First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
NCT ID: NCT01555125
Last Updated: 2018-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
177 participants
INTERVENTIONAL
2012-05-08
2016-10-24
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 150 mg
Drug
secukinumab 150 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
secukinumab 300 mg
Drug
secukinumab 300 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
placebo
placebo
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
Interventions
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secukinumab 150 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
secukinumab 300 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
placebo
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
Eligibility Criteria
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Inclusion Criteria
* Severity of psoriasis disease meeting all of the following three criteria:
Psoriasis Area and Severity Index (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.
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
Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Glendale, Arizona, United States
Novartis Investigative Site
Hot Springs, Arkansas, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Newnan, Georgia, United States
Novartis Investigative Site
Skokie, Illinois, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Fridley, Minnesota, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Lake Oswego, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Goodlettsville, Tennessee, United States
Novartis Investigative Site
Austin, Texas, United States
Novartis Investigative Site
Bryan, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
North Bay, Ontario, Canada
Novartis Investigative Site
Waterloo, Ontario, Canada
Novartis Investigative Site
Québec, , Canada
Novartis Investigative Site
Tallinn, , Estonia
Novartis Investigative Site
Tartu, , Estonia
Novartis Investigative Site
Martigues, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Gera, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Osnabrück, , Germany
Countries
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References
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Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
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.
Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.
Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.
Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.
Other Identifiers
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2011-006057-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2308
Identifier Type: -
Identifier Source: org_study_id
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