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Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis (VIP-S)

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ClinicalTrials.gov Identifier: NCT02690701
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Plaque Psoriasis
Interventions Drug: Secukinumab 300 mg
Biological: Placebo
Enrollment 91
Recruitment Details Randomized Set consisted of all 91 participants who were randomly assigned to a treatment group
Pre-assignment Details  
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48 Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Period Title: Treatment Period 1
Started [1] 46 45
Completed [2] 44 42
Not Completed 2 3
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             0             1
[1]
46
[2]
44
Period Title: Treatment Period 2
Started [1] 44 [2] 42
Completed [3] 41 [4] 37
Not Completed 3 5
Reason Not Completed
Adverse Event             2             0
Lack of Efficacy             1             0
Lost to Follow-up             0             2
Withdrawal by Subject             0             2
Protocol Violation             0             1
[1]
44
[2]
Completed Treatment Period 1 and continued to Treatment Period 2
[3]
41
[4]
Completed Treatment Period 2
Arm/Group Title Secukinumab Placebo Total
Hide Arm/Group Description Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48 Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48 Total of all reporting groups
Overall Number of Baseline Participants 46 45 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 91 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
  89.1%
39
  86.7%
80
  87.9%
>=65 years
5
  10.9%
6
  13.3%
11
  12.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 91 participants
Female
13
  28.3%
17
  37.8%
30
  33.0%
Male
33
  71.7%
28
  62.2%
61
  67.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 45 participants 91 participants
Caucasian 36 36 72
Black 1 3 4
Asian 6 2 8
Other 3 4 7
1.Primary Outcome
Title Aortic Vascular Inflammation as Measured by FDG-PET/CT
Hide Description

Change from baseline in the target to background ratio from the whole aorta.

Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12.

Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)

Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants assigned medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from this analysis set. Following intent-to-treat principle, participants were analyzed according to treatment they were assigned to at randomization
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: target to background ratio (TBR)
Baseline Number Analyzed 43 participants 42 participants
1.6615  (0.37380) 1.6333  (0.33228)
Change from Baseline at Week 12 Number Analyzed 43 participants 42 participants
0.0143  (0.25520) 0.0655  (0.28086)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab, Placebo
Comments Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)
Type of Statistical Test Superiority
Comments This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.
Statistical Test of Hypothesis P-Value 0.3712
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -0.053
Confidence Interval (2-Sided) 95%
-0.169 to 0.064
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.059
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Adiponectin Total
Hide Description Change from baseline in Adiponectin to measure adiposity
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Number Analyzed 44 participants 42 participants
18799.0  (18608.48) 19475.00  (18343.00)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
1594.90  (15146.84) -1076.40  (14565.60)
3.Secondary Outcome
Title Change in Apolipoprotein B
Hide Description Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Number Analyzed 43 participants 42 participants
0.1014  (0.04651) 0.1033  (0.04451)
Change from Baseline at Week 12 Number Analyzed 43 participants 42 participants
0.0020  (0.06331) 0.0017  (0.04835)
4.Secondary Outcome
Title Change in CRP
Hide Description Change from baseline in C reactive protein (CRP), a measure of inflammation
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 44 participants 41 participants
6.1525  (8.23016) 7.8676  (7.59860)
Change from Baseline at Week 12 Number Analyzed 43 participants 42 participants
-1.0016  (9.45281) 1.1622  (15.84088)
5.Secondary Outcome
Title Change in Cholesterol
Hide Description Change from baseline in Cholesterol level
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 40 participants 41 participants
179.350  (30.01243) 178.707  (38.92573)
Change from Baseline at Week 12 Number Analyzed 43 participants 42 participants
10.6000  (30.27379) -8.4878  (35.18247)
6.Secondary Outcome
Title Change in Fetuin A
Hide Description Change from baseline in Fetuin A, a marker predictive of diabetes
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Number Analyzed 44 participants 41 participants
988677.800781  (488494.3491043) 1169947.724848  (79644.6884632)
Change from Baseline at Week 12 Number Analyzed 44 participants 41 participants
90810.212003  (444791.4700461) 45731.298018  (452743.5932412)
7.Secondary Outcome
Title Change in Ferritin
Hide Description Change from baseline in Ferritin, a marker predictive of diabetes
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline Number Analyzed 44 participants 42 participants
111.953  (91.17931) 122.040  (114.8715)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
-6.1006  (60.71995) -17.118  (63.86703)
8.Secondary Outcome
Title Change in GlycA
Hide Description Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: μmol/L
Baseline Number Analyzed 40 participants 41 participants
413.860  (65.34929) 439.622  (60.44873)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
0.5152  (59.46394) -1.5420  (40.25958)
9.Secondary Outcome
Title Change in HDL Cholesterol
Hide Description Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 40 participants 41 participants
43.3000  (10.20357) 43.0732  (12.52276)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
-0.7500  (8.80195) -1.1220  (8.10924)
10.Secondary Outcome
Title Change in HDL Function (Cholesterol Efflux)
Hide Description

Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker

Ratio of the pleated serum to removal of Cholesterol

Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline Number Analyzed 41 participants 41 participants
0.9535  (0.18986) 1.0456  (0.17819)
Change from Baseline at Week 12 Number Analyzed 41 participants 41 participants
0.1473  (0.23262) 0.0541  (0.21902)
11.Secondary Outcome
Title HDL Particle Total
Hide Description Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: μmol/L
Baseline Number Analyzed 40 participants 41 participants
29.2875  (5.38184) 29.3634  (6.27442)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
-0.1375  (5.22900) -0.1707  (5.12973)
12.Secondary Outcome
Title HDL Size
Hide Description Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: nm
Baseline Number Analyzed 40 participants 41 participants
8.9350  (0.53280) 8.9585  (0.56656)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
0.0500  (0.47932) 0.0073  (0.34161)
13.Secondary Outcome
Title HOMA-IR
Hide Description Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: HOMA-IR units
Baseline Number Analyzed 44 participants 42 participants
3.4901  (3.02479) 5.5112  (6.22334)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
0.9563  (2.23669) -1.2764  (5.13505)
14.Secondary Outcome
Title Change in IL-2 Receptor A
Hide Description Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 41 participants 41 participants
25.5554  (59.47232) 21.0665  (61.46295)
Change from Baseline at Week 12 Number Analyzed 41 participants 41 participants
-3.3606  (38.52458) -1.1162  (6.31189)
15.Secondary Outcome
Title Change in IL-18
Hide Description Interleukin-18 (IL-18) is a marker predictive of diabetes
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 44 participants 42 participants
1259.45  (1910.327) 1308.47  (2454.672)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
34555.1  (231199.6) -627.77  (1874.377)
16.Secondary Outcome
Title Change in IL-6
Hide Description Interleukin 6 (IL-6) is a marker of inflammation
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 44 participants 42 participants
5.6477  (20.81242) 1.6658  (1.50954)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
0.1334  (29.35524) -0.0900  (1.78692)
17.Secondary Outcome
Title Change in Intermediate-Density Lipoprotein (IDL) Particle
Hide Description Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: nmol/mL
Baseline Number Analyzed 40 participants 41 participants
284.350  (179.6482) 271.049  (155.7413)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
47.0500  (167.6253) 2.3902  (160.6046)
18.Secondary Outcome
Title Change LDL Cholesterol
Hide Description Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 40 participants 41 participants
122.475  (28.86040) 121.049  (36.39708)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
9.9750  (29.84532) -6.2927  (34.42401)
19.Secondary Outcome
Title Change in Leptin
Hide Description Change from baseline in Leptin a marker of adiposity
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 44 participants 42 participants
19913.4  (21835.66) 36813.3  (62138.25)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
-1886.0  (11701.00) -5595.9  (17042.08)
20.Secondary Outcome
Title LDL Particle Total
Hide Description Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline Number Analyzed 40 participants 41 participants
1236.35  (317.9542) 1263.00  (447.3457)
Change from Baseline at Week 12 Number Analyzed 43 participants 42 participants
114.250  (294.8695) -111.39  (343.2109)
21.Secondary Outcome
Title LDL Size
Hide Description Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: nm
Baseline Number Analyzed 40 participants 41 participants
21.2200  (0.74977) 21.1171  (0.76384)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
-0.0025  (0.70036) 0.1439  (0.53807)
22.Secondary Outcome
Title Change in Triglycerides
Hide Description Triglycerides are a marker of cardiometabolic function
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 40 participants 41 participants
123.200  (52.90398) 125.293  (79.10633)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
11.5000  (62.56279) -10.732  (60.25281)
23.Secondary Outcome
Title Change in TNF-α
Hide Description Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha
Time Frame baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 44 participants 42 participants
2.3919  (1.79049) 2.8089  (4.11492)
Change from Baseline at Week 12 Number Analyzed 44 participants 42 participants
-0.3577  (1.52948) -0.9818  (3.85715)
24.Secondary Outcome
Title Change VLDL Particle Total
Hide Description Change in Very-low-density lipoprotein (VLDL) cholesterol level
Time Frame baseline, 12 weeks
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FAS
Arm/Group Title Secukinumab Placebo
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Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline Number Analyzed 40 participants 41 participants
52.9125  (26.92102) 54.5829  (27.57024)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
3.2500  (28.56421) 3.2024  (25.40299)
25.Secondary Outcome
Title VLDL Size
Hide Description Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
Time Frame baseline, 12 weeks
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FAS
Arm/Group Title Secukinumab Placebo
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Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: nm
Baseline Number Analyzed 40 participants 41 participants
51.5650  (9.11152) 50.1195  (9.51641)
Change from Baseline at Week 12 Number Analyzed 40 participants 41 participants
-0.3950  (9.30271) -0.7927  (7.72572)
26.Secondary Outcome
Title Area and Severity Index 75 (PASI 75)
Hide Description

Percentage of participants with PASI75 response (yes, no) PASI75 response = at least a 75% improvement (reduction) in PASI score compared to baseline

Psoriasis Area and Severity Index ( PASI) is a tool for measuring the severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

Time Frame week 12
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FAS
Arm/Group Title Secukinumab Placebo
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Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: percentage of participants
84.8 0.0
27.Secondary Outcome
Title Psoriasis Area and Severity Index 90 (PASI 90)
Hide Description Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90& improvement (reduction) in PASI score compared to baseline
Time Frame week 12
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FAS
Arm/Group Title Secukinumab Placebo
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Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: percentage of participants
73.9 0.0
28.Secondary Outcome
Title Psoriasis Area and Severity Index 100 (PASI100)
Hide Description Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis
Time Frame week 12
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FAS
Arm/Group Title Secukinumab Placebo
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Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: percentage of participants
37.0 0.0
29.Secondary Outcome
Title Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
Hide Description

percentage of participants with IGA mod 2011 score of 0 or 1 (yes, no)

Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1

Statistical analysis (Cochran-Mantel-Haenszel test) of Novartis Investigator’s Global Assessment Modified 2011 0 or 1 response by visit (Non-responder Imputation)

Time Frame week 12
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FAS
Arm/Group Title Secukinumab Placebo
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Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Measure Type: Number
Unit of Measure: percentage of participants
78.3 0.0
30.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Total Score
Hide Description

Change from baseline in the DLQI total score

Summary of analysis of change from baseline in DLQI at Week 12 and statistical analysis (using Analysis of Covariance) of change from baseline in DLQI at Week 12

The higher the score, the more quality of life is impaired.

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

Time Frame baseline, 12 weeks
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FAS
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Eligible participants received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by monthly dosing starting at Week 8 through Week 48
Eligible participants received placebo once weekly at Baseline, Weeks 1, 2, 3, and 4 followed by a dose after four weeks at Week 8; participants were switched to once weekly secukinumab 300 mg at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing through Week 48
Overall Number of Participants Analyzed 46 45
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 12.30  (7.65) 12.6  (7.21)
Change from baseline at Week 12 -9.4  (7.91) -0.5  (3.97)
Time Frame Adverse Events (AEs) were 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 48 weeks
Adverse Event Reporting Description

Arms/Groups cannot be provided for each intervention separately after week 12 because placebo participants were switched to secukinumab 300mg.

Adverse Events were collected irrespective of intervention for the Placebo/Secukinumab 300 mg Arm/Group and it is not possible to determine which intervention each Adverse Event corresponded to

 
Arm/Group Title Secukinumab 300 mg Placebo/Secukinumab 300 mg Total
Hide Arm/Group Description Secukinumab 300 mg Placebo/Secukinumab 300 mg Total
All-Cause Mortality
Secukinumab 300 mg Placebo/Secukinumab 300 mg Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/45 (0.00%)   0/91 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Secukinumab 300 mg Placebo/Secukinumab 300 mg Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/46 (10.87%)   0/45 (0.00%)   5/91 (5.49%) 
Gastrointestinal disorders       
Abdominal pain  1  1/46 (2.17%)  0/45 (0.00%)  1/91 (1.10%) 
Injury, poisoning and procedural complications       
Rib fracture  1  1/46 (2.17%)  0/45 (0.00%)  1/91 (1.10%) 
Upper limb fracture  1  1/46 (2.17%)  0/45 (0.00%)  1/91 (1.10%) 
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  1/46 (2.17%)  0/45 (0.00%)  1/91 (1.10%) 
Vascular disorders       
Aortic stenosis  1  1/46 (2.17%)  0/45 (0.00%)  1/91 (1.10%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Secukinumab 300 mg Placebo/Secukinumab 300 mg Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/46 (45.65%)   18/45 (40.00%)   39/91 (42.86%) 
Gastrointestinal disorders       
Diarrhoea  1  3/46 (6.52%)  2/45 (4.44%)  5/91 (5.49%) 
Infections and infestations       
Bronchitis  1  3/46 (6.52%)  0/45 (0.00%)  3/91 (3.30%) 
Nasopharyngitis  1  9/46 (19.57%)  7/45 (15.56%)  16/91 (17.58%) 
Sinusitis  1  0/46 (0.00%)  3/45 (6.67%)  3/91 (3.30%) 
Upper respiratory tract infection  1  6/46 (13.04%)  4/45 (8.89%)  10/91 (10.99%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/46 (10.87%)  3/45 (6.67%)  8/91 (8.79%) 
Nervous system disorders       
Dizziness  1  1/46 (2.17%)  3/45 (6.67%)  4/91 (4.40%) 
Headache  1  0/46 (0.00%)  4/45 (8.89%)  4/91 (4.40%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/46 (2.17%)  4/45 (8.89%)  5/91 (5.49%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1 (800) 778-8300
EMail: Novartis.email@novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02690701     History of Changes
Other Study ID Numbers: CAIN457AUS02
First Submitted: February 19, 2016
First Posted: February 24, 2016
Results First Submitted: February 19, 2019
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019