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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• Has diagnosis of Crohn's disease or indeterminate colitis
• Has had extensive colonic resection
• Has colostomy or ileostomy
• Has uncontrolled primary sclerosing cholangitis

Where this trial is running

• Sunshine Coast University, Birtinya, Australia
• Eastern Health, Box Hill, Australia
• Coastal Digestive Health, Maroochydore, Australia
• Alfred Health, Melbourne, Australia
• Fiona Stanley Hospital, Murdoch, Australia
• Royal Melbourne Hospital, Parkville, Australia
• Medical University of Graz, Graz, Austria
• CHUM, Montreal, Canada
• Montreal General Hospital/McGill University, Montreal, Canada
• CHUM - Pavillon R, Polička, Czechia
• Jordan University Hospital, Amman, Jordan
• The Specialty Hospital (TSH) / Advanced Clinical Center, Amman, Jordan

+ 20 more sites.

Who to contact

Head of Clinical Operations · 857-393-6160 · clinicaltrials@odysseytx.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06850727.