Active not recruitingPHASE3INTERVENTIONAL

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

This research study is about a medicine called nemolizumab for individuals living with moderate to severe atopic dermatitis, more commonly known as eczema. Many people with eczema find their skin can be very itchy, red, and dry, which can impact their daily lives. This study is dedicated to understanding how well nemolizumab works and how safe it is over a longer period. Participants in this study will have already taken part in an earlier study looking at nemolizumab. This is a common way to gather more information about a new treatment by continuing to monitor its effects in people who have already started taking it. The aim is to make sure it's both helpful and gentle enough for long-term use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Galderma R&D

Enrolment target

1,700

Start

30 Dec 2019

Estimated completion

31 Aug 2026

Moderate-to-Severe Atopic Dermatitis

What is this study about?

This study is focused on a new medicine called nemolizumab, which is being investigated as a potential treatment for moderate to severe atopic dermatitis, also known as eczema. Eczema can cause uncomfortable symptoms like intense itching, dry skin, and rashes, which can be very distressing and affect everyday life. The main goal of this particular study is to check on the safety and effectiveness of nemolizumab for people over a longer period. We already have some initial information from earlier studies, but continuing to follow participants helps us understand how the medicine works in the long run.

The 'phase 3' part of a study means it's a larger study involving more people, carried out after earlier stages have shown promising results. This stage is crucial for gathering enough information to decide if a new medicine is ready to be made available more widely. By looking at long-term safety, we can make sure there are no unexpected problems that might only show up with continued use. And by checking long-term effectiveness, we can see if the medicine continues to help manage eczema symptoms over time.

Taking part in a study like this helps researchers gain vital knowledge about new treatments. This information can ultimately lead to more options and better care for everyone living with challenging conditions like eczema. The more we understand, the better we can develop treatments that truly make a difference to people's lives.

Key takeaways

This study is for people who have already taken part in a previous nemolizumab study for their severe eczema.
It aims to understand the long-term safety and how well nemolizumab continues to work.
Nemolizumab is being investigated as a treatment for moderate to severe atopic dermatitis (eczema).
Participation involves regular medical check-ups and assessment of your eczema.
It's a 'Phase 3' study, which is an important step towards potentially making the medicine available more widely.
You can always ask questions and withdraw from the study at any time.

Who may be eligible?

To be able to take part in this study, you must have previously participated in an earlier study looking at nemolizumab for your moderate to severe eczema. The study doctor will need to agree that continuing with nemolizumab treatment is suitable for you.

There are also some important points for women. If you could become pregnant, you must either agree not to have sex, or to use effective contraception (birth control) throughout the study and for 12 weeks after your last dose of the study medicine. This is to protect any potential pregnancy.

You would not be able to join this study if you had a serious side effect in a previous nemolizumab study that the doctor feels would make it unsafe to continue. Also, if you are pregnant, breastfeeding, or planning to become pregnant during the study, you cannot take part. If you weigh less than 30 kg (about 4 stone 10 pounds), this study is not for you. You also couldn't join if you have certain infections, like a skin infection in the last week, or other infections needing medication in the last two weeks, including COVID-19. Anyone with a known allergy to similar medicines (like some antibody treatments) would also be excluded, as would anyone with any other significant health concern that the study doctor thinks makes it unsafe to participate.

Quick self-check

Have you participated in a previous nemolizumab study for your eczema?
Do you have moderate to severe eczema?
Are you able to use effective contraception if you could become pregnant?
Are you NOT pregnant, breastfeeding, or planning to become pregnant during the study?
Do you weigh at least 30 kg (about 4 stone 10 pounds)?
Have you been free from significant infections in the last several weeks?

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

What does participation involve?

As this is a long-term study for people who have already been in a nemolizumab trial, you would continue to receive the nemolizumab medicine. The study team will regularly assess your skin condition and overall health, which would involve check-ups and potentially blood tests or other examinations. We can't give you the exact number of visits or the total duration in this summary, but these details would be fully explained by the study team if you were considering joining. All information about the frequency of visits, the assessments involved, and how long you'd be in the study would be given to you in writing before you make any decisions.

Potential risks and benefits

Participating in this study might offer the potential benefit of continuing a treatment that has helped your eczema in the past, and you would be closely monitored by a medical team. However, as with any medicine, nemolizumab can have side effects, which would be discussed in detail with you. The study involves a time commitment for appointments and procedures. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (343)

Galderma Investigational Site 8749
Birmingham, United States
Galderma Investigational Site 8893
Birmingham, United States
Galderma Investigational Site 8866
Guntersville, United States
Galderma Investigational Site 8808
Scottsdale, United States
Galderma Investigational Site 8873
Scottsdale, United States
Galderma Investigational Site 8447
Fort Smith, United States
Galderma Investigational Site 8880
North Little Rock, United States
Galderma Investigational Site 8831
Anaheim, United States
Galderma Investigational Site 8906
Bell Gardens, United States
Galderma Investigational Site 8456
Beverly Hills, United States
Galderma Investigational Site 8578
Cerritos, United States
Galderma Investigational Site 8577
Encinitas, United States

+331 more sites — see the official record for the full list.

Common questions

What is moderate to severe atopic dermatitis?

It's a more serious form of eczema, where the skin is very itchy, red, and dry, often covering larger areas of the body and significantly impacting daily life.

What is Nemolizumab?

Nemolizumab is an investigational medicine being studied for eczema. It's a type of 'monoclonal antibody' designed to target specific parts of the body's immune system that contribute to the inflammation and itchiness of eczema.

Why is this a 'long-term' study?

Long-term studies help researchers understand how well a new medicine works and how safe it is over many months or years, which is important for conditions like eczema that can be ongoing.

Can anyone with eczema join this study?

No, this specific study is only for people who have already participated in a previous study looking at nemolizumab for their eczema.

What does 'Phase 3' mean for a clinical trial?

Phase 3 is an advanced stage of drug development. It usually involves a larger number of people and aims to confirm the medicine's effectiveness, monitor side effects, and compare it to existing treatments, if applicable, to gather enough data for regulatory approval.