Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE April 20, 2021
First Posted Date  ICMJE April 23, 2021
Last Update Posted Date March 10, 2022
Actual Study Start Date  ICMJE April 20, 2021
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Food Allergy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Biological: ADP101 vs Placebo Dose Regimen A
  • Experimental: Arm 2
    Intervention: Biological: ADP101 vs Placebo Dose Regimen B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 24, 2022)
73
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)
72
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04856865
Other Study ID Numbers  ICMJE ADP101-MA-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alladapt Immunotherapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alladapt Immunotherapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mei-Lun Wang, MD VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
PRS Account Alladapt Immunotherapeutics, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP