Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
NCT ID: NCT01406938
Last Updated: 2015-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
967 participants
INTERVENTIONAL
2011-08-31
2013-05-31
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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AIN457150 mg- Induction period Only(IPO)
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
AIN457 300 mg - IPO
secukinumab- 2 x 150mg injections per dose
AIN457 300mg
secukinumab 150 mg (2 injections per dose)
AIN457 150 mg - Fixed Interval (FI)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
AIN457 300 mg FI
2 s.c. secukinumab 150 mg injections
AIN457 300mg
secukinumab 150 mg (2 injections per dose)
AIN457 150 mg- Start of relapse (SoR)
1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
AIN457 300 mg- SoR
2 s.c. secukinumab 150 mg injections
AIN457 300mg
secukinumab 150 mg (2 injections per dose)
Interventions
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AIN457 150mg
(1 injection per dose) and placebo to secukinumab 150 mg
AIN457 300mg
secukinumab 150 mg (2 injections per dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Severity of disease meeting all of the following three criteria:
* PASI score of 12 or greater,
* Investigator's Global Assessment (IGA) score of 3 or greater
* Total body surface area (BSA) affected of 10% or greater.
* Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion Criteria
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women.
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
Fresno, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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South Miami, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Champaign, Illinois, United States
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Skokie, Illinois, United States
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Springfield, 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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Fridley, Minnesota, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Verona, New Jersey, United States
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Greensboro, North Carolina, United States
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High Point, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Goodlettsville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Wels, Austria, Austria
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Graz, , Austria
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Linz, , Austria
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Vienna, , Austria
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Sofia, Bulgaria, Bulgaria
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Barrie, Ontario, Canada
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Oakville, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Brno - Bohunice, Czech Republic, Czechia
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Hradec Králové, CZE, Czechia
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Prague, CZE, Czechia
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České Budějovice, , Czechia
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Nový Jičín, , Czechia
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Prague, , Czechia
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Toulouse, France, France
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Antony, , France
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Nice, , France
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Pierre-Benite Cédex, , France
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Rouen, , France
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Münster, Germany, Germany
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Bad Wildbad, , Germany
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Bochum, , Germany
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Buchholz I. D. Nordheide, , Germany
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Cologne, , Germany
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Dippoldiswalde-Schmiedeberg, , Germany
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Duisburg, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Mahlow, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Pommelsbrunn, , Germany
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Wuppertal, , Germany
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Roma, RM, Italy
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Roma, RM, Italy
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Siena, SI, Italy
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Verona, VR, Italy
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Nagoya, Aichi-ken, Japan
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Kisarazu, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Osaka, Osaka, Japan
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Shimotsuke, Tochigi, Japan
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Chiyoda-ku, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Lodz, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Košice, Slovak Republic, Slovakia
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Košice, Slovakia, Slovakia
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Poprad, Slovakia, Slovakia
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Svidník, Slovakia, Slovakia
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Žilina, Slovakia, Slovakia
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Bratislava, , Slovakia
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Bern, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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London, England, United Kingdom
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Birmingham, , United Kingdom
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Blackpool, , United Kingdom
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Leicester, , United Kingdom
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Poole, , United Kingdom
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Hanoi, Vietnam, Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.
Other Identifiers
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2011-000767-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2304
Identifier Type: -
Identifier Source: org_study_id
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