A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis

Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human
antibody that targets IL-17A and neutralizes activity. Secukinumab treatment
has demonstrated significant and clinically meaningful efficacy in treating
adults with ankylosing spondylitis (AS) and
psoriatic arthritis (PsA), both approved indications.
The adult AS and PsA secukinumab data support the proposed secukinumab study in
children with similar pediatric spondyloarthritic conditions: ERA and JPsA.
This study will investigate secukinumab treatment in children * 2 to < 18 years
of age with active JPsA or ERA JIA using
a pediatric dose equivalent to the adult 150mg dose.

The purpose of the study is to investigate the use of secukinumab (AIN457)
treat ment in children from 2 to18 years of age with either active Enthesitis
-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) subtypes of
Juvenile Idiopathic Arthritis (JIA). The study aims to demonstrate the efficacy
of secukinumab (AIN457) treatment to prevent a disease flare (worsening) during
a double-blind placebo-control treatment withdrawal part of the trial.

There are three parts to this study. If the patient meets the requirements to
continue participation in the study, he/she will enter Treatment Period 1. In
this part of the study, all children will receive the medication secukinumab
(AIN457). The patient will receive this medication once a week for the first
month, then every 4 weeks until Week12.
At Week 12, your child will be assessed to see if he/she has adequately
responded to the medication. If he/she has not, then he/she will not receive
any more study medication and not go into Treatment Period 2. Instead, he/she
will be asked to undergo a 12-week post-treatment
follow-up and then leave the study. During this period, your child will not
receive any study drug, but the Study Doctor will continue to check on your
child*s health.
If the patient does respond adequately to the medication, he/she will enter
Treatment Period 2. During Treatment Period 2, the patient will be randomized
to receive either secukinumab (AIN457) or a placebo every 4 weeks, starting at
Week 12.
If during Treatment Period 2 the patient experiences a disease flare , then the
patient will immediately enter Treatment Period 3, and will receive (or
continue to receive) on the same day the medication secukinumab (AIN457). Once
33 children in Treatment Period 2 have experienced a disease flare, all
children in the study will move into Treatment Period 3.
In Treatment Period 3 all children will receive secukinumab (AIN457) just as
they had in Treatment Period 1. The treatment portion of the study will
finish at Week 104 ( 2 years) and then the children will either enter a follow
up period lasting 12 weeks from last stud drug administration.

Investigational treatment:
* Secukinumab 150mg/1mL, liquid formulation provided in 1 mL PFS (Pre-filled
syringe)
* Secukinumab 75mg/0.5mL, liquid formulation provided in 0.5 mL PFS
Reference treatment
* Placebo, liquid formulation in a 1 mL and 0.5 mL PFS

Possible common side effects reported in adult patients with psoriasis,
psoriatic arthritis or ankylosing spondylitis who participated in studies
treated with secukinumab treatment include:
* Upper respiratory tract infections/disorders such as a common cold
* Diarrhea
* Urticaria (hives)
More uncommon side effects include:
* Conjunctivitis (inflammation of the white part of the eye, usually due to an
infection)
* Neutropenia (low number of a special type of white blood cell which is part
of the immune system)
* Oral candidiasis (oral thrush; a fungal infection involving the mouth)

Although secukinumab is a marketed drug for adult patients with psoriasis,
psoriatic arthritis or ankylosing spondylitis, it has not yet been tested in
children with Juvenile psoriatic arthritis (JPsA) or enthesitis-related
arthritis (ERA). Consequently, not all of the potential side effects are known
at this time for children who have JPsA or ERA treated with secukinumab.
The risks of collecting blood may include fainting, pain and/or bruising.
Rarely, these may be a small blood clot or infection at the site of the needle
puncture.