The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
Active powder formulation
Active powder formulation.
Placebo powder
Study Site
Mission Viejo, California, United States
Study Site
Rolling Hills Estates, California, United States
Study Site
San Diego, California, United States
600mg Desensitization in at Least One Qualifying Food
The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.
Time frame: 40 Weeks
1000mg Desensitization Threshold in Pediatric ITT Population
Proportion of participants in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.
Time frame: 40 weeks
600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
Proportion of participants with \>=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 600mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.
Time frame: 40 weeks
1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
Proportion of participants with \>=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.
Time frame: 40 Weeks
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Study Site
Denver, Colorado, United States
Study Site
Tampa, Florida, United States
Study Site
Atlanta, Georgia, United States
Study Site
Marietta, Georgia, United States
Study Site
Normal, Illinois, United States
Study Site
Ann Arbor, Michigan, United States
Study Site
Chapel Hill, North Carolina, United States
...and 5 more locations