Open-label Extension Study of ADP101

NCT ID: NCT05243719

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2024-02-27

Brief Summary

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

Detailed Description

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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).

Conditions

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Food Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ADP101

Intervention Type BIOLOGICAL

Active dry powder formulation at various volumes.

Interventions

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ADP101

Active dry powder formulation at various volumes.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alladapt Immunotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mei-Lun Wang, MD

Role: STUDY_DIRECTOR

VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

Locations

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Study Site

Mission Viejo, California, United States

Site Status

Study Site

Rolling Hills Estates, California, United States

Site Status

Study Site

San Diego, California, United States

Site Status

Study Site

Colorado Springs, Colorado, United States

Site Status

Study Site

Denver, Colorado, United States

Site Status

Study Site

Tampa, Florida, United States

Site Status

Study Site

Atlanta, Georgia, United States

Site Status

Study Site

Marietta, Georgia, United States

Site Status

Study Site

Normal, Illinois, United States

Site Status

Study Site

Ann Arbor, Michigan, United States

Site Status

Study Site

Chapel Hill, North Carolina, United States

Site Status

Study Site

Cincinnati, Ohio, United States

Site Status

Study Site

Charleston, South Carolina, United States

Site Status

Study Site

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ADP101-MA-02

Identifier Type: -

Identifier Source: org_study_id

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