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ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Study Purpose

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

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 - 55 Years
Gender All
More Inclusion & Exclusion 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

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.

NCT04856865
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries United States
Conditions

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

Food Allergy
Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm 1

Experimental: Arm 2

Interventions

Biological: - ADP101 vs Placebo Dose Regimen A

Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Biological: - ADP101 vs Placebo Dose Regimen B

Active powder formulation at various volumes. Placebo 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, Birmingham, Alabama

Status

Recruiting

Address

Study Site

Birmingham, Alabama, 35209

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Tucson, Arizona

Status

Not yet recruiting

Address

Study Site

Tucson, Arizona, 85724

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Little Rock, Arkansas

Status

Not yet recruiting

Address

Study Site

Little Rock, Arkansas, 72202

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Mission Viejo, California

Status

Recruiting

Address

Study Site

Mission Viejo, California, 92691

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Rolling Hills Estates, California

Status

Not yet recruiting

Address

Study Site

Rolling Hills Estates, California, 90274

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, San Diego, California

Status

Recruiting

Address

Study Site

San Diego, California, 92123

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Denver, Colorado

Status

Recruiting

Address

Study Site

Denver, Colorado, 80230

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Tampa, Florida

Status

Not yet recruiting

Address

Study Site

Tampa, Florida, 33620

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Atlanta, Georgia

Status

Not yet recruiting

Address

Study Site

Atlanta, Georgia, 30329

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Marietta, Georgia

Status

Recruiting

Address

Study Site

Marietta, Georgia, 30060

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Chicago, Illinois

Status

Not yet recruiting

Address

Study Site

Chicago, Illinois, 60637

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Normal, Illinois

Status

Not yet recruiting

Address

Study Site

Normal, Illinois, 61761

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Ann Arbor, Michigan

Status

Not yet recruiting

Address

Study Site

Ann Arbor, Michigan, 48108

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, New York, New York

Status

Not yet recruiting

Address

Study Site

New York, New York, 10016

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Chapel Hill, North Carolina

Status

Not yet recruiting

Address

Study Site

Chapel Hill, North Carolina, 27599

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Cincinnati, Ohio

Status

Not yet recruiting

Address

Study Site

Cincinnati, Ohio, 45229

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Happy Valley, Oregon

Status

Recruiting

Address

Study Site

Happy Valley, Oregon, 97086

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Study Site

Philadelphia, Pennsylvania, 19104

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Charleston, South Carolina

Status

Recruiting

Address

Study Site

Charleston, South Carolina, 29420

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

Study Site, Seattle, Washington

Status

Recruiting

Address

Study Site

Seattle, Washington, 98115

Site Contact

Alladapt Clinical Trial Team

clinicaltrials@alladapt.com

650-420-3900

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