Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
This research is investigating a skin patch called DBV712 for young children (aged 4 to 7) who have a peanut allergy. The main goal is to find out if using this patch daily can help children become less sensitive to peanuts and how safe it is over a year. The study will compare children using the real patch with those using a dummy patch (placebo). After the first year, children may continue on the active treatment for up to three years in total. Researchers will then check if the children remain less sensitive to peanuts even after stopping treatment. Before joining, children will have tests to confirm their peanut allergy and how much peanut protein causes a reaction.
At a glance
What is this study about?
This study is all about helping young children, specifically those aged 4 to 7, who have a peanut allergy. We know that living with a peanut allergy can be very worrying for both children and their families. This research is testing a new way of treating peanut allergy using a special skin patch called DBV712. The idea behind the patch is to slowly introduce very tiny amounts of peanut protein to the body through the skin. This gradual exposure might help the body get used to peanuts, making children less likely to have a severe reaction if they accidentally eat some.
The main aim of the study is to see how well this patch works and if it's safe for children to use every day. To do this, some children will receive the active patch with the peanut protein, while others will get a 'dummy' patch (a placebo) that looks the same but contains no peanut protein. This allows researchers to compare the two groups and understand the true effect of the treatment. The study will run for at least a year, and some children might continue receiving the treatment for up to three years.
After treatment, researchers will carefully check if children remain less sensitive to peanuts, even after they stop using the patch. This is an important step to see if the benefits of the treatment last. By doing this research, we hope to find new and safe ways to manage peanut allergy, potentially improving the quality of life for many children and their families.
Key takeaways
- This study is testing a skin patch treatment (DBV712) for peanut allergy in children aged 4-7.
- It aims to make children less sensitive to peanuts and assess the patch's safety.
- Children will either receive the active patch or a dummy patch for 12 months, then potentially active treatment for up to 3 years total.
- Participation involves screening tests, regular clinic visits, and supervised peanut food challenges.
- The study lasts for up to 4 to 4.5 years in total.
- Families can withdraw from the study at any time without affecting medical care.
Who may be eligible?
To be considered for this study, children must be between 4 and 7 years old when they first join. They must also have a clear diagnosis of peanut allergy from a doctor, or a history of allergic reactions to peanuts. This will be confirmed with blood and skin tests.
Critically, for children to be eligible, they must have an allergic reaction to a very small amount of peanut protein (no more than 100 milligrams) during a special food test. This test helps confirm the allergy and measure how sensitive they are. Children who have severe skin conditions in the area where the patch would be placed (between the shoulder blades) or who have uncontrolled asthma, won't be able to join.
Also, children who have had other peanut allergy treatments in the past, or treatments for other allergies within the last six months, usually can't take part. The research team will carefully go through all the requirements to see if your child is a good fit for the study.
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.
- Is your child aged between 4 and 7 years?
- Has a doctor diagnosed your child with a peanut allergy?
- Does your child currently avoid peanuts completely due to their allergy?
- Does your child not have severe skin conditions in the upper back area?
- Has your child not received other peanut allergy treatments before?
What does participation involve?
If your child takes part in this study, the first step is a four-week 'screening period'. During this time, they will have tests, including skin and blood tests, and a supervised food challenge to confirm their peanut allergy and how sensitive they are. They will need to react to a small amount of peanut protein to be eligible.
After screening, your child will be randomly assigned to either receive the active skin patch or a dummy patch daily for 12 months. No one, not even the doctors or your family, will know which patch your child is using during this time. Throughout this year, there will be regular visits to the clinic for check-ups and to see how your child is responding. After this first year, your child may have the option to continue receiving the active patch treatment for another 24 or 36 months, meaning they could be on the treatment for a total of three years.
At key points, including after the first year and again after 36 months of treatment, your child will have specially supervised food challenges to see how their sensitivity to peanuts has changed. After the 36-month treatment period, they'll be monitored again at 2, 4, and 6 months *after* stopping the patch to see if any improvements last. The total time your child could be involved in the study ranges from about 44 to 56 months, depending on which group they were in.
Potential risks and benefits
Locations (87)
- DBV Investigative SiteVerified postcodeBirmingham, United States
- DBV Investigative SiteVerified postcodeTucson, United States
- DBV Investigative SiteVerified postcodeLittle Rock, United States
- DBV Investigative SiteVerified postcodeLos Angeles, United States
- DBV Investigative SiteVerified postcodeLos Angeles, United States
- DBV Investigative siteVerified postcodeMission Viejo, United States
- DBV Investigative SiteVerified postcodeSan Diego, United States
- DBV Investigative SiteVerified postcodeSan Francisco, United States
- DBV Investigative SiteVerified postcodeSan Jose, United States
- DBV Investigative SiteVerified postcodeAurora, United States
- DBV Investigative SiteVerified postcodeColorado Springs, United States
- DBV Investigative SiteVerified postcodeWashington D.C., United States
Common questions
What is DBV712?
DBV712 is a special skin patch being tested as a treatment for peanut allergy. It delivers a tiny amount of peanut protein through the skin.
Will my child know if they are getting the real patch or a dummy patch?
No, neither you, your child, nor the study doctors will know during the first 12 months. This is to ensure the results are accurate and fair.
How long will my child be in the study?
Your child could be in the study for up to 3 years receiving treatment, plus an initial screening period and follow-up, making the total time roughly 4 to 4.5 years.
What happens during the 'food challenge'?
During a food challenge, your child will carefully eat very small, increasing amounts of peanut protein under strict medical supervision to see how their body reacts.
Can my child leave the study at any time?
Yes, you and your child are free to withdraw from the study at any point, and it won't affect their future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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