Moderate to Severe Plaque Psoriasis Clinical Trial
— AMAGINE-2Official 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-2
| NCT number | NCT01708603 |
| Other study ID # | 20120103 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | August 2012 |
| Est. completion date | October 2015 |
| Verified date | January 2020 |
| 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
| Status | Terminated |
| Enrollment | 1831 |
| Est. completion date | October 2015 |
| Est. primary completion date | September 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 | Benowa | Queensland |
| Australia | Research Site | Box Hill | Victoria |
| Australia | Research Site | Carlton | Victoria |
| Australia | Research Site | Gold Coast | Queensland |
| Australia | Research Site | Kogarah | New South Wales |
| Australia | Research Site | Parkville | Victoria |
| Australia | Research Site | Phillip | Australian Capital Territory |
| Australia | Research Site | Woolloongabba | Queensland |
| Austria | Research Site | Graz | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wien | |
| Canada | Research Site | Ajax | Ontario |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Mississauga | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Oakville | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Peterborough | Ontario |
| Canada | Research Site | Sudbury | Ontario |
| Canada | Research Site | Surrey | British Columbia |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Waterloo | Ontario |
| Canada | Research Site | Windsor | Ontario |
| Canada | Research Site | Windsor | Ontario |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Jihlava | |
| Czechia | Research Site | Novy Jicin | |
| Czechia | Research Site | Praha 10 | |
| Czechia | Research Site | Praha 5 | |
| Czechia | Research Site | Praha 8 | |
| Czechia | Research Site | Usti nad Labem | |
| France | Research Site | Amiens Cedex 1 | |
| France | Research Site | Besancon Cedex | |
| France | Research Site | Brest Cedex | |
| France | Research Site | Clermont-Ferrand | |
| France | Research Site | Marseille cedex 05 | |
| France | Research Site | Montpellier cedex 5 | |
| France | Research Site | Paris Cedex 10 | |
| France | Research Site | Pessac Cedex | |
| France | Research Site | Pierre-Bénite | |
| France | Research Site | Rouen Cedex | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Kecskemet | |
| Hungary | Research Site | Miskolc | |
| Hungary | Research Site | Nyiregyhaza | |
| Hungary | Research Site | Veszprem | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Breda | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Tarnow | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Wroclaw | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Porto | |
| Spain | Research Site | A Coruña | Galicia |
| Spain | Research Site | Alcañiz | Aragón |
| Spain | Research Site | Alcorcon | Madrid |
| Spain | Research Site | Badalona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Cordoba | AndalucÃ-a |
| Spain | Research Site | Córdoba | AndalucÃ-a |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Manacor | Baleares |
| Spain | Research Site | Sevilla | AndalucÃ-a |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| United States | Research Site | Anderson | South Carolina |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Aventura | Florida |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Beachwood | Ohio |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Carmel | Indiana |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Fridley | Minnesota |
| United States | Research Site | Gahanna | Ohio |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hot Springs | Arkansas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Irvine | California |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | New Haven | Connecticut |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Newnan | Georgia |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | North Andover | Massachusetts |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plainfield | Indiana |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Roanoke | Virginia |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Rockville | Maryland |
| United States | Research Site | Sacramento | California |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Silver Spring | Maryland |
| United States | Research Site | Skokie | Illinois |
| United States | Research Site | Snellville | Georgia |
| United States | Research Site | South Bend | Indiana |
| United States | Research Site | South Euclid | Ohio |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Vista | California |
| United States | Research Site | West Jordan | Utah |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Australia, Austria, Canada, Czechia, France, Hungary, Netherlands, Poland, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear). | 12 weeks | |
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12. | 12 weeks | |
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12. | 12 Weeks |
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