Ulcerative Colitis
Conditions
Brief summary
Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658
Detailed 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.
Interventions
DRUGSAR339658
Pharmaceutical form: Solution for infusion Route of administration: Intravenous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with Adverse Events | Up to Week 68 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with abnormal safety parameters (laboratory data and vital signs) | Up to Week 68 |
| Proportion of participants with Clinical Remission by Mayo Score | At Week 62 |
| Proportion of participants with Mucosal Healing | At Week 62 |
| Change from baseline in the partial Mayo Score | At Weeks 10, 22, 34, 46 and 58 |
| Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) | At Weeks 34 and 62 |
Countries
United States
Outcome results
None listed