AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

An Early-Stage Study in Multiple Clinics of how Afimkibart May Affect the Body’s Processing of Medicines that Rely on Cytochrome P450 Enzymes in Patients with Ulcerative Colitis

This is an early-stage study looking at a new medicine called Afimkibart, especially for people who have active ulcerative colitis. The main goal is to understand how Afimkibart interacts with your body's natural way of processing other medicines. Our bodies have special enzymes (like tiny workers) that break down medicines. This study wants to see if Afimkibart affects these 'workers' and how they do their job. This is an important first step, known as a Phase I study, to make sure the medicine is safe and behaves as expected in the body. It helps researchers decide if it's safe to study further in more people.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

19 May 2026

Active Ulcerative Colitis (UC)

What is this study about?

This study is about a new medicine called Afimkibart, created to help people with active ulcerative colitis (UC). UC is a long-term condition where your large intestine becomes inflamed, causing symptoms like tummy pain, diarrhoea, and tiredness. Researchers are trying to find new and better ways to manage this condition.

The main purpose of this particular study is to understand something very specific: how Afimkibart affects your body's ability to process other medicines. Our bodies have special natural processes, involving things called 'enzymes' (like little helpers), which are responsible for breaking down and getting rid of medicines we take. This study aims to see if Afimkibart changes the way these enzymes work. This is important because if Afimkibart affects these processes, it could change how other medicines you take work in your body.

This is a very early study, sometimes called 'Human Pharmacology' or 'Phase I'. This means it's one of the first times this medicine is being tested in people. The main focus at this stage is always safety and understanding how the medicine behaves in the body, rather than how well it treats the disease itself. By carefully studying these interactions, doctors and scientists can make sure that if Afimkibart is developed further, it will be as safe and effective as possible for future patients.

Key takeaways

This is an early safety study for a new medicine called Afimkibart.
It's for adults, 18 or older, who have active ulcerative colitis.
The study wants to see how Afimkibart affects how your body handles other medicines.
Participation means contributing important information for future treatments.
You'll get close medical attention if you take part.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit mentioned.

This study is open to both men and women.

Crucially, you must have active ulcerative colitis. This means your UC symptoms are currently flaring up or are not fully controlled.

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 18 years old or older?
Do you have a diagnosis of ulcerative colitis?
Are your ulcerative colitis symptoms currently active (e.g., flaring up)?
Are you able to commit to the study's requirements, such as clinic visits?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves was not provided in the original information. However, for a Phase I study like this, you would typically expect to:

* **Have multiple visits:** This would likely involve several trips to the clinic for check-ups, tests, and to receive the study medicine. * **Undergo various assessments:** These could include blood tests, urine tests, physical exams, and possibly other specialised tests to see how your body is handling the medicine and if your UC is active. * **Take the study medication:** You would be given Afimkibart according to a specific schedule outlined by the study doctors. * **Have follow-up appointments:** Even after you stop taking the main medication, you would likely have follow-up visits to ensure your safety and monitor any lasting effects. * **Total duration:** Phase I studies can vary in length, but they often involve a period of active treatment and monitoring, followed by a follow-up period. The exact length would be explained by the study team.

Potential risks and benefits

Taking part in any study always involves some potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that could help future patients with ulcerative colitis, and you would receive careful medical attention throughout. However, because Afimkibart is a new medicine, there's always a risk of unexpected side effects or that it might affect other medicines you take. You would be fully informed of all known and potential risks before deciding to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

—
Unverified
Germany
—
Unverified
Poland
—
Unverified
Belgium

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine becomes inflamed and develops small sores, causing symptoms like stomach pain and diarrhoea.

What does 'active' ulcerative colitis mean?

It means your ulcerative colitis symptoms are currently present or flaring up, rather than being in a period of remission (when symptoms are quiet).

What is a Phase I study?

A Phase I study is one of the first times a new medicine is tested in people. The main aim is to check its safety and how it works in the body, rather than how well it treats a disease yet.

What does 'affect the body's processing of medicines' mean?

It means the study is looking at whether the new medicine changes how your body naturally breaks down and uses other medicines you might be taking.

Will this study cure my ulcerative colitis?

This early-stage study is primarily focused on understanding the safety and how Afimkibart works with your body's systems, not on curing ulcerative colitis. Any direct benefits to your UC symptoms at this stage would be a secondary observation.