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New oral drug aims to tame ulcerative colitis Flare-Ups

NCT ID NCT07686081

Disease control Sponsor: Vanda Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This trial tests whether the oral drug ponesimod can help people with moderately to severely active ulcerative colitis achieve remission. Participants receive either ponesimod or a placebo daily for 16 weeks, with an option to continue on ponesimod for another 36 weeks. The study measures how many people reach clinical remission and symptom improvement by week 16.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ponesimod (also known as VSP-128)
What this could lead to
If successful, ponesimod could offer a new oral treatment option for people with moderate-to-severe ulcerative colitis who have not responded to other therapies.
What could go wrong
This is a Phase 3 trial, but results may not confirm benefit. Ponesimod can have side effects, and long-term safety is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Vanda Investigational Site

    RECRUITING

    Chula Vista, California, 91910, United States

  • Vanda Investigational Site

    RECRUITING

    Nashville, Tennessee, 37211, United States

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