Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

This study is testing a new medicine called Lebrikizumab for people aged 18 and over who have moderate to severe eczema, also known as atopic dermatitis. It's an 'open-label' study, meaning everyone knows they are receiving Lebrikizumab. Researchers want to understand how effective and safe this treatment is in real-world use. The main thing they'll measure is how many people experience a significant improvement in their eczema symptoms, such as less redness, itching, and dry skin, after 24 weeks of treatment. They will also look at other important details like how much the itching improves, how well people sleep, and the overall impact on daily life. This phase of the study helps confirm the medicine's benefits before it can become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Almirall S.A.

Enrolment target

218

Start

11 Oct 2023

Atopic Dermatitis

What is this study about?

This research study is focused on a new medicine called Lebrikizumab, designed to help adults and teenagers (aged 18 and older) who live with moderate to severe atopic dermatitis. Atopic dermatitis is a common type of eczema that can cause very itchy, red, and dry skin, significantly affecting daily life.

In this study, researchers want to see how well Lebrikizumab works in a larger group of people. They also want to make sure it's safe to use. This kind of study helps confirm earlier findings and collects more information about the medicine's benefits and any side effects. By understanding how Lebrikizumab performs in a real-world setting, doctors can get a clearer picture of its potential to help people manage their eczema.

The main goal is to measure the percentage of participants who achieve a noticeable improvement in their eczema symptoms after 24 weeks of taking Lebrikizumab. But they're also looking at many other important aspects, such as relief from intense itching, reduction in sleep problems caused by eczema, and how much the treatment improves a person's quality of life. All this information is vital for determining if Lebrikizumab could be a valuable new option for treating eczema.

Key takeaways

Tests a new medicine (Lebrikizumab) for moderate to severe eczema.
Aims to confirm how well it works and if it's safe for adults and teenagers.
Will track improvements in eczema symptoms, itching, sleep, and quality of life.
You'll receive the study medicine if you join (open-label study).
Participation involves clinic visits over several months.
You can stop participating at any time.

Who may be eligible?

This study is looking for volunteers who are adults or older teenagers, meaning you must be 18 years old or older. There is no upper age limit, so people of all adult ages are welcome to inquire. The study welcomes both men and women to take part.

To be considered, you must have been diagnosed with moderate to severe atopic dermatitis, which is a type of eczema. This means your eczema is quite bothersome and has a significant impact on your daily life.

Beyond these basic requirements, there will be specific medical checks to make sure the study medicine is safe and appropriate for you. Your doctor will need to confirm that you meet all the health criteria set by the researchers.

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 atopic dermatitis (eczema)?
Are you able to attend regular clinic appointments?
Are you willing to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the medicine Lebrikizumab as part of your treatment. This is called an 'open-label' study, which means everyone involved, including you and the study team, will know you are receiving Lebrikizumab.

You will have several clinic visits over a period of 24 weeks (about 6 months) and potentially longer for follow-up. During these visits, the study team will carefully monitor your eczema, take measurements of your skin, and ask you questions about your symptoms, like how much your skin itches and how well you're sleeping. They will also check on your general health and look for any side effects. The total duration of your participation, including any follow-up after the 24-week treatment period, 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 access to a new eczema treatment (Lebrikizumab) that is not yet widely available. You would also receive regular medical care and monitoring from experienced healthcare professionals. However, there are also potential risks; all medicines can have side effects, and Lebrikizumab might cause unexpected reactions. The study team will explain all known potential side effects. It's very important to remember that joining is entirely voluntary, and you have the right to withdraw from 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
Netherlands

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common type of eczema that makes your skin red, itchy, and dry. It's a long-term condition that can flare up from time to time.

What is Lebrikizumab?

Lebrikizumab is a new medicine being tested to treat moderate to severe eczema. It aims to calm down the skin's inflammation that causes eczema symptoms.

What does 'Phase 3b' mean?

Phase 3b means the medicine has already been through earlier tests and is now being looked at in a larger group of people to confirm its benefits and safety before it can be made widely available.

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

Yes, this is an 'open-label' study, so everyone who joins will receive Lebrikizumab as the study treatment.

How long will the study last for me?

The main treatment period is 24 weeks (about 6 months), but there might be additional follow-up visits. The exact total time will be explained by the study team.