Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

This research study is looking at a new potential medicine, IMG-007, for adults who have moderate to severe eczema, also known as atopic dermatitis. The main goals are to check how safe this new medicine is for people to take, how it's absorbed and used by the body, and if it helps to improve their eczema symptoms. Participants will be randomly assigned to either receive the new medicine or a placebo (a treatment that looks the same but contains no active drug). This helps researchers compare the effects accurately. The study is in early stages (Phase 1 and 2), meaning it's one of the first times it's being tested in a larger group of people to understand its potential benefits and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Inmagene LLC

Enrolment target

Start

19 Mar 2024

Atopic dermatitis

What is this study about?

This study is about exploring a new potential treatment for eczema, specifically moderate to severe atopic dermatitis. Eczema can be a very challenging condition, causing itchy, red, and dry skin, and sometimes significantly affecting daily life. Researchers are interested in a new medicine, IMG-007, to see if it could offer a new way to manage these symptoms.

The study has a few important aims. Firstly, safety is paramount. The researchers will closely monitor all participants for any side effects or unwanted reactions to the medicine. This is a crucial step in developing any new treatment. Secondly, they want to understand how the medicine works in the body – how much is absorbed, how long it stays, and how it's broken down. This helps them work out the best way to give the medicine.

Finally, the study will look at whether IMG-007 actually helps to improve eczema. They will measure changes in symptoms from the beginning to the end of the study. By comparing participants who receive IMG-007 with those who receive a 'dummy' treatment (placebo), they can get a clearer picture of the new medicine's potential benefits. This research helps us learn more about eczema and hopefully find better ways to treat it in the future.

Key takeaways

This study is testing a new eczema medicine, IMG-007.
It's for adults with moderate to severe eczema.
The main goals are to check safety and see if it helps eczema.
Some participants will receive the active medicine; others will receive a placebo.
Participation involves regular clinic visits and health checks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult volunteers, specifically those aged 18 and older, with no upper age limit. Both men and women are welcome to participate.

To be considered for the study, you must have been diagnosed with moderate to severe atopic dermatitis, which is a common type of eczema. This means your eczema affects a significant part of your body and is quite bothersome.

There will also be other specific health requirements and medical checks to make sure the study is safe for you and that the results will be clear. For example, you might need to meet certain health criteria or not be taking particular medicines that could interfere with the study drug.

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 over?
Have you been diagnosed with moderate to severe atopic dermatitis (eczema)?
Are you willing and able to attend all required study appointments?
Are you comfortable potentially receiving either the study drug or a placebo?
Are you generally in good health apart from your eczema?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have several visits to the study clinic. During these visits, the medical team will carry out health checks, take blood samples, and assess your eczema symptoms. You will then be given either the new study medicine, IMG-007, or a placebo, which looks identical but contains no active ingredient. You won't know which one you are receiving.

Your eczema symptoms will be regularly assessed, and you'll be monitored closely for any side effects. There will be specific times for follow-up appointments after you stop taking the study medicine to ensure your health is still good and to collect any final information. The total duration of your involvement, from the first screening visit to your final follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medicine for eczema that isn't yet widely available, and having your health and eczema closely monitored by a specialist team. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine might not help your eczema. It's important to remember that you can stop participating in 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 eczema (atopic dermatitis)?

Eczema, or atopic dermatitis, is a common skin condition that causes dry, red, itchy, and sometimes cracked skin. It can come and go, and ranges from mild to severe.

What does 'Phase 1b/2a' mean?

This means the study is in early stages. It's looking closely at safety and how the medicine works in the body (Phase 1), and also starting to look at whether it helps with symptoms (Phase 2), in a smaller group of people before wider testing.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the new medicine accurately.

Will I know if I'm getting the drug or the placebo?

No, you won't know whether you are receiving the active medicine or the placebo. This is to ensure the study results are unbiased and reliable.

How long will I be in the study?

The team will tell you the exact time commitment, but generally, studies like this involve a period of taking the medicine and then follow-up appointments, which could last several months.