A Phase 2 interventional study of OD-07656 and Vedolizumab in Ulcerative Colitis (UC) and UC - Ulcerative Colitis, sponsored by Odyssey Therapeutics. Recruiting at 32 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Odyssey Therapeutics · Phase 2, Interventional, and Treatment
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.
1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.
This study's planned enrollment of 57 is below the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Odyssey Therapeutics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Open Label, Oral, twice daily dose
Drug: OD-07656 · Drug: Vedolizumab
Randomized, Oral, twice daily dose
Drug: OD-07656 · Drug: Vedolizumab
Randomized, Oral, twice daily dose
Drug: OD-07656 · Drug: Vedolizumab
Experimental intervention
Active standard of care comparator
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
The 3-component MMCS ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding and stool frequency subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease.
Time frame: Baseline and 12 weeks
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment
Time frame: Up to 12 weeks
Proportion of participants who achieve clinical remission
Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1 and not greater than baseline.
Time frame: Baseline and 12 weeks
Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment
Clinical remission is based on the MMCS and is defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0 and stool frequency scubscore of 0 or 1 and not greater than baseline.
Time frame: Baseline and 50 weeks
Plan to share: Undecided
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Odyssey Therapeutics