Peanut Allergy Study for Children, Teens and Adults
Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to see if a study medicine called Ligelizumab can safely help reduce allergic reactions in children, teens and adults when they are accidentally exposed to peanuts.
Who can participate?
Children, teens and adults 6 to 55 years old who have been diagnosed with a peanut allergy may be eligible to participate.
What will happen in the study?
This study includes at least 24 study visits over approximately 52 weeks. The average study visit could take 3 to 4 hours, with the exception of a few visits. Here are some of the things that will happen in this study.
You, as the participant, or your child will be randomized to either receive Ligelizumab or placebo (no active treatment). Randomization means that you will be randomly assigned by a computer system into 1 of the 5 treatment groups. The study drug or placebo will be given as an injection under the skin every 4 weeks for 1 year.
Routine health checks and tests at the study visits will include:
- Questionnaires and questions about your or your child’s peanut allergy, other health conditions, any medications, etc.
- Physical exams
- Spirometry tests for those who have asthma
- Blood, stool and urine tests
- Heart tests or ECGs (electrocardiograms)
- Allergy tests including skin prick tests and oral food challenges
What are the good things that can happen from this research?
You, as the participant, or your child may or may not receive a direct medical benefit from being part of this study. If you are randomized to receive the study medicine, you or your child may experience improvement in your symptoms. If you or your child receives placebo for part of this study, you will not receive a benefit during that time. Overall, this study may help doctors to better treat patients with a peanut allergy.
What are the bad things that can happen from this research?
Possible risks or discomforts could include bruising, swelling, redness, pain, itching, etc. at the site of the injections. We will discuss possible risks or discomforts with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
Participants may receive up to $1,225 for time and effort.