OD-07656 followed by vedolizumab for moderate to severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives participants with moderately to severely active ulcerative colitis OD-07656 and monitors safety and clinical outcomes using measures such as the 3-component Modified Mayo clinic score. Eligible participants are those with inadequate response, loss of response, or intolerance to prior therapies including aminosalicylates, corticosteroids, immunosuppressants, biologics, JAK inhibitors, or S1P modulators. A key objective is to determine whether OD-07656 can enhance the therapeutic benefit of vedolizumab when vedolizumab is administered after OD-07656. Study visits will take place at Australian sites including Sunshine Coast University (Birtinya), Eastern Health (Box Hill), and Coastal Digestive Health (Maroochydore).

Why it matters

Who can join: the full rules

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

Where it's running

• Sunshine Coast University
  Birtinya, Australia Recruiting
• Eastern Health
  Box Hill, Australia Recruiting
• Coastal Digestive Health
  Maroochydore, Australia Recruiting
• Alfred Health
  Melbourne, Australia Recruiting
• Fiona Stanley Hospital
  Murdoch, Australia Recruiting
• Royal Melbourne Hospital
  Parkville, Australia Recruiting

Study contacts

• Study coordinator: Head of Clinical Operations
• Email: clinicaltrials@odysseytx.com
• Phone: 857-393-6160

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fecal Transplants from Dai vs Han Donors for Ulcerative Colitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.