ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

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)

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

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Biological: Low dose ADP101; Biological: High dose ADP101; Biological: Pooled Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Study Site
    • Rolling Hills Estates, California, United States, 90274
      • Study Site
    • San Diego, California, United States, 92123
      • Study Site
  • Colorado
    • Denver, Colorado, United States, 80230
      • Study Site
  • Florida
    • Tampa, Florida, United States, 33620
      • Study Site
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Study Site
    • Marietta, Georgia, United States, 30060
      • Study Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • Study Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Study Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Study Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Study Site
  • Oregon
    • Happy Valley, Oregon, United States, 97086
      • Study Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Study Site
  • South Carolina
    • Charleston, South Carolina, United States, 29420
      • Study Site
  • Washington
    • Seattle, Washington, United States, 98115
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Low dose ADP101; Active powder formulation; Other Names: 1500mg target dose ADP101
Experimental: 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.	Biological: High dose ADP101; Active powder formulation.; Other Names: 4500mg target dose ADP101
Experimental: 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.	Biological: Pooled Placebo; Placebo powder; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
600mg Desensitization in at Least One Qualifying Food	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.	40 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1000mg Desensitization Threshold in Pediatric ITT Population	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.	40 weeks
600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population	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.	40 weeks
1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population	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.	40 Weeks

Collaborators and Investigators

• Sponsor: Alladapt Immunotherapeutics, Inc.
• Investigators: Study Director: Mei-Lun Wang, MD, VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Hypersensitivity; Allergy; Peanut allergy; Egg allergy; Shrimp allergy; Desensitization; Immune system disease; OIT; Oral immunotherapy; Allergies; Tree nut allergy; Fish allergy; Milk allergy; Food allergies; ADP101; Multi-food allergic; Multi-allergen oral immunotherapy; Wheat allergy; Fin fish allergy; Sesame seed allergy; Soy allergy; Shellfish allergy; Seafood allergy; Dairy allergy; Food hypersensitivity; Hypersensitivity, immediate
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: ADP101-MA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No