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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Vanda Pharmaceuticals
Study ID
NCT07686081
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ponesimod — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ponesimod (VSP-128)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Clinical Remission at Week 16 [ Time Frame: Week 16 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Vanda Investigational SiteChula VistaCalifornia91910-
Vanda Investigational SiteNashvilleTennessee37211-

Find similar trials in Chula Vista, CA

By research site
Vanda Investigational Site· Chula Vista, CAVanda Investigational Site· Nashville, TN

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