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

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

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Hills, California, United States, 91345
      • Investigational Site Number 840059
  • Florida
    • Miramar,, Florida, United States, 33025
      • Investigational Site Number 840008
    • Winter Park, Florida, United States, 32789
      • Investigational Site Number 840048
  • Missouri
    • Mexico, Missouri, United States, 65265
      • Investigational Site Number 840024
  • Texas
    • San Antonio, Texas, United States, 78229
      • Investigational Site Number 840088

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: LTS12593; 2013-001012-30 (EudraCT Number); U1111-1141-4634 (Other Identifier: UTN)