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Clinical Trial Results:
A randomized, multicenter 28 week study to compare the efficacy and safety of combining Cosentyx (Secukinumab) (4-weekly, 300 mg s.c.) with a lifestyle intervention to Cosentyx therapy alone in adult patients with moderate to severe plaque-type psoriasis and concomitant metabolic syndrome, followed by a 28 week extension period

Summary
EudraCT number	2016-001671-79
Trial protocol	DE
Global end of trial date	03 Jun 2022

Results information
Results version number	v1(current)
This version publication date	02 Jun 2023
First version publication date	02 Jun 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CAIN457ADE08

ISRCTN number

US NCT number

NCT03440736

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

Novartis Campus, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 Jun 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Jun 2022

Was the trial ended prematurely?

Main objective of the trial

The primary objective of the Core Study was to demonstrate that the combination of Secukinumab (300 mg, 4-weekly s.c.) with lifestyle intervention results in higher psoriasis treatment efficacy than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Feb 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 781

Worldwide total number of subjects

781

EEA total number of subjects

781

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

673

From 65 to 84 years

107

85 years and over

Subject disposition

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Recruitment details

This study was conducted at 81 centers in Germany.

Screening details

Patients were screened for eligibility for a period of 1 to 4 weeks prior to inclusion in the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Secukinumab 300 mg subcutaneous (s.c.)

Arm description

Patients received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).

Arm type

Active comparator

Investigational medicinal product name

Secukinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24)

Secukinumab 300 mg s.c. and lifestyle intervention

Arm description

Arm type

Experimental

Investigational medicinal product name

Secukinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24)

Number of subjects in period 1 ^[1]	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Started	371	409
Full Analysis Set (FAS)	371	409
Safety Set (SAF)	371	409
Completed	342	374
Not completed	29	35
Physician decision	2	2
Consent withdrawn by subject	9	10
Adverse event, non-fatal	8	7
Non-compliance with study treatment	1	1
Lost to follow-up	2	8
Subject discontinued the study due to emergency	1	-
Lack of efficacy	2	3
Protocol deviation	4	4

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: One participant in the Secukinumab 300 mg s.c. and lifestyle intervention arm was never treated and was therefore excluded from all analysis (including patient disposition and baseline characteristics)

Baseline characteristics

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Reporting group title

Secukinumab 300 mg subcutaneous (s.c.)

Reporting group description

Reporting group title

Secukinumab 300 mg s.c. and lifestyle intervention

Reporting group description

Reporting group values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention	Total
Number of subjects	371	409	780
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	313	359	672
From 65-84 years	57	50	107
85 years and over	1	0	1
Age Continuous
Units: Years
arithmetic mean (standard deviation)	50.4 ( 13.29 )	50.1 ( 12.48 )	-
Sex: Female, Male
Units: Participants
Female	105	115	220
Male	266	294	560
Race/Ethnicity, Customized
Units: Subjects
Asian	7	1	8
Caucasian	359	397	756
Black or African American	2	2	4
Other	3	8	11
Unknown	0	1	1

End points

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Reporting group title

Secukinumab 300 mg subcutaneous (s.c.)

Reporting group description

Reporting group title

Secukinumab 300 mg s.c. and lifestyle intervention

Reporting group description

Primary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 at week 28

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End point title

Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 at week 28

End point description

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 represents patients achieving >= 90% improvement (reduction) in PASI score compared to Baseline. Patients with missing PASI at Week 28 were counted as non-responders.

End point type

Primary

End point timeframe

Baseline, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Participants	219	261

PASI 90 at week 28

Statistical analysis description

Comparison of mean change between treatments in PASI 90 at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3857

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.17

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.67

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 75 over time

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End point title

Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 75 over time

End point description

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 represents patients achieving >= 75% improvement (reduction) in PASI score compared to Baseline.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Participants
Week 1	2	1
Week 2	11	3
Week 3	50	56
Week 4	108	135
Week 8	239	265
Week 12	241	276
Week 16	287	332
Week 20	290	333
Week 24	285	333
Week 28	286	335

PASI 75 at Week 28

Statistical analysis description

Comparison of mean change between treatments in PASI 75 at Week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.03

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.06

upper limit

3.06

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 over time

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End point title

Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 over time

End point description

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 represents patients achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Participants
Week 1	0	0
Week 2	2	0
Week 3	7	4
Week 4	25	30
Week 8	130	141
Week 12	159	182
Week 16	215	241
Week 20	217	242
Week 24	224	251
Week 28	219	261

No statistical analyses for this end point

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 100 over time

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End point title

Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 100 over time

End point description

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 100 response/remission represents patients achieving complete clearing of psoriasis (PASI = 0) compared to Baseline.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Participants
Week 1	0	0
Week 2	1	0
Week 3	1	0
Week 4	5	4
Week 8	35	39
Week 12	48	71
Week 16	82	115
Week 20	100	108
Week 24	101	115
Week 28	105	118

PASI 100 at Week 28

Statistical analysis description

Comparison of mean change between treatments in PASI 100 at Week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.4351

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.24

Secondary: Mean absolute Psoriasis Area and Severity Index (PASI) Score over time

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End point title

Mean absolute Psoriasis Area and Severity Index (PASI) Score over time

End point description

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change in absolute PASI score means that the severity of psoriasis has decreased, indicating an improvement in the patient's condition.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Unit on a scale
arithmetic mean (standard error)
Baseline (n= 371, 409)	19.8 ( 0.39 )	19.7 ( 0.38 )
Week 1 (n= 365, 402)	-2.8 ( 0.22 )	-2.9 ( 0.21 )
Week 2 (n= 361, 394)	-6.6 ( 0.23 )	-6.9 ( 0.22 )
Week 3 (n= 362, 392)	-9.9 ( 0.25 )	-10.1 ( 0.23 )
Week 4 (n= 364, 393)	-12.0 ( 0.26 )	-12.4 ( 0.25 )
Week 8 (n= 360, 394)	-15.5 ( 0.26 )	-15.5 ( 0.25 )
Week 12 (n= 309, 335)	-16.6 ( 0.26 )	-16.9 ( 0.25 )
Week 16 (n= 354, 388)	-17.2 ( 0.27 )	-17.3 ( 0.26 )
Week 20 (n= 346, 380)	-17.4 ( 0.27 )	-17.5 ( 0.26 )
Week 24 (n= 337, 376)	-17.4 ( 0.28 )	-17.6 ( 0.26 )
Week 28 (n= 334, 366)	-17.3 ( 0.29 )	-17.6 ( 0.27 )

Absolute PASI Score at week 28

Statistical analysis description

Mean change from Baseline in absolute PASI Score at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5443

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

0.5

Variability estimate

Standard error of the mean

Dispersion value

0.38

Secondary: Mean change from Baseline in high-sensitivity C-reactive Protein (hsCRP)

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End point title

Mean change from Baseline in high-sensitivity C-reactive Protein (hsCRP)

End point description

High-sensitivity C-reactive Protein (hsCRP) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	370	409
Units: milligram/litre (mg/L)
arithmetic mean (standard deviation)
Baseline (n=370, 409)	0.648 ( 0.7565 )	0.575 ( 0.6239 )
Change from BL @ Week 2 (n=354, 386)	-0.087 ( 0.7242 )	-0.124 ( 0.5178 )
Change from BL @ Week 4 (n=362, 392)	-0.098 ( 0.6860 )	-0.117 ( 0.5218 )
Change from BL @ Week 8 (n=357, 392)	-0.117 ( 0.6797 )	-0.092 ( 0.5733 )
Change from BL @ Week 12 (n=310, 334)	-0.069 ( 0.7539 )	-0.078 ( 0.7599 )
Change from BL @ Week 16 (n=352, 387)	-0.100 ( 0.6654 )	-0.116 ( 0.4679 )
Change from BL @ Week 20 (n=345, 378)	-0.074 ( 0.7019 )	-0.113 ( 0.5109 )
Change from BL @ Week 24 (n=333, 373)	-0.087 ( 0.7964 )	-0.097 ( 0.5783 )
Change from BL @ Week 28 (n=332, 362)	-0.101 ( 0.7694 )	-0.141 ( 0.4254 )

hsCRP at week 28

Statistical analysis description

Comparison of mean change between treatments in hsCRP at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

779

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0057

Method

Mixed models analysis

Parameter type

Comparison of mean change between treatm

Point estimate

-0.114

Confidence interval

level

95%

sides

2-sided

lower limit

-0.194

upper limit

-0.033

Secondary: Mean change from Baseline in Hemoglobin A1c (HbA1c)

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End point title

Mean change from Baseline in Hemoglobin A1c (HbA1c)

End point description

Hemoglobin A1c (HbA1c) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 8, Week 16, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	365	402
Units: Percentage (%)
arithmetic mean (standard deviation)
Baseline (n= 365, 402)	5.69 ( 0.706 )	5.69 ( 0.694 )
Change from BL @ Week 8 (n=346, 378)	0.01 ( 0.293 )	-0.07 ( 0.314 )
Change from BL @ Week 16 (n=346, 380)	0.03 ( 0.389 )	-0.06 ( 0.342 )
Change from BL @ Week 24 (n=180, 180))	0.03 ( 0.388 )	-0.04 ( 0.332 )
Change from BL @ Week 28 (n=317, 348)	0.03 ( 0.417 )	-0.05 ( 0.353 )

HbA1c at week 28

Statistical analysis description

HbA1c - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

767

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0012

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-0.14

upper limit

-0.04

Variability estimate

Standard error of the mean

Dispersion value

0.027

Secondary: Mean change from Baseline in Fructosamine

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End point title

Mean change from Baseline in Fructosamine

End point description

Fructosamine was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	365	402
Units: micromole/liter (µmol/L)
arithmetic mean (standard deviation)
Baseline (n=365, 402)	270.1 ( 61.62 )	266.7 ( 61.91 )
Change from BL @ Week 4 (n=127, 135)	-1.0 ( 43.96 )	-9.6 ( 43.23 )
Change from BL @ Week 8 (n=349, 378)	-2.4 ( 41.24 )	-4.2 ( 48.95 )
Change from BL @ Week 12 (n=137, 135)	6.6 ( 45.84 )	-6.4 ( 39.15 )
Change from BL @ Week 16 (n=346, 381)	0.8 ( 45.17 )	-0.4 ( 48.15 )
Change from BL @ Week 20 (n=157, 154)	-0.6 ( 46.43 )	-6.4 ( 56.76 )
Change from BL @ Week 24 (n=177, 179)	0.6 ( 44.51 )	3.9 ( 51.88 )
Change from BL @ Week 28 (n=317, 347)	2.3 ( 47.29 )	1.7 ( 48.00 )

Fructosamine at week 28

Statistical analysis description

Fructosamine - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

767

Analysis specification

Pre-specified

Analysis type

P-value

= 0.9835

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-6.4

upper limit

6.3

Variability estimate

Standard error of the mean

Dispersion value

3.23

Secondary: Mean change from Baseline in Fasting Plasma Glucose (FPG)

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End point title

Mean change from Baseline in Fasting Plasma Glucose (FPG)

End point description

Fasting Plasma Glucose (FPG) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 8, Week 16, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	366	402
Units: milligram per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline (n=366, 402)	102.8 ( 23.35 )	103.1 ( 25.61 )
Change from BL @ Week 8 (n=347, 375)	0.8 ( 17.14 )	-1.7 ( 16.71 )
Change from BL @ Week 16 (n=343, 377)	1.9 ( 20.51 )	-2.1 ( 16.26 )
Change from BL @ Week 28 (n=320, 347)	2.9 ( 22.29 )	-0.5 ( 18.60 )

FPG at week 28

Statistical analysis description

FPG - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

768

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0086

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-3.5

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

-0.9

Variability estimate

Standard error of the mean

Dispersion value

1.35

Secondary: Mean change from Baseline in Total cholesterol

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End point title

Mean change from Baseline in Total cholesterol

End point description

Total cholesterol was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 8, Week 16, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	370	409
Units: milligram per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline (n=370, 409)	203.4 ( 42.38 )	208.2 ( 41.61 )
Change from BL @ Week 8 (n=355, 394)	1.9 ( 26.75 )	-2.5 ( 24.84 )
Change from BL @ Week 16 (n=350, 386)	-0.2 ( 25.33 )	-1.3 ( 25.30 )
Change from BL @ Week 28 (n=332, 359)	-0.4 ( 30.13 )	-3.1 ( 25.45 )

Total cholesterol at week 28

Statistical analysis description

Total cholesterol - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

779

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2755

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-6.4

upper limit

1.8

Variability estimate

Standard error of the mean

Dispersion value

2.08

Secondary: Mean change from Baseline in Low-Density Lipoprotein (LDL)

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End point title

Mean change from Baseline in Low-Density Lipoprotein (LDL)

End point description

Low-Density Lipoprotein (LDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 8, Week 16, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	370	409
Units: milligram per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline (n=370, 409)	136.6 ( 39.98 )	143.3 ( 39.39 )
Change from BL @ Week 8 (n=355, 394)	1.6 ( 21.53 )	-2.2 ( 22.00 )
Change from BL @ Week 16 (n=350, 386)	-1.4 ( 22.67 )	-0.9 ( 24.14 )
Change from BL @ Week 28 (n=332, 359)	1.9 ( 25.57 )	-1.2 ( 25.10 )

LDL at week 28

Statistical analysis description

LDL - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

779

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1298

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

0.8

Variability estimate

Standard error of the mean

Dispersion value

1.86

Secondary: Mean change from Baseline in High-Density Lipoprotein (HDL)

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End point title

Mean change from Baseline in High-Density Lipoprotein (HDL)

End point description

High-Density Lipoprotein (HDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 8, Week 16, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	370	409
Units: milligram per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline (n=370, 409)	45.5 ( 11.81 )	46.1 ( 10.62 )
Change from BL @ Week 8 (n=355, 394)	-0.5 ( 5.29 )	-1.0 ( 6.20 )
Change from BL @ Week 16 (n=350, 386)	-0.8 ( 5.92 )	0.0 ( 6.69 )
Change from BL @ Week 28 (n=332, 359)	0.0 ( 6.91 )	0.5 ( 7.29 )

HDL at week 28

Statistical analysis description

HDL - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

779

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2084

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

1.7

Variability estimate

Standard error of the mean

Dispersion value

0.53

Secondary: Mean change from Baseline in Triglycerides

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End point title

Mean change from Baseline in Triglycerides

End point description

Triglycerides were evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 8, Week 16, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	370	409
Units: milligram per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline (n=370, 409)	210.4 ( 169.58 )	195.8 ( 126.83 )
Change from BL @ Week 8 (n=355, 394)	2.5 ( 100.55 )	-2.7 ( 100.29 )
Change from BL @ Week 16 (n=350, 386)	11.0 ( 146.64 )	-1.7 ( 111.36 )
Change from BL @ Week 28 (n=332, 359)	-5.9 ( 187.93 )	-6.3 ( 98.69 )

TRIG at week 28

Statistical analysis description

TRIG - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

779

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5187

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-5.8

Confidence interval

level

95%

sides

2-sided

lower limit

-23.3

upper limit

11.7

Variability estimate

Standard error of the mean

Dispersion value

8.92

Secondary: Mean change from Baseline in Waist circumference

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End point title

Mean change from Baseline in Waist circumference

End point description

Waist circumference was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Centimeter (cm)
arithmetic mean (standard deviation)
Baseline (n=371, 409)	115.3 ( 15.10 )	114.9 ( 13.99 )
Change from BL @ Week 1 (n=365, 402)	-0.5 ( 2.97 )	-0.3 ( 3.41 )
Change from BL @ Week 2 (n=361, 393)	-0.7 ( 3.74 )	-1.1 ( 4.30 )
Change from BL @ Week 3 (n=362, 391)	-0.8 ( 3.66 )	-1.3 ( 4.71 )
Change from BL @ Week 4 (n=363, 393)	-0.9 ( 3.92 )	-2.0 ( 4.54 )
Change from BL @ Week 8 (n=359, 394)	-1.2 ( 4.53 )	-2.6 ( 5.34 )
Change from BL @ Week 12 (n=309, 335)	-1.1 ( 4.43 )	-2.9 ( 5.68 )
Change from BL @ Week 16 (n=353, 388)	-1.4 ( 5.22 )	-3.5 ( 6.09 )
Change from BL @ Week 20 (n=346, 381)	-1.3 ( 5.47 )	-3.5 ( 6.09 )
Change from BL @ Week 24 (n=337, 375)	-1.4 ( 5.34 )	-3.7 ( 6.72 )
Change from BL @ Week 28 (n=331, 366)	-1.5 ( 5.50 )	-3.9 ( 7.04 )

Waist circumference at week 28

Statistical analysis description

Waist circumference - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

-1.8

Variability estimate

Standard error of the mean

Dispersion value

0.47

Secondary: Mean change from Baseline in Body weight

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End point title

Mean change from Baseline in Body weight

End point description

Body weight was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Kilogram (kg)
arithmetic mean (standard deviation)
Baseline (n=371, 409)	107.16 ( 22.624 )	107.9 ( 20.765 )
Change from BL @ Week 1 (n=365, 402)	0.06 ( 2.120 )	-0.33 ( 1.401 )
Change from BL @ Week 2 (n=361, 394)	-0.04 ( 1.729 )	-0.75 ( 1.739 )
Change from BL @ Week 3 (n=362, 392)	-0.05 ( 2.189 )	-1.08 ( 2.278 )
Change from BL @ Week 4 (n=363, 394)	-0.08 ( 2.326 )	-1.20 ( 2.177 )
Change from BL @ Week 8 (n=360, 393)	-0.15 ( 2.447 )	-1.84 ( 3.471 )
Change from BL @ Week 12 (n=310, 335)	0.02 ( 2.726 )	-2.38 ( 4.150 )
Change from BL @ Week 16 (n=355, 388)	-0.21 ( 3.243 )	-2.65 ( 4.892 )
Change from BL @ Week 20 (n=346, 381)	-0.36 ( 3.581 )	-2.72 ( 5.480 )
Change from BL @ Week 24 (n=337, 376)	-0.30 ( 3.815 )	-2.86 ( 6.056 )
Change from BL @ Week 28 (n=334, 366)	-0.17 ( 3.803 )	-3.03 ( 6.107 )

Body weight at week 28

Statistical analysis description

Body weight - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-2.85

Confidence interval

level

95%

sides

2-sided

lower limit

-3.61

upper limit

-2.09

Variability estimate

Standard error of the mean

Dispersion value

0.385

Secondary: Mean change from Baseline in Body Mass Index (BMI)

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End point title

Mean change from Baseline in Body Mass Index (BMI)

End point description

Body Mass Index (BMI) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Kilogram by square meter (kg/m^2)
arithmetic mean (standard deviation)
Baseline (n=371, 409)	34.788 ( 6.8112 )	34.631 ( 6.4232 )
Change from BL @ Week 1 (n=365, 402)	0.015 ( 0.6846 )	-0.110 ( 0.4515 )
Change from BL @ Week 2 (n=361, 394)	-0.015 ( 0.5545 )	-0.240 ( 0.5649 )
Change from BL @ Week 3 (n=362, 392)	-0.014 ( 0.7076 )	-0.346 ( 0.7352 )
Change from BL @ Week 4 (n=363, 394)	-0.027 ( 0.7451 )	-0.386 ( 0.7128 )
Change from BL @ Week 8 (n=360, 393)	-0.047 ( 0.7838 )	-0.582 ( 1.1641 )
Change from BL @ Week 12 (n=310, 335)	0.009 ( 0.8768 )	-0.758 ( 1.3522 )
Change from BL @ Week 16 (n=355, 388)	-0.070 ( 1.0432 )	-0.843 ( 1.5780 )
Change from BL @ Week 20 (n=346, 381)	-0.113 ( 1.1627 )	-0.864 ( 1.7769 )
Change from BL @ Week 24 (n=337, 376)	-0.094 ( 1.2417 )	-0.906 ( 1.9591 )
Change from BL @ Week 28 (n=334, 366)	-0.054 ( 1.2309 )	-0.961 ( 1.9665 )

BMI at week 28

Statistical analysis description

BMI - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-0.907

Confidence interval

level

95%

sides

2-sided

lower limit

-1.151

upper limit

-0.663

Variability estimate

Standard error of the mean

Dispersion value

0.1243

Secondary: Mean change from Baseline in Systolic Blood Pressure

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End point title

Mean change from Baseline in Systolic Blood Pressure

End point description

Systolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: millimeter of mercury (mmHg)
arithmetic mean (standard deviation)
Baseline (n=371, 409)	139.44 ( 11.703 )	139.19 ( 11.711 )
Change from BL @ Week 1 (n=365, 402)	-0.66 ( 10.033 )	-1.44 ( 10.964 )
Change from BL @ Week 2 (n=361, 394)	-1.24 ( 11.499 )	-3.12 ( 11.422 )
Change from BL @ Week 3 (n=362, 392)	-1.05 ( 11.086 )	-3.67 ( 12.740 )
Change from BL @ Week 4 (n=362, 394)	-3.02 ( 10.693 )	-4.33 ( 11.763 )
Change from BL @ Week 8 (n=360, 394)	-2.52 ( 12.394 )	-3.88 ( 12.545 )
Change from BL @ Week 12 (n=310, 335)	-1.64 ( 12.054 )	-3.65 ( 12.982 )
Change from BL @ Week 16 (n=354, 388)	-3.03 ( 12.646 )	-4.33 ( 12.980 )
Change from BL @ Week 20 (n=346, 381)	-1.65 ( 12.067 )	-3.70 ( 13.323 )
Change from BL @ Week 24 (n=337, 376)	-2.53 ( 12.681 )	-4.35 ( 13.455 )
Change from BL @ Week 28 (n=334, 366)	-2.56 ( 12.179 )	-4.28 ( 13.475 )

SYSBP at week 28

Statistical analysis description

SYSBP - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0204

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.87

Secondary: Mean change from Baseline in Diastolic Blood Pressure

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End point title

Mean change from Baseline in Diastolic Blood Pressure

End point description

Diastolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

End point type

Secondary

End point timeframe

Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: millimeter of mercury (mmHg)
arithmetic mean (standard deviation)
Baseline (n=371, 409)	86.44 ( 7.116 )	86.50 ( 7.305 )
Change from BL @ Week 1 (n=365, 402)	-0.39 ( 6.761 )	-1.02 ( 7.495 )
Change from BL @ Week 2 (n=361, 394)	-0.65 ( 7.460 )	-1.16 ( 7.630 )
Change from BL @ Week 3 (n=362, 392)	-0.62 ( 7.180 )	-1.66 ( 8.030 )
Change from BL @ Week 4 (n=362, 394)	-1.29 ( 7.349 )	-2.00 ( 7.925 )
Change from BL @ Week 8 (n=360, 394)	-0.60 ( 7.510 )	-1.51 ( 7.517 )
Change from BL @ Week 12 (n=310, 335)	-0.37 ( 7.820 )	-1.56 ( 8.754 )
Change from BL @ Week 16 (n=354, 388)	-0.60 ( 7.969 )	-1.99 ( 8.211 )
Change from BL @ Week 20 (n=346, 381)	-0.59 ( 8.040 )	-2.28 ( 8.275 )
Change from BL @ Week 24 (n=337, 376)	-0.73 ( 8.270 )	-2.04 ( 8.701 )
Change from BL @ Week 28 (n=334, 366)	-0.48 ( 8.417 )	-1.65 ( 8.877 )

DIABP at week 28

Statistical analysis description

DIABP - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0652

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

0.1

Variability estimate

Standard error of the mean

Dispersion value

0.58

Secondary: Dermatology Life Quality Index (DLQI) Total Score over time

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End point title

Dermatology Life Quality Index (DLQI) Total Score over time

End point description

The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question refers to the impact of the skin disease on the patient’s life (symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment) over the previous week and is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Unit on a scale
arithmetic mean (standard deviation)
Baseline (n=371, 409)	19.55 ( 5.124 )	19.12 ( 5.449 )
Week 4 (n=366, 394)	8.57 ( 5.932 )	7.92 ( 6.119 )
Week 8 (n=360, 395)	5.47 ( 5.725 )	5.18 ( 5.405 )
Week 12 (n= 309, 335)	4.29 ( 5.341 )	4.16 ( 5.100 )
Week 16 (n= 354, 388)	3.90 ( 5.374 )	3.73 ( 4.927 )
Week 20 (n= 346, 380)	3.43 ( 5.101 )	3.43 ( 5.061 )
Week 24 (n=337, 378)	3.42 ( 5.261 )	3.33 ( 4.824 )
Week 28 (n=334, 366)	3.42 ( 5.242 )	3.30 ( 5.312 )

No statistical analyses for this end point

Secondary: Mean change from Baseline in Dermatology Life Quality Index (DLQI) Total Score over time

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End point title

Mean change from Baseline in Dermatology Life Quality Index (DLQI) Total Score over time

End point description

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Unit on a scale
arithmetic mean (standard deviation)
Baseline (n=371, 409)	19.5 ( 5.12 )	19.1 ( 5.45 )
Change from BL @ Week 4 (n=366, 394)	-11.0 ( 6.66 )	-11.3 ( 6.68 )
Change from BL @ Week 8 (n=360, 395)	-14.1 ( 6.91 )	-14.1 ( 6.60 )
Change from BL @ Week 12 (n=309, 335)	-15.5 ( 6.68 )	-15.1 ( 6.51 )
Change from BL @ Week 16 (n=354, 388)	-15.7 ( 6.60 )	-15.4 ( 6.33 )
Change from BL @ Week 20 (n=346, 380)	-16.2 ( 6.81 )	-15.7 ( 6.66 )
Change from BL @ Week 24 (n=337, 378)	-16.1 ( 6.75 )	-15.8 ( 6.46 )
Change from BL @ Week 28 (n=334, 366)	-16.1 ( 6.80 )	-15.9 ( 6.67 )

DLQI Total Score at Week 28

Statistical analysis description

DLQI Total Score - Comparison of mean change between treatments at Week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.7733

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

-0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.7

Variability estimate

Standard error of the mean

Dispersion value

0.41

Secondary: Percentage of patients with Dermatology Life Quality Index (DLQI) Response

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End point title

Percentage of patients with Dermatology Life Quality Index (DLQI) Response

End point description

All patients with DLQI score 0 and 1 were considered as responders and patients with DLQI score >=2 were considered as non-responders. Subjects with missing DLQI score were counted as non-responders.

End point type

Secondary

End point timeframe

Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Participants
Non-Responders @ Week 4	323	344
Responders @ Week 4	43	50
Non-Responders @ Week 8	249	269
Responders @ Week 8	111	126
Non-Responders @ Week 12	179	192
Responders @ Week 12	130	143
Non-Responders @ Week 16	176	201
Responders @ Week 16	178	187
Non-Responders @ Week 20	153	170
Responders @ Week 20	193	210
Non-Responders @ Week 24	148	175
Responders @ Week 24	189	203
Non-Responders @ Week 28	145	154
Responders @ Week 28	189	212

No statistical analyses for this end point

Secondary: World Health Organization Well-Being Index (WHO-5) Total score over time

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End point title

World Health Organization Well-Being Index (WHO-5) Total score over time

End point description

The 5-item World Health Organization Well-Being Index (WHO-5) is a validated, short questionnaire consisting of 5 simple questions, assessing subjective psychological well-being of the respondents: Felt cheerful and in good spirits, Felt calm and relaxed, Felt active and vigorous, Feeling fresh and rested and Things that interest me in daily life. The recall period is the previous two weeks. Each item has 6 response categories, ranging from 5 (“the whole time”) to 0 (“at no time point”). The raw score ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Unit on a scale
arithmetic mean (standard deviation)
Baseline (n=371, 409)	10.46 ( 5.208 )	10.62 ( 5.283 )
Week 4 (n=365, 394)	14.45 ( 5.236 )	15.52 ( 4.921 )
Week 8 (n=360, 395)	15.65 ( 4.889 )	15.99 ( 4.697 )
Week 12 (n=309, 335)	15.77 ( 5.083 )	16.37 ( 4.824 )
Week 16 (n=353, 388)	15.91 ( 5.334 )	16.45 ( 4.902 )
Week 20 (n=346, 379)	16.30 ( 5.364 )	16.44 ( 4.978 )
Week 24 (n=337, 378)	16.47 ( 5.173 )	16.55 ( 4.865 )
Week 28 (n=334, 366)	16.20 ( 5.583 )	16.69 ( 4.910 )

No statistical analyses for this end point

Secondary: Mean change from Baseline in World Health Organization Well-Being Index (WHO-5) Total score over time

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End point title

Mean change from Baseline in World Health Organization Well-Being Index (WHO-5) Total score over time

End point description

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Unit on a scale
arithmetic mean (standard deviation)
Baseline (n=371, 409)	10.5 ( 5.21 )	10.6 ( 5.28 )
Week 4 (n= 365, 394)	4.0 ( 5.21 )	4.9 ( 5.51 )
Week 8 (n= 360, 395)	5.1 ( 5.61 )	5.4 ( 5.76 )
Week 12 (n= 309, 335)	5.2 ( 5.73 )	5.7 ( 5.95 )
Week 16 (n= 353, 388)	5.4 ( 5.59 )	5.8 ( 5.85 )
Week 20 (n= 346, 379)	5.8 ( 6.08 )	5.8 ( 5.79 )
Week 24 (n= 337, 378)	5.9 ( 5.65 )	5.9 ( 6.19 )
Week 28 (n= 334, 366)	5.6 ( 6.20 )	5.9 ( 6.12 )

WHO-5 at week 28

Statistical analysis description

WHO-5 - Comparison of mean change between treatments at week 28

Comparison groups

Secukinumab 300 mg subcutaneous (s.c.) v Secukinumab 300 mg s.c. and lifestyle intervention

Number of subjects included in analysis

780

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0982

Method

Mixed models analysis

Parameter type

least squares (LS) mean change

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

1.3

Variability estimate

Standard error of the mean

Dispersion value

0.36

Secondary: Participant’s self-assessed pain, itching and scaling over time

Top of page

End point title

Participant’s self-assessed pain, itching and scaling over time

End point description

A self-administered, 11-point numeric rating scale (NRS, 0-10) was used to evaluate the subject’s assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment of: * Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours * Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours * Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours Subjects had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represented the absence or null end of the pain, itching, or scale intensity (i.e., no pain, itching or scaling) and the 10 represented the other extreme of pain, itching, or scaling intensity (i.e., pain, itching or scaling as bad as it could be). The number that the patient selected represented his or her intensity score.

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Unit on a scale
arithmetic mean (standard deviation)
Pain at Baseline (n=371, 409)	4.9 ( 2.93 )	4.6 ( 2.87 )
Pain at week 4 (n= 366, 392)	1.9 ( 2.29 )	1.7 ( 2.23 )
Pain at week 8 (n= 359, 394)	1.1 ( 1.88 )	1.3 ( 2.05 )
Pain at week 12 (n= 309, 335)	1.2 ( 2.14 )	1.0 ( 1.84 )
Pain at week 16 (n= 353, 388)	1.1 ( 2.04 )	1.1 ( 1.88 )
Pain at week 20 (n= 346, 380)	1.0 ( 1.93 )	1.0 ( 1.81 )
Pain at week 24 (n= 337, 378)	1.0 ( 1.91 )	1.0 ( 1.85 )
Pain at week 28 (n= 333, 366)	1.2 ( 2.10 )	1.0 ( 2.00 )
Itching at Baseline (n=371, 409)	7.4 ( 2.08 )	7.1 ( 2.39 )
Itching at week 4 (n=366, 393)	3.2 ( 2.43 )	3.0 ( 2.60 )
Itching at week 8 (n=359, 394)	2.4 ( 2.36 )	2.3 ( 2.47 )
Itching at week 12 (n=309, 335)	2.2 ( 2.38 )	2.0 ( 2.29 )
Itching at week 16 (n=353, 388)	2.0 ( 2.29 )	2.0 ( 2.43 )
Itching at week 20 (n= 346, 380)	1.9 ( 2.23 )	1.9 ( 2.19 )
Itching at week 24 (n= 337, 378)	1.9 ( 2.35 )	1.8 ( 2.23 )
Itching at week 28 (n=334, 366)	2.0 ( 2.47 )	1.9 ( 2.38 )
Scaling at Baseline (n=371, 409)	7.5 ( 2.01 )	7.3 ( 2.17 )
Scaling at week 4 (n=366, 393)	2.7 ( 2.18 )	2.4 ( 2.16 )
Scaling at week 8 (n=359, 394)	1.7 ( 1.94 )	1.7 ( 2.03 )
Scaling at week 12 (n=309, 335)	1.7 ( 2.00 )	1.6 ( 1.90 )
Scaling at week 16 (n=353, 388)	1.6 ( 2.10 )	1.5 ( 1.95 )
Scaling at week 20 (n=346, 380)	1.6 ( 2.10 )	1.5 ( 1.98 )
Scaling at week 24 (n=337, 378)	1.7 ( 2.22 )	1.4 ( 1.84 )
Scaling at week 28 (n=334, 366)	1.8 ( 2.28 )	1.5 ( 2.04 )

No statistical analyses for this end point

Secondary: Percentage change from Baseline in Participant’s self-assessed pain, itching and scaling

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End point title

Percentage change from Baseline in Participant’s self-assessed pain, itching and scaling

End point description

End point type

Secondary

End point timeframe

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

End point values	Secukinumab 300 mg subcutaneous (s.c.)	Secukinumab 300 mg s.c. and lifestyle intervention
Number of subjects analysed	371	409
Units: Percentage change
arithmetic mean (standard deviation)
Pain at Baseline (n=371, 409)	4.9 ( 2.93 )	4.6 ( 2.87 )
Pain at week 4 (n= 328, 349)	-61.4 ( 44.13 )	-60.2 ( 59.10 )
Pain at week 8 (n= 321, 352)	-74.4 ( 44.39 )	-68.5 ( 53.86 )
Pain at week 12 (n= 276, 299)	-72.2 ( 54.73 )	-76.6 ( 40.64 )
Pain at week 16 (n= 315, 345)	-77.3 ( 38.93 )	-74.0 ( 46.10 )
Pain at week 20 (n= 308, 339)	-78.4 ( 41.88 )	-75.2 ( 43.55 )
Pain at week 24 (n= 302, 340)	-78.4 ( 41.88 )	-75.7 ( 47.05 )
Pain at week 28 (n= 299, 328)	-76.3 ( 42.22 )	-75.3 ( 52.42 )
Itching at Baseline (n=371, 409)	7.4 ( 2.08 )	7.1 ( 2.39 )
Itching at week 4 (n=365, 386)	-54.1 ( 33.82 )	-55.8 ( 41.19 )
Itching at week 8 (n=358, 387)	-63.7 ( 39.78 )	-66.7 ( 34.31 )
Itching at week 12 (n=308, 329)	-66.6 ( 40.58 )	-70.0 ( 33.53 )
Itching at week 16 (n=352, 381)	-70.6 ( 34.79 )	-70.0 ( 35.79 )
Itching at week 20 (n= 345, 373)	-71.1 ( 37.64 )	-73.0 ( 35.36 )
Itching at week 24 (n= 326, 374)	-69.6 ( 46.85 )	-72.6 ( 35.64 )
Itching at week 28 (n=333, 361)	-68.5 ( 48.46 )	-72.1 ( 35.97 )
Scaling at Baseline (n=371, 409)	7.5 ( 2.01 )	7.3 ( 2.17 )
Scaling at week 4 (n=366, 389)	-62.2 ( 30.65 )	-64.9 ( 34.27 )
Scaling at week 8 (n=359, 390)	-74.9 ( 38.02 )	-75.1 ( 30.50 )
Scaling at week 12 (n=309, 332)	-76.5 ( 29.91 )	-76.9 ( 31.93 )
Scaling at week 16 (n=353, 384)	-74.3 ( 40.92 )	-77.2 ( 32.84 )
Scaling at week 20 (n=346, 376)	-76.4 ( 31.93 )	-76.2 ( 36.76 )
Scaling at week 24 (n=337, 375)	-75.4 ( 35.21 )	-78.2 ( 33.38 )
Scaling at week 28 (n=334, 362)	-74.3 ( 36.50 )	-77.7 ( 35.84 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were reported from first dose of secukinumab in the Core Study up to 84 days after the last dose (Week 24).

Adverse event reporting additional description

Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Core Period Secukinumab

Reporting group description

Core Period Secukinumab

Reporting group title

Core Period Secukinumab + Lifestyle Intervention

Reporting group description

Core Period Secukinumab + Lifestyle Intervention

Reporting group title

Extension Period Lifestyle Intervention

Reporting group description

Extension Period Lifestyle Intervention

Reporting group title

Extension Period Lifestyle Intervention + Secukinumab

Reporting group description

Extension Period Lifestyle Intervention + Secukinumab

Reporting group title

Extension Period Secukinumab

Reporting group description

Extension Period Secukinumab

Serious adverse events	Core Period Secukinumab	Core Period Secukinumab + Lifestyle Intervention	Extension Period Lifestyle Intervention	Extension Period Lifestyle Intervention + Secukinumab	Extension Period Secukinumab
Total subjects affected by serious adverse events
subjects affected / exposed	18 / 371 (4.85%)	20 / 409 (4.89%)	11 / 189 (5.82%)	10 / 164 (6.10%)	32 / 427 (7.49%)
number of deaths (all causes)	2	0	0	0	2
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urethral cancer
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Scrotal cancer
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Flushing
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arteriovenous fistula
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	1 / 371 (0.27%)	1 / 409 (0.24%)	0 / 189 (0.00%)	2 / 164 (1.22%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	2 / 371 (0.54%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	2 / 427 (0.47%)
occurrences causally related to treatment / all	1 / 3	0 / 0	0 / 0	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Cystocele
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	3 / 371 (0.81%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	4 / 427 (0.94%)
occurrences causally related to treatment / all	1 / 3	0 / 1	0 / 0	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Mania
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
Device loosening
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Aspartate aminotransferase increased
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary contusion
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reactive gastropathy
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	2 / 371 (0.54%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	2 / 427 (0.47%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 371 (0.27%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	2 / 427 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	2 / 427 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Coronary artery disease
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Endocrine ophthalmopathy
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Macular oedema
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ocular fistula
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ulcerative keratitis
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Enterocolitis haemorrhagic
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertrophy of tongue papillae
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal polyp
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	2 / 371 (0.54%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	3 / 427 (0.70%)
occurrences causally related to treatment / all	1 / 2	1 / 1	0 / 1	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erythrodermic psoriasis
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	1 / 189 (0.53%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	2 / 371 (0.54%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	3 / 427 (0.70%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	1 / 189 (0.53%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bursitis
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchiolitis
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	2 / 427 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	0 / 371 (0.00%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	1 / 189 (0.53%)	0 / 164 (0.00%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulpitis dental
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 371 (0.00%)	1 / 409 (0.24%)	0 / 189 (0.00%)	1 / 164 (0.61%)	0 / 427 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	1 / 371 (0.27%)	0 / 409 (0.00%)	0 / 189 (0.00%)	0 / 164 (0.00%)	1 / 427 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Core Period Secukinumab	Core Period Secukinumab + Lifestyle Intervention	Extension Period Lifestyle Intervention	Extension Period Lifestyle Intervention + Secukinumab	Extension Period Secukinumab
Total subjects affected by non serious adverse events
subjects affected / exposed	178 / 371 (47.98%)	204 / 409 (49.88%)	101 / 189 (53.44%)	103 / 164 (62.80%)	225 / 427 (52.69%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	10 / 371 (2.70%)	7 / 409 (1.71%)	2 / 189 (1.06%)	9 / 164 (5.49%)	9 / 427 (2.11%)
occurrences all number	14	9	2	14	10
Vascular disorders
Hypertension
subjects affected / exposed	19 / 371 (5.12%)	16 / 409 (3.91%)	9 / 189 (4.76%)	9 / 164 (5.49%)	20 / 427 (4.68%)
occurrences all number	19	18	9	10	21
Nervous system disorders
Headache
subjects affected / exposed	40 / 371 (10.78%)	36 / 409 (8.80%)	18 / 189 (9.52%)	20 / 164 (12.20%)	40 / 427 (9.37%)
occurrences all number	57	51	22	34	59
General disorders and administration site conditions
Fatigue
subjects affected / exposed	14 / 371 (3.77%)	10 / 409 (2.44%)	2 / 189 (1.06%)	9 / 164 (5.49%)	16 / 427 (3.75%)
occurrences all number	14	14	2	13	16
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	19 / 371 (5.12%)	22 / 409 (5.38%)	14 / 189 (7.41%)	10 / 164 (6.10%)	23 / 427 (5.39%)
occurrences all number	26	25	20	12	27
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	6 / 371 (1.62%)	16 / 409 (3.91%)	3 / 189 (1.59%)	9 / 164 (5.49%)	11 / 427 (2.58%)
occurrences all number	6	18	4	9	13
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	16 / 371 (4.31%)	17 / 409 (4.16%)	3 / 189 (1.59%)	14 / 164 (8.54%)	22 / 427 (5.15%)
occurrences all number	17	22	4	14	27
Psoriasis
subjects affected / exposed	17 / 371 (4.58%)	18 / 409 (4.40%)	19 / 189 (10.05%)	19 / 164 (11.59%)	37 / 427 (8.67%)
occurrences all number	20	18	19	20	40
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	11 / 371 (2.96%)	40 / 409 (9.78%)	18 / 189 (9.52%)	19 / 164 (11.59%)	19 / 427 (4.45%)
occurrences all number	14	50	25	23	26
Back pain
subjects affected / exposed	23 / 371 (6.20%)	22 / 409 (5.38%)	19 / 189 (10.05%)	9 / 164 (5.49%)	23 / 427 (5.39%)
occurrences all number	24	22	19	9	26
Infections and infestations
Nasopharyngitis
subjects affected / exposed	83 / 371 (22.37%)	96 / 409 (23.47%)	41 / 189 (21.69%)	49 / 164 (29.88%)	108 / 427 (25.29%)
occurrences all number	107	121	51	67	145

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Were there any global substantial amendments to the protocol? Yes

25 Jan 2018

Amendment 1: The original protocol was amended in order to align details of the protocol with the patient documents of the lifestyle intervention program (“Lesebuch”) and in order to complement the protocol with a few details that made the study procedure more clear. • Section 5.5.3.2: Additional explanation about the time point (visit 2) when patients in arm B receive the materials which are part of the lifestyle intervention • Section 6.5.4.1: Two laboratory markers are additionally captured at visit 1. • Section 6: Additional explanatory footnote for table 6-1. • Section 6.4.5: Waist circumference measurement method is adapted in order to align it with the patient documents of the lifestyle intervention program (“Lesebuch”).

05 Sep 2018

Amendment 2: The protocol was amended in order to incorporate a biomarker sub-study. Moreover, regulations of study treatment discontinuations are being improved, minor inconsistencies are being corrected and clarifications are being added. • Descriptions of the biomarker sub-study were added to the sections 2, 3.1, 3.6, 4.1, 6, 6.6.5, 7.1, 9.5.6, and 9.6. • Section 5.6.2 and table 5-1: After study treatment discontinuation (i.e. discontinuation of secukinumab, lifestyle intervention or both) the patient will now continue to attend regular study visits as per visit schedule and all assessments will be performed as planned. If one study treatment is discontinued (i.e. secukinumab or lifestyle intervention) this should not lead to discontinuation of the other, unless there is a reason for discontinuation of the other. If a study treatment is discontinued, adequate replacement for this treatment may be sought outside of the study despite continued study participation. • Table 6-1: Clarification that physical examination and drug accounting will only be performed at unscheduled visits if necessary, as determined by the treating physician. • Section 6.2.2: Clarification that topical therapies are only collected for the last 24 month prior to signing the informed consent. • Section 6.5.4.3.: Clarification that urine microscopy assessment, if needed, will be performed locally and correction of parameters assessed with the dipstick measurement. • Section 9.5.1: Clarification that PASI assessments will also be performed at weeks 1, 2 and 3 and addition of missing secondary endpoints. • Section 9.5.2.2: Change of wording from serum chemistry to clinical chemistry to align with the rest of the protocol. • The list of abbreviations has been updated.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 at week 28

Primary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 at week 28

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 75 over time

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 75 over time

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 over time

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 90 over time

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 100 over time

Secondary: Percentage of patients achieving Psoriasis Area and Severity Index (PASI) Score of 100 over time

Secondary: Mean absolute Psoriasis Area and Severity Index (PASI) Score over time

Secondary: Mean absolute Psoriasis Area and Severity Index (PASI) Score over time

Secondary: Mean change from Baseline in high-sensitivity C-reactive Protein (hsCRP)

Secondary: Mean change from Baseline in high-sensitivity C-reactive Protein (hsCRP)

Secondary: Mean change from Baseline in Hemoglobin A1c (HbA1c)

Secondary: Mean change from Baseline in Hemoglobin A1c (HbA1c)

Secondary: Mean change from Baseline in Fructosamine

Secondary: Mean change from Baseline in Fructosamine

Secondary: Mean change from Baseline in Fasting Plasma Glucose (FPG)

Secondary: Mean change from Baseline in Fasting Plasma Glucose (FPG)

Secondary: Mean change from Baseline in Total cholesterol

Secondary: Mean change from Baseline in Total cholesterol

Secondary: Mean change from Baseline in Low-Density Lipoprotein (LDL)

Secondary: Mean change from Baseline in Low-Density Lipoprotein (LDL)

Secondary: Mean change from Baseline in High-Density Lipoprotein (HDL)

Secondary: Mean change from Baseline in High-Density Lipoprotein (HDL)

Secondary: Mean change from Baseline in Triglycerides

Secondary: Mean change from Baseline in Triglycerides

Secondary: Mean change from Baseline in Waist circumference

Secondary: Mean change from Baseline in Waist circumference

Secondary: Mean change from Baseline in Body weight

Secondary: Mean change from Baseline in Body weight

Secondary: Mean change from Baseline in Body Mass Index (BMI)

Secondary: Mean change from Baseline in Body Mass Index (BMI)

Secondary: Mean change from Baseline in Systolic Blood Pressure

Secondary: Mean change from Baseline in Systolic Blood Pressure

Secondary: Mean change from Baseline in Diastolic Blood Pressure

Secondary: Mean change from Baseline in Diastolic Blood Pressure

Secondary: Dermatology Life Quality Index (DLQI) Total Score over time

Secondary: Dermatology Life Quality Index (DLQI) Total Score over time

Secondary: Mean change from Baseline in Dermatology Life Quality Index (DLQI) Total Score over time

Secondary: Mean change from Baseline in Dermatology Life Quality Index (DLQI) Total Score over time

Secondary: Percentage of patients with Dermatology Life Quality Index (DLQI) Response

Secondary: Percentage of patients with Dermatology Life Quality Index (DLQI) Response

Secondary: World Health Organization Well-Being Index (WHO-5) Total score over time

Secondary: World Health Organization Well-Being Index (WHO-5) Total score over time

Secondary: Mean change from Baseline in World Health Organization Well-Being Index (WHO-5) Total score over time

Secondary: Mean change from Baseline in World Health Organization Well-Being Index (WHO-5) Total score over time

Secondary: Participant’s self-assessed pain, itching and scaling over time

Secondary: Participant’s self-assessed pain, itching and scaling over time

Secondary: Percentage change from Baseline in Participant’s self-assessed pain, itching and scaling

Secondary: Percentage change from Baseline in Participant’s self-assessed pain, itching and scaling

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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