A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
This study is looking into a new medication called Afimkibart (also known as RO7790121) for people who have Crohn's disease that is moderate to severe. Crohn's disease causes inflammation in the gut, leading to stomach pain, diarrhoea, and other issues. We want to find out how well Afimkibart works to reduce these symptoms and if it is safe to use. Participants will be given either the new medicine or a 'dummy' medicine (placebo) without knowing which one they are receiving. This is a common way to test new medicines and find out their true effects. The study aims to help us understand if Afimkibart could be a new treatment option for Crohn's disease.
At a glance
What is this study about?
Crohn's disease is a long-term condition where parts of your digestive system become inflamed. This can cause tummy pain, diarrhoea, tiredness, and weight loss. For some people, current treatments don't work well enough, or they have unpleasant side effects. This study is exploring a new medicine called Afimkibart as a possible treatment for people with moderate to severe Crohn's disease. The main goal is to see if this new medicine can help calm down the inflammation and reduce symptoms.
Researchers want to understand two key things: first, how effective Afimkibart is compared to a 'dummy' medicine (placebo) in improving the symptoms of Crohn's disease. Second, they want to carefully check for any side effects or safety concerns. By comparing the new medicine to a placebo, doctors can get a clear picture of whether the improvements seen are truly due to Afimkibart or something else.
Finding new and effective treatments is really important for people living with Crohn's disease. This study is a crucial step in discovering if Afimkibart could offer a new option to help manage this challenging condition, potentially improving the quality of life for many patients.
Key takeaways
- Tests a new medicine (Afimkibart) for Crohn's disease.
- Compares the new medicine to a 'dummy' medicine (placebo).
- Aims to find out if it's effective and safe.
- For people with moderate to severe Crohn's that hasn't responded to other treatments.
- Participants will be closely looked after by a medical team.
Who may be eligible?
To join this study, you must have been officially diagnosed with Crohn's disease, and your condition needs to be moderately to severely active – meaning you're experiencing noticeable symptoms. You also need to weigh at least 40 kilograms (about 6 stone 4 pounds) and be between 16 and 80 years old. An important point is that previous treatments for your Crohn's disease must not have worked well for you, or you couldn't tolerate them.
There are certain reasons why you might not be able to join. For example, if you have other specific gut conditions like ulcerative colitis or have had many past operations on your bowel. You also can't take part if you have certain severe bowel problems like a completely blocked bowel, bad infections (like C. difficile or tuberculosis that isn't fully treated), or some serious liver problems.
Women who are pregnant, breastfeeding, or planning to become pregnant during the study cannot participate. Also, if you have or have had certain cancers, you might not be eligible. These rules help make sure the study is safe for everyone involved and that the results are clear.
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 16 and 80 years old?
- Do you have a confirmed diagnosis of Crohn's disease that is currently active?
- Have other Crohn's treatments not worked well for you, or could you not tolerate them?
- Do you weigh at least 40 kilograms (6 stone 4 pounds)?
- Are you NOT pregnant or breastfeeding, and not planning to be during the study?
- Do you NOT have certain severe bowel issues or specific types of infections?
What does participation involve?
If you decide to take part in this study, you will receive either the new medicine, Afimkibart, or a dummy medicine called a placebo. You won't know which one you're getting, and neither will your study doctor. This is standard practice in medical research to ensure fair and accurate results. You'll need to attend regular visits to the hospital or clinic so the study team can monitor your health, check your symptoms, and see how you're responding to the treatment.
During these visits, you can expect to have various assessments, which might include blood tests, stool (poo) samples, physical examinations, and possibly some scans or scopes to look inside your bowel. You will also be asked to keep track of your symptoms and any side effects you experience. The medicine itself will likely be given over a period to see its full effect. You'll be closely supported by the study team throughout the whole process. The total time you'd be involved in the study would depend on the study design, but generally, these types of studies involve several months of treatment and follow-up.
Potential risks and benefits
Locations (173)
- Sun City Clinical ResearchVerified postcodeGlendale, United States· Recruiting
- Om Research LLCVerified postcodeLancaster, United States· Recruiting
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and EducationVerified postcodeNewport Beach, United States· Recruiting
- Empire Clinical ResearchVerified postcodePomona, United States· Withdrawn
- Stanford Medicine Outpatient CenterVerified postcodeRedwood City, United States· Recruiting
- Clinical Applications Laboratories, Inc.Verified postcodeSan Diego, United States· Recruiting
- Amicis Research CenterVerified postcodeSanta Clarita, United States· Recruiting
- Peak Gastroenterology AssociatesVerified postcodeColorado Springs, United States· Recruiting
- J&A Clinical ResearchVerified postcodeDoral, United States· Recruiting
- Homestead Associates in Research, Inc.Verified postcodeMiami, United States· Recruiting
- Allied Biomedical Research Institute, IncVerified postcodeMiami, United States· Recruiting
- Rejuvaline Medical ResearchVerified postcodeMiami, United States· Recruiting
Common questions
What is Afimkibart?
Afimkibart is a new investigational medicine being tested for people with Crohn's disease. It's designed to help reduce the inflammation that causes Crohn's symptoms.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real medicine but contains no active drug. It helps researchers fairly compare the effects of the new medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving Afimkibart or the placebo. This is to ensure unbiased results.
How long does the study last?
The study involves a period of treatment to see how well the medicine works, followed by close monitoring. The exact duration will be explained by the study team.
What if I feel unwell during the study?
You will be closely monitored, and the study team will be available to address any concerns. You can withdraw from the study at any time if you feel unwell or for any other reason.
How to find out more
Reference Study ID Number: GA45332 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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