New oral drug shows promise for ulcerative colitis in early trial

NCT ID NCT05291689

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental pill called MORF-057 in 39 adults with moderate to severe ulcerative colitis. The drug aims to reduce gut inflammation by blocking a specific protein. Researchers measured changes in colon tissue health and symptom scores after 12 weeks of treatment.

What this could mean

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

Active substance
MORF-057 (an oral pill that blocks a protein involved in gut inflammation)
What this could lead to
If it works, this could point toward a new daily pill to control ulcerative colitis symptoms and reduce gut damage.
What could go wrong
This is a small, early-phase trial with only 39 people and no placebo group, so results may not hold up in larger studies. The drug may cause side effects or not work for everyone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2025

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 85 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: * Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening * Has evidence of UC extending at least 15 cm from the anal verge * Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs * Agrees to abide by the study guidelines and requirements * Capable of giving signed informed consent Exclusion Criteria: * Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease * Has positive findings on a subjective neurological screening questionnaire * Has a concurrent, clinically significant, serious, unstable comorbidity * Primary non-responder to vedolizumab or other integrin inhibitors * Participation in any other interventional study or received any investigational therapy within 30 days * Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057 * Unable to attend study visits or comply with study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Clinical Study Site

    Tampa, Florida, 33609, United States

  • Clinical Study Site

    Lafayette, Louisiana, 70503, United States

  • Clinical Study Site

    Freehold, New Jersey, 07728, United States

  • Clinical Study Site

    Brooklyn, New York, 11235, United States

  • Clinical Study Site

    New York, New York, 10075, United States

  • Clinical Study Site

    Bydgoszcz, 85-794, Poland

  • Clinical Study Site

    Elblag, 82-300, Poland

  • Clinical Study Site

    Katowice, 40-748, Poland

  • Clinical Study Site

    Lodz, 90-349, Poland

  • Clinical Study Site

    Lodz, 90-752, Poland

  • Clinical Study Site

    Oświęcim, 32-600, Poland

  • Clinical Study Site

    Sopot, 81-756, Poland

  • Clinical Study Site

    Sosnowiec, 41-209, Poland

  • Clinical Study Site

    Staszów, 28-200, Poland

  • Clinical Study Site

    Tychy, 43-100, Poland

  • Clinical Study Site

    Warsaw, 00-728, Poland

  • Clinical Study Site

    Warsaw, 02-665, Poland

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