Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2016-12-12
2018-06-08
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
QUADRUPLE
Study Groups
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Placebo
Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
Placebo
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
Secukinumab 2 mL form
Secukinumab 300 mg, provided in a 2 mL pre-filled syringe
Secukinumab 2 mL form
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Secukinumab 1 mL form
Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
Secukinumab 1 mL form
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Interventions
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Placebo
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
Secukinumab 2 mL form
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Secukinumab 1 mL form
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Eligibility Criteria
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Inclusion Criteria
1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
2. Men or women of at least 18 years of age at the time of Screening.
3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
4. Moderate to severe psoriasis as defined at Randomization by:
* PASI score of 12 or greater, and
* IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
* Topical treatment and/or
* Phototherapy and/or
* Previous systemic therapy
Exclusion Criteria
2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited.
Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
5. 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 hCG laboratory test.
6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
7. History of hypersensitivity to any of study drug constituent
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Fountain Valley, California, United States
Novartis Investigative Site
Fremont, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Marietta, Georgia, United States
Novartis Investigative Site
Savannah, Georgia, United States
Novartis Investigative Site
Saint Joseph, Missouri, United States
Novartis Investigative Site
Verona, New Jersey, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Sugar Land, Texas, United States
Novartis Investigative Site
Norfolk, Virginia, United States
Novartis Investigative Site
Tacoma, Washington, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Surrey, British Columbia, Canada
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Kopavogur, , Iceland
Novartis Investigative Site
Daugavpils, LVA, Latvia
Novartis Investigative Site
Jelgava, LVA, Latvia
Novartis Investigative Site
Riga, LVA, Latvia
Novartis Investigative Site
Ventspils, LVA, Latvia
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Olsztyn, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Chelyabinsk, , Russia
Novartis Investigative Site
Kazan', , Russia
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Sant Joan Despí, Barcelona, Spain
Novartis Investigative Site
Bilbao, Bizkaia, Spain
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Pontevedra, , Spain
Novartis Investigative Site
Bursa, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Dudley, West Midlands, United Kingdom
Novartis Investigative Site
Cambridge, , United Kingdom
Novartis Investigative Site
Dundee, , United Kingdom
Novartis Investigative Site
Surrey, , United Kingdom
Countries
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References
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Sigurgeirsson B, Schakel K, Hong CH, Effendy I, Placek W, Rich P, Keefe D, Bruin G, Charef P, Fu R, Hampele I, Patekar M. Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study. J Dermatolog Treat. 2022 May;33(3):1718-1726. doi: 10.1080/09546634.2021.1902925. Epub 2021 Apr 26.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CAIN457A2323
Identifier Type: -
Identifier Source: org_study_id
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