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

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

ClinicalTrials.gov Identifier: NCT02696031

Novartis Reference Number: CAIN457H2315

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 followed by an optional 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Condition 
Non-radiographic Spondyloarthritis
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
555 participants
Start date 
Apr 29, 2016
Completion date 
Dec 16, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Drug
Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Drug
Secukinumab
150 mg Secukinumab s.c. monthly
Drug
Secukinumab
Dose escalation to 300mg at Year 2

Eligibility Criteria

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 TNFα 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 Locations

United States
Novartis Investigative Site
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Birmingham, 35205
Alabama
United States
Novartis Investigative Site
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Beverly Hills, 90211
California
United States
Novartis Investigative Site
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Fullerton, 92835
California
United States
Novartis Investigative Site
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Denver, 80230
Colorado
United States
Novartis Investigative Site
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Gainesville, 32608
Florida
United States
Novartis Investigative Site
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Idaho Falls, 83404
Idaho
United States
Novartis Investigative Site
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Bowling Green, 42101
Kentucky
United States
Novartis Investigative Site
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Lansing, 48910
Michigan
United States
Novartis Investigative Site
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Great Falls, 59405
Montana
United States
Novartis Investigative Site
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Albany, 12206
New York
United States
Novartis Investigative Site
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Potsdam, 13676
New York
United States
Novartis Investigative Site
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Charlotte, 28204
North Carolina
United States
Novartis Investigative Site
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Oklahoma City, 73102
Oklahoma
United States
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Portland, 97239
Oregon
United States
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Duncansville, 16635
Pennsylvania
United States
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Charleston, 29460
South Carolina
United States
Novartis Investigative Site
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Leander, 78641
Texas
United States
Novartis Investigative Site
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Mesquite, 75150
Texas
United States
Australia
Novartis Investigative Site
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Coffs Harbour, 2450
New South Wales
Australia
Novartis Investigative Site
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Maroochydore, 4558
Queensland
Australia
Novartis Investigative Site
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Hobart, 7000
Tasmania
Australia
Novartis Investigative Site
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Malvern East, 3145
Victoria
Australia
Novartis Investigative Site
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Woolloongabba, QLD 4102
-
Australia
Austria
Novartis Investigative Site
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Graz, 8036
-
Austria
Novartis Investigative Site
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Vienna, A-1060
-
Austria
Belgium
Novartis Investigative Site
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Bruxelles, 1200
-
Belgium
Novartis Investigative Site
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Genk, 3600
-
Belgium
Novartis Investigative Site
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Gent, 9000
-
Belgium
Bulgaria
Novartis Investigative Site
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Pleven, 5800
-
Bulgaria
Novartis Investigative Site
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Sofia, 1606
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Bulgaria
Novartis Investigative Site
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Sofia, 1784
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Bulgaria
Czechia
Novartis Investigative Site
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Praha 11, 148 00
Czech Republic
Czechia
Novartis Investigative Site
-
Praha 2, 128 50
Czech Republic
Czechia
Novartis Investigative Site
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Praha 5, 150 06
Czech Republic
Czechia
Novartis Investigative Site
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Brno-Zidonice, 61500
CZE
Czechia
Novartis Investigative Site
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Brno, 625 00
CZ
Czechia
Novartis Investigative Site
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Uherske Hradiste, 686 01
-
Czechia
France
Novartis Investigative Site
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Limoges cedex, 87000
Haute Vienne
France
Novartis Investigative Site
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Bordeaux Cedex, 33076
-
France
Novartis Investigative Site
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Boulogne Billancourt, 92104
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France
Novartis Investigative Site
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Chambray les Tours, 37170
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France
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Monaco, 98000
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France
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Paris Cedex 14, 75679
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France
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Poitiers, 86021
-
France
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Rouen Cedex, 76031
-
France
Germany
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Hannover, 30159
Niedersachsen
Germany
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Berlin, 13125
-
Germany
Novartis Investigative Site
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Berlin, 13353
-
Germany
Novartis Investigative Site
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Cottbus, 03042
-
Germany
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Dresden, 01307
-
Germany
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Erlangen, 91054
-
Germany
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Freiburg, 79106
-
Germany
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Hamburg, 22081
-
Germany
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Hamburg, 22143
-
Germany
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Hamburg, 22415
-
Germany
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Hamburg, 22767
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Germany
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Herne, 44649
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Germany
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Hildesheim, 31134
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Germany
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Magdeburg, 39110
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Germany
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Potsdam, 14469
-
Germany
Hungary
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Budapest, 1027
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Hungary
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Debrecen, 4032
-
Hungary
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Eger, 3300
-
Hungary
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Szeged, 6720
-
Hungary
Novartis Investigative Site
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Szekesfehervar, 8000
-
Hungary
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Szombathely, 9700
-
Hungary
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Veszprem, 8200
-
Hungary
Israel
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Haifa, 3525408
-
Israel
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Kfar Saba, 4428164
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Israel
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Ramat Gan, 52621
-
Israel
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Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
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Verona, 37126
VR
Italy
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Bologna, 40138
-
Italy
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Novara, 28100
-
Italy
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Padova, 35128
-
Italy
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Pisa, 56126
-
Italy
Japan
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Kita-gun, 761-0793
Kagawa
Japan
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Kawachinagano, 586-8521
Osaka
Japan
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Bunkyo ku, 113-8431
Tokyo
Japan
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-
Chuo ku, 104-8560
Tokyo
Japan
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Meguro, 153-8515
Tokyo
Japan
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Shinjuku ku, 162 8666
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
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Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 06351
-
Korea, Republic of
Mexico
Novartis Investigative Site
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Torreon, 27000
Coahuila
Mexico
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Metepec, 52140
Estado De Mexico
Mexico
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Guadalajara, 44160
Jalisco
Mexico
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Culiacan, 80000
MEX
Mexico
Netherlands
Novartis Investigative Site
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Amsterdam, 1105 AZ
-
Netherlands
Novartis Investigative Site
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Groningen, 9713 GZ
-
Netherlands
Novartis Investigative Site
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Maastricht, 6229 HX
-
Netherlands
Norway
Novartis Investigative Site
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Kongsvinger, 2212
-
Norway
Novartis Investigative Site
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Moss, 1538
-
Norway
Poland
Novartis Investigative Site
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Krakow, 30-510
-
Poland
Novartis Investigative Site
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Poznan, 60-218
-
Poland
Novartis Investigative Site
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Poznan, 61 113
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Poland
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Warszawa, 02 118
-
Poland
Novartis Investigative Site
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Warszawa, 04 305
-
Poland
Novartis Investigative Site
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Wroclaw, 53-224
-
Poland
Portugal
Novartis Investigative Site
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Almada, 2801 951
-
Portugal
Novartis Investigative Site
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Braga, 4710243
-
Portugal
Novartis Investigative Site
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Lisboa, 1050-034
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Portugal
Novartis Investigative Site
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Lisboa, 1649-035
-
Portugal
Novartis Investigative Site
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Ponte de Lima, 4990 041
-
Portugal
Russian Federation
Novartis Investigative Site
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Barnaul, 656024
-
Russian Federation
Novartis Investigative Site
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Ekaterinburg, 620028
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Russian Federation
Novartis Investigative Site
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Kemerovo, 650000
-
Russian Federation
Novartis Investigative Site
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Moscow, 115522
-
Russian Federation
Novartis Investigative Site
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Moscow, 127473
-
Russian Federation
Novartis Investigative Site
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Saint Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
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Saratov, 410053
-
Russian Federation
Novartis Investigative Site
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Smolensk, 214019
-
Russian Federation
Spain
Novartis Investigative Site
-
Elda, 03600
Alicante
Spain
Novartis Investigative Site
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Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
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Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
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Sevilla, 41009
Andalucia
Spain
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-
Hospitalet de Llobregat, 08907
Barcelona
Spain
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-
Sabadell, 08208
Barcelona
Spain
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-
Santander, 39008
Cantabria
Spain
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Valencia, 46026
Comunidad Valenciana
Spain
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-
La Coruna, 15006
Galicia
Spain
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-
Santiago de Compostela, 15706
Galicia
Spain
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-
Bilbao, 48013
Pais Vasco
Spain
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Vigo, 36200
Pontevedra
Spain
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Madrid, 28009
-
Spain
Novartis Investigative Site
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Madrid, 28041
-
Spain
Novartis Investigative Site
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Madrid, 28046
-
Spain
Sweden
Novartis Investigative Site
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Goteborg, SE-413 45
-
Sweden
Novartis Investigative Site
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Lund, 221 85
-
Sweden
Novartis Investigative Site
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Uppsala, 751 85
-
Sweden
Switzerland
Novartis Investigative Site
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Basel, 4031
-
Switzerland
Novartis Investigative Site
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Fribourg, 1708
-
Switzerland
Turkey
Novartis Investigative Site
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Ankara, 06100
-
Turkey
United Kingdom
Novartis Investigative Site
-
Westcliff-on-Sea, SS0 0RY
Essex
United Kingdom
Novartis Investigative Site
-
Leytonstone, E11 1NR
London
United Kingdom
Novartis Investigative Site
-
Stoke on Trent, ST6 7AG
Staffordshire
United Kingdom
Novartis Investigative Site
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Worthing, BN11 2DH
West Sussex
United Kingdom
Novartis Investigative Site
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Bath, BA1 3NG
-
United Kingdom
Novartis Investigative Site
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Doncaster, DN2 5LT
-
United Kingdom
Novartis Investigative Site
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Middlesborough, TS4 3BW
-
United Kingdom
Novartis Investigative Site
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Northampton, NN1 5BD
-
United Kingdom
Novartis Investigative Site
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Wolverhampton, WV10 0QP
-
United Kingdom

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