ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic
 children and adults.
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and
 safety of ADP101 for oral immunotherapy in food allergic children and adults.
Inclusion Criteria:

 -  Age 4 to 55 (inclusive)

 -  Clinical history of allergy to at least 1 of the foods contained in ADP101

 -  Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple
 food sources in ADP101

 Exclusion Criteria:

 -  Experience dose limiting symptoms at or below the 100 mg challenge dose level to more
 than 5 food sources contained in ADP101

 -  History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock
 within 60 days of screening

 -  History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or
 severe GERD, symptoms of dysphagia

 -  Severe asthma

 -  Mild or moderate asthma, if uncontrolled or difficult to control

 -  History of mast cell disorder, including mastocytosis, urticaria pigmentosa or
 angioedema

 -  History of chronic disease (other than asthma, atopic dermatitis, or allergic
 rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic
 regimen e.g. uncontrolled diabetes

 -  History of cardiovascular disease, including hypertension requiring > 2
 antihypertensive medications

 -  History of interstitial lung disease

 -  History of celiac disease

 -  Active autoimmune disease that has required systemic treatment within 3 months

 -  Known malignancy that is progressing or has required active treatment within the past
 3 years

 -  Known history of HIV, known active hepatitis B infection or known active hepatitis C
 virus infection

 -  Prior/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

 -  In the build up phase of non-food immunotherapy

 -  Residing at the same address as another subject (e.g. siblings) participating in this
 or any other OIT study

 -  Develops dose-limiting symptoms to placebo during the Screening DBPCFC

 -  Any other condition that might preclude safe participation in the study