Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis (FUTURE5)

A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Biological: Secukinumab

Detailed Description

This multicenter study uses a randomized, double-blind, placebo-controlled, parallel-group design. A screening period (SCR) running up to 10 weeks before randomization will be used to assess subject eligibility followed by 104 weeks of treatment.

At BSL approximately 990 subjects whose eligibility is confirmed will be randomized to one of four treatment groups in 2:2:2:3 ratio:

• Group 1 - secukinumab 150 mg s.c. without loading regimen
• Group 2 - secukinumab 150 mg s.c. with loading dose regimen
• Group 3 - secukinumab 300 mg s.c. with loading dose regimen
• Group 4 - Placebo s.c. NOTE: Group 4 is split into 2 treatment arms, detailed description below. At randomization, subjects will be stratified on the basis of previous anti-TNF therapy as TNFα inhibitor naïve (TNF-naïve) or TNFα inhibitor inadequate responders (TNF-IR).

At each study treatment visit, one (for secukinumab 150 mg) or two (for secukinumab 300 mg) s.c. injections in the form of PFS will be administered, since secukinumab is available in 1.0 mL (150 mg) PFSs. Placebo to secukinumab is also available in 1.0 mL to match the active drug.

At Week 16, subjects who have been randomized to secukinumab groups at BSL (Groups 1-3) will be classified as either responders (≥20% improvement from BSL in both tender joint count (TJC) and swollen joint counts (SJC)) or non-responders (<20% improvement from BSL TJC or SJC), however they will continue on the same treatment irrespective of their response status.

At Week 16, subjects who have been randomized to placebo at BSL (Group 4) will be classified as either responders (≥20% improvement from BSL in both TJC and SJC) or non-responders (<20% improvement from BSL TJC or SJC):

• Subjects who are non-responders will receive either secukinumab 150 mg or 300 mg s.c. every 4 weeks starting at Week 16 (as dictated by treatment sequence assigned to these subjects at BSL).
• Subjects who are responders will continue to receive placebo every 4 weeks. Starting Week 24, these subjects will receive either secukinumab 150 mg s.c. or 300 mg s.c. every 4 weeks starting at Week 24 (as dictated by treatment sequence assigned to these subjects at BSL).

At Week 24, the assessments to address the primary objective will be performed. As described above, subjects who are still receiving placebo s.c. injection will receive either secukinumab 150 mg s.c. or 300 mg s.c. every 4 weeks starting at Week 24 (as dictated by treatment sequence assigned to these subjects at BSL).

At week 52, based on Investigator's decision, the subjects on a 150 mg dose whose signs and symptoms do not show satisfactory response have the possibility to be allocated to secukinumab 300 mg s.c.

After the Week 52 database lock and analyses have been completed, site personnel and subjects will be unblinded to the original randomized treatment (sequence) assignment at randomization. In addition, treatment will be given open-label in order to eliminate the placebo injection. The subject will continue to receive the same active dose of secukinumab as open-label treatment administered until Week 100.

• Study Type: Interventional
• Enrollment (Actual): 997
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Tucuman, Argentina, 4000
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1221ADC
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina
      • Novartis Investigative Site
• Austria
  • Graz, Austria, 8036
    • Novartis Investigative Site
  • Vienna, Austria, 1100
    • Novartis Investigative Site
  • Vienna, Austria, A-1160
    • Novartis Investigative Site
  • Vienna, Austria, A-1060
    • Novartis Investigative Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Novartis Investigative Site
    • Victoria, British Columbia, Canada, V8V 3M9
      • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M1
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  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • Novartis Investigative Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1v 3M7
      • Novartis Investigative Site
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Novartis Investigative Site
• Chile
  • Santiago, Chile, 8207257
    • Novartis Investigative Site
  • Santiago
    • Vitacura, Santiago, Chile, 7640881
      • Novartis Investigative Site
• Czechia
  • Uherske Hradiste, Czechia, 686 01
    • Novartis Investigative Site
  • Czech Republic
    • Bruntal, Czech Republic, Czechia, 792 01
      • Novartis Investigative Site
    • Ostrava, Czech Republic, Czechia, 70200
      • Novartis Investigative Site
    • Praha 11, Czech Republic, Czechia, 148 00
      • Novartis Investigative Site
    • Praha 2, Czech Republic, Czechia, 128 50
      • Novartis Investigative Site
    • Praha 4, Czech Republic, Czechia, 140 00
      • Novartis Investigative Site
    • Praha 4, Czech Republic, Czechia, 140 59
      • Novartis Investigative Site
• Denmark
  • Odense, Denmark, 5000 C
    • Novartis Investigative Site
• Estonia
  • Tartu, Estonia, 50406
    • Novartis Investigative Site
• Finland
  • Hyvinkaa, Finland, 05800
    • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52064
    • Novartis Investigative Site
  • Bad Abbach, Germany, 93077
    • Novartis Investigative Site
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Berlin, Germany, 13353
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  • Germering, Germany, 82110
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  • Gommern, Germany, 39245
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  • Gottingen, Germany, 37075
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  • Hamburg, Germany, 22081
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  • Hamburg, Germany, 22143
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  • Herne, Germany, 44649
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  • Leipzig, Germany, 04103
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  • Lubeck, Germany, 23538
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  • Nienburg, Germany, 31582
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• Greece
  • Athens, Greece, 115 27
    • Novartis Investigative Site
  • Athens, Greece, 12462
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  • Patras, Greece, 265 00
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  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
    • Thessaloniki, GR, Greece, 564 29
      • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01011
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1062
    • Novartis Investigative Site
  • Budapest, Hungary, 1036
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  • Eger, Hungary, 3300
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  • Kistarcsa, Hungary, 2143
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  • Szekesfehervar, Hungary, H-8000
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  • Veszprem, Hungary, 8200
    • Novartis Investigative Site
• India
  • New Delhi, India, 110029
    • Novartis Investigative Site
  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500003
      • Novartis Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 053
      • Novartis Investigative Site
    • Nashik, Maharashtra, India, 422 101
      • Novartis Investigative Site
    • Pune, Maharashtra, India, 411007
      • Novartis Investigative Site
• Ireland
  • Dublin 4, Ireland
    • Novartis Investigative Site
• Israel
  • Ashkelon, Israel, 78278
    • Novartis Investigative Site
  • Haifa, Israel, 343621
    • Novartis Investigative Site
  • Kfar Saba, Israel, 4428164
    • Novartis Investigative Site
  • Petach Tikva, Israel, 49100
    • Novartis Investigative Site
  • Ramat Gan, Israel, 5265601
    • Novartis Investigative Site
  • Tel Aviv, Israel, 6423906
    • Novartis Investigative Site
• Italy
  • BS
    • Brescia, BS, Italy, 25123
      • Novartis Investigative Site
  • PA
    • Palermo, PA, Italy, 90127
      • Novartis Investigative Site
  • PV
    • Pavia, PV, Italy, 27100
      • Novartis Investigative Site
  • PZ
    • Potenza, PZ, Italy, 85100
      • Novartis Investigative Site
  • UD
    • Udine, UD, Italy, 33100
      • Novartis Investigative Site
• Latvia
  • Liepaja, Latvia, LV 3401
    • Novartis Investigative Site
  • Riga, Latvia, LV 1002
    • Novartis Investigative Site
  • Riga, Latvia, LV-1038
    • Novartis Investigative Site
  • Valmiera, Latvia, LV-4201
    • Novartis Investigative Site
  • LV
    • Riga, LV, Latvia, LV-1005
      • Novartis Investigative Site
• Lithuania
  • Klaipeda, Lithuania, LT-92288
    • Novartis Investigative Site
  • Siauliai, Lithuania, LT-76231
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-07195
    • Novartis Investigative Site
  • Vilnius, Lithuania, 09310
    • Novartis Investigative Site
  • LT
    • Kaunas, LT, Lithuania, LT-45130
      • Novartis Investigative Site
    • Kaunas, LT, Lithuania, LT-50128
      • Novartis Investigative Site
• Mexico
  • San Luis Potosi, Mexico, 78200
    • Novartis Investigative Site
  • Baja California
    • Mexicali, Baja California, Mexico, 21100
      • Novartis Investigative Site
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 11850
      • Novartis Investigative Site
  • Estado De Mexico
    • Metepec, Estado De Mexico, Mexico, 52140
      • Novartis Investigative Site
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Novartis Investigative Site
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Novartis Investigative Site
  • Rotterdam, Netherlands, 3079 DZ
    • Novartis Investigative Site
  • Schiedam, Netherlands, 3118 JH
    • Novartis Investigative Site
  • Utrecht, Netherlands, 3508 GA
    • Novartis Investigative Site
• Philippines
  • Manila, Philippines, 1008
    • Novartis Investigative Site
  • Quezon City, Philippines, 1102
    • Novartis Investigative Site
  • Metro Manila
    • Manila, Metro Manila, Philippines, 1000
      • Novartis Investigative Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454076
    • Novartis Investigative Site
  • Chelyabinsk, Russian Federation, 454000
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620028
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620137
    • Novartis Investigative Site
  • Kazan, Russian Federation, 420064
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650000
    • Novartis Investigative Site
  • Moscow, Russian Federation, 129301
    • Novartis Investigative Site
  • Nizhniy Novgorod, Russian Federation, 603005
    • Novartis Investigative Site
  • Nizhny Novgorod, Russian Federation, 603018
    • Novartis Investigative Site
  • Orenburg, Russian Federation, 460018
    • Novartis Investigative Site
  • Rostov on Don, Russian Federation, 344022
    • Novartis Investigative Site
  • Saint-Petersburg, Russian Federation, 194021
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214019
    • Novartis Investigative Site
  • St-Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Madrid, Spain, 28046
    • Novartis Investigative Site
  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
    • Sant Joan Despi, Barcelona, Spain, 08970
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08003
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Novartis Investigative Site
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Pais Vasco
    • Bilbao, Pais Vasco, Spain, 48013
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Novartis Investigative Site
  • Vizcaya
    • Baracaldo, Vizcaya, Spain, 48903
      • Novartis Investigative Site
• Sweden
  • Stockholm, Sweden, SE-17176
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Chiang Mai, Thailand, 50200
    • Novartis Investigative Site
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Novartis Investigative Site
  • Hat Yai
    • Songkhla, Hat Yai, Thailand, 90110
      • Novartis Investigative Site
  • THA
    • Khon Kaen, THA, Thailand, 40002
      • Novartis Investigative Site
• United Kingdom
  • Bath, United Kingdom, BA1 1RL
    • Novartis Investigative Site
  • Dundee, United Kingdom, DD1 9SY
    • Novartis Investigative Site
  • Eastbourne, United Kingdom, BN21 2UD
    • Novartis Investigative Site
  • Edinburgh, United Kingdom, EH4 2XU
    • Novartis Investigative Site
  • Glasgow, United Kingdom, G31 2ER
    • Novartis Investigative Site
  • Leicester, United Kingdom, LE1 5WW
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • London, United Kingdom, NW3 2QG
    • Novartis Investigative Site
  • London, United Kingdom, NW1 2BU
    • Novartis Investigative Site
  • Manchester, United Kingdom, M13 9WL
    • Novartis Investigative Site
  • Oxford, United Kingdom, OX3 7LD
    • Novartis Investigative Site
  • Portsmouth, United Kingdom, PO6 3LY
    • Novartis Investigative Site
  • Wigan, United Kingdom, WN6 9EP
    • Novartis Investigative Site
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Novartis Investigative Site
  • Dorset
    • Christchurch, Dorset, United Kingdom, BH23 2JX
      • Novartis Investigative Site
  • England
    • London, England, United Kingdom, E11 1NR
      • Novartis Investigative Site
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9NA
      • Novartis Investigative Site
  • Invernesshire
    • Inverness, Invernesshire, United Kingdom, IV2 3RE
      • Novartis Investigative Site
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Novartis Investigative Site
  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
      • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD5 0NA
      • Novartis Investigative Site
• United States
  • California
    • Upland, California, United States, 91786
      • Novartis Investigative Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Novartis Investigative Site
    • Denver, Colorado, United States, 80230
      • Novartis Investigative Site
  • Florida
    • Brandon, Florida, United States, 33511
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33624
      • Novartis Investigative Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Novartis Investigative Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Novartis Investigative Site
  • New York
    • Brooklyn, New York, United States, 11215
      • Novartis Investigative Site
    • Rochester, New York, United States, 14623
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Novartis Investigative Site
    • Oklahoma City, Oklahoma, United States, 73102
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novartis Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Novartis Investigative Site
    • Wexford, Pennsylvania, United States, 15090
      • Novartis Investigative Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Novartis Investigative Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Novartis Investigative Site
    • Kingsport, Tennessee, United States, 37660
      • Novartis Investigative Site
  • Texas
    • Mesquite, Texas, United States, 75150
      • Novartis Investigative Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Novartis Investigative Site
    • Seattle, Washington, United States, 98122
      • Novartis Investigative Site
    • Seattle, Washington, United States, 98101
      • Novartis Investigative Site
    • Spokane, Washington, United States, 99204
      • Novartis Investigative Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site
  • Ho Chi Minh, Vietnam, 7000
    • Novartis Investigative Site
  • VNM
    • Ho Chi Minh, VNM, Vietnam, 700000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion 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 BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).

• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
• Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a 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 who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
• 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 24.
• 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.
• Subjects on MTX must be on folic acid supplementation at randomization.
• Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
• Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
• Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization

Exclusion Criteria:

Chest X-ray or chest 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 IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
• Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
• Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
• Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
• Other protocol-defined exclusion criteria do apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Secukinumab 150 mg load (Group 1); Secukinumab 150 mg sc injection every week for 4 weeks followed by Secukinumab 150 mg every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks until week 100	Biological: Secukinumab; Anti IL-17a monoclonal antibody; Other Names: AIN457
EXPERIMENTAL: Secukinumab 150 mg no load (Group 2); Secukinumab 150 mg sc injection every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.	Biological: Secukinumab; Anti IL-17a monoclonal antibody; Other Names: AIN457
EXPERIMENTAL: Secukinumab 300 mg load (Group 3); Secukinumab 300 mg sc injection every week for 4 weeks followed by Secukinumab 300 mg every 4 weeks until week 100	Biological: Secukinumab; Anti IL-17a monoclonal antibody; Other Names: AIN457
PLACEBO_COMPARATOR: Placebo arm 1 (Group 4); Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders will be switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.	Biological: Secukinumab; Anti IL-17a monoclonal antibody; Other Names: AIN457
PLACEBO_COMPARATOR: Placebo arm 2 (Group 4); Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders were switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.	Biological: Secukinumab; Anti IL-17a monoclonal antibody; Other Names: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16	ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))	PsA modified vdH-mTSS scoring method was used to assess bone erosion & joint space narrowing (JSN) in hands & feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands & feet combined) ranges from 0 to 528, where higher scores indicate more articular damage	Baseline, Week 24
Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response	The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.	Week 16
Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response	The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response.	16 weeks
Count and Percentage of Patients Achieving an ACR50 Response	ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.	16 weeks
Change From Baseline in HAQ-DI© Score	The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.	16 weeks
Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))	The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline. Scores range from 0 (no difficulty) to 3 (unable to do)	16 weeks
Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline	The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline	16 weeks
Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline	The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline	16 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Mease P, van der Heijde D, Landewe R, Mpofu S, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Meiser K, Readie A, Pricop L, Abrams K. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018 Jun;77(6):890-897. doi: 10.1136/annrheumdis-2017-212687. Epub 2018 Mar 17.
• Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.
• Mease PJ, Landewe R, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Readie A, Mpofu S, Delicha EM, Pricop L, van der Heijde D. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study. RMD Open. 2021 Jul;7(2):e001600. doi: 10.1136/rmdopen-2021-001600.
• van der Heijde D, Mease PJ, Landewe RBM, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Zhu X, Ligozio G, Readie A, Mpofu S, Pricop L. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology (Oxford). 2020 Jun 1;59(6):1325-1334. doi: 10.1093/rheumatology/kez420.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2015
• Primary Completion (ACTUAL): August 16, 2017
• Study Completion (ACTUAL): January 24, 2019

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (ESTIMATE): March 31, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Arthritis; Psoriatic Arthritis; Psoriatic Arthropathy; Psoriatic; Spondylitis
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: CAIN457F2342; 2015-000050-38 (EUDRACT_NUMBER); 02404350 (REGISTRY: clinicaltrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No