18 and older, any sex, with Spondylitis, Ankylosing. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260Primary· Week 104 to Week 260
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the origi
Week 104
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
71.4
Secukinumab (AIN457) 150mg Group 2
80.0
Pbo in Core Then AIN457 75mg Group 1
78.6
Pbo in Core Then AIN457 150mg Group 2
73.0
Week 116
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
76.0
Secukinumab (AIN457) 150mg Group 2
82.1
Pbo in Core Then AIN457 75mg Group 1
76.1
Pbo in Core Then AIN457 150mg Group 2
70.7
Week 128
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
70.1
Secukinumab (AIN457) 150mg Group 2
77.1
Pbo in Core Then AIN457 75mg Group 1
84.8
Pbo in Core Then AIN457 150mg Group 2
75.0
Week 140
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
77.1
Secukinumab (AIN457) 150mg Group 2
75.0
Pbo in Core Then AIN457 75mg Group 1
75.6
Pbo in Core Then AIN457 150mg Group 2
72.5
Week 156
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
75.5
Secukinumab (AIN457) 150mg Group 2
80.2
Pbo in Core Then AIN457 75mg Group 1
76.1
Pbo in Core Then AIN457 150mg Group 2
67.5
Week 168
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
74.7
Secukinumab (AIN457) 150mg Group 2
78.3
Pbo in Core Then AIN457 75mg Group 1
83.3
Pbo in Core Then AIN457 150mg Group 2
78.4
Week 180
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
81.7
Secukinumab (AIN457) 150mg Group 2
80.0
Pbo in Core Then AIN457 75mg Group 1
81.0
Pbo in Core Then AIN457 150mg Group 2
78.4
Week 192
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
72.3
Secukinumab (AIN457) 150mg Group 2
84.8
Pbo in Core Then AIN457 75mg Group 1
81.0
Pbo in Core Then AIN457 150mg Group 2
73.0
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260Secondary· Week 104 to Week 260
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the origi
Week 104
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
53.6
Secukinumab (AIN457) 150mg Group 2
65.0
Pbo in Core Then AIN457 75mg Group 1
57.1
Pbo in Core Then AIN457 150mg Group 2
48.6
Week 116
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
56.3
Secukinumab (AIN457) 150mg Group 2
59.5
Pbo in Core Then AIN457 75mg Group 1
54.3
Pbo in Core Then AIN457 150mg Group 2
51.2
Week 128
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
54.6
Secukinumab (AIN457) 150mg Group 2
68.7
Pbo in Core Then AIN457 75mg Group 1
58.7
Pbo in Core Then AIN457 150mg Group 2
55.0
Week 140
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
53.1
Secukinumab (AIN457) 150mg Group 2
60.7
Pbo in Core Then AIN457 75mg Group 1
53.3
Pbo in Core Then AIN457 150mg Group 2
60.0
Week 156
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
50.0
Secukinumab (AIN457) 150mg Group 2
62.8
Pbo in Core Then AIN457 75mg Group 1
54.3
Pbo in Core Then AIN457 150mg Group 2
55.0
Week 168
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
54.7
Secukinumab (AIN457) 150mg Group 2
67.5
Pbo in Core Then AIN457 75mg Group 1
42.9
Pbo in Core Then AIN457 150mg Group 2
62.2
Week 180
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
52.7
Secukinumab (AIN457) 150mg Group 2
68.8
Pbo in Core Then AIN457 75mg Group 1
52.4
Pbo in Core Then AIN457 150mg Group 2
67.6
Week 192
Group
Value
95% CI
Secukinumab (AIN457) 75mg Group 1
57.4
Secukinumab (AIN457) 150mg Group 2
69.6
Pbo in Core Then AIN457 75mg Group 1
52.4
Pbo in Core Then AIN457 150mg Group 2
62.2
Adverse events — posted to ClinicalTrials.gov
Time frame: CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07477795 — Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients
· Phase 2
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07243782 — Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cose
· recruiting
NCT06751238 — Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in
· Phase 1
· recruiting
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 4
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 30 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01863732.