Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
16487 participants
INTERVENTIONAL
2015-05-07
2017-05-08
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
DOUBLE
Study Groups
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Secukinumab 300mg in PASI 90 responders (every 4 weeks)
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
Secukinumab
Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
Secukinumab 300mg in PASI 90 responders (longer intervals)
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 6 weeks.
Secukinumab
Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
Secukinumab
Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
Secukinumab 300mg in PASI 75-90 responders (shorter intervals)
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.
Secukinumab
Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
Interventions
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Secukinumab
Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe psoriasis at Baseline as evidenced by:
* PASI ≥ 10 and
* IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
* BSA affected by plaque-type psoriasis of ≥ 10%.
Exclusion Criteria
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
6. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.
9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
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
Locations
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Novartis Investigative Site
Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Jette, Brussels Capital, Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Loverval, , Belgium
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Sofia, BGR, Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Ivanić-Grad, , Croatia
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Osijek, , Croatia
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Zagreb, , Croatia
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Brno, Czech Republic, Czechia
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Ostrava Poruba, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Arhus C, , Denmark
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Hellerup, , Denmark
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Tampere, , Finland
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Turku, , Finland
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Le Mans, Cedex 09, France
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Bordeaux, , France
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Dijon, , France
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Grenoble, , France
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Lille, , France
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Montpellier, , France
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Nice, , France
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Rouen, , France
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Saint-Etienne, , France
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Toulouse, , France
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Trévenans, , France
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Vandœuvre-lès-Nancy, , France
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Augsburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Braunschweig, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanau, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Pommelsbrunn, , Germany
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Schwerin, , Germany
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Stade, , Germany
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Stuttgart, , Germany
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Ulm, , Germany
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Larissa, GR, Greece
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Thessaloniki, GR, Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Kecskemét, Bács-Kiskun county, Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Afula, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bolzano, BZ, Italy
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Messina, ME, Italy
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Modena, MO, Italy
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Palermo, PA, Italy
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Roma, RM, Italy
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Daugavpils, LVA, Latvia
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Riga, LVA, Latvia
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Ventspils, LVA, Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, LTU, Lithuania
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Klaipėda, LTU, Lithuania
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Kaunas, LT, Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Breda, CK, Netherlands
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Alkmaar, , Netherlands
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Almere Stad, , Netherlands
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Bergen op Zoom, , Netherlands
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Geldrop, , Netherlands
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Leiderdorp, , Netherlands
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Sittard-Geleen, , Netherlands
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Voorburg, , Netherlands
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Ossy, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Braga, , Portugal
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Coimbra, , Portugal
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Leiria, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Chelyabinsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Rostov on Don Region, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Bojnice, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Považská Bystrica, , Slovakia
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Svidník, , Slovakia
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Villajoyosa, Alicante, Spain
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Córdoba, Andalusia, Spain
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Granada, Andalusia, Spain
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Málaga, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Seville, Andalusia, Spain
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Palma de Mallorca, Balearic Islands, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Sant Joan Despí, Barcelona, Spain
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Bilbao, Basque Country, Spain
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Santander, Cantabria, Spain
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León, Castille and León, Spain
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Salamanca, Castille and León, 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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Barcelona, Catalonia, Spain
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A Coruña, Galicia, Spain
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Santiago de Compostela, Galicia, 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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Fuenlabrada, Madrid, Spain
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San Sebastián de los Reyes, Madrid, Spain
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Mallorca, Mallorca, Spain
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Pamplona, Navarre, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Alicante, Valencia, Spain
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Alzira, Valencia, Spain
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Castellon, Valencia, Spain
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Manises, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Barcelona, , Spain
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Huesca, , 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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Madrid, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Pontevedra, , Spain
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Zaragoza, , Spain
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Falun, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Canterbury, Kent, United Kingdom
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Salford, Manchester, United Kingdom
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Cliftonville, Northampton, United Kingdom
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Cannock, Staffordshire, United Kingdom
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Dudley, West Midlands, United Kingdom
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Leeds, West Yorkshire, United Kingdom
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Cambridge, , United Kingdom
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Harrogate, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CAIN457A3302
Identifier Type: -
Identifier Source: org_study_id
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