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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.