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

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of OD-07656 in adults with moderately to severely active ulcerative colitis (UC). The study also aims to assess whether OD-07656 can improve the benefits of vedolizumab when given after OD-07656 treatment. This Phase 2a study is sponsored by Odyssey Therapeutics and focuses on patients who have had an inadequate response or intolerance to various UC therapies. Participants will receive oral doses of OD-07656 twice daily in one of three dosing regimens, with some groups randomized to different doses. Following the OD-07656 treatment phase, subsequent vedolizumab therapy will be evaluated for its therapeutic effects. The study design includes an open-label part and a randomized part, each assessing treatment safety and efficacy over specified periods. During the study, participants will be monitored through regular assessments including the 3-component Modified Mayo Clinic Score at baseline and after 12 weeks of OD-07656 treatment. Researchers will track treatment-emergent adverse events and treatment discontinuations. Clinical remission rates will be evaluated both after OD-07656 treatment and following vedolizumab therapy up to 50 weeks. The total participation period and detailed monitoring schedules will be managed according to the study protocol.

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis