Active not recruitingPHASE3INTERVENTIONAL

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

This study is looking into a new medication called Afimkibart for adults aged 16 to 80 who have moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition affecting the large bowel, causing inflammation and symptoms like tummy pain and diarrhoea. The study wants to find out if Afimkibart can help reduce symptoms and improve the condition more effectively and safely than a placebo, which is a dummy drug with no active ingredients. Participants will be closely monitored, and the study will involve different stages to see how the new medicine works over time. This research is important for finding new ways to help people living with this challenging condition.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

400

Start

17 Sep 2024

Estimated completion

30 Jan 2031

Moderately to Severely Active Ulcerative Colitis

What is this study about?

This research is a 'Phase III' study, which means it's one of the final steps before a new medicine might become widely available. Doctors and scientists are looking into a new drug called Afimkibart for people who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-term illness where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, bloody stools, and needing the toilet often.

The main goal of this study is to see if Afimkibart can help improve these symptoms and reduce the inflammation. They also want to understand if it's a safe treatment. This is done by comparing Afimkibart to a 'placebo', which looks exactly like the study medicine but has no active drug in it. This comparison helps researchers truly understand if any changes are due to the new medicine or other factors.

Taking part in a study like this is a way to potentially access a new treatment that isn't yet available generally. It also helps contribute to medical knowledge, which could benefit many other people with ulcerative colitis in the future. The study will involve careful monitoring by doctors and nurses to ensure everyone's safety and to accurately track how the medicine works.

Key takeaways

This study evaluates a new medicine, Afimkibart, for moderate to severe ulcerative colitis.
It aims to check how well the medicine works and if it's safe compared to a placebo (dummy drug).
It's a Phase III study, meaning it's a key step in testing before potential wider use.
Participants must be 16-80 years old and have tried other UC treatments that weren't fully effective.
Participation involves regular hospital visits, tests, and careful medical monitoring.

Who may be eligible?

This study is looking for volunteers between 16 and 80 years old who have been diagnosed with ulcerative colitis. To join, your ulcerative colitis needs to be considered 'moderately to severely active', meaning your symptoms are significantly affecting you. Importantly, you should have tried at least one other standard treatment for ulcerative colitis, like conventional medicines or newer 'advanced' therapies, and these haven't worked well enough, stopped working, or you couldn't tolerate them.

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 complications of ulcerative colitis such as a very severe, sudden flare-up. You also can't take part if you have certain infections like active tuberculosis, HIV, or hepatitis, or if you've had cancer in the last five years (unless it was a very specific type that was fully removed). Women who are pregnant or breastfeeding, or planning to become pregnant during the study, also can't participate.

Quick self-check

Are you between 16 and 80 years old?
Do you have a confirmed diagnosis of ulcerative colitis?
Is your ulcerative colitis currently moderate to severe?
Have you tried at least one other UC treatment that didn't work well enough or caused problems?
Are you able to attend regular hospital visits for assessments?

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

What does participation involve?

If you decide to take part, you'll first go through a screening process to make sure the study is right for you. This will involve health checks and tests. If you qualify, you'll either receive the new medicine, Afimkibart, or a placebo (a dummy medicine) throughout the study. Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind' and helps keep the results fair. You'll have regular hospital visits for assessments, which will include physical exams, blood tests, and possibly other procedures to check your condition and how you're reacting to the medicine. The study has different stages, including an initial 'induction' phase to get symptoms under control, followed by a 'maintenance' phase to keep them controlled over a longer period. The total duration of your participation will be explained in detail by the study team, but it will involve ongoing visits and assessments.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational treatment that isn't widely available yet, which could help improve your ulcerative colitis symptoms. You will also receive careful medical monitoring throughout the study. However, like all medicines, Afimkibart may have side effects, which could range from mild to serious, and we don't know if it will be effective for everyone. There's also a chance you might receive the placebo and not the active drug. Your safety is paramount, and you will be closely monitored by the study team. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (229)

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, United States
Arizona Digestive Health, P.C (ADH)
Sun City, United States
Om Research LLC
Lancaster, United States
UCLA
Los Angeles, United States
University of California Irvine
Orange, United States
Stanford Medicine Outpatient Center
Redwood City, United States
Acclaim Clinical Research, Inc.
San Diego, United States
UCSF/Medical Center at Mount Zion
San Francisco, United States
Amicis Research Center
Santa Clarita, United States
Peak Gastroenterology Associates
Colorado Springs, United States
Peak Gastroenterology Surgery Center
Lone Tree, United States
Access Research Institute
Brooksville, United States

+217 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 inflamed and develops small ulcers, leading to symptoms like tummy pain and diarrhoea.

What is Afimkibart?

Afimkibart is a new medicine being tested in this study to see if it can help treat moderate to severe ulcerative colitis.

What does 'Phase III' mean?

Phase III means this is one of the final stages of testing a new medicine, where it's given to a larger group of people to confirm its effectiveness and safety before it can be approved for general use.

Will I know if I'm getting the real medicine or a dummy drug?

No, during the study, neither you nor your study doctor will know if you're receiving Afimkibart or a placebo. This helps ensure the study results are unbiased.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.