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This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Orally administered EVO756, dose 1 |
|
| Dose 2 | Experimental | Orally administered EVO756, dose 2 |
|
| Dose 3 | Experimental | Orally administered EVO756, dose 3 |
|
| Placebo control | Placebo Comparator | Orally administered placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO756 | Drug | Dose 1 |
| |
| EVO756 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in UAS7 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in UAS7 | Week 12 | |
| Mean and percent change from baseline in UAS7 | Weeks 1, 2, 4, 8 | |
| Mean and percent change from baseline in ISS7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology Skin Health Center | Birmingham | Alabama | 35244 | United States | ||
| Velocity Clinical Research, Mobile |
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| Drug |
Dose 2 |
|
| EVO756 | Drug | Dose 3 |
|
| Placebo control | Drug | Placebo control |
|
| Weeks 1, 2, 4, 8, 12 |
| Mean and percent change from baseline in HSS7 | Weeks 1, 2, 4, 8, 12 |
| Mean and percent change from baseline in AAS7 | Weeks 1, 2, 4, 8, 12 |
| Proportion of subjects achieving UAS7 ≤ 6 | Weeks 1, 2, 4, 8, 12 |
| Proportion of subjects achieving UAS7 = 0 | Weeks 1, 2, 4, 8, 12 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | United States |
| Northridge Clinical Trials | Northridge | California | 91325 | United States |
| NorthBay Clinical Research | Santa Rosa | California | 95405 | United States |
| Integrated Research of Inland | Upland | California | 91786 | United States |
| FOMAT Medical Research | Ventura | California | 93003 | United States |
| AMR Fort Myers | Fort Myers | Florida | 33912 | United States |
| Advanced Clinical Research Institute | Tampa | Florida | 33607 | United States |
| Sneeze, Wheeze & Itch Associates LLC | Normal | Illinois | 61761 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | United States |
| Hutchinson Clinic | Hutchinson | Kansas | 67502 | United States |
| Bluegrass Allergy Care | Lexington | Kentucky | 40509 | United States |
| Delricht Research Louisville | Louisville | Kentucky | 40205 | United States |
| Delricht Research Louisiana | Baton Rouge | Louisiana | 70809 | United States |
| Velocity Clinical Research, Lafayette | Lafayette | Louisiana | 70508 | United States |
| Delricht Research | New Orleans | Louisiana | 70115 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Boston Specialists | Boston | Massachusetts | 02111 | United States |
| MI Skin Innovations | Northville | Michigan | 48167 | United States |
| DelRicht Research - Town Center Dermatology | Wildwood | Missouri | 63040 | United States |
| Vitality Clinical Trials | Woodbury | New York | 11797 | United States |
| Allergy Partners Clinical Research | Asheville | North Carolina | 28803 | United States |
| Delricht Research - Priority Care | Charlotte | North Carolina | 28205 | United States |
| Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| Optima Research Boardman | Boardman | Ohio | 44512 | United States |
| DOCS Dermatology Research | Canal Winchester | Ohio | 43110 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45236 | United States |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | United States |
| AMR Myrtle Beach | Myrtle Beach | South Carolina | 29572 | United States |
| National Allergy and Asthma Research | North Charleston | South Carolina | 29420 | United States |
| Delricht Research Smyrna | Smyrna | Tennessee | 37167 | United States |
| Austin Regional Clinic ARC Clinical Research | Austin | Texas | 78726 | United States |
| Studies in Dermatology | Cypress | Texas | 77429 | United States |
| Western Sky Medical Research | El Paso | Texas | 79912 | United States |
| Delricht Research - Lockhard Matter Dermatology | Prosper | Texas | 75078 | United States |
| AMR Utah | Layton | Utah | 84041 | United States |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | United States |
| Allergy, Asthma, and Sinus Center | Greenfield | Wisconsin | 53228 | United States |
| Dandelion Allergy Centre | Mississauga | Ontario | L4W 5K3 | Canada |
| Allergy Research Canada | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Red Maple Trials | Ottawa | Ontario | K1H 1E4 | Canada |
| Centre de Recherche Saint-Louis - Montréal | Montreal | Quebec | H1Y 3L1 | Canada |
| Centre de Recherche Saint-Louis | Québec | Quebec | G1W 4R4 | Canada |
| Dermatology and Ophthalmology Kume Clinic | Sakai | Osaka | 5938324 | Japan |
| Yoshikawa Skin Clinic | Takatsuki | Osaka | 5690824 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | Osaka | 5698686 | Japan |
| Mita Dermatology | Minato-Ku | Tokyo | 1080014 | Japan |
| ThinkPark Dermatology Clinic | Shinagawa-Ku | Tokyo | 1416003 | Japan |
| Medical Corporation Jitai-kai Tachikawa Dermatology Clinic | Tachikawa | Tokyo | 1900023 | Japan |
| Ikebukuro Nishiguchi Fukurou Dermatology | Toshima-ku | Tokyo | 1710021 | Japan |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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