RecruitingPHASE1INTERVENTIONAL

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 Participants With Ulcerative Colitis

This study is for people with active ulcerative colitis and is looking into a new medicine called Afimkibart. Your body has special enzymes that break down medicines; this study wants to see if Afimkibart changes how these enzymes work. For example, we'll look at how it affects medicines like caffeine, omeprazole, and warfarin. Understanding this is important because it tells us if Afimkibart might affect how well other medications you take work, or if it could cause unexpected side effects. We're testing this by giving participants Afimkibart along with small doses of these common medicines and seeing how their bodies handle them.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Enrolment target

Start

30 Jun 2026

Estimated completion

31 Dec 2030

Active Ulcerative Colitis

What is this study about?

This study aims to understand how a new investigational drug, Afimkibart, interacts with your body's natural systems for processing medicines. Your body uses special proteins called 'enzymes' (specifically, cytochrome P450 enzymes) to break down many drugs you might take, from common painkillers to specific treatments. If a new medicine changes how these enzymes work, it could affect how well other drugs you're taking are processed.

For people with active ulcerative colitis (UC), knowing these interactions is particularly important. This study will give participants small, safe doses of common everyday substances like caffeine, and well-known medicines such as warfarin (a blood thinner) and omeprazole (for stomach acid), both before and after they start taking Afimkibart. By measuring how quickly these substances are cleared from the body, the researchers can tell if Afimkibart is influencing these enzyme systems.

The main goal is to find out if taking Afimkibart might speed up or slow down how your body handles other medications. This information is crucial for doctors to know so they can safely prescribe Afimkibart in the future, ensuring that any other medicines you take remain effective and do not cause unexpected problems.

Key takeaways

This study is testing a new medicine called Afimkibart for active ulcerative colitis.
It aims to understand how Afimkibart affects how your body processes other medicines.
Participants will take Afimkibart along with small doses of common medications like caffeine.
The information helps doctors know if Afimkibart might change how other drugs work.
The study is for adults with moderately to severely active ulcerative colitis.
Your health and safety are closely monitored throughout the study.

Who may be eligible?

This study is looking for adults aged 18 to 60 years old who have been diagnosed with active ulcerative colitis. To join, your UC needs to be currently active, which will be confirmed by a camera test (endoscopy) showing inflammation.

There are also some general health requirements, such as weighing at least 40kg. You'll need to agree to use reliable birth control methods if you're able to become pregnant or get someone pregnant. You won't be able to join if you have other bowel conditions like Crohn's disease, or if you've had major surgery recently, or have issues with your veins for blood draws.

Additionally, if you have a history of serious alcohol or drug use in the last year, you wouldn't be able to take part. The study team will review your full medical history to make sure taking part is safe and appropriate 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.

Are you between 18 and 60 years old?
Do you have a confirmed diagnosis of active ulcerative colitis?
Do you weigh at least 40kg (about 6 stone 4 pounds)?
Are you willing to use reliable birth control methods during the study?
Have you NOT had major surgery in the last 6 weeks?
Do you NOT have Crohn's disease or other specific bowel conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first go through a screening process to make sure you're suitable. Once confirmed, you would receive the study medication, Afimkibart, along with small, controlled doses of other common substances like caffeine and certain medications (such as warfarin, omeprazole, and others). Over the course of the study, you would have several visits to the clinic for medical checks, blood tests, and to monitor your overall health and how your body is processing the medicines. These visits allow the researchers to measure the levels of the medicines in your blood and see how they are affected. The total duration of your participation in this study would be clearly explained by the study team.

Potential risks and benefits

Participating in a clinical trial may offer the potential benefit of accessing an investigational new medicine before it's widely available, and you'll receive close medical monitoring. However, there are potential risks, including side effects from the study medicine or other medications given, discomfort from blood draws, or potential interactions with other medicines. Your health and safety are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Erick H. Alayo Medical Corporation - Gastro SB Clinic
Verified postcode
Chula Vista, United States· Recruiting
Gastro Health Research
Verified postcode
Miami, United States· Recruiting
Charite Research Organisation GmbH
Verified postcode
Berlin, Germany· Recruiting
Royal Liverpool University Hospital
Verified postcode
Liverpool, United Kingdom· Recruiting
University College London Hospitals
Verified postcode
London, United Kingdom· Recruiting
Royal Victoria Infirmary
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is Afimkibart?

Afimkibart is a new medicine being studied for treating ulcerative colitis. This particular study is looking at how it behaves in your body, rather than its direct effects on your UC symptoms.

What does 'Cytochrome P450 enzymes' mean?

These are special proteins, mainly in your liver, that help your body break down and remove many medicines. This study wants to see if Afimkibart changes how these proteins work.

Why will I be given caffeine and other medicines?

Researchers will give small, safe amounts of common substances like caffeine and other established medicines to see if Afimkibart changes how your body processes them. This helps understand drug interactions.

Will this study help my ulcerative colitis?

The primary goal of this particular study is to understand drug interactions, not to directly treat your UC. However, the knowledge gained will help ensure that Afimkibart can be safely used in future UC treatments.

How long will I be in the study?

The exact length of your participation would be fully explained by the study team during the consent process, as it involves multiple visits for assessments.

How to find out more

Reference Study ID Number : GA46438 https://forpatients.roche.com/

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

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