ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

• ClinicalTrials.gov Identifier: NCT04856865
• Recruitment Status: Completed
• First Posted: April 23, 2021
• Last Update Posted: May 3, 2023
• Sponsor: Alladapt Immunotherapeutics, Inc.
• Information provided by (Responsible Party): Alladapt Immunotherapeutics, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Food Allergy	Biological: ADP101 vs Placebo Dose Regimen A; Biological: ADP101 vs Placebo Dose Regimen B	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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)
• Actual Study Start Date: April 20, 2021
• Actual Primary Completion Date: November 22, 2022
• Actual Study Completion Date: December 13, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	Biological: ADP101 vs Placebo Dose Regimen A; Active powder formulation at various volumes. Placebo powder formulation at various volumes.
Experimental: Arm 2	Biological: ADP101 vs Placebo Dose Regimen B; Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Study Site

Mission Viejo, California, United States, 92691

Study Site

Rolling Hills Estates, California, United States, 90274

Study Site

San Diego, California, United States, 92123

United States, Colorado

Study Site

Denver, Colorado, United States, 80230

United States, Florida

Study Site

Tampa, Florida, United States, 33620

United States, Georgia

Study Site

Atlanta, Georgia, United States, 30329

Study Site

Marietta, Georgia, United States, 30060

United States, Illinois

Study Site

Normal, Illinois, United States, 61761

United States, Michigan

Study Site

Ann Arbor, Michigan, United States, 48108

United States, North Carolina

Study Site

Chapel Hill, North Carolina, United States, 27599

United States, Ohio

Study Site

Cincinnati, Ohio, United States, 45229

United States, Oregon

Study Site

Happy Valley, Oregon, United States, 97086

United States, Pennsylvania

Study Site

Philadelphia, Pennsylvania, United States, 19104

United States, South Carolina

Study Site

Charleston, South Carolina, United States, 29420

United States, Washington

Study Site

Seattle, Washington, United States, 98115

Sponsors and Collaborators

Alladapt Immunotherapeutics, Inc.

Investigators

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

More Information

• Responsible Party: Alladapt Immunotherapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04856865
• Other Study ID Numbers: ADP101-MA-01
• First Posted: April 23, 2021
• Last Update Posted: May 3, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alladapt Immunotherapeutics, Inc.:

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

Additional relevant MeSH terms:

Hypersensitivity; Food Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate