Chronic Plaque Type Psoriasis Clinical Trial
| Verified date | April 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis
| Status | Completed |
| Enrollment | 676 |
| Est. completion date | June 28, 2016 |
| Est. primary completion date | June 28, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients with moderate to severe plaque type psoriasis for at least 6 months before randomization - patients eligible for systemic therapy with inadequately controlled psoriasis Exclusion Criteria: - forms of sporiasis other than plaque type psoriasis - previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA Other protocol-defined inclusion/exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | East Melbourne | Victoria |
| Australia | Novartis Investigative Site | Phillip | Australian Capital Territory |
| Australia | Novartis Investigative Site | Sydney | New South Wales |
| Australia | Novartis Investigative Site | Woolloongabba | Queensland |
| Austria | Novartis Investigative Site | Innsbruck | |
| Austria | Novartis Investigative Site | Linz | |
| Austria | Novartis Investigative Site | Vienna | |
| Austria | Novartis Investigative Site | Wien | |
| Belgium | Novartis Investigative Site | Gent | |
| Belgium | Novartis Investigative Site | Liege | |
| Belgium | Novartis Investigative Site | Namur | |
| Bulgaria | Novartis Investigative Site | Pleven | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Varna | |
| Canada | Novartis Investigative Site | Etobicoke | Ontario |
| Canada | Novartis Investigative Site | Hamilton | Ontario |
| Canada | Novartis Investigative Site | Mississauga | Ontario |
| Canada | Novartis Investigative Site | Sainte-Foy | Quebec |
| Denmark | Novartis Investigative Site | Arhus C | |
| Estonia | Novartis Investigative Site | Tallinn | |
| Estonia | Novartis Investigative Site | Tartu | |
| France | Novartis Investigative Site | Bordeaux | |
| France | Novartis Investigative Site | Brest | |
| France | Novartis Investigative Site | La Rochelle | |
| France | Novartis Investigative Site | Martigues | |
| France | Novartis Investigative Site | Nice Cedex 3 | |
| Germany | Novartis Investigative Site | Augsburg | |
| Germany | Novartis Investigative Site | Bad Bentheim | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bielefeld | |
| Germany | Novartis Investigative Site | Bochum | |
| Germany | Novartis Investigative Site | Darmstadt | |
| Germany | Novartis Investigative Site | Dessau-Rosslau | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Erlangen | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Lubeck | |
| Germany | Novartis Investigative Site | Ludwigshafen | |
| Germany | Novartis Investigative Site | Mainz | |
| Germany | Novartis Investigative Site | Muenster | |
| Germany | Novartis Investigative Site | Münster | |
| Germany | Novartis Investigative Site | Pommelsbrunn | |
| Greece | Novartis Investigative Site | Heraklion, Crete | GR |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Szeged | |
| Israel | Novartis Investigative Site | Afula | |
| Israel | Novartis Investigative Site | Petach Tikva | |
| Israel | Novartis Investigative Site | Tel Aviv | |
| Israel | Novartis Investigative Site | Tel Aviv | |
| Italy | Novartis Investigative Site | Bologna | BO |
| Italy | Novartis Investigative Site | Modena | MO |
| Italy | Novartis Investigative Site | Verona | VR |
| Korea, Republic of | Novartis Investigative Site | Gwangju | |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Netherlands | Novartis Investigative Site | Breda | CK |
| Netherlands | Novartis Investigative Site | Nijmegen | |
| Netherlands | Novartis Investigative Site | Rotterdam | |
| Netherlands | Novartis Investigative Site | Sneek | |
| Netherlands | Novartis Investigative Site | Zwijndrecht | |
| Norway | Novartis Investigative Site | Bergen | |
| Portugal | Novartis Investigative Site | Coimbra | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Lisbon | |
| Portugal | Novartis Investigative Site | Porto | |
| Portugal | Novartis Investigative Site | Porto | |
| Slovakia | Novartis Investigative Site | Banska Bystrica | Slovak Republic |
| Slovakia | Novartis Investigative Site | Bojnice | |
| Slovakia | Novartis Investigative Site | Kosice | |
| Slovakia | Novartis Investigative Site | Kosice-Saca | Slovak republic |
| Spain | Novartis Investigative Site | Alcorcon | Madrid |
| Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Badalona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Bilbao | Pais Vasco |
| Spain | Novartis Investigative Site | Granada | Andalucia |
| Spain | Novartis Investigative Site | Hospitalet de Llobregat | Barcelona |
| Spain | Novartis Investigative Site | Las Palmas de Gran Canaria | Las Palmas de G.C |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Majadahonda | Madrid |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Oviedo | Asturias |
| Spain | Novartis Investigative Site | San Sebastian | Pais Vasco |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Switzerland | Novartis Investigative Site | Lausanne | |
| Taiwan | Novartis Investigative Site | Lin-Kou | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Turkey | Novartis Investigative Site | Balcova / Izmir | |
| Turkey | Novartis Investigative Site | Bursa | |
| United Kingdom | Novartis Investigative Site | Bradford | West Yorkshire |
| United Kingdom | Novartis Investigative Site | Coventry | |
| United Kingdom | Novartis Investigative Site | Dundee | Perthshire |
| United Kingdom | Novartis Investigative Site | Harrogate | |
| United Kingdom | Novartis Investigative Site | Hull | |
| United Kingdom | Novartis Investigative Site | Redhill | Surrey |
| United Kingdom | Novartis Investigative Site | Salford | Manchester |
| United Kingdom | Novartis Investigative Site | Stoke-on-Trent | |
| United States | Novartis Investigative Site | Arlington Heights | Illinois |
| United States | Novartis Investigative Site | Birmingham | Alabama |
| United States | Novartis Investigative Site | Boston | Massachusetts |
| United States | Novartis Investigative Site | Champaign | Illinois |
| United States | Novartis Investigative Site | Dallas | Texas |
| United States | Novartis Investigative Site | East Windsor | New Jersey |
| United States | Novartis Investigative Site | Forest Hills | New York |
| United States | Novartis Investigative Site | Greer | South Carolina |
| United States | Novartis Investigative Site | Hot Springs | Arkansas |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Indianapolis | Indiana |
| United States | Novartis Investigative Site | Los Angeles | California |
| United States | Novartis Investigative Site | Mobile | Alabama |
| United States | Novartis Investigative Site | Norfolk | Virginia |
| United States | Novartis Investigative Site | Oceanside | California |
| United States | Novartis Investigative Site | Overland Park | Kansas |
| United States | Novartis Investigative Site | Owensboro | Kentucky |
| United States | Novartis Investigative Site | Phoenix | Arizona |
| United States | Novartis Investigative Site | Portland | Oregon |
| United States | Novartis Investigative Site | Portland | Oregon |
| United States | Novartis Investigative Site | San Antonio | Texas |
| United States | Novartis Investigative Site | Santa Monica | California |
| United States | Novartis Investigative Site | Seattle | Washington |
| United States | Novartis Investigative Site | Skokie | Illinois |
| United States | Novartis Investigative Site | South Miami | Florida |
| United States | Novartis Investigative Site | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Norway, Portugal, Slovakia, Spain, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | PASI 90 | Proportion of PASI 90 responders at Week 52 | 52 weeks | |
| Primary | PASI 90 | Proportion of PASI 90 responders at Week 16 | 16 weeks | |
| Secondary | Speed of onset | Proportion of subjects achieving PASI75 at Week 4 | 4 weeks |