About the Encore Study

Encore is an optional open-label extension study for participants who complete the Harmony study. The Encore Study continues to investigate how well ADP101 works in patients with food allergies. But unlike Harmony where some participants received placebo, in the Encore Study, ALL participants will receive the active study drug ADP101.

The goal of Encore is to learn how ADP101 works in people over a long time and how safe it is. Your participation in the Encore study is completely voluntary; you don’t have to take part if you don’t want to. Feel free to ask the study team any questions you may have.

What will I be expected to do in the Encore Study?

If you want to participate, you will be asked to:

follow all study procedures and instructions
take ADP101 daily as directed
attend all scheduled visits to the study site or by telephone (tele-visits)
download a smartphone application to complete a daily electronic diary (a device will be provided to you if you don’t have one)
continue to avoid all foods that cause your allergic reactions

Some of the required study procedures include:

food challenges
lab tests
physical exam
completing questionnaires

How long will this study last?

You may be in this study until ADP101 is approved for use by the US Food and Drug Administration (FDA), which may take several years or until the study is ended for any other reason.

When does the Encore Study start?

If you decide to take part in the Encore study, your participation will start on the same day as the Harmony study End of Treatment visit. You will also need to read and sign a new informed consent form for the Encore study.

What are the costs to take part in the Encore study?

ADP101 will be given to you at no cost, and you will not be charged for any study visits, laboratory work, tests, or procedures that are needed for the study.

Where can I find more information about the Encore study?

Please ask your study team for more information about the Encore study.

You may also refer to ClinicalTrials.gov for more information about the Encore study.