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

Stopped early · Phase 2

Conditions studied: Ulcerative Colitis

In brief

Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658

Key facts

Study ID

NCT01861249

Run by

Sanofi

People needed

6

Starts

2013-07-01

Expected to finish

2016-04-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840059 — Mission Hills, California, United States
• Investigational Site Number 840008 — Miramar, Florida, United States
• Investigational Site Number 840048 — Winter Park, Florida, United States
• Investigational Site Number 840024 — Mexico, Missouri, United States
• Investigational Site Number 840088 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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