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
- Montreal, CanadaSee the 2 sites
- Phase
- Phase 2
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 Canada
- CHUMMontreal, CanadaTaking people
- Montreal General Hospital/McGill UniversityMontreal, CanadaTaking 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?
Trial 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.