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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ponesimod (VSP-128)
  • 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.
    Other names:
    • VSP-128
Placebo Comparator
Placebo
  • 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.

Recruiting Locations

Vanda Investigational Site
Chula Vista, California 91910

Vanda Investigational Site
Nashville, Tennessee 37211

More Details

Status
Recruiting
Sponsor
Vanda Pharmaceuticals

Study Contact

Vanda Pharmaceuticals Inc.
202-734-3400
clinicaltrials@vandapharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.