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

NCT07686081 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-18

No results posted yet for this study

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

Conditions

  • Ulcerative Colitis (UC)

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-04-30
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686081 on ClinicalTrials.gov