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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01861249
• Date of registration: 21/05/2013
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
• Scientific title: A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
• Date of first enrolment: July 2013
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01861249
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: SAR339658

Primary Outcome(s)

Percentage of participants with Adverse Events [Time Frame: Up to Week 68]

Secondary Outcome(s)

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: At Weeks 34 and 62]

Proportion of participants with Mucosal Healing [Time Frame: At Week 62]

Proportion of participants with Clinical Remission by Mayo Score [Time Frame: At Week 62]

Change from baseline in the partial Mayo Score [Time Frame: At Weeks 10, 22, 34, 46 and 58]

Percentage of participants with abnormal safety parameters (laboratory data and vital signs) [Time Frame: Up to Week 68]

Secondary ID(s)

U1111-1141-4634

2013-001012-30

LTS12593

Source(s) of Monetary Support

Please refer to primary and secondary sponsors