New oral drug shows promise for ulcerative colitis in early trial
NCT ID NCT05291689
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Feb 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Clinical Study Site
Tampa, Florida, 33609, United States
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Clinical Study Site
Lafayette, Louisiana, 70503, United States
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Clinical Study Site
Freehold, New Jersey, 07728, United States
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Clinical Study Site
Brooklyn, New York, 11235, United States
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Clinical Study Site
New York, New York, 10075, United States
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Clinical Study Site
Bydgoszcz, 85-794, Poland
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Clinical Study Site
Elblag, 82-300, Poland
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Clinical Study Site
Katowice, 40-748, Poland
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Clinical Study Site
Lodz, 90-349, Poland
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Clinical Study Site
Lodz, 90-752, Poland
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Clinical Study Site
Oświęcim, 32-600, Poland
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Clinical Study Site
Sopot, 81-756, Poland
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Clinical Study Site
Sosnowiec, 41-209, Poland
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Clinical Study Site
Staszów, 28-200, Poland
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Clinical Study Site
Tychy, 43-100, Poland
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Clinical Study Site
Warsaw, 00-728, Poland
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Clinical Study Site
Warsaw, 02-665, Poland
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