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

Sanofi

Status and phase

Terminated

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: SAR339658

Study type

Interventional

Funder types

Industry

Identifiers

NCT01861249

LTS12593

U1111-1141-4634 (Other Identifier)

2013-001012-30 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

Full description

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.