ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

• ClinicalTrials.gov Identifier: NCT04856865
• Recruitment Status: Active, not recruiting
• First Posted: April 23, 2021
• Last Update Posted: March 10, 2022
• Sponsor: Alladapt Immunotherapeutics, Inc.
• Information provided by (Responsible Party): Alladapt Immunotherapeutics, Inc.

Tracking Information

• First Submitted Date: April 20, 2021
• First Posted Date: April 23, 2021
• Last Update Posted Date: March 10, 2022
• Actual Study Start Date: April 20, 2021
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Food Allergy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 24, 2022): 73
• Original Estimated Enrollment (submitted: April 20, 2021): 72
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 55 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04856865
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Alladapt Immunotherapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Alladapt Immunotherapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Mei-Lun Wang, MD; VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

• PRS Account: Alladapt Immunotherapeutics, Inc.
• Verification Date: March 2022