A Phase 2a Study of the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

Launched by ODYSSEY THERAPEUTICS · Feb 22, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called OD-07656 for people with moderately to severely active ulcerative colitis (UC), a condition that causes inflammation and ulcers in the lining of the colon. The study aims to see how safe and effective OD-07656 is and whether it can improve the benefits of another treatment called vedolizumab when given afterward.

To participate, individuals must have a confirmed diagnosis of ulcerative colitis and have not responded well to at least one previous treatment, such as oral medications or biologic therapies. The trial is expected to include participants aged 18 to 75, and both men and women can join. Those who have certain other conditions, such as Crohn's disease or have had significant surgeries on their colon, will not be able to participate. While the trial is not recruiting participants yet, those who join can expect monitoring and support throughout their treatment journey.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Has a confirmed diagnosis of ulcerative colitis (UC)
• • 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:
• The main exclusion criteria include but are not limited to the following:
• • Has diagnosis of Crohn's disease or indeterminate colitis
• • Has had extensive colonic resection
• • Has colostomy or ileostomy
• • Has uncontrolled primary sclerosing cholangitis