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NOT YET RECRUITING
NCT07686081
PHASE3

Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis

Sponsor: Vanda Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-09

Completion Date

2029-08

Last Updated

2026-07-07

Healthy Volunteers

No

Interventions

DRUG

Ponesimod

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.

DRUG

Placebo

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.

Locations (2)

Vanda Investigational Site

Chula Vista, California, United States

Vanda Investigational Site

Nashville, Tennessee, United States