RecruitingPhase 2NCT06850727
Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
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
Sponsor
Odyssey Therapeutics
Enrollment
57 participants
Start Date
Jun 2, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria3
- 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 Criteria4
- Has diagnosis of Crohn's disease or indeterminate colitis
- Has had extensive colonic resection
- Has colostomy or ileostomy
- Has uncontrolled primary sclerosing cholangitis
Interventions
DRUGOD-07656
Experimental intervention
DRUGVedolizumab
Active standard of care comparator
Locations(32)
View Full Details on ClinicalTrials.gov
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NCT06850727
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