Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An open-label, DDI study to investigate the effects of amlitelimab on the PK of selected cytochrome P450 substrates

This study is an early-stage trial (Phase 1) looking at a new medicine called amlitelimab. The main goal is to understand how amlitelimab might affect the way your body processes other common medications. Our bodies have special systems (like the cytochrome P450 system) that break down and get rid of medicines. This study wants to see if amlitelimab interferes with these systems. This is important to make sure that if amlitelimab is used in the future, it doesn't cause problems by changing how other medicines work. It's for adults with eczema and is designed to gather basic information about the drug's interactions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

01 Nov 2024

Dermatitis atopic

What is this study about?

This study is a very early stage (called Phase I) investigation into a new medicine named amlitelimab. You might not have heard of amlitelimab before because it's still being tested. The main purpose of this particular study is to understand how amlitelimab behaves in the body when someone is also taking other common medicines.

Our bodies have natural systems that help break down and remove medicines. Think of it like a processing plant inside you. Some medicines can speed up or slow down how this processing plant works for other drugs. This study aims to see if amlitelimab changes how this 'processing plant' handles other common medicines. This kind of information is really important for doctors and scientists to know, so they can make sure any new medicine can be used safely alongside others.

By understanding these potential interactions early on, researchers can better predict how amlitelimab might work when people take it in the real world, especially if they are already taking other medications for conditions like eczema. This study is a crucial step in developing new treatments and ensuring they are safe and effective for everyone.

Key takeaways

This is an early-stage study (Phase I) for a new medicine called amlitelimab.
The main goal is to understand how amlitelimab might affect other medicines in your body.
It's for adults, aged 18 and over, with eczema.
Participation involves regular clinic visits and blood tests.
You would be contributing to important medical research for future treatments.
You can stop participating at any time.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. There is no upper age limit, meaning older adults can also take part if they meet other health criteria.

Both men and women are welcome to participate in this study. The researchers are looking for a diverse group of participants to get a broad understanding of the medicine's effects.

While the main condition mentioned is eczema (atopic dermatitis), this early study is mainly focused on how the drug interacts with other medicines, so your overall health and any other medications you take will be carefully checked to make sure it's safe for you to join.

Quick self-check

Are you 18 years old or older?
Do you have eczema (atopic dermatitis)?
Are you able to attend several clinic visits?
Are you comfortable with regular blood tests?
Are you willing to share your medical history and current medications?

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

What does participation involve?

As this is an early study, participation will likely involve several visits to a clinic or hospital. You would receive doses of amlitelimab and also some 'marker' medicines (drugs that help researchers see how your body processes them). Blood samples would be taken regularly after each dose to measure the levels of these medicines in your body. You might also have other health checks like blood pressure and heart rate measurements. The total duration of your participation, including follow-up visits, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of taking part in research is contributing to medical knowledge that could help future patients with eczema. You would also receive close medical attention during the study. However, there are potential risks, such as side effects from the study medication or discomfort from blood tests. The specific risks for amlitelimab are not fully known yet, but they would be explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Germany
—
Bulgaria

Common questions

What is 'Phase I' of a clinical trial?

Phase I is the first stage of testing a new medicine in people. It mainly checks how safe the medicine is, how it moves through the body, and how it interacts with other medicines. Only a small number of people usually take part.

What is eczema (atopic dermatitis)?

Eczema is a long-term (chronic) skin condition that makes your skin dry, red, itchy, and sometimes cracked. It's quite common, especially in children, but can affect adults too.

What does 'DDI' mean?

DDI stands for 'Drug-Drug Interaction'. It means how one medicine might affect the way another medicine works in your body. This study specifically looks at these interactions.

Will I get better from my eczema in this study?

This early study primarily aims to understand how the new medicine interacts with others, not to treat your eczema. While researchers monitor your health, the main goal isn't to see if your eczema improves at this stage.

How long will I have to be in the study?

The exact duration would be explained by the study team. Early-stage studies can last from a few weeks to a few months, including follow-up checks.