Clinical Trial 47089

San Diego, CA 92123


<b>Food Allergies - Multiple Locations in the US</b>

    Does food allergy follow you wherever you go?

    You may want to learn more about a food allergy clinical study, called The Harmony Study, if your child has been diagnosed with food allergy to one or more of the following foods: peanut, tree nuts, wheat, cow’s milk, chicken’s egg, fin fish, shrimp, sesame seed, or soy.

    This study is enrolling eligible participants between the ages of 4 to 17 years to research an investigational oral immunotherapy (OIT) called ADP101 that contains the above-mentioned food sources. If you are the parent or caregiver of the study participant, “you” throughout this listing refers to the study participant.

    What is OIT?
    OIT involves exposing somebody with food allergy to increasing amounts of the food source(s) that cause their allergic reactions. The goal is to make the person less sensitive to the food(s) that cause the 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 and how safe ADP101 is compared with placebo. A placebo is an inactive material that is like ADP101 but does not contain any of the active ingredients (or food sources).

    Who can participate in this study?
    To be eligible for this study, 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

    This is not a complete list of study eligibility requirements. The study doctor will review the full eligibility requirements for this study with you.

    How long will the study last?
    The study schedule of visits lasts for approximately 1 year.

    What are the costs to take part in this trial?
    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 conducted for the study.

    What can participants expect by taking part in this study?
    Study participants that are eligible to participate will be expected to:

    • Follow all study procedures and instructions
    • Take the study drug (either ADP101 or placebo) daily as directed
    • Attend scheduled visits at the study site
    • Complete certain study procedures and tests, including food challenges, lab tests, physical exam, questionnaires, medical history, and other assessments
    • Download a smartphone application (Study App) to complete a daily electronic diary (e-diary). A device will be provided if you do not have one.
    • Continue to avoid all foods that cause allergic reactions

    Note that participation is strictly voluntary.

    Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.