NCT05243719

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2022

Typical duration for phase_1

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 3, 2022

Last Update Submit

March 22, 2024

Conditions

Food Allergy

Keywords

ADP101AllergyOral immunotherapyOITAllergiesFood allergiesMulti-food allergicMulti-allergen oral immunotherapyTree nut allergyMilk allergyWheat allergyEgg allergyFin fish allergyShrimp allergyPeanut allergySesame seed allergySoy allergyShellfish allergyFish allergySeafood allergyDairy allergyDesensitizationFood hypersensitivityImmune system diseaseHypersensitivity, immediateHypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Food Allergy Desensitization

    Week 40

Study Arms (1)

Treatment Options 1, 2, 3, 4, 5

EXPERIMENTAL

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

Interventions

ADP101BIOLOGICAL

Active dry powder formulation at various volumes.

Treatment Options 1, 2, 3, 4, 5

Eligibility Criteria

Age4 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Study Site

Mission Viejo, California, 92691, United States

Location

Study Site

Rolling Hills Estates, California, 90274, United States

Location

Study Site

San Diego, California, 92123, United States

Location

Study Site

Colorado Springs, Colorado, 80907, United States

Location

Study Site

Denver, Colorado, 80230, United States

Location

Study Site

Tampa, Florida, 33620, United States

Location

Study Site

Atlanta, Georgia, 30329, United States

Location

Study Site

Marietta, Georgia, 30060, United States

Location

Study Site

Normal, Illinois, 61761, United States

Location

Study Site

Ann Arbor, Michigan, 48108, United States

Location

Study Site

Chapel Hill, North Carolina, 27599, United States

Location

Study Site

Cincinnati, Ohio, 45229, United States

Location

Study Site

Charleston, South Carolina, 29420, United States

Location

Study Site

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Food HypersensitivityHypersensitivityNut HypersensitivityMilk HypersensitivityWheat HypersensitivityEgg HypersensitivityPeanut HypersensitivityShellfish HypersensitivityImmune System DiseasesHypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity

Study Officials

  • Mei-Lun Wang, MD

    VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 17, 2022

Study Start

March 14, 2022

Primary Completion

February 27, 2024

Study Completion

February 27, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(14)