A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
CompletedPhase 3Results postedLast updated 23 April 2019
What this trial tests
Phase 3 trial testing Secukinumab in Plaque Type Psorisis in 434 participants. Completed in 8 June 2017.
18 and older, any sex, with Plaque Type Psorisis. 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 Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)Primary· Baseline up to 16 weeks
PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.
Group
Value
95% CI
Cw6-positive AIN457 300 mg
80.4
74.0 – 85.9
Cw6-negative AIN457 300 mg
81.7
76.3 – 86.3
Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)Secondary· Baseline up to approximately 72 weeks
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).
W1 IGA 0/1
Group
Value
95% CI
Cw6-positive AIN457 300 mg
2.2
0.62 – 5.65
Cw6-negative AIN457 300 mg
2.1
0.68 – 4.79
Difference in % (Cw6-pos vs Cw6-neg)
0.16
-2.86 – 3.75
W1 PASI 50
Group
Value
95% CI
Cw6-positive AIN457 300 mg
13.4
8.78 – 19.29
Cw6-negative AIN457 300 mg
12.1
8.24 – 16.89
Difference in % (Cw6-pos vs Cw6-neg)
1.32
-5.02 – 8.09
W1 PASI 75
Group
Value
95% CI
Cw6-positive AIN457 300 mg
2.2
0.61 – 5.62
Cw6-negative AIN457 300 mg
0.4
0.01 – 2.30
Difference in % (Cw6-pos vs Cw6-neg)
1.82
-0.52 – 5.20
W2 IGA 0/1
Group
Value
95% CI
Cw6-positive AIN457 300 mg
8.7
5.05 – 13.74
Cw6-negative AIN457 300 mg
6.9
4.08 – 10.83
Difference in % (Cw6-pos vs Cw6-neg)
1.79
-3.29 – 7.36
W2 PASI 50
Group
Value
95% CI
Cw6-positive AIN457 300 mg
44.0
36.73 – 51.51
Cw6-negative AIN457 300 mg
44.5
38.16 – 50.95
Difference in % (Cw6-pos vs Cw6-neg)
-0.47
-9.84 – 8.98
W2 PASI 75
Group
Value
95% CI
Cw6-positive AIN457 300 mg
15.8
10.82 – 21.84
Cw6-negative AIN457 300 mg
10.2
6.71 – 14.69
Difference in % (Cw6-pos vs Cw6-neg)
5.56
-0.80 – 12.32
W2 PASI 90
Group
Value
95% CI
Cw6-positive AIN457 300 mg
3.3
1.21 – 6.96
Cw6-negative AIN457 300 mg
2.4
0.90 – 5.25
Difference in % (Cw6-pos vs Cw6-neg)
0.81
-2.49 – 4.71
W2 PASI 100
Group
Value
95% CI
Cw6-positive AIN457 300 mg
0.5
0.01 – 2.99
Cw6-negative AIN457 300 mg
0.4
0.01 – 2.25
Difference in % (Cw6-pos vs Cw6-neg)
0.14
-1.78 – 2.63
Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)Secondary· Baseline up to approximately 72 weeks
IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').
W1
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-8.5
± 16.08
Cw6-negative AIN457 300 mg
-7.3
± 17.04
W2
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-22.4
± 22.73
Cw6-negative AIN457 300 mg
-21.6
± 22.72
W3
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-38.0
± 25.45
Cw6-negative AIN457 300 mg
-36.5
± 27.20
W4
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-49.6
± 29.36
Cw6-negative AIN457 300 mg
-49.5
± 29.24
W8
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-71.2
± 28.60
Cw6-negative AIN457 300 mg
-71.2
± 28.91
W12
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-78.7
± 27.31
Cw6-negative AIN457 300 mg
-79.0
± 25.37
W16
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-84.1
± 24.52
Cw6-negative AIN457 300 mg
-83.3
± 22.97
W20
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-85.3
± 24.26
Cw6-negative AIN457 300 mg
-84.5
± 23.80
Median Time to Reach PASI 90 and 75 (ITT)Secondary· Baseline up to approximately 72 weeks
Time in days to reach PASI scores of 90 and 75.
PASI 90
Group
Value
95% CI
Cw6-positive AIN457 300 mg
57
30 – 89
Cw6-negative AIN457 300 mg
58
55 – 92
PASI 75
Group
Value
95% CI
Cw6-positive AIN457 300 mg
29
22 – 57
Cw6-negative AIN457 300 mg
29
22 – 57
Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)Secondary· Baseline up to approximatly 72 weeks
The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort
Week 16
Group
Value
95% CI
All Patients
-8.5
± 6.79
Week 24
Group
Value
95% CI
All Patients
-8.8
± 7.05
Week 48
Group
Value
95% CI
All Patients
-8.9
± 7.13
Week 72
Group
Value
95% CI
All Patients
-8.3
± 6.70
Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)Secondary· Baseline up approximately 72 weeks
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not
W16 Anxiety
Group
Value
95% CI
All Patients
-1.7
± 3.37
W24 Anxiety
Group
Value
95% CI
All Patients
-2.0
± 3.38
W48 Anxiety
Group
Value
95% CI
All Patients
-2.5
± 3.67
W72 Anxiety
Group
Value
95% CI
All Patients
-2.3
± 3.44
W16 Depression
Group
Value
95% CI
All Patients
-1.3
± 3.19
W24 Depression
Group
Value
95% CI
All Patients
-1.4
± 3.22
W48 Depression
Group
Value
95% CI
All Patients
-1.5
± 3.31
W72 Depression
Group
Value
95% CI
All Patients
-1.7
± 3.19
Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)Secondary· Baseline up to approximately 72 weeks
PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort
Baseline
Group
Value
95% CI
All Patients
0.02
Week 16
Group
Value
95% CI
All Patients
0.19
Week 24
Group
Value
95% CI
All Patients
0.18
Week 48
Group
Value
95% CI
All Patients
0.21
Week 72
Group
Value
95% CI
All Patients
0.32
Changes From Baseline in Body Mass Index (Safety Set)Secondary· Baseline up to approximately 72 weeks
Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit
Week 16
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-0.064
± 0.7748
Cw6-negative AIN457 300 mg
-0.047
± 0.9905
Week 24
Group
Value
95% CI
Cw6-positive AIN457 300 mg
0.086
± 1.0213
Cw6-negative AIN457 300 mg
-0.071
± 1.2260
Week 48
Group
Value
95% CI
Cw6-positive AIN457 300 mg
0.302
± 1.3474
Cw6-negative AIN457 300 mg
-0.052
± 1.4991
Week 72
Group
Value
95% CI
Cw6-positive AIN457 300 mg
0.533
± 1.8101
Cw6-negative AIN457 300 mg
-0.015
± 1.8982
Changes From Baseline in Waist Circumference (Safety Set)Secondary· Baseline up to approximately 72 weeks
Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit
Week 16
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-0.86
± 3.147
Cw6-negative AIN457 300 mg
-0.40
± 3.006
Week 24
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-0.81
± 3.689
Cw6-negative AIN457 300 mg
-0.73
± 4.119
Week 48
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-0.76
± 4.596
Cw6-negative AIN457 300 mg
-0.72
± 5.547
Week 72
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-1.81
± 4.583
Cw6-negative AIN457 300 mg
-0.47
± 4.501
Changes From Baseline in Weight (Safety Set)Secondary· Baseline up to approximately 72 weeks
Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit
Week 16
Group
Value
95% CI
Cw6-positive AIN457 300 mg
-0.20
± 2.242
Cw6-negative AIN457 300 mg
-0.13
± 2.809
Week 24
Group
Value
95% CI
Cw6-positive AIN457 300 mg
0.24
± 3.008
Cw6-negative AIN457 300 mg
-0.21
± 3.572
Week 48
Group
Value
95% CI
Cw6-positive AIN457 300 mg
0.87
± 3.909
Cw6-negative AIN457 300 mg
-0.15
± 4.329
Week 72
Group
Value
95% CI
Cw6-positive AIN457 300 mg
1.40
± 4.678
Cw6-negative AIN457 300 mg
-0.05
± 5.538
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 72 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A study to evaluate the differences in the efficacy and safety of secukinumab between Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
Publications & conference data
4 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 Plaque Type Psorisis
Currently open trials in the same condition.
NCT07410793 — Acupuncture With Chinese Herbal Cream Compare With Acupuncture With Calcipotriol in Plaque Psoriasis.
· Phase 2
· 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: 23 April 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/NCT02394561.