Psoriasis Clinical Trial

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Summary

The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
Inadequate control of symptoms with NSAID.
Other protocol-defined inclusion criteria do apply.

Exclusion Criteria:

Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
Subjects taking high potency opioid analgesics.
Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
Ongoing use of prohibited psoriasis treatments / medications.
Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
Previous treatment with any cell-depleting therapies.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

341

Study ID:

NCT02294227

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 64 Locations for this study

See Locations Near You

Novartis Investigative Site
Mesa Arizona, 85202, United States
Novartis Investigative Site
Upland California, 91786, United States
Novartis Investigative Site
Denver Colorado, 80230, United States
Novartis Investigative Site
Palm Harbor Florida, 34684, United States
Novartis Investigative Site
Sarasota Florida, 34239, United States
Novartis Investigative Site
Peoria Illinois, 61602, United States
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Shreveport Louisiana, 71101, United States
Novartis Investigative Site
Saint Clair Shores Michigan, 48081, United States
Novartis Investigative Site
Saint Louis Missouri, 63117, United States
Novartis Investigative Site
Lincoln Nebraska, 68516, United States
Novartis Investigative Site
Albany New York, 12206, United States
Novartis Investigative Site
Oklahoma City Oklahoma, 73103, United States
Novartis Investigative Site
Duncansville Pennsylvania, 16635, United States
Novartis Investigative Site
Charleston South Carolina, 29460, United States
Novartis Investigative Site
Greenville South Carolina, 29601, United States
Novartis Investigative Site
Mesquite Texas, 75150, United States
Novartis Investigative Site
Burlington Vermont, 05401, United States
Novartis Investigative Site
Seattle Washington, 98104, United States
Novartis Investigative Site
Seattle Washington, 98122, United States
Novartis Investigative Site
Kogarah New South Wales, 2217, Australia
Novartis Investigative Site
Maroochydore Queensland, 4558, Australia
Novartis Investigative Site
Hobart Tasmania, 7000, Australia
Novartis Investigative Site
Malvern East Victoria, 3145, Australia
Novartis Investigative Site
Aalst , 9300, Belgium
Novartis Investigative Site
Bruxelles , 1070, Belgium
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Yvoir , 5530, Belgium
Novartis Investigative Site
Plovdiv , 4000, Bulgaria
Novartis Investigative Site
Sofia , 1431, Bulgaria
Novartis Investigative Site
Victoria British Columbia, V8V 3, Canada
Novartis Investigative Site
Winnipeg Manitoba, R3A 1, Canada
Novartis Investigative Site
Pointe-Claire Quebec, H9R 3, Canada
Novartis Investigative Site
Trois Rivieres Quebec, G8Z 1, Canada
Novartis Investigative Site
Bruntal Czech Republic, 792 0, Czechia
Novartis Investigative Site
Hlucin Czech Republic, 748 0, Czechia
Novartis Investigative Site
Praha 2 Czech Republic, 128 5, Czechia
Novartis Investigative Site
Praha 4 Czech Republic, 140 0, Czechia
Novartis Investigative Site
Uherske Hradiste Czech Republic, 686 0, Czechia
Novartis Investigative Site
Le Mans , 72037, France
Novartis Investigative Site
Montpellier , 34195, France
Novartis Investigative Site
Erlangen , 91054, Germany
Novartis Investigative Site
Frankfurt am Main , 60528, Germany
Novartis Investigative Site
Gottingen , 37075, Germany
Novartis Investigative Site
Hamburg , 20095, Germany
Novartis Investigative Site
Hamburg , 22415, Germany
Novartis Investigative Site
Herne , 44649, Germany
Novartis Investigative Site
Magdeburg , 39110, Germany
Novartis Investigative Site
Nienburg , 31582, Germany
Novartis Investigative Site
Rozzano MI, 20089, Italy
Novartis Investigative Site
Verona VR, 37126, Italy
Novartis Investigative Site
Bologna , 40138, Italy
Novartis Investigative Site
Bialystok , 15-46, Poland
Novartis Investigative Site
Dopiewo , 62 06, Poland
Novartis Investigative Site
Elblag , 82-30, Poland
Novartis Investigative Site
Lodz , 90-26, Poland
Novartis Investigative Site
Poznan , 60-21, Poland
Novartis Investigative Site
Poznan , 61 11, Poland
Novartis Investigative Site
Ekaterinburg , 62002, Russian Federation
Novartis Investigative Site
Ekaterinburg , 62003, Russian Federation
Novartis Investigative Site
Petrozavodsk , 18501, Russian Federation
Novartis Investigative Site
St Petersburg , 19006, Russian Federation
Novartis Investigative Site
Yaroslavl , 15000, Russian Federation
Novartis Investigative Site
Stockholm , SE-17, Sweden
Novartis Investigative Site
Leytonstone London, E11 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

341

Study ID:

NCT02294227

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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