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

Primary Purpose

Ulcerative Colitis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SAR339658

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Investigational Site Number 840059
Investigational Site Number 840008
Investigational Site Number 840048
Investigational Site Number 840024
Investigational Site Number 840088

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR339658

Arm Description

SAR339658, every 2 weeks (Q2W) or every 4 weeks (Q4W) according to clinical response at Week 8 in the ACT12688 trial

Outcomes

Primary Outcome Measures

Percentage of participants with Adverse Events

Secondary Outcome Measures

Percentage of participants with abnormal safety parameters (laboratory data and vital signs)

Proportion of participants with Clinical Remission by Mayo Score

Proportion of participants with Mucosal Healing

Change from baseline in the partial Mayo Score

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

Full Information

NCT ID

NCT01861249

First Posted

May 21, 2013

Last Updated

July 12, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01861249

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.

Study Start Date

July 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR339658

Arm Type

Experimental

Arm Description

SAR339658, every 2 weeks (Q2W) or every 4 weeks (Q4W) according to clinical response at Week 8 in the ACT12688 trial

Intervention Type

Drug

Intervention Name(s)

SAR339658

Other Intervention Name(s)

Vatelizumab

Intervention Description

Pharmaceutical form: Solution for infusion Route of administration: Intravenous

Primary Outcome Measure Information:

Title

Percentage of participants with Adverse Events

Time Frame

Up to Week 68

Secondary Outcome Measure Information:

Title

Percentage of participants with abnormal safety parameters (laboratory data and vital signs)

Time Frame

Up to Week 68

Title

Proportion of participants with Clinical Remission by Mayo Score

Time Frame

At Week 62

Title

Proportion of participants with Mucosal Healing

Time Frame

At Week 62

Title

Change from baseline in the partial Mayo Score

Time Frame

At Weeks 10, 22, 34, 46 and 58

Title

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

Time Frame

At Weeks 34 and 62

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840059

City

Mission Hills

State/Province

California

ZIP/Postal Code

91345

Country

United States

Facility Name

Investigational Site Number 840008

City

Miramar,

State/Province

Florida

ZIP/Postal Code

33025

Country

United States

Facility Name

Investigational Site Number 840048

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Investigational Site Number 840024

City

Mexico

State/Province

Missouri

ZIP/Postal Code

65265

Country

United States

Facility Name

Investigational Site Number 840088

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

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

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