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RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

This research study is looking at a new medicine, IMG-007, for adults who have moderate to severe eczema, also known as atopic dermatitis. Eczema can make your skin very itchy and inflamed. The main goal of the study is to find out how well IMG-007 works to improve these symptoms and if it's safe to use, compared to a placebo (a dummy medicine with no active ingredients). Participants will be randomly assigned to receive either different doses of IMG-007 or the placebo. The study will last up to 48 weeks and involves doctors and researchers carefully checking how people respond to the treatment. This is a Phase 2 study, meaning it's an early stage of testing new medicines to understand their effects.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Inmagene LLC
Enrolment target
405
Start
17 Jun 2025
Estimated completion
01 Aug 2028

What is this study about?

Eczema, or atopic dermatitis, is a common skin condition that can cause dry, itchy, and inflamed patches of skin. For some people, these symptoms can be quite severe and can significantly impact their daily lives. While there are existing treatments, researchers are always looking for new and better ways to help manage the condition, especially for those whose current treatments aren't working well enough.

This particular study is focusing on a new medicine called IMG-007. It's designed for adults who have moderate to severe eczema. The main purpose is to see if IMG-007 can help reduce the symptoms of eczema more effectively than a placebo – a substance that looks exactly like the study medicine but has no active ingredients. This helps researchers understand if any improvements are genuinely due to the new medicine or other factors.

The study will also look carefully at the safety of IMG-007. Like all medicines, new treatments can have side effects. By testing different doses and comparing them to a placebo, the research team can get a clearer picture of how safe the medicine is and what potential side effects might occur. This is an important step in the process of developing new medicines, ensuring that any new treatment is both effective and well-tolerated.

Key takeaways

  • Tests a new medicine (IMG-007) for moderate to severe eczema.
  • Compares IMG-007 to a placebo (dummy medicine).
  • Aimed at adults aged 18-74 whose current treatments haven't worked well.
  • Will look at how well the medicine works and if it's safe.
  • Participation involves regular clinic visits for up to 48 weeks.
  • You won't know if you're getting the medicine or placebo.

Who may be eligible?

This study is looking for adults aged 18 to 74 years old who have moderate to severe eczema. To be considered, your eczema should cover at least 10% of your body, and you should have an eczema severity score (EASI) of 16 or higher, along with a doctor's assessment indicating your eczema is at least 'moderate'. You also need to have experienced significant itching, with a score of 4 or higher on a pain scale during the week before joining.

Crucially, you would only be suitable if your past treatments for eczema, such as creams or ointments, haven't worked well enough, or you couldn't tolerate them. Researchers also want to make sure participants are not pregnant or breastfeeding. If you're a woman who could become pregnant, you'd need to agree to use effective contraception. Similarly, men taking part would also need to use effective contraception.

There are also some reasons why you might not be able to join. For example, if you have certain infections like hepatitis B or C, HIV, or active tuberculosis, you wouldn't be eligible. Also, if you have other serious health conditions or are taking certain medicines that could interfere with the study results or put your health at risk, you might not be able to participate. The study doctor would review all your health information to make the final decision.

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.

  1. Are you an adult between 18 and 74 years old?
  2. Do you have eczema that a doctor would describe as moderate to severe?
  3. Have your current eczema creams or treatments not worked well enough?
  4. Are you able to use effective contraception if needed (for both men and women)?
  5. Do you not have active serious infections like hepatitis B/C, HIV, or tuberculosis?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. If you're eligible, you would then be randomly assigned to one of several groups. Some groups will receive different doses of the new medicine, IMG-007, while others will receive a placebo (a dummy medicine).

Neither you nor the study team will know which treatment you are receiving – this is called a 'double-blind' study and helps ensure the results are unbiased. You will be asked to take the study medicine or placebo regularly for a period, and you'll have scheduled visits to the clinic over several months, for up to 48 weeks in total. During these visits, the study team will carry out various assessments, such as checking your eczema symptoms, asking about any side effects, and possibly taking blood samples. They will be closely monitoring your health and how you respond to the treatment throughout the study.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from a new treatment before it's widely available, and you'll receive regular medical attention from the study team. The potential benefit here is that IMG-007 might improve your eczema symptoms, like itching and skin inflammation, more effectively than your current treatments. However, there's no guarantee it will work for you, and you might receive the placebo. Like all medicines, IMG-007 could have side effects, which might be mild or more serious. The study team will explain these to you fully, and they will carefully monitor you for any problems. 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 (23)

  • Inmagene Site 1
    Verified postcode
    Lancaster, United States· Recruiting
  • Inmagene Site 23
    Verified postcode
    Los Angeles, United States· Recruiting
  • Inmagene Site 19
    Verified postcode
    Ocala, United States· Recruiting
  • Inmagene Site 4
    Verified postcode
    Tampa, United States· Recruiting
  • Inmagene Site 2
    Verified postcode
    Rolling Meadows, United States· Recruiting
  • Inmagene Site 6
    Verified postcode
    Kew Gardens, United States· Recruiting
  • Inmagene Site 21
    Verified postcode
    New York, United States· Recruiting
  • Inmagene Site 11
    Verified postcode
    Woodbury, United States· Recruiting
  • Inmagene Site 20
    Verified postcode
    Charlotte, United States· Recruiting
  • Inmagene Site 10
    Verified postcode
    Fargo, United States· Recruiting
  • Inmagene Site 9
    Verified postcode
    Columbus, United States· Recruiting
  • Inmagene Site 5
    Verified postcode
    Mayfield Heights, United States· Recruiting

Common questions

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers see if the new medicine is truly effective.

How long will the study last if I join?

The study involves taking the medicine and having regular check-ups for up to 48 weeks, which is about 11 months.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctors will know if you're receiving IMG-007 or the placebo. This is to ensure the results are fair.

What does 'moderate-to-severe eczema' mean for this study?

It means your eczema is quite widespread (at least 10% of your body) and your symptoms, especially itching, are significantly affecting you, and have been rated as moderate or severe by a doctor.

Can I continue my usual eczema treatments if I join?

This will depend on your specific situation and the study rules. You would need to discuss all your current medications with the study team.

How to find out more

ADAPTIVE Study Lead

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Efficacy and Safety of IMG-007 in Ad…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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