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least 4 weeks intotal prior to baseline with an inadequate response or failure to respond, or lessif therapy had to be withdrawn due to intolerance, toxicity or contraindications.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
Genk, 3600
BelgiumSite Not Available
Novartis Investigative Site
Ghent, 9000
BelgiumSite Not Available
Novartis Investigative Site
Mons, 7000
BelgiumSite Not Available
Novartis Investigative Site
Juiz de Fora, Minas Gerais 36010 570
BrazilSite Not Available
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul 90480-000
BrazilSite Not Available
Novartis Investigative Site
Barretos, São Paulo 14784 400
BrazilSite Not Available
Novartis Investigative Site
Bogota, Cundinamarca 110221
ColombiaSite Not Available
Novartis Investigative Site
Chía, Cundinamarca 250001
ColombiaSite Not Available
Novartis Investigative Site
Bucaramanga, Santander Department 680003
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla, 080020
ColombiaActive - Recruiting
Novartis Investigative Site
Prague, 128 00
CzechiaSite Not Available
Novartis Investigative Site
Prague 3067696, 128 00
CzechiaSite Not Available
Novartis Investigative Site
Uherské Hradiště, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Chambray-lès-Tours, 37170
FranceSite Not Available
Novartis Investigative Site
Le Mans, 72000
FranceSite Not Available
Novartis Investigative Site
Nice, 06001
FranceSite Not Available
Novartis Investigative Site
Orleans, 45067
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75012
FranceSite Not Available
Novartis Investigative Site
Bad Doberan, 18209
GermanySite Not Available
Novartis Investigative Site
Berlin, 13125
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 13125
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22415
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Ratingen, 40878
GermanySite Not Available
Novartis Investigative Site
Székesfehérvár, Fejér 8000
HungarySite Not Available
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye 4032
HungarySite Not Available
Novartis Investigative Site
Debrecen 721472, 4032
HungaryActive - Recruiting
Novartis Investigative Site
Kistarcsa, 2143
HungarySite Not Available
Novartis Investigative Site
Miskolc, 3526
HungarySite Not Available
Novartis Investigative Site
Szeged, 6725
HungarySite Not Available
Novartis Investigative Site
Szeged 715429, 6720
HungaryActive - Recruiting
Novartis Investigative Site
Veszprém, 8200
HungarySite Not Available
Novartis Investigative Site
Haifa, 3339419
IsraelActive - Recruiting
Novartis Investigative Site
Kfar Saba, 4428164
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan, 5265601
IsraelSite Not Available
Novartis Investigative Site
Tel Aviv, 6423906
IsraelSite Not Available
Novartis Investigative Site
Ancona, AN 60126
ItalySite Not Available
Novartis Investigative Site
Torino, TO 10128
ItalySite Not Available
Novartis Investigative Site
Negrar, VR 37024
ItalySite Not Available
Novartis Investigative Site
Verona, VR 37126
ItalySite Not Available
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaSite Not Available
Novartis Investigative Site
Guadalajara, Jalisco 44690
MexicoSite Not Available
Novartis Investigative Site
Guadalajara 4005539, Jalisco 4004156 44690
MexicoSite Not Available
Novartis Investigative Site
Mérida, Yucatán 97070
MexicoSite Not Available
Novartis Investigative Site
Chihuahua City, 31000
MexicoSite Not Available
Novartis Investigative Site
Heerlen, Limburg 6419 PC
NetherlandsSite Not Available
Novartis Investigative Site
Amsterdam, North Holland 1105 AZ
NetherlandsSite Not Available
Novartis Investigative Site
Makati City, National Capital Region 1218
PhilippinesSite Not Available
Novartis Investigative Site
Manila, 1008
PhilippinesSite Not Available
Novartis Investigative Site
Krakow, Lesser Poland Voivodeship 30-727
PolandSite Not Available
Novartis Investigative Site
Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz, 85-168
PolandSite Not Available
Novartis Investigative Site
Bydgoszcz 3102014, 85 168
PolandActive - Recruiting
Novartis Investigative Site
Sochaczew, 96-500
PolandSite Not Available
Novartis Investigative Site
Torun, 87-100
PolandSite Not Available
Novartis Investigative Site
Warsaw, 02-637
PolandSite Not Available
Novartis Investigative Site
Cluj-Napoca, Cluj 400006
RomaniaSite Not Available
Novartis Investigative Site
Bucharest, 011055
RomaniaSite Not Available
Novartis Investigative Site
Bucharest 683506, 011172
RomaniaSite Not Available
Novartis Investigative Site
Cluj-Napoca 681290, 400006
RomaniaActive - Recruiting
Novartis Investigative Site
Bangkok, 10400
ThailandSite Not Available
Novartis Investigative Site
Bangkok 1609350, 10400
ThailandSite Not Available
Novartis Investigative Site
Adana, Yuregir 01230
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Konya, 42080
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Ho Chi Minh City, VNM 700000
VietnamSite Not Available
Novartis Investigative Site
Ho Chi Minh, 700000
VietnamActive - Recruiting
Novartis Investigative Site
Ho Chi Minh City 1566083, 700000
VietnamSite Not Available

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