Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)

April 4, 2022 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Patients were randomized to one of three treatment groups (1:1:1) in the core phase:

  • Secukinumab 150 mg Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4
  • Secukinumab 150 mg No Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4
  • Placebo: placebo (1 mL) s.c. PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4.

All patients received secukinumab 150 mg as open-label treatment from Week 52 up to Week 100, unless they had discontinued study treatment.

At Week 104, all patients who finished the core phase according to the protocol were asked to continue in an optional, exploratory extension phase. Patients who achieved ASAS20 response at Week 104 (Core Phase Responders) were randomized to the following treatment groups (blinded) in the extension phase:

  • Core Phase Responder 150 mg: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS and placebo (1 mL) s.c. PFS every four weeks;
  • Core Phase Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks.

Core Phase Non-Responders (not achieving ASAS20 at Week 104) were escalated to secukinumab 300 mg in an open-label manner.

- Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks open-label.

Starting from Week 156 onward, a patient could switch to secukinumab 300 mg open-label based on the clinical judgment of disease activity by the investigator.

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Woolloongabba, Australia, QLD 4102
        • Novartis Investigative Site
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Novartis Investigative Site
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
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    • Tasmania
      • Hobart, Tasmania, Australia, 7000
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    • Victoria
      • Malvern East, Victoria, Australia, 3145
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      • Graz, Austria, 8036
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      • Vienna, Austria, A-1060
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      • Bruxelles, Belgium, 1200
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      • Genk, Belgium, 3600
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      • Gent, Belgium, 9000
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      • Pleven, Bulgaria, 5800
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      • Sofia, Bulgaria, 1606
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      • Sofia, Bulgaria, 1784
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      • Uherske Hradiste, Czechia, 686 01
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    • CZ
      • Brno, CZ, Czechia, 625 00
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    • CZE
      • Brno-Zidonice, CZE, Czechia, 61500
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    • Czech Republic
      • Praha 11, Czech Republic, Czechia, 148 00
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      • Praha 2, Czech Republic, Czechia, 128 50
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      • Praha 5, Czech Republic, Czechia, 150 06
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      • Bordeaux Cedex, France, 33076
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      • Boulogne Billancourt, France, 92104
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      • Chambray les Tours, France, 37170
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      • Monaco, France, 98000
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      • Paris Cedex 14, France, 75679
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      • Poitiers, France, 86021
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      • Rouen Cedex, France, 76031
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    • Haute Vienne
      • Limoges cedex, Haute Vienne, France, 87000
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      • Berlin, Germany, 13125
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      • Berlin, Germany, 13353
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      • Cottbus, Germany, 03042
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      • Dresden, Germany, 01307
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      • Erlangen, Germany, 91054
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      • Freiburg, Germany, 79106
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      • Hamburg, Germany, 22415
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      • Hamburg, Germany, 22143
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      • Hamburg, Germany, 22767
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      • Herne, Germany, 44649
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      • Magdeburg, Germany, 39110
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      • Potsdam, Germany, 14469
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    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
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      • Budapest, Hungary, 1027
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      • Debrecen, Hungary, 4032
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      • Eger, Hungary, 3300
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      • Szeged, Hungary, 6720
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      • Szekesfehervar, Hungary, 8000
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      • Veszprem, Hungary, 8200
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      • Haifa, Israel, 3109601
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      • Kfar Saba, Israel, 4428164
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      • Ramat Gan, Israel, 52621
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      • Tel Aviv, Israel, 6423906
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      • Bologna, Italy, 40138
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      • Novara, Italy, 28100
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      • Padova, Italy, 35128
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      • Pisa, Italy, 56126
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    • VR
      • Verona, VR, Italy, 37126
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    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
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    • Osaka
      • Kawachinagano, Osaka, Japan, 586-8521
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    • Tokyo
      • Bunkyo ku, Tokyo, Japan, 113-8431
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      • Chuo ku, Tokyo, Japan, 104-8560
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      • Meguro, Tokyo, Japan, 153-8515
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      • Shinjuku ku, Tokyo, Japan, 162 8666
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      • Seoul, Korea, Republic of, 03080
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      • Seoul, Korea, Republic of, 06351
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    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
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    • Estado De Mexico
      • Metepec, Estado De Mexico, Mexico, 52140
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    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
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    • MEX
      • Culiacan, MEX, Mexico, 80000
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      • Amsterdam, Netherlands, 1105 AZ
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      • Groningen, Netherlands, 9713 GZ
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      • Maastricht, Netherlands, 6229 HX
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      • Kongsvinger, Norway, 2212
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      • Moss, Norway, 1538
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      • Krakow, Poland, 30-510
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      • Poznan, Poland, 60-218
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      • Poznan, Poland, 61 113
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      • Warszawa, Poland, 04 305
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      • Warszawa, Poland, 02 118
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      • Wroclaw, Poland, 53-224
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      • Almada, Portugal, 2801 951
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      • Braga, Portugal, 4710243
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      • Lisboa, Portugal, 1050-034
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      • Lisboa, Portugal, 1649-035
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      • Ponte de Lima, Portugal, 4990 041
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      • Barnaul, Russian Federation, 656024
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      • Ekaterinburg, Russian Federation, 620028
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      • Kemerovo, Russian Federation, 650000
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      • Moscow, Russian Federation, 115522
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      • Moscow, Russian Federation, 127473
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      • Saint Petersburg, Russian Federation, 197022
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      • Saratov, Russian Federation, 410053
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      • Smolensk, Russian Federation, 214019
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      • Madrid, Spain, 28041
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      • Madrid, Spain, 28046
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      • Madrid, Spain, 28009
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    • Alicante
      • Elda, Alicante, Spain, 03600
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    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
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      • Malaga, Andalucia, Spain, 29010
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      • Sevilla, Andalucia, Spain, 41009
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    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
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      • Sabadell, Barcelona, Spain, 08208
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    • Cantabria
      • Santander, Cantabria, Spain, 39008
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    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
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    • Galicia
      • La Coruna, Galicia, Spain, 15006
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      • Santiago de Compostela, Galicia, Spain, 15706
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    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48013
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    • Pontevedra
      • Vigo, Pontevedra, Spain, 36200
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      • Goteborg, Sweden, SE-413 45
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      • Lund, Sweden, 221 85
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      • Uppsala, Sweden, 751 85
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      • Basel, Switzerland, 4031
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      • Fribourg, Switzerland, 1708
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      • Ankara, Turkey, 06100
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      • Bath, United Kingdom, BA1 3NG
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      • Doncaster, United Kingdom, DN2 5LT
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      • Middlesbrough, United Kingdom, TS4 3BW
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      • Northampton, United Kingdom, NN1 5BD
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      • Wolverhampton, United Kingdom, WV10 0QP
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    • Essex
      • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
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    • London
      • Leytonstone, London, United Kingdom, E11 1NR
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    • Staffordshire
      • Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
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    • West Sussex
      • Worthing, West Sussex, United Kingdom, BN11 2DH
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    • Alabama
      • Birmingham, Alabama, United States, 35205
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    • California
      • Beverly Hills, California, United States, 90211
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      • Fullerton, California, United States, 92835
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    • Colorado
      • Denver, Colorado, United States, 80230
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    • Florida
      • Gainesville, Florida, United States, 32608
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    • Idaho
      • Idaho Falls, Idaho, United States, 83404
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    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
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    • Michigan
      • Lansing, Michigan, United States, 48910
        • Novartis Investigative Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Novartis Investigative Site
    • New York
      • Albany, New York, United States, 12206
        • Novartis Investigative Site
      • Potsdam, New York, United States, 13676
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
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    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
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    • Oregon
      • Portland, Oregon, United States, 97239
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    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
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    • South Carolina
      • Charleston, South Carolina, United States, 29460
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    • Texas
      • Leander, Texas, United States, 78641
        • Novartis Investigative Site
      • Mesquite, Texas, United States, 75150
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Male or non-pregnant, non-nursing female patients at least 18 years of age
  • Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
  • objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
  • active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
  • Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
  • Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
  • Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
  • Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response

Exclusion Criteria:

  • Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
  • Inability or unwillingness to undergo MRI
  • Chest X-ray or MRI with evidence of ongoing infectious or malignant process
  • Patients taking high potency opioid analgesics
  • Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
  • Pregnant or nursing (lactating) women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Secukinumab, 150 mg Load (Core phase)
Secukinumab 150 mg s.c., pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4, Load, Core phase
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Other Names:
  • AIN457
EXPERIMENTAL: Secukinumab, 150 mg No Load (Core phase)
Secukinumab 150 mg s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4, No Load, Core phase
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Other Names:
  • AIN457
PLACEBO_COMPARATOR: Placebo (Core phase)
Placebo s.c., PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4, Core phase
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Other Names:
  • AIN457
EXPERIMENTAL: Core Phase Responder 150 mg (Extension phase)
Core Phase Responder 150 mg blinded: secukinumab 150 mg s.c. PFS and placebo (1 mL) s.c. PFS every four weeks, in the Extension phase
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Other Names:
  • AIN457
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Other Names:
  • AIN457
EXPERIMENTAL: Core Phase Responder 300 mg (Extension phase)
Core Phase Responder 300 mg blinded: 2 injections with secukinumab 150 mg s.c. PFS every four weeks, in the Extension phase
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Other Names:
  • AIN457
EXPERIMENTAL: Core Phase Non-Responder 300 mg (Extension phase)
Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg s.c. PFS every four weeks open-label, in the Extension phase
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Other Names:
  • AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16
Time Frame: Week 16

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.

Week 16
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52
Time Frame: Week 52

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.

Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response
Time Frame: Week 16 and week 52

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.

Week 16 and week 52
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Time Frame: Week 16

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.

Week 16
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response
Time Frame: Week 16

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity.

Week 16
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)
Time Frame: Week 16

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant).

The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity.

Week 16
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Baseline and Week 16
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS. The ten questions were chosen with a major input from subjects with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the subjects' ability to cope with everyday life. A 100 mm visual analog scale (VAS) is used to answer the questions. The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)). A higher score on the VAS signifies higher severity.
Baseline and Week 16
The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Time Frame: Week 16 and 52
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS. The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline. A higher score on the VAS signifies higher severity.
Week 16 and 52
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline and Week 16
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated assessment tool using 1 through 10 scales (1 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of Ankylosing Spondylitis (AS). The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease. A higher score on the VAS signifies higher severity.
Baseline and Week 16
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16
Time Frame: Baseline and Week 16
The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.
Baseline and Week 16
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52
Time Frame: Baseline and Week 52

The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.

Summary statistics are presented for participants (n) without intercurrent events.

Baseline and Week 52
The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease
Time Frame: Week 52
Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3. Higher score indicates worse symptoms. The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1)
Week 52
Change in High Sensitivity C-reactive Protein
Time Frame: Baseline and Week 16
High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.
Baseline and Week 16
Change in Short Form-36 Physical Component Summary (SF-36 PCS)
Time Frame: Baseline and Week 16

The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions.

It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10.

Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.

Baseline and Week 16
Change in Sacroiliac Joint Edema - Week 16
Time Frame: Baseline and Week 16
Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.
Baseline and Week 16
Change in Sacroiliac Joint Edema - Week 52
Time Frame: Baseline and Week 52
Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2016

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

March 11, 2021

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

February 25, 2016

First Posted (ESTIMATE)

March 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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