NCT06850727

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Odyssey Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis (UC)
• UC - Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	OD-07656	Experimental intervention
DRUG	Vedolizumab	Active standard of care comparator

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-04-01
• Completion: 2026-11-01
• First posted: 2025-02-27
• Last updated: 2026-02-11

Locations

32 sites across 10 countries: Australia, Austria, Canada, Czechia, Jordan, Lithuania, Moldova, New Zealand, Poland, Ukraine

Regulatory

• FDA-regulated drug study