Chronic Plaque Psoriasis Clinical Trial
— DERMIS-OLEOfficial title:
A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis
| Verified date | March 2024 |
| Source | Arcutis Biotherapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 333 |
| Est. completion date | January 22, 2024 |
| Est. primary completion date | January 22, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 11 Years |
| Eligibility | 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: 1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or 2. Are naïve to treatment with ARQ-151 cream (Cohort 2) - 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: - Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study. - Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. - Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. - Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. - Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product. - Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Arcutis Biotherapeutics Clinical Site 205 | Ajax | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 218 | Barrie | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 132 | Calgary | Alberta |
| Canada | Arcutis Biotherapeutics Clinical Site 234 | Fredericton | New Brunswick |
| Canada | Arcutis Biotherapeutics Clinical Site 103 | London | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 133 | Mississauga | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 107 | Montreal | Quebec |
| Canada | Arcutis Biotherapeutics Clinical Site 140 | Ottawa | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 109 | Peterborough | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 126 | Québec | Quebec |
| Canada | Arcutis Biotherapeutics Clinical Site 207 | Surrey | British Columbia |
| Canada | Arcutis Biotherapeutics Clinical Site 226 | Surrey | British Columbia |
| Canada | Arcutis Biotherapeutics Clinical Site 235 | Toronto | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 106 | Waterloo | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 204 | Windsor | Ontario |
| Canada | Arcutis Biotherapeutics Clinical Site 232 | Winnepeg | Manitoba |
| Dominican Republic | Arcutis Clinical Site 601 | Santo Domingo | |
| United States | Arcutis Biotherapeutics Clinical Site 206 | Arlington | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 111 | Baton Rouge | Louisiana |
| United States | Arcutis Biotherapeutics Clinical Site 239 | Beverly Hills | California |
| United States | Arcutis Clinical Site 602 | Boise | Idaho |
| United States | Arcutis Biotherapeutics Clinical Site 223 | Boynton Beach | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 101 | Brighton | Massachusetts |
| United States | Arcutis Biotherapeutics Clinical Site 229 | Broomall | Pennsylvania |
| United States | Arcutis Biotherapeutics Clinical Site 116 | Clinton Township | Michigan |
| United States | Arcutis Biotherapeutics Clinical Site 104 | College Station | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 119 | Dallas | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 237 | DeLand | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 118 | Delray Beach | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 212 | Detroit | Michigan |
| United States | Arcutis Biotherapeutics Clinical Site 128 | Duncansville | Pennsylvania |
| United States | Arcutis Biotherapeutics Clinical Site 129 | East Windsor | New Jersey |
| United States | Arcutis Biotherapeutics Clinical Site 127 | Encinitas | California |
| United States | Arcutis Biotherapeutics Clinical Site 225 | Encino | California |
| United States | Arcutis Biotherapeutics Clinical Site 113 | Exton | Pennsylvania |
| United States | Arcutis Biotherapeutics Clinical Site 124 | Fairborn | Ohio |
| United States | Arcutis Biotherapeutics Clinical Site 509 | Fountain Valley | California |
| United States | Arcutis Biotherapeutics Clinical Site 112 | Fremont | California |
| United States | Arcutis Biotherapeutics Clinical Site 216 | Fridley | Minnesota |
| United States | Arcutis Biotherapeutics Clinical Site 519 | Frisco | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 202 | Hialeah | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 115 | High Point | North Carolina |
| United States | Arcutis Biotherapeutics Clinical Site 238 | Houston | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 214 | Indianapolis | Indiana |
| United States | Arcutis Biotherapeutics Clinical Site 120 | Irvine | California |
| United States | Arcutis Biotherapeutics Clinical Site 233 | Knoxville | Tennessee |
| United States | Arcutis Biotherapeutics Clinical Site 211 | Lake Charles | Louisiana |
| United States | Arcutis Biotherapeutics Clinical Site 228 | Largo | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 219 | Las Vegas | Nevada |
| United States | Arcutis Biotherapeutics Clinical Site 231 | Las Vegas | Nevada |
| United States | Arcutis Biotherapeutics Clinical Site 508 | Los Angeles | California |
| United States | Arcutis Biotherapeutics Clinical Site 217 | Louisville | Kentucky |
| United States | Arcutis Biotherapeutics Clinical Site 213 | Metairie | Louisiana |
| United States | Arcutis Biotherapeutics Clinical Site 131 | Miami | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 221 | Murfreesboro | Tennessee |
| United States | Arcutis Biotherapeutics Clinical Site 224 | New Orleans | Louisiana |
| United States | Arcutis Biotherapeutics Clinical Site 121 | New York | New York |
| United States | Arcutis Biotherapeutics Clinical Site 201 | North Miami Beach | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 137 | Ocala | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 134 | Oklahoma City | Oklahoma |
| United States | Arcutis Biotherapeutics Clinical Site 222 | Oklahoma City | Oklahoma |
| United States | Arcutis Biotherapeutics Clinical Site 135 | Pittsburgh | Pennsylvania |
| United States | Arcutis Biotherapeutics Clinical Site 114 | Plainfield | Illinois |
| United States | Arcutis Biotherapeutics Clinical Site 236 | Portsmouth | New Hampshire |
| United States | Arcutis Biotherapeutics Clinical Site 511 | Rancho Santa Margarita | California |
| United States | Arcutis Biotherapeutics Clinical Site 139 | Reno | Nevada |
| United States | Arcutis Biotherapeutics Clinical Site 240 | Reno | Nevada |
| United States | Arcutis Biotherapeutics Clinical Site 230 | Richmond | Virginia |
| United States | Arcutis Biotherapeutics Clinical Site 130 | Rochester | New York |
| United States | Arcutis Biotherapeutics Clinical Site 125 | Rockville | Maryland |
| United States | Arcutis Biotherapeutics Clinical Site 138 | Rockville | Maryland |
| United States | Arcutis Biotherapeutics Clinical Site 102 | Rolling Meadows | Illinois |
| United States | Arcutis Biotherapeutics Clinical Site 227 | Saint Joseph | Missouri |
| United States | Arcutis Biotherapeutics Clinical Site 110 | San Antonio | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 117 | San Antonio | Texas |
| United States | Arcutis Biotherapeutics Clinical Site 123 | San Diego | California |
| United States | Arcutis Biotherapeutics Clinical Site 220 | San Diego | California |
| United States | Arcutis Biotherapeutics Clinical Site 136 | San Francisco | California |
| United States | Arcutis Biotherapeutics Clinical Site 105 | Sanford | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 208 | Santa Monica | California |
| United States | Arcutis Biotherapeutics Clinical Site 215 | Santa Monica | California |
| United States | Arcutis Biotherapeutics Clinical Site 203 | Scottsdale | Arizona |
| United States | Arcutis Biotherapeutics Clinical Site 108 | Stony Brook | New York |
| United States | Arcutis Biotherapeutics Clinical Site 209 | Sweetwater | Florida |
| United States | Arcutis Biotherapeutics Clinical Site 210 | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Arcutis Biotherapeutics, Inc. |
United States, Canada, Dominican Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of treatment emergent AEs (TEAEs) | The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs | 24 weeks | |
| Secondary | Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. | 24 weeks | ||
| Secondary | In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). | 24 weeks | ||
| Secondary | Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time | 24 weeks | ||
| Secondary | Achievement of a 75% reduction in PASI over time | 24 weeks | ||
| Secondary | Achievement of a 90% reduction in PASI over time | 24 weeks | ||
| Secondary | Achievement of a 100% reduction in PASI over time | 24 weeks | ||
| Secondary | Change in Worst Itch Numeric Rating Scale) WI-NRS score over time | 24 weeks |
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