18 and older, any sex, with Ankylosing Spondylitis. 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.
Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria)Primary· Baseline to Week 16
ASAS40 is ≥ 40% and an absolute improvement from baseline of ≥20 units (range 0-100) in ≥ 3 of the following 4 domains: back pain \[10 cm visual analogue scale (VAS)\], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0-100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain.
ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented b
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
40.85
34.94 – 46.76
Placebo - AIN457 3 mg/kg i.v.
22.94
17.86 – 28.02
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major ImprovementSecondary· Baseline to Week 16
ASDAS-CRP was utilized to assess disease activity status. Parameters used for the ASDAS included: total back pain (BASDAI question 2), patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and CRP in mg/L. Disease activity states: inactive disease, moderate disease activity, high disease activity, and very high disease activity. The three values selected to separate these states are: \< 1.3 between inactive disease and moderate disease activity; \< 2.1 between moderate disease activity and high disease a
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
27.99
22.86 – 33.12
Placebo - AIN457 3 mg/kg i.v.
7.54
4.44 – 10.64
The Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)Secondary· Baseline to Week 16
BASDAI consists of a 0 through 10 scale (0 indicating no problem and 10 indicating the worst problem, captured as a continuous VAS), which was used to answer six questions pertaining to the five major symptoms of AS: fatigue, spinal pain, peripheral joint pain / swelling,, areas of localized tenderness (enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, morning stiffness severity.
To give each symptom equal weight, the mean of the two scores relating to morning stiffness is taken into account (questions 5 and 6). The resulting 0 to 10 score is added to the scor
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
-2.70
± 0.144
Placebo - AIN457 3 mg/kg i.v.
-1.69
± 0.144
Percentage of Participants Who Achieved an ASAS 5/6 (Assessment of Spondylarthritis International Society Criteria)Secondary· Baseline to Week 16
The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity.
ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represe
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
43.92
37.94 – 49.90
Placebo - AIN457 3 mg/kg i.v.
21.77
16.77 – 26.77
The Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI)Secondary· Baseline to Week 16
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The questions were chosen on the basis of predominant input from subjects with AS. The first eight questions consider activities related to functional anatomy. The final two questions assess the subjects' ability to cope with everyday life. A 0-10 scale (captured as a continuous VAS) is used to answer the questions. The BASFI score is the mean of the ten scales - a value between 0 and 10.
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
-2.33
± 0.147
Placebo - AIN457 3 mg/kg i.v.
-1.39
± 0.148
The Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS)Secondary· Baseline to Week 16
The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions.
It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-bas
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
7.70
± 0.473
Placebo - AIN457 3 mg/kg i.v.
4.69
± 0.473
The Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQol)Secondary· Baseline to Week 16
The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult subjects with AS. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response, resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower scores indicate better quality of life. Items include an assessment of mobility/energy, self care and mood/emotion. The recall period is "at the moment".
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
-4.65
± 0.291
Placebo - AIN457 3 mg/kg i.v.
-2.88
± 0.290
The Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)Secondary· Baseline to Week 16
This assessment (laboratory assessment) was performed in order to identify the presence of inflammation, to determine its severity and to monitor the response to treatment. Exponentially transformed LSM, the geometric mean ratio of post-baseline/baseline. A value \<1 indicates a reduced CRP
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
0.39
± 1.063
Placebo - AIN457 3 mg/kg i.v.
0.89
± 1.062
Percentage of Participants Who Achieved an ASAS20 (Assessment of SpondyloArthritis International Society Criteria)Secondary· Baseline to Week 16
The ASAS Response Criteria (ASAS20) is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity.
ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) measured by VAS; 4. Inflammation represented by mean durati
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
63.94
58.19 – 69.70
Placebo - AIN457 3 mg/kg i.v.
40.53
34.62 – 46.44
The Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease.Secondary· Baseline to Week 16
ASDAS-CRP was utilized to assess disease activity status. Parameters used for the ASDAS included: total back pain (BASDAI question 2), patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and CRP in mg/L.
Disease activity states: inactive disease, moderate disease activity, high disease activity, and very high disease activity. The three values selected to separate these states are: \< 1.3 between inactive disease and moderate disease activity; \< 2.1 between moderate disease activity and high disease
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
15.66
11.53 – 19.78
Placebo - AIN457 3 mg/kg i.v.
3.08
1.00 – 5.15
Percentage of Participants Who Achieved ASAS20 (Assessment of Spondylarthritis International Society Criteria) Partial Remission.Secondary· Baseline to Week 16
ASAS partial remission criteria are defined as a value not above 2 units in each of the four main ASAS domains on a scale of 0-10.
ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Met
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
14.76
10.49 – 19.03
Placebo - AIN457 3 mg/kg i.v.
4.20
1.77 – 6.63
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)Secondary· Baseline to Week 16
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each item is weighted on a 0-3 interval scale. The global PSQI score is then ca
Group
Value
95% CI
AIN457 6 mg/kg - 3 mg/kg i.v.
-2.42
± 0.222
Placebo - AIN457 3 mg/kg i.v.
-1.76
± 0.221
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported for a maximum of 478 days for participants on AIN457 (including placebo switchers) and 182 days for participants on placebo which includes the 84 days in safety follow up..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this global study was to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in participants with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA ) at Week 16 despite current or previous non-steroidal anti inflammatory drugs (NSAID), disease-modifying antirheumatic drugs (DMARD) and/or anti Tumor Necrosis Factor (TNF) therapy. In addition, to further support efficacy and safety of an i.v. regimen, data was collected for up to 52 weeks of treatment.
Publications & conference data
7 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
Other recruiting trials for Ankylosing Spondylitis
Currently open trials in the same condition.
NCT07510789 — Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis
· recruiting
NCT07261644 — A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
· Phase 3
· recruiting
NCT07390929 — Clinical Trial Study on the Improved New Method of Acupotomy for AS
· NA
· recruiting
NCT06905288 — Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
· recruiting
NCT07166874 — The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis
· NA
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
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: 18 June 2024
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/NCT04156620.