A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
This research study is testing a new medicine called amlitelimab for moderate-to-severe eczema, also known as atopic dermatitis. It's for people aged 12 and older whose eczema hasn't improved much with previous treatments like biologic medicines or JAK inhibitors. Participants will continue using their usual steroid creams alongside the study medicine or a dummy medicine (placebo). The main goal is to find out if amlitelimab is safe and effective in reducing eczema symptoms compared to a placebo. The study will last up to 56 weeks, but some participants might choose to join a longer follow-up study. Your involvement would include regular visits, and careful checks of your skin and overall health. This study aims to find better ways to help people living with challenging eczema.
At a glance
What is this study about?
This study is looking for new ways to treat moderate-to-severe eczema, also called atopic dermatitis. Eczema is a long-lasting skin condition that causes dry, itchy, and inflamed patches. For many people, existing treatments don't work well enough, and they continue to struggle with their symptoms. This research focuses on a new drug called amlitelimab.
The main purpose of this study is to see how well amlitelimab works and if it's safe for people aged 12 and older who have moderate-to-severe eczema. Importantly, this study is for individuals whose eczema hasn't gotten better with other strong treatments they've tried in the past, such as certain biologic medicines or oral JAK inhibitors. Participants in the study will also continue to use their usual steroid creams or other topical medicines for their eczema.
The study will compare amlitelimab to a placebo (a dummy medicine that looks like the real thing but has no active drug). By comparing these two groups, doctors can carefully determine if amlitelimab is truly making a difference in improving eczema symptoms and overall skin health, and whether it has any side effects.
Key takeaways
- This study is for people aged 12 and up with moderate-to-severe eczema.
- It's for those whose eczema hasn't responded well to previous biologic or JAK inhibitor treatments.
- The study tests a new medicine, amlitelimab, given by injection, alongside usual steroid creams.
- Participants will receive either amlitelimab or a placebo.
- The study involves regular clinic visits over a period of up to 56 weeks.
- This research aims to find better treatment options for challenging eczema.
Who may be eligible?
To join this study, you must be at least 12 years old and have been diagnosed with eczema for at least one year. Your eczema should be considered moderate-to-severe, meaning it covers a noticeable part of your body and significantly impacts you. You also need to have tried other strong eczema medicines in the past, such as specific biologic drugs or oral JAK inhibitors, and found that they didn't help enough.
There are also some health conditions that would prevent you from joining. For example, if you have other skin conditions that might make it hard to check your eczema, or if you have a weakened immune system, certain serious infections (like HIV, Hepatitis B or C, or active tuberculosis), or a history of certain cancers, you generally wouldn't be able to participate. You also can't join if you've had an organ or stem cell transplant in the past.
The study team will carefully review your medical history and current health to make sure it's safe for you to take part and that the study is right for you.
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 12 years old or older?
- Have you had eczema for at least one year?
- Is your eczema considered moderate-to-severe?
- Have you tried biologic medicines or oral JAK inhibitors for your eczema, but they didn't work well enough?
- Are you able and willing to attend regular study visits?
- Do you weigh at least 25 kilograms (about 3 stone 13 pounds)?
What does participation involve?
If you decide to join this study, you will be put into one of three groups by chance, like flipping a coin. One group will receive the new medicine amlitelimab, another group will receive a different dose of amlitelimab, and a third group will receive a placebo (dummy medicine). You won't know which one you're getting, and neither will your study doctor. You will continue to use your regular topical steroid creams or other creams for your eczema throughout the study.
The study involves regular visits to the clinic, which could be up to 13 visits in total. These visits will involve health checks, blood tests, and assessments of your eczema to see how it's changing. The main treatment part of the study lasts for 36 weeks. After this, if you don't join a longer-term safety study, there will be a 16-week follow-up period to monitor your health. The total time you'd be in the study can be up to 56 weeks, or up to 40 weeks if you choose to join the long-term safety study.
Potential risks and benefits
Locations (147)
- University of Alabama at Birmingham- Site Number : 8401267Verified postcodeBirmingham, United States· Recruiting
- Center for Dermatology and Plastic Surgery- Site Number : 8401119Verified postcodeScottsdale, United States· Recruiting
- Arkansas Dermatology - North Little Rock- Site Number : 8401244Verified postcodeNorth Little Rock, United States· Recruiting
- Encino Research Center- Site Number : 8401042Verified postcodeEncino, United States· Recruiting
- Center for Dermatology Clinical Research- Site Number : 8401018Verified postcodeFremont, United States· Recruiting
- Long Beach Clinical Trials- Site Number : 8401188Verified postcodeLong Beach, United States· Recruiting
- Dermatology Research Associates - Los Angeles- Site Number : 8401092Verified postcodeLos Angeles, United States· Recruiting
- LA Universal Research Center- Site Number : 8401064Verified postcodeLos Angeles, United States· Recruiting
- University Dermatology Trials- Site Number : 8401339Verified postcodeNewport Beach, United States· Recruiting
- Rady Children's Hospital- Site Number : 8401291Verified postcodeSan Diego, United States· Recruiting
- Therapeutics Clinical Research- Site Number : 8401283Verified postcodeSan Diego, United States· Recruiting
- Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245Verified postcodeWheat Ridge, United States· Recruiting
Common questions
What is moderate-to-severe eczema?
It's a form of eczema that causes widespread rashes, intense itching, and significantly impacts daily life, and has not improved with standard treatments.
What is amlitelimab?
Amlitelimab is a new medicine being tested. It's given by an injection under the skin, and aims to reduce eczema symptoms.
What is a 'placebo' in a study?
A placebo is an inactive substance that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.
What are 'topical corticosteroids'?
These are steroid creams or ointments applied directly to the skin to reduce inflammation and itching in eczema.
How long will I be in the study if I participate?
It could be up to 56 weeks, or up to 40 weeks if you join the optional longer-term safety study.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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