A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Sanofi
- Enrollment
- 28
- Locations
- 41
- Primary Endpoint
- Proportion of Participants with Clinical Response by Mayo Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAR339658
SAR339658 at Weeks 0, 2, 4, and 6
Intervention: SAR339658 (Drug)
Placebo
Placebo at Weeks 0, 2, 4, and 6
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Proportion of Participants with Clinical Response by Mayo Score
Time Frame: At Week 8
Secondary Outcomes
- 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)