Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT01659138
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the efficacy of SAR339658
Secondary Objective:
To assess the safety of SAR339658
- Detailed Description
The study period per patient will include up to 4 weeks screening, 8 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.
After completion of the 8-week treatment phase, patients may be eligible to enter a long term safety study (LTS12593) for active treatment with SAR339658.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR339658 SAR339658 SAR339658 at Weeks 0, 2, 4, and 6 Placebo Placebo Placebo at Weeks 0, 2, 4, and 6
- Primary Outcome Measures
Name Time Method Proportion of Participants with Clinical Response by Mayo Score At Week 8
- Secondary Outcome Measures
Name Time Method Proportion of Participants with Clinical Remission by Mayo Score At Week 8 Proportion of Participants with Mucosal Healing At Week 8 Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) At Weeks 4 and 8 Change from Baseline in Quality of Life (QoL) SF-36 At Weeks 4 and 8 Change from Baseline in the partial Mayo Score At Weeks 4 and 6 Number of Participants with adverse events Up to Week 17
Trial Locations
- Locations (41)
Investigational Site Number 840071
🇺🇸Rochester, New York, United States
Investigational Site Number 840065
🇺🇸Sun City, Arizona, United States
Investigational Site Number 840059
🇺🇸Mission Hills, California, United States
Investigational Site Number 840074
🇺🇸San Diego, California, United States
Investigational Site Number 840061
🇺🇸Littleton, Colorado, United States
Investigational Site Number 840008
🇺🇸Miramar,, Florida, United States
Investigational Site Number 840048
🇺🇸Winter Park,, Florida, United States
Investigational Site Number 840003
🇺🇸Miami, Florida, United States
Investigational Site Number 840053
🇺🇸Savannah,, Georgia, United States
Investigational Site Number 840001
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840005
🇺🇸Oak Lawn, Illinois, United States
Investigational Site Number 840070
🇺🇸Rochester Hills, Michigan, United States
Investigational Site Number 840078
🇺🇸Hammond, Louisiana, United States
Investigational Site Number 840060
🇺🇸Ocean Springs, Mississippi, United States
Investigational Site Number 840089
🇺🇸Winston Salem, North Carolina, United States
Investigational Site Number 840024
🇺🇸Mexico, Missouri, United States
Investigational Site Number 840051
🇺🇸Great Neck, New York, United States
Investigational Site Number 840046
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840068
🇺🇸Charlottesville,, Virginia, United States
Investigational Site Number 840038
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 840019
🇺🇸Pasadena,, Texas, United States
Investigational Site Number 840088
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840064
🇺🇸Wauwatosa, Wisconsin, United States
Investigational Site Number 124002
🇨🇦Vancouver, Canada
Investigational Site Number 040003
🇦🇹Innsbruck, Austria
Investigational Site Number 250003
🇫🇷Grenoble, France
Investigational Site Number 250006
🇫🇷Vandoeuvre Les Nancy, France
Investigational Site Number 276005
🇩🇪Hamburg, Germany
Investigational Site Number 380003
🇮🇹Firenze, Italy
Investigational Site Number 276001
🇩🇪Berlin, Germany
Investigational Site Number 380006
🇮🇹San Giovanni Rotondo, Italy
Investigational Site Number 276007
🇩🇪Hamburg, Germany
Investigational Site Number 616002
🇵🇱Lodz, Poland
Investigational Site Number 616001
🇵🇱Gdynia, Poland
Investigational Site Number 616004
🇵🇱Lodz, Poland
Investigational Site Number 616005
🇵🇱Lodz, Poland
Investigational Site Number 616007
🇵🇱Poznan, Poland
Investigational Site Number 616006
🇵🇱Sroda Wielkopolska, Poland
Investigational Site Number 616008
🇵🇱Warszawa, Poland
Investigational Site Number 840045
🇺🇸Phoenixville, Pennsylvania, United States
Investigational Site Number 840034
🇺🇸Seattle, Washington, United States