Active not recruitingPHASE2INTERVENTIONAL

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

This research is testing a new medication called amlitelimab for people aged 12 and over who have moderate to severe eczema (atopic dermatitis). It's an "open-label" study, meaning everyone involved knows they are receiving the study drug. The main goal is to see if amlitelimab is safe and effective when used for a long time. Participants will receive the treatment for up to five years, with follow-up appointments afterward. Doctors will be checking on participants regularly to monitor their health and how their eczema is responding. This study helps us understand if amlitelimab could be a good treatment option for eczema in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Sanofi

Enrolment target

999

Start

03 Apr 2023

Estimated completion

11 Jun 2031

Dermatitis Atopic

What is this study about?

This study is about a new treatment called amlitelimab for a skin condition known as atopic dermatitis, also commonly called eczema. If you have moderate to severe eczema, this study is designed to see how safe and effective amlitelimab is over a long period. We know that eczema can be very uncomfortable and affect daily life, and this research aims to find better ways to manage it.

The study is "open-label," which means that everyone taking part will know they are receiving the study medication. This is different from some studies where people might receive a dummy treatment (placebo). The main focus is to keep a close eye on participants over several years, checking for any side effects and seeing how well the treatment helps their eczema symptoms.

By carefully studying amlitelimab in this way, researchers hope to gather important information that could help doctors decide if this medication should become a widely available treatment option for people living with eczema. The information from studies like this is crucial for developing new medicines.

Key takeaways

Tests a new eczema treatment called amlitelimab.
For people aged 12 and older with moderate to severe eczema.
Aims to understand long-term safety and effectiveness.
Involves regular clinic visits and lasts up to 5.5 years.
Participants will receive the study medication.

Who may be eligible?

To join this study, you need to be at least 12 years old. You must have had eczema (atopic dermatitis) for at least one year and your eczema should be considered moderate to severe. This means your eczema hasn't improved enough with usual treatments, or those treatments weren't suitable for you.

Your eczema needs to cover at least 10% of your body and have certain severity scores according to checks by the study doctor. You also need to have experienced a certain level of itchiness recently. Your body weight must be at least 25 kilograms (about 3 stone 13 pounds).

There are also reasons you might not be able to join. For example, if you have other serious skin conditions that would make it hard to check your eczema, or if you have a history of certain serious infections or cancers. Women taking part cannot be pregnant or breastfeeding, and all participants must agree to use effective birth control if needed.

Quick self-check

Are you 12 years old or older?
Do you have moderate to severe eczema that hasn't responded well to other treatments?
Does your eczema cover at least 10% of your body?
Are you able to attend appointments regularly for several years?
Are you not pregnant or breastfeeding (if applicable)?

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, the study will last for quite a while – up to 284 weeks, which is about five and a half years in total. It starts with an initial check-up period of 2 to 4 weeks to make sure you're suitable for the study.

Following that, you'll receive the study medication, amlitelimab, for up to 268 weeks (about 5 years). This medication is given as an injection under the skin. After your last dose, there will be a follow-up period of at least 20 weeks to monitor your health and any long-term effects of the treatment.

Throughout the study, you'll have a total of 35 visits to the clinic or study site. During these visits, doctors and nurses will perform examinations, ask about your symptoms, and do tests to check your eczema and overall health. You must be able and willing to attend all these appointments.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new treatment for your eczema that might improve your symptoms, and you'll be closely monitored by medical professionals. However, there are also potential risks, including side effects from the medication, which will be carefully explained to you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (174)

Allervie Clinical Research - Birmingham- Site Number : 8400050
Birmingham, United States
Research Solutions of Arizona- Site Number : 8400020
Litchfield Park, United States
Dermatology Trial Associates- Site Number : 8400027
Bryant, United States
University Dermatology Trials- Site Number : 8400052
Newport Beach, United States
Children's Hospital Colorado - Aurora- Site Number : 8400041
Aurora, United States
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
Centennial, United States
Renaissance Research and Medical Group- Site Number : 8400006
Cape Coral, United States
Florida Pharmaceutical Research and Associates- Site Number : 8400018
Miami, United States
Miami Clinical Research Tower- Site Number : 8400036
Miami, United States
Florida Research Center- Site Number : 8400011
Miami, United States
Clinical Research Trials of Florida- Site Number : 8400054
Tampa, United States
Advanced Medical Research - Atlanta- Site Number : 8400044
Atlanta, United States

+162 more sites — see the official record for the full list.

Common questions

What is amlitelimab?

Amlitelimab is the new medication being tested in this study for treating moderate to severe eczema.

How long does the study last?

The study can last up to 5 and a half years (284 weeks) for each participant.

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

Yes, in this "open-label" study, all participants will receive the study medication, amlitelimab.

How often do I need to visit the clinic?

You will have a total of 35 visits over the entire study period.

What age do I need to be to join?

You must be at least 12 years old to be considered for this study.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.