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.
Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 ResponsePrimary· 16 weeks
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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
43
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
46
Placebo i.v. and s.c.
28
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
31
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
30
Placebo i.v. and s.c.
48
ASAS 40 ResponseSecondary· 16 weeks
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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
30
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
32
Placebo i.v. and s.c.
16
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
44
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
44
Placebo i.v. and s.c.
60
Serum hsCRPSecondary· Baseline and 16 weeks
Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.
Baseline
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
15.79
± 21.075
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
11.08
± 13.285
Placebo i.v. and s.c.
13.91
± 19.999
Week 16
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7.68
± 13.277
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
4.34
± 5.433
Placebo i.v. and s.c.
15.34
± 21.694
Change from Baseline to Week 16
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
-8.06
± 21.132
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
-6.75
± 13.778
Placebo i.v. and s.c.
0.57
± 11.629
ASAS 5/6 ResponseSecondary· 16 weeks
ASAS 5/6 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 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
31
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
30
Placebo i.v. and s.c.
11
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
43
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
46
Placebo i.v. and s.c.
65
Bath Ankylosing Spondylitis Disease Activity Index / BASDAISecondary· Baseline and 16 weeks
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Baseline
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
6.958
± 1.3913
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
6.963
± 1.3766
Placebo i.v. and s.c.
6.907
± 1.2600
Week 16
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
4.451
± 2.5623
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
4.178
± 2.7038
Placebo i.v. and s.c.
5.369
± 2.2574
Change from Baseline to Week 16
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
-2.548
± 2.4559
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
-2.796
± 2.6374
Placebo i.v. and s.c.
-1.590
± 2.0084
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)Secondary· Week 8 and Week 12
Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.
Self-administration Week 8
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
72
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
73
Placebo i.v. and s.c.
71
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
0
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
0
Placebo i.v. and s.c.
1
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
2
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
3
Placebo i.v. and s.c.
3
Self-administration Week 12
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
74
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
75
Placebo i.v. and s.c.
72
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
0
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
0
Placebo i.v. and s.c.
0
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
0
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
1
Placebo i.v. and s.c.
3
Pre-filled Syringe Possible HazardSecondary· Week 8 and Week 12
The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.
The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.
Week 0: Feeling about injections
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7.97
± 1.946
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
7.66
± 2.369
Placebo i.v. and s.c.
8.01
± 1.927
Week 8: Feeling about injections
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7.96
± 2.538
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
7.68
± 2.296
Placebo i.v. and s.c.
8.24
± 2.082
Week 12: Feeling about injections
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
8.45
± 1.968
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
7.93
± 2.201
Placebo i.v. and s.c.
8.25
± 1.997
Week 16: Feeling about injections
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
8.15
± 2.337
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
7.99
± 2.269
Placebo i.v. and s.c.
8.41
± 2.037
Week 0: Self-confidence
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
6.27
± 2.811
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
6.66
± 2.315
Placebo i.v. and s.c.
6.52
± 2.273
Week 8: Self-confidence
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7.08
± 2.520
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
6.66
± 2.855
Placebo i.v. and s.c.
7.41
± 2.198
Week 12: Self-confidence
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7.01
± 2.603
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
7.28
± 2.231
Placebo i.v. and s.c.
7.42
± 2.230
Week 16: Self-confidence
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7.51
± 2.388
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
7.23
± 2.566
Placebo i.v. and s.c.
7.64
± 2.192
ASAS Partial RemissionSecondary· 16 weeks
ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Group
Value
95% CI
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
7
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
16
Placebo i.v. and s.c.
1
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
67
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
60
Placebo i.v. and s.c.
75
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
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: 8 January 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/NCT02008916.