Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of NM26-2198 in healthy subjects and in patients with moderate-to-severe atopic dermatitis (AD)

Researchers are conducting a very early-stage study (Phase 1) to investigate a new medication called NM26-2198. The main goal is to understand if this medicine is safe and how well the body can handle it. They also want to see how the medicine moves through the body and if it causes an immune response. The study will involve both healthy volunteers and people who suffer from moderate to severe eczema, also known as atopic dermatitis. By studying both groups, researchers hope to learn how the medicine behaves and get an initial idea of whether it might help treat eczema.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Yellow Jersey Therapeutics AG

Enrolment target

Start

15 Sep 2023

Atopic Dermatitis

What is this study about?

This clinical trial is designed to investigate a brand new medicine, called NM26-2198, for the treatment of a common skin condition known as eczema (atopic dermatitis). Eczema can cause red, itchy, and inflamed patches of skin, and for some people, it can be quite severe.

This is a very early study, often called 'Phase 1'. This means it's one of the first times this medicine will be given to people. The main aims are to check if the medicine is safe and if people can tolerate it without too many side effects. Researchers will also look at how the medicine is absorbed, distributed, and removed from the body, and if it triggers any immune reactions.

The study will include both healthy people and those with moderate to severe eczema. This approach helps researchers understand the basic properties of the medicine in healthy individuals before gathering initial information on how it works in people who actually have the condition. The findings from this study will be crucial for deciding whether to proceed with further research into NM26-2198 as a potential new treatment for eczema.

Key takeaways

This is an early-stage study for a new eczema medicine.
The main goals are to check for safety and how the medicine works.
It involves both healthy people and those with moderate to severe eczema.
You might receive the new medicine or a placebo (dummy medicine).
Participation involves regular clinic visits for tests and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Since this study is looking at eczema, it's particularly focused on people who have been diagnosed with moderate to severe atopic dermatitis. This means your eczema is more than just mild and might be causing quite a bit of discomfort or affecting your daily life.

There will be other important health checks and criteria that the study doctors will go through with you. These are to make sure the study medication is safe for you and that the results of the study are clear and accurate. It’s important to discuss your full medical history with the study team.

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 moderate to severe eczema (atopic dermatitis)?
Are you able to attend regular clinic visits?
Are you willing to potentially receive a placebo?
Are you comfortable with blood tests and other medical assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medicine, NM26-2198, or a placebo (a dummy medicine with no active ingredients). This will be decided by chance, like flipping a coin. You won't know which one you're getting, and neither will the study team, to keep the results fair.

You'll have several visits to the clinic for check-ups, blood tests, and other assessments. These help the doctors monitor your health and see how the medicine is affecting your body. You'll also need to keep track of your symptoms and any side effects you experience.

The total duration of your participation in the study, including the medication period and follow-up, will be explained in detail by the study team. It's important to be able to commit to all scheduled visits and procedures.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as gaining access to a new medicine before it's widely available and receiving expert medical care and monitoring. However, there are also potential risks, including side effects from the study medicine which might not be fully known yet, as well as the inconvenience of clinic visits and tests. It's very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Poland

Common questions

What is atopic dermatitis?

Atopic dermatitis is another name for eczema, a common skin condition that causes dry, red, and itchy patches on the skin.

What does 'Phase 1' mean for a trial?

Phase 1 means this is one of the very first times this new medicine is being tested in humans. The main goal is to check its safety and how the body handles it.

Will I definitely get the new medicine?

No, not necessarily. In this type of study, some participants will receive the new medicine, while others will receive a 'placebo' (a dummy medicine) to make sure the results are accurate.

How long will the study last if I join?

The exact duration for each participant varies, but the study team will provide you with a clear timeline for your involvement, including all visits and follow-ups.

Can I stop participating if I want to?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without needing to explain why or affecting your regular medical care.