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NCT Number: NCT07686081

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

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

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects aged 18-75 years
  • Able to provide written informed consent
  • Diagnosis of ulcerative colitis for ≥90 days prior to screening
  • Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1
  • History of inadequate response, loss of response, or intolerance to at least one approved UC therapy

Exclusion criteria

  • Severe or fulminant UC likely to require hospitalization or surgery
  • Diagnosis of Crohn's disease or other non-UC colitis
  • Prior exposure to S1P receptor modulators
  • Active or chronic infections
  • Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease
  • History of an allergic reaction or significant sensitivity to constituents of study drug

Treatment and study plan

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.

Other names: VSP-128

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.

Primary outcomes

  1. Clinical Remission at Week 16

    Time frame: Week 16

    Proportion of participants achieving clinical remission at Week 16.

Secondary outcomes

  1. Clinical Response at Week 16

    Time frame: Week 16

    Proportion of participants achieving clinical response at Week 16.

  2. Change From Baseline in Mayo Score at Week 16

    Time frame: Baseline to Week 16.

    Change from baseline in Mayo score at Week 16.

  3. Endoscopic Improvement at Week 16

    Time frame: Week 16

    Proportion of participants achieving endoscopic improvement at Week 16.

  4. Symptomatic Remission at Week 16

    Time frame: Week 16

    Proportion of participants achieving symptomatic remission at Week 16.

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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