Study Description
This study will establish whether prolonged chronic dosing with secukinumab is needed in
participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved
remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score -
C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3).
Maintenance of remission on continued secukinumab treatment will be evaluated compared to
placebo using a randomized withdrawal design. The primary outcome measure for this study
is the proportion of participants remaining flare-free at Week 120. This study will establish whether prolonged chronic dosing with secukinumab is needed in
participants with nr-axSpA who have achieved remission. Remission is defined as
Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive
Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance
of remission on continued secukinumab treatment will be evaluated compared to placebo
using a randomized withdrawal design. The primary outcome measure for this study is the
proportion of participants remaining flare-free at Week 120.
Study treatment will be as follows:
- Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL
- Double-blind Secukinumab and Placebo PFS will be labeled as AIN457
150mg/1mL/Placebo.
Study duration will be up to 128 weeks from Baseline.
The treatment duration will be up to 120 weeks with last treatment administration at Week
116.
In the Treatment Period 1 participant will attend a site visit approximately 1 month
after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2
participant will attend site visits approximately every 4 weeks.
Interventions
Placebo
Secukinumab
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant, non-lactating female participants at least 18 years of age
- Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
1. Inflammatory back pain for at least 6 months
2. Onset before 45 years of age
3. Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central
reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
- Objective signs of inflammation at screening, evident by either MRI with Sacroiliac
Joint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as defined
by the central lab)
- Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline.
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline.
- Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at
baseline.
- Participants should have been on at least 2 different NSAIDs (non-steroidal
anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in
total prior to baseline with an inadequate response or failure to respond, or less
if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
Exclusion Criteria:
- Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or
grade ≥ 3 unilaterally (radiological criterion according to the modified New York
diagnostic criteria for AS) as assessed by central reader.
- Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone,
morphine).
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
or IL-17 receptor or previous treatment with immunomodulatory biologic agents
including those targeting TNFα (tumor necrosis factor α) (unless participants
discontinued the treatment with TNFα inhibitor due to a reason other than efficacy
[primary or secondary lack of efficacy, inadequate response] and only after
appropriate wash-out period prior to baseline was observed).
- History of hypersensitivity to the study drug or its excipients or to drugs of
similar chemical classes.
- Active ongoing inflammatory diseases other than nr-axSpA that might confound the
evaluation of the benefit of secukinumab therapy, including uveitis.
- Active inflammatory bowel disease.
- History of ongoing, chronic or recurrent infectious disease or evidence of
tuberculosis infection.
Study Location
Novartis Investigative Site
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Brugge,8000,Belgium
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Mons,7000,Belgium
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Genk,3600,Belgium
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Gent,9000,Belgium
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Juiz de Fora,MG,36010 570,Brazil
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Barretos,Sao Paulo,14784 400,Brazil
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Porto Alegre,RS,90480-000,Brazil
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Sao Paulo,01409-902,Brazil
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Bogota,Cundinamarca,110111,Colombia
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Bucaramanga,Santander,0001,Colombia
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Cundinamarca,111121,Colombia
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Bogota,110221,Colombia
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Barranquilla,080020,Colombia
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Praha 2,128 50,Czechia
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Praha 5,150 06,Czechia
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Plzen Bory,30599,Czechia
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Uherske Hradiste,686 01,Czechia
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Praha 11,14900,Czechia
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Orleans,Cedex 2,45067,France
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Paris,75012,France
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Chambray les Tours,37170,France
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Le Mans,72037,France
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Toulouse Cedex 9,31059,France
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Nice,Cedex1,06001,France
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Berlin,12161,Germany
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Hamburg,22415,Germany
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Freiburg,79106,Germany
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Berlin,12203,Germany
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Ratingen,40878,Germany
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Bad Doberan,18209,Germany
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Berlin,13125,Germany
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Rendsburg,24768,Germany
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Herne,44649,Germany
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Magdeburg,39110,Germany
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Eger,3300,Hungary
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Miskolc,H-3529,Hungary
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Kistarcsa,2143,Hungary
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Szeged,6720,Hungary
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Szekesfehervar,Fejer,8000,Hungary
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Debrecen,4032,Hungary
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Veszprem,8200,Hungary
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Budapest,1027,Hungary
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Tel Aviv,6423906,Israel
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Haifa,3339419,Israel
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Kfar Saba,4428164,Israel
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Ramat Gan,52621,Israel
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Torino,TO,10128,Italy
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Firenze,FI,50134,Italy
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Ancona,AN,60020,Italy
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Negrar,VR,37024,Italy
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Roma,RM,00161,Italy
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Verona,VR,37126,Italy
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Kuala Lumpur,59100,Malaysia
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Selangor Darul Ehsan,68100,Malaysia
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Kuching,Sarawak,93586,Malaysia
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Guadalajara,Jalisco,44690,Mexico
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Merida,Yucatan,97070,Mexico
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Chihuahua,31000,Mexico
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Guadalajara,Jalisco,44650,Mexico
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Amsterdam,1105 az,Netherlands
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Heerlen,6419,Netherlands
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Maastricht,6229 hx,Netherlands
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Makati,Metro Manila,1218,Philippines
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Manila,1008,Philippines
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Warszawa,02 637,Poland
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Bydgoszcz,85 168,Poland
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Torun,87-100,Poland
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Sochaczew,96-500,Poland
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Bialystok,15-351,Poland
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Krakow,Malopolskie,30-727,Poland
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Krakow,30 002,Poland
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Brasov,500283,Romania
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Sibiu,550245,Romania
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Suceava,727525,Romania
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Cluj Napoca,400006,Romania
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Bucharest,011055,Romania
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Bucuresti,011172,Romania
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Bangkok,10400,Thailand
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Bangkok,10700,Thailand
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Adana,01160,Turkey
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Pendik,Istanbul,34899,Turkey
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Konya,42080,Turkey
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Ho Chi Minh,VNM,700000,Vietnam
Worldwide Contacts
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