- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856865
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
May 1, 2023 updated by: Alladapt Immunotherapeutics, Inc.
A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Mission Viejo, California, United States, 92691
- Study site
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Rolling Hills Estates, California, United States, 90274
- Study site
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San Diego, California, United States, 92123
- Study site
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Colorado
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Denver, Colorado, United States, 80230
- Study site
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Florida
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Tampa, Florida, United States, 33620
- Study site
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Georgia
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Atlanta, Georgia, United States, 30329
- Study site
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Marietta, Georgia, United States, 30060
- Study site
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Illinois
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Normal, Illinois, United States, 61761
- Study site
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Michigan
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Ann Arbor, Michigan, United States, 48108
- Study site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Study site
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Ohio
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Cincinnati, Ohio, United States, 45229
- Study site
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Oregon
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Happy Valley, Oregon, United States, 97086
- Study site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Study site
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South Carolina
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Charleston, South Carolina, United States, 29420
- Study site
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Washington
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Seattle, Washington, United States, 98115
- Study site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 53 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
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Active powder formulation at various volumes.
Placebo powder formulation at various volumes.
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Experimental: Arm 2
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Active powder formulation at various volumes.
Placebo powder formulation at various volumes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Allergy Desensitization
Time Frame: Week 40
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The proportion of subjects who tolerate a highest dose of at least 600-mg of protein from a relevant allergen or allergens with no more than mild symptoms at the final/exit double-blind placebo-controlled food challenge.
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Week 40
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events, including serious adverse events during the study period (Safety and Tolerability)
Time Frame: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mei-Lun Wang, MD, VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2021
Primary Completion (Actual)
November 22, 2022
Study Completion (Actual)
December 13, 2022
Study Registration Dates
First Submitted
April 20, 2021
First Submitted That Met QC Criteria
April 20, 2021
First Posted (Actual)
April 23, 2021
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 1, 2023
Last Verified
May 1, 2023
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
Other Study ID Numbers
- ADP101-MA-01
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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