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ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856865
Recruitment Status : Active, not recruiting
First Posted : April 23, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Alladapt Immunotherapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Food Allergy Biological: ADP101 vs Placebo Dose Regimen A Biological: ADP101 vs Placebo Dose Regimen B Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Biological: ADP101 vs Placebo Dose Regimen A
Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Experimental: Arm 2 Biological: ADP101 vs Placebo Dose Regimen B
Active powder formulation at various volumes. Placebo powder formulation at various volumes.




Primary Outcome Measures :
  1. Food Allergy Desensitization [ Time Frame: Week 40 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856865


Locations
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United States, California
Study Site
Mission Viejo, California, United States, 92691
Study Site
Rolling Hills Estates, California, United States, 90274
Study Site
San Diego, California, United States, 92123
United States, Colorado
Study Site
Denver, Colorado, United States, 80230
United States, Florida
Study Site
Tampa, Florida, United States, 33620
United States, Georgia
Study Site
Atlanta, Georgia, United States, 30329
Study Site
Marietta, Georgia, United States, 30060
United States, Illinois
Study Site
Normal, Illinois, United States, 61761
United States, Michigan
Study Site
Ann Arbor, Michigan, United States, 48108
United States, North Carolina
Study Site
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Study Site
Cincinnati, Ohio, United States, 45229
United States, Oregon
Study Site
Happy Valley, Oregon, United States, 97086
United States, Pennsylvania
Study Site
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Study Site
Charleston, South Carolina, United States, 29420
United States, Washington
Study Site
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Alladapt Immunotherapeutics, Inc.
Investigators
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Study Director: Mei-Lun Wang, MD VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
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Responsible Party: Alladapt Immunotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04856865    
Other Study ID Numbers: ADP101-MA-01
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alladapt Immunotherapeutics, Inc.:
ADP101
Allergy
Oral immunotherapy
OIT
Allergies
Food allergies
Multi-food allergic
Multi-allergen oral immunotherapy
Tree nut allergy
Milk allergy
Wheat allergy
Egg allergy
Fin fish allergy
Shrimp allergy
Peanut allergy
Sesame seed allergy
Soy allergy
Shellfish allergy
Fish allergy
Seafood allergy
Dairy allergy
Desensitization
Food hypersensitivity
Immune system disease
Hypersensitivity, immediate
Hypersensitivity
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate