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

A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

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.