A Randomized, Open-label, Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment, and to Assess the Long-term Safety, Tolerability, Efficacy in Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
Phase: PHASE3
Conditions: Moderate to Severe Chronic Plaque-type Psoriasis
Sponsor: Novartis Pharmaceuticals

Global Clinical Development - General Medicine 
Secukinumab (AIN457) 
Clinical Trial Protocol CAIN457A2311 / NCT03668613
A randomized, open-label, multicenter trial to assess the 
efficacy of subcutaneous secukinumab after twelve weeks 
of treatment, and to assess the long-term safety, 
tolerability and efficacy in subjects from 6 to less than 18 
years of age with moderate to severe chronic plaque 
psoriasis 
Document type: 
Amended Protocol Version 
EUDRACT number: 
2017-004515-39 
Version number: 
01 (Amendment 1) Clean 
Clinical trial phase: 
III 
Release date: 
25-Sep-2020
Property of Novartis 
Confidential 
May not be used, divulged, published, or otherwise disclosed 
without the consent of Novartis 
Clinical Trial Protocol Template Version 3.4 (May 2017) 

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Table of contents 
Table of contents .................................................................................................................. 2 
List of tables ......................................................................................................................... 6 
List of figures ....................................................................................................................... 6 
List of abbreviations ............................................................................................................. 7 
Glossary of terms ............................................................................................................... 10 
Amendment 1 (25-Sep-2020) .................................................................................................... 11 
Protocol summary .............................................................................................................. 13 
 
Introduction ........................................................................................................................ 16 
1.1 
Background ............................................................................................................ 16 
1.2 
Purpose ................................................................................................................... 18 
 
Study objectives and endpoints .......................................................................................... 19 
2.1 
Objectives and related endpoints ............................................................................ 19 
 
Investigational plan ............................................................................................................ 20 
3.1 
Study design ........................................................................................................... 20 
3.2 
Rationale for study design ...................................................................................... 22 
3.3 
Rationale for dose/regimen, route of administration and duration of treatment ..... 23 
3.4 
Rational for choice of comparator .......................................................................... 24 
3.5 
Purpose and timing of interim analyses/design adaptations ................................... 24 
3.6 
Risks and benefits .................................................................................................. 24 
 
Population .......................................................................................................................... 25 
4.1 
Inclusion criteria ..................................................................................................... 25 
4.2 
Exclusion criteria ................................................................................................... 26 
 
Treatment ........................................................................................................................... 28 
5.1 
Study treatment ...................................................................................................... 28 
5.1.1 
Investigational and control drugs ........................................................... 28 
5.1.2 
Additional treatment .............................................................................. 28 
5.2 
Treatment arms ....................................................................................................... 28 
5.3 
Treatment assignment and randomization .............................................................. 29 
5.4 
Treatment blinding ................................................................................................. 30 
5.5 
Treating the subject ................................................................................................ 30 
5.5.1 
Subject numbering ................................................................................. 30 
5.5.2 
Dispensing the study drug ..................................................................... 31 
5.5.3 
Handling of study and additional treatment ........................................... 32 
5.5.4 
Instructions for prescribing and taking study treatment ......................... 32 
5.5.5 
Permitted dose adjustments and interruptions of study treatment .......... 33 

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5.5.6 
Rescue medication ................................................................................. 33 
5.5.7 
Prior and Concomitant medication ........................................................ 33 
5.5.8 
Prohibited medication ............................................................................ 35 
5.5.9 
Emergency breaking of assigned treatment code ................................... 36 
5.6 
Study completion and discontinuation ................................................................... 36 
5.6.1 
Study completion and post-study treatment ........................................... 36 
5.6.2 
Discontinuation of study treatment ........................................................ 37 
5.6.3 
Withdrawal of informed consent ........................................................... 38 
5.6.4 
Loss to follow-up ................................................................................... 38 
5.6.5 
Early study termination by the sponsor ................................................. 39 
 
Visit schedule and assessments .......................................................................................... 39 
6.1 
Information to be collected on screening failures .................................................. 47 
6.2 
Subject demographics/other baseline characteristics .............................................. 47 
6.2.1 
Demographics ........................................................................................ 47 
6.2.2 
Psoriasis medical history / Previous psoriasis therapy ........................... 47 
6.2.3 
Relevant medical history / current medical conditions .......................... 47 
6.2.4 
Determination of Tuberculosis status .................................................... 48 
6.2.5 
Other baseline characteristics ................................................................ 51 
6.3 
Treatment exposure and compliance ...................................................................... 51 
6.4 
Efficacy .................................................................................................................. 51 
6.4.1 
Investigator Global assessment (IGA mod 2011) .................................. 51 
6.4.2 
Assessment of total body surface area (BSA) and psoriasis area 
safety index (PASI) ............................................................................... 52 
 
 54 
6.4.4 
Appropriateness of efficacy assessments ............................................... 54 
6.5 
Safety ..................................................................................................................... 55 
6.5.1 
Physical examination ............................................................................. 55 
 
 55 
6.5.3 
Vital signs .............................................................................................. 56 
6.5.4 
Height and weight .................................................................................. 56 
6.5.5 
Laboratory evaluations .......................................................................... 56 
6.5.6 
Electrocardiogram (ECG) ...................................................................... 58 
6.5.7 
Immunogenicity ..................................................................................... 58 
6.5.8 
Pregnancy and assessments of fertility .................................................. 59 
6.5.9 
Appropriateness of safety measurements ............................................... 60 
6.6 
Other assessments .................................................................................................. 60 

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6.6.1 
Clinical Outcome Assessments (COAs) ................................................ 60 
6.6.2 
Resource utilization ............................................................................... 61 
6.6.3 
Pharmacokinetics ................................................................................... 62 
6.6.4 
Other biomarkers ................................................................................... 62 
 
Safety monitoring ............................................................................................................... 62 
7.1 
Adverse events ....................................................................................................... 62 
7.2 
Serious adverse events ........................................................................................... 64 
7.2.1 
Definition of SAE .................................................................................. 64 
7.2.2 
SAE reporting ........................................................................................ 65 
7.3 
Liver safety monitoring .......................................................................................... 66 
7.4 
Renal safety monitoring ......................................................................................... 66 
7.5 
Reporting of study treatment errors including misuse/abuse .................................. 66 
7.6 
Pregnancy reporting ............................................................................................... 67 
 
Data review and database management ............................................................................. 67 
8.1 
Site monitoring ....................................................................................................... 67 
8.2 
Data collection ....................................................................................................... 68 
8.3 
Database management and quality control ............................................................. 68 
8.4 
Data Monitoring Committee .................................................................................. 69 
8.5 
Adjudication Committee ........................................................................................ 69 
 
Data analysis ...................................................................................................................... 69 
9.1 
Analysis sets ........................................................................................................... 69 
9.2 
Subject demographics and other baseline characteristics ....................................... 70 
9.3 
Treatments .............................................................................................................. 70 
9.4 
Analysis of the primary variable(s) ........................................................................ 70 
9.4.1 
Primary Variable(s) ............................................................................... 71 
9.4.2 
Statistical model, hypothesis, and method of analysis ........................... 71 
9.4.3 
Handling of missing values/censoring/discontinuations ........................ 71 
9.4.4 
Sensitivity analyses ................................................................................ 72 
9.5 
Analysis of secondary variables ............................................................................. 72 
9.5.1 
Efficacy variables .................................................................................. 72 
9.5.2 
Safety variables ...................................................................................... 72 
9.5.3 
Resource utilization ............................................................................... 74 
9.5.4 
Health-Related Quality of Life .............................................................. 74 
9.5.5 
Pharmacokinetics ................................................................................... 74 
9.5.6 
DNA ...................................................................................................... 74 
9.5.7 
Biomarkers ............................................................................................ 74 

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9.5.8 
PK/PD .................................................................................................... 74 
9.6 
Analysis of exploratory variables ........................................................................... 74 
9.7 
Interim analyses ..................................................................................................... 75 
9.8 
Sample size calculation .......................................................................................... 75 
 Ethical considerations ........................................................................................................ 76 
10.1 
Regulatory and ethical compliance ........................................................................ 76 
10.2 
Informed consent procedures ................................................................................. 77 
10.3 
Responsibilities of the investigator and IRB/IEC .................................................. 78 
10.4 
Publication of study protocol and results ............................................................... 78 
10.5 
Quality Control and Quality Assurance .................................................................. 78 
 Protocol adherence ............................................................................................................. 78 
11.1 
Protocol amendments ............................................................................................. 79 
 References .......................................................................................................................... 80 
 Appendix 1: Clinically notable laboratory parameters ...................................................... 83 
 Appendix 2: Blood collection log for pharmacokinetics and immunogenicity ................. 85 
 86 
 Appendix 4: Weight and recommended blood volumes .................................................... 87 

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List of tables 
Table 2-1 
Objectives and related endpoints ........................................................... 19 
Table 5-1 
Number of injections per visit per treatment arm .................................. 29 
Table 5-2 
Disease severity classification ............................................................... 30 
Table 5-3 
Prohibited medication ............................................................................ 35 
Table 6-1 
Assessment schedule (Year 1) ............................................................... 41 
Table 6-2 
Assessment schedule - Years 2-4 (continued) ....................................... 44 
Table 6-3 
IGA mod 2011 scale .............................................................................. 52 
Table 6-4 
PASI scoring system .............................................................................. 53 
Table 6-5 
Recommended Dimensions for Blood Pressure Cuff Bladders ............. 56 
Table 7-1 
Guidance for capturing the study treatment errors including 
misuse/abuse .......................................................................................... 66 
Table 9-1 
Treatment groups for analyses .............................................................. 69 
Table 9-2 
Predictive placebo response rates for this study from model of 
historical data ........................................................................................ 76 
Table 14-1 
Blood collection log for pharmacokinetics ............................................ 85 
Table 14-2 
Blood Collection for Immunogenicity ................................................... 85 
Table 16-1 
Total blood volume, 1% and 3% of total blood volume by weight 
assuming 85mL per kg total blood volume ........................................... 87 
List of figures 
Figure 3-1 
Study design .......................................................................................... 20 
Figure 3-2 
Average concentration for the proposed low dose and high dose 
secukinumab arms ................................................................................. 23 
Figure 6-1 
Tuberculosis screening flowchart .......................................................... 50 

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List of abbreviations 
 
AE 
Adverse Event 
ALP 
Alkaline Phosphatase 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BDR 
Bioanalytical Data Report 
BP 
Blood Pressure 
BSA 
Body Surface Area 
BUN 
Blood Urea Nitrogen 
CDLQI 
Children’s Dermatology Life Quality Index 
COVID-19 
Coronavirus disease of 2019 
CFR 
Code of Federal Regulations 
CRF 
Case Report/Record Form (paper or electronic) 
CPO 
Country Pharma Organization 
CRO 
Contract Research Organization 
CS 
Corticosteroid 
CTC 
Common Toxicity Criteria 
DMC 
Data Monitoring Committee 
DS & E 
Drug Safety and Epidemiology 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
eCRF 
Electronic Case Report/Record Form 
eg 
Example 
eGFR 
estimated Glomerular Filtration Rate 
EMA 
European Medical Association 
EOT 
End of Treatment 
EOF 
End of Follow-up 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GGT 
Gamma –glutamyl transferase 
hCG 
Human chorionic gonadotropin 
HIV 
Human Immunodeficiency Virus 
HrQoL 
Health-related Quality of Life 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
IEC 
Independent Ethics Committee 
IG 
Immunogenicity 
IGA 
Investigator Global Assessment 

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IgG 
Immunoglobulin G 
IL 
Interleukin 
IQS 
Integrated Quantitative Sciences 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IN 
Investigator Notification 
IUD 
Intrauterine Device 
IUS 
Intrauterine System 
LLN 
Lower Limit of Normal 
LOCF 
Last Observation Carried Forward 
MACE 
Major Adverse Cardiovascular Events 
MAP 
Meta-analytical-prediction 
MedDRA 
Medical dictionary for regulatory activities 
MI 
Myocardial Infarction 
PASI 
Psoriasis Area and Severity Index 
PDCO 
Pediatric Committee of the European Medicines Agency 
PPD 
Purified Protein derivative 
PFS 
Pre-filled syringe 
PK 
pharmacokinetic 
PRO 
Patient reported outcome 
PS 
Patient Safety 
PUVA 
Photochemotherapy (eg psoralen + UVA treatment) 
QFT 
QuantiFERON TB-Gold test 
QM 
Quality Management 
R 
Randomization 
rpm 
Rate per minute 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
sc 
subcutaneous 
SGOT 
Serum glutamic oxaloacetic transaminase 
SGPT 
Serum glutamic pyruvic transaminase 
SST 
Serum Separator Tube 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TB 
tuberculosis 
TBL 
Total Bilirubin 
TCS 
Topical corticosteroids 
Th17 
T helper 17 cells 
ULN 
Upper Limit of Normal 
UV 
Ultraviolet 
UVA 
Ultraviolet A, long wave 400 nm–315 nm 
UVB 
Ultraviolet B, medium wave 315 nm–280 nm 
Vs 
Versus 
WBC 
White blood cells / leukocytes 

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WHO 
World Health Organization 
WoC 
Withdrawal of Consent 

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Glossary of terms 
 
Cohort 
A specific group of subjects/subjects fulfilling certain criteria 
Historical control 
drug 
Drugs(s) used from historical data to act as a comparator to evaluate 
comparative effects of the investigational drug 
Dosage 
Dose of the study treatment given to the subject in a time unit (eg 100 mg once 
a day, 75 mg twice a day) 
Electronic Data 
Capture (EDC) 
Electronic data capture (EDC) is the electronic acquisition of clinical study data 
using data collection systems, such as Web-based applications, interactive 
voice response systems and clinical laboratory interfaces. 
EDC includes the use of Electronic Case Report Forms (eCRFs) which are 
used to capture data transcribed from paper source forms used at the point of 
care. 
Enrollment 
Point/time of subject entry into the study at which informed consent must be 
obtained (eg prior to starting any of the procedures described in the protocol) 
Investigational 
drug 
The drug whose properties are being tested in the study; this definition is 
consistent with US CFR 21 Section 312.3 and is synonymous with 
“investigational new drug” or “investigational medicinal product.” 
Medication pack 
number 
A unique identifier on the label of each investigational drug package 
Subject/subject 
ID 
A unique number assigned to each subject upon signing the informed consent 
Period 
The subdivisions of the trial design (eg Screening, Treatment, Follow-up) which 
are described in the Protocol. Periods define the study phases and will be used 
in clinical trial database setup and eventually in analysis 
Randomization 
number 
A unique identifier assigned to each randomized subject, corresponding to a 
specific treatment arm assignment 
Source 
Data/Document 
Source data refers to the initial record, document, or primary location from 
where data comes. The data source can be a database, a dataset, a 
spreadsheet or even hard-coded data, such as paper or eSource. 
Study drug/ 
treatment 
Any single drug or combination of drugs administered to the subject as part of 
the required study procedures; includes investigational drug (s), 
placebo/comparator active drug run-ins or background therapy 
Study Treatment 
Discontinuation 
(TD) 
When the subject permanently stops taking study treatment prior to the defined 
study treatment completion date 
Variable 
A measured value or assessed response that is determined in specific 
assessments and used in data analysis to evaluate the drug being tested in the 
study 
Withdrawal of 
study consent 
(WoC) 
Withdrawal of consent from the study is defined as when a subject does not 
want to participate in the study any longer, and does not want any further visits 
or assessments, and does not want any further study related contact, and does 
not allow analysis of already obtained biologic material 

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Amendment 1 (25-Sep-2020) 
Amendment rationale 
The rationale for the amendment is to introduce a level of flexibility in drug dispensation, 
protocol assessment and visit schedule if a major health care event requires it (i.e. COVID-19 
pandemic) allowing patients to remain in the trial and continue treatment while being 
monitored for safety. 
The purpose of these changes is to reduce the risk of exposure for patients and site staff and 
potentially the risk of transmission of infectious diseases (e.g. COVID-19). 
These changes are limited to the duration of COVID-19 pandemic or of any other major health 
care event and must be done in accordance with the local rules and regulations relevant to 
pandemic containment measures. 
Further to the above, minor corrections, clarifications and editorial changes were undertaken in 
the protocol. 
Changes to the protocol: 
Changes to specific sections of the protocol are shown in the track changes version of the 
protocol using strike through red font for deletions and red underlined for insertions. 
The Amendment includes changes: 
• Due to COVID-19 pandemic or any other pandemic 
• Allowing shipment of study medication to patient's home (Section 5.5.2) 
• Alternative options visits (Sections 6, 6.5, 7.1) 
• Local laboratory testing for safety purposes (Section 6.5.5) 
• Home Pregnancy testing (Section 6.5.8) 
• Remote PRO collection (Section 6.6.1.1) 
• Informed Consent Form (Section 10.2) 
• Home Nursing Informed Consent Form (Section 10.2) 
• Significant Update to Original Protocol: 
• Added Inflammatory Bowel Disease as an example for discontinuation ofstudy 
treatment (Section 5.6.2). 
• ICF (Section 10.2) 
• To manage inconsistencies and provide clarifications in the original protocol 
• clarify prior medication (Section 5.5.7) 
• correct data collection to source only (weight in IRT, Table 6-1; Table 6-2) 
• Imputation method (Section 9.4.3) 
• Remove sensitivity analysis (Section 9.4.4) 
• Add growth/weight 
 to Safety Section 9.5.2 
• As well as other miscellaneous minor corrections, modifications and text adjustments 
• Modification in Protocol summary secondary objectives. 

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• Modification in footnote 13 of Table 6-1. 
• Modification in Urine pregnanacy test, 
weight in IRT and footnote 10 
in Table 6-2. 
• Modification in Section 9.5.4. 
• Modification in Section 9.6. 
IRBs/IECs 
A copy of this amended protocol will be sent to the Institutional Review Board 
(IRBs)/Independent Ethics Committee (IECs) and Health Authorities. 
This protocol amendment is considered substantial. However many countries participating in 
this study have released Urgent Safety Measure guidance stating that certain changes to a 
protocol due to the COVID-19 pandemic are permissible by notification or by non-substantial 
amendment. Therefore the final determination of the protocol classification will be done on a 
country by country basis based on the latest local HA guidance. 
COVID-19 related measures may/will be implemented immediately and prior to IRB/IEC and 
HA approvals. Submission for review and approval to IRB/IEC and Health Authorities should 
occur as early as possible.The changes herein affect the Informed Consent. Sites are required 
to update and submit for approval a revised Informed Consent that takes into account the 
changes described in this protocol amendment. 

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Protocol summary 
Protocol number 
CAIN457A2311 
Full Title 
A randomized, open-label, multicenter trial to assess the efficacy of SC 
Secukinumab after twelve weeks of treatment, and to assess the long-term safety, 
tolerability and efficacy in subjects from 6 to less than 18 years of age with 
moderate to severe chronic plaque psoriasis 
Brief title 
Study to assess the efficacy, safety, tolerability and PK of secukinumab in subjects 
6 to less than 18 years of age with moderate to severe chronic plaque psoriasis 
Sponsor 
and 
Clinical 
Phase 
Novartis 
Phase III 
Investigation type 
Drug 
Study type 
Interventional 
Purpose and rationale 
The purpose of this study is to assess the efficacy of secukinumab at Week 12, 
based on both Psoriasis Area and Severity Index (PASI) 75 and Investigator’s 
Global Assessment (IGA) mod 2011 0 or 1 response rates in children and 
adolescents aged 6 to less than 18 years at randomization with moderate to severe 
chronic plaque psoriasis who are candidates for systemic therapy. 
This study will provide efficacy, safety and pharmacokinetic data to support the 
extension of label of secukinumab to include children and adolescents (6 years to 
< 18 years) with moderate to severe chronic plaque psoriasis. 
The study will assess the long-term efficacy, safety and tolerability of 
secukinumab over a period of up to 4 years to support the long-term use of 
secukinumab in pediatric patients. 
Primary Objective(s) 
To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less 
than 18 years old with moderate to severe chronic plaque psoriasis with respect to 
PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12, 
compared to placebo (historical control). 
Secondary Objectives 
Objective 1: To evaluate the efficacy of secukinumab in pediatric subjects aged 6 
years to less than 18 years old with moderate to severe chronic plaque psoriasis 
with respect to PASI 90 at Week 12, compared to placebo (historical control). 
Objective 2: To investigate the clinical safety and tolerability of secukinumab as 
assessed by growth, weight gain, vital signs, clinical laboratory variables, 
Electrocardiogram and AE monitoring 
Objective 3: To evaluate the pharmacokinetics of secukinumab doses in subjects 
Study design 
Multi-center, open label, parallel group, two arm study. 
Three periods, screening (up to 4 weeks), treatment (of 208 weeks) and follow-up 
(of 16 weeks) 
Population 
Approximately 80 pediatric subjects aged 6 years to less than 18 years with 
moderate to severe chronic plaque psoriasis will be enrolled. 
Key Inclusion criteria 
Written informed assent and parental permission obtained at screening. Subjects 
reaching the age of consent during the study, will need to also sign the 
corresponding study Informed Consent. 
Must be 6 to less than 18 years of age at the time of randomization. 

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Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 
2011 score of ≥ 3, and Body Surface Area (BSA) involvement of ≥ 10%, at 
randomization 
History of plaque psoriasis for at least 3 months before randomization 
Subject being regarded by the investigator to be a candidate for systemic therapy 
because of: 
inadequate control of symptoms with topical treatment, and/or 
failure to respond to or tolerate previous systemic treatment and/or ultraviolet 
therapy 
Key Exclusion criteria 
Forms of psoriasis other than chronic plaque-type (eg pustular, erythrodermic and 
guttate psoriasis), active at randomization 
Female subjects of childbearing potential (menarchal or becoming menarchal 
during the study) who do not agree to abstinence or, if sexually active, do not agree 
to the use of contraception. 
Active ongoing inflammatory diseases other than psoriasis that might confound 
the evaluation of the benefit of secukinumab therapy 
Underlying condition (including, but not limited to metabolic, hematologic, renal, 
hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) 
which in the opinion of the investigator significantly immunocompromises the 
subject and/or places the subject at unacceptable risk for receiving an 
immunomodulatory therapy. 
History of an ongoing, chronic or recurrent infectious disease, or evidence of 
tuberculosis infection. 
History of lymphoproliferative disease or any known malignancy or history of 
malignancy of any organ system within the past 5 years prior to screening. 
Active systemic infections during the last two weeks prior to randomization and 
any infections that reoccur on a regular basis. 
Study treatment 
Secukinumab prefilled syringes available as 75 mg /0.5 mL and 150 mg/1 ml will 
be provided by Novartis in an open-label fashion. 
Efficacy assessments 
Investigator’s Global Assessment (IGA mod 2011) 
Psoriasis Area and Severity Index (PASI) 
Key safety assessments 
Adverse Events 
Physical Exam 
Vital Signs 
Height and Weight 
Laboratory evaluations (hematology, clinical chemistry, urinalysis) 
ECG 
Pregnancy and assessments of fertility 
Other assessments 
Pharmacokinetics 
Immunogenicity IG 

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Children’s Dermatology Life Quality Index (CDLQI) 
Data analysis 
PASI 75 response at Week 12 and IGA 0 or 1 response at Week 12 will be 
evaluated and compared to historical placebo control. The secondary variable of 
PASI 90 response at Week 12 will be analyzed in the same way as the primary 
variable. Efficacy analysis will report the Bayesian posterior of the log-odds ratio 
between the secukinumab treatment groups and the historical placebo control. The 
median, 95% CI and the probability of a positive treatment difference of the 
posterior logs odds ratio will be presented. The co-primary efficacy variables and 
secondary efficacy variables will be analyzed using the Full Analysis Set (FAS). 
Key words 
Pediatric, psoriasis, children, adolescents, secukinumab 

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Introduction 
1.1 
Background 
Psoriasis is a chronic relapsing inflammatory skin disease with an estimated prevalence of 0.32% 
in children under the age of 18 in 1996 (National Center for Health Statistics of the Centers for 
Disease Control and Prevention 1996). Since then, more epidemiologic studies have provided 
estimates on the prevalence of psoriasis in children in Europe and the United States of America. 
• In the United Kingdom, prevalence of psoriasis was 0.55% in children aged 0 to 9 years 
and 1.37% in children and adolescents aged 10 to 19 years, with a higher prevalence in 
girls than in boys (Gelfand et al 2005). 
• In Germany, 0.71% of children were affected by psoriasis and the prevalence increased 
from 0.12% at the age of 1 year to 1.2% at the age of 18 years (Augustin et al 2010). 
• Results from a survey among dermatologists and general practitioners in the Netherlands 
suggested a prevalence of 0.37% in children aged 0 to 10 years, and 1.09% in children 
aged 11 to 19 years (de Jager et al 2009). 
• In the USA, a Southern California study in children enrolled in an integrated health plan 
reported a 0.30% prevalence of psoriasis in children aged 2 to 19 years. The prevalence 
increased consistently after 5 years of age and was higher in females than in males. 
Stratification by gender (males vs. females) and age group yielded an overall prevalence 
of 0.17 % vs 0.21%; ages 2-5 years, 0.03% vs. 0.04%; ages 6-11 years, 0.16% vs. 0.15%; 
ages 12-19 years, 0.25% vs. 0.33% (Wu et al 2011). 
The incidence of psoriasis in childhood in the US has been shown to increase with increasing 
age but also in recent years the incidence of psoriasis in children increased significantly from 
29.6 per 100,000 in 1970-1974 to 62.7 per 100,000 in 1995-1999 (Tollefson et al 2010). 
Plaque psoriasis affects 80% to 90% of all psoriasis subjects of all age-groups (Griffiths and 
Barker 2007, Pariser et al 2007) and hence is the most common variant in pediatric subjects. 
Most children manifest with plaque psoriasis in patterns similar to adult subjects, with lesions 
localized to the scalp, post auricular region, elbows, and knees; however, lesions in children are 
often smaller, thinner, and less scaly than those seen in adults. Involvement of the face and 
flexural regions is more common in children than adults, and psoriatic lesions in the diaper area 
are prevalent during infancy. 
As in adults, pediatric psoriasis is frequently associated with significant co-morbidities like 
diabetes mellitus, Crohn’s disease, obesity, and hypertension, and high cholesterol, 
psychological and psychiatric impact. The overall rate of comorbid conditions in psoriasis 
subjects under 20 years of age is double that of their peers who do not have psoriasis (Augustin 
2010). A pediatric study using an international cohort of psoriasis subjects found that a 
significantly higher percentage of children with psoriasis showed excess adiposity (37.9% vs. 
20.5%) or obesity (20.2% vs. 7.3%), significantly higher than the general pediatric population 
(Paller et al 2013). 
The psychological impact of psoriasis can be particularly traumatic to children and adolescents. 
In children with at least one of 12 different skin diseases, children with psoriasis reported the 
greatest impairment to quality of life. Itch or pain was reported in the same study as the most 

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significant problem affecting their Health-related Quality of Life (HrQoL) (Beattie 2006). 
Psoriasis, a debilitating and disfiguring skin condition, is an independent risk factor for 
psychiatric comorbidities in children and adolescents. Compared with a matched psoriasis-free 
control cohort in a study based on health services claims data in the USA, pediatric subjects had 
approximately 25% to 30% greater risks of being given a diagnosis of any psychiatric disorder, 
depression, or anxiety subsequent to the psoriasis diagnosis (Kimball et al 2012). 
Due to the higher prevalence of plaque psoriasis in children compared to other types and the 
significant physical and psychological burden it carries in the pediatric population, Novartis 
plans to study secukinumab in the treatment of plaque psoriasis in patients from 6 to less than 
18 years of age. 
The treatments for psoriasis have expanded over the past decade though in children treatment 
is frequently off-label. The use of topical therapy in childhood is the first line of treatment for 
skin-limited disease. With chronicity of illness and in more severe cases, phototherapy and 
systemic therapy are added to help induce remission (Silverberg 2009). 
Topical therapies represent the vast majority of prescriptions (57 to 91%), while systemic agents 
are rarely used (4%), and biologics being even more rarely used (0.4%) (Wu 2011, Kimball 
2012). Commonly used topical treatments for psoriasis include corticosteroids, coal tar, 
anthralin, calcipotriol either alone or in combination with topical steroids, tazarotene and 
calcineurin inhibitors (Burden 1999, Farber 1999, Benoit 2007). None of these treatments have 
been approved for the treatment of psoriasis in children below 12 years of age. Phototherapy is 
extensively used in adults and is a treatment option for some children with widespread plaques. 
Narrow-Band-Ultraviolet B (UVB) is considered the first-line phototherapy because it is 
similarly effective as Psoralen + Ultraviolet A (PUVA), more convenient, and less carcinogenic 
(Van Weelden 1990). PUVA therapy is not generally recommended in children, but may be 
used with caution in adolescents (Burden 1999). 
Systemic therapy is usually considered if the disease is moderate to severe in intensity, and not 
adequately controlled by topical therapies. Systemic treatments approved for use in adult 
psoriasis include acitretin, methotrexate, cyclosporine, and biologics. Acitretin is approved for 
subsets of psoriatic pediatric patients in some European Union (EU) countries and Switzerland. 
However cyclosporine and methotrexate are not currently approved for the treatment of 
children/adolescents suffering from psoriasis. 
Use of methotrexate, cyclosporine, retinoids (particularly acitretin), and, with a much lower 
frequency, dapsone and hydroxyurea has been reported in the literature (Zappel 2004; Benoit 
2007). Most experience has been reported with retinoids, but the potential effect on bone growth 
and teratogenicity limit their use in children and adolescents. Use of cyclosporine and 
methotrexate is limited by their adverse event (AE) profile (kidney dysfunction, hypertension 
and liver dysfunction, respectively). Reports on the use of biologics in pediatric patients are 
scarce (Benoit 2007). 
Amongst biologics, etanercept and ustekinumab have been approved not so long ago in US for 
moderate to severe psoriasis in pediatric patients (ustekinumab only for adolescents that is 
children 12 years or older). In Europe, apart from etanercept and ustekinumab (ustekinumab 
only for adolescents), adalimumab has also been approved recently but only for severe psoriasis 

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in children from 4 years of age. The details are available in respective prescribing information 
/ summary of product characteristics. 
In summary, a very limited number of systemic drugs for the treatment of psoriasis are approved 
for children, and the few approved drugs all have limitations. There is a high medical need to 
evaluate the treatment of psoriasis in patients less than 18 years of age where controlled studies 
are mostly missing (Burden 1999; Farber 1999; Benoit 2007; Paller et al 2008). 
Secukinumab (AIN457) is a recombinant high-affinity fully human monoclonal anti-human 
Interleukin-17A (IL-17A) antibody of the Immunoglobulin IgG1/κ-class. Secukinumab binds 
to human IL-17A and neutralizes the bioactivity of this cytokine. IL-17A is the central 
lymphokine of a newly defined subset of inflammatory T cells, the T helper 17 cells which, in 
several animal models, are pivotal in several autoimmune and inflammatory processes. IL-17A 
is mainly produced by memory effector CD4+ and CD8+ T lymphocytes. IL-17A is being 
recognized as one of the principal pro-inflammatory cytokines in immune mediated 
inflammatory diseases. Its neutralization is expected to treat the underlying pathophysiology of 
immune mediated disease, and as a consequence provide relief of symptoms. 
Based on the natural history of psoriasis and the similar clinical features and histology in adults 
and pediatric population (Burden 1999; Farber 1999; Benoit 2007), it is expected that a human 
monoclonal antibody such as secukinumab will have an identical mode of action in children 
when compared to adults. It is also expected that the exposure-response to secukinumab in 
pediatric psoriasis patients would be similar to the exposure-response relationship observed in 
adults. 
Now that efficacy and safety have been demonstrated in adults in a comprehensive phase II/III 
program, it seems appropriate that the pediatric population can be exposed to secukinumab in 
long term studies with a dosing regimen that is extrapolated from the adult efficacious dose. 
Currently, another clinical trial (CAIN457A2310) with secukinumab is already ongoing in 
pediatric patients with severe psoriasis. This planned trial (CAIN457A2311) will assess 
efficacy, safety and pharmacokinetics of secukinumab in moderate psoriasis (pediatric) patients 
as well as a few severe psoriasis patients. 
1.2 
Purpose 
The purpose of this study is to assess the efficacy of secukinumab at Week 12, based on both 
PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less 
than 18 years at randomization with moderate to severe chronic plaque psoriasis who are 
candidates for systemic therapy. 
This study will provide efficacy, safety and pharmacokinetic data to support the extension of 
label of secukinumab to include children and adolescents (6 years to <18 years) with moderate 
to severe chronic plaque psoriasis. 
Moreover, this study will assess the long-term efficacy, safety and tolerability of secukinumab 
over a period of up to 4 years to support the long-term use of secukinumab in pediatric patients. 

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Study objectives and endpoints 
2.1 
Objectives and related endpoints 
Table 2-1 
Objectives and related endpoints 
 
Objective(s) 
Endpoint(s) 
Primary Objective(s) 
Endpoint(s) for primary objective(s) 
To evaluate the efficacy of secukinumab in 
pediatric subjects aged 6 years to less than 18 
years old with moderate to severe chronic 
plaque psoriasis with respect to PASI 75 and 
IGA mod 2011 0 or 1 response (co-primary 
endpoints) at Week 12, compared to placebo 
(historical control). 
Proportion of subjects who achieved PASI 75 and 
IGA mod 2011 0 or 1 response at Week 12 in 
each secukinumab treatment group (low dose and 
high dose). Placebo data are obtained from adult 
secukinumab placebo-controlled trials and 
pediatric placebo-controlled trials with 
secukinumab or other biologics 
Secondary Objective(s) 
Endpoint(s) for secondary objective(s) 
To evaluate the efficacy of secukinumab in 
pediatric subjects with respect to PASI 90 at 
Week 12, compared to placebo (historical 
control). 
Proportion of subjects who achieved PASI 90 
response at Week 12 in each secukinumab 
treatment group (low dose and high dose). 
Placebo data are obtained from adult placebo- 
controlled trials and pediatric placebo-controlled 
trials 
To investigate the clinical safety and tolerability 
of secukinumab as assessed by growth, weight 
gain, vital signs, clinical laboratory variables, 
ECGs, and adverse event monitoring 
Height and weight, vital signs, laboratory 
evaluations, ECG and adverse events 
To evaluate the pharmacokinetics of 
secukinumab in pediatric subjects 
Secukinumab concentration in serum at various 
time points 
Exploratory Objective(s) 
Endpoint(s) for exploratory objective(s) 
To investigate the effects of treatment with 
secukinumab with respect to changes in 
CDLQI over time up to End of Treatment 
Absolute and percentage change from baseline of 
CDLQI score over time up to End of Treatment 
To investigate the effects of treatment with 
secukinumab with respect to CDLQI 0 or 1 
score over time, up to End of Treatment 
Proportion of subjects achieving CDLQI 0 or 1 
over time up to End of Treatment 

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Exploratory Objective(s) 
Endpoint(s) for exploratory objective(s) 
To investigate the development of 
immunogenicity against secukinumab 
Development of anti-Drug Antibodies (ADA) to 
secukinumab 
 
Investigational plan 
3.1 
Study design 
This is an open-label, parallel-group, two-arm, multi-center, trial in pediatric subjects aged 6 
years to less than 18 years, at randomization, with moderate to severe chronic, plaque psoriasis. 
Approximately 80 subjects (at least 60 subjects with moderate severity) will be enrolled. It is 
expected that subjects will be enrolled in about 40 centers worldwide. It will be targeted to have 
at least 5 subjects in the < 25kg weight, and at least 10 subjects in each of the other two weight 
groups. 
Figure 3-1 
Study design 
 
 
The study consists of 3 periods: screening (up to 4 weeks), treatment (of 208 weeks) and post- 
treatment follow-up (of 16 weeks). An outline of the visits is presented in Figure 3-1 while a 
detailed visit and assessment schedule can be found in Table 6-1, Table 6-2. 

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Screening Period 
The screening period of up to 4 weeks will be used to assess eligibility of the subjects and to 
taper subjects off prohibited medication. 
Treatment Period 
The treatment period is defined as randomization to Week 208. In this period the endpoints are 
assessed and subjects are followed for long-term safety and efficacy. Subjects will be 
randomized using 1:1 ratio into either secukinumab low dose or secukinumab high dose. 
Randomization will be stratified by body weight (< 25kg, 25-< 50 kg, ≥ 50kg) and disease 
severity (either moderate (PASI score 12-<20 and IGA 3 or 4 or PASI score ≥ 20 and IGA 3) 
or severe (PASI score ≥ 20 and IGA of 4), collected at Randomization Visit. The study aims to 
recruit at least 60 subjects with moderate disease severity and approximately 20 subjects with 
severe disease severity. It will be targeted to have at least 5 subjects in the < 25kg weight, and 
at least 10 subjects in each of the other two weight groups. Subjects will receive the appropriate 
dose based on their body weight category. If a subject moves into a higher or lower weight 
group at two consecutive visits with weight measurements during the maintenance (from Week 
12 onwards as assessed at 4 weekly visits or during extension treatment period (as assessed at 
scheduled site visits), the subject will receive dosing according to the new (higher or lower) 
weight group respectively. The dose will be adapted starting from the visit of the second 
consecutive weight change. 
Adolescents (12-< 18 years) and children (6-< 12 years) can be included from the beginning of 
this study, since the DMC has approved already the enrollment of children (6-< 12 years) in 
study CAIN457A2310. 
All subjects will visit the study site at Randomization (Day 1) and at Weeks 1, 2, 3, 4, 8, 12, 16 
during which they will receive either high-dose or low-dose secukinumab treatment sub- 
cutaneously. Additionally, subjects will visit the site at Weeks 13, 14, 15 to provide blood 
samples for pharmacokinetics. 
During the Treatment period subjects will receive treatment of the assigned secukinumab dose 
every 4 weeks. However during Weeks 16-52 site visits will be scheduled every 8 weeks and 
from Weeks 64-208 site visits will be scheduled every 12 or 16 weeks, to minimize the burden 
on the subject. Subjects will have the option to receive treatment between scheduled visits at 
home, following instructions provided to the subject (if ≥12 years old), parent or caregiver. 
Subjects who discontinue study treatment for any reason before the end of the Treatment Period 
(Week 208) should have the Week 208 visit assessments performed approximately 4 weeks 
after their last dose of secukinumab. The subject will then enter the treatment–free Follow-up 
Period. 
Follow-up Period 
The treatment-free follow-up visits will be at Week 212, Week 216 and Week 224 (End Of 
Follow-up/EOF). Subjects who complete or discontinue the treatment early are expected to 
perform the complete treatment-free follow-up period unless they start another systemic anti- 
psoriatic treatment. In this case they do not need to continue with the remaining follow-up 

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visits but will be expected to return to the site after the start of the systemic treatment and 
perform the EOF visit. 
3.2 
Rationale for study design 
The rationale behind this design is based on a full extrapolation approach. Novartis’ proposal 
for a pediatric extrapolation approach is based on the Food and Drug Administration draft 
guidance, General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and 
Biological Products, which is also reflected in ICH E11 (R1) guidance and an European Medical 
Association reflection Paper on extrapolation of efficacy and safety in pediatric medicine 
development (ICH 2000; FDA 2014; EMA 2016; ICH 2016). 
Its intent is to minimize exposure of children to placebo and to overall clinical trial burden while 
leveraging the broad clinical information available from secukinumab trials in adult subjects as 
well as ongoing pediatric trial CAIN457A2310. This approach is considered appropriate due to 
the substantial similarity of the disease between the adults and pediatric population (Augustin 
2010, Feldman and Krueger 2005, Griffiths 2007, Kimball 2012, Langley et al 2005, Leman 
and Burden 2001, Paller et al 2008, Pariser 2007, Tollefson 2014) as well the similarity of 
exposure-response, which will be validated in the small population of children and adolescents 
of this study. The similarity of disease characteristics of psoriasis between adult and pediatric 
subjects has been described extensively. 
Following consultation with Health Authorities (FDA and EMA (PDCO) for overall pediatric 
program, the open label, design with no control arm was chosen for this particular study. 
Collection of pharmacokinetic information for pediatric subjects based on age and/or weight 
strata was recommended. In principle, if pediatric doses matching adult exposures are 
reasonably identified, then an uncontrolled open-label trial in pediatric subjects to collect safety 
and efficacy data can be acceptable. An interim PK analysis of data from the ongoing 
CAIN457A2310 trial (a double-blind placebo controlled and single blind active-controlled 
study in pediatric subjects with severe psoriasis) showed that pediatric trough concentrations 
for the weight and dose groups studied are consistent with the predictions from a population PK 
model in psoriasis patients (data on file; see Section 3.3 for more details). 
The present study is being conducted to collect long term safety data and evaluate efficacy and 
pharmacokinetics in children. The efficacy data collected in this uncontrolled study will be 
compared with historical placebo data obtained from the adult program with secukinumab and 
pediatric placebo-controlled trials with other biologics. If data from CAIN457A2310 (pediatric 
subjects with severe psoriasis) are available when this study report is created, the placebo 
efficacy data may also be used in the efficacy analysis of study CAIN457A2311. 
Finally, the lower age of enrollment has been limited to 6 years since the prevalence of psoriasis 
in the 0 to less than 6 age group is very low (with the highest prevalence published of 0.3%) 
and the proportion of children with a severe condition in need of a systemic treatment is 4%, 
giving a final prevalence of the condition to be about 1 per 10,000 in this age group. 

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3.3 
Rationale for dose/regimen, route of administration and duration 
of treatment 
The dose selection for secukinumab in pediatric psoriasis subjects is based on the completed 
phase III program in adults as well as on modeling and simulation based on the results from 
adult phase II/III studies. Secukinumab 300 mg and 150 mg are selected based on evidence 
from adult phase III studies that demonstrated both doses to be safe and effective in treating 
moderate to severe plaque psoriasis. 
The same doses were also selected for the first and ongoing pediatric study CAIN457A2310 
which is a double-blind placebo controlled and single blind active-controlled study in pediatric 
subjects with severe psoriasis. 
The proposed doses for the high dose and low dose secukinumab arms are based on a 
population-PK model that has been built based on the pool of key phase II/III adult trials to 
predict exposure of secukinumab according to various body weights. This dosing rationale 
assumes that the concentration-response relationship and disease characteristics (onset, severity, 
progression) in children are similar to adults with no major differences in target expression of 
IL-17A. Therefore, similar PK concentration profiles across the adult and pediatric populations 
will achieve comparable response. 
Figure 3-2 
Average concentration for the proposed low dose and high dose 
secukinumab arms 
 
Extrapolation of the exposure in children / adolescents in a bodyweight range down to 20 kg to 
allow maintaining exposure levels similar to those observed in adults with 50 kg body weight 
led to selection of 75mg, 150 mg and 300 mg within weight categories as follows: 
• Subjects ≥50 kg: 150 mg (low dose group) or 300 mg (high dose group) 
• Subjects 25 kg to < 50 kg: 75 mg (low dose group) or 150 mg (high dose group) 
• Subjects < 25 kg: 75 mg (for both dose groups in order to ensure no overly high exposures 
in this sub-population). 

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Interim PK data from 23 secukinumab-treated subjects in the age range of 12 to 17 years old 
from study CAIN457A2310 have been evaluated (data on file). The observed pediatric trough 
concentrations are consistent with model predictions for the weight and dose groups studied. 
These data, therefore, support the selected dosing regimen from a safety and efficacy point of 
view for study CAIN457A2310 and for the present study CAINA457A2311. 
3.4 
Rational for choice of comparator 
No comparator drug is included in this study. Historical placebo data from qualifying trials will 
be used as the control for primary and key secondary endpoint analysis as discussed in Section 
9.4. This is in line with guidance from and discussions with Health Authorities including FDA 
and EMA (PDCO) which suggested reducing placebo exposure as well as overall clinical trial 
burden for pediatric population and suggest/accept use of extrapolation approach. 
3.5 
Purpose and timing of interim analyses/design adaptations 
There are two planned interim analysis. An interim analysis, including the primary endpoint 
(Week 12) analysis will be conducted when all subjects have completed the Week 16 visit or 
the premature treatment discontinuation visit. Another interim analysis will be performed when 
all subjects have completed the Week 52 visit or the premature treatment discontinuation visit. 
Additional analyses may be performed to support health authority interactions, as necessary. 
Thereafter, efficacy and safety data collected after Week 52 until the end of study may be 
reported yearly in separate reports. 
Trial modifications are not planned based on any interim analysis. 
3.6 
Risks and benefits 
The risk to subjects in this trial will be minimized by compliance with the eligibility criteria 
and study procedures and by close clinical monitoring. 
Biologics are being considered a safe and effective option for treating psoriasis in the pediatric 
population as they are convenient to use, requiring less frequent dosing than traditional systemic 
agents such as methotrexate, cyclosporine, and acitretin. In addition, they lack many of the 
potential end-organ toxicities of traditional agents because of their targeted action. 
Results from non-clinical studies and phase II and III clinical studies in adults did not reveal a 
safety concern that would preclude the use of secukinumab in children. In adult studies, 
secukinumab has shown a very good efficacy profile in the treatment of moderate to severe 
chronic plaque psoriasis. The safety data from the completed and ongoing studies, including 
Adverse Event and Serious Adverse Event data, laboratory parameters and immunogenicity 
data, demonstrate a good safety profile. 
Known risks of secukinumab administration includes an increased risk of infections, in 
particular candida infections, neutropenia and hypersensitivity reactions that can be seen with 
administration of any foreign proteins. Most of the infections were non-serious upper 
respiratory tract infections and candidiasis, mild to moderate in severity, clinically manageable 
and did not lead to treatment discontinuation. Cases of neutropenia were uncommon, generally 

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mild to moderate and transient and did not lead to treatment discontinuation, and only a few 
cases were timely associated with non-serious infections. 
Potential risks for subjects on secukinumab may include malignancies, major adverse 
cardiovascular events (MACE), Crohn’s disease, immunogenicity, and interactions with live 
vaccines. 
Since the immune system was shown to reach adult levels of maturation by 6 years of age 
(Comans-Bitter et al 1997), no adverse effects of secukinumab on development of this system 
are expected in this trial’s pediatric population (age 6 to < 18 years). Consequently, no 
additional risks of infections, malignancies, or impact on peripheral competent immune cells 
over those described for adults are anticipated for this pediatric group. 
A potential for increased exposure of secukinumab at lower body weights has been suggested 
by the analysis of population pharmacokinetic data. Consequently, weight category based 
dosing has been instituted to ensure that exposure levels of secukinumab are comparable across 
all weight groups in the study population. 
No adverse effects are anticipated with respect to linear bone growth and development given 
the absence of bone findings in knock-out mice (Kokubu et al 2008) and in toxicology studies 
with secukinumab. Height, to measure linear growth, will be monitored throughout the study. 
Prior to participating in a clinical trial with secukinumab, participants should consider 
completion of all age appropriate immunizations according to immunization guidelines. 
Subjects treated with secukinumab should not receive live vaccines. Non-live vaccinations 
received during secukinumab treatment may not elicit an immune response sufficient to prevent 
disease (refer to Table 5-3). 
 
Population 
The study population will consist of male and female subjects age 6 to less than 18 years of age 
(at the start of study treatment) with moderate to severe plaque psoriasis who are candidates for 
systemic treatment. 
The investigator must ensure that all subjects being considered for the study meet the following 
eligibility criteria. No additional exclusions should be applied by the investigator, in order that 
the study population will be representative of all eligible subjects. 
Approximately 80 subjects (at least 60 with moderate psoriasis) will be randomized in 
approximately 40 centers worldwide. Since a 15% screening failure rate is expected, 
approximately 95 subjects will be screened. 
4.1 
Inclusion criteria 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1. Written informed assent and parental permission (age as per local law) obtained at 
screening before any assessment is performed. Of note, if subjects reach age of consent 
(age as per local law) during the study, at that time they will need to also sign the 
corresponding study Informed Consent. 
2. Must be 6 to less than 18 years of age at the time of randomization. 

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3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 
score of ≥ 3, and BSA involvement of ≥ 10%, at randomization 
4. History of plaque psoriasis for at least 3 months before randomization 
5. Subject being regarded by the investigator to be a candidate for systemic therapy because 
of: 
• inadequate control of symptoms with topical treatment, and/or 
• failure to respond to or tolerate previous systemic treatment and/or UV therapy 
4.2 
Exclusion criteria 
Subjects fulfilling any of the following criteria are not eligible for inclusion in this study. No 
additional exclusions may be applied by the investigator, in order to ensure that the study 
population will be representative of all eligible subjects/subjects. 
1. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate 
psoriasis), active at randomization. 
2. Drug-induced psoriasis (ie new onset or current exacerbation from beta-blockers, calcium 
channel blockers or lithium) 
3. Ongoing use of prohibited treatments as mentioned in Table 5-3 (Washout periods as 
detailed in Table 5-3 have to be adhered to). 
4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or 
the IL-17 receptor, 
5. Use of any other investigational treatment within 30 days for small molecules or within a 
period of 5 half-lives of the investigational treatment from randomization, or until the 
expected pharmacodynamic effect has returned to baseline, whichever is longer. 
6. History of severe hypersensitivity reaction or anaphylaxis to any biological agent (human 
monoclonal antibody or soluble receptor) 
7. Pregnant or nursing (lactating) females, where pregnancy is defined as the state of a 
female after conception and until the termination of gestation, confirmed by a positive 
human Chorionic Gonadotropin (hCG)laboratory test 
8. Female subjects of childbearing potential and/or who are at least 12 years of age; defined 
as all women physiologically capable of becoming pregnant, unless they are using 
effective methods of contraception during dosing and for 16 weeks after stopping study 
treatment (or longer if local label requires it (eg in EU 20 weeks), (menarchal or becoming 
menarchal during the study) who do not agree to abstinence or, if sexually active, do not 
agree to the use of contraception. Effective contraception methods include: 
• Total abstinence (when this is in line with the preferred and usual lifestyle of the 
subject). Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation 
methods) and withdrawal are not acceptable methods of contraception 
• Female sterilization (have had surgical bilateral oophorectomy with or without 
hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking 
investigational drug. In case of oophorectomy alone, only when the reproductive 
status of the woman has been confirmed by follow-up hormone level assessment 
• Male sterilization (at least 6 months prior to screening). For female subjects on the 
study, the vasectomized male partner should be the sole partner for that subject 

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• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or 
cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/ 
vaginal suppository 
• Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of 
contraception or placement of an intrauterine device (IUD) or intrauterine system 
(IUS) or other forms of hormonal contraception that have comparable efficacy (failure 
rate < 1%), for example hormone vaginal ring or transdermal hormone contraception 
In case of use of oral contraception women should have been stable on the same pill for 
a minimum of 3 months before taking investigational drug. 
In case local regulations deviate from the contraception methods listed above, local 
regulations apply and will be described in the Informed Consent Form 
9. Active ongoing inflammatory diseases other than psoriasis that might confound the 
evaluation of the benefit of secukinumab therapy 
10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, 
pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the 
opinion of the investigator significantly immunocompromises the subject and/or places the 
subject at unacceptable risk for receiving an immunomodulatory therapy. In addition, 
current severe progressive or uncontrolled diseases which render the subject unsuitable for 
the trial or puts the subject at increased risk, including any medical or psychiatric 
condition which, in the Investigator’s opinion, would preclude the participant from 
adhering to the protocol or completing the study per protocol. 
11. Investigator discretion should be used for subjects with preexisting or recent-onset central 
or peripheral nervous system demyelinating disorders 
12. Subjects with an estimated Glomerular Filtration Rate (eGFR), estimated by the Schwartz 
equation, of < 60 mL/min/1.73 m2 at screening. Assessment may be repeated once, two or 
more days later, and if eGFR value ≥ 60, subject may be included at the discretion of the 
investigator. 
13. Subjects with total White Blood Cell count < 2,500/μL, or platelets < 100,000/μL or 
neutrophils < 1,500/μL or hemoglobin < 8.5 g/dL at screening 
14. Active systemic infections during the last two weeks (exception: common cold) prior to 
randomization and any infections that reoccur on a regular basis. Investigator/qualified 
site staff discretion should be used regarding subjects who have traveled or resided in 
areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis 
and for subjects with underlying conditions that may predispose them to infection, such as 
advanced or poorly controlled diabetes 
15. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis 
infection as defined by a positive central laboratory test result at screening. Subjects with a 
positive test result may participate in the study if further work up (according to local 
practice/guidelines) establishes conclusively that the subject has no evidence of active 
tuberculosis. If presence of latent tuberculosis is established, then treatment must have 
been initiated and maintained according to local country guidelines prior to 
randomization. 

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16. Past medical history record of, or known current infection with Human Immunodeficiency 
Virus, hepatitis B or hepatitis C at screening 
17. History of lymphoproliferative disease or any known malignancy or history of malignancy 
of any organ system within the past 5 years prior to screening, except for skin Bowen’s 
disease, or basal cell carcinoma or actinic keratoses that have been treated with no 
evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non- 
invasive malignant colon polyps that have been removed. 
18. Plans for administration of live vaccines during the study period or within 6 weeks prior to 
randomization. 
19. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude 
the participant from adhering to the protocol or completing the study per protocol. 
20. Hypersensitivity or allergy to any of the ingredients of study treatment 
21. History or evidence of ongoing alcohol or drug abuse, within the last 24 weeks before 
randomization. 
22. Subjects not willing to limit UV light exposure (eg, sunbathing and/or the use of tanning 
devices) during the course of the study. 
23. Unwillingness to undergo repeated venipuncture or subcutaneous injections. 
 
Treatment 
5.1 
Study treatment 
5.1.1 
Investigational and control drugs 
Secukinumab prefilled syringes available as 75mg/0.5ml and 150mg/1ml will be provided by 
Novartis in an open-label fashion. 
Syringes will be labeled as: 
• AIN457 75mg/0.5 mL or 
• AIN457 150mg/1mL 
5.1.2 
Additional treatment 
No additional treatment beyond investigational drug is included in this trial. 
5.2 
Treatment arms 
Subjects will be randomized using a 1:1 ratio at the Randomization visit to two treatment 
arms, secukinumab low dose or secukinumab high dose. Subjects will receive sc dose 
according to the weight category (< 25 kg, 25- < 50kg, ≥ 50 kg). 
Subjects in the two secukinumab arms weighing ≥ 50kg will receive 150 mg (low dose group) 
and 300 mg (high dose group), 25 to < 50 kg will receive 75mg (low dose group) and 150 mg 
(high dose group) and < 25kg will receive 75mg for both dose groups as summarized in the 
Table 5-1 below. Subjects will be receiving one sc injection at each drug administration of either 
secukinumab 75 mg or 150 mg Pre-filled Syringe (PFS) according to their treatment group. 

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Only the subjects in the ≥ 50 kg high dose treatment groups will be receiving two sc injections 
of 150 mg secukinumab at each administration. 
Secukinumab low dose group: 
According to the weight category, sc secukinumab 75 mg (in < 25 kg and 25 to < 50 kg) or 150 
mg (≥ 50 kg) injections will be administered at Randomization, Weeks 1, 2, 3, 4 and thereafter 
every 4 weeks during the entire treatment period of the study until Week 204. After Week 16, 
treatment which occurs outside of the site visits, may be administered at home every 4 weeks, 
either by subject (self-injection is allowed for subjects ≥ 12 years ) or parent/caregiver. If 
subject/parent does not feel confident in performing treatment administration at home they are 
still allowed to receive study treatment administration at site. 
Secukinumab high dose group: 
According to the weight category, sc secukinumab 75 mg (in < 25 kg), 150 mg (in 25 to < 50 
kg) or 2 x 150 mg (≥ 50 kg) injections will be administered at Randomization, Weeks 1, 2, 3, 
4 and thereafter every 4 weeks during the entire treatment period of the study until Week 204. 
After Week 16, treatment which occurs outside of the site visits, may be administered at home 
every 4 weeks, either by subject (self-injection is allowed for subjects ≥ 12 years ) or 
parent/caregiver. If subject/parent does not feel confident in performing treatment 
administration at home they are still allowed to receive study treatment administration at site. 
Table 5-1 
Number of injections per visit per treatment arm 
 
Weight 
Dose (PFS) 
Number of injections at each dosing 
<25 kg 
- low dose 
75 mg 
1 
-high dose 
75mg 
1 
25 to <50 kg - low dose 
75 mg 
1 
-high dose 
150 mg 
1 
≥50 kg 
- low dose 
150 mg 
1 
-high dose 
300mg 
2 
5.3 
Treatment assignment and randomization 
At Randomization (Day 1) all eligible subjects/subjects will be randomized via Interactive 
Response Technology (IRT) to one of the two treatment arms. The investigator or his/her 
delegate will contact the IRT after confirming that the subject fulfills all the inclusion/exclusion 
criteria. The subject number, the weight of the subject, the age and any relevant information 
related to severity, as described in the user manual, will be entered. The IRT will assign a 
randomization number to the subject, which will be used to link the subject to a treatment arm 
and will specify a unique medication number for the first package of study drug to be dispensed 
to the subject. 
The randomization numbers will be generated using the following procedure to ensure that 
treatment assignment is unbiased. A subject randomization list will be produced by the IRT 
provider using a validated system that automates the random assignment of subject numbers to 
randomization numbers. These randomization numbers are linked to the different treatment 

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arms, which in turn are linked to medication numbers. A separate medication list will be 
produced by or under the responsibility of Novartis Drug Supply Management using a validated 
system that automates the random assignment of medication numbers to packs containing the 
investigational drug(s). 
Stratification 
Randomization will be stratified by disease severity and body weight collected at 
Randomization Visit. This stratification ensures balanced allocation of subjects to treatment 
groups within the disease severity and weight strata. 
The weight strata will be “body weight < 25 kg”, “25 kg ≤ body weight < 50 kg” or “body 
weight ≥ 50 kg” and disease severity strata (refer to Table 5-2). Stratification by disease severity 
and body weight will occur at Randomization Visit. 
Table 5-2 
Disease severity classification 
 
IGA 
PASI score 
Psoriasis severity 
3 
12-< 20 
Moderate 
3 
≥ 20 
Moderate 
4 
12-< 20 
Moderate 
4 
≥ 20 
Severe 
It will be targeted to have at least about 5 subjects in the < 25kg weight, and at least about 10 
subjects in each of the other two weight groups. 
The randomization scheme for subjects will be reviewed and approved by a member of the 
Integrated Quantitative Sciences Randomization Group. 
5.4 
Treatment blinding 
Medication will be labeled in an open-label fashion. Blinding requirements are not applicable 
for any of the parties involved. 
5.5 
Treating the subject 
Sponsor qualified medical personnel will be readily available to advise on trial related medical 
questions or problems. 
5.5.1 
Subject numbering 
Each subject is uniquely identified by a Subject Number assigned by Novartis. The subject 
number is composed of a site number and a sequential subject number. Once assigned to a 
subject, the Subject Number will not be reused. 
Upon signing the informed consent form, the subject is assigned the next sequential number 
available in the electronic data capture (EDC) system. The investigator or his/her staff will 
contact the IRT and provide the requested identifying information for the subject to register 
them into the IRT. The site must select the eCRF book with a matching Subject Number in the 
EDC system to enter data. 

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If the subject fails to be treated for any reason, the IRT must be notified within 2 days that the 
subject was not treated. The reason for not being treated will be entered on the appropriate 
Screening period eCRF. 
5.5.2 
Dispensing the study drug 
Each study site will be supplied by Novartis with study treatment. 
At all visits where secukinumab is dispensed, the IRT system will allocate a unique medication 
number which will be transmitted to the pharmacist (or other qualified site personnel) 
responsible for dispensation of study treatments. The pharmacist (or other qualified site 
personnel) will then identify the study treatment package(s) to administer to the subject 
corresponding to the medication number(s). The study drug packaging has a 2-part label. The 
unique medication number is printed on each part of this label. Immediately before preparation 
of the study treatment, the pharmacist (or other qualified site personnel) will detach the outer 
part of the label from the packaging and affix it to the source document for that subject’s unique 
subject number. These documents will be kept in a secured location as appropriate. The study 
treatment will be administered by study nurse/ qualified site personnel individual. 
During the COVID-19 pandemic or similar major health care disruption that limits or prevents 
on-site study visits, delivery of study drug directly to a participant’s home is generally permitted 
in the event the Investigator has decided that an on-site visit by the participant is no longer 
appropriate or possible, and that it is in the interest of the participant’s health to administer the 
study treatment even without performing an on-site visit. The dispatch of study drug from the 
site to the participant’s home remains under the accountability of the Investigator. 
At the site level, the agreement with approval of the Principal Investigator, Independent Ethics 
Committee/ Institutional Review Board (IEC/IRB) and any other Board as appropriate should 
be in place to implement home delivery. 
Home administration of secukinumab 
After Week 16, subjects/custodians will be expected to perform home administrations of 
secukinumab at the time points specified in the protocol, when they are not visiting the site for 
other trial related procedures. Subjects/custodians must be previously trained by site staff 
regarding the administration of secukinumab PFS. 
It must be noted that subjects 12- < 18 years of age can self-inject only under caregiver or health 
care professional supervision. Subjects < 12 years of age are not allowed to self –inject at any 
time. 
If the subject or custodian is not confident to administer medication at home, subjects should 
visit the site every 4 weeks and according to the visit schedule to have the administrations 
performed there by the site staff. Alternatively, if possible, local arrangements can be done for 
a trained nurse to administer medication to the subject at home. This person must be sufficiently 
trained. 
For home administrations the pharmacist/ qualified site personnel will dispense, via IRT, an 
appropriate number of investigational treatment packages and detach outer part of the label 
from the packaging as indicated above. The custodians/subjects will record the date(s) of 

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administration at home and will return the used PFS and packaging at their next visit to the site. 
Site staff are to transcribe this information into the appropriate Dosage Administration Record 
eCRF. 
The used PFS should be disposed immediately after use in a sharps container OR according to 
the requirements of the respective countries and brought back to site. Subjects will be asked to 
return all unused PFS the latest at the completion of the study or at the time of discontinuation 
of the investigational treatment. Detailed instructions will be provided separately. 
5.5.3 
Handling of study and additional treatment 
5.5.3.1 
Handling of study treatment 
Study treatment must be received by a designated person at the study site, handled and stored 
safely and properly, and kept in a secured location to which only the investigator and designees 
have access. Upon receipt, all study treatment must be stored according to the instructions 
specified on the labels. Clinical supplies are to be dispensed only in accordance with the 
protocol. Technical complaints are to be reported to the respective Novartis Country Pharma 
Organization Quality Assurance. 
Medication labels for secukinumab prefilled syringes will be in the local language and comply 
with the legal requirements of each country. They will include storage conditions for the 
investigational treatment but no information about the subject except for the medication number. 
They must be stored in a secured refrigerator at 2°C-8°C (36°F-46°F), and must be carefully 
controlled in accordance with regulations governing investigational medicinal products and 
local regulations. Study treatments should not be frozen and must be protected from light. 
The investigator must maintain an accurate record of the shipment and dispensing of study 
treatment in a drug accountability log. Monitoring of drug accountability will be performed by 
monitors during site visits or remotely and at the completion of the trial. Subjects will be asked 
to return all used PFS and packaging at frequent intervals (i.e. at next scheduled study visit) and 
unused PFS and packaging latest at the end of the study or at the time of discontinuation of 
study treatment. 
At the conclusion of the study, and as appropriate during the course of the study, the investigator 
will return all unused PFS, packaging, drug labels, and a copy of the completed drug 
accountability log to the Novartis monitor or to the Novartis address provided in the investigator 
folder at each site. 
5.5.3.2 
Handling of additional treatment 
Not applicable. 
5.5.4 
Instructions for prescribing and taking study treatment 
All study treatments will be administered subcutaneously throughout the study. All doses of 
study treatments at scheduled site visits will be administered at the study site after the study 
assessments for the visit have been completed. Prior to administration to the subject, the study 
treatment will be dispensed by the qualified site personnel appointed at the study site. 
For home administrations the processes described earlier at Section 5.5.2 must be followed. 

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The first study treatment administration will occur at the Randomization Visit (Day 1), after all 
study scheduled assessments have been performed (and inclusion/exclusion criteria confirmed) 
and only after the scheduled blood samples have been drawn. Similarly, at each other visit, all 
study assessments should be completed prior to the administration of study treatment. 
Subjects will be administered study medication weekly for the first 4 weeks of the treatment 
period and then every 4 weeks until Week 204. 
During the Follow-up period, no study medication will be administered. 
Administration of secukinumab 
Secukinumab Solution for Subcutaneous Injection will be provided in Prefilled syringes (75 
mg/0.5 mL and 150 mg/1mL). 
The study treatment solution must be injected into non-affected areas of the skin. 
If possible, throughout the trial, the study treatment should be administered to body regions, 
changing the injection site from visit to visit, for example: right thigh, left thigh, right abdominal 
area, left abdominal area. 
Single prefilled syringes will be packed in individual boxes. The boxes containing the syringes 
with study treatment solution should be kept at 2 to 8°C (36°F to 46°F) and protected from light. 
They should not be frozen or shaken. Prior to administration the boxes containing the syringes 
with study treatment solution should be allowed to come to room temperature unopened for 
about 15-30 minutes before administration. Used syringes should be disposed immediately after 
use in a sharps container or according to the requirements of the respective countries. For home 
administration please refer to Section 5.5.2. 
Note: The removable cap of the secukinumab pre-filled syringe 1 mL and 0.5mL form contains 
a derivative of natural rubber latex. Although no natural rubber latex is detected in the cap, the 
safe use of the secukinumab 1 mL or 0.5 mL pre-filled syringe in latex-sensitive individuals has 
not been studied. 
All kits of study treatment assigned by the IRT will be recorded/databased in the IRT. 
The investigator must promote compliance by instructing the subject to take the study treatment 
exactly as prescribed and by stating that compliance is necessary for the subject’s safety and 
the validity of the study. The subject must also be instructed to contact the investigator if he/she 
is unable for any reason to take the study treatment as prescribed. 
5.5.5 
Permitted dose adjustments and interruptions of study treatment 
Investigational or other treatment dose adjustments and/or interruptions are not permitted. 
5.5.6 
Rescue medication 
Rescue medication for psoriasis is not permitted in this study 
5.5.7 
Prior and Concomitant medication 
Relevant treatments (excluding those for psoriasis) taken within 6 months from screening date 
must be entered in the Prior and Concomitant Medications eCRF. Any psoriasis treatments used 

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from the time subject started to treat psoriasis will be reported on the Prior psoriasis therapy 
eCRF and not in the prior and concomitant medications eCRF. 
The investigator must instruct the subject to notify the study site about any new medications 
he/she takes after the subject was enrolled into the study. All medications, procedures and 
significant non-drug therapies (including physical therapy and blood transfusions) administered 
after the subject was enrolled into the study must be recorded in the appropriate CRF. 
Each concomitant drug must be individually assessed against all exclusion criteria/prohibited 
medication. If in doubt the investigator should contact the Novartis medical monitor before 
randomizing a subject or allowing a new medication to be started. 
5.5.7.1 
Permitted concomitant medications (not for psoriasis) 
Concomitant medications are allowed if not listed in Table 5-3. Dose adjustments of these 
medications should be avoided during the study. If a dose adjustment of these medications does 
occur, they must be recorded on the Concomitant medications eCRF or the Procedures and 
Significant non-drug therapies eCRF. 
Subjects who are receiving treatments known to worsen psoriasis (eg beta-blockers) must be on 
stable dose for at least 4 weeks before Randomization Visit. 
Topical corticosteroids (TCS) and other topical treatments will be allowed from Week 12 visit 
and until the end of study only if: medication was started after the week 12 visit was completed 
AND medication was used for 14 consecutive calendar days or less AND medication was used 
for an indication other than psoriasis and not on the area affected with psoriasis. 
Use of these TCS must be recorded on the Concomitant medications TCS eCRF. 
There is no restriction on the use of anti-histamines or of corticosteroid drops used in the eye 
or ear during the study 
5.5.7.2 
Permitted concomitant medication for psoriasis 
After the screening period, the use of concomitant medication for psoriasis in all body regions 
is restricted to bland emollients (not supplied by Novartis) and other non-medicated 
interventions (not listed in Table 5-3). Use of bland emollients must be recorded on the 
Concomitant medications eCRF. Use of any other non-medicated interventions must be 
recorded on the Procedures and Significant non-drug therapies eCRF. 
The definition of “bland” excludes all topical medications that contain pharmacologically active 
ingredients such as (but not limited to) lactic acid, salicylic acid, urea, α-hydroxy acids or fruit 
acids. 
The use of bland emollients should be avoided during the 12 hours preceding a scheduled study 
visit. 
A TCS treatment of mild or moderate activity is allowed for the face, scalp, and genitoanal area 
during the screening period, but not after the subject has been randomized. These TCS must not 
be used during the 12 hours preceding the Randomization study visit. Use of these TCS must 
be recorded on the Prior psoriasis therapy eCRF if they were used to treat psoriasis. If not used 
to treat psoriasis they should be entered in the TCS eCRF (Section 5.5.7.1). 

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5.5.8 
Prohibited medication 
Use of any treatments displayed in Table 5-3 that could confound the efficacy are NOT allowed 
during the study for any indication and wash-out periods for these treatments prior to 
randomization are indicated in the table. If the use of these treatments is required, then the 
subject should NOT be randomized into the study 
The investigator should instruct the subject to notify the study site about any new treatments 
he/she takes after the start of the study treatment. All prohibited medications and significant 
non-drug therapies administered after the subject starts treatment with study treatment must be 
listed on appropriate eCRF. 
If a prohibited treatment listed in Table 5-3 was used during the study, the subject must 
discontinue use of the prohibited treatment if he/she wishes to continue in the study. At the 
discretion of the investigator, if the subject’s use during the study of a prohibited treatment 
listed in Table 5-3 presents undue safety risk for the subject, the subject should be discontinued 
from study treatment as per Section 5.6.2. If the subject received a live vaccination during the 
study, the subject must discontinue study treatment. 
During the screening period, subjects will be allowed to use some active topical treatments for 
any indication in the following body regions: face, scalp, and genitoanal area. The active topical 
treatments are limited to: mild or moderate potency corticosteroid. The subject must stop use 
of these topical corticosteroids (TCS) at least 12 hours preceding the Randomization visit. 
For all other body regions, a washout period of 2 weeks applies for all active topical treatments 
for any indication as indicated in Table 5-3 below 
The Sponsor will be notified if a prohibited treatment is taken while the subject is on study. 
Table 5-3 
Prohibited medication 
 
Prohibited Treatment 
Wash-out period up 
to Randomization 
Treatment 
Period1,2 
Secukinumab 
No prior use allowed 
Used as 
study 
treatment 
Any biologic drug directly targeting IL-17 or the IL-17 receptor 
(other than secukinumab [eg brodalumab, ixekizumab]) 
No prior use allowed 
Not 
allowed 
Any biologic directly targeting IL-12/23 or IL-23, eg 
briakinumab, stekinumab, guselkumab, tildrakizumab 
26 weeks 
Not 
allowed 
Alefacept, efalizumab 
26 weeks 
Not 
allowed 
Etanercept 
4 weeks 
Not 
allowed 
Biological immunomodulating agents other than above (eg, 
adalimumab, infliximab) 
12 weeks 
Not 
allowed 
Other systemic immunomodulating treatments 
(eg, methotrexate (MTX), cyclosporine A [CSA], 
corticosteroid, cyclophosphamide) 
4 weeks 
Not 
allowed 
Photochemotherapy (eg, PUVA) 
4 weeks 
Not 
allowed 

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Prohibited Treatment 
Wash-out period up 
to Randomization 
Treatment 
Period1,2 
Other systemic therapy for psoriasis (eg, retinoids, fumarates, 
apremilast) 
4 weeks 
Not 
allowed 
Any other investigational treatment or participation in any 
interventional trial 
4 weeks or 5 half- 
lives (whichever is 
longer) 
Not 
allowed 
Phototherapy (eg, UVA, UVB) 
2 weeks 
Not 
allowed 
Topical treatment3 for psoriasis or any other skin condition 
(eg, corticosteroids, vitamin D analogues, pimecrolimus, 
retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, 
tar, urea, α-hydroxy or fruit acids), except on the face, scalp, 
hands and feet and genitoanal area during screening 
2 weeks4 
Not 
allowed 5 
Live vaccinations 
6 weeks 
Not 
allowed 6 
1 If a prohibited treatment of psoriasis is used during the study, the subject must discontinue use of the prohibited treatment if 
he/she wishes to continue in the study. 
2 In case of undue safety risk for the subject, the subject should discontinue study treatment at the discretion of the investigator. 
3 Including intra-articular or peri-articular injections. Note that inhaled corticosteroids as well as corticosteroid drops in the eye or 
ear or nasal sprays are permitted. 
4 Mild to moderate topical corticosteroids are allowed only during the screening period if used only on the face, scalp, hands and 
feet and/or genitoanal area and if not used during at least 12hrs preceding the randomization visit 
5 Topical corticosteroids and other topical treatments will be allowed after Week 12 Visit only if (all must apply): 
•medication was started after the Week 12 visit was completed; 
•medication was used for 14 consecutive calendar days or less; 
•medication was used for an indication other than psoriasis and not on the area affected with psoriasis. 
6 If the subject received a live vaccination during the study, the subject must discontinue study treatment. 
 
Exposure to light 
Subjects need to be advised to limit exposure to ultraviolet (UV) light (including sunbathing 
and/or use of UV tanning devices) during the study to avoid possible effect on psoriasis. 
5.5.9 
Emergency breaking of assigned treatment code 
Not Applicable as treatment is open label. 
5.6 
Study completion and discontinuation 
5.6.1 
Study completion and post-study treatment 
A subject will be considered to have completed the study when the subject has completed the 
Week 224 visit as per the protocol. For subjects who discontinue prior to this, the study 
completion corresponds to the last study visit of the subject or contact of the site with 
custodian/subject. Study completion for the study will occur when all randomized subjects have 
completed the study as stated above. 
The investigator must provide follow-up medical care for all subjects who are prematurely 
withdrawn from the study, or must refer them for appropriate ongoing care. 

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5.6.2 
Discontinuation of study treatment 
Discontinuation of study treatment for a subject occurs when study drug is stopped earlier than 
the protocol planned duration, and can be initiated by either the subject/custodian or the 
investigator. 
The investigator must discontinue study treatment for a given subject if, on balance, he/she 
believes that continuation would negatively impact the risk/benefit of trial participation. 
Study treatment must be discontinued under the following circumstances: 
• Subject/custodian’s wish 
• Withdrawal of consent 
• Pregnancy (see Section 6.5.8 and Section 7.6) 
• Ongoing use of prohibited treatment as per recommendations in Table 5-3 
• Emergence of the following AEs: AEs that in the judgment of the investigator/qualified 
site staff, taking into account the subject’s overall status, prevent the subject from 
continuing study treatment, for example sepsis, or newly occuring or worsening 
Inflammatory Bowel Disease, including Crohn’s disease and ulcerative colitis. 
• Any laboratory abnormalities that in the judgment of the investigator/qualified site staff, 
and taking into consideration the subject’s overall status, prevents the subject from 
continuing study treatment. 
• Live vaccination 
• Any situation where study participation results in a significant risk to subject’s safety 
If discontinuation of study treatment occurs, the subject should NOT be considered withdrawn 
from the study. If the subject discontinued study treatment within the treatment period, the 
subject should return to the clinic after discontinuation of study drug, for Week 208 and 
Follow-up visits (Week 212, Week 216 and Week 224). 
At the time of the study treatment discontinuation visit, if it has been approximately 4 weeks 
post last dose of study treatment then the assessments described at Week 208 visit in Table 6- 
2 should be completed and recorded in the eCRF. 
If it has not been approximately 4 weeks post last dose of study treatment at the time of the 
study treatment discontinuation visit, then the subject should be scheduled to return 4 weeks 
post last dose for their Week 208 visit. 
The investigator must determine the primary reason for the subject’s premature 
discontinuation of study treatment and record this along with the date treatment was stopped 
on the eCRF page. The investigator must also contact the IRT to register the subject’s 
discontinuation from study treatment. As mentioned above if subjects discontinues treatment 
early, subject is expected to perform the visits of the treatment –free follow up period. 
If the subject cannot or is unwilling to attend any further visit(s), the site staff should maintain 
regular telephone contact with the custodian/subject to obtain at least information on adverse 
events or concomitant medication. This telephone contact should preferably be done according 
to the study visit schedule. 

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Discontinuation from the treatment-free follow-up period 
Subsequently to the Week 208 visit the subject will be expected to return to the site and 
perform all visits of the treatment-free follow-up period as indicated in Table 6-2. 
If premature withdrawal occurs for any reason in the treatment-free period (follow-up period, 
Week 208-Week 224), the subject is expected to return to the site and perform all assessment 
of visit EOF /Week 224 (see Table 6-2). The investigator must make every effort to determine 
the primary reason for a subject’s premature withdrawal from the study and record this 
information on the relevant eCRF). 
Of note, if subjects start another systemic anti psoriatic treatment during follow up, they do not 
need to continue with the remaining follow-up visits but they will be expected to return to site 
after the start of the systemic treatment and perform Week 224 visit. 
5.6.3 
Withdrawal of informed consent 
Custodians/subjects may voluntarily withdraw consent for participation in the study for any 
reason at any time. Withdrawal of consent from the study is defined as when a subject: 
• Does not want to participate in the study anymore 
and 
• Does not want any further visits or assessments 
and 
• Does not want any further study related contacts 
and 
• Does not allow analysis of already obtained biologic material 
In this situation, the investigator must make every effort (eg telephone, e-mail, letter) to 
determine the primary reason for the subject’s decision to withdraw his/her consent and record 
this information. 
Study treatment must be discontinued and no further assessments conducted, and the data that 
would have been collected at subsequent visits will be considered missing. 
Further attempts to contact the subject are not allowed unless safety findings require 
communicating or follow-up. 
All efforts should be made to complete the assessments prior to study withdrawal. A final 
evaluation at the time of the subject’s study withdrawal should be made as detailed in the 
assessment table below. 
5.6.4 
Loss to follow-up 
For subjects whose status is unclear because they fail to appear for study visits without stating 
an intention to discontinue or withdraw, the investigator must show "due diligence" by 
documenting in the source documents steps taken to contact the subject, eg dates of telephone 
calls, registered letters, etc. 

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5.6.5 
Early study termination by the sponsor 
The study can be terminated by Novartis at any time for any reason. This may include reasons 
related to the benefit risk assessment of participating in the study, practical reasons, or for 
regulatory or medical reasons (including slow enrolment). Should this be necessary, the subject 
must be seen as soon as possible and treated as a prematurely discontinued subject. The 
investigator may be informed of additional procedures to be followed in order to ensure that 
adequate consideration is given to the protection of the subject’s interests. The investigator will 
be responsible for informing the Institutional Review Board/Independent Ethics Committee 
(IRBs/IECs) of the early termination of the trial. 
 
Visit schedule and assessments 
Subjects should be seen for all visits on the designated day or as closely as possible to the 
original planned visit schedule. 
During the COVID-19 pandemic or similar major health care disruption that limits or prevents 
on-site study visits, alternative methods of providing continuing care may be implemented 
Phone calls, virtual contacts (e.g. teleconsult) or visits by site staff or home nursing service to 
the participant´s home depending on local regulations and capabilities, can partially replace on- 
site study visits, for the duration of the pandemic/ health care disruption until it is safe for the 
participant to visit the site again. These contacts should occur on or around the scheduled visit 
dates (or more frequently if needed). Events qualifying for being reported in CRF should be 
entered as appropriate. Every effort should be made to complete all study visit assessments 
feasible per protocol. Special effort should be made to conduct the scheduled EOT and EOF 
visit on site. If it is not feasible to conduct the EOT and EOF visit on-site, at least phone contact 
or if possible visits to the patient´s home by site staff as mentioned previously should be 
attempted. 
Screening will be flexible in duration and will last up to a maximum of 4 weeks. During this 
time, the custodian(s) and subject will sign first the informed consent and assent form 
respectively, subject will then be evaluated for eligibility and will have all screening visit 
assessments done as indicated in Table 6-1. 
Table 6-1 and Table 6-2 list all study assessments and indicate with an “x” at which visits the 
assessments are performed. 
If for any reason the subject is a screen failure, the subject may be rescreened. There is no 
restriction on the number of times a potential subject may be rescreened or on how much time 
must pass from the date of screen failure and the date of rescreening. 
If a subject rescreens for the study, then the custodian/subject must sign a new ICF/assent form 
and be issued a new subject number prior to any screening assessment being conducted for the 
subject under the new screening subject number. For all subjects, the investigator/qualified site 
staff will record if the subject was rescreened on the eCRF and any applicable screening 
numbers the subject was issued prior to the current screening number. 
The date of the new informed consent signature must be entered on the eCRF to correspond to 
the new screening subject number. Informed Consent for a rescreened subject must be obtained 

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prior to performing any study related assessment or collecting any data for the Screening Visit. 
For rescreening, all screening assessments must be performed as per protocol, except for the 
tuberculosis (TB) work up, if applicable, if performed not more than 12 weeks before 
randomization. 
If the date of a TB work up is less than 12 weeks from the projected randomization date, then 
it is not required that the TB work up be repeated. However, the subject must repeat the 
tuberculosis test performed by the central laboratory. 
At the discretion of the investigator, laboratory assessments at randomization visit need not be 
performed if screening laboratory assessments were performed within 7 days from 
randomization. 
During the treatment period, subjects may be seen at an unscheduled visit, eg if they experience 
deterioration of psoriasis, or AEs that in the opinion of the investigator need intervention or 
repeated laboratory testing. During these unscheduled visits, study treatment will NOT be 
administered. The assessment(s) performed at an unscheduled visit are at the investigator’s 
discretion. 
Suggested order of assessments: 
Suggested guidelines for conduct of the visit assessments (as applicable) are below: 
• Subject to complete CDLQI at the study site prior to any study assessments. 
• Investigator to complete investigator assessments: 
• IGA mod 2011 
• PASI 
• Review of CDLQI data 
• Physical exam 
• All remaining study visit procedures (eg, AE and concomitant medication collection, 
laboratory sample collection, vital signs measurements, etc) must be completed and results 
reviewed by the investigator or qualified designee prior to study treatment dosing. 
• Enter PASI data into the source data worksheets and perform calculations as needed 
BEFORE contacting IRT at randomization Visit. 
• Contact IRT to register the subject visit, as applicable 
• Administration of study treatment, as applicable 

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Table 6-1 
Assessment schedule (Year 1) 
 
Period 
Scr 
Treatment Year 1 
Week 
-4-Ra 
Day 1 (R) 
1 
2 
3 
4 
8 
12 
13 
14 
15 
16 
24 
32 
40 
48 
52 
Day 
-28-Ra 
1 (R) 
8 
15 
22 
29 
57 
85 
92 
99 
106 
113 
169 
225 
281 
337 
365 
Obtain informed consent1 
x 
Subject demographics 
x 
Inclusion/ exclusion2 
S 
S 
Psoriasis history/prior therapies 
x 
Medical history and prior medications 
x 
Concomitant medications3 
update as necessary 
Surgeries and non-drug procedures 
update as necessary 
Physical Exam 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
Height4 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Weight 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Vital signs (BP & pulse) 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Labs: Hematology6 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Blood chemistry6, Urinalysis(local) 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Tuberculosis test7 
x 
Serum pregnancy test(in females of 
childbearing potential) 6 
x 
Urine Pregnancy test8(local; in females of 
childbearing potential) 
x 
x 
x 
x 
ECG (standard 12-lead) 
x 
x 
x 
x 
Blood sample for immunogenicity(pre-dose)9 
x 
x 
x 
x 
Blood sample for PK (pre-dose)9 
x 
x 
x 
x 
x 
x 
x 
x 
x 
PASI 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
IGA mod 2011 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 

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Period 
Scr 
Treatment Year 1 
Week 
-4-Ra 
Day 1 (R) 
1 
2 
3 
4 
8 
12 
13 
14 
15 
16 
24 
32 
40 
48 
52 
Day 
-28-Ra 
1 (R) 
8 
15 
22 
29 
57 
85 
92 
99 
106 
113 
169 
225 
281 
337 
365 
CDLQI10 
x 
x 
x 
x 
x 
x 
(Serious) Adverse event assessment 
update as necessary 
Randomization via IRT 
x11 
Data entry of weight into IRT12 
x 
x 
x 
x 
x 
x 
x 
x 
Administration of study drug13 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Contact IRT 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Scr= screening, R=randomization, PK=pharmacokinetics, ECG=Electrocardiogram, CDLQI= children’s dermatology life quality index, IRT=Interactive 
response technology, 
X=assessment entered or transferred into the clinical database. S= assessment only recorded in source 
a Before randomizing the subject, the site must ensure that all assessments of the screening visit have been performed, all lab results are available and 
subject is eligible. Special attention must be given to tuberculosis testing as results take longer to be available. 
1 Apart from the Informed consent for this study signed by parent(s) /legal representatives, assent form will be completed as appropriate by the pediatric 
subjects. 
2 These assessments are supported by and are stored with the source documentation. However, data regarding to which inclusion/exclusion criteria are 
met are captured on the appropriate eCRF 
3 Information on Topical Corticosteroid medication, that a subject may use, is entered in the concomitant medications-topical corticosteroids eCRF 
4 Measured standing and barefoot, using the same stadiometer. 
 
 
6 Samples will be shipped to and analyzed by the central lab. At the discretion of the investigator, laboratory assessments need not to be performed 
again at Day 1-Randomization (R) visit if screening labs were performed within 7 days from randomization. 
7 If the first tuberculosis central lab test is indeterminate, the investigator may choose to perform a second test (as part of an unscheduled visit) or refer 
the subject for tuberculosis workup per local guidelines. If the result of any tuberculosis central lab test is “positive” or the results of two sequential tests 
are “indeterminate”, the subject must be referred to have a tuberculosis workup per local guidelines (if no workup within 12 weeks prior to randomization 
is available). The subject will not be eligible for randomization if active tuberculosis is present or if latent tuberculosis is present and is untreated as per 
local guidelines. 
8 Urine pregnancy test will be performed locally. If there is a positive urine pregnancy test, study treatment must be withheld and a serum pregnancy test 
done at the same visit. Pregnancy tests will be performed in female subjects of child bearing potential, i.e. those who have started menstruation and/or 
are of age 12 or older. 

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9 Samples shipped by the sites will be stored at the central laboratory and then shipped to reference laboratories for analysis. Each PK and IG blood 
sample should be collected pre-dose between Day 1 (Randomization) and Wk 52. 
10 CDLQI will no longer be completed once subjects reach 18 years of age 
11 At Day 1- Randomization the PASI Score and BSA must be calculated by appropriate site staff prior to contacting IRT. The investigator must ensure 
subject meets all eligibility criteria before contacting IRT to randomize the subject. 
12 For every visit (including unscheduled), weight measured at that visit will be entered into IRT. 
13 Secukinumab will be dispensed at site visits. After Week 16 and until Week 52 monthly treatment which occurs outside the site visits, may be 
administered at home every 4 weeks, either by subject (self-injection is allowed for subjects ≥ 12 years ) or parent/caregiver. In case subject or parent 
does not feel confident in performing home administrations subjects will be allowed to continue to perform drug administrations at site. These home 
administrations in the first year occur at Wk 20, Wk 28, Wk 36, Wk 44. During the COVID-19 pandemic, or any other pandemic, study medication may be shipped 
to the patient’s home and administration should be completed at the scheduled timepoints. 

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Table 6-2 
Assessment schedule - Years 2-4 (continued) 
 
Period 
Treatment Period (years 2-4) 
Follow-up Periodb 
Unscheduled d 
Week 
64 
76 
88 
104 
116 
128 
140 
156 
168 
180 
192 
208 
EOT 
212 
216 
224 
EOF 
Day 
449 
533 
617 
729 
813 
897 
981 
1093 
1177 
1261 
1345 
1457 
1681 
1709 
1765 
Concomitant medications1 
Update as necessary 
x 
Surgeries and non-drug procedures 
Update as necessary 
x 
Physical Exam 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
s 
S 
S 
Height2 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Weight 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Vital signs (BP & pulse) 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Hematology4 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Blood Chemistry4, Urinalysis (local) 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Urine Pregnancy test (local; in females of childbearing 
potential)5 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
S 
ECG (standard 12-lead) 
x 
x 
x 
x 
x 
x 
x 
Blood sample for IG6 
x 
x 
x 
x 
x7 
Blood sample for PK6 
x 
x 
x 
x 
x7 
PASI 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
IGA mod 2011 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
CDLQI8 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 

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Period 
Treatment Period (years 2-4) 
Follow-up Periodb 
Unscheduled d 
Week 
64 
76 
88 
104 
116 
128 
140 
156 
168 
180 
192 
208 
EOT 
212 
216 
224 
EOF 
Day 
449 
533 
617 
729 
813 
897 
981 
1093 
1177 
1261 
1345 
1457 
1681 
1709 
1765 
(Serious) Adverse event assessment 
Update as necessary 
x 
Data entry of weight into IRT9 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Contact IRT 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Administration of Study Drug10 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
End of Treatment 
x 
Study completion 
x 
R=randomization, PK=pharmacokinetics, ECG=Electrocardiogram, CDLQI= children’s dermatology life quality index, IRT=Interactive response technology, 
X=assessment entered or transferred into the clinical database. S= assessment only recorded in source 
a During EOT visit, subjects will have their last assessments performed for treatment period. This visit will also be performed for all subjects who will discontinue early the 
treatment period. 
b Follow-up assessments are to be conducted for subjects who complete treatment period and for subjects who discontinue study treatment early 
c EOF assessments are to be conducted for subjects who complete treatment free follow up period and for subjects who discontinue this period early 
d The assessments performed at an unscheduled visit are at the investigator’s discretion 
1Information on Topical Corticosteroid medication, that a subject may use, is entered in the concomitant medications- topical corticosteroids eCRF 
2 Measured standing and barefoot, using the same calibrated stadiometer, 
 
4 Samples will be shipped to and analyzed by the central lab. 
5If there is a positive urine pregnancy test, study treatment must be withheld and a serum pregnancy test must be done at the same visit and sent to central lab. 
Pregnancy tests will be performed in female subjects of child bearing potential, that is those who have started menstruation and/or are of age 12 or older. 
6 Samples shipped by the sites will be stored at the central laboratory and then shipped to reference laboratories for analysis. Each PK and IG sample should be collected 
pre-dose for Week 52 to Week 208. 
7 An unscheduled IG and/or PK sample is collected only to replace an IG or PK sample not taken at a regular scheduled visit. In case unscheduled IG sample is taken, 
there should always be a matching unscheduled PK sample taken at the same time point. 
8 CDLQI will no longer be completed once subjects reach 18 years of age 

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9 For every visit, the weight measured at that visit will be entered into IRT 
10 Secukinumab will be dispensed at site visits. Between site visits, study medication will be administered every 4-weeks at home either by the subject (self-injection is 
allowed for subjects ≥ 12 years) or parent/caregiver until Week 204. In case subject or parent/caregiver does not feel confident in performing home administrations 
subjects will be allowed to continue to perform drug administrations at site. Home administrations in the years 2-4 occur at Wk 56, Wk 60, Wk 68, Wk 72, Wk 80, Wk 84, 
Wk 92, Wk 96, Wk 100, Wk 108, Wk 112, Wk 120, Wk 124, Wk 132, Wk 136, Wk 144, Wk 148, Wk 152, Wk 160, Wk 164, Wk 172, Wk 176, Wk 184, Wk 188, Wk 196, 
Wk 200, Wk 204. During the COVID-19 pandemic, or any other pandemic, study medication may be shipped to the patient’s home and administration should be 
completed at the scheduled timepoints. 

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6.1 
Information to be collected on screening failures 
All subjects who sign the informed consent but discontinue prior to randomization at Day 1 are 
considered to be screen failures. 
If a subject discontinues prior to randomization, the IRT provider must be notified within 5 
days, and the reason for the subject not being randomized will be entered in the respective 
Disposition eCRF. The Screening visit date, the Demography eCRF, the Informed Consent 
eCRF, the Inclusion/Exclusion eCRF, and the subject rescreening eCRF must be completed. 
The AE eCRF should be completed for any SAEs that occurred during the screening period. 
Adverse events that are not SAEs will be followed by the investigator and collected only in the 
source data. The Death eCRF should be completed in the case of a death during the screening 
period. The withdrawal of consent eCRF must be completed if consent was withdrawn during 
the screening period before the subject was randomized. 
6.2 
Subject demographics/other baseline characteristics 
All Baseline assessments should be performed prior to first study treatment administration. 
These may be in the screening period (eg demographics) or at the Randomization Visit eg 
patient reported outcomes (PROs), depending on the assessment. 
6.2.1 
Demographics 
Data to be collected on all subjects include: age, sex, race, and ethnicity). 
6.2.2 
Psoriasis medical history / Previous psoriasis therapy 
Disease history will be collected at the screening visit. The information to be collected and 
entered in the Psoriasis History eCRF and Prior Psoriasis Therapies eCRF includes the 
following: 
• The date of first diagnosis of plaque psoriasis (by a physician) 
• The previous treatments of psoriasis (including previous use systemic therapies, biologic 
therapies, as well as phototherapy and/or photo chemotherapy or topical use) and the 
reason for discontinuation of each therapy 
• The presence of psoriatic arthritis and the date of first diagnosis (by a physician) 
6.2.3 
Relevant medical history / current medical conditions 
Relevant medical history and current medical conditions, not including psoriasis or psoriatic 
arthritis, prior to signing of the informed consent will be recorded in the Medical History eCRF. 
Whenever possible, diagnoses and not symptoms will be recorded. 
Significant findings that are observed after the subject has signed the informed consent form 
and that meet the definition of an AE must be recorded in the AE eCRF. 
Investigators will have the discretion to record abnormal test findings on the medical history 
CRF whenever in their judgment, the test abnormality occurred prior to the informed consent 
signature. 

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6.2.4 
Determination of Tuberculosis status 
Determination of tuberculosis (TB) status will be required before administration of study 
treatment and should be performed as defined by local guidelines. TB status must be determined 
by medical history, signs, symptoms and TB central lab testing. Any significant findings will 
be recorded in the relevant TB assessment eCRF and the Medical History eCRF, as necessary. 
A central lab testing will be performed to assess the TB status at screening for all subjects. This 
test will only be used to determine subject’s eligibility for the trial. The test will be used to 
screen the subject population for latent tuberculosis infection (Doherty et al 2008). 
This blood-based assay is specific for Mycobacterium tuberculosis and is not influenced by 
previous Bacillus Calmette-Guérin vaccination or exposure to other Mycobacteria species. This 
test, in contrast to the purified protein derivative (PPD) skin test, is also insensitive to a booster 
effect since the subject is not exposed to the vaccine. The assay measures the production of 
interferon-gamma and presents it relative to a negative and a positive control sample. Further 
information is available in Manuel and Kumar (2008). 
The tuberculosis assay test will be supplied by the central laboratory. Details on the collection, 
shipment of samples and reporting of results by the central laboratory are provided to 
investigators in the laboratory manual. 
Refer to Figure 6-1 for guidance on subject eligibility with respect to TB testing. The results of 
a workup for a subject with a positive or indeterminate test must be recorded on the Tuberculosis 
assessment eCRF. 
• If the test result is negative, the subject may be randomized. 
• If the test result is positive, the investigator should perform workup for the test result as 
per local procedures. If a TB workup was conducted prior to the screening the subject, 
results of the workup can be used to assess eligibility if the workup was conducted within 
12 weeks prior to randomization. 
• Subject positive for latent TB per workup may be randomized to the trial if sufficient 
treatment has been initiated according to local routine clinical practice and will be 
maintained for the prescribed duration. 
• Subjects positive for active TB per workup are not eligible for the study. 
• Subjects negative for TB (no signs of latent or active TB) per workup may be 
randomized to the trial. 
• If the test result is indeterminate, the investigator may repeat the test once or may 
proceed directly to perform workup for the test result as per local procedures. This 
action is at the discretion of the investigator. If a TB workup was conducted prior to the 
screening the subject, results of the workup can be used to assess eligibility if the workup 
was conducted within 12 weeks prior to randomization. 
• If the second test is negative, the subject may be randomized. 
• If the second test is positive or indeterminate, the investigator should perform workup 
as per local guidelines. Subject positive for latent TB per workup may be randomized 
to the trial if sufficient treatment has been initiated according to local routine clinical 
practice and will be maintained for the prescribed duration. The subject will not be 

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eligible for randomization if “active tuberculosis is present” or “latent tuberculosis is 
present” and is untreated per local guidelines. 
• Subjects negative for TB per workup (no signs of latent or active TB) may be 
randomized to the trial if the workup was conducted 12 within weeks prior to 
randomization. 
If eligibility is being assessed with only 1 test result and a TB workup (i.e., no second TB test 
will be performed), the TB test to assess eligibility must have been done via the central 
laboratory for the study within the screening period (within 4 weeks prior to randomization) 
and TB workup will only be considered if it was completed within 12 weeks prior to 
randomization. 

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Figure 6-1 
Tuberculosis screening flowchart 
 

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6.2.5 
Other baseline characteristics 
Baseline characteristic data to be collected on all subjects include (all labs are central except 
where indicated): 
ECG, vital signs; hematology; clinical chemistry; local urinalysis; immunogenicity; PK; PASI; 
IGA mod 2011; CDLQI. A serum pregnancy test will be performed for females of child bearing 
potential or of at least 12 years of age at screening. 
6.3 
Treatment exposure and compliance 
All doses of study treatment administered will be recorded on the appropriate Dosage 
Administration Record eCRF page. Information on drug dispensing, administration, 
accountability will be collected in drug accountability logs and other documents as appropriate. 
For drug administrations at home subject will record relevant information at home which will 
then be transcribed at the corresponding documents at site including Dosage Administration 
Record eCRF page, 
Subject compliance to the study treatment should be assessed by qualified site personnel at each 
study visit using the study kits and documentation regarding study treatment dispensation and 
administration. 
Site compliance will also be assessed continuously during the conduct of the study by Novartis 
study personnel using medication kits and the corresponding documentation. 
6.4 
Efficacy 
All efficacy assessments should be performed prior to administration of study treatment. There 
are two co-primary efficacy variables in this study: PASI 75 response and IGA mod 2011 0 or 
1 response. 
The following order should be applied when performing the efficacy assessments during study 
visits: 
• Investigator’s Global Assessment (IGA mod 2011; scale from 0 – 4) 
• Psoriasis Area and Severity Index (PASI; score from 0 – 72) 
 
 
6.4.1 
Investigator Global assessment (IGA mod 2011) 
The IGA mod 2011 will be conducted for overall psoriatic disease as indicated in Table 6-1 and 
Table 6-2. It is recommended that the same evaluator conducts the efficacy assessment 
throughout the study whenever possible. 
The IGA mod 2011 rating scale for overall psoriatic disease is shown in Table 6-3 below. 
The IGA mod 2011 scale has been developed based on a previous version of the scale used in 
secukinumab phase II studies in collaboration with health authorities, in particular the FDA. 
The explanations/descriptions of the points on the scale have been improved to ensure 
appropriate differentiation between the points. 

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The IGA mod 2011 used in this study is static, ie, it refers exclusively to the subject’s disease 
state at the time of the assessments, and does not attempt a comparison with any of the subject’s 
previous disease states, whether at baseline or at a previous visit. 
The IGA mod 2011 score will be recorded in the eCRF. 
Table 6-3 
IGA mod 2011 scale 
 
 
0 
Clear, No signs of psoriasis. Post-inflammatory hyperpigmentation may be present 
1 
Almost clear- Normal to pink coloration of lesions; no thickening; no to minimal focal 
scaling 
2 
Mild- Pink to light red coloration; just detectable to mild thickening; predominantly fine 
scaling 
3 
Moderate -Dull bright red, clearly distinguishable erythema; clearly distinguishable to 
moderate thickening; moderate scaling 
4 
Severe- Bright to deep dark red coloration; severe thickening with hard edges; severe / 
coarse scaling covering almost all or all lesions 
Based on this scale, a subject will be eligible to participate in the study if the subject has an IGA 
mod 2011 score at baseline of 3 or 4. 
Based on this scale, a subject will be considered an IGA mod 2011 0 or 1 responder if the 
subject achieves a score of 0 or 1 and improved by at least 2 points on the IGA mod 2011 scale 
compared to baseline. 
6.4.2 
Assessment of total body surface area (BSA) and psoriasis area safety 
index (PASI) 
The investigator or trained qualified designee will complete the PASI assessment as indicated 
in Table 6-1, Table 6-2. Whenever possible, the same evaluator should perform this efficacy 
assessment at all visits. 
The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas 
affected, including head, trunk, upper limbs and lower limbs (see below for full details of the 
PASI assessment). The following calculations will be done: Each reported percentage will be 
multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper 
limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the 
total BSA affected by plaque-type psoriasis. 
A PASI score (Fredriksson and Petterson 1978, Weisman et al 2003, Gottlieb et al 2005) will 
be derived as indicated in Table 6-4. The head, trunk, upper limbs and lower limbs are assessed 
separately for erythema, thickening (plaque elevation, induration), and scaling (desquamation). 
The average degree of severity of each sign in each of the four body regions is assigned a score 
of 0-4. The area covered by lesions on each body region is estimated as a percentage of the total 
area of that particular body region. Further practical details help the assessment: 
• The neck is assessed as part of the head. 
• The axillae and groin are assessed as part of the trunk. 
• The buttocks are assessed as part of the lower limbs. 

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• When scoring the severity of erythema, scales should not be removed. 
Table 6-4 
PASI scoring system 
 
Body region 
Erythema (E) 
Thickening (I) 
(plaque 
elevation, 
induration) 
Scaling (D) 
(desquamation) 
Area score (A) 
(based on true area %)* 
Head (H)† 
0=none 
0=none 
0=none 
0 = no involvement 
1= slight 
1= slight 
1= slight 
1 = >0-<10% 
2= moderate 
2= moderate 
2= moderate 
2 = 10-<30% 
3= severe 
3= severe 
3= severe 
3 = 30-<50% 
4=very severe 
4=very severe 
4=very severe 
4 = 50- <70% 
5 = 70-<90% 
6= 90 -100% 
Trunk (T)‡ 
0=none 
0=none 
0=none 
0 = no involvement 
1= slight 
1= slight 
1= slight 
1 = >0-<10% 
2= moderate 
2= moderate 
2= moderate 
2 = 10-<30% 
3= severe 
3= severe 
3= severe 
3 = 30-<50% 
4=very severe 
4=very severe 
4=very severe 
4 = 50- <70% 
5 = 70-<90% 
6= 90-100% 
Upper limbs (U) 
0=none 
0=none 
0=none 
0 = no involvement 
1=slight 
1=slight 
1=slight 
1 = >0-<10% 
2=moderate 
2=moderate 
2=moderate 
2 = 10-<30% 
3=severe 
3=severe 
3=severe 
3 = 30-<50% 
4=very severe 
4=very severe 
4=very severe 
4 = 50- <70% 
5 = 70-<90% 
6 = 90-100% 
Lower limb (L)§ 
0=none 
0=none 
0=none 
0 = no involvement 
1=slight 
1=slight 
1=slight 
1 = >0-<10% 
2=moderate 
2=moderate 
2=moderate 
2 = 10-<30% 
3=severe 
3=severe 
3=severe 
3 = 30-<50% 
4=very severe 
4=very severe 
4=very severe 
4 = 50- <70% 
5 = 70-<90% 
6 = 90-100% 
* Percentage (not score) of body region (not whole body) affected will be entered in the eCRF 
† Neck is assessed as part of the Head (H) body region. 
‡ Axillae and groin are assessed as part of the Trunk (T) body region. 
§ Buttocks are assessed as part of the Lower limbs (L) body region. 
Because the head and neck, upper limbs, trunk and lower limbs correspond to approximately 
10%, 20%, 30% and 40% of the body surface area, respectively, the PASI score is calculated 
using the formula: 
PASI=0.1 (EH+IH+DH)AH+0.2(EU+IU+DU)AU+0.3(ET+IT+DT)AT +0.4(EL+IL+DL)AL 

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The keys for the letters are provided in Table 6-4. 
PASI scores can range from a lowest value of 0, corresponding to no signs of psoriasis, up to a 
theoretic maximum of 72. 
The investigator or qualified designee is responsible for evaluating the subject and collecting 
the PASI components, scoring signs and total regional area. The PASI data will be entered into 
the PASI eCRF. 
Based on PASI, to be eligible, a subject must have a score of 12 or more at the Randomization 
Visit. 
Based on total BSA, to be eligible, a subject must have 10% or more total BSA involved at the 
Randomization Visit. 
Only if the above eligibility criteria and all other eligibility criteria are fulfilled should site 
contact IRT at the Randomization Visit to randomize the subject. 
Definitions of efficacy variables based on PASI 
The following definitions are used in this study (see CHMP guidelines for psoriasis 
(CHMP/EWP/2454/02 2004)): 
PASI 75 response: subjects achieving ≥ 75% improvement (reduction) in PASI score compared 
to baseline are defined as PASI 75 responders 
PASI 90 response: subjects achieving ≥ 90% improvement (reduction) in PASI score compared 
to baseline are defined as PASI 90 responders 
PASI 100 response / remission: complete clearing of psoriasis (PASI=0) 
 
 
6.4.4 
Appropriateness of efficacy assessments 
The PASI score, the assessment of the severity of the psoriasis symptoms and the extent to 
which the subject’s body area is affected by the disease, is considered acceptable by health 
authorities (CHMP guideline on the treatment of psoriasis-CHMP/EWP/2454/02 2004) to 
assess efficacy in conjunction with Investigator’s Global Assessment (IGA). 

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6.5 
Safety 
All blood draws and safety assessments should be done prior to study treatment administration. 
Appropriate safety assessments (eg, evaluation of AEs and SAEs including injection site 
reactions) should be repeated after the dose is administered. 
During the COVID-19 pandemic or similar major health care disruption that limits or prevents 
on-site study visits, phone calls, virtual contacts (e.g. teleconsult), or visits by site staff or home 
nursing service depending on local regulations and capabilities may occur on or around 
scheduled protocol visit dates (or more frequently if needed). This will be done for safety 
monitoring and discussion of the subject´s health status until the subject can again visit the 
site. Case report forms (e.g. AEs, concomitant medications, procedures and non-drug therapies) 
should be updated as appropriate. 
6.5.1 
Physical examination 
A physical examination, including general appearance, skin, neck, eyes, ears, nose, throat, lungs, 
heart, abdomen, back, lymph nodes, and extremities, and vascular and neurological systems 
will be performed as indicated in Table 6-1, Table 6-2. Investigator should pay special attention 
to any signs or symptoms of potential skin or mucosal candida infections. 
If indicated, based on medical history and/or symptoms, additional exams will be performed at 
the discretion of the investigator. 
If possible, assessments for an individual subject should be performed by the same member of 
the study site staff throughout the study. 
Information for all physical examinations must be included in the source documentation at the 
study site. Significant findings that are present prior to the screening visit must be included in 
the Medical History screen on the subject’s eCRF. Significant findings made after the start of 
study (Day 1) that meet the definition of an adverse event must be recorded on the Adverse 
Event screen of the subject’s eCRF. 

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6.5.3 
Vital signs 
Vital signs (including blood pressure and pulse measurements) will be assessed at every 
scheduled visit as indicated in Table 6-1, Table 6-2. If possible, assessments should be 
performed by the same study site staff member throughout the study. 
After the subject has been sitting for five minutes, with back supported and both feet placed on 
the floor, systolic and diastolic blood pressure will be measured twice (measurements 
separated by 1 to 2 minutes) using a validated device, with a cuff that is appropriately sized for 
the subject’s arm circumference. The average of the two measurements will be entered on the 
Vital Signs eCRF. 
The Recommendations for the dimensions of Blood Pressure Cuff Bladders are noted in the 
following table. 
Table 6-5 
Recommended Dimensions for Blood Pressure Cuff Bladders 
 
Width [cm] 
Length [cm] 
Maximum Arm 
Circumference [cm]* 
Newborn 
4 
8 
10 
Infant 
6 
12 
15 
Child 
9 
18 
22 
Small adult 
10 
24 
26 
Adult 
13 
30 
34 
Large adult 
16 
38 
44 
*calculated so that the bladder can encircle even the largest arm by at least 80% 
Source: Feld and Corey H (2007): Hypertension in childhood, Pediatric in Review 28: 283-98 
Whether action needs to be taken to address notable vital signs will be decided by the 
investigator/qualified site staff, taking into account the overall status of the subject. No specific 
action is foreseen as part of the study protocol. 
6.5.4 
Height and weight 
Height and body weight will be measured at visits as in Table 6-1, Table 6-2. Height 
measurements (in indoor clothing, but without shoes, socks, hats or hair accessories interfering 
with assessment) will be made using a stadiometer that is calibrated on a regular basis. Height 
measurements will be performed twice and the reported height will be the mean of the 2 
measurements. 
If possible, body weight assessments (in indoor clothing, but without shoes) should be 
performed by the same study site staff member and using the same scale throughout the study. 
The body weight recorded at Randomization (Day 1) will be used to categorize the subject 
population at randomization to receive the corresponding doses in the high dose and low dose 
secukinumab groups. 
6.5.5 
Laboratory evaluations 
Subjects should avoid smoking within the hour preceding the blood draws. 

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A central laboratory will be used for analysis of all specimens listed below, unless noted 
otherwise. Details on the collections, shipment of samples and reporting of results by the central 
laboratory are provided to investigators in the laboratory manual. The blood volume drawn will 
be adjusted for pediatric subjects and will be stated in the laboratory manual. 
During the COVID-19 pandemic or a major healthcare disruption that limits or prevents on-site 
study visits and central lab sampling, performing the safety lab tests locally will be allowed in 
case it is needed to check safety parameters. Depending on local regulations, technical 
capabilities and following any applicable training in the required process, qualified staff may 
visit the subject at home to draw blood/ urine samples if needed to check safety parameters. 
Clinically notable values for key laboratory tests are defined in Section 13, Appendix 1. For 
identification of pediatric abnormal values for all parameters, the laboratory manual must also 
be consulted. 
Whether action needs to be taken to address notable laboratory values will be decided by the 
investigator, taking into account the overall status of the subject. No specific action is foreseen 
as part of the study protocol. 
6.5.5.1 
Hematology 
Hemoglobin, hematocrit, red blood cell count, white blood cell count with differential 
(neutrophils including bands, lymphocytes, monocytes, eosinophils, basophils) and platelet 
count will be measured at scheduled study visits, as specified in Table 6-1, Table 6-2. 
6.5.5.2 
Clinical chemistry 
Serum chemistry will include urea or BUN, creatinine, total bilirubin, AST (SGOT), ALT 
(SGPT), GGT, alkaline phosphatase, sodium, potassium, bicarbonate, calcium, phosphorous, 
total protein, albumin, and uric acid. 
Serum chemistry will be measured at scheduled study visits as specified in Table 6-1, Table 6- 
2. 
6.5.5.3 
Estimated GFR 
In addition estimated Glomerular Filtration Rate (eGFR) as per Schwartz et al (Schwartz et al 
2009) will be calculated and reported by the Central Laboratory, whenever a serum creatinine 
is performed. 
The calculation is based on the following formula: 
eGFR (ml/min/1.73m2) = 0.413 x height (cm) / serum creatinine (mg/dl) 
Height will be provided by the site to the central lab. 
For eGFR, baseline value for the decrease from baseline criterion will be calculated as the 
average of values prior to the first dose (i.e. screening and baseline values). 

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6.5.5.4 
Urinalysis 
Urine Dipstick (local) 
A midstream urine sample (approximately 30 mL) will be obtained, in order to avoid 
contamination with epithelial cells and sediments, and allow proper assessments. 
A semi-quantitative ‘dipstick’ evaluation for the following parameters will be performed: 
specific gravity, pH, glucose, protein, bilirubin, ketones, leukocytes and blood, micro albumin. 
Urinalysis will be measured locally at scheduled study visits as specified in Table 6-1, Table 6- 
2. 
6.5.6 
Electrocardiogram (ECG) 
A standard 12-lead ECG will be performed as indicated in Table 6-1, Table 6-2. When the ECG 
is performed at scheduled visits, the investigator will review and initial tracing, and store with 
the subject’s source documentation. All ECGs must be performed on the ECG machines 
provided to the study site. 
All ECGs will be independently reviewed by a central reader. Instructions for the collection and 
transmission of the ECGs to the independent reviewer will be provided in the ECG investigator 
manual. 
Even though there is no exclusion criterion specifically based on the ECG, the ECG performed 
at Screening must be reviewed for major abnormalities before dosing at the randomization visit. 
If the ECG findings are clinically relevant and would prevent the subject from participating in 
the study (taking into account the subject's overall status including medical history and 
concomitant medications), the subject should not receive treatment and should exit the study. 
If a clinically relevant abnormality is noted on the screening ECG it should be reported in the 
Medical History eCRF. Clinically relevant abnormalities noted after the screening ECG should 
be recorded as AEs. 
6.5.7 
Immunogenicity 
Blood samples for immunogenicity (anti-secukinumab antibodies) will be taken pre-dose by 
direct venipuncture at the scheduled time points as indicated in Table 6-1, Table 6-2 and 
Appendix 2, Table 14-2. Blood samples (approximately 2 mL) will be collected into serum 
separator tube (SST) tubes. The blood sample will be allowed to clot over a minimum of 30 
minutes at room temperature prior to harvesting of the serum. The serum will be obtained by 
centrifugation at approximately 2500 revolutions per minute (rpm) for 10 minutes, or within 
sufficient time and speed to allow formation of a clear supernatant layer. 
Serum samples will be split into 2 aliquots (labeled plain barrier polypropylene tubes) and then 
stored (within 30 minutes of serum collection by centrifugation) at approximately -70˚C to - 
20˚C prior to shipment on dry ice to the central laboratory. Shipment of stored aliquots from 
the site to the central lab should be on a pre-specified basis. To the extent possible, the site 
should send each aliquot of the sample to the central laboratory separately. The central lab will 
ship aliquots of the samples on dry ice to the analytical laboratory as per agreement with 
Novartis. Immunogenicity samples will only be disposed of after approval by the Sponsor. 

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The actual sample collection date and time will be entered on the relevant Blood collection for 
IG eCRF. In case unscheduled IG samples are taken, matching PK samples must be taken as 
well. 
A laboratory manual will be provided by the central laboratory with detailed information on 
sample collection, sample handling and shipment. 
Tubes and labels will be provided by the central laboratory with study/sample type and sample 
number preprinted on the label. 
Further details on labeling of the immunogenicity samples can be found in Appendix 2, Table 
14-2 . 
Sample stability 
Due to the nature of the immunogenicity response, no real stability data can be given for 
immunogenicity samples. 
The serum samples will be transferred on dry ice (enough dry ice to avoid thawing) from the 
central laboratory to the analytical laboratory at Novartis or a designated Clinical Research 
Organization (CRO). 
Immunogenicity analytical method 
An electrochemiluminescence based method will be used for the detection of potential anti- 
AIN457 antibody formation. The detailed method description to assess immunogenicity will be 
described in the bioanalytical raw data of the study and in the respective Bioanalytical Data 
Report (BDR). 
6.5.8 
Pregnancy and assessments of fertility 
Females of child-bearing potential are defined as all females physiologically capable of 
becoming pregnant. This includes female pediatric subjects who are menarchal or who become 
menarchal during the study. In this study pregnancy tests will be performed in female subjects 
who are menarchal or become menarchal during the study and/or are 12 years of age or older at 
the beginning or at any point during the study. Sites must ensure that pregnancy testing 
commences once any of these conditions are fulfilled. 
Serum pregnancy test will be performed for all females of child-bearing potential according to 
the schedule in Table 6-1, Table 6-2. 
During the COVID-19 pandemic or similar major health care disruption that limits or prevents 
female subjects of childbearing potential or at least of 12 years of age for on-site study visits, 
urine pregnancy test kits may be shipped or provided directly to the subject. After appropriate 
instruction, patients can perform the urine pregnancy test at home at the time points specified 
in the protocol and report the result to the site. It is important that patients perform the pregnancy 
test first and only if the test result is negative, they then should proceed with the administration 
of the study drug. 
A communication process should be established with the subject so that the site is informed of 
the pregnancy test results. 

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All menarchal girls and their parents/custodians should be informed about the potential risks of 
pregnancy and the need to prevent pregnancy during the study. It is important to be sensitive in 
introducing this issue, as understanding and comprehension of puberty, sexual activity, 
pregnancy and contraception is influenced by age, as well as factors such as precocity, socio- 
educational economic and familial background. These discussions with the subject and her 
parents/custodians are therefore best performed by investigators familiar with the pediatric 
subject and her family and should be guided by requirements of the local regulatory authorities. 
These discussions should take into account the socio-economic, cultural factors and religious 
beliefs of the adolescent participant and her family. The investigator should also discuss the 
management of the pregnancy test results with the subject and her parents/custodians. The 
privacy of the subject should be considered in accordance with the local law and ethics. 
Additional pregnancy tests may be performed at the investigator’s discretion during the study. 
Subjects becoming pregnant must be discontinued from study drug. However, a subject may 
choose to remain in the study should she become pregnant, and be followed in the treatment- 
free follow-up period as described in Table 6-1, Table 6-2. 
Female subjects of child-bearing potential who do not agree to abstinence and who are or might 
become sexually active must be informed of the need to prevent pregnancy, by using effective 
methods of contraception during dosing of study treatment and for a minimum of 16 weeks 
after stopping study treatment or longer if local label requires it (eg in EU 20 weeks). 
Details on contraception methods can be found in the Exclusion criteria, Section 4.2. 
It is recommended that the decision on the contraceptive method should be reviewed at least 
every 3 months to evaluate the individual need and compatibility of the method chosen. 
6.5.9 
Appropriateness of safety measurements 
The safety measures used in this study are reliable and relevant standard measures for a biologic 
immunomodulating agent in psoriasis. 
6.6 
Other assessments 
6.6.1 
Clinical Outcome Assessments (COAs) 
6.6.1.1 
Subject/Patient Reported Outcomes (PRO) 
The impact of psoriasis on various aspects of subject’s health-related quality of life (HRQoL) 
will be assessed by Children’s Dermatology Life Quality Index (CDLQI). 
The Children’s Dermatology Life Quality Index (Lewis-Jones and Finlay 1995) is a 10-item 
general dermatology disability index designed to assess health-related quality of life in pediatric 
subjects aged 4 to 16 years. It is self-explanatory and may be completed by the child with 
assistance from parents or caregivers as necessary. The 10 questions cover six areas of daily 
activities including symptoms and feelings, leisure, school or holidays, personal relationships, 
sleep and treatment. The questions are based on the preceding week to permit accurate recall. 

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Each question is answered on a 4-point Likert scale scored from 0 to 3. These are added to give 
a minimum score of 0 and maximum score of 30. A higher CDLQI score indicates greater 
degree of QoL impairment. 
CDLQI is available in two versions, text only and text with cartoons. The text only version will 
be used in this study. The mean completion time of the text version is 120 seconds. 
This questionnaire should be completed in the language the subject is most familiar with before 
any other clinical assessments, 
All subjects will complete the PRO questions via an electronic tablet. The questionnaire should 
be completed by the subject with the help of parent/custodian if and as needed. The site staff 
may help understand the questions, as necessary. The subject should be given sufficient space 
and time to complete the questionnaire. If subject experiences any difficulties with submission 
after they complete the PROs, the study staff should assist with submitting the PRO responses. 
Attempts should be made to collect responses to all PROs for all subjects, including from those 
who prematurely discontinue prior to the study evaluation completion visit, however, if 
subjects/subjects refuse to complete PROs, this should be documented in study source records. 
Subject’s refusal to complete study PROs are not protocol deviations. 
The study coordinator should check the questionnaire for completeness and encourage the 
subject to complete any missing responses before the clinical examination. Missing data will 
not be imputed. 
The CDLQI questionnaire will be completed by the subject as indicated in Table 6-1, Table 6- 
2. CDLQI will no longer be completed, once the subjects reach 18 years of age. 
During the COVID-19 pandemic or similar major health care disruption that limits or prevents 
on-site study visits, CDLQI questionnaire data may be collected remotely (e.g. via telephone 
interview of the subject) by qualified site personnel. This will depend on local regulations, 
technical capabilities and following any applicable training in the required process. 
Documentation of the procedure should follow the vendor emergency manual directives. 
Completed questionnaires will be reviewed and examined by the investigator, before the clinical 
examination, for responses that may indicate potential adverse events (AEs) or serious adverse 
events (SAEs). The investigator should review not only the responses to the questions in the 
questionnaires but also for any unsolicited comments written by the subject. If AEs or SAEs 
are confirmed, then the physician must record the events as per instructions given in Section 
7.1 and Section 7.2 of the protocol. 
6.6.1.2 
Performance Outcomes (PerfO) 
Not applicable 
6.6.1.4 
Proxy Reported Outcomes 
Not applicable 
6.6.2 
Resource utilization 
Not applicable 

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6.6.3 
Pharmacokinetics 
At all study sites, blood samples will be collected for pharmacokinetics (PK) at the scheduled 
visits as indicated in Table 6-1, Table 6-2. 
Pharmacokinetic samples will be obtained for all subjects. For a detailed description of the 
blood sampling schema, including time points, refer to the Blood Log in Appendix 2. 
All blood samples will be taken by direct venipuncture in a forearm vein. 
PK sample handling, labeling and shipment instructions 
Blood samples (1 mL,) will be collected into SST tubes. The blood sample will be allowed to 
clot over a minimum of 30 minutes at room temperature prior to harvesting of the serum. The 
serum will be obtained by centrifugation at approximately 2500 rpm for 10 minutes, or within 
sufficient time and speed to allow formation of a clear supernatant layer. Serum samples will 
be split into 2 aliquots (polypropylene tubes) and then stored (within 30 min of serum collection 
by centrifugation) at -20°C or -70°C (approximately) prior to shipment to the central laboratory. 
Shipment of stored aliquots from the site to the central lab should be on a pre-specified basis. 
To the extent possible, the site should send each aliquot of a sample to the central laboratory 
separately. The central lab will ship aliquots of the samples on dry ice to the analytical 
laboratory as per agreement with Novartis. PK samples will only be disposed of after approval 
by the Sponsor. 
The actual date and time of sample collection will be entered on the appropriate CRF page. 
Laboratory manuals will be provided by the central laboratory with detailed information on 
sample collection, sample handling and shipment. 
Tubes and labels will be provided by the central laboratory with study/sample type and sample 
number preprinted on the label. 
Further details on labeling of the pharmacokinetic samples can be found in Appendix 2 of the 
protocol. 
PK sample stability 
Secukinumab is stable in serum samples for at least 12 months at -20°C or 32 months at -80°C. 
6.6.4 
Other biomarkers 
Not applicable 
 
Safety monitoring 
7.1 
Adverse events 
An adverse event (AE) is any untoward medical occurrence (eg, any unfavorable and 
unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or 
clinical investigation subject after providing written informed consent for participation in the 
study until the end of study visit. Therefore, an AE may or may not be temporally or causally 
associated with the use of a medicinal (investigational) product. 

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In addition, all reports of intentional misuse and abuse of the product are also considered an 
adverse event irrespective if a clinical event has occurred. 
The occurrence of adverse events must be sought by non-directive questioning of the subject at 
each visit or scheduled phone/virtual contact during the study. Adverse events also may be 
detected when they are volunteered by the subject during or between visits or through physical 
examination findings, laboratory test findings, or other assessments. 
Abnormal laboratory values or test results constitute adverse events only if they fulfill at least 
one of the following criteria: 
• they induce clinical signs or symptoms, 
• they are considered clinically significant, 
• they require therapy. 
Clinically significant abnormal laboratory values or test results must be identified through a 
review of values outside of normal ranges/clinically notable ranges, significant changes from 
baseline or the previous visit, or values which are considered to be non-typical in subject with 
underlying disease. Investigators have the responsibility for managing the safety of individual 
subject and identifying adverse events. Alert ranges for laboratory and other test abnormalities 
are included in Appendix 1. 
Adverse events must be recorded in the appropriate CRF capturing AEs under the signs, 
symptoms or diagnosis associated with them, accompanied by the following information: 
• the severity grade 
• mild: usually transient in nature and generally not interfering with normal activities 
• moderate: sufficiently discomforting to interfere with normal activities 
• severe: prevents normal activities 
• its relationship to the study treatment 
• its duration (start and end dates) or if the event is ongoing an outcome of not 
recovered/not resolved must be reported. 
• whether it constitutes a serious adverse event (SAE - See Section 7.2 for definition of 
SAE) and which seriousness criteria have been met. 
• action taken regarding secukinumab treatment 
All adverse events must be treated appropriately. Treatment may include one or more of the 
following: 
• no action taken (eg further observation only) 
• 
secukinumab treatment interrupted/withdrawn 
• concomitant medication or non-drug therapy given 
• non-drug therapy given 
• subject hospitalized/subject’s hospitalization prolonged (see Section 7.2 for definition of 
SAE) 
• its outcome (not recovered/not resolved; recovered/resolved; recovered/resolved with 
sequelae; fatal; or unknown) 

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Once an adverse event is detected, it must be followed until its resolution or until it is judged 
to be permanent, and assessment must be made at each visit (or more frequently, if necessary) 
of any changes in severity, the suspected relationship to the study drug, the interventions 
required to treat it, and the outcome. 
Worsening of psoriasis in this study is evaluated via the use of PASI, IGA mod 2011 and 
CDLQI assessments and is not expected to be captured as an AE in the eCRF. Exceptions 
include cases when a) a new type of psoriasis is diagnosed eg guttate psoriasis) or b) the 
worsening of psoriasis is so severe that a qualitatively different status is reached. 
Information about common side effects already known about the investigational drug can be 
found in the Investigator Brochure (IB). This information will be included in the subject 
informed consent and should be discussed with the subject during the study as needed. Any 
new information regarding the safety profile of the medicinal product that is identified 
between IB updates will be communicated as appropriate, for example, via an IN or an 
Aggregate Safety Finding. New information might require an update to the informed consent 
and has then to be discussed with the subject. 
The investigator must also instruct each subject to report any new adverse event (beyond the 
protocol observation period) that the subject, or the subject’s personal physician, believes might 
reasonably be related to study treatment. This information must be recorded in the investigator’s 
source documents; however, if the AE meets the criteria of an SAE, it must be reported to 
Novartis. 
7.2 
Serious adverse events 
7.2.1 
Definition of SAE 
An SAE is defined as any adverse event [appearance of (or worsening of any pre-existing)] 
undesirable sign(s), symptom(s) or medical conditions(s)) which meets any one of the following 
criteria: 
• is fatal or life-threatening 
• results in persistent or significant disability/incapacity 
• constitutes a congenital anomaly/birth defect 
• requires in-subject hospitalization or prolongation of existing hospitalization, unless 
hospitalization is for: 
• routine treatment or monitoring of the studied indication, not associated with any 
deterioration in condition 
• elective or pre-planned treatment for a pre-existing condition that is unrelated to the 
indication under study and has not worsened since signing the informed consent 
• treatment on an emergency out-subject basis for an event not fulfilling any of the 
definitions of a SAE given above and not resulting in hospital admission 
• social reasons and respite care in the absence of any deterioration in the subject’s 
general condition 
• is medically significant, eg defined as an event that jeopardizes the subject or may require 
medical or surgical intervention. 

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All malignant neoplasms will be assessed as serious under “medically significant” if other 
seriousness criteria are not met. 
Life-threatening in the context of a SAE refers to a reaction in which the subject was at risk of 
death at the time of the reaction; it does not refer to a reaction that hypothetically might have 
caused death if it were more severe (please refer to Annex IV, ICH-E2D Guideline). 
Medical and scientific judgment should be exercised in deciding whether other situations should 
be considered serious reactions, such as important medical events that might not be immediately 
life threatening or result in death or hospitalization but might jeopardize the subject or might 
require intervention to prevent one of the other outcomes listed above. Examples of such events 
are intensive treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization or development of dependency or 
abuse (please refer to Annex IV, ICH-E2D Guideline). 
Any suspected transmission via a medicinal product of an infectious agent is also considered a 
serious adverse reaction. 
7.2.2 
SAE reporting 
To ensure patient safety, every SAE, regardless of causality, occurring after the patient has 
provided informed consent and until 20 weeks after last dose was taken or until 30 days after 
the last study visit (whichever is later) must be reported to Novartis within 24 hours of learning 
of its occurrence. Any SAE reported until 20 weeks after last dose was taken or until End of 
study visit (whichever is later) must be recorded in the AE eCRF. SAEs beyond that date will 
only be recorded in the Novartis DS&E database. 
Any SAEs experienced after 30 days from end of study visit or 20 weeks after last dose was 
taken (whichever is later) should only be reported to Novartis if the investigator suspects a 
causal relationship to study treatment. Recurrent episodes, complications, or progression of the 
initial SAE must be reported as follow-up to the original episode, regardless of when the event 
occurs. This report must be submitted within 24 hours of the investigator receiving the follow- 
up information. An SAE that is considered completely unrelated to a previously reported one 
should be reported separately as a new event. All follow-up information for the SAE including 
information on complications, progression of the initial SAE and recurrent episodes must be 
reported as follow-up to the original episode within 24 hours of the investigator receiving the 
follow-up information. An SAE occurring at a different time interval or otherwise considered 
completely unrelated to a previously reported one must be reported separately as a new event. 
Information about all SAEs is collected and recorded on the Serious Adverse Event Report 
Form; all applicable sections of the form must be completed in order to provide a clinically 
thorough report. The investigator must assess the relationship of each SAE to study treatment, 
complete the SAE Report Form in English, and submit the completed form within 24 hours to 
Novartis. Detailed instructions regarding the submission process and requirements for signature 
are to be found in the investigator folder provided to each site. 
Follow-up information is submitted as instructed in the investigator folder. Each re-occurrence, 
complication, or progression of the original event must be reported as a follow-up to that event 
regardless of when it occurs. The follow-up information should describe whether the event has 

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resolved or continues, if and how it was treated, and whether the patient continued or withdrew 
from study participation. 
If the SAE is not previously documented in the Investigator’s Brochure or Package Insert (new 
occurrence) and is thought to be related to the study treatment a Drug Safety and Epidemiology 
Department associate may urgently require further information from the investigator for health 
authority reporting. Novartis may need to issue an Investigator Notification (IN) to inform all 
investigators involved in any study with the same study treatment that this SAE has been 
reported. Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected and 
reported to the competent authorities and relevant ethics committees in accordance with EU 
Guidance 2011/C 172/01 or as per national regulatory requirements in participating countries. 
Note: SAEs must be reported to Novartis within 24 hours of the investigator learning of its 
occurrence/receiving follow-up information. 
7.3 
Liver safety monitoring 
Not Applicable. 
 
7.4 
Renal safety monitoring 
Not Applicable. 
7.5 
Reporting of study treatment errors including misuse/abuse 
Medication errors are unintentional errors in the prescribing, dispensing, administration or 
monitoring of a medicine while under the control of a healthcare professional, subject or 
consumer (EMA definition). 
Misuse refers to situations where the medicinal product is intentionally and inappropriately 
used not in accordance with the protocol. 
Abuse corresponds to the persistent or sporadic, intentional excessive use of a medicinal product, 
which is accompanied by harmful physical or psychological effects. 
Study treatment errors and uses outside of what is foreseen in the protocol will be collected in 
the appropriate CRF, irrespective of whether or not associated with an AE/SAE and reported to 
Safety only if associated with an SAE. Misuse or abuse will be collected and reported in the 
safety database irrespective of it being associated with an AE/SAE. 
Table 7-1 
Guidance for capturing the study treatment errors including 
misuse/abuse 
Treatment error 
type 
Document in CRF 
(Yes/No) 
Document in AE 
eCRF 
Complete SAE form 
Unintentional study 
treatment error 
Yes 
Only if associated with 
an AE 
Only if associated with an 
SAE 
Misuse/Abuse 
Yes 
Yes 
Yes, even if not 
associated with a SAE 

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7.6 
Pregnancy reporting 
To ensure subject safety, each pregnancy occurring after signing the informed consent must be 
reported to Novartis within 24 hours of learning of its occurrence. The pregnancy should be 
followed up to determine outcome, including spontaneous or voluntary termination, details of 
the birth, and the presence or absence of any birth defects, congenital abnormalities, or maternal 
and/or newborn complications. 
Pregnancy should be recorded on the Pharmacovigilance Pregnancy Form and reported by the 
investigator to the local Novartis Drug Safety and Epidemiology Department. Pregnancy 
follow-up should be recorded on the same form and should include an assessment of the 
possible relationship to the study treatment. 
Any SAE experienced during the pregnancy and unrelated to the pregnancy must be reported 
on a SAE form. 
 
Data review and database management 
8.1 
Site monitoring 
Before study initiation, at a site initiation visit or at an investigator’s meeting, a Novartis 
representative will review the protocol and data capture requirements (eCRFs) with the 
investigators and their staff. During the study, Novartis employs several methods of ensuring 
protocol and Good Clinical Practice (GCP) compliance and the quality/integrity of the sites’ 
data. The field monitor will visit the site to check the completeness of subject records, the 
accuracy of data capture / data entry, the adherence to the protocol and to Good Clinical Practice, 
the progress of enrollment, and to ensure that study treatment is being stored, dispensed, and 
accounted for according to specifications. Key study personnel must be available to assist the 
field monitor during these visits. Continuous remote monitoring of each site’s data may be 
performed by a centralized Novartis CRA organization. Additionally, a central analytics 
organization may analyze data & identify risks & trends for site operational parameters, and 
provide reports to Novartis Clinical Teams to assist with trial oversight. 
The investigator must maintain source documents for each subject in the study, consisting of 
case and visit notes (hospital or clinic medical records) containing demographic and medical 
information, laboratory data, electrocardiograms, and the results of any other tests or 
assessments. All information on CRFs must be traceable to these source documents in the 
subject's file. (Data not requiring a separate written record will be defined before study start and 
will be recorded directly on the CRFs). The investigator must also keep the original informed 
consent form signed by the subject (a signed copy is given to the subject). 
The investigator must give the monitor access to all relevant source documents to confirm their 
consistency with the data capture and/or data entry. Novartis monitoring standards require full 
verification for the presence of informed consent, adherence to the inclusion/exclusion criteria, 
documentation of SAEs, and of data that will be used for all primary variables. Additional 
checks of the consistency of the source data with the CRFs are performed according to the 
study-specific monitoring plan. No information in source documents about the identity of the 
subjects/subjects will be disclosed. 

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8.2 
Data collection 
Designated investigator staff will enter the data required by the protocol into the Electronic 
Case Report Forms (eCRFs) using fully validated secure web-enabled software that conforms 
to US CFR 21 Part 11 requirements. Designated investigator site staff will not be given access 
to the system until they have been trained. 
Automatic validation procedures within the system check for data discrepancies during and 
after data entry and, by generating appropriate error messages, allow the data to be confirmed 
or corrected online by the designated investigator site staff. The Investigator must certify that 
the data entered into the electronic Case Report Forms are complete and accurate. After 
database lock, the investigator will receive copies of the subject data for archiving at the 
investigational site. 
Designated sites and investigator staff will enter the data required by the protocol into the EDC 
system. Designated investigator site staff will not be given access to the system until they have 
been trained. 
Automatic validation procedures within the system check for data discrepancies during and 
after data entry and, by generating appropriate error messages, allow the data to be confirmed 
or corrected online by the designated investigator site staff. The Investigator must certify that 
the data entered into the electronic Case Report Forms are complete and accurate. After 
database lock, the investigator will receive copies of the subject data for archiving at the 
investigational site. 
8.3 
Database management and quality control 
Novartis personnel will review the data entered by investigational staff for completeness and 
accuracy. Electronic data queries stating the nature of the problem and requesting clarification 
will be created for discrepancies and missing values and sent to the investigational site via the 
EDC system. Designated investigator site staff is required to respond promptly to queries and 
to make any necessary changes to the data. 
Concomitant medications entered into the database will be coded using the Word Health 
Organization (WHO) Drug Reference List, which employs the Anatomical Therapeutic 
Chemical classification system. Concomitant procedures, non-drug therapies and adverse 
events will be coded using the Medical dictionary for regulatory activities (MedDRA) 
terminology. 
Laboratory samples will be processed centrally and the results will be sent electronically to 
Novartis. 
ECG readings will be processed centrally and the results will be sent electronically to Novartis. 
Randomization codes and data about all study drug dispensed to the subject and all dosage 
changes will be tracked using an Interactive Response Technology (IRT). The system will be 
supplied by a vendor, who will also manage the database. The data will be sent electronically 
to Novartis. 
The occurrence of relevant protocol deviations will be determined. After these actions have 
been completed and the database has been declared to be complete and accurate, it will be 

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locked. Any changes to the database after that time can only be made after written agreement 
by Novartis Development management. 
8.4 
Data Monitoring Committee 
An external data monitoring committee (DMC) will be appointed to monitor the safety of the 
study subjects. 
Details regarding the DMC process, responsibilities and membership will be available, as 
needed, in the relevant secukinumab DMC charter. 
8.5 
Adjudication Committee 
Not required. 
 
Data analysis 
Treatment groups for analyses will be presented as shown in Table 9-1. 
Table 9-1 
Treatment groups for analyses 
 
Weight Category 
Low dose secukinumab 
High dose secukinumab 
<25kg 
75mg 
75mg 
25-<50kg 
75mg 
150mg 
≥50kg 
150mg 
300mg 
Any data analysis carried out independently by the investigator should be submitted to Novartis 
before publication or presentation. 
9.1 
Analysis sets 
The following analysis sets will be used in this trial: 
Randomized set: The randomized set will be defined as all subjects who were randomized at 
baseline visit. Unless otherwise specified, subjects with missing informed consent form as well 
as misrandomized subjects will be excluded from the randomized set. 
Misrandomized subjects are subjects who are screen-failures, but have been randomized by the 
investigator before eligibility was finally assessed, however have not been treated. If subjects 
were re-screened and successfully randomized, they will be included in the randomized set 
according to the treatment assigned in the last randomization. 
Full analysis set (FAS): The FAS will be comprised of all subjects from the randomized set to 
whom study treatment has been assigned. Following the intent-to-treat principle, subjects will 
be analyzed according to the treatment assigned to at randomization. If the actual randomization 
stratum is different to the assigned stratum in IRT, the actual stratum will be used in analyses. 
The subjects with severe GCP violation will not be included in the FAS. 
Of note, subjects excluded from the randomized set will be excluded from the FAS. 
Safety set: The safety set will include all subjects who took at least one dose of study drug 
during the treatment period. Subjects will be analyzed according to treatment received. 

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9.2 
Subject demographics and other baseline characteristics 
Demographics and baseline characteristics 
Summary statistics will be presented for continuous demographic and baseline characteristics 
variables by treatment group and for all subjects. The number and percentage of subjects in 
each category will be presented for categorical variables by treatment group. Summaries will 
be performed on the randomized set unless otherwise specified. 
Medical history 
All conditions entered as medical history or current medical condition at baseline will be coded 
using the MedDRA dictionary. These will be summarized by system organ class and preferred 
term of the MedDRA dictionary. In addition, summaries for psoriasis specific medical history 
will be provided. 
9.3 
Treatments 
Study treatment 
Exposure to study treatment will be summarized by treatment group on the safety population. 
The total number of injections per subject will be summarized in contingency tables and 
summary statistics will be performed on the duration of exposure. In addition, exposure will be 
categorized to certain time thresholds (eg any exposure, ≥ 1 week, ≥ 2 weeks, ≥ 3 weeks, ≥ 4 
weeks, ≥ 8 weeks, etc.) and the number of subjects within each category will be presented. 
Prior and concomitant medication(s) 
Prior and concomitant medications will be summarized by treatment group in separate tables. 
Prior medications are defined as medications taken and stopped prior to date of first dose of 
study treatment. Any medication given at least once between the day of first dose of randomized 
study treatment and the last day of study visit will be regarded as concomitant medication, 
including those which started pre-baseline and continued into the treatment period. 
Medications will be presented in alphabetical order, by Anatomical Therapeutic Classification 
(ATC) codes and grouped by anatomical main group. Tables will also show the overall number 
and percentage of subjects receiving at least one medication of a particular ATC code and at 
least one medication in a particular anatomical main group. 
Psoriasis specific prior medication will be presented, and summary will include number of prior 
systemic and biologic psoriasis therapies as well as reason for discontinuation. 
In addition, medical procedures and significant non-drug therapies as coded in MedDRA will 
be summarized. 
9.4 
Analysis of the primary variable(s) 
This section will detail the statistical analysis of the primary endpoint. A Bayesian analysis has 
been chosen to allow the direct incorporation into the analysis of information about placebo 
response rates from historical data. 

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Data from four secukinumab adult placebo-controlled trials (CAIN457A2302, CAIN457A2303, 
CAIN457A2308 and CAIN457A2309) and pediatric placebo-controlled trials from other 
biologics (Paller 2008, Landells et al 2015) will be used to obtain a historical placebo control 
through the Bayesian meta-analytic-predictive (MAP) framework (Spiegelhalter et al 2004, 
Neuenschwander et al. 2010). CAIN457A2310 data will be used if they are reported prior to 
the present study. 
9.4.1 
Primary Variable(s) 
The co-primary efficacy variables are PASI 75 response at Week 12 and IGA mod 2011 0 or 1 
response at Week 12. A PASI 75 responder is defined as a subject achieving ≥ 75% 
improvement (reduction) in PASI score compared to baseline. A subject is considered as IGA 
mod 2011 0 or 1 responder if the subject achieves a score of 0 or 1 and improved from baseline 
by at least 3 points on the IGA mod 2011 scale if the subject enrolled into the study with a score 
of 4 and by at least 2 points on the IGA mod 2011 scale if the subject enrolled into the study 
with a score of 3. 
9.4.2 
Statistical model, hypothesis, and method of analysis 
In order to evaluate the efficacy of secukinumab after 12 weeks, a Bayesian model will be fitted 
to the co-primary endpoint on secukinumab and placebo treatments. A Bayesian method has 
been chosen to allow the direct incorporation into the analysis of information about placebo 
response rates from historical data. These data will be used to calculate the Bayesian posterior 
of the log odds ratio between secukinumab and placebo treatment. For the log odds of the 
secukinumab treatment group a non-informative prior will be used, whilst the placebo treatment 
group log odds response rate will be represented though the MAP prior. The MAP prior will be 
derived from the historical placebo data using a logistic Bayesian mixed-effects model and will 
represent the predicted placebo log odds response rate for this trial. The analysis will report the 
median of the means, the 95% credible interval and the probability of a positive treatment effect 
of the posterior log odds ratio. Comparisons with placebo will be performed for the low and 
high dose group of secukinumab separately. Analysis of the co-primary variables will be based 
on the Full Analysis Set (FAS). 
9.4.3 
Handling of missing values/censoring/discontinuations 
 
The following imputation methods will apply to the missing data for analysis up to Week 52. 
• Pure non-responder imputation (includes Bayesian Primary endpoint analysis at Week 
12): Missing values with respect to response variables based on PASI score and IGA 
mod 2011 categories were to be imputed with non-response regardless to the reason for 
missing data (e.g. premature study discontinuation, missed visit, administrative issues). 
Patients with missing baseline or those with all post-baseline missing were to be imputed 
with non-response (in the secukinumab treatment groups). 
• Descriptive summaries on response variables based on PASI score and IGA mod 2011 
categories will be imputed with multiple imputations (MI) method as sensitivity 
imputation method. Multiple imputation (MI) is a simulation based approach where 

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missing values are replaced by multiple Bayesian draws from the conditional 
distribution of missing data given the observed data and covariates, creating multiple 
completed data sets. These completed data sets can then be analyzed using standard 
methods. Within this analysis the PASI score (absolute change from baseline) or IGA 
mod 2011 categories will be imputed and response variables will be derived based on 
the imputed scores. In the multiple imputation analysis the response status will be 
imputed based on the individual treatment arm information. 
The following imputation methods will apply to the missing data for analysis of the long term 
data beyond Week 52: 
• Response variables based on PASI score and IGA mod 2011 categories will be 
generally be presented as ‘observed case’; i.e. all available data for each time point 
will be included in the analyses. 
• Summaries on multiple imputation will be provided as sensitivity analysis where 
appropriate. 
9.4.4 
Sensitivity analyses 
No sensitivity analysis is planned for the Bayesian primary endpoint analysis. 
9.5 
Analysis of secondary variables 
The secondary efficacy variable is PASI 90 response at Week 12 
9.5.1 
Efficacy variables 
The key secondary efficacy endpoint of this study is the proportion of subjects with a PASI 90 
response at Week 12. These data will be analyzed in the same way as the primary endpoint 
though a Bayesian framework, using a Bayesian mixed-effects model. Efficacy of secukinumab 
low and high dose compared to historical placebo control will be performed separately. 
Analyses will be based on the FAS population, and historical placebo data will be incorporation 
into the analysis as before through the MAP framework. 
Missing data will be handled with the same methods as primary endpoint analysis. 
9.5.2 
Safety variables 
All safety evaluations will be performed on the Safety set. 
Adverse events 
Treatment emergent adverse events will be summarized, and all AEs will be presented in the 
listings. 
AEs will be summarized by presenting, for each treatment group, the number and percentage 
of subjects having at least one AE, having an AE in each primary system organ class and having 
each individual AE (preferred term). Summaries will also be presented for AEs by severity and 
for study treatment related AEs. 

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If a particular AE ‘severity’ is missing, this variable will be listed as missing and treated as 
missing in summaries. If a subject reported more than one adverse event with the same preferred 
term, the adverse event with the greatest severity will be presented. If a subject reported more 
than one adverse event within the same primary system organ class, the subject will be counted 
only once with the greatest severity at the system organ class level, where applicable. 
Separate summaries will be provided for death, serious adverse event, other significant adverse 
events leading to discontinuation and adverse events leading to dose adjustment (including 
study treatment discontinuation). A separate AE listing will be produced for subjects who 
reported a treatment deviation, where AEs occurring after treatment deviation will be flagged. 
Laboratory data 
The summary of laboratory evaluations will be presented for three groups of laboratory tests 
(hematology, serum chemistry and urinalysis). Descriptive summary statistics for the change 
from baseline to each study visit will be presented. These descriptive summaries will be 
presented by test group, laboratory test and treatment group. Change from baseline will only be 
summarized for subjects with both baseline and post baseline. 
In addition, shift tables will be provided for all parameters to compare a subject’s baseline 
laboratory evaluation relative to the visit’s observed value. For the shift tables, the normal 
laboratory ranges will be used to evaluate whether a particular laboratory test value was normal, 
low, or high for each visit value relative to whether or not the baseline value was normal, low, 
or high. These summaries will be presented by laboratory test and treatment group. Shifts will 
be presented for most extreme values post-baseline. 
Immunogenicity 
Immunogenicity data will be listed. 
Vital signs 
Analysis of vital sign measurements using summary statistics for the change from baseline for 
each post-baseline visit will be performed. These descriptive summaries will be presented by 
vital sign and treatment group. Change from baseline will only be summarized for subjects with 
both baseline and post-baseline values. 
Only “on-treatment” vital signs will be summarized (i.e. assessments within last dose plus 84 
days). All information collected will be listed by subject where on treatment and abnormal 
values will be flagged. 
The number and percentage of subjects with newly occurring notable vital sign abnormalities 
will be presented. Further details on the criteria for notable abnormalities will be presented in 
the Statistical Analysis Plan. 
ECG 
Summary statistics will be presented for ECG variables by visit and treatment group. 

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Physical development 
Growth and weight changes will be summarised descriptively. 
 
. 
9.5.3 
Resource utilization 
Not applicable 
9.5.4 
Health-Related Quality of Life 
Children’s Dermatology Quality of Life Index (CDLQI) 
Seven scores will be derived from the CDLQI: the total score of each of the six dimensions 
(symptoms and feeling, leisure, school or holidays, personal relationships, sleep, treatment) as 
well as the total score over all items. The higher the score, the more quality of life is impaired. 
For each of the seven scores the percentage change from baseline will be derived. Summary 
statistics will be provided for absolute values as well as for the percentage change by visit and 
treatment group in contingency tables .(LOCF). 
9.5.5 
Pharmacokinetics 
All completed subjects with quantifiable pharmacokinetic (PK) measurements of secukinumab 
will be included in the pharmacokinetic data analysis. Serum concentrations will be expressed 
in mass per volume units. All concentrations below the limit of quantification or missing data 
will be labeled as such in the concentration data listings. PK concentrations will be summarized 
by visit and treatment group. In addition to mean, standard deviation, coefficient of variation, 
median and quartiles, the geometric mean and geometric coefficient of variation and n(log) will 
be presented. 
9.5.6 
DNA 
Not Applicable. 
9.5.7 
Biomarkers 
Not applicable 
9.5.8 
PK/PD 
Not applicable 
9.6 
Analysis of exploratory variables 
The following exploratory efficacy endpoints will be assessed: 

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PASI 75, PASI 90, PASI 100 and IGA 2011 0 or 1 response over time 
Number of subjects with PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response by 
treatment and visit will be presented in frequency contingency tables and will include absolute 
and relative frequencies. 
Figures will be provided displaying responder rates by treatment including confidence intervals. 
PASI score over time 
Summary statistics will be provided for absolute PASI scores as well as for percent change from 
baseline by treatment and visit. Figures will also be provided. 
9.7 
Interim analyses 
There are two planned interim analysis. An interim analysis of the data collected up until Week 
16, including the co-primary endpoint (at Week 12) will be performed after all subjects have 
completed either their Week 16 visit or the premature treatment discontinuation visit. Another 
interim analysis will be performed when all subjects have completed the Week 52 visit, (or 
premature treatment discontinuation visit). 
Additional analyses may be performed to support health authority interactions, as necessary. 
Thereafter, efficacy and safety data collected after Week 52 until the end of study may be 
reported yearly in separate reports. 
Trial modifications are not planned based on any interim analysis. 
9.8 
Sample size calculation 
The sample size for this study is calculated to ensure an adequate number of subjects for PK 
analyses and powered efficacy analyses. Approximately 80 pediatric subjects from 6 to less 
than 18 years of age at randomization will be recruited. Since a 15% screening failure rate is 

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expected, approximately 95 patients will be screened. The study will aim to recruit at least 60 
subjects with moderate severity and approximately 20 subjects with severe severity. 
Power calculations were performed to support the co-primary endpoints PASI 75 and IGA 0 or 
1 response at week 12, and secondary endpoint PASI 90 at week 12, versus placebo (historical 
control) for the low and high secukinumab dose regimens. Data from four adult placebo- 
controlled trials (CAIN457A2302, CAIN457A2303, CAIN457A2308 and CAIN457A2309) 
and pediatric placebo controlled trials (Paller et al 2008, Landells et al 2015) were used to 
estimate the historical placebo response rate. For study CAIN457A2310, a 10% response rate 
was assumed for PASI 75, IGA 0 or 1 and PASI 90 response for the placebo group. The power 
calculation was performed assigning pediatric data moderate heterogeneity and adult trial data 
substantial heterogeneity (Neuenschwander et al.2010), thus allowing pediatric trial data to be 
given twice the weight compared to adult trial data. All the calculations were performed in the 
R package RBesT (version 1.1) through the meta-analytical-predictive framework 
(Spiegelhalter et al. 2004, Neuenschwander et al. 2010), and the predicted response rate of the 
placebo group for this study are presented in Table 9-2 below by endpoint. 
Table 9-2 
Predictive placebo response rates for this study from model of 
historical data 
 
Endpoint 
Mean 
Standard 
Deviation 
Median 
95% CI 
IGA 0 or 1 
9% 
6% 
8% 
1-23% 
PASI 75 
10% 
6% 
9% 
2-25% 
PASI 90 
6% 
4% 
5% 
1-18% 
Requiring that the posterior probability of the log odds ratio difference between placebo and 
secukinumab exceeds with at least 97.5% zero leads to a power of approximately 99% for each 
co-primary endpoint when assuming a sample size of 40 pediatric patients per treatment group 
and true response rates of 10% and 65% for PASI 75 and 9% and 45% for IGA mod 2011 0 or 
1 response for placebo and secukinumab respectively. 
For the secondary endpoint of PASI 90 response, assuming a response rate of 6% and 39% for 
placebo and secukinumab respectively, the power to provide a posterior probability of at least 
97.5% that the PASI 90 response rate on secukinumab is greater than placebo at week 12 is 
approximately 99%. 
The assumed response rates for secukinumab are based on confirmatory efficacy in the adult 
phase III program (CAIN457A2302, CAIN457A2303, CAIN457A2308 and CAIN457A2309). 
 
Ethical considerations 
10.1 
Regulatory and ethical compliance 
This clinical study was designed and shall be implemented, executed and reported in accordance 
with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable 
local regulations (including European Directive 2001/20/EC, US CFR 21, and Japanese 

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Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the 
Declaration of Helsinki. 
10.2 
Informed consent procedures 
Eligible patients may only be included in the study after providing written (witnessed, where 
required by law or regulation), IRB/IEC-approved informed consent, or, if incapable of doing 
so, after such consent has been provided by a legally acceptable representative(s) of the patient. 
In cases where the patient’s representative gives consent, the patient should be informed about 
the study to the extent possible given his/her understanding. If the patient is capable of doing 
so, he/she should indicate assent by personally signing and dating the written informed consent 
document or a separate assent form. Informed consent must be obtained before conducting any 
study-specific procedures (i.e. all of the procedures described in the protocol). The process of 
obtaining informed consent should be documented in the patient source documents. 
Novartis will provide to investigators in a separate document a proposed informed consent form 
that complies with the ICH GCP guideline and regulatory requirements and is considered 
appropriate for this study. Any changes to the proposed consent form suggested by the 
investigator must be agreed to by Novartis before submission to the IRB/ IEC, and a copy of 
the approved version must be provided to the Novartis monitor after IRB/IEC approval. 
In pediatric patients (< 18 years of age) parental permission and, whenever possible, child assent 
is needed instead of the procedure for informed consent used for research involving adults. In 
general, one or both parents or a guardian must be provided with the information ordinarily 
required for informed consent, so that they may decide whether to allow the child to participate, 
and children capable of assent must also express their willingness to participate. These forms 
will be submitted for IRB/IEC/REB approval. Subjects who turn 18 years of age during the 
trial must sign the general informed consent form. 
Women of child bearing potential should be informed that taking the study treatment may 
involve unknown risks to the fetus if pregnancy were to occur during the study and agree that 
in order to participate in the study they must adhere to the contraception requirement for the 
duration of the study. If there is any question that the patient will not reliably comply, they 
should not be entered in the study. 
In the event that Novartis wants to perform testing on the samples that are not described in this 
protocol, additional Institutional Review Board and/or Ethics Committee approval will be 
obtained. 
During the COVID-19 pandemic or similar major health care disruption that may challenge the 
ability to obtain a standard written informed consent due to limitations that prevent an on-site 
visit, the Investigator may conduct the informed consent discussion remotely (e.g. telephone, 
videoconference). Guidance issued by local regulatory bodies on this aspect prevails and must 
be implemented and appropriately documented (e.g. the presence of an impartial witness, 
sign/dating separate ICFs or assent forms by trial subject/ guardian and person obtaining 
informed consent, etc). 
In case Home Nursing (other than study treatment administration) is implemented during the 
COVID-19 pandemic or similar major health care disruption, a separate Home Nursing 
informed consent document must be used in addition to the study ICF. 

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10.3 
Responsibilities of the investigator and IRB/IEC 
Before initiating a trial, the investigator/institution must obtain approval/favorable opinion from 
the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the trial protocol, 
informed consent form, consent form updates, subject recruitment procedures (eg, 
advertisements) and any other written information to be provided to subjects/subjects. Prior to 
study start, the investigator is required to sign a protocol signature page confirming his/her 
agreement to conduct the study in accordance with these documents and all of the instructions 
and procedures found in this protocol and to give access to all relevant data and records to 
Novartis monitors, auditors, Novartis Quality Assurance representatives, designated agents of 
Novartis, IRBs/IECs, and regulatory authorities as required. If an inspection of the clinical site 
is requested by a regulatory authority, the investigator must inform Novartis immediately that 
this request has been made. 
10.4 
Publication of study protocol and results 
The key design elements of this protocol will be posted in a publicly accessible database such 
as clinicaltrials.gov. In addition, upon study completion and finalization of the study report the 
results of this trial will be either submitted for publication and/or posted in a publicly accessible 
database of clinical trial results. 
10.5 
Quality Control and Quality Assurance 
Novartis maintains a robust Quality Management (QM) system that includes all activities 
involved in quality assurance and quality control, including the assignment of roles and 
responsibilities, the reporting of results, and the documentation of actions and escalation of 
issues identified during the review of quality metrics, incidents, audits and inspections. 
Audits of investigator sites, vendors, and Novartis systems are performed by Novartis Pharma 
Auditing and Compliance Quality Assurance, a group independent from those involved in 
conducting, monitoring or performing quality control of the clinical trial. The clinical audit 
process uses a knowledge/risk based approach. 
Audits are conducted to assess GCP compliance with global and local regulatory requirements, 
protocols and internal SOPs, and are performed according to written Novartis processes. 
 
Protocol adherence 
This protocol defines the study objectives, the study procedures and the data to be collected on 
study participants. Additional assessments required to ensure safety of subjects/subjects should 
be administered as deemed necessary on a case by case basis. Under no circumstances including 
incidental collection is an investigator allowed to collect additional data or conduct any 
additional procedures for any purpose involving any investigational drugs under the protocol, 
other than the purpose of the study. If despite this interdiction, data, information, observation 
would be incidentally collected, the investigator shall immediately disclose it to Novartis and 
not use it for any purpose other than the study, except for the appropriate monitoring on study 
participants. 

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Investigators ascertain they will apply due diligence to avoid protocol deviations. If an 
investigator feels a protocol deviation would improve the conduct of the study this must be 
considered a protocol amendment, and unless such an amendment is agreed upon by Novartis 
and approved by the IRB/IEC and health authorities, where required, it cannot be implemented. 
11.1 
Protocol amendments 
Any change or addition to the protocol can only be made in a written protocol amendment that 
must be approved by Novartis, health authorities where required, and the IRB/IEC prior to 
implementation. Only amendments that intended to eliminate an apparent immediate hazard to 
subjects may be implemented immediately provided the health authorities are subsequently 
notified by protocol amendment and the reviewing IRB/IEC is notified. Notwithstanding the 
need for approval of formal protocol amendments, the investigator is expected to take any 
immediate action required for the safety of any subject included in this study, even if this action 
represents a deviation from the protocol. In such cases the reporting requirements identified in 
Section 7 Safety Monitoring must be followed. 

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References 
References are available upon request 
Augustin M, Reich K, Glaeske G, et al (2010) Co-morbidity and age-related prevalence of 
psoriasis: analysis of health insurance data in Germany. Acta Derm Venereol; 90:147–151. 
Beattie PE and Lewis-Jones MS (2006). A comparative study of impairment of quality of life 
in children with skin disease and children with other chronic childhood diseases; Br J 
Dermatol 2006 Jul; 155(1), 145–151. 
Benoit S, Hamm H (2007) Childhood psoriasis. Clin Dermatol; 25(6):555–62. 
Blondell RD, Roster MB, Dave KC (1999) Disorders of puberty. Am Fam Physician; 
60(1):209-18, 223-4. 
Burden AD (1999); Management of psoriasis in childhood; CED, 24, 341–345. 
Comans-Bitter WM et al (1997) Immunophenotyping of blood lymphocytes in childhood. J 
Pediatr Volume; 130, Number 3: 388-393. 
Committee for medicinal products for human use (CHMP), European Medicines Agency for 
the Evaluation of Medicines for Human Use. (2004) Guideline on clinical investigation of 
medicinal products indicated for the treatment of psoriasis. CHMP/EWP/2454/02 corr 
393document. London, UK. 
De Jager MEA et al (2009) Epidemiology and prescribed treatments in childhood psoriasis: A 
survey among medical professionals. Journal of Dermatological Treatment; 20:254–258. 
Doherty SD, Van Voohees A, Lebwohl MG (2008) National psoriasis foundation consensus 
statement on screening for latent tuberculosis infection in patients with psoriasis treated with 
systemic and biologic agents. J. Am Acad Dermatol; 59(2): 209–217. 
EMA (2016) Reflection paper on extrapolation of efficacy and safety in paediatric medicine 
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Appendix 1: Clinically notable laboratory parameters 
The following criteria will be used to define expanded limits and notable abnormalities of key 
laboratory tests. 
Unless otherwise indicated, no specific action is pre-defined within this protocol to respond to 
specific abnormal laboratory values, as it will be decided by the investigator whether & which 
specific action needs to be taken to respond to any abnormal values, taking into account the 
overall status of the subject. 
Laboratory values 
Newly occurring selected notable laboratory abnormalities in pediatric patients at the time of 
the assessment: 
Biochemistry and Urinalysis 
• Alamine Aminotranferase (ALT)(SGPT): 
>Upper Limit of Normal () 
≥3 x ULN 
≥5 x ULN 
≥8 x ULN 
≥10 x ULN 
• Aspartate Aminotranferase (AST) (SGOT): 
>ULN 
≥3 x ULN 
≥5 x ULN 
≥8 x ULN 
≥10 x ULN 
• Total Bilirubin (TBL) 
>ULN, 
≥1.5xULN, 
≥ 2xULN 
• Alkaline Phosphatase (ALP) 
>ULN 
≥1.5xULN, 
≥2xULN, 
≥3x ULN 
≥5xULN 
• ALT and/or AST >3x-, 5x-, 10x ULN accompanied by TBL >2xULN 
• ALT or AST >3x ULN and TBL >2x-, and ALP >2 x ULN. 
• ALP >3x ULN and TBL >2x ULN 
• Gamma-Glutamyltransferase (GGT): 
>ULN 

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≥3 x ULN 
≥5 x ULN 
Hematology 
• Hemoglobin: 
• ≥ 20 g/L decrease from baseline, or 
• < 85 g/L for < 16 years of age 
• < 100 g/L for ≥ 16 years of age 
• Absolute neutrophils: 
• Grade 1: <LLN – 1.5 x 10E9/L 
• Grade 2: <1.5 – 1.0 x 10E9/L 
• Grade 3: <1.0 – 0.5 x 10E9/L 
• Grade 4: <0.5 x 10E9/L 
• Criteria based on CTC grades for platelet count: 
• Grade 1: <LLN – 75.0 x 10E9/L 
• Grade 2: <75.0 – 50.0 x 10E9/L 
• Grade 3: <50.0 – 25.0 x 10E9/L 
• Grade 4: <25.0 x 10E9/L 
• Criteria based on CTC grades for WBC: 
• Grade 1:<LLN – 3.0 x10E9/L 
• Grade 2:<3.0 – 2.0 x10E9/L 
• Grade 3:<2.0 – 1.0 x10E9/L 
• Grade 4: <1.0 x10E9/L 
• Absolute Lymphocytes: < LLN 
• Absolute Eosinophils: ≥ 1.1 x ULN 
• Absolute Eosinophils: ≥0.45 x 109/L 

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Appendix 2: Blood collection log for pharmacokinetics and 
immunogenicity 
Table 14-1 
Blood collection log for pharmacokinetics 
 
Visit 
Timepoint 
Volume 
Analyte 
 Sample 
number1 
PK collection 
number /Dose 
Reference ID1 
Randomization/Day 1 
Pre-dose 
1 mL 
AIN457 for PK 
1 
1 
Week 4 
Pre-dose 
1 mL 
AIN457 for PK 
2 
2 
Week 12 
Pre-dose 
1 mL 
AIN457 for PK 
3 
3 
Week 13 
168 hours2 
1 mL 
AIN457 for PK 
4 
3 
Week 14 
336 hours2 
1 mL 
AIN457 for PK 
5 
3 
Week 15 
504 hours2 
1 mL 
AIN457 for PK 
6 
3 
Week 16 
672 hours2 
1 mL 
AIN457 for PK 
7 
3 
Week 24 
Pre-dose 
1 mL 
AIN457 for PK 
8 
4 
Week 52 
Pre-dose 
1 mL 
AIN457 for PK 
9 
5 
Week 104 
Pre-dose 
1 mL 
AIN457 for PK 
10 
6 
Week 156 
Pre-dose 
1 mL 
AIN457 for PK 
11 
7 
Week 208 
672 hours3 
1 mL 
AIN457 for PK 
12 
8 
Week 224 
3360 hours3 
1 mL 
AIN457 for PK 
13 
8 
1 If a PK sample is collected at an unscheduled visit, the sample numbers will follow the pattern: 1001, 1002, etc. 
2 Scheduled time points for sample numbers 4, 5, 6, 7 (168, 336, 504 and 672 hours post-dose, respectively) refer 
to the last previous dose given at Week 12 (Dose Reference ID = 3) 
3 Scheduled time points for sample numbers 12 and 13 (672 and 3360 hours post-dose, respectively) refer to the 
last dose given at Week 204 (Dose Reference ID = 8) 
 
Table 14-2 
Blood Collection for Immunogenicity 
 
Visit 
Timepoint 
Volume 
Analyte 
Immunogenicity 
Sample number1 
Randomization/Day 1 
Pre-dose 
2 mL 
anti-AIN457 for IG 
501 
Week 16 
Pre-dose 
2 mL 
anti-AIN457 for IG 
502 
Week 24 
Pre-dose 
2 mL 
anti-AIN457 for IG 
503 
Week 52 
Pre-dose 
2 mL 
anti-AIN457 for IG 
504 
Week 104 
Pre-dose 
2 mL 
Anti-AIN457 for IG 
505 
Week 156 
Pre-dose 
2 mL 
Anti-AIN457 for IG 
506 
Week 208 
672 hours2 
2 mL 
Anti-AIN457 for IG 
507 
Week 224 
3360 hours2 
2 mL 
anti-AIN457 for IG 
508 
1 If an IG sample is collected at an unscheduled visit, the sample numbers will follow the pattern: 3001, 3002, 
etc. 
2 Scheduled time points for sample numbers 12 and 13 (672 and 3360 hours post-dose, respectively) refer to 
the last dose given at Week 204 

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Appendix 4: Weight and recommended blood volumes 
European Medicines Agency (EMA) recommendations for trial related blood loss (including 
any losses in the maneuver) in pediatric populations are that no more than 3% of total blood 
volume should be taken during a four week period and not more than 1% of total blood volume 
at a single time-point. At a total blood volume estimated at 80 to 90ml per kilogram (kg) body 
weight, this equates to 2.4mL to 2.7mL blood per kg body weight during a four week period, 
or 0.8mL to 0.9mL blood per kg at any one time. 
These recommended volumes must not be exceeded for any patient. Please use the information 
below to ensure that the recommended volumes are adhered to. 
Table 16-1 
Total blood volume, 1% and 3% of total blood volume by weight 
assuming 85mL per kg total blood volume 
 
Weight (Kg)
Total Blood Volume* 
1% Blood Volume* 
3% Blood Volume* 
(mL) 
(mL) 
(mL) 
5 
425 
4 
12 
10 
850 
8 
24 
15 
1275 
12 
36 
20 
1700 
17 
51 
25 
2125 
21 
63 
30 
2550 
25 
75 
35 
2975 
29 
87 
40 
3400 
34 
102 
45 
3825 
38 
114 
50 
4250 
42 
126 
55 
4675 
46 
138 
60 
5100 
51 
103 
65 
5525 
55 
165 
70 
5950 
59 
177 
75 
6375 
63 
186 
80 
6800 
68 
204 
*all blood volumes are rounded down