Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A 2-year Open-label Extension Study to Assess the Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Patients with Moderate-to-Severe Atopic Dermatitis

This two-year study is designed to understand the long-term effects of a medication called Lebrikizumab. It's for adults and teenagers who have moderate to severe eczema, also known as atopic dermatitis. The main goal is to check how safe Lebrikizumab is over a longer period, specifically looking at whether people stop taking the medicine because of side effects. We also want to see how well it helps improve eczema symptoms, such as how much the skin clears up, how much itching is reduced, and how it affects their daily life and quality of sleep. This information helps us understand if Lebrikizumab is a good long-term treatment option for eczema.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Almirall S.A.

Enrolment target

202

Start

05 May 2023

Atopic Dermatitis

What is this study about?

This study is a long-term look at a medicine called Lebrikizumab for people who have moderate to severe eczema. Eczema (or atopic dermatitis) can be very uncomfortable, causing red, itchy, and dry skin. This special study, called an "open-label extension," means that everyone taking part will receive Lebrikizumab, and the study team will be carefully watching how you get on with the medicine over a two-year period.

The main thing we want to learn from this study is about the long-term safety of Lebrikizumab. We're interested in understanding if any side effects might cause people to stop taking the medicine over time. But we also want to see how well Lebrikizumab continues to help with eczema symptoms in the long run. This includes checking things like how much your skin improves, how much the itching goes away, and how your overall quality of life is affected, as eczema can really impact daily activities and sleep.

By carefully tracking these things, the researchers can gather important information about Lebrikizumab. This helps doctors understand if it's a good and safe choice for treating eczema over many months or even years. The aim is to find better ways to help people living with this common and often challenging skin condition.

Key takeaways

This study is for adults and teenagers (18+) with moderate to severe eczema.
It's looking at the long-term safety and effectiveness of a medicine called Lebrikizumab.
The study lasts for two years with regular check-ups.
You'll be monitored closely for improvements in eczema and any side effects.
Participation helps researchers find better treatments for eczema.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be an adult or a teenager aged 18 years or older. There is no upper age limit for joining.

This study is open to both men and women. The most important thing is that you have moderate to severe atopic dermatitis, which is the medical term for eczema.

Because this is an "extension study," it means that participants must have already taken part in a previous study of Lebrikizumab. This helps the researchers continue to follow people who are already familiar with the medication and the study process. Your study doctor will be able to tell you if you meet all the specific requirements.

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)?
Have you previously taken part in a Lebrikizumab study?
Are you prepared to attend regular clinic visits for two years?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be taking Lebrikizumab as part of your treatment for eczema. This is a long-term study, lasting for two years. During this time, you'll have regular visits to the clinic so the study team can monitor your health and how you're responding to the medicine.

At these visits, you can expect to have assessments of your skin, such as checking for improvements in redness, dryness, and itching. You might be asked to complete questionnaires about how your eczema is affecting your daily life and how much you itch. These regular checks help the doctors understand both the safety of the medicine and how well it's working for you over time.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as continued access to a new treatment and close monitoring of your eczema by medical professionals. This could lead to an improvement in your symptoms and overall quality of life. However, like all medicines, Lebrikizumab may have side effects, which could be mild or more serious, and there's no guarantee it will work for everyone. You will be told about all known potential risks before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Poland

Common questions

What is Lebrikizumab?

Lebrikizumab is a new medicine being studied to treat moderate or severe eczema (atopic dermatitis).

How long will I be in the study?

This particular study is designed to last for two years to look at the long-term effects of the medicine.

What will happen during the study visits?

You'll have regular check-ups where your skin will be examined, and you might fill out questionnaires about your symptoms and how you're feeling.

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

Yes, in this type of study (open-label), everyone receives the study medicine, Lebrikizumab.

Can I leave the study if I want to?

Absolutely, you can decide to stop participating at any time without needing to give a reason, and it won't affect your future medical care.