New hope for ulcerative colitis: experimental drug OD-07656 enters Mid-Stage trial
NCT ID NCT06850727
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called OD-07656 in people with moderate to severe ulcerative colitis, a chronic bowel disease. The goal is to see if it safely reduces symptoms like bleeding and diarrhea, and if it can make a follow-up treatment (vedolizumab) work better. About 57 adults will participate in this early-phase trial.
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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About 57 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- 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
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18 to 75 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: The main inclusion criteria include but are not limited to the following: * Has a confirmed diagnosis of ulcerative colitis (UC) * Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score * Has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of Crohn's disease or indeterminate colitis * Has had extensive colonic resection * Has colostomy or ileostomy * Has uncontrolled primary sclerosing cholangitis
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Uc - ulcerative colitis are added.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
32 sites in 10 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Locations
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Alfred Health
RECRUITINGMelbourne, 3004, Australia
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CHUM
RECRUITINGMontreal, H2X OA9, Canada
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CHUM - Pavillon R
RECRUITINGPolička, 1549, Czechia
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Centrum Medyczne
RECRUITINGBydgoszcz, Poland
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Centrum Medyczne LukaMed
RECRUITINGChojnice, Poland
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Centrum Medyczne Medyk
RECRUITINGRzeszów, Poland
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Coastal Digestive Health
RECRUITINGMaroochydore, Australia
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Danylo Halytsky Lviv National Medical University
RECRUITINGLviv, 79000, Ukraine
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Eastern Health
RECRUITINGBox Hill, Australia
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Endoskopia Sp. z.o.o
RECRUITINGSopot, Poland
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Fiona Stanley Hospital
RECRUITINGMurdoch, 6150, Australia
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IMSP Spitalul Clinic Republican Timofei Moneaga
RECRUITINGChisinau, Md-2025, Moldova
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Irbid Specialty Hospital
RECRUITINGIrbid, 21110, Jordan
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Jordan University Hospital
RECRUITINGAmman, 11942, Jordan
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Lviv Regional Clinical Hospital
RECRUITINGLviv, 79010, Ukraine
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Medical Network Company
RECRUITINGWarsaw, Poland
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Medical University of Graz
RECRUITINGGraz, Austria
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Medical centre of ARENSIA Exploratory Medicine LCC
RECRUITINGKyiv, 01135, Ukraine
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Montreal General Hospital/McGill University
RECRUITINGMontreal, Canada
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Nowe zdrowie-CK, Kiełtucki
RECRUITINGStaszów, Poland
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PCRN Auckland
RECRUITINGAuckland, 0622, New Zealand
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PCRN Christchurch
RECRUITINGChristchurch, 0622, New Zealand
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PCRN Tasman
RECRUITINGNelson, 7011, New Zealand
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PCRN Waikato
RECRUITINGHamilton, 3200, New Zealand
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PCRN Wellington
RECRUITINGUpper Hutt, 5018, New Zealand
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Penta Hospitals Przychodnie
RECRUITINGWroclaw, 54-239, Poland
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Regional Clinical Hospital
RECRUITINGIvano-Frankivsk, 76008, Ukraine
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Royal Melbourne Hospital
RECRUITINGParkville, Australia
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Sunshine Coast University
RECRUITINGBirtinya, Australia
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The Hospital of Lithuanian University of Health Sciences
RECRUITINGKaunas, Lithuania
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The Specialty Hospital (TSH) / Advanced Clinical Center
RECRUITINGAmman, Jordan
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Vita Longa Sp. z.o.o.
RECRUITINGKatowice, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Triple-Pronged attack on gut inflammation put to the test
- Two biologics go head to head in ulcerative colitis
- New drug ATTO-1091 put to the test for safety in ulcerative colitis
- Antiparasitic drug tested as new weapon against ulcerative colitis
- Could your Donor's gut bacteria decide whether a stool transplant works?