AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis

This study is testing a new medicine called IMG-007 for adults who have eczema (atopic dermatitis) that is moderate to severe. It's a type of research called a 'Phase 2b' trial, which means it's still in the earlier stages, focusing on finding the best dose and understanding its effects. Participants will receive either the study medicine or a dummy medicine (placebo) and will be closely monitored for 20 weeks. The main goal is to see how much their eczema improves and to check for any side effects. Researchers hope to learn if IMG-007 could be a helpful new treatment option for people living with eczema.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Inmagene LLC

Enrolment target

132

Start

24 Sep 2025

Atopic Dermatitis

What is this study about?

Imagine you have moderate to severe eczema, a condition that makes your skin red, itchy, and irritated. Doctors are always looking for better ways to help people manage this condition. This study is exploring a new medicine called IMG-007 to see if it can be a part of that solution.

This kind of study, called a 'Phase 2b trial', is an important step in developing new medicines. It's designed to understand how well the medicine works at different doses and to keep a close eye on safety. Participants will be organised into groups, and some will receive different doses of IMG-007, while others will receive a 'placebo' – a dummy medicine that looks the same but has no active ingredients. This helps researchers compare the effects accurately.

The main thing doctors will be looking at is how much a person's eczema symptoms improve over a period of 20 weeks. They will also be checking for any side effects. By carefully collecting this information, researchers hope to determine if IMG-007 is effective and safe enough to move forward to larger studies, bringing us closer to potentially new treatments for eczema.

Key takeaways

This study is testing a new medicine (IMG-007) for moderate to severe eczema.
It's a Phase 2b trial, aiming to find the right dose and check safety.
Participants will receive either the new medicine or a dummy medicine (placebo).
Study duration is 20 weeks, with careful monitoring of eczema improvement and side effects.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with moderate to severe eczema (atopic dermatitis).

To be considered for this study, you would need to meet certain health criteria that the study doctors will check. This ensures that the study is as safe as possible for you and that the results are clear.

Both men and women can take part in this research. The study team will review your medical history and current health to confirm if it's suitable 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 18 years old or older?
Have you been diagnosed with moderate to severe eczema (atopic dermatitis)?
Are you generally in good health apart from your eczema?
Are you able to attend regular clinic appointments for 20 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to a group and receive either the study medicine (IMG-007) or a dummy medicine (placebo). Neither you nor your study doctor will know which one you're receiving. You'll have regular visits to the clinic where doctors will check your eczema, take blood samples, and ask about your general health and any side effects. These visits will happen over 20 weeks. After the 20 weeks, there will likely be some follow-up appointments to ensure everything is okay. The exact number of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of trying a new medicine that could improve your eczema symptoms, possibly even before it's widely available. However, there's no guarantee the medicine will work for you, and there's a chance you might receive the placebo. All medicines have potential risks and side effects, some of which might be unknown at this stage. The study team will closely monitor your health to identify and manage any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Czechia
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Unverified
Spain
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Unverified
Germany
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Unverified
Hungary
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Unverified
Poland

Common questions

What is eczema (atopic dermatitis)?

Eczema is a long-lasting skin condition that makes your skin very itchy, dry, and sometimes red and inflamed.

What does 'moderate to severe' eczema mean?

This means your eczema is affecting a significant part of your body, or it's causing severe symptoms that have a big impact on your daily life.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

How long will I be in the study?

The main treatment period for the study is 20 weeks, with additional follow-up appointments after that.

Will I get paid for taking part?

Payment for participation varies between studies. The study team will tell you if you will be reimbursed for travel or time.