 weeks. |
| BG001 | Vehicle Cream | Participants with mild to moderate AD applied vehicle cream QD for 4 weeks. |
| BG002 | 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/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Randomization validated Investigator's Global Assessment Scale for Atopic Dermatitis (vIGA-AD) | The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Count of Participants | Participants |
| |||||||||||||||
| Verified vIGA-AD | The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | Count of Participants | Participants |
|
| 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 | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 | The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores | The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants who were included in the "moderate" baseline vIGA-AD group during randomization are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | All randomized participants ≥12 years of age with a baseline WI-NRS ≥4 are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | All randomized participants ≥12 years of age with a baseline WI-NRS ≥4 are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 | The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. 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 participant experienced in the previous 24 hours (higher scores indicate higher itch severity). | All randomized participants ≥12 years of age with a baseline WI-NRS ≥4 are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 | The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of vIGA-AD Success at Week 2 | The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of vIGA-AD Success at Week 1 | The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 | The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity. | All randomized participants are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 |
|
|
Up to approximately 29 days
Not provided
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 0.15% | Participants with mild to moderate AD applied roflumilast cream 0.15% once daily (QD) for 4 weeks. | 0 | 433 | 4 | 433 | 0 | 433 |
| EG001 | Vehicle Cream | Participants with mild to moderate AD applied vehicle cream QD for 4 weeks. | 0 | 221 | 0 | 221 | 0 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
The Sponsor is generally supportive of publication of trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arcutis Medical Information | Arcutis | +1 (844) 692-6729 | medinfo@arcutis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2022 | Sep 13, 2024 | SAP_002.pdf |
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| American Indian or Alaska native |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| Black or African American |
|
| Multiple |
|
| Other |
|
| 3 - Moderate |
|
| Moderate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|