Psoriasis Clinical Trial
— AMAGINE-1Official title:
A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
| Verified date | December 2019 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
| Status | Terminated |
| Enrollment | 661 |
| Est. completion date | August 2015 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Subject has had stable moderate to severe plaque psoriasis for at least 6 months - Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling - Subject has involved body surface area (BSA) = 10%, PASI = 12, and sPGA = 3 at screening and at baseline Exclusion Criteria: - Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations - Subject has known history of Crohn's disease - Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol - Subject has stopped using certain psoriasis therapies as defined in the study protocol - Subject has previously used any anti-IL-17 biologic therapy |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Moncton | New Brunswick |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | North Bay | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sudbury | Ontario |
| Canada | Research Site | Surrey | British Columbia |
| Canada | Research Site | Waterloo | Ontario |
| Canada | Research Site | Windsor | Ontario |
| France | Research Site | Nice | |
| France | Research Site | Pessac Cedex | |
| France | Research Site | Saint Priest en Jarez | |
| France | Research Site | Toulouse Cedex 9 | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Blankenfelde | |
| Germany | Research Site | Bochum | |
| Germany | Research Site | Bonn | |
| Germany | Research Site | Buchholz | |
| Germany | Research Site | Dülmen | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Friedrichshafen | |
| Germany | Research Site | Halle (Saale) | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Kiel | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Osnabrück | |
| Poland | Research Site | Iwonicz Zdroj | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Switzerland | Research Site | Basel | |
| Switzerland | Research Site | Bern | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | Lausanne | |
| Switzerland | Research Site | Zürich | |
| United States | Research Site | Alpharetta | Georgia |
| United States | Research Site | Arlington | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Encino | California |
| United States | Research Site | Forest Hills | New York |
| United States | Research Site | Fort Gratiot | Michigan |
| United States | Research Site | Goodlettsville | Tennessee |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Richmond | Kentucky |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | San Ramon | California |
| United States | Research Site | Santa Monica | California |
| United States | Research Site | Stony Brook | New York |
| United States | Research Site | West Dundee | Illinois |
| United States | Research Site | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Canada, France, Germany, Poland, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 | to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12. | 0-12 weeks | |
| Primary | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12 | 0 - 12 Weeks | |
| Secondary | Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 | to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52. | Week 0 - Week 52 |
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