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

Study Overview
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Brief Summary
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Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658

Detailed Description
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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.

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: SAR339658


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR339658<br>SAR339658, every 2 weeks (Q2W) or every 4 weeks (Q4W) according to clinical response at Week 8 in the ACT12688 trial | Drug: SAR339658<br>* Pharmaceutical form: Solution for infusion Route of administration: Intravenous<br>* Other names: Vatelizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with Adverse Events |  | Up to Week 68 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |