Recruiting
Phase 3

Ponesimod

Sponsor:

Vanda Pharmaceuticals

Code:

NCT07686081

Conditions

Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ponesimod

Placebo

Study Details

Brief 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)

Study ID

NCT07686081

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ponesimod (VSP-128)

placebo comparator: Placebo

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals Inc.

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Chula Vista, California, United States, 91910

Vanda Investigational Site

Recruiting

Nashville, Tennessee, United States, 37211

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • ulcerative colitis
  • moderately to severely active ulcerative colitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2026-08-18.