18 and older, any sex, with Moderate to Severe Chronic Plaque-type Psoriasis. 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 Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)Primary· 16 weeks
A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.
Group
Value
95% CI
Secukinumab 300 mg Every 2 Weeks (Q2W)
121
Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose)
92
Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)Secondary· 16 weeks
IGA mod 2011 was conducted for overall psoriatic disease. The IGA modified 2011 used in this study was static, i.e., it referred exclusively to the subject's disease state at the time of the assessments, and did not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. The scale has 0 (clear) as min and 4 (severe) as max, i.e., a higher score indicates more severity.
Group
Value
95% CI
Secukinumab 300 mg Every 2 Weeks (Q2W)
122
Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose)
109
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set)Secondary· Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Patients with any AE(s)
Group
Value
95% CI
Secukinumab 300 mg Every 2 Weeks (Q2W)
127
Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)
97
Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)
24
Patients with serious or other significant events - Death
Group
Value
95% CI
Secukinumab 300 mg Every 2 Weeks (Q2W)
0
Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)
1
Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)
0
Patients with serious or other significant events - Non-fatal SAE(s)
Group
Value
95% CI
Secukinumab 300 mg Every 2 Weeks (Q2W)
14
Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)
17
Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)
4
Patients with serious or other significant events - Discontinued study treatment due to any AE(s)
Group
Value
95% CI
Secukinumab 300 mg Every 2 Weeks (Q2W)
4
Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)
9
Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Secukinumab 300 mg Every 2 Weeks (Q2W)
Serious: 14/165 (8%)
Deaths: 0/165
Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)
Serious: 18/134 (13%)
Deaths: 1/134
Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)
The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01806597 — Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
· Phase 3
· completed
NCT01555125 — First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
· Phase 3
· completed
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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: 11 October 2021
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/NCT03504852.