A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
This study is investigating a new medication called RO7837195 for people living with ulcerative colitis (UC) that is moderate to severe. It focuses on individuals who haven't found enough relief from their current or past UC treatments. The main goal is to find out if this new drug can effectively reduce UC symptoms and improve well-being, while also checking for any side effects. Participants will receive either the new drug or a dummy treatment (placebo) for the first 12 weeks. After this, everyone will get the active study drug. This research is important for finding new ways to help those with UC when other options haven't been successful.
At a glance
What is this study about?
This research is looking at a new medicine called RO7837195. It's for people who have ulcerative colitis (UC) that is active and causing moderate to severe symptoms. This means their condition isn't well controlled, even after trying other treatments, including standard medicines or more advanced therapies. The study wants to discover if this new medication can help relieve symptoms, improve health, and is safe to use.
Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the lining of the large intestine. Symptoms can include tummy pain, diarrhoea, and needing to go to the toilet urgently. Finding effective treatments is really important for people living with active UC, especially when their current treatments aren't working as well as hoped.
By taking part in this study, doctors can learn more about how RO7837195 works. This could pave the way for new and better treatment options for people with ulcerative colitis in the future.
Key takeaways
- This study explores a new drug (RO7837195) for moderate to severe ulcerative colitis.
- It's for people whose current or previous treatments haven't worked well.
- The study includes a period where participants receive either the new drug or a dummy treatment.
- After an initial phase, all participants will receive the active study drug.
- Close medical monitoring and care will be provided throughout the study.
Who may be eligible?
To be part of this study, you would need to have been diagnosed with ulcerative colitis for at least three months. Your UC should be causing moderate to severe symptoms, meaning it's quite active despite your current treatments. Importantly, your past or current treatments for UC, whether standard or advanced ones, should not have worked well enough for you, or you might have had a bad reaction to them.
There are also some reasons why you might not be able to join. For example, if you've had a large part of your colon removed, or if you're planning to have surgery for your UC. You also can't participate if you've been diagnosed with Crohn's disease or a similar condition, or if you've had certain advanced treatments for UC that target specific proteins (TL1a, IL-12, or IL-23) and they didn't work for you.
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.
- Have I been diagnosed with ulcerative colitis for at least 3 months?
- Is my ulcerative colitis still quite active, even with treatment?
- Have my past or current UC treatments (standard or advanced) not worked well enough?
- Do I have Crohn's disease or have I had a large part of my colon removed?
- Have I used certain advanced UC treatments (targeting TL1a, IL-12, or IL-23) that didn't work for me?
What does participation involve?
If you join this study, it would involve several stages. First, there's a 'screening' period that could last up to 5 weeks. During this time, doctors will check to make sure the study is right for you. After that, you'll enter the main 'induction phase' which lasts for 12 weeks. In this phase, you'll either receive the new study drug, RO7837195, or a dummy treatment (a 'placebo'). You won't know which one you're getting.
After these 12 weeks, everyone in the study will then receive the active study drug for about 40 weeks, regardless of what treatment you had initially. Throughout these phases, you'll have regular visits to the clinic for check-ups, assessments, and to make sure everything is going well. After your last dose of the study drug, there will be a follow-up period to monitor your health and any long-term effects. The total length of your involvement in the study will vary, but it includes these different treatment and follow-up phases.
Potential risks and benefits
Locations (90)
- Gastro Care InstituteVerified postcodeLancaster, United States· Recruiting
- Medical Associates Research Group, Inc.Verified postcodeSan Diego, United States· Recruiting
- Peak Gastroenterology AssociatesVerified postcodeColorado Springs, United States· Recruiting
- Clinical Research of Osceola, LLCVerified postcodeKissimmee, United States· Recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- Intercity GastroenterologyVerified postcodeFresh Meadows, United States· Recruiting
- Monroe Biomedical ResearchVerified postcodeMonroe, United States· Recruiting
- University of Utah Hospitals & ClinicsVerified postcodeSalt Lake City, United States· Recruiting
- Mater Misericordiae LimitedVerified postcodeSouth Brisbane, Australia· Recruiting
- HUWC - UFC - Hospital Universitrio Walter Cantdio - Universidade Federal do CearVerified postcodeFortaleza, Brazil· Recruiting
- L2IP ?Instituto de Pesquisas Clínicas Ltda.Verified postcodeBrasília, Brazil· Recruiting
- Chronos Pesquisa ClinicaVerified postcodeBrasília, Brazil· Recruiting
Common questions
What is ulcerative colitis?
Ulcerative colitis is a condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops small sores or ulcers. This can cause tummy pain, urgency to go to the toilet, and diarrhoea.
What does 'moderately to severely active' mean?
This means your ulcerative colitis is currently causing significant symptoms and is not well controlled, despite your best efforts with existing treatments.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the study drug but contains no active medicine. It helps researchers compare the effects of the new drug against not having it.
Will I know if I'm getting the real drug or the placebo?
For the first 12 weeks (the 'induction phase'), neither you nor the study team will know if you're receiving the actual drug or the placebo. After this, everyone gets the active study drug.
What happens if the drug doesn't work for me?
Your doctors will regularly monitor your condition. If the treatment isn't working or if you experience significant side effects, they will discuss your options with you, and you can withdraw from the study at any time.
How to find out more
Reference Study ID Number: GA45977 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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