Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
NCT ID: NCT02074982
Last Updated: 2017-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
676 participants
INTERVENTIONAL
2014-02-26
2016-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AIN457 300 mg
patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
AIN457 300 mg
Ustekinumab
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
ustekinumab 45/90 mg
placebo secukinumab
Placebo
Interventions
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AIN457 300 mg
ustekinumab 45/90 mg
placebo secukinumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients eligible for systemic therapy with inadequately controlled psoriasis
Exclusion Criteria
* previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Hot Springs, Arkansas, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Santa Monica, California, United States
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South Miami, Florida, United States
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Arlington Heights, Illinois, United States
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Champaign, Illinois, United States
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Skokie, Illinois, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Owensboro, Kentucky, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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East Windsor, New Jersey, United States
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Forest Hills, New York, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Greer, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Phillip, Australian Capital Territory, Australia
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Sydney, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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East Melbourne, Victoria, Australia
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Ghent, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Etobicoke, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Arhus C, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Bordeaux, , France
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Brest, , France
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La Rochelle, , France
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Martigues, , France
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Nice, , France
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Augsburg, , Germany
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Bad Bentheim, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Darmstadt, , Germany
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Dessau, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Kiel, , Germany
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Ludwigshafen, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Münster, , Germany
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Münster, , Germany
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Pommelsbrunn, , Germany
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Heraklion, Crete, GR, Greece
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Budapest, , Hungary
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Szeged, , Hungary
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Afula, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Bologna, BO, Italy
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Modena, MO, Italy
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Verona, VR, Italy
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Breda, CK, Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Sneek, , Netherlands
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Zwijndrecht, , Netherlands
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Bergen, , Norway
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Banská Bystrica, Slovak Republic, Slovakia
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Kosice-Saca, Slovak Republic, Slovakia
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Bojnice, , Slovakia
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Košice, , Slovakia
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Gwangju, , South Korea
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Granada, Andalusia, Spain
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Málaga, Andalusia, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Bilbao, Basque Country, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Las Palmas de Gran Canaria, Las Palmas de G.C, Spain
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Alcorcón, Madrid, Spain
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Majadahonda, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Lausanne, , Switzerland
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Linkou District, , Taiwan
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Taipei, , Taiwan
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Balcova / Izmir, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Salford, Manchester, United Kingdom
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Dundee, Perthshire, United Kingdom
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Redhill, Surrey, United Kingdom
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Bradford, West Yorkshire, United Kingdom
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Coventry, , United Kingdom
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Harrogate, , United Kingdom
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Hull, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.
Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.
Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.
Other Identifiers
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2013-003434-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2317
Identifier Type: -
Identifier Source: org_study_id
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