Trial Outcomes & Findings for Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA) (NCT NCT03031782)

NCT ID: NCT03031782

Last Updated: 2022-08-15

Results Overview

Survival analysis of time to flare in treatment period 2 (TP2) FAS2 Subjects are either ERA or JPsA

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

86 participants

Primary outcome timeframe

From Week 12 until max Week 104

Results posted on

2022-08-15

Participant Flow

86 subjects entered TP1

AIN457 treatment group refers to all subjects who did not take any placebo before or during the period in the study. The term Placebo in TP2 refers to all subjects who took placebo in TP2 and secukinumab in other periods. For ease of reading, Placebo in TP2 treatment group is referred as placebo treatment group or placebo hereafter in this document.

Participant milestones

Participant milestones
Measure	AIN457 in TP1 Treatment Period 1	AIN457 in TP 2 Treatment Period 2	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	AIN457 in TP3 Treatment Period 3	Placebo in TP 3 Treatment Period 3
Treatment Period 1 STARTED	86	0	0	0	0
Treatment Period 1 COMPLETED	83	0	0	0	0
Treatment Period 1 NOT COMPLETED	3	0	0	0	0
Treatment Period 2 STARTED	0	37	38	0	21
Treatment Period 2 COMPLETED	0	31	36	0	16
Treatment Period 2 NOT COMPLETED	0	6	2	0	5
Treatment Period 3 STARTED	0	0	0	11	0
Treatment Period 3 COMPLETED	0	0	0	10	0
Treatment Period 3 NOT COMPLETED	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN457 in TP1 Treatment Period 1	AIN457 in TP 2 Treatment Period 2	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	AIN457 in TP3 Treatment Period 3	Placebo in TP 3 Treatment Period 3
Treatment Period 1 Lack of Efficacy	3	0	0	0	0
Treatment Period 2 Physician Decision	0	1	0	0	3
Treatment Period 2 Lack of Efficacy	0	1	0	0	1
Treatment Period 2 Withdrawal by Subject	0	3	0	0	1
Treatment Period 2 Adverse Event	0	1	2	0	0
Treatment Period 3 Withdrawal by Subject	0	0	0	1	0

Baseline Characteristics

Safety Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=86 Participants TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (\<50 kg or \>= 50 kg) was administered s.c. At Week 12 (end of TP1), subject's response to study drug was determined (responders entered TP2 and non-responders entered post-treatment follow-up)
Age, Categorical AIN457 in Treatment Period 1 · <=18 years	86 Participants n=86 Participants • Safety Set
Age, Categorical AIN457 in Treatment Period 1 · Between 18 and 65 years	0 Participants n=86 Participants • Safety Set
Age, Categorical AIN457 in Treatment Period 1 · >=65 years	0 Participants n=86 Participants • Safety Set
Age, Categorical AIN457 in Treatment Period 2 · <=18 years	37 Participants n=37 Participants • Safety Set
Age, Categorical AIN457 in Treatment Period 2 · Between 18 and 65 years	0 Participants n=37 Participants • Safety Set
Age, Categorical AIN457 in Treatment Period 2 · >=65 years	0 Participants n=37 Participants • Safety Set
Age, Categorical placebo in TP2 · <=18 years	38 Participants n=38 Participants • Safety Set
Age, Categorical placebo in TP2 · Between 18 and 65 years	0 Participants n=38 Participants • Safety Set
Age, Categorical placebo in TP2 · >=65 years	0 Participants n=38 Participants • Safety Set
Age, Continuous AIN457 in Treatment Period 1 - JIA Category: ERA	13.7 years STANDARD_DEVIATION 2.62 • n=52 Participants • Safety Set
Age, Continuous AIN457 in Treatment Period 1 - JIA Category: JPsA	12.2 years STANDARD_DEVIATION 3.66 • n=34 Participants • Safety Set
Age, Continuous AIN457 in Treatment Period 2 - JIA Category: ERA	14 years STANDARD_DEVIATION 2.46 • n=22 Participants • Safety Set
Age, Continuous AIN457 in Treatment Period 2 - JIA Category: JPsA	13.1 years STANDARD_DEVIATION 3.14 • n=16 Participants • Safety Set
Age, Continuous Placebo in TP2- JIA Category: ERA	13 years STANDARD_DEVIATION 2.94 • n=22 Participants • Safety Set
Age, Continuous Placebo in TP2 - JIA Category JPsA	10.6 years STANDARD_DEVIATION 3.70 • n=16 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 1 - JIA Category: ERA · Female	11 Participants n=52 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 1 - JIA Category: ERA · Male	41 Participants n=52 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 1 -JIA Category: JPsA · Female	18 Participants n=34 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 1 -JIA Category: JPsA · Male	16 Participants n=34 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 2 - JIA Category: ERA · Female	4 Participants n=22 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 2 - JIA Category: ERA · Male	18 Participants n=22 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 2 -JIA Category: JPsA · Female	9 Participants n=15 Participants • Safety Set
Sex: Female, Male AIN457 in Treatment Period 2 -JIA Category: JPsA · Male	6 Participants n=15 Participants • Safety Set
Sex: Female, Male Placebo in TP2 - JIA Category: ERA · Female	4 Participants n=22 Participants • Safety Set
Sex: Female, Male Placebo in TP2 - JIA Category: ERA · Male	18 Participants n=22 Participants • Safety Set
Sex: Female, Male Placebo in TP2 - JIA Category: JPsA · Female	7 Participants n=16 Participants • Safety Set
Sex: Female, Male Placebo in TP2 - JIA Category: JPsA · Male	9 Participants n=16 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · American Indian or Alaska Native	0 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · Asian	0 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · Native Hawaiian or Other Pacific Islander	0 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · Black or African American	0 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · White	51 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · More than one race	0 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: ERA · Unknown or Not Reported	1 Participants n=52 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · American Indian or Alaska Native	0 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · Asian	1 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · Native Hawaiian or Other Pacific Islander	0 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · Black or African American	0 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · White	31 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · More than one race	0 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 1 - JIA Category: JPsA · Unknown or Not Reported	2 Participants n=34 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · American Indian or Alaska Native	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · Asian	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · Black or African American	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · White	22 Participants n=22 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · More than one race	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: ERA · Unknown or Not Reported	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · Black or African American	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · White	21 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · More than one race	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · Unknown or Not Reported	1 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · American Indian or Alaska Native	0 Participants n=16 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · Asian	0 Participants n=16 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · Native Hawaiian or Other Pacific Islander	1 Participants n=16 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · Black or African American	0 Participants n=16 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · White	14 Participants n=16 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · More than one race	0 Participants n=16 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: JPsA · Unknown or Not Reported	1 Participants n=16 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · American Indian or Alaska Native	0 Participants n=15 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · Asian	0 Participants n=15 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · Black or African American	14 Participants n=15 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · White	0 Participants n=15 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · More than one race	0 Participants n=15 Participants • Safety Set
Race (NIH/OMB) AIN457 in Treatment Period 2 - JIA Category: JPsA · Unknown or Not Reported	1 Participants n=15 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · American Indian or Alaska Native	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · Asian	0 Participants n=22 Participants • Safety Set
Race (NIH/OMB) Placebo in TP2 - JIA Category: ERA · Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • Safety Set

PRIMARY outcome

Timeframe: From Week 12 until max Week 104

Population: Full Analysis Set for TP2: The FAS TP2 (FAS 2) consisted of all randomized subjects who received at least one dose of study drug in TP2. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization in TP2.

Survival analysis of time to flare in treatment period 2 (TP2) FAS2 Subjects are either ERA or JPsA

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=37 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 n=38 Participants Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Number of Participants Experiencing a Flare During Treatment Period 2	10 Participants	21 Participants	—

SECONDARY outcome

Timeframe: baseline, week 12

Population: Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.

Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category - TP1 (FAS1) The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components * Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity. * Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor. * Functional ability: Childhood Health Assessment Questionnaire (CHAQ©) * Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity) * Number of joints with limitation of motion * Laboratory measure of inflammation: CRP (mg/L)

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=52 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 n=34 Participants Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category ACR 30	86.3 percent of participants Interval 73.1 to 93.8	96.9 percent of participants Interval 82.0 to 99.8	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category ACR 50	80.4 percent of participants Interval 66.5 to 89.7	96.9 percent of participants Interval 82.0 to 99.8	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category ACR 70	66.7 percent of participants Interval 52.0 to 78.9	75.0 percent of participants Interval 56.2 to 87.9	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category ACR 90	33.3 percent of participants Interval 21.1 to 48.0	50.0 percent of participants Interval 32.2 to 67.8	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category ACR 100	27.5 percent of participants Interval 16.3 to 42.0	21.9 percent of participants Interval 9.9 to 40.4	—

SECONDARY outcome

Timeframe: baseline, week 12

Population: Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.

Summary of JIA ACR 30/50/70/90/100 for all subjects - TP1 (FAS1) The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components * Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity. * Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor. * Functional ability: Childhood Health Assessment Questionnaire (CHAQ©) * Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity) * Number of joints with limitation of motion * Laboratory measure of inflammation: CRP (mg/L)

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=86 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total ACR 30	90.4 percent of participants Interval 81.4 to 95.4	—	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total ACR 50	86.7 percent of participants Interval 77.1 to 92.9	—	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total ACR 70	69.9 percent of participants Interval 58.7 to 79.2	—	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total ACR 90	39.8 percent of participants Interval 29.4 to 51.1	—	—
Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total ACR 100	25.3 percent of participants Interval 16.7 to 36.2	—	—

SECONDARY outcome

Timeframe: baseline, week 12

Population: FAS TP1 including patients with valid measurements at week 12

Summary of JIA ACR core components for all subjects and each JIA category - Treatment period 1 Negative percent change indicates improvement Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=86 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Percent Change From Baseline for JIA ACR Core Components in TP1 physician global assessment of disease activity	-77.4 percent change Standard Deviation 22.67	—	—
Percent Change From Baseline for JIA ACR Core Components in TP1 parent/subject global assessment of overall well-being	-53.1 percent change Standard Deviation 58.43	—	—
Percent Change From Baseline for JIA ACR Core Components in TP1 functional ability (CHAQ)	-53.776 percent change Standard Deviation 70.5034	—	—
Percent Change From Baseline for JIA ACR Core Components in TP1 number of joints with active arthritis	-79.3 percent change Standard Deviation 34.86	—	—
Percent Change From Baseline for JIA ACR Core Components in TP1 number of joints with limited range of motion	-72.5 percent change Standard Deviation 38.19	—	—

SECONDARY outcome

Timeframe: baseline, week 12

Population: FAS TP1

Median Percent Change from baseline for C-reactive protein standardized value (mg/L)

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=82 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Percent Change in C-reactive Protein Standardized Value (mg/L)	-13.587 percent change Standard Deviation 227.6901	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: FAS treatment period 1

JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=86 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score JADAS-27	-10.487 score Standard Deviation 7.2262	—	—
Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score JADAS-71	-13.403 score Standard Deviation 9.7300	—	—

SECONDARY outcome

Timeframe: Baseline and week 12

Population: FAS TP1 including patients with valid measurements at week 12

Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis. This is the mean (SD) enthesitis count (range 0-16) for FAS subjects A zero score means no enthesitis, so a zero score is better for the patient

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=83 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Change From Baseline in Total Enthesitis Events - TP1 (FAS1)	-1.8 Number of enthesitis events Standard Deviation 2.31	—	—

SECONDARY outcome

Timeframe: baseline, week 12

Population: FAS TP1 including patients with valid measurements at week 12

Summary of total dactylitis count for all subjects - TP1 (FAS1) Total dactylitis count ranges from 0 to 20. A zero score means no dactylitis, so a zero score is better for the patient

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=78 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Change From Baseline in Total Dactylitis Count	-0.8 Number of dactylitis events Standard Deviation 1.83	—	—

SECONDARY outcome

Timeframe: 104 weeks

Population: FAS

Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=86 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 n=37 Participants Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 n=38 Participants Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Number of Participants With Anti-secukinumab Anitbodies	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline, week 12

Population: Safety Set

Summary of pharmacokinetic concentrations - Treatment period 1

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=86 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Secukinumab Serum Concentration <50 kg	30.9 mcg/mL Standard Deviation 12.9	—	—
Secukinumab Serum Concentration >=50 kg	34.6 mcg/mL Standard Deviation 11.2	—	—

SECONDARY outcome

Timeframe: week 12

Population: FAS1

Summary of inactive disease status for all subjects - TP1 (FAS1) Clinical inactive disease definition was adapted from the JIA ACR criteria. All were required to be met: * No joints with active arthritis * No uveitis * CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA * Physician's global assessment of disease activity score ≤ 10mm * Duration of morning stiffness attributable to JIA ≤15 min

Outcome measures

Outcome measures
Measure	AIN457 in Treatment Period 2 n=83 Participants Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Placebo TP2 Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s
Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1)	30 partcipants Interval 26.1 to 47.5	—	—

Adverse Events

AIN457 in Entire Treatment Period

Serious events: 7 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo in TP2

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Total

Serious events: 11 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AIN457 in Entire Treatment Period n=48 participants at risk Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.	Placebo in TP2 n=38 participants at risk Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.	Total n=86 participants at risk Includes all participants who were treated with study medication. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.
Gastrointestinal disorders Crohn's disease	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Gastrointestinal disorders Food poisoning	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Acute sinusitis	0.00% 0/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	2.6% 1/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Appendicitis	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Folliculitis	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Pilonidal cyst	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Pneumonia	0.00% 0/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	2.6% 1/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Postoperative wound infection	0.00% 0/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	2.6% 1/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Infections and infestations Tonsillitis	0.00% 0/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	2.6% 1/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Injury, poisoning and procedural complications Abdominal injury	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Musculoskeletal and connective tissue disorders Juvenile psoriatic arthritis	0.00% 0/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	2.6% 1/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	2.1% 1/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	0.00% 0/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/48 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	2.6% 1/38 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1	1.2% 1/86 • Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later) AEs are any untoward sign or symptom that occurred during the study treatment period. AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: (862) 778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER