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least 4 weeks intotal prior to baseline with an inadequate response or failure to respond, or lessif therapy had to be withdrawn due to intolerance, toxicity or contraindications.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
Brugge, 8000
BelgiumActive - Recruiting
Novartis Investigative Site
Genk, 3600
BelgiumActive - Recruiting
Novartis Investigative Site
Gent, 9000
BelgiumActive - Recruiting
Novartis Investigative Site
Mons, 7000
BelgiumActive - Recruiting
Novartis Investigative Site
Juiz de Fora, MG 36010 570
BrazilActive - Recruiting
Novartis Investigative Site
Porto Alegre, RS 90480-000
BrazilActive - Recruiting
Novartis Investigative Site
Barretos, Sao Paulo 14784 400
BrazilActive - Recruiting
Novartis Investigative Site
Sao Paulo, 01409-902
BrazilSite Not Available
Novartis Investigative Site
Bucaramanga, Santander 0001
ColombiaActive - Recruiting
Novartis Investigative Site
Barranquilla, 080020
ColombiaActive - Recruiting
Novartis Investigative Site
Bogota, 110221
ColombiaActive - Recruiting
Novartis Investigative Site
Cundinamarca, 111121
ColombiaActive - Recruiting
Novartis Investigative Site
Plzen Bory, 30599
CzechiaActive - Recruiting
Novartis Investigative Site
Praha 11, 14900
CzechiaActive - Recruiting
Novartis Investigative Site
Praha 2, 128 50
CzechiaActive - Recruiting
Novartis Investigative Site
Praha 5, 150 06
CzechiaActive - Recruiting
Novartis Investigative Site
Uherske Hradiste, 686 01
CzechiaActive - Recruiting
Novartis Investigative Site
Nice, Cedex1 06001
FranceActive - Recruiting
Novartis Investigative Site
Chambray les Tours, 37170
FranceActive - Recruiting
Novartis Investigative Site
Le Mans, 72000
FranceActive - Recruiting
Novartis Investigative Site
Orleans, 45100
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75012
FranceActive - Recruiting
Novartis Investigative Site
Toulouse Cedex 9, 31059
FranceActive - Recruiting
Novartis Investigative Site
Bad Doberan, 18209
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 12161
GermanyActive - Recruiting
Novartis Investigative Site
Freiburg, 79106
GermanyActive - Recruiting
Novartis Investigative Site
Hamburg, 22415
GermanyActive - Recruiting
Novartis Investigative Site
Herne, 44649
GermanyActive - Recruiting
Novartis Investigative Site
Magdeburg, 39110
GermanyActive - Recruiting
Novartis Investigative Site
Ratingen, 40878
GermanyActive - Recruiting
Novartis Investigative Site
Rendsburg, 24768
GermanyActive - Recruiting
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungaryActive - Recruiting
Novartis Investigative Site
Budapest, 1023
HungaryActive - Recruiting
Novartis Investigative Site
Debrecen, 4032
HungaryActive - Recruiting
Novartis Investigative Site
Eger, 3300
HungaryActive - Recruiting
Novartis Investigative Site
Kistarcsa, 2143
HungaryActive - Recruiting
Novartis Investigative Site
Miskolc, H-3526
HungaryActive - Recruiting
Novartis Investigative Site
Szeged, 6720
HungaryActive - Recruiting
Novartis Investigative Site
Veszprem, 8200
HungaryActive - Recruiting
Novartis Investigative Site
Zalaegerszeg, 8900
HungarySite Not Available
Novartis Investigative Site
Haifa, 3339419
IsraelActive - Recruiting
Novartis Investigative Site
Kfar Saba, 44281
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 52621
IsraelActive - Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
IsraelActive - Recruiting
Novartis Investigative Site
Ancona, AN 60126
ItalyActive - Recruiting
Novartis Investigative Site
Firenze, FI 50134
ItalyActive - Recruiting
Novartis Investigative Site
Roma, RM 00161
ItalyActive - Recruiting
Novartis Investigative Site
Torino, TO 10128
ItalyActive - Recruiting
Novartis Investigative Site
Negrar, VR 37024
ItalyActive - Recruiting
Novartis Investigative Site
Verona, VR 3712
ItalyActive - Recruiting
Novartis Investigative Site
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaActive - Recruiting
Novartis Investigative Site
Guadalajara, Jalisco 44650
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Chihuahua, 31000
MexicoActive - Recruiting
Novartis Investigative Site
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Novartis Investigative Site
Heerlen, 6419 PC
NetherlandsActive - Recruiting
Novartis Investigative Site
Maastricht, 6229 HX
NetherlandsActive - Recruiting
Novartis Investigative Site
Makati, Metro Manila 1218
PhilippinesActive - Recruiting
Novartis Investigative Site
Manila, 1008
PhilippinesActive - Recruiting
Novartis Investigative Site
Krakow, Malopolskie 30-727
PolandActive - Recruiting
Novartis Investigative Site
Bialystok, 15-351
PolandActive - Recruiting
Novartis Investigative Site
Bydgoszcz, 85 168
PolandActive - Recruiting
Novartis Investigative Site
Sochaczew, 96-500
PolandActive - Recruiting
Novartis Investigative Site
Torun, 87-100
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 02 637
PolandActive - Recruiting
Novartis Investigative Site
Brasov, 500283
RomaniaActive - Recruiting
Novartis Investigative Site
Bucharest, 011055
RomaniaActive - Recruiting
Novartis Investigative Site
Bucuresti, 011172
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaActive - Recruiting
Novartis Investigative Site
Sibiu, 550245
RomaniaActive - Recruiting
Novartis Investigative Site
Suceava, 727525
RomaniaActive - Recruiting
Novartis Investigative Site
Bangkok, 10700
ThailandActive - Recruiting
Novartis Investigative Site
Pendik, Istanbul 34899
TurkeySite Not Available
Novartis Investigative Site
Adana, 01160
TurkeyActive - Recruiting
Novartis Investigative Site
Konya, 42080
TurkeyActive - Recruiting
Novartis Investigative Site
Pendik Istanbul, 34899
TurkeyActive - Recruiting
Novartis Investigative Site
Ho Chi Minh, VNM 700000
VietnamActive - Recruiting
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