Tests OD-07656 and vedolizumab in ulcerative colitis
Tests OD-07656, then vedolizumab, in adults with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Birtinya, Box Hill, Maroochydore, Melbourne, Murdoch, and Parkville, AustraliaSee the 6 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis. They must have had an inadequate response, lost response, or could not take at least one earlier ulcerative colitis treatment.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed ulcerative colitis that is moderately to severely active, as defined by the 3-component Modified Mayo clinic score.
- Earlier treatment
- Must have had an inadequate response, loss of response, or intolerance/medical contraindication to at least one of: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators.
Main reasons for not taking part
- Crohn's disease or indeterminate colitis
- Extensive colonic resection
- Colostomy or ileostomy
- Uncontrolled primary sclerosing cholangitis
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06850727, who can take part
Where in Australia
- Sunshine Coast UniversityBirtinya, AustraliaTaking people
- Eastern HealthBox Hill, AustraliaTaking people
- Coastal Digestive HealthMaroochydore, AustraliaTaking people
- Alfred HealthMelbourne, AustraliaTaking people
- Fiona Stanley HospitalMurdoch, AustraliaTaking people
- Royal Melbourne HospitalParkville, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Odyssey Therapeutics, Inc.
- Trial code
- NCT06850727
- Record updated
- 11 February 2026
- Original description
The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.Read full original descriptionShow less
A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.
Inclusion: 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: Has had extensive colonic resection; Has diagnosis of Crohn's disease or indeterminate colitis; The main exclusion criteria include but are not limited to the following:; Has colostomy or ileostomy; Has uncontrolled primary sclerosing cholangitis.