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This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-151 Cream 0.3% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical roflumilast | Drug | Active treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment emergent AEs (TEAEs) | The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. | 24 weeks | |
| In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). | 24 weeks |
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Inclusion Criteria:
Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
Males and females ages 2 years and older (inclusive)
Subjects with chronic plaque psoriasis who meet eligibility criteria and:
Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
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 Biotherapeutics Clinical Site 203 | Scottsdale | Arizona | 85255 | United States | ||
| Arcutis Biotherapeutics Clinical Site 239 |
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| Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time | 24 weeks |
| Achievement of a 75% reduction in PASI over time | 24 weeks |
| Achievement of a 90% reduction in PASI over time | 24 weeks |
| Achievement of a 100% reduction in PASI over time | 24 weeks |
| Change in Worst Itch Numeric Rating Scale) WI-NRS score over time | 24 weeks |
| Beverly Hills |
| California |
| 90212 |
| United States |
| Arcutis Biotherapeutics Clinical Site 127 | Encinitas | California | 92024 | United States |
| Arcutis Biotherapeutics Clinical Site 225 | Encino | California | 91436 | United States |
| Arcutis Biotherapeutics Clinical Site 509 | Fountain Valley | California | 92708 | United States |
| Arcutis Biotherapeutics Clinical Site 112 | Fremont | California | 94538 | United States |
| Arcutis Biotherapeutics Clinical Site 120 | Irvine | California | 92697 | United States |
| Arcutis Biotherapeutics Clinical Site 508 | Los Angeles | California | 90057 | United States |
| Arcutis Biotherapeutics Clinical Site 511 | Rancho Santa Margarita | California | 92688 | United States |
| Arcutis Biotherapeutics Clinical Site 123 | San Diego | California | 92123 | United States |
| Arcutis Biotherapeutics Clinical Site 220 | San Diego | California | 92123 | United States |
| Arcutis Biotherapeutics Clinical Site 136 | San Francisco | California | 94132 | United States |
| Arcutis Biotherapeutics Clinical Site 208 | Santa Monica | California | 90404 | United States |
| Arcutis Biotherapeutics Clinical Site 215 | Santa Monica | California | 90503 | United States |
| Arcutis Biotherapeutics Clinical Site 223 | Boynton Beach | Florida | 91436 | United States |
| Arcutis Biotherapeutics Clinical Site 237 | DeLand | Florida | 32720 | United States |
| Arcutis Biotherapeutics Clinical Site 118 | Delray Beach | Florida | 33484 | United States |
| Arcutis Biotherapeutics Clinical Site 202 | Hialeah | Florida | 33016 | United States |
| Arcutis Biotherapeutics Clinical Site 228 | Largo | Florida | 33770 | United States |
| Arcutis Biotherapeutics Clinical Site 131 | Miami | Florida | 33174 | United States |
| Arcutis Biotherapeutics Clinical Site 201 | North Miami Beach | Florida | 33162 | United States |
| Arcutis Biotherapeutics Clinical Site 137 | Ocala | Florida | 34470 | United States |
| Arcutis Biotherapeutics Clinical Site 105 | Sanford | Florida | 32771 | United States |
| Arcutis Biotherapeutics Clinical Site 209 | Sweetwater | Florida | 33172 | United States |
| Arcutis Clinical Site 602 | Boise | Idaho | 83706 | United States |
| Arcutis Biotherapeutics Clinical Site 114 | Plainfield | Illinois | 46168 | United States |
| Arcutis Biotherapeutics Clinical Site 102 | Rolling Meadows | Illinois | 60008 | United States |
| Arcutis Biotherapeutics Clinical Site 214 | Indianapolis | Indiana | 46250 | United States |
| Arcutis Biotherapeutics Clinical Site 217 | Louisville | Kentucky | 40217 | United States |
| Arcutis Biotherapeutics Clinical Site 111 | Baton Rouge | Louisiana | 70809 | United States |
| Arcutis Biotherapeutics Clinical Site 211 | Lake Charles | Louisiana | 70605 | United States |
| Arcutis Biotherapeutics Clinical Site 213 | Metairie | Louisiana | 70006 | United States |
| Arcutis Biotherapeutics Clinical Site 224 | New Orleans | Louisiana | 70115 | United States |
| Arcutis Biotherapeutics Clinical Site 125 | Rockville | Maryland | 20850 | United States |
| Arcutis Biotherapeutics Clinical Site 138 | Rockville | Maryland | 20850 | United States |
| Arcutis Biotherapeutics Clinical Site 101 | Brighton | Massachusetts | 02135 | United States |
| Arcutis Biotherapeutics Clinical Site 116 | Clinton Township | Michigan | 48038 | United States |
| Arcutis Biotherapeutics Clinical Site 212 | Detroit | Michigan | 48202 | United States |
| Arcutis Biotherapeutics Clinical Site 216 | Fridley | Minnesota | 55432 | United States |
| Arcutis Biotherapeutics Clinical Site 227 | Saint Joseph | Missouri | 64506 | United States |
| Arcutis Biotherapeutics Clinical Site 219 | Las Vegas | Nevada | 89148 | United States |
| Arcutis Biotherapeutics Clinical Site 231 | Las Vegas | Nevada | 89148 | United States |
| Arcutis Biotherapeutics Clinical Site 139 | Reno | Nevada | 89509 | United States |
| Arcutis Biotherapeutics Clinical Site 240 | Reno | Nevada | 89703 | United States |
| Arcutis Biotherapeutics Clinical Site 236 | Portsmouth | New Hampshire | 03801 | United States |
| Arcutis Biotherapeutics Clinical Site 129 | East Windsor | New Jersey | 08520 | United States |
| Arcutis Biotherapeutics Clinical Site 121 | New York | New York | 10029 | United States |
| Arcutis Biotherapeutics Clinical Site 130 | Rochester | New York | 14623 | United States |
| Arcutis Biotherapeutics Clinical Site 108 | Stony Brook | New York | 11790 | United States |
| Arcutis Biotherapeutics Clinical Site 115 | High Point | North Carolina | 27262 | United States |
| Arcutis Biotherapeutics Clinical Site 124 | Fairborn | Ohio | 45324 | United States |
| Arcutis Biotherapeutics Clinical Site 222 | Oklahoma City | Oklahoma | 73112 | United States |
| Arcutis Biotherapeutics Clinical Site 134 | Oklahoma City | Oklahoma | 73118 | United States |
| Arcutis Biotherapeutics Clinical Site 229 | Broomall | Pennsylvania | 19008 | United States |
| Arcutis Biotherapeutics Clinical Site 128 | Duncansville | Pennsylvania | 16635 | United States |
| Arcutis Biotherapeutics Clinical Site 113 | Exton | Pennsylvania | 19003 | United States |
| Arcutis Biotherapeutics Clinical Site 135 | Pittsburgh | Pennsylvania | 15213 | United States |
| Arcutis Biotherapeutics Clinical Site 233 | Knoxville | Tennessee | 37922 | United States |
| Arcutis Biotherapeutics Clinical Site 221 | Murfreesboro | Tennessee | 37130 | United States |
| Arcutis Biotherapeutics Clinical Site 206 | Arlington | Texas | 76011 | United States |
| Arcutis Biotherapeutics Clinical Site 104 | College Station | Texas | 77845 | United States |
| Arcutis Biotherapeutics Clinical Site 119 | Dallas | Texas | 75246 | United States |
| Arcutis Biotherapeutics Clinical Site 519 | Frisco | Texas | 75034 | United States |
| Arcutis Biotherapeutics Clinical Site 238 | Houston | Texas | 77030 | United States |
| Arcutis Biotherapeutics Clinical Site 110 | San Antonio | Texas | 78218 | United States |
| Arcutis Biotherapeutics Clinical Site 117 | San Antonio | Texas | 78229 | United States |
| Arcutis Biotherapeutics Clinical Site 210 | West Jordan | Utah | 84088 | United States |
| Arcutis Biotherapeutics Clinical Site 230 | Richmond | Virginia | 23220 | United States |
| Arcutis Biotherapeutics Clinical Site 132 | Calgary | Alberta | T1Y 0B4 | Canada |
| Arcutis Biotherapeutics Clinical Site 207 | Surrey | British Columbia | V3R 6A7 | Canada |
| Arcutis Biotherapeutics Clinical Site 226 | Surrey | British Columbia | V3V0C6 | Canada |
| Arcutis Biotherapeutics Clinical Site 232 | Winnepeg | Manitoba | R3M 3Z4 | Canada |
| Arcutis Biotherapeutics Clinical Site 234 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Arcutis Biotherapeutics Clinical Site 205 | Ajax | Ontario | L1S 7K8 | Canada |
| Arcutis Biotherapeutics Clinical Site 218 | Barrie | Ontario | L4M 7G1 | Canada |
| Arcutis Biotherapeutics Clinical Site 103 | London | Ontario | N6H 5L5 | Canada |
| Arcutis Biotherapeutics Clinical Site 133 | Mississauga | Ontario | L5H 1G9 | Canada |
| Arcutis Biotherapeutics Clinical Site 140 | Ottawa | Ontario | K2C 3N2 | Canada |
| Arcutis Biotherapeutics Clinical Site 109 | Peterborough | Ontario | K9J 5K2 | Canada |
| Arcutis Biotherapeutics Clinical Site 235 | Toronto | Ontario | M4W 2N2 | Canada |
| Arcutis Biotherapeutics Clinical Site 106 | Waterloo | Ontario | N2J 1C4 | Canada |
| Arcutis Biotherapeutics Clinical Site 204 | Windsor | Ontario | N8W 1E6 | Canada |
| Arcutis Biotherapeutics Clinical Site 107 | Montreal | Quebec | H3Z 2S6 | Canada |
| Arcutis Biotherapeutics Clinical Site 126 | Québec | Quebec | G1V4X7 | Canada |
| Arcutis Clinical Site 601 | Santo Domingo | Dominican Republic |
| ID | Term |
|---|---|
| C424423 | Roflumilast |
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