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Clinical Trial Results:
A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single-blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis

Summary
EudraCT number	2014-005663-32
Trial protocol	LV EE DE BE ES HU FR GB PL IT
Global end of trial date	30 Mar 2023

Results information
Results version number	v1(current)
This version publication date	15 Oct 2023
First version publication date	15 Oct 2023
Other versions

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

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Trial information

Top of page

Sponsor protocol code

CAIN457A2310

ISRCTN number

-

US NCT number

NCT02471144

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)

Yes

EMA paediatric investigation plan number(s)

EMEA-000380-PIP01-08

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

No

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

Yes

Analysis stage

Final

Date of interim/final analysis

30 Mar 2023

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

30 Mar 2023

Was the trial ended prematurely?

No

Main objective of the trial

To demonstrate the superiority of secukinumab (low and high dose) in pediatric patients with severe chronic plaque psoriasis with respect to both PASI 75 and IGA mod 2011 0/1 response (co-primary endpoints) 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

29 Sep 2015

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Estonia: 11

Country: Number of subjects enrolled

Latvia: 4

Country: Number of subjects enrolled

Spain: 8

Country: Number of subjects enrolled

Belgium: 7

Country: Number of subjects enrolled

Hungary: 8

Country: Number of subjects enrolled

Israel: 10

Country: Number of subjects enrolled

Poland: 28

Country: Number of subjects enrolled

United Kingdom: 1

Country: Number of subjects enrolled

Guatemala: 10

Country: Number of subjects enrolled

Japan: 5

Country: Number of subjects enrolled

Germany: 25

Country: Number of subjects enrolled

Switzerland: 1

Country: Number of subjects enrolled

Colombia: 9

Country: Number of subjects enrolled

Italy: 2

Country: Number of subjects enrolled

France: 3

Country: Number of subjects enrolled

Egypt: 11

Country: Number of subjects enrolled

Romania: 4

Country: Number of subjects enrolled

United States: 2

Country: Number of subjects enrolled

Russian Federation: 13

Worldwide total number of subjects

162

EEA total number of subjects

100

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

37

Adolescents (12-17 years)

125

Adults (18-64 years)

0

From 65 to 84 years

0

85 years and over

0

Subject disposition

Top of page

Recruitment details

Participants took part in 57 investigative sites in 19 countries.

Screening details

The screening period of up to 4 weeks was used to assess eligibility of the patients and to taper patients off prohibited medications.

Period 1 title

Induction Period (Up to Week 12)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 Low Dose (Induction Period)

Arm description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) s.c. at each dosing.

AIN457 High Dose (Induction Period)

Arm description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) s.c. at each dosing.

Placebo (Induction Period)

Arm description

Patients received matching placebo to secukinumab at each dosing

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received placebo s.c. at each dosing.

Etanercept Comparator (Induction Period)

Arm description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Arm type

Active comparator

Investigational medicinal product name

Etanercept Comparator

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg).

Number of subjects in period 1	AIN457 Low Dose (Induction Period)	AIN457 High Dose (Induction Period)	Placebo (Induction Period)	Etanercept Comparator (Induction Period)
Started	40	40	41	41
Completed	39	38	39	40
Not completed	1	2	2	1
Adverse Event	-	1	1	-
Protocol Deviation	-	-	1	-
Subject/Guardian Decision	1	1	-	-
Lack of efficacy	-	-	-	1

Period 2 title

Maintenance Period (Week 12 to Week 52)

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 Low Dose (Maintenance Period)

Arm description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) s.c. at each dosing.

AIN457 High Dose (Maintenance Period)

Arm description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) s.c. at each dosing.

Placebo-AIN457 Low Dose (Maintenance Period)

Arm description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study.

Placebo-AIN457 High Dose (Maintenance Period

Arm description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study.

Etanercept Comparator (Maintenance Period)

Arm description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Arm type

Active comparator

Investigational medicinal product name

Etanercept Comparator

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg).

Number of subjects in period 2 ^[1]	AIN457 Low Dose (Maintenance Period)	AIN457 High Dose (Maintenance Period)	Placebo-AIN457 Low Dose (Maintenance Period)	Placebo-AIN457 High Dose (Maintenance Period	Etanercept Comparator (Maintenance Period)
Started	39	38	16	18	40
Completed	38	37	15	16	34
Not completed	1	1	1	2	6
Adverse Event	1	-	1	-	1
Protocol Deviation	-	-	-	2	1
Pregnancy	-	-	-	-	1
Lack of efficacy	-	1	-	-	3

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Due to change of treatment and/or stopping of arms between periods, the number of subjects starting the period is not consistent with the number completing the preceding period.

Period 3 title

Extension Period (Week 52 to Week 236)

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Any AIN457 Low Dose (Extension Period)

Arm description

Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) s.c. at each dosing. Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study.

Any AIN457 High Dose (Extension Period)

Arm description

Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups

Arm type

Experimental

Investigational medicinal product name

AIN457

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) s.c. at each dosing. Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study.

Number of subjects in period 3 ^[2]	Any AIN457 Low Dose (Extension Period)	Any AIN457 High Dose (Extension Period)
Started	53	53
Completed	39	43
Not completed	14	10
Technical problems	1	-
Adverse event, non-fatal	2	2
Pregnancy	2	-
Subject/Guardian Decision	3	3
Lost to follow-up	-	2
Lack of efficacy	6	3

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Due to change of treatment and/or stopping of arms between periods, the number of subjects starting the period is not consistent with the number completing the preceding period.

Baseline characteristics

Top of page

Reporting group title

AIN457 Low Dose (Induction Period)

Reporting group description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Reporting group title

AIN457 High Dose (Induction Period)

Reporting group description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Reporting group title

Placebo (Induction Period)

Reporting group description

Patients received matching placebo to secukinumab at each dosing

Reporting group title

Etanercept Comparator (Induction Period)

Reporting group description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Reporting group values	AIN457 Low Dose (Induction Period)	AIN457 High Dose (Induction Period)	Placebo (Induction Period)	Etanercept Comparator (Induction Period)	Total
Number of subjects	40	40	41	41	162
Age Categorical
Age Categorical
Units: Participants
<12 years	8	9	10	10	37
>=12 years	32	31	31	31	125
Age Continuous
Units: Years
arithmetic mean (standard deviation)	13.7 ± 2.92	13.2 ± 3.21	13.7 ± 3.27	13.5 ± 2.94	-
Sex: Female, Male
Units: Participants
Female	27	23	22	25	97
Male	13	17	19	16	65
Race/Ethnicity, Customized
Units: Subjects
Caucasian	34	34	36	30	134
Black	1	1	0	0	2
Asian	1	2	1	3	7
Native American	3	3	3	8	17
Other	1	0	1	0	2

Subject analysis set title

AIN457 Low Dose

Subject analysis set type

Full analysis

Subject analysis set description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Subject analysis set title

AIN457 High Dose

Subject analysis set type

Full analysis

Subject analysis set description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Subject analysis set title

Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Patients received matching placebo to secukinumab at each dosing

Subject analysis set title

Etanercept

Subject analysis set type

Full analysis

Subject analysis set description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Subject analysis set title

Placebo - AIN457 Low Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

Subject analysis set title

Placebo - AIN457 High Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

Subject analysis sets values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects	40	40	41	41	16	18
Age Categorical
Age Categorical
Units: Participants
<12 years	8	9	10	10
>=12 years	32	31	31	31
Age Continuous
Units: Years
arithmetic mean (standard deviation)	13.7 ± 2.92	13.2 ± 3.21	13.7 ± 3.27	13.5 ± 2.94	±	±
Sex: Female, Male
Units: Participants
Female	27	23	22	25
Male	13	17	19	16
Race/Ethnicity, Customized
Units: Subjects
Caucasian	34	34	36	30
Black	1	1	0	0
Asian	1	2	1	3
Native American	3	3	3	8
Other	1	0	1	0

End points

Top of page

Reporting group title

AIN457 Low Dose (Induction Period)

Reporting group description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Reporting group title

AIN457 High Dose (Induction Period)

Reporting group description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Reporting group title

Placebo (Induction Period)

Reporting group description

Patients received matching placebo to secukinumab at each dosing

Reporting group title

Etanercept Comparator (Induction Period)

Reporting group description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Reporting group title

AIN457 Low Dose (Maintenance Period)

Reporting group description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Reporting group title

AIN457 High Dose (Maintenance Period)

Reporting group description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Reporting group title

Placebo-AIN457 Low Dose (Maintenance Period)

Reporting group description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

Reporting group title

Placebo-AIN457 High Dose (Maintenance Period

Reporting group description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

Reporting group title

Etanercept Comparator (Maintenance Period)

Reporting group description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Reporting group title

Any AIN457 Low Dose (Extension Period)

Reporting group description

Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups

Reporting group title

Any AIN457 High Dose (Extension Period)

Reporting group description

Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups

Subject analysis set title

AIN457 Low Dose

Subject analysis set type

Full analysis

Subject analysis set description

Patients received secukinumab 75mg (if weighing < 50kg) or 150 mg (if weighing >=50 kg) at each dosing

Subject analysis set title

AIN457 High Dose

Subject analysis set type

Full analysis

Subject analysis set description

Patients received secukinumab 75mg (if weighing < 25kg) or 150 mg (if weighing 25 to < 50kg ) or 300 mg (if weighing >=50 kg) at each dosing

Subject analysis set title

Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Patients received matching placebo to secukinumab at each dosing

Subject analysis set title

Etanercept

Subject analysis set type

Full analysis

Subject analysis set description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg)

Subject analysis set title

Placebo - AIN457 Low Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 Low Dose for the remainder of the study

Subject analysis set title

Placebo - AIN457 High Dose

Subject analysis set type

Intention-to-treat

Subject analysis set description

Patients received placebo during Induction and if they were PASI 75 non-responders at Week 12 switched to AIN457 High Dose for the remainder of the study

Primary: Number and Percentage of Participants achieving a 75% Improvement from Baseline in PASI Score at week 12

Top of page

End point title

Number and Percentage of Participants achieving a 75% Improvement from Baseline in PASI Score at week 12

End point description

Psoriasis Area and Severity Index (PASI):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 and 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.

End point type

Primary

End point timeframe

12 weeks

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: Participants	32	31	6	26

PASI score

Comparison groups

AIN457 Low Dose v Placebo

Number of subjects included in analysis

81

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

25.78

Confidence interval

level

95%

sides

2-sided

lower limit

7.08

upper limit

114.66

PASI score

Comparison groups

AIN457 High Dose v Placebo

Number of subjects included in analysis

81

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

22.65

Confidence interval

level

95%

sides

2-sided

lower limit

6.31

upper limit

98.93

Primary: Number and Percentage of Participants who showed Investigator's Global Assessment (IGA) mod 2011 response of 0 or 1 at week 12

Top of page

End point title

Number and Percentage of Participants who showed Investigator's Global Assessment (IGA) mod 2011 response of 0 or 1 at week 12

End point description

IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

End point type

Primary

End point timeframe

12 Weeks

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	40	41
Units: Participants	28	24	2	14

Investigator's Global Assessment (IGA)

Comparison groups

AIN457 High Dose v Placebo

Number of subjects included in analysis

80

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

32.52

Confidence interval

level

95%

sides

2-sided

lower limit

6.48

upper limit

329.52

Investigator's Global Assessment (IGA)

Comparison groups

AIN457 Low Dose v Placebo

Number of subjects included in analysis

80

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

51.77

Confidence interval

level

95%

sides

2-sided

lower limit

10.02

upper limit

538.64

Secondary: Number and Percentage of Participants achieving a 90% Improvement from baseline in PASI score at week 12

Top of page

End point title

Number and Percentage of Participants achieving a 90% Improvement from baseline in PASI score at week 12

End point description

Psoriasis Area and Severity Index (PASI):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 and 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline.

End point type

Secondary

End point timeframe

12 weeks

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: Participants	29	27	1	12

PASI score

Comparison groups

AIN457 High Dose v Placebo

Number of subjects included in analysis

81

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

67.5

Confidence interval

level

95%

sides

2-sided

lower limit

50.8

upper limit

80.9

PASI score

Comparison groups

AIN457 Low Dose v Placebo

Number of subjects included in analysis

81

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

72.5

Confidence interval

level

95%

sides

2-sided

lower limit

55.9

upper limit

84.9

Secondary: Number and Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score at week 12

Top of page

End point title

Number and Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score at week 12

End point description

Psoriasis Area and Severity Index (PASI):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 and 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

End point type

Secondary

End point timeframe

12 weeks

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: Participants
PASI 50	34	34	9	34
PASI 100	12	11	0	7

No statistical analyses for this end point

Secondary: Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 up to Week 12 (Induction)

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End point title

Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 up to Week 12 (Induction)

End point description

Psoriasis Area and Severity Index (PASI):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 and 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, Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). PASI will be assessed/calculated as per standard procedure. IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

End point type

Secondary

End point timeframe

Weeks 4, 8

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: Participants
Week 4- IGA 0/1	6	13	0	1
Week 4- PASI 50	26	28	6	19
Week 4- PASI 75	13	22	0	5
Week 4- PASI 90	5	9	0	1
Week 4- PASI 100	3	3	0	0
Week 8- IGA 0/1	21	18	0	6
Week 8- PASI 50	32	32	11	30
Week 8- PASI 75	27	26	1	15
Week 8- PASI 90	20	20	0	4
Week 8-PASI 100	9	7	0	2

No statistical analyses for this end point

Secondary: Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 Up to Week 52 (Maintenance)

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End point title

Number and Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in PASI Score and IGA mod 2011 score of 0 or 1 Up to Week 52 (Maintenance)

End point description

Psoriasis Area and Severity Index (PASI):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 and 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, Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). PASI will be assessed/calculated as per standard procedure. IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

End point type

Secondary

End point timeframe

Weeks 16, 20, 24, 36, 48 and 52

End point values	AIN457 Low Dose	AIN457 High Dose	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects analysed	40	40	41	16	18
Units: Participants
Week 16- IGA 0/1	32	28	19	5	8
Week 16- PASI 50	37	35	30	11	16
Week 16- PASI 75	36	32	26	5	11
Week 16- PASI 90	33	30	16	4	7
Week 16- PASI 100	19	14	8	0	1
Week 20- IGA 0/1	33	28	21	12	13
Week 20- PASI 50	38	36	32	15	17
Week 20- PASI 75	38	35	29	13	15
Week 20- PASI 90	33	30	19	12	12
Week 20- PASI 100	20	16	8	5	4
Week 24- IGA 0/1	35	30	20	14	14
Week 24- PASI 50	38	37	31	15	16
Week 24- PASI 75	37	35	26	15	14
Week 24- PASI 90	33	31	19	13	12
Week 24- PASI 100	22	17	9	7	6
Week 36- IGA 0/1	32	29	21	14	14
Week 36- PASI 50	37	37	31	16	16
Week 36- PASI 75	35	35	26	16	16
Week 36-PASI 90	32	31	18	10	7
Week 36-PASI 100	17	20	10	10	7
Week 48- IGA 0/1	28	28	21	14	14
Week 48-PASI 50	38	35	31	15	15
Week 48- PASI 75	35	35	27	14	15
Week 48- PASI 90	29	30	23	12	14
Week 48- PASI 100	16	18	12	10	8
Week 52- 1GA 0/1	29	30	23	14	13
Week 52- PASI 50	39	37	32	15	17
Week 52- PASI 75	35	35	28	14	17
Week 52- PASI 90	30	32	21	13	14
Week 52- PASI 100	16	19	9	10	10

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area & Severity Index (PASI) score at Week 12

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End point title

Change From Baseline in Psoriasis Area & Severity Index (PASI) score at Week 12

End point description

Psoriasis Area and Severity Index (PASI):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 and 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	39	39	40	41
Units: Scores on a scale
arithmetic mean (standard deviation)	-22.27 ± 8.518	-22.67 ± 11.904	-7.94 ± 9.396	-20.91 ± 10.055

No statistical analyses for this end point

Secondary: Percentage of Participants in IGA mod 2011 Score Categories at Week 12

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End point title

Percentage of Participants in IGA mod 2011 Score Categories at Week 12

End point description

IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: Participants
Week 12- IGA Category: Clear	12	11	0	7
Week 12- IGA Category: Almost Clear	14	13	2	7
Week 12- IGA Category: Mild Disease	8	7	4	18
Week 12- IGA Category: Moderate Disease	3	4	11	6
Week 12- IGA Category: Severe Disease	2	4	23	3

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area & Severity Index (PASI) scores at Week 52

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End point title

Change From Baseline in Psoriasis Area & Severity Index (PASI) scores at Week 52

End point description

Psoriasis Area and Severity Index (PASI):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 and 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

End point type

Secondary

End point timeframe

Week 52

End point values	AIN457 Low Dose	AIN457 High Dose	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects analysed	39	39	41	16	18
Units: Scores on a scale
arithmetic mean (standard deviation)	-25.26 ± 7.150	-25.75 ± 8.593	-21.16 ± 11.779	-28.49 ± 7.984	-24.69 ± 5.520

No statistical analyses for this end point

Secondary: Percentage of Participants in IGA mod 2011 Score Categories at Week 52

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End point title

Percentage of Participants in IGA mod 2011 Score Categories at Week 52

End point description

IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe

End point type

Secondary

End point timeframe

Week 52

End point values	AIN457 Low Dose	AIN457 High Dose	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects analysed	40	40	41	16	18
Units: Participants
Week 52- IGA Category: Clear	16	20	9	10	10
Week 52- IGA Category: Almost Clear	13	10	14	4	4
Week 52- IGA Category: Mild Disease	7	4	9	2	4
Week 52- IGA Category: Moderate Disease	2	2	4	0	0
Week 52- IGA Category: Severe Disease	1	3	5	0	0

No statistical analyses for this end point

Secondary: Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 12 (Induction)

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End point title

Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 12 (Induction)

End point description

The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.

End point type

Secondary

End point timeframe

Weeks 4, 8, 12

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: percentage change of score
arithmetic mean (standard deviation)
Week 4	-47.71 ± 45.743	-50.71 ± 37.003	1.67 ± 104.216	-35.13 ± 56.832
Week 8	-61.60 ± 54.371	-66.97 ± 32.040	-17.77 ± 66.451	-42.73 ± 54.026
Week 12	-67.43 ± 41.602	-62.5 ± 50.08	-18.48 ± 80.018	-62.80 ± 34.419

No statistical analyses for this end point

Secondary: Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 52 (Maintenance)

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End point title

Percentage Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score Up to Week 52 (Maintenance)

End point description

The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.

End point type

Secondary

End point timeframe

Weeks 24, 36, 52

End point values	AIN457 Low Dose	AIN457 High Dose	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects analysed	40	40	41	16	18
Units: percentage change of score
arithmetic mean (standard deviation)
Week 24	-73.7 ± 55.02	-53.9 ± 74.63	-55.0 ± 44.98	40.3 ± 477.93	-73.8 ± 53.09
Week 36	-79.0 ± 31.99	-56.2 ± 107.65	-47.7 ± 45.01	-89.5 ± 19.11	-69.4 ± 46.46
Week 52	-80.9 ± 39.38	-58.6 ± 77.56	-53.4 ± 56.99	-89.0 ± 15.73	-86.0 ± 23.19

No statistical analyses for this end point

Secondary: Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 12 (Induction)

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End point title

Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 12 (Induction)

End point description

The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.

End point type

Secondary

End point timeframe

Weeks 4, 8, 12

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	40	40	41	41
Units: Participants
Week 4	8	11	2	9
Week 8	15	19	7	10
Week 12	17	19	6	15

No statistical analyses for this end point

Secondary: Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 52 (Maintenance)

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End point title

Number and Percentage of participants achieving a Children's DLQI score of 0 or 1 over time up to Week 52 (Maintenance)

End point description

The CDLQI measures functional disability of subjects with dermatological disorders who are less than 18 years of age and it has been utilized as a relevant clinical measure in atopic dermatitis, as well as other dermatitis clinical trials. The CDLQI is a simple, validated, self-administered 10-item questionnaire. The instrument contains six functional scales (i.e., symptoms and feeling, leisure, school or holidays, personal relationships, sleep and treatment). The questions are based on the preceding week to permit accurate recall. For the CDLQI, each question will be answered on a 4-point Likert scale scored from 0 to 3. Seven scores will be derived from the CDLQI: the total score of each of the six dimensions as well as the total score over all items. The higher the score, the more quality of life is impaired.

End point type

Secondary

End point timeframe

Weeks 24, 36, 52

End point values	AIN457 Low Dose	AIN457 High Dose	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects analysed	40	40	41	16	18
Units: Participants
Week 24	19	17	17	8	9
Week 36	21	21	12	9	8
Week 52	20	22	16	8	11

No statistical analyses for this end point

Secondary: Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 12

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End point title

Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 12

End point description

The CHAQ questionnaire is only done for children who in addition to psoriasis are also suffering from psoriatic arthritis. The questionnaire is completed by parent or legal guardian. It consists of multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. The person completing the questionnaire chooses from four response categories, ranging from ‘without any difficulty’ to ‘unable to do’. Additionally two visual analog scales (overall well-being and pain of patient) must be performed.

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 Low Dose	AIN457 High Dose	Placebo	Etanercept
Number of subjects analysed	4	2	2	3
Units: Participants	2	0	0	2

No statistical analyses for this end point

Secondary: Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 52

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End point title

Number and Percentage of participants with clinically important reduction in disability as evaluated by CHAQ questionnaire over time at Week 52

End point description

The CHAQ questionnaire is only done for children who in addition to psoriasis are also suffering from psoriatic arthritis. The questionnaire is completed by parent or legal guardian. It consists of multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. The person completing the questionnaire chooses from four response categories, ranging from ‘without any difficulty’ to ‘unable to do’. Additionally two visual analog scales (overall well-being and pain of patient) must be performed.

End point type

Secondary

End point timeframe

Week 52

End point values	AIN457 Low Dose	AIN457 High Dose	Etanercept	Placebo - AIN457 Low Dose	Placebo - AIN457 High Dose
Number of subjects analysed	4	1	3	2	1
Units: Participants	2	0	2	1	0

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 until end of study treatment plus 16 weeks post- treatment follow-up period. In total up to 252 weeks for AIN457 low and high dose, 28 weeks for Placebo and 68 weeks for Etanercept).

Adverse event reporting additional description

Adverse Events are reported according to the actual treatment received at the onset of the AE.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Any AIN457 low dose

Reporting group description

Includes patients from the AIN457 Low Dose and from the Placebo-AIN457 Low Dose groups. AEs were collected for up to 252 weeks.

Reporting group title

Any AIN457 high dose

Reporting group description

Includes patients from the AIN457 High Dose and from the Placebo-AIN457 High Dose groups. AEs were collected for up to 252 weeks.

Reporting group title

Etanercept

Reporting group description

Patients received weekly open label etanercept 0.8 mg/kg of body weight (up to a maximum of 50 mg). AEs were collected for up to 68 weeks.

Reporting group title

Placebo

Reporting group description

Patients received matching placebo to secukinumab at each dosing. AEs were collected for up to 28 weeks (12 weeks if participant switched to AIN457 at week 12).

Reporting group title

Any AIN457 dose

Reporting group description

Any AIN457 dose AEs were collected for up to 252 weeks.

Serious adverse events	Any AIN457 low dose	Any AIN457 high dose	Etanercept	Placebo	Any AIN457 dose
Total subjects affected by serious adverse events
subjects affected / exposed	7 / 56 (12.50%)	8 / 58 (13.79%)	6 / 41 (14.63%)	0 / 41 (0.00%)	15 / 114 (13.16%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Vascular disorders
Thrombophlebitis
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Venous thrombosis limb
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Reproductive system and breast disorders
Testicular torsion
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Psychiatric disorders
Major depression
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Suicidal ideation
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Clavicle fracture
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Contusion
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Nervous system disorders
Syncope
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Gastrointestinal disorders
Gastrointestinal toxicity
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Autoimmune pancreatitis
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Hepatobiliary disorders
Gallbladder polyp
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis reactive
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Psoriatic arthropathy
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Pneumonia
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pilonidal disease
subjects affected / exposed	0 / 56 (0.00%)	0 / 58 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 114 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Infectious pleural effusion
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Enterocolitis bacterial
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Cellulitis
subjects affected / exposed	1 / 56 (1.79%)	0 / 58 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Toxic shock syndrome
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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
Metabolism and nutrition disorders
Lactose intolerance
subjects affected / exposed	0 / 56 (0.00%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 114 (0.88%)
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

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

Non-serious adverse events	Any AIN457 low dose	Any AIN457 high dose	Etanercept	Placebo	Any AIN457 dose
Total subjects affected by non serious adverse events
subjects affected / exposed	48 / 56 (85.71%)	50 / 58 (86.21%)	30 / 41 (73.17%)	19 / 41 (46.34%)	98 / 114 (85.96%)
Investigations
Glomerular filtration rate decreased
subjects affected / exposed	7 / 56 (12.50%)	4 / 58 (6.90%)	1 / 41 (2.44%)	0 / 41 (0.00%)	11 / 114 (9.65%)
occurrences all number	9	4	2	0	13
Aspartate aminotransferase increased
subjects affected / exposed	2 / 56 (3.57%)	4 / 58 (6.90%)	2 / 41 (4.88%)	0 / 41 (0.00%)	6 / 114 (5.26%)
occurrences all number	2	4	2	0	6
Nervous system disorders
Headache
subjects affected / exposed	11 / 56 (19.64%)	11 / 58 (18.97%)	4 / 41 (9.76%)	4 / 41 (9.76%)	22 / 114 (19.30%)
occurrences all number	35	22	4	6	57
Blood and lymphatic system disorders
Eosinophilia
subjects affected / exposed	3 / 56 (5.36%)	0 / 58 (0.00%)	0 / 41 (0.00%)	1 / 41 (2.44%)	3 / 114 (2.63%)
occurrences all number	3	0	0	1	3
Neutropenia
subjects affected / exposed	3 / 56 (5.36%)	1 / 58 (1.72%)	1 / 41 (2.44%)	0 / 41 (0.00%)	4 / 114 (3.51%)
occurrences all number	5	1	1	0	6
General disorders and administration site conditions
Fatigue
subjects affected / exposed	3 / 56 (5.36%)	3 / 58 (5.17%)	0 / 41 (0.00%)	1 / 41 (2.44%)	6 / 114 (5.26%)
occurrences all number	6	3	0	1	9
Pyrexia
subjects affected / exposed	4 / 56 (7.14%)	6 / 58 (10.34%)	2 / 41 (4.88%)	0 / 41 (0.00%)	10 / 114 (8.77%)
occurrences all number	4	11	2	0	15
Asthenia
subjects affected / exposed	1 / 56 (1.79%)	3 / 58 (5.17%)	0 / 41 (0.00%)	1 / 41 (2.44%)	4 / 114 (3.51%)
occurrences all number	3	3	0	1	6
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	4 / 56 (7.14%)	6 / 58 (10.34%)	5 / 41 (12.20%)	0 / 41 (0.00%)	10 / 114 (8.77%)
occurrences all number	10	10	5	0	20
Abdominal pain upper
subjects affected / exposed	4 / 56 (7.14%)	5 / 58 (8.62%)	4 / 41 (9.76%)	2 / 41 (4.88%)	9 / 114 (7.89%)
occurrences all number	5	5	5	2	10
Dental caries
subjects affected / exposed	1 / 56 (1.79%)	3 / 58 (5.17%)	1 / 41 (2.44%)	1 / 41 (2.44%)	4 / 114 (3.51%)
occurrences all number	1	3	1	1	4
Vomiting
subjects affected / exposed	1 / 56 (1.79%)	5 / 58 (8.62%)	1 / 41 (2.44%)	0 / 41 (0.00%)	6 / 114 (5.26%)
occurrences all number	1	7	1	0	8
Toothache
subjects affected / exposed	1 / 56 (1.79%)	4 / 58 (6.90%)	2 / 41 (4.88%)	0 / 41 (0.00%)	5 / 114 (4.39%)
occurrences all number	1	5	3	0	6
Nausea
subjects affected / exposed	2 / 56 (3.57%)	2 / 58 (3.45%)	4 / 41 (9.76%)	2 / 41 (4.88%)	4 / 114 (3.51%)
occurrences all number	3	2	4	2	5
Diarrhoea
subjects affected / exposed	7 / 56 (12.50%)	7 / 58 (12.07%)	1 / 41 (2.44%)	0 / 41 (0.00%)	14 / 114 (12.28%)
occurrences all number	8	10	2	0	18
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	1 / 56 (1.79%)	4 / 58 (6.90%)	2 / 41 (4.88%)	0 / 41 (0.00%)	5 / 114 (4.39%)
occurrences all number	4	8	10	0	12
Menstruation irregular
subjects affected / exposed	0 / 56 (0.00%)	3 / 58 (5.17%)	0 / 41 (0.00%)	0 / 41 (0.00%)	3 / 114 (2.63%)
occurrences all number	0	3	0	0	3
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	4 / 56 (7.14%)	6 / 58 (10.34%)	1 / 41 (2.44%)	1 / 41 (2.44%)	10 / 114 (8.77%)
occurrences all number	4	11	1	1	15
Nasal congestion
subjects affected / exposed	3 / 56 (5.36%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	4 / 114 (3.51%)
occurrences all number	3	1	0	0	4
Epistaxis
subjects affected / exposed	0 / 56 (0.00%)	3 / 58 (5.17%)	0 / 41 (0.00%)	1 / 41 (2.44%)	3 / 114 (2.63%)
occurrences all number	0	4	0	2	4
Cough
subjects affected / exposed	4 / 56 (7.14%)	9 / 58 (15.52%)	2 / 41 (4.88%)	0 / 41 (0.00%)	13 / 114 (11.40%)
occurrences all number	4	11	2	0	15
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	7 / 56 (12.50%)	1 / 58 (1.72%)	4 / 41 (9.76%)	0 / 41 (0.00%)	8 / 114 (7.02%)
occurrences all number	7	1	4	0	8
Pruritus
subjects affected / exposed	3 / 56 (5.36%)	5 / 58 (8.62%)	2 / 41 (4.88%)	1 / 41 (2.44%)	8 / 114 (7.02%)
occurrences all number	3	5	2	1	8
Intertrigo
subjects affected / exposed	3 / 56 (5.36%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	4 / 114 (3.51%)
occurrences all number	5	1	0	0	6
Seborrhoeic dermatitis
subjects affected / exposed	2 / 56 (3.57%)	4 / 58 (6.90%)	1 / 41 (2.44%)	0 / 41 (0.00%)	6 / 114 (5.26%)
occurrences all number	2	7	2	0	9
Acne
subjects affected / exposed	8 / 56 (14.29%)	5 / 58 (8.62%)	0 / 41 (0.00%)	1 / 41 (2.44%)	13 / 114 (11.40%)
occurrences all number	8	8	0	1	16
Eczema
subjects affected / exposed	3 / 56 (5.36%)	5 / 58 (8.62%)	1 / 41 (2.44%)	0 / 41 (0.00%)	8 / 114 (7.02%)
occurrences all number	7	5	1	0	12
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	4 / 56 (7.14%)	5 / 58 (8.62%)	2 / 41 (4.88%)	1 / 41 (2.44%)	9 / 114 (7.89%)
occurrences all number	5	6	3	3	11
Infections and infestations
Bronchitis
subjects affected / exposed	3 / 56 (5.36%)	6 / 58 (10.34%)	3 / 41 (7.32%)	2 / 41 (4.88%)	9 / 114 (7.89%)
occurrences all number	4	8	3	2	12
COVID-19
subjects affected / exposed	4 / 56 (7.14%)	5 / 58 (8.62%)	0 / 41 (0.00%)	0 / 41 (0.00%)	9 / 114 (7.89%)
occurrences all number	4	5	0	0	9
Conjunctivitis
subjects affected / exposed	2 / 56 (3.57%)	5 / 58 (8.62%)	1 / 41 (2.44%)	0 / 41 (0.00%)	7 / 114 (6.14%)
occurrences all number	2	7	1	0	9
Folliculitis
subjects affected / exposed	3 / 56 (5.36%)	4 / 58 (6.90%)	0 / 41 (0.00%)	0 / 41 (0.00%)	7 / 114 (6.14%)
occurrences all number	3	4	0	0	7
Gastroenteritis
subjects affected / exposed	5 / 56 (8.93%)	3 / 58 (5.17%)	1 / 41 (2.44%)	1 / 41 (2.44%)	8 / 114 (7.02%)
occurrences all number	6	4	1	1	10
Gastroenteritis viral
subjects affected / exposed	3 / 56 (5.36%)	1 / 58 (1.72%)	2 / 41 (4.88%)	1 / 41 (2.44%)	4 / 114 (3.51%)
occurrences all number	3	1	2	1	4
Gastrointestinal infection
subjects affected / exposed	2 / 56 (3.57%)	4 / 58 (6.90%)	0 / 41 (0.00%)	2 / 41 (4.88%)	6 / 114 (5.26%)
occurrences all number	2	5	0	2	7
Paronychia
subjects affected / exposed	1 / 56 (1.79%)	3 / 58 (5.17%)	1 / 41 (2.44%)	0 / 41 (0.00%)	4 / 114 (3.51%)
occurrences all number	1	4	1	0	5
Oral herpes
subjects affected / exposed	3 / 56 (5.36%)	2 / 58 (3.45%)	4 / 41 (9.76%)	1 / 41 (2.44%)	5 / 114 (4.39%)
occurrences all number	4	13	5	1	17
Nasopharyngitis
subjects affected / exposed	17 / 56 (30.36%)	25 / 58 (43.10%)	11 / 41 (26.83%)	1 / 41 (2.44%)	42 / 114 (36.84%)
occurrences all number	47	61	15	1	108
Influenza
subjects affected / exposed	4 / 56 (7.14%)	0 / 58 (0.00%)	3 / 41 (7.32%)	3 / 41 (7.32%)	4 / 114 (3.51%)
occurrences all number	6	0	4	3	6
Impetigo
subjects affected / exposed	0 / 56 (0.00%)	3 / 58 (5.17%)	1 / 41 (2.44%)	0 / 41 (0.00%)	3 / 114 (2.63%)
occurrences all number	0	3	3	0	3
Pharyngitis
subjects affected / exposed	9 / 56 (16.07%)	8 / 58 (13.79%)	3 / 41 (7.32%)	4 / 41 (9.76%)	17 / 114 (14.91%)
occurrences all number	17	11	3	4	28
Viral upper respiratory tract infection
subjects affected / exposed	3 / 56 (5.36%)	4 / 58 (6.90%)	2 / 41 (4.88%)	0 / 41 (0.00%)	7 / 114 (6.14%)
occurrences all number	5	13	2	0	18
Urinary tract infection
subjects affected / exposed	5 / 56 (8.93%)	2 / 58 (3.45%)	1 / 41 (2.44%)	0 / 41 (0.00%)	7 / 114 (6.14%)
occurrences all number	8	3	1	0	11
Upper respiratory tract infection
subjects affected / exposed	7 / 56 (12.50%)	3 / 58 (5.17%)	3 / 41 (7.32%)	3 / 41 (7.32%)	10 / 114 (8.77%)
occurrences all number	18	5	7	3	23
Tonsillitis
subjects affected / exposed	11 / 56 (19.64%)	7 / 58 (12.07%)	1 / 41 (2.44%)	0 / 41 (0.00%)	18 / 114 (15.79%)
occurrences all number	18	9	1	0	27
Sinusitis
subjects affected / exposed	4 / 56 (7.14%)	2 / 58 (3.45%)	1 / 41 (2.44%)	0 / 41 (0.00%)	6 / 114 (5.26%)
occurrences all number	4	2	1	0	6
Rhinitis
subjects affected / exposed	5 / 56 (8.93%)	7 / 58 (12.07%)	1 / 41 (2.44%)	4 / 41 (9.76%)	12 / 114 (10.53%)
occurrences all number	6	9	1	4	15
Respiratory tract infection
subjects affected / exposed	3 / 56 (5.36%)	4 / 58 (6.90%)	0 / 41 (0.00%)	0 / 41 (0.00%)	7 / 114 (6.14%)
occurrences all number	4	4	0	0	8
Pharyngotonsillitis
subjects affected / exposed	4 / 56 (7.14%)	1 / 58 (1.72%)	0 / 41 (0.00%)	0 / 41 (0.00%)	5 / 114 (4.39%)
occurrences all number	4	1	0	0	5

More information

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Were there any global substantial amendments to the protocol? Yes

01 Apr 2015

The protocol was amended to provide more details and clarification on the duration of contraception requested during the study and to give option to align the duration on local label requirements.

10 Feb 2016

The protocol was amended to modify inclusion criterion 5 to align with the text agreed with the Pediatric Committee (PDCO) of the European Medicines Agency (EMA). Another key purpose of this Amendment, is to include the Childhood Health Assessment Questionnaire (CHAQ©) for those subjects with History of Psoriatic Arthritis. This addition is made following a request by the Japanese Health Authority. Further to that, some protocol text changes were undertaken following requests from IRBs.

16 Apr 2018

The protocol was amended to to include an additional Interim Analysis prior to the Week 24 analysis once sufficient safety and pharmacokinetic data have been collected. This analysis aligned with the efficacy extrapolation principle, is expected to provide the basis for a submission package to health authorities (HA), with the intent to allow earlier availability of secukinumab to pediatric patients in countries which accept a submission of clinical data with use of extrapolation methodology. This analysis may be performed before all subjects have reached the primary endpoint. In addition to that, some clarifications, as well as editorial changes were undertaken in the protocol.

18 Sep 2020

The protocol was amended to introduce a level of flexibility in drug dispensation, protocol assessments and visit schedule if a major health care event like COVID-19requires it, thus allowing patients to remain in the trial and continue treatment while being monitored for safety. In addition, renal and liver monitoring procedures will no longer be followed for subjects who reach adulthood (≥ 18 years).

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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