Food Allergy
Conditions
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
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.
Interventions
BIOLOGICALHigh dose ADP101
Active powder formulation.
BIOLOGICALPooled Placebo
Placebo powder
BIOLOGICALLow dose ADP101
Active powder formulation
Sponsors
Alladapt Immunotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 600mg Desensitization in at Least One Qualifying Food | 40 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1000mg Desensitization Threshold in Pediatric ITT Population | 40 weeks | 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. |
| 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 40 weeks | 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. |
| 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 40 Weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Eligible participants were randomized in a 2:2:1:1 ratio to 1 of 4 arms, with 2 arms in each dosing regimen (low or high), to receive daily oral doses of study drug (either ADP101 or matching placebo) in a blinded fashion. Data from placebo participants (high-dose or low-dose) was analyzed in a pooled fashion (Pooled Placebo)
Participants by arm
| Arm | Count |
|---|---|
| Low Dose ADP101 Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. | 25 |
| High Dose ADP101 Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. | 24 |
| Pooled Placebo Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo (see randomization scheme in pre-assignment details) over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. | 24 |
| Total | 73 |
Baseline characteristics
| Characteristic | Low Dose ADP101 | High Dose ADP101 | Pooled Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 20 Participants | 20 Participants | 61 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Age, Continuous | 13.9 years STANDARD_DEVIATION 9.9 | 12.1 years STANDARD_DEVIATION 6 | 14.8 years STANDARD_DEVIATION 11.3 | 13.6 years STANDARD_DEVIATION 9.3 |
| Age, Customized Mean (SD) age (years) of pediatric ITT population | 10.3 years STANDARD_DEVIATION 3.4 | 9.9 years STANDARD_DEVIATION 2.8 | 10.1 years STANDARD_DEVIATION 3.5 | 10.1 years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 20 Participants | 22 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Primary analysis population (pediatric ITT) | 21 Participants | 20 Participants | 20 Participants | 61 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 18 Participants | 20 Participants | 14 Participants | 52 Participants |
| Region of Enrollment United States | 25 Participants | 24 Participants | 24 Participants | 73 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 13 Participants | 44 Participants |
| Sex/Gender, Customized Gender Female | 7 Participants | 6 Participants | 7 Participants | 20 Participants |
| Sex/Gender, Customized Gender Male | 14 Participants | 14 Participants | 13 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 | 0 / 20 | 0 / 25 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 20 / 21 | 19 / 20 | 19 / 20 | 24 / 25 | 23 / 24 | 23 / 24 |
| serious Total, serious adverse events | 0 / 21 | 1 / 20 | 0 / 20 | 0 / 25 | 1 / 24 | 0 / 24 |
Outcome results
Primary
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
Population: The primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose ADP101 | 600mg Desensitization in at Least One Qualifying Food | 8 Participants |
| High Dose ADP101 | 600mg Desensitization in at Least One Qualifying Food | 11 Participants |
| Pooled Placebo | 600mg Desensitization in at Least One Qualifying Food | 4 Participants |
Secondary
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
Population: Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose ADP101 | 1000mg Desensitization Threshold in Pediatric ITT Population | 5 Participants |
| High Dose ADP101 | 1000mg Desensitization Threshold in Pediatric ITT Population | 10 Participants |
| Pooled Placebo | 1000mg Desensitization Threshold in Pediatric ITT Population | 3 Participants |
Secondary
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
Population: The primary analysis population is the pediatric ITT population, age 4-17 years at the time of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose ADP101 | 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 1 Participants |
| High Dose ADP101 | 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 4 Participants |
| Pooled Placebo | 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 0 Participants |
Secondary
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
Population: Primary analysis population is the pediatric ITT population age 4-17 years at the time of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose ADP101 | 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 2 Participants |
| High Dose ADP101 | 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 5 Participants |
| Pooled Placebo | 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | 0 Participants |