ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

NCT ID: NCT04856865

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-12-13

Brief Summary

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

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.

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low dose ADP101

Intervention Type: BIOLOGICAL

Active powder formulation

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.

Group Type: EXPERIMENTAL

High dose ADP101

Intervention Type: BIOLOGICAL

Active powder formulation.

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.

Group Type: EXPERIMENTAL

Pooled Placebo

Intervention Type: BIOLOGICAL

Placebo powder

Interventions

Low dose ADP101

Active powder formulation

Intervention Type: BIOLOGICAL

High dose ADP101

Active powder formulation.

Intervention Type: BIOLOGICAL

Pooled Placebo

Placebo powder

Intervention Type: BIOLOGICAL

Other Intervention Names

1500mg target dose ADP101; 4500mg target dose ADP101; Placebo

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alladapt Immunotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei-Lun Wang, MD

Role: STUDY_DIRECTOR

VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

Locations

Study Site

Mission Viejo, California, United States

Study Site

Rolling Hills Estates, California, United States

Study Site

San Diego, California, United States

Study Site

Denver, Colorado, United States

Study Site

Tampa, Florida, United States

Study Site

Atlanta, Georgia, United States

Study Site

Marietta, Georgia, United States

Study Site

Normal, Illinois, United States

Study Site

Ann Arbor, Michigan, United States

Study Site

Chapel Hill, North Carolina, United States

Study Site

Cincinnati, Ohio, United States

Study Site

Happy Valley, Oregon, United States

Study Site

Philadelphia, Pennsylvania, United States

Study Site

Charleston, South Carolina, United States

Study Site

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ADP101-MA-01

Identifier Type: -

Identifier Source: org_study_id