RecruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Induction and Maintenance 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 moderately to severely active. It's a Phase 3 study, which is an important stage where researchers want to see if the new medicine is effective and safe compared to a dummy medicine (placebo). They are studying whether Afimkibart can help people go into remission (induction therapy) and then stay well (maintenance therapy). The study will involve many centres and neither you nor your doctor will know if you are receiving the new medicine or the placebo. This helps us understand the true effect of the medicine.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

600

Start

17 Mar 2025

Estimated completion

31 Dec 2033

Moderately to Severely Active Crohns Disease

What is this study about?

This study is a clinical trial focusing on a new treatment called Afimkibart for individuals living with Crohn's disease that is currently active. Crohn's disease is a condition where parts of your digestive system become inflamed, leading to symptoms like tummy pain, diarrhoea, and weight loss. When Crohn's is 'moderately to severely active,' it means these symptoms are significantly affecting your daily life and current treatments might not be working as well as hoped.

The main goal of this study is to see if Afimkibart can help people feel better by reducing their Crohn's symptoms (this is called 'induction therapy') and then to see if it can also help them stay well over a longer period (this is called 'maintenance therapy'). Researchers will be carefully checking how effective Afimkibart is compared to a 'placebo' – which looks exactly like the study medicine but contains no active drug. This comparison is vital to understand if any improvements are genuinely due to Afimkibart or something else.

The study is in 'Phase 3,' meaning it's one of the final steps before a new medicine might be approved for general use. It will involve many participants across different locations, and it's designed so that neither you nor your doctors will know whether you're receiving Afimkibart or the placebo. This setup helps ensure the results are as fair and accurate as possible, giving us a clear picture of the medicine's potential benefits and any side effects.

Key takeaways

This study is testing a new medicine called Afimkibart for active Crohn's disease.
It's a Phase 3 study, a major step before potential wider availability.
The new medicine is being compared to a 'dummy' medicine (placebo).
It aims to see if Afimkibart can help people get well and stay well.
Close monitoring of your health will happen throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have received a confirmed diagnosis of Crohn's disease and your condition would need to be currently active, ranging from moderate to severe. You also need to weigh at least 40 kilograms (about 6 stone 4 pounds). It's important that you have already tried at least one standard or advanced treatment for Crohn's disease, but it either didn't work well enough, stopped working, or caused side effects that you couldn't tolerate.

There are also some reasons why you might not be able to join. For example, if you have other bowel conditions like ulcerative colitis, or if you've had too many bowel operations. You also can't take part if you have a stoma or an internal pouch. Certain serious bowel issues like severe blockages or a very swollen colon would also prevent you from joining. If you have active infections (like C. difficile, HIV, Hepatitis B or C, or active tuberculosis), or certain types of cancer, you wouldn't be able to participate. If you are pregnant, breastfeeding, or planning to become pregnant, this study is not suitable 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.

Do I have a confirmed diagnosis of Crohn's disease?
Is my Crohn's disease currently active, and not responding well to my current treatments?
Do I weigh at least 40 kilograms?
Am I between 16 and 80 years old?
Do I have any other inflammatory bowel disease like ulcerative colitis?
Am I pregnant or breastfeeding, or planning to be during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the total duration would involve an 'induction' period to help get your Crohn's under control, followed by a 'maintenance' period to keep you well. Throughout the study, you would receive the study medicine, which could be Afimkibart or a placebo, and you wouldn't know which one you are getting. You would have regular visits to the clinic for various assessments. These visits will involve physical examinations, providing blood and possibly stool or urine samples, and answering questions about your symptoms and how you're feeling. Doctors and nurses will monitor your health closely and check for any potential side effects. More details about the exact schedule of visits and what happens at each visit will be given to you if you are considered for the study.

Potential risks and benefits

Taking part in a clinical trial like this could mean you receive a new medicine that might help improve your Crohn's symptoms, potentially offering a new treatment option if current ones aren't working. However, as with any new medicine, there are potential risks, including side effects that are not yet fully known or understood. You might also receive a placebo, meaning your Crohn's symptoms might not improve during the study. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (364)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Verified postcode
Dothan, United States· Recruiting
Mayo Clinic Hospital
Verified postcode
Phoenix, United States· Recruiting
Arizona Digestive Health, P.C (ADH)
Verified postcode
Sun City, United States· Recruiting
University of Arizona-CATS Research Center
Verified postcode
Tucson, United States· Recruiting
Valley View Internal Medicine
Verified postcode
Garden Grove, United States· Recruiting
310 Clinical Research
Verified postcode
Inglewood, United States· Recruiting
UCSD Medical Center
Verified postcode
La Jolla, United States· Recruiting
Gastro Care Associates
Verified postcode
Lancaster, United States· Recruiting
Om Research LLC
Verified postcode
Lancaster, United States· Recruiting
United Gastroenterologists
Verified postcode
Los Alamitos, United States· Recruiting
Acclaim Clinical Research, Inc.
Verified postcode
San Diego, United States· Recruiting
Kaiser Permanente
Verified postcode
San Francisco, United States· Recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition where parts of your digestive system become inflamed. This can cause tummy pain, severe diarrhoea, tiredness, and weight loss.

What is Afimkibart?

Afimkibart is a new medicine being tested to see if it can help reduce inflammation and symptoms in people with Crohn's disease.

What does 'Phase 3' mean for a study?

Phase 3 means this is a large study trying to see how well the new medicine works and if it's safe, usually comparing it to existing treatments or a dummy medicine, before it can be offered more widely.

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

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving Afimkibart or the placebo. This helps ensure fair results.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real study medicine but contains no active drug. It helps researchers understand if the new medicine works better than no treatment.

How to find out more

Reference Study ID Number: GA45331 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.