Open-label Extension Study of ADP101

An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)

This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).

Study Overview

• Status: Terminated
• Conditions: Food Allergy
• Intervention / Treatment: Biological: ADP101

Detailed Description

This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • 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
    • Colorado Springs, Colorado, United States, 80907
      • Study Site
    • 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
  • South Carolina
    • Charleston, South Carolina, United States, 29420
      • Study Site
  • Washington
    • Seattle, Washington, United States, 98115
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 57 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol

Key Exclusion Criteria:

• History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
• Hypersensitivity to epinephrine or any of the excipients in ADP101

• Prior or 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, except ADP101
  • investigational agents other than ADP101
  • in the build up phase of non-food immunotherapy
• Any other condition that might preclude safe participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Options 1, 2, 3, 4, 5; Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study.	Biological: ADP101; Active dry powder formulation at various volumes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term safety and tolerability of ADP101	Incidence of adverse events including serious adverse events during the study period.	Through study completion, approximately 4-6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Allergy Desensitization	The proportion of subjects who tolerate a highest dose of at least 600-mg level of protein from a relevant allergen or allergens without dose-limiting symptoms at the Week 40 double-blind placebo-controlled food challenge.	Week 40

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): February 27, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypersensitivity; Allergy; Peanut allergy; Egg allergy; Shrimp allergy; Desensitization; Immune system disease; OIT; Oral immunotherapy; Allergies; Tree nut allergy; Fish allergy; Milk allergy; Food allergies; ADP101; Multi-food allergic; Multi-allergen oral immunotherapy; Wheat allergy; Fin fish allergy; Sesame seed allergy; Soy allergy; Shellfish allergy; Seafood allergy; Dairy allergy; Food hypersensitivity; Hypersensitivity, immediate
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: ADP101-MA-02

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