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Completed

NCT Number: NCT04856865

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.

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Key information

Conditions

Food Allergy Egg Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity Nut Hypersensitivity Nut and Peanut Hypersensitivity Peanut Hypersensitivity Shellfish Hypersensitivity Wheat Hypersensitivity

Age range

4 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Study Site, Mission Viejo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose ADP101

Biological

Active powder formulation

Other names: 1500mg target dose ADP101

High dose ADP101

Biological

Active powder formulation.

Other names: 4500mg target dose ADP101

Pooled Placebo

Biological

Placebo powder

Other names: Placebo

Primary outcomes

  1. 600mg Desensitization in at Least One Qualifying Food

    Time frame: 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 outcomes

  1. 1000mg Desensitization Threshold in Pediatric ITT Population

    Time frame: 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.

  2. 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population

    Time frame: 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.

  3. 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alladapt Immunotherapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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