Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT06850727
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
57 participants
INTERVENTIONAL
2025-06-02
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OD-07656 Dosing Regimen 1
Open Label, Oral, twice daily dose
OD-07656
Experimental intervention
Vedolizumab
Active standard of care comparator
OD-07656 Dosing Regimen 2
Randomized, Oral, twice daily dose
OD-07656
Experimental intervention
Vedolizumab
Active standard of care comparator
OD-07656 Dosing Regimen 3
Randomized, Oral, twice daily dose
OD-07656
Experimental intervention
Vedolizumab
Active standard of care comparator
Interventions
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OD-07656
Experimental intervention
Vedolizumab
Active standard of care comparator
Eligibility Criteria
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Inclusion Criteria
* 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
* Has had extensive colonic resection
* Has colostomy or ileostomy
* Has uncontrolled primary sclerosing cholangitis
18 Years
75 Years
ALL
No
Sponsors
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Odyssey Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Odyssey Therapeutics
Locations
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Alfred Health
Melbourne, , Australia
IMSP Spitalul Clinic Republican Timofei Moneaga
Chisinau, , Moldova
PCRN Auckland
Auckland, , New Zealand
PCRN Waikato
Hamilton, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Other Identifiers
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OD-07656-201
Identifier Type: -
Identifier Source: org_study_id
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