Ulcerative Colitis study: Ponesimod
Official title Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07686081
What this study is testing
What is Ponesimod?
This is an investigational pill being studied to see if it can help treat moderately to severely active ulcerative colitis. It is designed to block specific signals in the immune system that cause inflammation in the gut.
Also referred to as VSP-128.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if ponesimod is safe and effective for treating moderately to severely active ulcerative colitis.
- Who it's for
- The study is looking for people who have moderately to severely active ulcerative colitis.
- What's involved
- Participants will be randomly assigned to receive either the new drug ponesimod or a placebo (a pill with no active medicine). The study is double-blind, meaning neither the patient nor the doctor knows which one is being given.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and female people 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Chula Vista, California, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chula Vista, California, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.