Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis
This research study is looking at a new treatment called OD-07656 for people in the UK aged 18 to 75 who have ulcerative colitis (UC) that is moderate to severe. Ulcerative Colitis is a long-term condition that causes inflammation in the large bowel. The study aims to find out if OD-07656 is effective in managing UC symptoms and if it is safe to use. Researchers are also investigating if giving OD-07656 first can make another existing UC medicine, vedolizumab, work even better. You might be suitable if your current UC treatments haven't worked well enough or if you couldn't tolerate them. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments.
At a glance
What is this study about?
This study is about finding better ways to help people living with ulcerative colitis (UC). UC is a condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. When UC symptoms are moderate to severe, it can really affect daily life.
Researchers are testing a new potential medicine called OD-07656. They want to see how well it works to reduce inflammation and symptoms in people with moderate to severe UC. They also want to make sure it's safe to use. This is a 'Phase 2' study, which means it's an earlier stage of research designed to gather more information about the treatment's safety and effectiveness before it can be widely approved.
An interesting part of this study is that it also looks at whether OD-07656 can make an existing UC medicine called vedolizumab work more effectively. Vedolizumab is sometimes used when other treatments haven't worked well. By giving OD-07656 *before* vedolizumab, the researchers hope to understand if this new approach could offer even greater relief for people with UC.
Key takeaways
- This study is testing a new medicine, OD-07656, for moderate to severe ulcerative colitis.
- It also checks if OD-07656 can boost the effect of an existing UC medicine, vedolizumab.
- You might be eligible if other UC treatments haven't worked well for you.
- Participants will receive close medical monitoring throughout the study.
- It's a Phase 2 study, focusing on safety and how well the treatment works in earlier stages of testing.
Who may be eligible?
To be considered for this study, you would need to be an adult between 18 and 75 years old and have a confirmed diagnosis of ulcerative colitis. Your doctor would need to confirm that your UC is currently moderately to severely active, which means it's causing notable symptoms.
Another important requirement is that your current treatments for UC haven't been fully effective. This could mean they didn't work well enough, stopped working over time, or you couldn't take them due to side effects or other medical reasons. This applies to various common UC medicines, including tablets like aminosalicylates, steroids, and immunosuppressants, as well as some injections or infusions like biologic therapies (such as anti-TNF, anti-IL-12/23), JAK inhibitors, or S1P modulators.
There are also some reasons you wouldn't be able to join. For example, if you have Crohn's disease instead of UC, or if you've had a lot of your large bowel removed, or you have a colostomy or ileostomy. Certain other conditions, like uncontrolled primary sclerosing cholangitis, would also prevent you from taking part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Have you been diagnosed with ulcerative colitis?
- Is your ulcerative colitis currently causing moderate to severe symptoms?
- Have your current UC treatments (like steroids, biologics, or other tablets) not worked well enough or caused problems?
- Do you *not* have Crohn's disease or an ileostomy/colostomy?
What does participation involve?
If you decide to take part in this study, you would receive either the new study medicine, OD-07656, or a placebo (a dummy drug with no active ingredients). This is usually decided by chance, like flipping a coin. You would also have regular visits to the clinic for check-ups, where the study team would monitor your health and symptoms closely. These visits would involve physical examinations, blood tests, and possibly other assessments like stool samples or scans, to see how you are responding to the treatment and to ensure your safety.
After a certain period on OD-07656 (or placebo), some participants might go on to receive vedolizumab treatment, which is another part of the study to see if OD-07656 can improve its effectiveness. The study team will explain the exact schedule of treatments, visits, and tests. You would be carefully followed by the study team throughout the whole study. The total time you would be involved in the study would be explained to you, but clinical trials usually involve several months of active treatment and follow-up.
Potential risks and benefits
Locations (32)
- Sunshine Coast UniversityVerified postcodeBirtinya, Australia· Recruiting
- Eastern HealthVerified postcodeBox Hill, Australia· Recruiting
- Coastal Digestive HealthVerified postcodeMaroochydore, Australia· Recruiting
- Alfred HealthVerified postcodeMelbourne, Australia· Recruiting
- Fiona Stanley HospitalVerified postcodeMurdoch, Australia· Recruiting
- Royal Melbourne HospitalVerified postcodeParkville, Australia· Recruiting
- Medical University of GrazVerified postcodeGraz, Austria· Recruiting
- CHUMVerified postcodeMontreal, Canada· Recruiting
- Montreal General Hospital/McGill UniversityVerified postcodeMontreal, Canada· Recruiting
- CHUM - Pavillon RVerified postcodePolička, Czechia· Recruiting
- Jordan University HospitalVerified postcodeAmman, Jordan· Recruiting
- The Specialty Hospital (TSH) / Advanced Clinical CenterVerified postcodeAmman, Jordan· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a long-term condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops small sores, causing symptoms like abdominal pain and diarrhoea.
What does 'moderately to severely active' mean for my UC?
It means your ulcerative colitis symptoms are currently causing significant problems and are not well controlled, requiring more intensive treatment.
What is a 'Phase 2' study?
Phase 2 studies are an important step in testing new medicines. They aim to find out more about how safe the medicine is and if it has a good effect on the condition, before being tested in a larger number of people.
Will I definitely get the new medicine?
In studies like this, participants are usually randomly assigned to receive either the new medicine or a placebo (a dummy drug). This helps researchers fairly compare its effects.
What is vedolizumab?
Vedolizumab is an existing medicine approved for treating ulcerative colitis. This study is exploring if the new medicine, OD-07656, can make vedolizumab work even better when used afterwards.
How to find out more
Head of Clinical Operations
Always speak to your GP or specialist before deciding to take part in a study.
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