RecruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

This study is investigating a new potential treatment called Afimkibart for people living with moderately to severely active ulcerative colitis. This condition causes ongoing inflammation in the large bowel. The study is in its final main phase, meaning it's been tested before, and now researchers want to confirm its effectiveness and safety on a larger group of people. Participants will be randomly given either Afimkibart or a placebo (a dummy drug) to see if the new medication can help reduce symptoms and improve their condition. It's a 'double-blind' study, so neither the participants nor their doctors will know who is receiving the actual medication. This approach helps ensure the results are as fair and accurate as possible, bringing us closer to understanding if Afimkibart could become a valuable new treatment option for ulcerative colitis.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

350

Start

11 Dec 2024

Estimated completion

30 Jan 2031

Moderately to Severely Active Ulcerative Colitis

What is this study about?

This important study is looking for new ways to help people living with ulcerative colitis (UC), specifically those whose condition is moderately to severely active. Ulcerative colitis is a long-term condition where the lining of the large bowel (colon and rectum) becomes inflamed. This can cause symptoms like tummy pain, diarrhoea, and tiredness, and it can significantly impact daily life. We understand that finding effective treatments can be a journey, and this research aims to explore a new option called Afimkibart.

The study is in its 'Phase III', which means it's a large-scale study that compares the new treatment with a placebo, or dummy drug. This is a common and necessary step in medical research to carefully assess if the new medication works better than no treatment and to check for any side effects. By involving many people, researchers can get a clear picture of how safe and effective Afimkibart is. The goal is to see if it can help reduce the inflammation and symptoms for people who haven't responded well to other treatments.

Taking part in a study like this could offer an opportunity to access a new treatment that isn't widely available yet. It's also a way to contribute to medical science, helping to find better treatments for everyone with ulcerative colitis in the future. The researchers are committed to ensuring the safety and well-being of all participants throughout the study.

Key takeaways

This study is for people with moderately to severely active ulcerative colitis.
It's testing a new medicine called Afimkibart against a dummy drug (placebo).
You'd get close medical monitoring by a specialist team.
It’s in Phase III, meaning it’s a big step towards a potential new treatment.
Joining could contribute to better treatments for UC in the future.
You can stop participating at any time.

Who may be eligible?

To join this study, you first need to have a confirmed diagnosis of ulcerative colitis that is currently moderately to severely active. This study is for people aged between 16 and 80 years old, who weigh at least 40 kilograms (about 6 stone 4 pounds). It's also important that your regular checks for bowel cancer are up-to-date, as per local health guidelines.

Crucially, this study is for individuals whose ulcerative colitis hasn't responded well to at least one other standard treatment, or who couldn't tolerate those treatments. If you are a man or woman who could have children, there are specific contraception rules you'd need to follow throughout the study to ensure safety.

There are also some reasons why you might not be able to join. For example, if you have other bowel conditions like Crohn's disease, or certain complications from ulcerative colitis like toxic megacolon. You also wouldn’t be eligible if you have an ostomy or an internal pouch, or certain infections like C. difficile, HIV, or active tuberculosis. If you've had cancer in the last five years (with some exceptions like certain skin cancers), or if you are pregnant, breastfeeding, or planning to become pregnant, you wouldn't be able to take part.

Quick self-check

Do I have a confirmed diagnosis of ulcerative colitis?
Is my ulcerative colitis currently moderately to severely active?
Am I between 16 and 80 years old and weigh at least 40 kg?
Have I tried at least one other UC treatment that didn't work well or I couldn't tolerate?
Am I up-to-date with my bowel cancer screening?
Do I not have other specific bowel conditions like Crohn's disease or certain infections?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'd be given either the new medicine, Afimkibart, or a placebo (a dummy treatment). Neither you nor your doctor would know which one you are receiving – this is called 'double-blind' and helps ensure the study results are fair. You would need to attend regular visits at a study clinic, where doctors and nurses would monitor your health closely, check your symptoms, and do various assessments to see if the treatment is working. These assessments might include blood tests, stool tests, and possibly endoscopies (a camera test to look inside your bowel). You'd also be asked to report any changes in your health or any side effects you experience. The total duration of your participation in the study, including all treatments and follow-up checks, would be discussed fully with you before you agree to take part.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as gaining access to a new treatment (Afimkibart) that isn't yet widely available, and receiving close medical attention from a specialist team throughout the study. However, like all medications, Afimkibart may have side effects, and some people may not respond to the treatment. There's also a chance you might receive the placebo, meaning you wouldn’t get the active drug. The study team will explain all known risks and potential side effects in detail. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (200)

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, United States· Recruiting
Mayo Clinic Hospital
Scottsdale, United States· Recruiting
Arizona Digestive Health, P.C (ADH)
Sun City, United States· Recruiting
Om Research LLC
Apple Valley, United States· Recruiting
Valley View Internal Medicine
Garden Grove, United States· Recruiting
Gastro Care Associates
Lancaster, United States· Recruiting
University of Southern California
Los Angeles, United States· Recruiting
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, United States· Recruiting
Stanford Medicine Outpatient Center
Redwood City, United States· Recruiting
Peak Gastroenterology Associates
Colorado Springs, United States· Recruiting
Hi Tech and Global Research, LLC
Coral Gables, United States· Recruiting
The Sister Life Research
Hialeah, United States· Recruiting

+188 more sites — see the official record for the full list.

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large bowel (colon and rectum) becomes swollen and inflamed. This can lead to symptoms like tummy pain, urgent trips to the toilet, and diarrhoea.

What is Afimkibart?

Afimkibart is the name of the new medication being tested in this study. It's designed to help reduce the inflammation in people with ulcerative colitis. It's not yet approved for general use.

What does 'moderately to severely active' mean?

It means your ulcerative colitis symptoms are currently significant and impacting your daily life, and your regular treatments might not be fully controlling them.

What is a placebo?

A placebo is a dummy medicine that looks just like the real medicine but contains no active drug. It helps researchers see if the new medicine works better than no treatment at all.

Can I still take my other medicines during the study?

Some medicines might not be allowed during the study. The study team will review all your current medications and tell you which, if any, you might need to stop or change.

How to find out more

Reference Study ID Number: GA45330 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.