Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
This research is a continuation study involving a medicine called amlitelimab, used for moderate to severe eczema (atopic dermatitis). It's for people who have already taken part in previous amlitelimab trials. The main goal is to understand the long-term safety of the medicine and how well it continues to work in controlling eczema. Some participants will initially stop taking the medicine to see if their improvements last, and will restart if their eczema gets worse. Others will continue treatment from the start. We will be checking in with participants regularly to monitor their health and the effects of the treatment, sometimes even allowing medicine to be given at home.
At a glance
What is this study about?
You might be reading this because you, or someone you care for, has moderate to severe eczema, also known as atopic dermatitis. It's a condition that can make your skin very itchy, red, and dry. This particular study is about a medicine called amlitelimab, and it's a follow-up for people who have already tried amlitelimab in earlier research studies. We call these earlier studies 'feeder trials' because they 'feed' into this current, longer-term study.
The main aim of this long-term study is to understand two important things: first, how safe amlitelimab is when used over a longer period, and second, how well it continues to help with eczema symptoms. By tracking people for an extended time, we can get a much clearer picture of its overall benefits and any side effects. Knowing this helps doctors and researchers decide if this medicine is a good and safe option for people with eczema in the long run.
Some participants who responded well to amlitelimab in previous studies will initially pause their treatment to see if their eczema stays under control. If their eczema flares up, they'll start taking the medicine again. Others, who perhaps didn't respond as well before or are joining from certain other studies, will continue to take the medicine from the start of this study. This helps us learn about different treatment approaches and how the medicine works for different people.
Key takeaways
- This study is for people who have already used amlitelimab for eczema in previous research.
- It aims to understand the long-term safety and how well the medicine works.
- Some participants will temporarily stop treatment to see if their eczema stays clear.
- Visits can be flexible, including remote or home-based options for taking medicine.
- Participants will be closely monitored for their eczema and overall health.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, the main thing is that you must have already taken part in a specific amlitelimab study for moderate to severe eczema. You generally need to be at least 12 years old and weigh at least 25 kilograms. You should also have finished the previous study as planned and followed all the rules.
There are a few ways people from previous studies can join this one. For example, if you were in studies called SFY17915, INT18404, EFC17599, or EFC17600, and you've reached the right point in those studies, you might be able to move into this long-term study. If you were in study DRI17366, there are specific conditions detailing when you can join, perhaps if your eczema isn't well controlled, if your response wore off, or if it got worse after your previous study ended.
You won't be able to join if you have developed a new significant medical condition that would make it unsafe for you, or if you have a history of a weakened immune system or serious infections. The study team will review all your medical information carefully to make sure it's safe for you to take part.
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 at least 12 years old?
- Do you weigh 25 kilograms (about 3 stone 13 pounds) or more?
- Have you participated in a previous amlitelimab study for moderate to severe eczema?
- Did you complete your previous amlitelimab study as planned?
- Do you have a clear medical history without certain serious or immune-related conditions?
What does participation involve?
If you join this study, you'll continue to receive amlitelimab, or in some cases, you'll temporarily stop it and restart if needed. You’ll have appointments with the study team every four weeks to check how you're doing, assess your eczema, and monitor your general health. These appointments will be crucial for understanding the long-term effects of the medicine.
One convenient aspect is that some of these appointments can happen remotely, meaning you might not always have to travel to a clinic. You or a trained caregiver might even be able to give yourself the study medicine at home, after proper training from the study team. However, if needed, a healthcare professional can visit you at home to help with the medicine, or you can still go to the clinic for your doses.
The study will continue for a long time, as it's designed to look at safety and effectiveness over an extended period. If you decide to stop taking amlitelimab permanently during the study, the team will continue to check on your health for at least 140 days (about 4.5 months) to make sure you stay well and to record any changes after stopping the medicine.
Potential risks and benefits
Locations (388)
- Allervie Clinical Research - Birmingham- Site Number : 8401101Verified postcodeBirmingham, United States
- Cahaba Dermatology & Skin Health Center- Site Number : 8401066Verified postcodeBirmingham, United States
- Center for Dermatology and Plastic Surgery- Site Number : 8401119Verified postcodeScottsdale, United States
- Scottsdale Clinical Trials- Site Number : 8401149Verified postcodeScottsdale, United States
- Eclipse Clinical Research- Site Number : 8401158Verified postcodeTucson, United States
- Arkansas Research Trials- Site Number : 8401244Verified postcodeNorth Little Rock, United States
- Orange County Clinical Trials- Site Number : 8401271Verified postcodeAnaheim, United States
- Encino Research Center- Site Number : 8401042Verified postcodeEncino, United States
- First OC Dermatology- Site Number : 8401025Verified postcodeFountain Valley, United States
- Center for Dermatology Clinical Research- Site Number : 8401018Verified postcodeFremont, United States
- Marvel Clinical Research- Site Number : 8401102Verified postcodeHuntington Beach, United States
- Sunwise Clinical Research- Site Number : 8401022Verified postcodeLafayette, United States
Common questions
What is amlitelimab?
Amlitelimab is a medicine being tested for moderate to severe eczema (atopic dermatitis).
Why is this study only for people who've already taken amlitelimab?
This is a 'long-term' study to see how safe and effective the medicine is over a longer period for people who have already experienced it in earlier research.
Will I have to go to the clinic for every visit?
Not necessarily. Some visits can be remote, and you might even be able to take your medicine at home after training, or have a healthcare professional help you at home.
What if my eczema gets worse during the study?
If your eczema gets worse, especially if you paused treatment, the study team will likely restart your amlitelimab treatment.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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