Trial Outcomes & Findings for Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers (NCT NCT02362789)

Last Updated: 2018-12-28

Results Overview

On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

132 participants

Primary outcome timeframe

Week 32

Results posted on

2018-12-28

Participant Flow

Of the 132 subjects enrolled in the study, 130 entered the Run-In phase.

Participant milestones

Participant milestones
Measure	Run-in 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12	Secukinumab 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28	Placebo Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
Run-in Phase (Week 0 to 16) STARTED	130	0	0
Run-in Phase (Week 0 to 16) COMPLETED	128	0	0
Run-in Phase (Week 0 to 16) NOT COMPLETED	2	0	0
Randomized Withdrawal (Wk 16 to 32) STARTED	0	42	38
Randomized Withdrawal (Wk 16 to 32) COMPLETED	0	38	26
Randomized Withdrawal (Wk 16 to 32) NOT COMPLETED	0	4	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12	Secukinumab 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28	Placebo Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
Run-in Phase (Week 0 to 16) Death unrelated to study treatment	1	0	0
Run-in Phase (Week 0 to 16) Adverse Event	1	0	0
Randomized Withdrawal (Wk 16 to 32) Lack of Efficacy	0	2	6
Randomized Withdrawal (Wk 16 to 32) Withdrawal by Subject	0	1	4
Randomized Withdrawal (Wk 16 to 32) Subject/guardian decision	0	1	2

Baseline Characteristics

Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab n=42 Participants 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28	Placebo n=38 Participants Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28	Total n=80 Participants Total of all reporting groups
Age, Customized <65	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Age, Customized >=65	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=5 Participants	0 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 32

Population: FAS-R, LOCF

Outcome measures

Outcome measures
Measure	Secukinumab n=42 Participants 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28	Placebo n=38 Participants Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
Pruritus Intensity Visual Analogue Scale Score at Week 32	8.8 Units on a scale Standard Error 4.7	27.1 Units on a scale Standard Error 4.9

Adverse Events

Run-In

Serious events: 6 serious events

Other events: 43 other events

Deaths: 0 deaths

Secukinumab

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Run-In n=130 participants at risk 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12	Secukinumab n=42 participants at risk 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28	Placebo n=38 participants at risk Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Cardiac disorders MYOCARDIAL INFARCTION	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	2.4% 1/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Gastrointestinal disorders PANCREATITIS ACUTE	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Hepatobiliary disorders CHOLELITHIASIS	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations ERYSIPELAS	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.00% 0/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	2.4% 1/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations URINARY TRACT INFECTION	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Vascular disorders ANEURYSM RUPTURED	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Run-In n=130 participants at risk 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 0, 1, 2, 3, 4, 8, and 12	Secukinumab n=42 participants at risk 300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28	Placebo n=38 participants at risk Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	7.9% 3/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations INFLUENZA	1.5% 2/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	2.4% 1/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	5.3% 2/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations NASOPHARYNGITIS	23.8% 31/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	28.6% 12/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	28.9% 11/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations RHINITIS	0.00% 0/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	2.4% 1/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	5.3% 2/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Infections and infestations SINUSITIS	0.00% 0/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	2.4% 1/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	5.3% 2/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Musculoskeletal and connective tissue disorders BACK PAIN	6.2% 8/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	0.00% 0/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Nervous system disorders HEADACHE	3.8% 5/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	7.1% 3/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	2.6% 1/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.
Vascular disorders HYPERTENSION	0.77% 1/130 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	4.8% 2/42 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.	5.3% 2/38 • 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 1 year, 3 months. The safety set included all patients that received at least one dose of study drug.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER