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History of Changes for Study: NCT04856865
Placebo-Controlled Study of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Latest version (submitted March 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 20, 2021 None (earliest Version on record)
2 April 22, 2021 Outcome Measures, Study Status and Study Identification
3 June 16, 2021 Study Status, Contacts/Locations and Conditions
4 July 1, 2021 Contacts/Locations and Study Status
5 July 29, 2021 Contacts/Locations and Study Status
6 August 3, 2021 Study Status and IPDSharing
7 September 20, 2021 Contacts/Locations and Study Status
8 October 8, 2021 Study Status and Contacts/Locations
9 November 5, 2021 Study Status and Contacts/Locations
10 January 24, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
11 February 28, 2022 Study Status and Contacts/Locations
12 March 9, 2022 Study Status and Contacts/Locations
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Study NCT04856865
Submitted Date:  April 20, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: ADP101-MA-01
Brief Title: Placebo-Controlled Study of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2021
Overall Status: Recruiting
Study Start: April 20, 2021
Primary Completion: November 2022 [Anticipated]
Study Completion: December 2022 [Anticipated]
First Submitted: April 20, 2021
First Submitted that
Met QC Criteria:
April 20, 2021
First Posted: April 23, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 20, 2021
Last Update Posted: April 23, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Alladapt Immunotherapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
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.
Open or close this module Conditions
Conditions: Food Allergy
Keywords: 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 see allergy
Soy allergy
Shellfish allergy
Fish allergy
Seafood allergy
Dairy allergy
Desensitization
Food hypersensitivity
Immune system disease
Hypersensitivity, immediate
Hypersensitivity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 72 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Efficacy of ADP101
[ 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.
Open or close this module Eligibility
Minimum Age: 4 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Alladapt Clinical Trial Team
Telephone: 650-420-3900
Email: clinicaltrials@alladapt.com
Locations: United States, Alabama
Study Site
[Recruiting]
Birmingham, Alabama, United States, 35209
Contact:Contact: Alladapt Clinical Trial Team
United States, Arizona
Study Site
[Not yet recruiting]
Tucson, Arizona, United States, 85724
Contact:Contact: Alladapt Clinical Trial Team
United States, Arkansas
Study Site
[Not yet recruiting]
Little Rock, Arkansas, United States, 72202
Contact:Contact: Alladapt Clinical Trial Team
United States, California
Study Site
[Recruiting]
Mission Viejo, California, United States, 92691
Contact:Contact: Alladapt Clinical Trial Team
Study Site
[Not yet recruiting]
Rolling Hills Estates, California, United States, 90274
Contact:Contact: Alladapt Clinical Trial Team
Study Site
[Recruiting]
San Diego, California, United States, 92123
Contact:Contact: Alladapt Clinical Trial Team
United States, Colorado
Study Site
[Recruiting]
Denver, Colorado, United States, 80230
Contact:Contact: Alladapt Clinical Trial Team
United States, Florida
Study Site
[Not yet recruiting]
Tampa, Florida, United States, 33620
Contact:Contact: Alladapt Clinical Trial Team
United States, Georgia
Study Site
[Not yet recruiting]
Atlanta, Georgia, United States, 30329
Contact:Contact: Alladapt Clinical Trial Team
Study Site
[Recruiting]
Marietta, Georgia, United States, 30060
Contact:Contact: Alladapt Clinical Trial Team
United States, Illinois
Study Site
[Not yet recruiting]
Chicago, Illinois, United States, 60637
Contact:Contact: Alladapt Clinical Trial Team
Study Site
[Not yet recruiting]
Normal, Illinois, United States, 61761
Contact:Contact: Alladapt Clinical Trial Team
United States, Michigan
Study Site
[Not yet recruiting]
Ann Arbor, Michigan, United States, 48108
Contact:Contact: Alladapt Clinical Trial Team
United States, New York
Study Site
[Not yet recruiting]
New York, New York, United States, 10016
Contact:Contact: Alladapt Clinical Trial Team
United States, North Carolina
Study Site
[Not yet recruiting]
Chapel Hill, North Carolina, United States, 27599
Contact:Contact: Alladapt Clinical Trial Team
United States, Ohio
Study Site
[Not yet recruiting]
Cincinnati, Ohio, United States, 45229
Contact:Contact: Alladapt Clinical Trial Team
United States, Oregon
Study Site
[Recruiting]
Happy Valley, Oregon, United States, 97086
Contact:Contact: Alladapt Clinical Trial Team
United States, Pennsylvania
Study Site
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Alladapt Clinical Trial Team
United States, South Carolina
Study Site
[Recruiting]
Charleston, South Carolina, United States, 29420
Contact:Contact: Alladapt Clinical Trial Team
United States, Washington
Study Site
[Recruiting]
Seattle, Washington, United States, 98115
Contact:Contact: Alladapt Clinical Trial Team
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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