Phase
Condition
Ankylosing Spondylitis
Treatment
Placebo
Secukinumab
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
Inflammatory back pain for at least 6 months
Onset before 45 years of age
Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by centralreader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
Objective signs of inflammation at screening, evident by either MRI with SacroiliacJoint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as definedby 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) atbaseline.
Participants should have been on at least 2 different NSAIDs (non-steroidalanti-inflammatory drugs) at the highest recommended dose for at least 4 weeks intotal prior to baseline with an inadequate response or failure to respond, or lessif therapy had to be withdrawn due to intolerance, toxicity or contraindications.
Exclusion
Exclusion Criteria:
Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally orgrade ≥ 3 unilaterally (radiological criterion according to the modified New Yorkdiagnostic 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-17or IL-17 receptor or previous treatment with immunomodulatory biologic agentsincluding those targeting TNFα (tumor necrosis factor α) (unless participantsdiscontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only afterappropriate wash-out period prior to baseline was observed).
History of hypersensitivity to the study drug or its excipients or to drugs ofsimilar chemical classes.
Active ongoing inflammatory diseases other than nr-axSpA that might confound theevaluation of the benefit of secukinumab therapy, including uveitis.
Active inflammatory bowel disease.
History of ongoing, chronic or recurrent infectious disease or evidence oftuberculosis infection.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Bruges, 8000
BelgiumSite Not Available
Novartis Investigative Site
Bruges 2800931, 8000
BelgiumSite Not Available
Novartis Investigative Site
Brugge, 8000
BelgiumSite Not Available
Novartis Investigative Site
Genk, 3600
BelgiumSite Not Available
Novartis Investigative Site
Genk 2797670, 3600
BelgiumSite Not Available
Novartis Investigative Site
Gent, 9000
BelgiumSite Not Available
Novartis Investigative Site
Ghent, 9000
BelgiumSite Not Available
Novartis Investigative Site
Ghent 2797656, 9000
BelgiumSite Not Available
Novartis Investigative Site
Mons, 7000
BelgiumSite Not Available
Novartis Investigative Site
Mons 2790869, 7000
BelgiumSite Not Available
Novartis Investigative Site
Juiz de Fora, Minas Gerais 36010 570
BrazilSite Not Available
Novartis Investigative Site
Juiz de Fora 3459505, Minas Gerais 3457153 36010 570
BrazilSite Not Available
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul 90480-000
BrazilSite Not Available
Novartis Investigative Site
Porto Alegre 3452925, Rio Grande do Sul 3451133 90480-000
BrazilSite Not Available
Novartis Investigative Site
Barretos, São Paulo 14784 400
BrazilSite Not Available
Novartis Investigative Site
Barretos 3470451, São Paulo 3448433 14784 400
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, 01409-902
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, 01409-902
BrazilSite Not Available
Novartis Investigative Site
Barranquilla, Atlantico 080020
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaSite Not Available
Novartis Investigative Site
Bogota, Cundinamarca 110111
ColombiaSite Not Available
Novartis Investigative Site
Chia, Cundinamarca 250001
ColombiaSite Not Available
Novartis Investigative Site
Chía, Cundinamarca 250001
ColombiaSite Not Available
Novartis Investigative Site
Chía 3686675, Cundinamarca 3685413 250001
ColombiaSite Not Available
Novartis Investigative Site
Bucaramanga, Santander Department 680003
ColombiaSite Not Available
Novartis Investigative Site
Bucaramanga 3688465, Santander Department 3668578 680003
ColombiaSite Not Available
Novartis Investigative Site
Bogotá 3688689, 110221
ColombiaSite Not Available
Novartis Investigative Site
Cundinamarca, 111121
ColombiaSite Not Available
Novartis Investigative Site
Plzen Bory, 30599
CzechiaSite Not Available
Novartis Investigative Site
Prague, 128 00
CzechiaSite Not Available
Novartis Investigative Site
Prague 3067696, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Praha, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Praha 11, 14900
CzechiaSite Not Available
Novartis Investigative Site
Praha 2, 128 50
CzechiaSite Not Available
Novartis Investigative Site
Praha 5, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Uherske Hradiste, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Uherské Hradiště, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Uherské Hradiště 3063739, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Chambray les Tours, 37170
FranceSite Not Available
Novartis Investigative Site
Chambray-lès-Tours, 37170
FranceSite Not Available
Novartis Investigative Site
Chambray-lès-Tours 3027343, 37170
FranceSite Not Available
Novartis Investigative Site
Le Mans, 72000
FranceSite Not Available
Novartis Investigative Site
Le Mans 3003603, 72000
FranceSite Not Available
Novartis Investigative Site
Nice, 06001
FranceSite Not Available
Novartis Investigative Site
Nice 2990440, 06001
FranceSite Not Available
Novartis Investigative Site
Orleans, 45100
FranceSite Not Available
Novartis Investigative Site
Orléans 2989317, 45100
FranceSite Not Available
Novartis Investigative Site
Paris, 75012
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75012
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31059
FranceSite Not Available
Novartis Investigative Site
Toulouse 2972315, 31059
FranceSite Not Available
Novartis Investigative Site
Toulouse Cedex 9, 31059
FranceSite Not Available
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg 79106
GermanySite Not Available
Novartis Investigative Site
Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79106
GermanySite Not Available
Novartis Investigative Site
Bad Doberan, 18209
GermanySite Not Available
Novartis Investigative Site
Bad Doberan 2953528, 18209
GermanySite Not Available
Novartis Investigative Site
Berlin, 12161
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 12161
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22415
GermanySite Not Available
Novartis Investigative Site
Hamburg 2911298, 22415
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Herne 2905891, 44649
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen, 67063
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen 2875377, 67063
GermanySite Not Available
Novartis Investigative Site
Magdeburg, 39110
GermanySite Not Available
Novartis Investigative Site
Magdeburg 2874545, 39110
GermanySite Not Available
Novartis Investigative Site
Ratingen, 40878
GermanySite Not Available
Novartis Investigative Site
Ratingen 2850174, 40878
GermanySite Not Available
Novartis Investigative Site
Rendsburg, 24768
GermanySite Not Available
Novartis Investigative Site
Rendsburg 2848245, 24768
GermanySite Not Available
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungarySite Not Available
Novartis Investigative Site
Székesfehérvár, Fejér 8000
HungarySite Not Available
Novartis Investigative Site
Székesfehérvár 3044774, Fejér 3053028 8000
HungarySite Not Available
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye 4032
HungarySite Not Available
Novartis Investigative Site
Debrecen 721472, Hajdu Bihar Megye 4032
HungarySite Not Available
Novartis Investigative Site
Budapest, 1023
HungarySite Not Available
Novartis Investigative Site
Budapest 3054643, 1023
HungarySite Not Available
Novartis Investigative Site
Eger, 3300
HungarySite Not Available
Novartis Investigative Site
Eger 721239, 3300
HungarySite Not Available
Novartis Investigative Site
Kistarcsa, 2143
HungarySite Not Available
Novartis Investigative Site
Kistarcsa 3050290, 2143
HungarySite Not Available
Novartis Investigative Site
Miskolc, 3526
HungarySite Not Available
Novartis Investigative Site
Miskolc 717582, 3526
HungarySite Not Available
Novartis Investigative Site
Szeged, 6725
HungarySite Not Available
Novartis Investigative Site
Szeged 715429, 6725
HungarySite Not Available
Novartis Investigative Site
Veszprem, 8200
HungarySite Not Available
Novartis Investigative Site
Veszprém, 8200
HungarySite Not Available
Novartis Investigative Site
Veszprém 3042929, 8200
HungarySite Not Available
Novartis Investigative Site
Zalaegerszeg, 8900
HungarySite Not Available
Novartis Investigative Site
Haifa, 3104802
IsraelSite Not Available
Novartis Investigative Site
Haifa 294801, 3104802
IsraelSite Not Available
Novartis Investigative Site
Kfar Saba, 4428164
IsraelSite Not Available
Novartis Investigative Site
Kfar Saba 294514, 4428164
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan, 5265601
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan 293788, 5265601
IsraelSite Not Available
Novartis Investigative Site
Tel Aviv, 6423906
IsraelSite Not Available
Novartis Investigative Site
Tel Aviv 293397, 6423906
IsraelSite Not Available
Novartis Investigative Site
Ancona, AN 60126
ItalySite Not Available
Novartis Investigative Site
Ancona 3183089, AN 60126
ItalySite Not Available
Novartis Investigative Site
Bologna, BO 40136
ItalySite Not Available
Novartis Investigative Site
Bologna 3181928, BO 40136
ItalySite Not Available
Novartis Investigative Site
Firenze, FI 50134
ItalySite Not Available
Novartis Investigative Site
Florence 3176959, FI 50134
ItalySite Not Available
Novartis Investigative Site
Milan 6951411, MI 20100
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20100
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00161
ItalySite Not Available
Novartis Investigative Site
Roma 8957247, RM 00161
ItalySite Not Available
Novartis Investigative Site
Siena 3166548, SI 53100
ItalySite Not Available
Novartis Investigative Site
Torino, TO 10128
ItalySite Not Available
Novartis Investigative Site
Torino 8980539, TO 10128
ItalySite Not Available
Novartis Investigative Site
Negrar, VR 37024
ItalySite Not Available
Novartis Investigative Site
Negrar 3172338, VR 37024
ItalySite Not Available
Novartis Investigative Site
Verona, VR 3712
ItalySite Not Available
Novartis Investigative Site
Verona 3164527, VR 3712
ItalySite Not Available
Novartis Investigative Site
Kuching, Sarawak 93586
MalaysiaSite Not Available
Novartis Investigative Site
Kuching 1735634, Sarawak 1733038 93586
MalaysiaSite Not Available
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaSite Not Available
Novartis Investigative Site
Kuala Lumpur 1735161, 59100
MalaysiaSite Not Available
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaSite Not Available
Novartis Investigative Site
Guadalajara, Jalisco 44650
MexicoSite Not Available
Novartis Investigative Site
Guadalajara 4005539, Jalisco 4004156 44650
MexicoSite Not Available
Novartis Investigative Site
Merida, Yucatan 97070
MexicoSite Not Available
Novartis Investigative Site
Mérida, Yucatán 97070
MexicoSite Not Available
Novartis Investigative Site
Mérida 3523349, Yucatán 3514211 97070
MexicoSite Not Available
Novartis Investigative Site
Chihuahua, 31000
MexicoSite Not Available
Novartis Investigative Site
Chihuahua City, 31000
MexicoSite Not Available
Novartis Investigative Site
Chihuahua City 4014338, 31000
MexicoSite Not Available
Novartis Investigative Site
Heerlen, Limburg 6419 PC
NetherlandsSite Not Available
Novartis Investigative Site
Heerlen 2754652, Limburg 2751596 6419 PC
NetherlandsSite Not Available
Novartis Investigative Site
Maastricht 2751283, Limburg 2751596 6229 HX
NetherlandsSite Not Available
Novartis Investigative Site
Amsterdam, North Holland 1105 AZ
NetherlandsSite Not Available
Novartis Investigative Site
Amsterdam 2759794, North Holland 2749879 1105 AZ
NetherlandsSite Not Available
Novartis Investigative Site
Maastricht, 6229 HX
NetherlandsSite Not Available
Novartis Investigative Site
Makati, Metro Manila 1218
PhilippinesSite Not Available
Novartis Investigative Site
Makati City, National Capital Region 1218
PhilippinesSite Not Available
Novartis Investigative Site
Makati City 1703417, National Capital Region 7521311 1218
PhilippinesSite Not Available
Novartis Investigative Site
Manila, 1008
PhilippinesSite Not Available
Novartis Investigative Site
Manila 1701668, 1008
PhilippinesSite Not Available
Novartis Investigative Site
Bialystok, 15-351
PolandSite Not Available
Novartis Investigative Site
Bialystok 776069, 15-351
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz, 85-168
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz 3102014, 85-168
PolandSite Not Available
Novartis Investigative Site
Krakow, 30-002
PolandSite Not Available
Novartis Investigative Site
Krakow 3094802, 30-002
PolandSite Not Available
Novartis Investigative Site
Sochaczew, 96-500
PolandSite Not Available
Novartis Investigative Site
Sochaczew 758682, 96-500
PolandSite Not Available
Novartis Investigative Site
Torun, 87-100
PolandSite Not Available
Novartis Investigative Site
Torun 3083271, 87-100
PolandSite Not Available
Novartis Investigative Site
Warsaw, 02-637
PolandSite Not Available
Novartis Investigative Site
Warsaw 756135, 02 637
PolandSite Not Available
Novartis Investigative Site
Warszawa, 02 637
PolandSite Not Available
Novartis Investigative Site
Cluj-Napoca, Cluj 400006
RomaniaSite Not Available
Novartis Investigative Site
Cluj-Napoca 681290, Cluj 681291 400006
RomaniaSite Not Available
Novartis Investigative Site
Brasov, 500283
RomaniaSite Not Available
Novartis Investigative Site
Brasov 683844, 500283
RomaniaSite Not Available
Novartis Investigative Site
Bucharest, 011172
RomaniaSite Not Available
Novartis Investigative Site
Bucharest 683506, 011055
RomaniaSite Not Available
Novartis Investigative Site
Bucuresti, 011172
RomaniaSite Not Available
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaSite Not Available
Novartis Investigative Site
Sibiu, 550245
RomaniaSite Not Available
Novartis Investigative Site
Sibiu 667268, 550245
RomaniaSite Not Available
Novartis Investigative Site
Suceava, 727525
RomaniaSite Not Available
Novartis Investigative Site
Suceava 665850, 727525
RomaniaSite Not Available
Novartis Investigative Site
Bangkok, 10400
ThailandSite Not Available
Novartis Investigative Site
Bangkok 1609350, 10700
ThailandSite Not Available
Novartis Investigative Site
Pendik, Istanbul 34899
TurkeySite Not Available
Novartis Investigative Site
Adana, 01160
TurkeySite Not Available
Novartis Investigative Site
Konya, 42080
TurkeySite Not Available
Novartis Investigative Site
Pendik Istanbul, 34899
TurkeySite Not Available
Novartis Investigative Site
Istanbul 745044, Pendik 34899
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Adana, Yuregir 01230
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Adana 325363, Yuregir 1230
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Konya, 42080
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Konya 306571, 42080
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Ho Chi Minh, VNM 700000
VietnamSite Not Available
Novartis Investigative Site
Ho Chi Minh City, VNM 700000
VietnamSite Not Available
Novartis Investigative Site
Ho Chi Minh City 1566083, VNM 700000
VietnamSite Not Available

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