About the Study

The Harmony Study is testing a type of oral immunotherapy (OIT) with an investigational drug called ADP101 that contains 15 food sources.

Pharmaceutical companies use clinical studies like this one to test if an investigational drug works and if it is safe before it can be approved by the US FDA to be prescribed by a doctor. Not all new drugs work or are found to be safe. Study participants can help us in this important research. Thank you for taking the time to learn more about the Harmony Study.

What is OIT?
  • OIT involves exposing somebody with food allergy to the food source(s) that cause their allergic reactions
  • OIT starts by taking very small amounts of the food source(s), and over time the amount is slowly increased until a target dose is reached and can be maintained
  • The goal of OIT is to make the person less sensitive to the food(s) that cause their allergic reactions
  • A doctor oversees the OIT process
What is the purpose of this study?

The main purpose of this study is to learn how well ADP101 works to treat food allergy and how safe ADP101 is compared with placebo.

Who can participate in this study?
  • We have already fulfilled adult participation in this study. As such, participants must be 4 to 17 years of age
  • Diagnosed with food allergy to at least one of the following: peanut, tree nuts, wheat, cow’s milk, chicken’s egg, fin fish, shrimp, sesame seed, or soy
  • Able to commit to the study schedule

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with potential participants and their parents.

How long will the study last?

Participants will be in this study for approximately 1 year.

What are the costs of taking part in this study?

Participants will receive the study drug at no cost and will not be charged for any study doctor visits, laboratory work, tests, or procedures that are needed for the study.

What will participants be expected to do during this study?

Study participants will be expected to:

  • Follow all study procedures and instructions
  • Take the study drug (either ADP101 or placebo) daily as directed
  • Attend all scheduled visits at the study site, which will occur approximately every 2 weeks. Some of the required study procedures include:
    • food challenges
    • lab tests
    • physical exams
    • questionnaires
  • Download a smartphone application to complete a daily electronic diary
    • a device will be provided to participants who don’t have a smart phone
  • Continue to avoid all foods that cause allergic reactions
What will happen when the Harmony study ends?

The study doctor will tell the participants and their parents whether they were taking ADP101 or placebo and whether they are eligible to continue into a new study where all participants will receive the investigational drug ADP101, with no placebo. It is up to the participant and their parents to decide if he or she wants to be in this new study, and it is possible that participants may not be eligible to continue into the new study. Participants who do not continue into this new study will stop study drug once they finish the Harmony Study.

Where else can I find information about this study?

Please refer to ClinicalTrials.gov for more information about the Harmony study.