ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Food Allergy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856865
• Other study ID #: ADP101-MA-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 20, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: May 2024
• Source: Alladapt Immunotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 13, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Biological:
• Low dose ADP101
Active powder formulation
• High dose ADP101
Active powder formulation.
• Pooled Placebo
Placebo powder

Locations

Country	Name	City	State
United States	Study Site	Ann Arbor	Michigan
United States	Study Site	Atlanta	Georgia
United States	Study Site	Chapel Hill	North Carolina
United States	Study Site	Charleston	South Carolina
United States	Study Site	Cincinnati	Ohio
United States	Study Site	Denver	Colorado
United States	Study Site	Happy Valley	Oregon
United States	Study Site	Marietta	Georgia
United States	Study Site	Mission Viejo	California
United States	Study Site	Normal	Illinois
United States	Study Site	Philadelphia	Pennsylvania
United States	Study Site	Rolling Hills Estates	California
United States	Study Site	San Diego	California
United States	Study Site	Seattle	Washington
United States	Study Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alladapt Immunotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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