Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

The total duration per patient is up to 58 weeks, which includes a 2 week screening period,
16 weeks principal treatment period, 34 weeks extension treatment period (or open label
treatment period), and 6 weeks after last treatment administration.

Non-responder patients, observed within the first 16 weeks, will be offered to be treated by
open-label sarilumab. Patients will be treated for 34 extra weeks (up to 18 extra
injections).

Inclusion criteria:

≥18 years of age. Non-infectious intermediate-, posterior-, or pan-uveitis in the study
eye. Active disease at screening or evidence of activity within the 3 months prior to
screening visit. Following the approval of Amendment 2, only patients with "active
disease" as defined above will be enrolled in the study.

Starting oral prednisone dose must be greater than or equal to 15 mg/day and less than 80
mg/day.

At screening, patients must be receiving oral prednisone (≥15 mg and < 80 mg/day [or
equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination
with Methotrexate (MTX) (≤ 25 mg/week) orally or intravenously or intra muscular or
subcutaneous). Patients can be receiving one or several of the following therapies:
Azathioprine (≤2.5 mg/kg/day), Mycophenolate mofetil (≤2g daily, orally), Cyclosporine (≤4
mg/kg daily, orally), Tacrolimus (≤4 mg daily, orally).

The doses may not have been increased for at least 4 weeks prior to the randomization
visit.

At randomization, patients have been receiving oral prednisone (≥15 mg and < 80 mg/day [or
equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination
with methotrexate (MTX) (≤ 25 mg/week) orally or intravenously or intra muscular or
subcutaneous).

Azathioprine, mycophenolate mofetil, cyclosporine and tacrolimus have to be permanently
discontinued at least 48 hours prior to the first study treatment injection, or longer as
per Investigator's judgment. These immunomodulatory therapy (IMTs) are not permitted
anytime during the treatment period.

Signed written informed consent.

Exclusion criteria:

Patient with best-corrected visual acuity worse than 20 ETDRS letters in at least one eye.

Patient with confirmed or suspected uveitis of infectious etiology or uveitis of traumatic
etiology.

Patient with primary diagnosis of anterior uveitis. Prior treatment with anti-IL-6 or
IL-6R antagonist therapies, including tocilizumab and sarilumab.

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