Clinical trial NCT04856865: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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 seed allergy
Soy allergy
Shellfish allergy
Fish allergy
Seafood allergy
Dairy allergy
Desensitization
Food hypersensitivity
Immune system disease
Hypersensitivity, immediate
Hypersensitivity
Lead sponsor: Alladapt Immunotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 600mg Desensitization in at Least One Qualifying Food
timeFrame: 40 Weeks
Secondary outcomes:
measure: 1000mg Desensitization Threshold in Pediatric ITT Population
timeFrame: 40 weeks
measure: 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
timeFrame: 40 weeks
measure: 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
timeFrame: 40 Weeks
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Study Site
state: California
city: Rolling Hills Estates
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
facility: Study Site
state: California
city: Denver
country: United States
facility: Study Site
state: Colorado
city: Tampa
country: United States
facility: Study Site
state: Florida
city: Atlanta
country: United States
facility: Study Site
state: Georgia
city: Marietta
country: United States
facility: Study Site
state: Georgia
city: Normal
country: United States
facility: Study Site
state: Illinois
city: Ann Arbor
country: United States
facility: Study Site
state: Michigan
city: Chapel Hill
country: United States
facility: Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Study Site
state: Ohio
city: Happy Valley
country: United States
facility: Study Site
state: Oregon
city: Philadelphia
country: United States
facility: Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Study Site
state: South Carolina
city: Seattle
country: United States
facility: Study Site
state: Washington
Study officials:
affiliation: VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
name: Mei-Lun Wang, MD
role: STUDY_DIRECTOR
References: