Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
NCT ID: NCT01636687
Last Updated: 2018-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2012-10-17
2016-10-27
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
Subjects who were in placebo at Week 52 cannot continue in the extension treatment period
Placebo
2 injections of placebo to secukinumab 150mg per dose
Secukinumab 150 mg
After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period.
Secukinumab 150mg
Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered
Secukinumab 300 mg
After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.
Secukinumab 300mg
Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
Interventions
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Placebo
2 injections of placebo to secukinumab 150mg per dose
Secukinumab 150mg
Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered
Secukinumab 300mg
Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
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.
* 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
Phoenix, Arizona, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Oceanside, California, United States
Novartis Investigative Site
Overland Park, Kansas, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Novartis Investigative Site
Johnston, Rhode Island, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Norfolk, Virginia, United States
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Mississauga, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, Canada
Novartis Investigative Site
Tallinn, , Estonia
Novartis Investigative Site
Tallinn, , Estonia
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Poitiers, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Augsburg, , Germany
Novartis Investigative Site
Augsburg, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Gera, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Osnabrück, , Germany
Novartis Investigative Site
Selters, , Germany
Novartis Investigative Site
Tübingen, , 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.
Paul C, Lacour JP, Tedremets L, Kreutzer K, Jazayeri S, Adams S, Guindon C, You R, Papavassilis C; JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1082-90. doi: 10.1111/jdv.12751. Epub 2014 Sep 22.
Other Identifiers
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2012-002609-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2309
Identifier Type: -
Identifier Source: org_study_id
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