Ulcerative Colitis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)
Primary Objective:
To assess the efficacy of SAR339658
Secondary Objective:
To assess the safety of SAR339658
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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