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Clinical Trial Results:
Multicenter, rAndomized, double-blind, placebo-conTrolled, 52-week stUdy to demonstRatE the efficacy, safety and tolerability of secukinumab injections with 2 mL auto-injectors (300 mg) in adult subjects with plaque psoriasis (MATURE)

Summary
EudraCT number	2018-000518-39
Trial protocol	DE ES PL IS
Global end of trial date	05 Aug 2020

Results information
Results version number	v1(current)
This version publication date	28 Jul 2021
First version publication date	28 Jul 2021
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

CAIN457A2325

ISRCTN number

US NCT number

NCT03589885

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, 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

05 Aug 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

19 Nov 2019

Global end of trial reached?

Yes

Global end of trial date

05 Aug 2020

Was the trial ended prematurely?

Main objective of the trial

The primary objective was to demonstrate the efficacy of secukinumab 300 mg when administered in 2 mL Auto-Injector (AI) in subjects with plaque-type psoriasis with respect to both Psoriasis Area and Severity Index (PASI) 75 and Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo. The key secondary objective was to demonstrate the efficacy of secukinumab 300 mg when administered in 2 mL AI in subjects with plaque-type psoriasis with respect to PASI 90 at Week 12, compared to placebo.

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

19 Dec 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 15

Country: Number of subjects enrolled

Germany: 17

Country: Number of subjects enrolled

Iceland: 22

Country: Number of subjects enrolled

Poland: 17

Country: Number of subjects enrolled

Spain: 13

Country: Number of subjects enrolled

United States: 38

Worldwide total number of subjects

122

EEA total number of subjects

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)

112

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 144 subjects were screened at 22 study centers in 6 countries, and 122 subjects were randomized.

Screening details

A total of 144 subjects were screened at 22 study centers in 6 countries, and 122 subjects were randomized.

Period 1 title

Treatment Period 1-Randomized Set

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Carer, Assessor, Subject

Are arms mutually exclusive

Yes

Secukinumab 300 mg 2 mL Auto-Injector (AI)

Arm description

Secukinumab 300 mg provided in 2 mL auto-injector form

Arm type

Experimental

Investigational medicinal product name

Secukinumab 300 mg (2 mL AI)

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Secukinumab 300 mg provided in 2 mL auto-injector form

Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)

Arm description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Arm type

Experimental

Investigational medicinal product name

Secukinumab 300 mg (2x 1 mL PFS)

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Secukinumab 300 mg provided as 2x 1mL prefilled syringe of 150 mg/mL

Placebo

Arm description

Placebo of Secukinumab

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo of Secukinumab

Number of subjects in period 1	Secukinumab 300 mg 2 mL Auto-Injector (AI)	Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)	Placebo
Started	41	41	40
Completed	41	39	37
Not completed	0	2	3
Consent withdrawn by subject	-	-	1
Adverse event, non-fatal	-	1	-
Lost to follow-up	-	1	-
Lack of efficacy	-	-	2

Period 2 title

Treatment Period 2-Randomized Set

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Secukinumab 300 mg 2 mL Auto-Injector (AI)

Arm description

Secukinumab 300 mg provided in 2 mL auto-injector form

Arm type

Experimental

Investigational medicinal product name

Secukinumab 300 mg (2 mL AI)

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Secukinumab 300 mg provided in 2 mL auto-injector form

Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)

Arm description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Arm type

Experimental

Investigational medicinal product name

Secukinumab 300 mg (2x 1 mL PFS)

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Secukinumab 300 mg (2x 1 mL PFS) provided as 2x 1mL prefilled syringe of 150 mg/mL

Placebo

Arm description

Placebo of Secukinumab

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo of Secukinumab

Placebo-Secukinumab 300 mg 2 mL Auto-Injector (AI)

Arm description

Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL AI up to the end of the study, if PASI 90 non-responders at Week 12

Arm type

Experimental

Investigational medicinal product name

Placebo-Secukinumab 300 mg 2 mL auto-injector (AI)

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo and Secukinumab 300 mg provided in 2mL auto-injector form

Placebo-Secukinumab 300 mg 2 x 1 mL Prefilled Syringe (PFS)

Arm description

Placebo patients up to Week 12 who thereafter received secukinumab in 2 x 1 mL PFS up to the end of the study, if PASI 90 non-responders at Week 12

Arm type

Experimental

Investigational medicinal product name

Placebo-Secukinumab 300 mg (2 x 1 mL PFS)

Investigational medicinal product code

AIN457

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo and Secukinumab provided as 2x 1mL prefilled syringe of 150 mg/mL

Number of subjects in period 2	Secukinumab 300 mg 2 mL Auto-Injector (AI)	Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)	Placebo	Placebo-Secukinumab 300 mg 2 mL Auto-Injector (AI)	Placebo-Secukinumab 300 mg 2 x 1 mL Prefilled Syringe (PFS)
Started	41	39	4	16	17
Completed	40	34	3	16	16
Not completed	1	5	1	0	1
Consent withdrawn by subject	-	1	-	-	-
Adverse event, non-fatal	-	1	-	-	-
Pregnancy	1	-	-	-	-
Lost to follow-up	-	3	1	-	1

Baseline characteristics

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Reporting group title

Secukinumab 300 mg 2 mL Auto-Injector (AI)

Reporting group description

Secukinumab 300 mg provided in 2 mL auto-injector form

Reporting group title

Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)

Reporting group description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Reporting group title

Placebo

Reporting group description

Placebo of Secukinumab

Reporting group values	Secukinumab 300 mg 2 mL Auto-Injector (AI)	Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)	Placebo	Total
Number of subjects	41	41	40	122
Age Categorical
Units: Participants
< 65	39	37	36	112
≥ 65	2	4	4	10
Age continuous
Age Mean and Standard Deviation per Arm
Units: years
arithmetic mean (standard deviation)	44.0 ( 13.81 )	44.7 ( 12.79 )	43.6 ( 14.08 )	-
Sex: Female, Male
Units: Participants
Female	13	12	12	37
Male	28	29	28	85
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	1	0	1
Asian	1	1	3	5
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	0	0	1
White	39	39	37	115

Subject analysis set title

Secukinumab 300 mg 2 mL Auto-Injector

Subject analysis set type

Full analysis

Subject analysis set description

Secukinumab 300 mg provided in 2 mL auto-injector form

Subject analysis set title

Secukinumab 300 mg 2x 1 mL Prefilled Syringe

Subject analysis set type

Full analysis

Subject analysis set description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Subject analysis set title

Placebo-Secukinumab 300 mg (2 mL Auto-Injector)

Subject analysis set type

Full analysis

Subject analysis set description

Placebo patients up to Week 12 who thereafter received Secukinumab 300 mg in 2 mL auto-injector up to the end of the study, if PASI 90 non-responders at Week 12

Subject analysis set title

Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe)

Subject analysis set type

Full analysis

Subject analysis set description

Placebo patients up to Week 12 who thereafter received Secukinumab 300 mg in 2x 1mL PFS up to the end of the study, if PASI 90 non-responders at Week 12

Subject analysis set title

Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Placebo to Secukinumab 300 mg

Subject analysis set title

PRE-Module By Visit

Subject analysis set type

Safety analysis

Subject analysis set description

PRE-Module by Visit Score (Entire Treatment Period). Safety Set was used for this analysis

Subject analysis set title

POST-Module By Visit

Subject analysis set type

Safety analysis

Subject analysis set description

POST-Module by Visit Score (Entire Treatment Period). Safety Set was used for this analysis

Subject analysis set title

Absolute Change POST -Module-PRE Module

Subject analysis set type

Safety analysis

Subject analysis set description

Absolute Change POST-Module/PRE-Module Scores

Subject analysis sets values	Secukinumab 300 mg 2 mL Auto-Injector	Secukinumab 300 mg 2x 1 mL Prefilled Syringe	Placebo-Secukinumab 300 mg (2 mL Auto-Injector)	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe)	Placebo	PRE-Module By Visit	POST-Module By Visit	Absolute Change POST -Module-PRE Module
Number of subjects	41	41	16	17	40	122	122	122
Age Categorical
Units: Participants
< 65	39	37	13	16	36	0	0	0
≥ 65	2	4	3	1	4	0	0	0
Age continuous
Age Mean and Standard Deviation per Arm
Units: years
arithmetic mean (standard deviation)	44.0 ( 13.81 )	44.7 ( 12.79 )	45.6 ( 16.60 )	43.5 ( 13.00 )	43.6 ( 14.08 )	0.0 ( 0.0 )	0.0 ( 0.0 )	0.0 ( 0.0 )
Sex: Female, Male
Units: Participants
Female	13	12	3	6	12	0	0	0
Male	28	29	13	11	28	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	1	0	0	0	0	0	0
Asian	1	1	0	3	3	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0		0	0	0	0
Black or African American	1	0	0	0	0	0	0	0
White	39	39	16	14	37	0	0	0

End points

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Reporting group title

Secukinumab 300 mg 2 mL Auto-Injector (AI)

Reporting group description

Secukinumab 300 mg provided in 2 mL auto-injector form

Reporting group title

Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)

Reporting group description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Reporting group title

Placebo

Reporting group description

Placebo of Secukinumab

Reporting group title

Secukinumab 300 mg 2 mL Auto-Injector (AI)

Reporting group description

Secukinumab 300 mg provided in 2 mL auto-injector form

Reporting group title

Secukinumab 300 mg 2x 1 mL Prefilled Syringe (PFS)

Reporting group description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Reporting group title

Placebo

Reporting group description

Placebo of Secukinumab

Reporting group title

Placebo-Secukinumab 300 mg 2 mL Auto-Injector (AI)

Reporting group description

Placebo patients up to Week 12 who thereafter received secukinumab in 2 mL AI up to the end of the study, if PASI 90 non-responders at Week 12

Reporting group title

Placebo-Secukinumab 300 mg 2 x 1 mL Prefilled Syringe (PFS)

Reporting group description

Placebo patients up to Week 12 who thereafter received secukinumab in 2 x 1 mL PFS up to the end of the study, if PASI 90 non-responders at Week 12

Subject analysis set title

Secukinumab 300 mg 2 mL Auto-Injector

Subject analysis set type

Full analysis

Subject analysis set description

Secukinumab 300 mg provided in 2 mL auto-injector form

Subject analysis set title

Secukinumab 300 mg 2x 1 mL Prefilled Syringe

Subject analysis set type

Full analysis

Subject analysis set description

Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Subject analysis set title

Placebo-Secukinumab 300 mg (2 mL Auto-Injector)

Subject analysis set type

Full analysis

Subject analysis set description

Placebo patients up to Week 12 who thereafter received Secukinumab 300 mg in 2 mL auto-injector up to the end of the study, if PASI 90 non-responders at Week 12

Subject analysis set title

Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe)

Subject analysis set type

Full analysis

Subject analysis set description

Placebo patients up to Week 12 who thereafter received Secukinumab 300 mg in 2x 1mL PFS up to the end of the study, if PASI 90 non-responders at Week 12

Subject analysis set title

Placebo

Subject analysis set type

Full analysis

Subject analysis set description

Placebo to Secukinumab 300 mg

Subject analysis set title

PRE-Module By Visit

Subject analysis set type

Safety analysis

Subject analysis set description

PRE-Module by Visit Score (Entire Treatment Period). Safety Set was used for this analysis

Subject analysis set title

POST-Module By Visit

Subject analysis set type

Safety analysis

Subject analysis set description

POST-Module by Visit Score (Entire Treatment Period). Safety Set was used for this analysis

Subject analysis set title

Absolute Change POST -Module-PRE Module

Subject analysis set type

Safety analysis

Subject analysis set description

Absolute Change POST-Module/PRE-Module Scores

Primary: PASI 75 response after 12 weeks of treatment

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End point title

PASI 75 response after 12 weeks of treatment ^[1]

End point description

Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).

End point type

Primary

End point timeframe

12 weeks

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis was not performed on all arms for this endpoint. Arms with statistical analysis are presented.

End point values	Placebo	Secukinumab 300 mg 2 mL Auto-Injector	Secukinumab 300 mg 2x 1 mL Prefilled Syringe
Number of subjects analysed	40	41	41
Units: Participants	4	39	34

Secukinumab 300 mg 2mL Auto-Injector vs Placebo

Statistical analysis description

PASI 75

Comparison groups

Placebo v Secukinumab 300 mg 2 mL Auto-Injector

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1014.07

Confidence interval

level

95%

sides

2-sided

lower limit

68.83

upper limit

14940.62

Secukinumab 300 mg 2x 1mL PFS vs Placebo

Statistical analysis description

PASI 75

Comparison groups

Placebo v Secukinumab 300 mg 2x 1 mL Prefilled Syringe

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

96.23

Confidence interval

level

95%

sides

2-sided

lower limit

17.22

upper limit

537.78

Primary: IGA mod 2011 0 or 1 response after 12 weeks of treatment

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End point title

IGA mod 2011 0 or 1 response after 12 weeks of treatment ^[2]

End point description

Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).

End point type

Primary

End point timeframe

12 weeks

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis was not performed on all arms for this endpoint. Arms with statistical analysis are presented.

End point values	Placebo	Secukinumab 300 mg 2 mL Auto-Injector	Secukinumab 300 mg 2x 1 mL Prefilled Syringe
Number of subjects analysed	40	41	41
Units: Participants	3	31	28

Secukinumab 300 mg 2mL Auto-Injector vs Placebo

Comparison groups

Placebo v Secukinumab 300 mg 2 mL Auto-Injector

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

51.46

Confidence interval

level

95%

sides

2-sided

lower limit

11.95

upper limit

221.64

Secukinumab 300 mg 2x1 mL PFS vs Placebo

Comparison groups

Placebo v Secukinumab 300 mg 2x 1 mL Prefilled Syringe

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

29.7

Confidence interval

level

95%

sides

2-sided

lower limit

7.38

upper limit

119.57

Secondary: PASI 90 response

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End point title

PASI 90 response ^[3]

End point description

Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline

End point type

Secondary

End point timeframe

12 weeks

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis was not performed on all arms for this endpoint. Arms with statistical analysis are presented.

End point values	Placebo	Secukinumab 300 mg 2 mL Auto-Injector	Secukinumab 300 mg 2x 1 mL Prefilled Syringe
Number of subjects analysed	40	41	41
Units: Participants	2	31	26

Secukinumab 300 mg 2mL Auto-Injector vs Placebo

Comparison groups

Placebo v Secukinumab 300 mg 2 mL Auto-Injector

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

88.46

Confidence interval

level

95%

sides

2-sided

lower limit

16.15

upper limit

484.52

Secukinumab 300 mg 2x 1 mL PFS vs Placebo

Comparison groups

Placebo v Secukinumab 300 mg 2x 1 mL Prefilled Syringe

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

37.9

Confidence interval

level

95%

sides

2-sided

lower limit

7.6

upper limit

189.01

Secondary: PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response

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End point title

PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response ^[4]

End point description

Percentage of participants who achieve ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline at each visit up to 52 weeks

End point type

Secondary

End point timeframe

52 weeks

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis was not performed on all arms for this endpoint. Arms with statistical analysis are presented.

End point values	Placebo	Secukinumab 300 mg 2 mL Auto-Injector	Secukinumab 300 mg 2x 1 mL Prefilled Syringe	Placebo-Secukinumab 300 mg (2 mL Auto-Injector)	Placebo-Secukinumab 300 mg (2x 1 mL Prefilled Syringe)
Number of subjects analysed	40	41	41	16	17
Units: Participants
PASI 50	4	41	40	15	15
PASI 75	1	38	37	13	14
PASI 90	0	30	28	12	14
PASI 100	0	23	18	11	11
IGA 0/1	0	30	33	12	13

No statistical analyses for this end point

Secondary: Successful self-injection

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End point title

Successful self-injection

End point description

Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience).

End point type

Secondary

End point timeframe

From randomization until Week 28

End point values	PRE-Module By Visit	POST-Module By Visit	Absolute Change POST -Module-PRE Module
Number of subjects analysed	113 ^[5]	113 ^[6]	113 ^[7]
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline	5.75 ( 2.442 )	0.0 ( 0.0 )	0.0 ( 0.0 )
Baseline (1) POST-module at baseline visit	5.75 ( 2.452 )	7.52 ( 2.046 )	1.77 ( 2.789 )
Week 1	5.72 ( 2.463 )	8.11 ( 1.759 )	2.39 ( 3.169 )
Week 4	5.70 ( 2.495 )	8.27 ( 1.731 )	2.57 ( 3.080 )
Week 8	5.68 ( 2.490 )	8.62 ( 1.545 )	2.94 ( 2.869 )
Week 12	5.70 ( 2.523 )	8.56 ( 1.623 )	2.86 ( 2.985 )
Week 28	5.62 ( 2.485 )	8.69 ( 1.681 )	3.07 ( 3.238 )

Notes
[5] - Baseline Number Analyzed was 114. Baseline (1) Post-Module at Baseline Visit 113
[6] - Baseline Number Analyzed was 0. Baseline (1) Post-Module at Baseline Visit 113
[7] - Baseline Number Analyzed was 0. Baseline (1) Post-Module at Baseline Visit 113

No statistical analyses for this end point

Secondary: Dermatology Life Quality Index, (DLQI) 0 or 1 score (total score)

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End point title

Dermatology Life Quality Index, (DLQI) 0 or 1 score (total score) ^[8]

End point description

The impact of psoriasis on various aspects of subject’s health-related quality of life assessed by the subject

End point type

Secondary

End point timeframe

Change from Baseline up to 52 weeks

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Statistical Analysis was not performed on all arms for this endpoint. Arms with statistical analysis are presented.

End point values	Placebo	Secukinumab 300 mg 2 mL Auto-Injector	Secukinumab 300 mg 2x 1 mL Prefilled Syringe
Number of subjects analysed	40	41	41
Units: Scores on a Scale
arithmetic mean (standard deviation)
Week 12	-1.97 ( 6.966 )	-13.21 ( 7.701 )	-11.95 ( 7.861 )
Week 28	-13.00 ( 12.490 )	-13.59 ( 7.639 )	-12.23 ( 8.438 )
Week 52	-14.33 ( 11.240 )	-12.44 ( 8.219 )	-12.23 ( 8.408 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were collected from first dose of study treatment until end of study treatment (Week 48) plus 4 weeks post treatment.

Adverse event reporting additional description

Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

Secukinumab 300 mg (2 mL AI)

Reporting group description

Secukinumab 300 mg (2 mL AI)

Reporting group title

Secukinumab 300 mg (2 x 1 mL PFS)

Reporting group description

Secukinumab 300 mg (2 x 1 mL PFS)

Reporting group title

Any Secukinumab 300 mg (2 mL AI)

Reporting group description

Any Secukinumab 300 mg (2 mL AI)

Reporting group title

Any Secukinumab 300 mg (2 x 1 mL PFS)

Reporting group description

Any Secukinumab 300 mg (2 x 1 mL PFS)

Reporting group title

Placebo

Reporting group description

Placebo to Secukinumab

Reporting group title

Any Secukinumab 300 mg

Reporting group description

Any Secukinumab 300 mg

Serious adverse events	Secukinumab 300 mg (2 mL AI)	Secukinumab 300 mg (2 x 1 mL PFS)	Any Secukinumab 300 mg (2 mL AI)	Any Secukinumab 300 mg (2 x 1 mL PFS)	Placebo	Any Secukinumab 300 mg
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 41 (2.44%)	3 / 41 (7.32%)	1 / 57 (1.75%)	4 / 58 (6.90%)	0 / 40 (0.00%)	5 / 115 (4.35%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Syncope
subjects affected / exposed	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Device related infection
subjects affected / exposed	1 / 41 (2.44%)	0 / 41 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 40 (0.00%)	1 / 115 (0.87%)
occurrences causally related to treatment / all	1 / 1	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	0 / 0

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

Non-serious adverse events	Secukinumab 300 mg (2 mL AI)	Secukinumab 300 mg (2 x 1 mL PFS)	Any Secukinumab 300 mg (2 mL AI)	Any Secukinumab 300 mg (2 x 1 mL PFS)	Placebo	Any Secukinumab 300 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	19 / 41 (46.34%)	16 / 41 (39.02%)	24 / 57 (42.11%)	21 / 58 (36.21%)	5 / 40 (12.50%)	45 / 115 (39.13%)
Vascular disorders
Hypertension
subjects affected / exposed	4 / 41 (9.76%)	2 / 41 (4.88%)	5 / 57 (8.77%)	2 / 58 (3.45%)	0 / 40 (0.00%)	7 / 115 (6.09%)
occurrences all number	4	2	5	2	0	7
Nervous system disorders
Headache
subjects affected / exposed	2 / 41 (4.88%)	4 / 41 (9.76%)	3 / 57 (5.26%)	4 / 58 (6.90%)	1 / 40 (2.50%)	7 / 115 (6.09%)
occurrences all number	2	7	3	7	1	10
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	3 / 41 (7.32%)	3 / 41 (7.32%)	4 / 57 (7.02%)	3 / 58 (5.17%)	1 / 40 (2.50%)	7 / 115 (6.09%)
occurrences all number	4	7	5	7	1	12
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 41 (0.00%)	3 / 41 (7.32%)	0 / 57 (0.00%)	3 / 58 (5.17%)	0 / 40 (0.00%)	3 / 115 (2.61%)
occurrences all number	0	3	0	3	0	3
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	3 / 41 (7.32%)	2 / 41 (4.88%)	3 / 57 (5.26%)	3 / 58 (5.17%)	2 / 40 (5.00%)	6 / 115 (5.22%)
occurrences all number	3	2	3	3	2	6
Infections and infestations
Nasopharyngitis
subjects affected / exposed	6 / 41 (14.63%)	6 / 41 (14.63%)	8 / 57 (14.04%)	8 / 58 (13.79%)	0 / 40 (0.00%)	16 / 115 (13.91%)
occurrences all number	7	6	10	8	0	18
Upper respiratory tract infection
subjects affected / exposed	3 / 41 (7.32%)	4 / 41 (9.76%)	4 / 57 (7.02%)	6 / 58 (10.34%)	1 / 40 (2.50%)	10 / 115 (8.70%)
occurrences all number	3	5	4	7	1	11

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Were there any global substantial amendments to the protocol? No

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

Clinical Trial Results:
Multicenter, rAndomized, double-blind, placebo-conTrolled, 52-week stUdy to demonstRatE the efficacy, safety and tolerability of secukinumab injections with 2 mL auto-injectors (300 mg) in adult subjects with plaque psoriasis (MATURE)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: PASI 75 response after 12 weeks of treatment

Primary: PASI 75 response after 12 weeks of treatment

Primary: IGA mod 2011 0 or 1 response after 12 weeks of treatment

Primary: IGA mod 2011 0 or 1 response after 12 weeks of treatment

Secondary: PASI 90 response

Secondary: PASI 90 response

Secondary: PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response

Secondary: PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response

Secondary: Successful self-injection

Secondary: Successful self-injection

Secondary: Dermatology Life Quality Index, (DLQI) 0 or 1 score (total score)

Secondary: Dermatology Life Quality Index, (DLQI) 0 or 1 score (total score)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
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Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
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Luxembourg
Malta
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Norway
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Portugal
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Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Multicenter, rAndomized, double-blind, placebo-conTrolled, 52-week stUdy to demonstRatE the efficacy, safety and tolerability of secukinumab injections with 2 mL auto-injectors (300 mg) in adult subjects with plaque psoriasis (MATURE)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: PASI 75 response after 12 weeks of treatment

Primary: PASI 75 response after 12 weeks of treatment

Primary: IGA mod 2011 0 or 1 response after 12 weeks of treatment

Primary: IGA mod 2011 0 or 1 response after 12 weeks of treatment

Secondary: PASI 90 response

Secondary: PASI 90 response

Secondary: PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response

Secondary: PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response

Secondary: Successful self-injection

Secondary: Successful self-injection

Secondary: Dermatology Life Quality Index, (DLQI) 0 or 1 score (total score)

Secondary: Dermatology Life Quality Index, (DLQI) 0 or 1 score (total score)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Multicenter, rAndomized, double-blind, placebo-conTrolled, 52-week stUdy to demonstRatE the efficacy, safety and tolerability of secukinumab injections with 2 mL auto-injectors (300 mg) in adult subjects with plaque psoriasis (MATURE)