ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

May 1, 2023 updated by: Alladapt Immunotherapeutics, Inc.

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 53 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Active powder formulation at various volumes. Placebo powder formulation at various volumes.
Experimental: Arm 2
Active powder formulation at various volumes. Placebo powder formulation at various volumes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Allergy Desensitization
Time Frame: Week 40
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
Time Frame
Incidence of adverse events, including serious adverse events during the study period (Safety and Tolerability)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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