Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the safety and effectiveness of an investigational, oral (by mouth) immunotherapy drug, called AR101, for the treatment of peanut allergy in children and teens.
Immunotherapy may reduce a person’s sensitivity to a specific allergy by exposing them to small amounts of what they are allergic to and then gradually increasing the amount over time. It does not cure an allergy but it may lessen the body’s sensitivity (or allergic response) to the allergen, resulting in fewer symptoms.
What will happen in the study?
If your child qualifies and you decide you want him/her to participate, you will both come to Cincinnati Children’s for up to 15 study visits over a period of 6 to 12 months.
The following is a list of tests and procedures that will happen at 1 or more study visits:
- Medical, Allergy and Allergen History: a review of your child’s current and past medical condition, including details of the peanut allergy
- Medication History: a review of your child’s current and past medications, including those for peanut allergy
- Vital Sign Measurements: measuring your child’s height, weight, temperature, blood pressure and heart rate
- Physical Exam: looking at your child’s general appearance, eyes, ears, nose, throat, neck, lymph nodes, lungs, heart, abdomen, skin, arms, legs, gastrointestinal tract, respiratory tract, and mental status
- Blood Samples: taken for routine lab, safety tests and pregnancy tests (if your child is female and able to become pregnant)
- Urine Samples: taken for pregnancy tests (if your child is female and able to become pregnant)
- Breathing Test: a test where your child breathes out air into a small hand held device
- Asthma Control Test: you and/or your child will complete a questionnaire about his/her asthma and use of asthma rescue medications (if your child has asthma)
- Allergic Rhinitis/Hay Fever Questionnaire: you and/or your child will complete a questionnaire about his/her allergic rhinitis symptoms (if your child has allergic rhinitis)
- Child/Parent Questions/Questionnaires: you and/or your child will be asked to complete various questionnaires and asked about any symptoms or adverse effects
- Skin Prick Test (SPT): your child’s skin will be scratched with a probe containing a small amount of peanut and other allergens and then watched for an allergic reaction
- Diary: you and/or your child will record information (the study drug dose and any reactions that may have occurred) into a paper diary every day and then bring it with you to every study visit
Your child will be randomly (by chance, like flipping a coin) assigned to receive either the investigational study drug AR101 (a formulation of characterized peanut proteins) or a placebo (an inactive substance that looks and tastes exactly like AR101). He/she will have a 2 in 3 (66.7%) chance of receiving AR101 and a 1 in 3 (33.3%) chance of receiving placebo.
Neither you, your child, nor the study doctor will know which study drug your child is taking; however, the study doctor will be able to find out in case of an emergency.
During the first study visit at Cincinnati Children’s, your child will receive a very low dose of his/her assigned study drug (either AR101 or placebo). The study drug will be in the form of a capsule, which contains a powder inside. The capsule will be broken open and the powder will be mixed with food such as applesauce, yogurt or pudding. Your child will then eat the mixture.
If your child shows no allergic symptoms, the dose will gradually increase every 20 to 30 minutes, as tolerated, up to 3mg. If your child can tolerate 3mg with little or no symptoms, he/she will be asked to return to Cincinnati Children’s the next day to receive another dose of study drug. If your child is not able to tolerate at least 3mg, he/she will be unable to continue in this study.
On the next day, your child will receive another 3mg dose of the study drug. If your child can again tolerate the single dose with little or no symptoms, he/she will be given a 2week supply of the study drug to take home.
Every day at home for the next 2 weeks, your child will take 1 capsule of the study drug and fill out the diary. When your child takes the dose at home, you will mix the study drug with foods such as applesauce, yogurt or pudding and your child will need to eat the entire mixture.
After 2 weeks, your child will return to Cincinnati Children’s for the next study visit. This visit begins the Up-Dosing Period, which lasts about 20 to 40 weeks and includes at least 10 study visits.
At each visit during the Up-Dosing Period, which occur every 2 weeks, your child’s study drug dose will be gradually increased from 3mg up to a maximum dosage of 300mg. After taking the new dose, your child will be monitored to ensure he/she does not have any allergic reactions. You and/or your child will also need to bring the study diary, any unused study drug, and all study drug containers (even if empty) with you to each of these visits.
At the end of each visit, you and your child will be given another 2-week supply of the study drug, but at the new dose. Your child will need to take 1 dose each day until the next visit and complete the daily entries for the study diary.
Study staff will call you and/or your child the day after each visit to ask how he/she is feeling. Your child may be asked to return for additional, unscheduled study visits if he/she experiences any symptoms or discomforts.
At the end of the study, you and your child will return to Cincinnati Children’s for an Exit Visit. If your child does not have any ongoing symptoms or discomforts during the final visit of the study, your child’s participation will be completed. If your child has ongoing symptoms or discomforts during this visit, study staff may contact you or ask your child to return to Cincinnati Children’s until the symptoms or discomforts are resolved.
You and/or your child will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and/or your child and will be sure that all your questions are answered.
Will you/your child be paid to be in this research study?
Participants will receive $50 per visit for their time and travel.