Psoriasis Clinical Trial

Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

Summary

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects with chronic, plaque-type psoriasis for at least 6 months
Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)

Exclusion Criteria:

Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
Drug induced psoriasis
Use of other psoriasis treatments during the study
Prior use of etanercept
Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor
Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.
History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
Allergy to rubber or latex

Other protocol-defined inclusion/exclusion criteria may apply

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1306

Study ID:

NCT01358578

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 146 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35205, United States
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Phoenix Arizona, 85013, United States
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San Diego California, 92103, United States
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San Diego California, 92123, United States
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Indianapolis Indiana, 46256, United States
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High Point North Carolina, 27262, United States
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Warren Ohio, 44483, United States
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Portland Oregon, 97210, United States
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Johnston Rhode Island, 02919, United States
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Charleston South Carolina, 29407, United States
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Kingsport Tennessee, 37660, United States
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San Antonio Texas, 78229, United States
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Norfolk Virginia, 23507, United States
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Caba Buenos Aires, C1062, Argentina
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Caba Buenos Aires, C1114, Argentina
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Caba Buenos Aires, C1181, Argentina
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Caba Buenos Aires, C1425, Argentina
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Caba Capital Federal, , Argentina
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Buenos Aires , C1425, Argentina
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Mendoza , M5502, Argentina
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Kogarah New South Wales, 2217, Australia
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Woolloongabba Queensland, 4102, Australia
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Carlton Victoria, 3053, Australia
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East Melbourne Victoria, 3002, Australia
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Brussel , 1090, Belgium
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Liège , 4000, Belgium
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Edmonton Alberta, T5K 1, Canada
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Surrey British Columbia, V3V 0, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Markham Ontario, L3P 1, Canada
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Richmond Hil Ontario, L4B 1, Canada
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Waterloo Ontario, N2J 1, Canada
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Sainte-Foy Quebec, G1V 4, Canada
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Barranquilla , , Colombia
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Bogotá , , Colombia
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Bucaramanga , , Colombia
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Alexandria , 21131, Egypt
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Helsinki , 00250, Finland
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Turku , FIN-2, Finland
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Marseille Cedex 9 , 13913, France
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Martigues , 13500, France
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Nice Cedex 3 , 06202, France
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Paris , 75475, France
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Pessac Cedex , 33604, France
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Reims , 51092, France
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Toulouse Cedex , 31059, France
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Augsburg , 86179, Germany
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Berlin , 10117, Germany
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Berlin , 10827, Germany
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Berlin , 13187, Germany
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Bielefeld , 33647, Germany
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Bochum , 44791, Germany
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Bochum , 44803, Germany
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Bonn , 53105, Germany
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Darmstadt , 64283, Germany
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Dresden , 01307, Germany
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Erfurt , 99089, Germany
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Erlangen , 91052, Germany
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Essen , 45122, Germany
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Frankfurt , 60590, Germany
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Gera , 07548, Germany
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Goettingen , 37075, Germany
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Greifswald , 17475, Germany
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Hamburg , 20354, Germany
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Hamburg , 22143, Germany
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Hamburg , 22391, Germany
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Hanau , 63450, Germany
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Heidelberg , 69115, Germany
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Kiel , 24105, Germany
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Krefeld , 47805, Germany
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Köln , 50937, Germany
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Muenster , 48149, Germany
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München , 80802, Germany
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Nuernberg , 90419, Germany
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Osnabrück , 49074, Germany
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Plauen , 08529, Germany
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Recklinghausen , 45657, Germany
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Regensburg , 93053, Germany
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Schwerin , 19055, Germany
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Tuebingen , 72076, Germany
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Witten , 58452, Germany
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Wuppertal , 42275, Germany
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Guatemala City , 01010, Guatemala
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Guatemala City , 01015, Guatemala
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Budapest , 1036, Hungary
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Budapest , 1134, Hungary
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Debrecen , 4032, Hungary
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Kaposvár , 7400, Hungary
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Miskolc , 3529, Hungary
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Szeged , H-672, Hungary
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Szombathely , 9700, Hungary
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Kopavogur , IS-20, Iceland
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Hyderabad Andhra Pradesh, 50000, India
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Hyderabad Andhra Pradesh, 50001, India
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Vishakhapatnam Andhra Pradesh, 532 0, India
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Bangalore Karnataka, 40003, India
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Bangalore Karnataka, 56000, India
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Bangalore Karnataka, 56000, India
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Mangalore Karnataka, 57500, India
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Dadar (east) Mumbai Maharashtra, 40001, India
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Mumbai Maharashtra, 400 0, India
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Nagpur Maharashtra, 44001, India
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Dehli New Delhi, 110 0, India
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Hyderabad , 50004, India
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L'Aquila AQ, 67100, Italy
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Catania CT, 95123, Italy
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Genova GE, 16132, Italy
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Terracina LT, 04019, Italy
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Modena MO, 41100, Italy
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Roma RM, 00167, Italy
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Napoli , 80131, Italy
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Anyang Gyeonggi-do, 431-0, Korea, Republic of
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Seoul Korea, 135-7, Korea, Republic of
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Busan , 602-7, Korea, Republic of
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Daejeon , 301-7, Korea, Republic of
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Gwangju , 501-5, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Seoul , 137-7, Korea, Republic of
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Seoul , 143-7, Korea, Republic of
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Seoul , 156-7, Korea, Republic of
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Seoul , 738-7, Korea, Republic of
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Las Pinas , 1740, Philippines
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Manila , 1000, Philippines
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Lodz , 90-26, Poland
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Lodz , 90-43, Poland
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Poznan , 60-52, Poland
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Wroclaw , 50-36, Poland
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Bucuresti , 01146, Romania
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Bucuresti , 02110, Romania
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Bucuresti , 04133, Romania
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Bucuresti , 06227, Romania
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Singapore , 11907, Singapore
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Sabadell Barcelona, 08208, Spain
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Santa Coloma De Gramanet Cataluña, 08923, Spain
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Valencia Comunidad Valenciana, 46014, Spain
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Barcelona , 08025, Spain
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Madrid , 28031, Spain
Novartis Investigative Site
Madrid , 28041, Spain
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Göteborg , 413 4, Sweden
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Luleå , 972 3, Sweden
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Malmo , SE-20, Sweden
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Uppsala , 751 8, Sweden
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Plymouth Devon, PL6 8, United Kingdom
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Salford Manchester, M6 8H, United Kingdom
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Yeovil Somerset, BA21 , United Kingdom
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Dudley , DY1 2, United Kingdom
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Harrogate , HG2 7, United Kingdom
Novartis Investigative Site
London , E11 1, United Kingdom
Novartis Investigative Site
Nuneaton , CV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1306

Study ID:

NCT01358578

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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