A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod.
Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod.
Vanda Investigational Site
Chula Vista, California, United States
RECRUITINGVanda Investigational Site
Nashville, Tennessee, United States
RECRUITINGClinical Remission at Week 16
Proportion of participants achieving clinical remission at Week 16.
Time frame: Week 16
Clinical Response at Week 16
Proportion of participants achieving clinical response at Week 16.
Time frame: Week 16
Change From Baseline in Mayo Score at Week 16
Change from baseline in the three-component Mayo Score at Week 16. The overall score value ranges from 0 to 9, with higher scores indicating more severe ulcerative colitis disease activity.
Time frame: Baseline to Week 16.
Endoscopic Improvement at Week 16
Proportion of participants achieving endoscopic improvement at Week 16.
Time frame: Week 16
Symptomatic Remission at Week 16
Proportion of participants achieving symptomatic remission at Week 16.
Time frame: Week 16
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