Ulcerative Colitis study: OD-07656 vs Vedolizumab
Official title Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT06850727
What this study is testing
What is OD-07656?
An investigational drug being studied as a potential treatment for moderately to severely active ulcerative colitis (UC).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether OD-07656 is safe and how well it works for people with moderate to severe ulcerative colitis. It also looks at whether OD-07656 can help a later treatment, vedolizumab, work better.
- Who it's for
- You may be able to join if you have moderate to severe ulcerative colitis and are not responding well to other treatments.
- What's involved
- You would take the drug OD-07656 at home or in the clinic. After a period, you might receive vedolizumab. You will have regular check‑ins and give stool or blood samples to see how you are doing.
- Time commitment
- The study lasts several months, with visits every few weeks to monitor your health and give the treatments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
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...
You likely can't 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birtinya, Australia
- Box Hill, Australia
- Maroochydore, Australia
- Melbourne, Australia
- Murdoch, Australia
- Parkville, Australia
- Graz, Austria
- Montreal, Canada
- Polička, Czechia
- Amman, Jordan
- Irbid, Jordan
- Kaunas, Lithuania
- Chisinau, Moldova
- Auckland, New Zealand
- Christchurch, New Zealand
- Hamilton, New Zealand
- Nelson, New Zealand
- Upper Hutt, New Zealand
- Bydgoszcz, Poland
- Chojnice, Poland
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birtinya, Australia; Box Hill, Australia; Maroochydore, Australia; Melbourne, Australia; Murdoch, Australia; Parkville, Australia and 23 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.