Peanut Allergy
Conditions
Keywords
AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARC007, Characterized Oral Desensitization Immunotherapy (CODIT™)
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
Detailed description
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.
Interventions
BIOLOGICALAR101
AR101 powder provided in capsules
BIOLOGICALPlacebo
Placebo powder provided in capsules
Sponsors
Aimmune Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
2:1 randomization to AR101 or placebo
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Ages 4 to 17 years, inclusive * History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut * Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening * Written informed consent from the subject's parent/guardian * Written assent from the subject as appropriate (per local regulatory requirements) * Use of effective birth control by sexually active female subjects of childbearing potential Key
Exclusion criteria
* Subjects in whom the clinical diagnosis of peanut allergy is uncertain * Severe or uncontrolled asthma * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening * History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology * History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema * Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Approximately 6 months | Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Approximately 6 months | — |
| Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Approximately 6 months | — |
| Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Approximately 6 months | — |
| Frequency of Anaphylaxis as Defined in the Protocol | Approximately 6 months | Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence). 2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain). 3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or \> 30% drop in systolic BP; Adults: systolic BP \< 90 mm Hg or \> 30% drop from their baseline. |
| Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | — |
| Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | — |
| Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control) |
| Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control). |
| Frequency of Adverse Events That Led to Early Withdrawal | Approximately 6 months | — |
| Frequency of Epinephrine Use as Rescue Medication | Approximately 6 months | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AR101 Powder Provided in Capsules Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
AR101: AR101 powder provided in capsules | 337 |
| Placebo Powder Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.
Placebo: Placebo powder provided in capsules | 168 |
| Total | 505 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 43 | 4 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Did not meet eligibility criteria subsequent to enrollment | 2 | 0 |
| Overall Study | Discontinued due to early termination and continuation in follow-on study due to study closure | 8 | 1 |
| Overall Study | Lack of dosing compliance | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Scheduling conflict | 1 | 0 |
| Overall Study | Withdrawal by Subject | 19 | 3 |
Baseline characteristics
| Characteristic | AR101 Powder Provided in Capsules | Placebo Powder | Total |
|---|---|---|---|
| Age, Continuous | 9.0 years | 9.5 years | 9.0 years |
| Age, Customized 12-17 years | 111 Participants | 54 Participants | 165 Participants |
| Age, Customized 4-11 years | 226 Participants | 114 Participants | 340 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 8 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 318 Participants | 159 Participants | 477 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 25 Participants | 64 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 4 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 33 Participants | 11 Participants | 44 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 14 Participants | 21 Participants |
| Race (NIH/OMB) White | 245 Participants | 113 Participants | 358 Participants |
| Sex: Female, Male Female | 119 Participants | 66 Participants | 185 Participants |
| Sex: Female, Male Male | 218 Participants | 102 Participants | 320 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 337 | 1 / 168 |
| other Total, other adverse events | 334 / 337 | 159 / 168 |
| serious Total, serious adverse events | 2 / 337 | 2 / 168 |
Outcome results
Primary
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Moderate AE | 151 Participants |
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Life Threatening AE | 1 Participants |
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Mild AE | 171 Participants |
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Death | 0 Participants |
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Severe AE | 11 Participants |
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Subjects with at least 1 serious adverse event | 2 Participants |
| AR101 Powder Provided in Capsules | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Subjects with at least 1 AE | 334 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Subjects with at least 1 serious adverse event | 2 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Subjects with at least 1 AE | 159 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Mild AE | 110 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Moderate AE | 47 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Severe AE | 1 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Life Threatening AE | 0 Participants |
| Placebo Powder | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Death | 1 Participants |
Secondary
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17
The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).
Time frame: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 12-17 only).~The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | End of Up-Dosing (300 mg) Visit | 23.7 Change in ACT total score from baseline | Standard Deviation 1.73 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Change from Baseline to Interim (80 mg) Visit | 0.3 Change in ACT total score from baseline | Standard Deviation 2.72 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Interim (80 mg) visit | 23.0 Change in ACT total score from baseline | Standard Deviation 2.69 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Change from Baseline to End of Up-Dosing (300 mg) Visit | 0.9 Change in ACT total score from baseline | Standard Deviation 1.92 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Study Exit | 23.8 Change in ACT total score from baseline | Standard Deviation 1.74 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Change from Baseline to Early Discontinuation / Study Exit | 0.7 Change in ACT total score from baseline | Standard Deviation 1.68 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Baseline | 22.8 Change in ACT total score from baseline | Standard Deviation 2.4 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Change from Baseline to Early Discontinuation / Study Exit | -0.2 Change in ACT total score from baseline | Standard Deviation 2.71 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Baseline | 22.9 Change in ACT total score from baseline | Standard Deviation 3.05 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Interim (80 mg) visit | 23.1 Change in ACT total score from baseline | Standard Deviation 2.9 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | End of Up-Dosing (300 mg) Visit | 23.2 Change in ACT total score from baseline | Standard Deviation 2.13 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Study Exit | 22.6 Change in ACT total score from baseline | Standard Deviation 2.63 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Change from Baseline to Interim (80 mg) Visit | 0.2 Change in ACT total score from baseline | Standard Deviation 2.93 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Change from Baseline to End of Up-Dosing (300 mg) Visit | 0.5 Change in ACT total score from baseline | Standard Deviation 3.1 |
Secondary
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11
The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control)
Time frame: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 4-11 only).~The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | End of Up-Dosing (300 mg) Visit | 24.2 Change in ACT total score from baseline | Standard Deviation 2.63 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Change from Baseline to Interim (80 mg) Visit | 0.3 Change in ACT total score from baseline | Standard Deviation 2.54 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Interim (80 mg) visit | 24.2 Change in ACT total score from baseline | Standard Deviation 2.52 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Change from Baseline to End of Up-Dosing (300 mg) Visit | 0.5 Change in ACT total score from baseline | Standard Deviation 3.08 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Study Exit | 24.0 Change in ACT total score from baseline | Standard Deviation 3.03 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Change from Baseline to Early Discontinuation / Study Exit | 0.3 Change in ACT total score from baseline | Standard Deviation 3.29 |
| AR101 Powder Provided in Capsules | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Baseline | 23.9 Change in ACT total score from baseline | Standard Deviation 2.57 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Change from Baseline to Early Discontinuation / Study Exit | 0.7 Change in ACT total score from baseline | Standard Deviation 2.76 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Baseline | 23.7 Change in ACT total score from baseline | Standard Deviation 2.93 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Interim (80 mg) visit | 23.7 Change in ACT total score from baseline | Standard Deviation 3.47 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | End of Up-Dosing (300 mg) Visit | 23.8 Change in ACT total score from baseline | Standard Deviation 3.55 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Study Exit | 24.5 Change in ACT total score from baseline | Standard Deviation 3.5 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Change from Baseline to Interim (80 mg) Visit | 0.2 Change in ACT total score from baseline | Standard Deviation 2.93 |
| Placebo Powder | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Change from Baseline to End of Up-Dosing (300 mg) Visit | 0.4 Change in ACT total score from baseline | Standard Deviation 2.61 |
Secondary
Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | 26 Participants |
| Placebo Powder | Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | 31 Participants |
Secondary
Frequency of Adverse Events That Led to Early Withdrawal
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Adverse Events That Led to Early Withdrawal | 36 Participants |
| Placebo Powder | Frequency of Adverse Events That Led to Early Withdrawal | 5 Participants |
Secondary
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Abdominal discomfort | 911 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Rhinorrhoea | 164 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Tongue pruritus | 305 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Paraesthesia oral | 159 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Pruritus | 510 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Rash | 139 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Sneezing | 296 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Nasal congestion | 127 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Abdominal pain | 1184 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Throat tightness | 100 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Vomiting | 266 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Headache | 56 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Abdominal pain upper | 374 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Diarrhoea | 52 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Urticaria | 251 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Erythema | 51 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Nausea | 557 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Anaphylactic reaction | 44 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Cough | 195 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Wheezing | 41 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Oral pruritus | 361 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Flushing | 37 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Lip pruritus | 170 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Eye pruritus | 34 number of events |
| AR101 Powder Provided in Capsules | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Throat irritation | 1434 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Eye pruritus | 13 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Throat irritation | 51 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Abdominal pain | 83 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Abdominal discomfort | 65 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Nausea | 26 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Pruritus | 106 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Abdominal pain upper | 31 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Oral pruritus | 6 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Tongue pruritus | 5 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Sneezing | 41 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Vomiting | 14 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Urticaria | 117 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Cough | 64 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Lip pruritus | 0 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Rhinorrhoea | 51 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Paraesthesia oral | 39 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Rash | 62 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Nasal congestion | 47 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Throat tightness | 3 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Headache | 10 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Diarrhoea | 15 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Erythema | 20 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Anaphylactic reaction | 9 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Wheezing | 6 number of events |
| Placebo Powder | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Flushing | 10 number of events |
Secondary
Frequency of Anaphylaxis as Defined in the Protocol
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence). 2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain). 3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or \> 30% drop in systolic BP; Adults: systolic BP \< 90 mm Hg or \> 30% drop from their baseline.
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Anaphylaxis as Defined in the Protocol | 36 Participants |
| Placebo Powder | Frequency of Anaphylaxis as Defined in the Protocol | 9 Participants |
Secondary
Frequency of Epinephrine Use as Rescue Medication
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Epinephrine Use as Rescue Medication | 37 Participants |
| Placebo Powder | Frequency of Epinephrine Use as Rescue Medication | 9 Participants |
Secondary
Frequency of Premature Discontinuation of Dosing Due to Adverse Events
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Premature Discontinuation of Dosing Due to Adverse Events | 41 Participants |
| Placebo Powder | Frequency of Premature Discontinuation of Dosing Due to Adverse Events | 5 Participants |
Secondary
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 Powder Provided in Capsules | Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | 20 Participants |
| Placebo Powder | Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | 0 Participants |
Secondary
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of randomized study treatment.~Number of participants analyzed: subjects who discontinued dosing due to chronic/recurrent gastrointestinal adverse events.~None of the subjects in Placebo group discontinued dosing due to chronic/recurrent gastrointestinal adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR101 Powder Provided in Capsules | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | 2-4 weeks | 2 Participants |
| AR101 Powder Provided in Capsules | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | ≥ 12 weeks | 0 Participants |
| AR101 Powder Provided in Capsules | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | 4-12 weeks | 0 Participants |
| AR101 Powder Provided in Capsules | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Unknown | 1 Participants |
| AR101 Powder Provided in Capsules | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | < 2 weeks | 17 Participants |
| Placebo Powder | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Unknown | 0 Participants |
| Placebo Powder | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | < 2 weeks | 0 Participants |
| Placebo Powder | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | 2-4 weeks | 0 Participants |
| Placebo Powder | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | 4-12 weeks | 0 Participants |
| Placebo Powder | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | ≥ 12 weeks | 0 Participants |