RightFit
RecruitingPhase 3

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 in Patients With Moderately to Severely Active Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well ponesimod (VSP-128) works and how safe it is compared with a placebo, which has no active drug. It is for adults with moderately to severely active ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 75 years old.
  • Can give written consent to join the study.
  • Have had a UC diagnosis for at least 90 days before screening.
  • Have a UC activity score (three-part Mayo score) of 5 to 9, with a bowel exam score of at least 2 and a rectal bleeding score of at least 1.
  • Have tried at least one approved UC treatment that did not work well, stopped working, or caused side effects you could not tolerate.

Who can't join

  • Have severe or rapidly worsening UC likely to need hospital care or surgery.
  • Have Crohn's disease or another type of large intestine inflammation that is not UC.
  • Have taken an S1P receptor modulator, the type of drug being studied.
  • Have an active or long-lasting infection.
  • Have serious heart, blood vessel, or liver disease, or another uncontrolled disease affecting the body.
  • Have had an allergic reaction or strong sensitivity to any ingredient in the study drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

CA

TN