ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

Detailed Description
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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.

Official Title
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A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)

Conditions
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Food Allergy

Intervention / Treatment
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* Biological: ADP101 vs Placebo Dose Regimen A
* Biological: ADP101 vs Placebo Dose Regimen B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Biological: ADP101 vs Placebo Dose Regimen A<br>* Active powder formulation at various volumes. Placebo powder formulation at various volumes.<br>|
| Experimental: Arm 2<br> | Biological: ADP101 vs Placebo Dose Regimen B<br>* Active powder formulation at various volumes. Placebo powder formulation at various volumes.<br>|

What is the study measuring?
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Primary 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 of protein from a relevant allergen or allergens with no more than mild symptoms at the final/exit double-blind placebo-controlled food challenge. | Week 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events, including serious adverse events during the study period (Safety and Tolerability) |  | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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