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

Ulcerative Colitis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861249
• Other study ID #: LTS12593
• Secondary ID: 2013-001012-30U1
• Status: Terminated
• Phase: Phase 2
• First received: May 21, 2013
• Last updated: July 12, 2016
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To assess the long term safety and tolerability of SAR339658

Secondary Objective:

To assess the long term efficacy of SAR339658

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• SAR339658
Pharmaceutical form: Solution for infusion Route of administration: Intravenous

Locations

Country	Name	City	State
United States	Investigational Site Number 840024	Mexico	Missouri
United States	Investigational Site Number 840008	Miramar,	Florida
United States	Investigational Site Number 840059	Mission Hills	California
United States	Investigational Site Number 840088	San Antonio	Texas
United States	Investigational Site Number 840048	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with Adverse Events		Up to Week 68	Yes
Secondary	Percentage of participants with abnormal safety parameters (laboratory data and vital signs)		Up to Week 68	Yes
Secondary	Proportion of participants with Clinical Remission by Mayo Score		At Week 62	Yes
Secondary	Proportion of participants with Mucosal Healing		At Week 62	No
Secondary	Change from baseline in the partial Mayo Score		At Weeks 10, 22, 34, 46 and 58	No
Secondary	Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)		At Weeks 34 and 62	No