Open-label Extension Study of ADP101

Study Overview
=================
Brief Summary
-----------------
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).

Detailed Description
-----------------
This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).

Official Title
-----------------
An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)

Conditions
-----------------
Food Allergy

Intervention / Treatment
-----------------
* Biological: ADP101


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: • Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol Key Exclusion Criteria: History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia Hypersensitivity to epinephrine or any of the excipients in ADP101 Prior or concurrent therapies as follows: beta-blockers, ACE inhibitors, ARBs or calcium channel blockers regular steroid medication use therapeutic antibody treatment currently or within the previous 6 months any food immunotherapy currently or within the previous 12 weeks, except ADP101 investigational agents other than ADP101 in the build up phase of non-food immunotherapy Any other condition that might preclude safe participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 57 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Options 1, 2, 3, 4, 5<br>Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study. | Biological: ADP101<br>* Active dry powder formulation at various volumes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety and tolerability of ADP101 | Incidence of adverse events including serious adverse events during the study period. | Through study completion, approximately 4-6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Allergy Desensitization | The proportion of subjects who tolerate a highest dose of at least 600-mg level of protein from a relevant allergen or allergens without dose-limiting symptoms at the Week 40 double-blind placebo-controlled food challenge. | Week 40 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OIT, Multi-food allergic, Multi-allergen oral immunotherapy, Tree nut allergy, Milk allergy, Wheat allergy, Egg allergy, Fin fish allergy, Shrimp allergy, Peanut allergy, Sesame seed allergy, Soy allergy, Shellfish allergy, Fish allergy, Seafood allergy, Dairy allergy, Desensitization, Food hypersensitivity, ADP101, Allergy, Oral immunotherapy, Allergies, Food allergies, Immune system disease, Hypersensitivity, immediate, Hypersensitivity