Psoriasis Clinical Trial

Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

Summary

This study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.

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Full Description

This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening (SCR) period running up to 10 weeks before randomization was used to assess subject eligibility followed by a treatment period of 52 weeks.

At baseline, 381 patients with active psoriatic arthritis were randomized to one of the two treatment groups in a 1:1 randomization:

Group 1: Approximately 190 patients with active psoriatic arthritis; These patients received secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4.

Group 2: Approximately 190 patients with active psoriatic arthritis; These patients received i.v. placebo at BSL and at Weeks 4, 8, and 12, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 16.

Study consisted of 4 periods: a screening period (up to 10 weeks), treatment period 1 (total duration of 16 weeks) and treatment period 2 (total duration of 36 weeks) followed by a safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52).

Primary endpoint analysis will be performed with Week 16 data (last patient completing Treatment period 1 (Week 16). Long-term efficacy and safety assessments will be performed up to Week 52.

View Eligibility Criteria

Eligibility Criteria

Patients eligible for inclusion in this study had to fulfill all of the following criteria:

Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
Rheumatoid factor and anti-CCP antibodies negative at screening
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis
Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 16
Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash-out periods need to be observed:
Oral or topical retinoids- 4 weeks
Photochemotherapy (e.g. PUVA)- 4 weeks
Phototherapy (UVA or UVB)- 2 weeks
Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks
Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization.
Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization.
Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved).
Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα.
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

381

Study ID:

NCT04209205

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 80 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35205, United States
Novartis Investigative Site
Fountain Valley California, 92708, United States
Novartis Investigative Site
Fullerton California, 92835, United States
Novartis Investigative Site
La Mesa California, 91942, United States
Novartis Investigative Site
Santa Monica California, 90404, United States
Novartis Investigative Site
Upland California, 91786, United States
Novartis Investigative Site
Van Nuys California, 91405, United States
Novartis Investigative Site
West Hills California, 91307, United States
Novartis Investigative Site
Denver Colorado, 80230, United States
Novartis Investigative Site
Clearwater Florida, 33765, United States
Novartis Investigative Site
Miami Florida, 33032, United States
Novartis Investigative Site
Ocoee Florida, 34761, United States
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Plantation Florida, 33324, United States
Novartis Investigative Site
Tampa Florida, 33624, United States
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Winter Park Florida, 32789, United States
Novartis Investigative Site
Marietta Georgia, 30060, United States
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Indianapolis Indiana, 46256, United States
Novartis Investigative Site
Bowling Green Kentucky, 42101, United States
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Saint Louis Missouri, 63117, United States
Novartis Investigative Site
Lincoln Nebraska, 68516, United States
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Voorhees New Jersey, 08043, United States
Novartis Investigative Site
Rochester New York, 14642, United States
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Greensboro North Carolina, 27408, United States
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Middleburg Heights Ohio, 44130, United States
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Oklahoma City Oklahoma, 73103, United States
Novartis Investigative Site
Tulsa Oklahoma, 74136, United States
Novartis Investigative Site
Duncansville Pennsylvania, 16635, United States
Novartis Investigative Site
Jackson Tennessee, 38305, United States
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Austin Texas, 78731, United States
Novartis Investigative Site
Mesquite Texas, 75150, United States
Novartis Investigative Site
Newport News Virginia, 23608, United States
Novartis Investigative Site
Salvador BA, 40150, Brazil
Novartis Investigative Site
Sao Paulo SP, 04266, Brazil
Novartis Investigative Site
Burgas , 8000, Bulgaria
Novartis Investigative Site
Plovdiv , 4000, Bulgaria
Novartis Investigative Site
Plovdiv , 4002, Bulgaria
Novartis Investigative Site
Sofia , 1413, Bulgaria
Novartis Investigative Site
Sofia , 1431, Bulgaria
Novartis Investigative Site
Barranquilla Atlantico, 08000, Colombia
Novartis Investigative Site
Bucaramanga Santander, 0001, Colombia
Novartis Investigative Site
Bogota , 11022, Colombia
Novartis Investigative Site
Cundinamarca , 11112, Colombia
Novartis Investigative Site
Prague 2 , 128 5, Czechia
Novartis Investigative Site
Praha 4 , 140 5, Czechia
Novartis Investigative Site
Praha 5 , 150 0, Czechia
Novartis Investigative Site
Uherske Hradiste , 686 0, Czechia
Novartis Investigative Site
Athens , 12462, Greece
Novartis Investigative Site
Thessaloniki , 54622, Greece
Novartis Investigative Site
Guatemala City , 01010, Guatemala
Novartis Investigative Site
Guatemala , 01001, Guatemala
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Guatemala , 01010, Guatemala
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Surat Gujarat, 39500, India
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Bangalore Karnataka, 560 0, India
Novartis Investigative Site
Nashik Maharashtra, 422 1, India
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New Delhi , 11002, India
Novartis Investigative Site
Seremban Negeri Sembilan, 70300, Malaysia
Novartis Investigative Site
Kuching Sarawak, 93586, Malaysia
Novartis Investigative Site
Selangor Darul Ehsan , 68100, Malaysia
Novartis Investigative Site
Lipa City Batangas, 4217, Philippines
Novartis Investigative Site
Dasmarinas Cavite, 4114, Philippines
Novartis Investigative Site
Manila , 1008, Philippines
Novartis Investigative Site
Quezon City , 1102, Philippines
Novartis Investigative Site
Krakow Malopolskie, 30-51, Poland
Novartis Investigative Site
Karwiany , 52-20, Poland
Novartis Investigative Site
Krakow , 30 00, Poland
Novartis Investigative Site
Sochaczew , 96-50, Poland
Novartis Investigative Site
Warszawa , 02-96, Poland
Novartis Investigative Site
Kemerovo , 65002, Russian Federation
Novartis Investigative Site
Nizhny Novgorod , 60301, Russian Federation
Novartis Investigative Site
Rostov On Don , 34402, Russian Federation
Novartis Investigative Site
Saint Petersburg , 19702, Russian Federation
Novartis Investigative Site
St Petersburg , 19006, Russian Federation
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Yaroslavl , 15000, Russian Federation
Novartis Investigative Site
Yekaterinburg , 62010, Russian Federation
Novartis Investigative Site
Panorama Western Cape, 7500, South Africa
Novartis Investigative Site
Stellenbosch , 7600, South Africa
Novartis Investigative Site
Bangkoknoi Bangkok, 10700, Thailand
Novartis Investigative Site
Songkhla Hat Yai, 90110, Thailand
Novartis Investigative Site
Khon Kaen THA, 40002, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Bursa Gorukle, 16059, Turkey

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

381

Study ID:

NCT04209205

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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