Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J4E-MC-IMMB: A Master Protocol for Randomized, Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis; J4E-MC-FR01: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients with Moderate-to-Severe Atopic Dermatitis

Doctors are running a study called J4E-MC-IMMB and J4E-MC-FR01 to find better treatments for adults who have troublesome eczema, known medically as moderate to severe atopic dermatitis. This particular part of the study is testing a new medicine called LY3454738. Participants will be split into groups; some will receive the new medicine, and others will receive a placebo – a dummy treatment that looks like the real thing but has no active ingredients. The main goal is to see if the new medicine can significantly improve eczema symptoms. The study will last for 52 weeks (about one year), and safety will also be carefully monitored throughout. It’s open to adults aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

11 Aug 2023

Atopic dermatitis

What is this study about?

This study is part of a larger research effort to find effective treatments for a persistent skin condition called atopic dermatitis, more commonly known as eczema. Many people experience eczema, but this study focuses on those whose eczema is considered 'moderate to severe,' meaning it significantly affects their daily life and hasn't responded well to standard treatments. The medical name for the specific part of the study you might hear is J4E-MC-FR01, and it's looking specifically at a new medication called LY3454738.

The main purpose of this research is to discover if this new medicine, LY3454738, can effectively reduce the symptoms of moderate to severe eczema. Researchers are particularly interested in seeing what percentage of people achieve a significant improvement in their eczema, specifically a 75% reduction in their Eczema Area and Severity Index (EASI) score. The EASI score is a common way doctors measure how widespread and severe someone's eczema is, so an EASI 75 means a really good improvement. They also want to make sure the treatment is safe.

This kind of study is called a 'Phase 2' trial. This means it's an early stage of testing where scientists are exploring how well a new medicine works and if it has any side effects before it can be considered for wider use. By taking part, you could be helping to advance our understanding of eczema treatments and potentially help many other people living with this condition in the future.

Key takeaways

This study is testing a new medicine (LY3454738) for moderate to severe eczema.
It's open to adults aged 18 and over, both men and women.
You will receive either the new medicine or a dummy treatment (placebo).
The study lasts for 52 weeks, with regular clinic visits.
The main goal is to see if the medicine significantly improves eczema symptoms (EASI 75).
Participation could help find better treatments for eczema in the future.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit for joining.

Both men and women are welcome to take part in this research.

The most important health condition for this study is that you must have moderate to severe atopic dermatitis, which is the medical term for eczema. The study will have other specific healthcare requirements that the study team will discuss with you to see if you are a good fit.

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 moderate to severe eczema (atopic dermatitis)?
Are you able to attend regular clinic appointments for about a year?
Are you willing to potentially receive a placebo instead of the study drug?
Have you discussed your eczema treatments with your doctor recently?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to one of two groups by chance. One group will receive the new study medicine, LY3454738, and the other group will receive a placebo, which is a dummy medicine that looks the same but contains no active ingredients. Neither you nor the study team will know which you are receiving, which helps make the results fair.

The study will last for a total of 52 weeks, which is about one year. During this time, you will have regular visits to the clinic. At these visits, doctors and nurses will assess your eczema symptoms using tools like the Eczema Area and Severity Index (EASI), check your general health, and ask about any side effects you might be experiencing. You will also have blood tests and other assessments to monitor your health and how the treatment is working. The study team will provide all the necessary medication, and it's important to follow their instructions carefully. After the 52 weeks, there may be a follow-up period to check on your health even after the treatment has finished.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving close medical attention from specialist doctors and nurses and possibly benefiting from a new treatment before it's widely available. The information gained from your participation could also help others with eczema in the future. However, there are also potential risks; for example, the new medicine may not work for you, or you could experience side effects. It’s also possible you could receive the placebo and not the active drug. As with any clinical trial, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Italy
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Unverified
Poland
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Unverified
Hungary

Common questions

What is 'atopic dermatitis'?

Atopic dermatitis is the medical name for eczema, a common skin condition that causes dry, itchy, and inflamed patches of skin.

What does 'moderate to severe' mean for eczema?

It means your eczema is quite widespread, often very itchy, and significantly affects your daily life, despite using standard treatments.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers see if the new medicine truly works better than doing nothing.

How long will I be in this study?

If you join, the study treatment period will last for 52 weeks, which is about one year. There might be some follow-up checks after that.

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

No, neither you nor the doctors will know who is getting the real medicine and who is getting the placebo. This is called 'double-blind' and ensures the study results are fair.