Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis

This research study is about finding better ways to treat moderate to severe eczema, also known as atopic dermatitis. Eczema is a skin condition that can cause itchy, inflamed rashes. The study aims to test a new drug called Lutikizumab, sometimes by itself and sometimes in combination with other treatments, to see how effective and safe it is. It's split into smaller parts, with the first part involving 80 people. Some will receive Lutikizumab, and others a placebo (a dummy treatment), through injections every two weeks for 16 weeks. Afterwards, everyone will receive Lutikizumab for another 32 weeks, totalling 52 weeks of treatment. This study helps doctors understand if these new approaches can improve eczema symptoms.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

Start

19 Dec 2024

Estimated completion

01 May 2027

Atopic Dermatitis

What is this study about?

This study is a research project designed to help people who have moderate to severe eczema, medically known as atopic dermatitis. Eczema is a common skin condition that makes your skin red, itchy, and inflamed. When it's moderate to severe, it can really affect your daily life and sometimes current treatments aren't enough.

The main goal of this study is to find out if new treatments, specifically a drug called Lutikizumab, can effectively improve eczema symptoms and be used safely. Researchers will look at Lutikizumab on its own and also how it works when combined with other treatments. By doing this, they hope to discover better ways to manage this challenging condition for patients in the future.

This study is split into several smaller parts. In the first part, 80 people will take part. For the first 16 weeks, half will receive the study drug (Lutikizumab) and the other half will receive a 'placebo', which looks exactly like the study drug but doesn't contain any active medicine. This helps researchers see if any improvements are truly due to the new drug. After these 16 weeks, everyone in this part of the study will then receive Lutikizumab for an additional 32 weeks, making the total treatment period one year.

Key takeaways

This study is for adults with moderate to severe eczema that hasn't responded well to other treatments.
It tests a new drug called Lutikizumab, sometimes alone, sometimes with other treatments.
You'll receive injections every two weeks for a year, with some participants starting on a placebo.
Regular hospital visits, blood tests, and health checks are part of taking part.
You can stop participating in the study at any time without affecting your normal care.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with a confirmed diagnosis of eczema that started at least a year ago. Your eczema must be considered moderate to severe, and you should have already tried standard treatments like creams, ointments, or even some stronger medicines, but they haven't worked well enough for you, or your doctor feels they're not suitable.

There are also some reasons why you might not be able to join. For example, if you've recently used certain strong eczema medicines, such as specific tablets, injections, or special light treatments, you might need to wait for a period of time before you can participate. This 'waiting period' ensures that any old medicines are out of your system, so researchers can accurately see the effects of the new study drug.

Also, if you've used some herbal remedies or particular topical creams in the very recent past, you might not be eligible. The study team needs to make sure that no other treatments affect the results of the new drug being tested.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with moderate to severe eczema for at least one year?
Have your eczema treatments (like creams or other medicines) not worked well enough for you?
Have you avoided certain strong eczema medicines or light treatments for a specific time recently?
Are you able to attend regular clinic appointments for a year?

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 will have regular visits to a hospital or clinic over a total period of 52 weeks (about a year). During the first 16 weeks, you will receive injections either of the study drug, Lutikizumab, or a placebo (a dummy drug) every two weeks. These injections are given under the skin, similar to some routine vaccinations. After the initial 16 weeks, everyone in this part of the study will then receive Lutikizumab injections every two weeks for another 32 weeks.

Throughout the study, you'll have frequent health checks, blood tests, and other medical assessments. These are important for the research team to monitor your health, how your eczema is responding, and to ensure the treatment is safe. You will need to attend these appointments regularly, which might mean more time at the clinic than your usual doctor's visits.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a new drug that could improve your eczema symptoms, or you might contribute to important research that helps others in the future. However, there's no guarantee that the treatment will work for you, and there could be side effects from the study drug or the regular tests. You might also find the frequent hospital visits and tests a bit demanding. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550
Fountain Hills, United States
Dermatology Research Associates - Los Angeles /ID# 272945
Los Angeles, United States
Integrative Skin Science and Research /ID# 274243
Sacramento, United States
Clinical Trials Research Institute /ID# 274234
Thousand Oaks, United States
Western States Clinical Res /ID# 271748
Wheat Ridge, United States
Skin Care Research Boca Raton /ID# 272544
Boca Raton, United States
Research Associates of South Florida /ID# 272549
Miami, United States
Advanced Clinical Research Institute /ID# 272558
Tampa, United States
Encore Medical Research - Weston /ID# 272539
Weston, United States
Arlington Dermatology /ID# 271735
Rolling Meadows, United States
Somnos Clinical Research /ID# 272943
Lincoln, United States
Equity Medical, LLC /ID# 272555
New York, United States

+18 more sites — see the official record for the full list.

Common questions

What is moderate to severe atopic dermatitis?

It's a form of eczema where the rash and itching are significant and seriously affect daily life, and common treatments might not be enough.

What is Lutikizumab?

Lutikizumab is the new drug being tested in this study to see if it can help improve eczema symptoms.

What is a placebo?

A placebo is a substance that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the new treatment's effects.

How will I get the study drug?

You will receive the study drug or placebo through injections given under the skin every other week during your clinic visits.

How long will I be in the study?

If you join, you will be part of the study for about 52 weeks, which is roughly a year.