Open-label Extension Study of ADP101
Food Allergy
About this trial
This is an interventional treatment trial for Food Allergy focused on measuring ADP101, Allergy, Oral immunotherapy, OIT, Allergies, Food allergies, 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, Immune system disease, Hypersensitivity, immediate, Hypersensitivity
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
Sites / Locations
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Arms of the Study
Arm 1
Experimental
Treatment Options 1, 2, 3, 4, 5
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.