Plaque Psoriasis Clinical Trial
— AMAGINE-3Official title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
| 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 at two different
doses compared with placebo in participants with moderate to severe plaque psoriasis.
A second purpose of this study is to assess the safety and efficacy brodalumab at two
different doses compared with ustekinumab in participants with moderate to severe plaque
psoriasis.
A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens
of brodalumab.
| Status | Terminated |
| Enrollment | 1881 |
| Est. completion date | October 2015 |
| Est. primary completion date | August 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 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 not stopped using certain psoriasis therapies as defined in the study protocol - Subject has previously used ustekinumab or any anti-IL-17 biologic therapy - Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study - Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Camperdown | New South Wales |
| Australia | Research Site | Darlinghurst | New South Wales |
| Australia | Research Site | Fremantle | Western Australia |
| Australia | Research Site | Hectorville | South Australia |
| Australia | Research Site | Kogarah | New South Wales |
| Australia | Research Site | St Leonards | New South Wales |
| Australia | Research Site | Sydney | New South Wales |
| Australia | Research Site | Westmead | New South Wales |
| Belgium | Research Site | Brugge | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Liege | |
| Belgium | Research Site | Montigny-le-Tilleul | |
| Canada | Research Site | Barrie | Ontario |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Drummondville | Quebec |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Markham | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Richmond Hill | Ontario |
| Canada | Research Site | Saint-Hyacinthe | Quebec |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Winnipeg | Manitoba |
| Canada | Research Site | Winnipeg | Manitoba |
| France | Research Site | Créteil | |
| France | Research Site | Limoges | |
| France | Research Site | Nice | |
| France | Research Site | Poitiers | |
| France | Research Site | Saint Priest en Jarez | |
| France | Research Site | Toulouse Cedex 9 | |
| France | Research Site | Vandoeuvre les Nancy | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Chaïdári | Athens |
| Greece | Research Site | Ioannina | |
| Greece | Research Site | Larissa | |
| Greece | Research Site | Maroussi | |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Thessaloniki | |
| Hungary | Research Site | Bekescsaba | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Szolnok | |
| Hungary | Research Site | Szombathely | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Roma | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Ventspils | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Dabrówka | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Iwonicz Zdroj | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Stalowa-Wola | |
| Poland | Research Site | Swidnik | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | St. Petersburg | |
| United States | Research Site | Alpharetta | Georgia |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Arlington Heights | Illinois |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Bartlett | Tennessee |
| United States | Research Site | Bellaire | Texas |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Boise | Idaho |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Burbank | California |
| United States | Research Site | Champaign | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clarksburg | West Virginia |
| United States | Research Site | Clarkston | Michigan |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Clinton Township | Michigan |
| United States | Research Site | Coral Gables | Florida |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | East Windsor | New Jersey |
| United States | Research Site | Encino | California |
| United States | Research Site | Exton | Pennsylvania |
| United States | Research Site | Farmington | Connecticut |
| United States | Research Site | Fremont | California |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Greer | South Carolina |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | High Point | North Carolina |
| United States | Research Site | Hoboken | New Jersey |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Irvine | California |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Johnston | Rhode Island |
| United States | Research Site | Lake Oswego | Oregon |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Macon | Georgia |
| United States | Research Site | Maywood | Illinois |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Albany | Indiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Normal | Illinois |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Owensboro | Kentucky |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Tamarac | Florida |
| United States | Research Site | Trumbull | Connecticut |
| United States | Research Site | Verona | New Jersey |
| United States | Research Site | Webster | Texas |
| United States | Research Site | Wheaton | Illinois |
| United States | Research Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Australia, Belgium, Canada, France, Greece, Hungary, Italy, Latvia, Poland, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed. | 12 weeks | |
| Primary | Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo | Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear). | 12 weeks |
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