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

NCT01861249 | Terminated Phase 2 DMC

• 3 other identifiers: LTS125932013-001012-30U1111-1141-4634
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

Brief Summary

Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with Adverse Events

  Up to Week 68

Secondary Outcomes (5)

• 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

Study Arms (1)

SAR339658

EXPERIMENTAL

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

Drug: SAR339658

Interventions

SAR339658 DRUG

Pharmaceutical form: Solution for infusion Route of administration: Intravenous

Also known as: Vatelizumab

SAR339658

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Investigational Site Number 840059

Mission Hills, California, 91345, United States

Location

Investigational Site Number 840008

Miramar, Florida, 33025, United States

Location

Investigational Site Number 840048

Winter Park, Florida, 32789, United States

Location

Investigational Site Number 840024

Mexico, Missouri, 65265, United States

Location

Investigational Site Number 840088

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (5)