- 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
About the Harmony 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.
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.
We have already completed enrollment in this study.
Participants will be in this study for approximately 1 year.
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.
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
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
The study doctor will tell the participants, or participants and their parents, 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, or 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.
Please refer to ClinicalTrials.gov for more information about the Harmony study.