ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Phase 1

Completed

Conditions: Food Allergy

Interventions: Biological: Pooled Placebo
Biological: Low dose ADP101
Biological: High dose ADP101

Registration Number: NCT04856865

Lead Sponsor: Alladapt Immunotherapeutics, Inc.

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 73

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pooled Placebo	Pooled Placebo	Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
Low dose ADP101	Low dose ADP101	Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High dose ADP101	High dose ADP101	Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.

Primary Outcome Measures

Name	Time	Method
600mg Desensitization in at Least One Qualifying Food	40 Weeks	The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.

Secondary Outcome Measures

Name	Time	Method
1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population	40 Weeks	Proportion of participants with \>=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.
600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population	40 weeks	Proportion of participants with \>=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 600mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.
1000mg Desensitization Threshold in Pediatric ITT Population	40 weeks	Proportion of participants in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.