Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

The study period per patient will include 62 weeks treatment, 6 weeks post treatment safety
follow-up, followed by a long term safety follow-up performed in the form of a phone
interview at 3, 6, 12, 18 and 24 months from the last administration of the study
medication.

Inclusion criteria:

- Patients with Ulcerative Colitis (UC) who were previously randomized and have
completed the 8-week treatment in ACT12688 study with an acceptable safety profile.
Patients who for administrative reasons could not be enrolled in the LTS12593 study
right after completion of the 8-week treatment in the ACT12688 study must be enrolled
within 3 months from the end of the ACT12688 study

- Signed written informed consent for Study LTS12593

Exclusion criteria:

- Patient with any adverse event leading to study drug (active or placebo) treatment
discontinuation from ACT12688 study.

- Patient with any abnormalities or adverse events that per investigator judgment would
adversely affect patient's participation in the long-term extension study.

- Use of any immunosuppressant (if patient is on immunosuppressant he or she must
discontinue immunosuppressant before starting the LTS12593).

- If the patient started biological treatment for UC while waiting to be enrolled in
the LTS12593, then he or she must stop the biological treatment and must have 8 weeks
of wash out period before starting treatment with SAR339658 (only anti-tumor necrosis
factors (TNFs) are allowed)

- Patients exposed to an anti-integrin or any investigational drug administered after
the end of treatment in ACT12688

- Positive pregnancy test

- Breast feeding woman

- Women of childbearing potential not protected by highly effective contraceptive
method of birth control and/or who are unwilling and unable to be tested for
pregnancy.

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