Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis

The study duration includes a screening period up to 4 weeks, a double-blind treatment period
of up to 96 weeks, an open-label period including the remainder of the initial 96 weeks,
where applicable, and a 96-week extension, i.e., up to a maximum of 192 weeks after
randomization. There will be a follow-up period of 4 weeks for participants discontinuing
treatment.

Within the 96 weeks double-blind treatment period, the first 4 weeks are pharmacokinetic (PK)
run-in phase in which PK samples (blood samples) will be collected from participants and then
4 weeks of analysis (no samples drawn). The PK run-in phase (total 8 weeks) is intended to
provide individual PK parameters to allow the dose adjustment to the 14 mg adult-equivalent
dose for the rest of the study.

Participants experiencing a relapse after the PK run-in phase (8 weeks) and if confirmed by
the Relapse Adjudication Panel (RAP) and patients fulfilling MRI criteria (high number of new
lesions at week 36, 48 or 72 compared to previous images) will have the option to continue in
an open label teriflunomide treatment arm up to 192 weeks from randomization.

An optional additional extension period is available for young participants with
teriflunomide until the participants are 18 years old and/or able to switch to commercial
product, whichever comes first.

Inclusion criteria :

- Patients with relapsing multiple sclerosis are eligible. Patients should meet the
criteria of multiple sclerosis (MS) based on McDonald criteria 2010 and International
Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version
of 2012 (5) and have:

- at least one relapse (or attack) in the 12 months preceding screening or

- at least two relapses (or attack) in the 24 months preceding screening.

- <18 years of age and ≥10 years of age at randomization. Specific for the Russian
Federation from 18 December 2014 to 26 July 2016, ≤17 years of age and ≥13 years of
age at randomization

- Signed informed consent/assent obtained from patient and patient's legal
representative (parents or guardians) according to local regulations.

Exclusion criteria:

- Expanded disability status scale (EDSS) score > 5.5 at screening or randomization
visits.

- Relapse within 30 days prior to randomization.

- Treated with:

glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization
fingolimod, or intravenous immunoglobulins within 3 months prior to randomization
natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide,
azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to
randomization, cladribine or mitoxantrone within 2 years prior to randomization

- Treated with alemtuzumab at any time.

- History of HIV infection.

- Contraindication for magnetic resonance imaging (MRI).

- Pregnant or breast-feeding females or those who plan to become pregnant during the
study.

- Female patients of child-bearing potential not using highly effective contraceptive
method (contraception in both female and male is required).

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.