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Open-label Extension Study of ADP101

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 4 Years - 57 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05243719
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Alladapt Immunotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mei-Lun Wang, MD
Principal Investigator Affiliation VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Additional Details

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).

Arms & Interventions

Arms

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.

Interventions

Biological: - ADP101

Active dry powder formulation at various volumes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Study Site, Mission Viejo, California

Status

Address

Study Site

Mission Viejo, California, 92691

Study Site, Rolling Hills Estates, California

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Address

Study Site

Rolling Hills Estates, California, 90274

Study Site, San Diego, California

Status

Address

Study Site

San Diego, California, 92123

Study Site, Colorado Springs, Colorado

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Address

Study Site

Colorado Springs, Colorado, 80907

Study Site, Denver, Colorado

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Address

Study Site

Denver, Colorado, 80230

Study Site, Tampa, Florida

Status

Address

Study Site

Tampa, Florida, 33620

Study Site, Atlanta, Georgia

Status

Address

Study Site

Atlanta, Georgia, 30329

Study Site, Marietta, Georgia

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Address

Study Site

Marietta, Georgia, 30060

Study Site, Normal, Illinois

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Address

Study Site

Normal, Illinois, 61761

Study Site, Ann Arbor, Michigan

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Address

Study Site

Ann Arbor, Michigan, 48108

Study Site, Chapel Hill, North Carolina

Status

Address

Study Site

Chapel Hill, North Carolina, 27599

Study Site, Cincinnati, Ohio

Status

Address

Study Site

Cincinnati, Ohio, 45229

Study Site, Charleston, South Carolina

Status

Address

Study Site

Charleston, South Carolina, 29420

Study Site, Seattle, Washington

Status

Address

Study Site

Seattle, Washington, 98115

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