Active not recruitingPHASE3INTERVENTIONAL

Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

This research study is investigating a new medication called lebrikizumab for people aged 12 and older who have moderate to severe atopic dermatitis (eczema). The main goal is to understand how effective lebrikizumab is at reducing the severity of eczema, including symptoms like itching and skin changes, over a period of 24 weeks. Researchers will also be monitoring the safety of the medication throughout the study. This trial is in its final phase of testing, which means it's one of the last steps before the medicine might become widely available if it proves to be safe and effective. It's an important step in finding new ways to help people manage their eczema.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Almirall, S.A.

Enrolment target

240

Start

20 Nov 2023

Estimated completion

23 Jun 2025

Atopic Dermatitis Eczema

What is this study about?

This study is focused on a new treatment called lebrikizumab for a skin condition known as atopic dermatitis, or eczema. Eczema is a common condition that makes your skin red, itchy, and inflamed. For many people, it can be mild, but for others, it can be moderate to severe, significantly impacting their daily lives. Current treatments can help, but researchers are always looking for new and more effective options.

The main purpose of this study is to find out if lebrikizumab can effectively improve the symptoms of moderate to severe eczema in both adults and teenagers. This includes looking at how well it reduces things like the redness, dryness, and itchiness of the skin, and how it affects the overall severity of the condition. They will also be carefully checking for any side effects to make sure the treatment is safe.

This is a 'Phase 3' study, which means the medicine has already been through earlier tests and shown some promise. This phase involves a larger group of people to confirm its effectiveness and safety before it could potentially be approved for wider use. By taking part, you could contribute to understanding a new potential treatment for eczema.

Key takeaways

This study is for adults and teenagers (12+) with moderate to severe eczema.
It's testing a new medicine called lebrikizumab over 24 weeks.
The aim is to see how well the medicine improves eczema symptoms and if it's safe.
You'll need to attend regular clinic visits and complete diaries.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for adults and teenagers (aged 12 to under 18) who weigh at least 40 kg and have moderate to severe eczema. To be considered, your eczema must have been present for at least a year and covers at least 10% of your body. Your eczema must also be severe enough that your doctor considers it appropriate for a stronger medication, and you must have tried and not responded well to usual creams and ointments, or your doctor feels these aren't suitable for you.

To help assess your current symptoms, you'll need to complete a daily electronic diary about your itching and sleep for at least four days in the week before the study officially starts. You must also be willing and able to attend all clinic visits and complete any questionnaires involved in the study.

There are also some reasons why you might not be able to join. For example, if you've previously taken certain specific medications for eczema (like tralokinumab, lebrikizumab, or certain oral JAK inhibitors), you wouldn't be eligible. Also, if you have other serious uncontrolled health conditions like severe asthma, or if you've had a severe allergic reaction (anaphylaxis) in the past, you generally wouldn't be able to participate.

Quick self-check

Are you 12 years old or older?
Do you have moderate to severe eczema that has been present for at least a year?
Has your doctor considered you a candidate for stronger eczema medication?
Have regular creams or ointments not worked well enough for your eczema, or are they not suitable for you?
Are you able to attend all study appointments and complete simple diaries?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the medication lebrikizumab according to the study plan. You would need to attend regular clinic visits to allow the study team to check on your eczema symptoms, collect blood samples, and monitor your overall health and any side effects. You will also be asked to continue completing an electronic diary about your symptoms, specifically your itching and how it affects your sleep. The main treatment part of the study lasts for 24 weeks, but there might be a follow-up period afterward. You will be given clear instructions on what to expect for each visit and assessment.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical attention from a dedicated research team. However, there are also potential risks, including side effects from the medication, which may or may not be known yet. It's important to remember that the new treatment might not be effective for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

Site 34
Augsburg, Germany
Site 9
Berlin, Germany
Site 29
Bonn, Germany
Site 27
Dresden, Germany
Site 28
Düsseldorf, Germany
Site 11
Erlangen, Germany
Site 37
Frankfurt, Germany
Site 32
Freiburg im Breisgau, Germany
Site 5
Göttingen, Germany
Site 15
Hamburg, Germany
Site 3
Hamburg, Germany
Site 8
Hamburg, Germany

+21 more sites — see the official record for the full list.

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common type of eczema that makes your skin itchy, red, dry, and sometimes cracked. It can come and go, and its severity varies from person to person.

What is lebrikizumab?

Lebrikizumab is a new medicine being tested as a treatment for moderate to severe atopic dermatitis. It works by targeting specific parts of your body's immune system to help reduce inflammation.

How long will the study last?

The main treatment period for this study is 24 weeks, but there might be a follow-up period after that.

Will I get the actual medicine or a dummy pill?

This study is testing the effectiveness of lebrikizumab. You will receive the active study drug according to the research plan.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time and for any reason. Your decision will not affect your future medical care.