Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
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Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
57estimated
Sites
32
Countries
Australia, Austria, Canada +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-02 | actual | When the study began enrolling |
| Primary completion | Apr 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-02-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Ulcerative Colitis (UC)
- UC - Ulcerative Colitis
Interventions
- Drug: OD-07656
- Drug: Vedolizumab
Primary outcomes
what the primary-completion date above is the date OFChange in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
measured Baseline and 12 weeks
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment
measured Up to 12 weeks
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