The purpose of this global study is to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in subjects with active axSpA at Week 16 despite current or previous NSAID, DMARD and/or anti Tumor Necrosis Factor (TNF) therapy. In addition, to further support efficacy and safety of an i.v. regimen, data will be collected for up to 52 weeks of treatment. Efficacy and safety data may be used to support the registration of i.v. secukinumab in the US and other countries for treatment of subjects with active axSpA.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04156620 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Belgium, Brazil, Bulgaria, Colombia, Czechia, Greece, Guatemala, India, Italy, Korea, Republic of, Malaysia, Philippines, Poland, Russian Federation, Sweden, Thailand, Turkey, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis |
This multicenter study uses a randomized, double-blind, placebo-controlled, parallel-group design to study the efficacy, safety, and tolerability of treatment with intravenous secukinumab (initial dose of 6 mg/kg followed thereafter with 3 mg/kg administered every four weeks starting at Week 4) in subjects with active axSpA. The study population consists of approximately 400 subjects with active AS and approximately 100 subjects with active nr-axSpA, despite current or previous NSAID, conventional DMARD and / or TNF inhibitor therapy, or intolerance to these therapies. A screening (SCR) period of up to 10 weeks will be used to assess eligibility, followed by randomization to 52 weeks of study treatment. At baseline, subjects with active AS and nr-axSpA will be randomized to one of the two treatment groups:
Experimental: Secukinumab
Secukinumab intravenous (i.v.) regimen
Placebo Comparator: Placebo
Placebo intravenous (i.v.) regimen
Drug: - Secukinumab
The subjects will receive secukinumab 6 mg/kg i.v. at randomization (Baseline (BSL) visit), followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
Drug: - Placebo
The subjects will receive i.v. placebo at randomization (BSL visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Novartis Investigative Site
Birmingham, Alabama, 35205
Status
Recruiting
Address
Novartis Investigative Site
Jonesboro, Arkansas, 72401
Status
Recruiting
Address
Novartis Investigative Site
Fullerton, California, 92835
Status
Recruiting
Address
Novartis Investigative Site
Irvine, California, 92604
Status
Recruiting
Address
Novartis Investigative Site
La Mesa, California, 91942
Status
Recruiting
Address
Novartis Investigative Site
San Leandro, California, 94578
Status
Recruiting
Address
Novartis Investigative Site
Upland, California, 91786
Status
Recruiting
Address
Novartis Investigative Site
Denver, Colorado, 80204
Status
Recruiting
Address
Novartis Investigative Site
Denver, Colorado, 80230
Status
Recruiting
Address
Novartis Investigative Site
Washington, District of Columbia, 20422
Status
Recruiting
Address
Novartis Investigative Site
Miami, Florida, 33155
Status
Recruiting
Address
Novartis Investigative Site
Ocoee, Florida, 34761
Status
Recruiting
Address
Novartis Investigative Site
Plantation, Florida, 33324
Status
Recruiting
Address
Novartis Investigative Site
Tamarac, Florida, 33321
Status
Recruiting
Address
Novartis Investigative Site
Winter Park, Florida, 32789
Status
Recruiting
Address
Novartis Investigative Site
Bowling Green, Kentucky, 42101
Status
Recruiting
Address
Novartis Investigative Site
Columbia, Maryland, 21046
Status
Recruiting
Address
Novartis Investigative Site
Cumberland, Maryland, 21740
Status
Recruiting
Address
Novartis Investigative Site
Grand Blanc, Michigan, 48439
Status
Recruiting
Address
Novartis Investigative Site
Lansing, Michigan, 48910
Status
Recruiting
Address
Novartis Investigative Site
Lincoln, Nebraska, 68516
Status
Recruiting
Address
Novartis Investigative Site
Santa Fe, New Mexico, 87505
Status
Recruiting
Address
Novartis Investigative Site
Potsdam, New York, 13676
Status
Recruiting
Address
Novartis Investigative Site
Greensboro, North Carolina, 27408
Status
Recruiting
Address
Novartis Investigative Site
Middleburg Heights, Ohio, 44130
Status
Recruiting
Address
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Status
Recruiting
Address
Novartis Investigative Site
Columbia, South Carolina, 29204
Status
Recruiting
Address
Novartis Investigative Site
Jackson, Tennessee, 38305
Status
Withdrawn
Address
Novartis Investigative Site
College Station, Texas, 77845
Status
Recruiting
Address
Novartis Investigative Site
Katy, Texas, 77494
Status
Recruiting
Address
Novartis Investigative Site
Spring, Texas, 77382
Status
Recruiting
Address
Novartis Investigative Site
The Woodlands, Texas, 77380
Status
Recruiting
Address
Novartis Investigative Site
Everett, Washington, 98208
Status
Recruiting
Address
Novartis Investigative Site
Spokane, Washington, 99204
Status
Recruiting
Address
Novartis Investigative Site
Beckley, West Virginia, 25801
Status
Recruiting
Address
Novartis Investigative Site
Charleston, West Virginia, 25304
Status
Recruiting
Address
Novartis Investigative Site
Bruxelles, , 1070
Status
Recruiting
Address
Novartis Investigative Site
Leuven, , 3000
Status
Recruiting
Address
Novartis Investigative Site
Salvador, BA, 40150 150
Status
Recruiting
Address
Novartis Investigative Site
Vitoria, ES, 29055 450
Status
Recruiting
Address
Novartis Investigative Site
Juiz de Fora, MG, 36010 570
Status
Recruiting
Address
Novartis Investigative Site
São Paulo, SP, 01244-030
Status
Recruiting
Address
Novartis Investigative Site
Rio de Janeiro, , 20241-180
Status
Recruiting
Address
Novartis Investigative Site
Sao Jose do Rio Preto, , 15090 000
Status
Recruiting
Address
Novartis Investigative Site
Pleven, , 5800
Status
Recruiting
Address
Novartis Investigative Site
Plovdiv, , 4000
Status
Recruiting
Address
Novartis Investigative Site
Plovdiv, , 4002
Status
Recruiting
Address
Novartis Investigative Site
Sofia, , 1413
Status
Recruiting
Address
Novartis Investigative Site
Sofia, , 1431
Status
Recruiting
Address
Novartis Investigative Site
Barranquilla, Atlantico,
Status
Recruiting
Address
Novartis Investigative Site
Bucaramanga, Santander, 0001
Status
Recruiting
Address
Novartis Investigative Site
Ibague, Tolima, 730006
Status
Recruiting
Address
Novartis Investigative Site
Barranquilla, ,
Status
Recruiting
Address
Novartis Investigative Site
Bogota, , 110221
Status
Recruiting
Address
Novartis Investigative Site
Cundinamarca, , 111121
Status
Recruiting
Address
Novartis Investigative Site
Ostrava, Czech Republic, 772 00
Status
Recruiting
Address
Novartis Investigative Site
Praha 2, , 128 50
Status
Recruiting
Address
Novartis Investigative Site
Praha 4, , 140 59
Status
Recruiting
Address
Novartis Investigative Site
Praha 5, , 150 06
Status
Recruiting
Address
Novartis Investigative Site
Uherske Hradiste, , 686 01
Status
Recruiting
Address
Novartis Investigative Site
Athens, , 115 27
Status
Recruiting
Address
Novartis Investigative Site
Heraklion Crete, , 711 10
Status
Recruiting
Address
Novartis Investigative Site
Patra, , 26443
Status
Recruiting
Address
Novartis Investigative Site
Guatemala City, , 01010
Status
Recruiting
Address
Novartis Investigative Site
Guatemala City, , 01011
Status
Recruiting
Address
Novartis Investigative Site
Guatemala, , 01009
Status
Recruiting
Address
Novartis Investigative Site
Guatemala, , 01010
Status
Recruiting
Address
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500018
Status
Recruiting
Address
Novartis Investigative Site
Surat, Gujarat, 395009
Status
Recruiting
Address
Novartis Investigative Site
Bangalore, Karnataka, 560 079
Status
Recruiting
Address
Novartis Investigative Site
Mumbai, Maharashtra, 400 053
Status
Recruiting
Address
Novartis Investigative Site
Nashik, Maharashtra, 422 101
Status
Recruiting
Address
Novartis Investigative Site
New Delhi, , 110029
Status
Recruiting
Address
Novartis Investigative Site
Siena, SI, 53100
Status
Recruiting
Address
Novartis Investigative Site
Verona, VR, 37134
Status
Recruiting
Address
Novartis Investigative Site
Gwangju, , 61469
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 04763
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 05030
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 05278
Status
Recruiting
Address
Novartis Investigative Site
Seoul, , 06273
Status
Recruiting
Address
Novartis Investigative Site
Seremban, Negeri Sembilan, 70300
Status
Recruiting
Address
Novartis Investigative Site
Ipoh, Perak, 30450
Status
Recruiting
Address
Novartis Investigative Site
Kuching, Sarawak, 93586
Status
Recruiting
Address
Novartis Investigative Site
Kuala Lumpur, , 59100
Status
Recruiting
Address
Novartis Investigative Site
Selangor Darul Ehsan, , 68100
Status
Recruiting
Address
Novartis Investigative Site
Lipa City, Batangas, 4217
Status
Recruiting
Address
Novartis Investigative Site
Dasmarinas, Cavite, 4114
Status
Recruiting
Address
Novartis Investigative Site
Manila, , 1008
Status
Recruiting
Address
Novartis Investigative Site
Quezon City, , 1102
Status
Recruiting
Address
Novartis Investigative Site
Bialystok, , 15-351
Status
Recruiting
Address
Novartis Investigative Site
Krakow, , 30 002
Status
Recruiting
Address
Novartis Investigative Site
Sochaczew, , 96-500
Status
Recruiting
Address
Novartis Investigative Site
Torun, , 87-100
Status
Recruiting
Address
Novartis Investigative Site
Warszawa, , 02 637
Status
Recruiting
Address
Novartis Investigative Site
Chelyabinsk, , 454076
Status
Recruiting
Address
Novartis Investigative Site
Ekaterinburg, , 620137
Status
Recruiting
Address
Novartis Investigative Site
Kazan, , 420064
Status
Recruiting
Address
Novartis Investigative Site
Kemerovo, , 650029
Status
Recruiting
Address
Novartis Investigative Site
Kemerovo, , 650070
Status
Recruiting
Address
Novartis Investigative Site
Novosibirsk, , 630047
Status
Recruiting
Address
Novartis Investigative Site
Novosibirsk, , 630099
Status
Recruiting
Address
Novartis Investigative Site
Petrozavodsk, , 185019
Status
Recruiting
Address
Novartis Investigative Site
Saint Petersburg, , 197341
Status
Recruiting
Address
Novartis Investigative Site
St Petersburg, , 190068
Status
Recruiting
Address
Novartis Investigative Site
Ulyanovsk, , 432063
Status
Recruiting
Address
Novartis Investigative Site
Yaroslavl, , 150003
Status
Recruiting
Address
Novartis Investigative Site
Danderyd, , 182 88
Status
Recruiting
Address
Novartis Investigative Site
Stockholm, , 171 76
Status
Recruiting
Address
Novartis Investigative Site
Uppsala, , 751 85
Status
Recruiting
Address
Novartis Investigative Site
Bangkoknoi, Bangkok, 10700
Status
Recruiting
Address
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Status
Recruiting
Address
Novartis Investigative Site
Khon Kaen, THA, 40002
Status
Recruiting
Address
Novartis Investigative Site
Bangkok, , 10400
Status
Recruiting
Address
Novartis Investigative Site
Adana, , 01160
Status
Recruiting
Address
Novartis Investigative Site
Ankara, , 06100
Status
Recruiting
Address
Novartis Investigative Site
Edirne, , 22030
Status
Recruiting
Address
Novartis Investigative Site
Istanbul, , 34093