Peanut Allergy
Conditions
Keywords
AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, Food Allergy
Brief summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Detailed description
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.
Interventions
BIOLOGICALAR101
AR101
Sponsors
Aimmune Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Received AR101 in study ARC007 * Completed the ARC007 study * Use of effective birth control by sexually active female subjects of childbearing potential Key
Exclusion criteria
* Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study. * Receiving a prohibited medication or anticipated use of a prohibited medication \[e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers\], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy. * Currently in the build-up phase of immunotherapy for any nonfood allergen. * Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Approximately 6 months | Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | Approximately 6 months | — |
| Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | Approximately 6 months | — |
| Number of Participants With Allergic Hypersensitivity Adverse Events | Approximately 6 months | — |
| Number of Participants With 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. |
| Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | — |
| Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods. |
| Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) | The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control). |
| Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) | The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control). |
| Number of Participants With Adverse Events That Led to Early Withdrawal | Approximately 6 months | — |
| Number of Participants With Epinephrine Use as Rescue Medication | Approximately 6 months | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AR101 Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.
AR101: AR101 powder provided in sachets | 242 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Allergic Adverse Event | 1 |
| Overall Study | Chronic /Recurrent GI Adverse Event/Symptoms | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Unable to Participate in Study Due to Relocation | 1 |
| Overall Study | Withdrew Consent | 17 |
Baseline characteristics
| Characteristic | AR101 |
|---|---|
| Age, Continuous | 9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 174 Participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 242 |
| other Total, other adverse events | 219 / 242 |
| serious Total, serious adverse events | 1 / 242 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of AR101.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Subjects with at least 1 Adverse Event (AE) | 219 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Mild AE | 176 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Moderate AE | 43 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Severe AE | 0 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Life-threatening AE | 0 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Death AE | 0 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Subjects with at least 1 Serious Adverse Event (SAE) | 1 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Mild SAE | 0 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Moderate SAE | 1 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Severe SAE | 0 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Life-threatening SAE | 0 Participants |
| AR101 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Death SAE | 0 Participants |
Secondary
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17
The ACT for subjects aged 12 to 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, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Population: Safety population defined as all subjects who received at least 1 dose of AR101.~The ACT questionnaire was not completed by all subjects and/or parents/caregivers at all protocol-defined points of collection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Change from Baseline to Study Exit | 0.3 score on a scale | Standard Deviation 2.68 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Baseline | 23.3 score on a scale | Standard Deviation 1.92 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Maintenance Visit 1 | 23.8 score on a scale | Standard Deviation 1.7 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Maintenance Visit 2 | 23.9 score on a scale | Standard Deviation 1.65 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Maintenance Visit 3 | 23.7 score on a scale | Standard Deviation 2.32 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Maintenance Visit 4 | 23.3 score on a scale | Standard Deviation 2.72 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Maintenance Visit 5 | 23.6 score on a scale | Standard Deviation 2.14 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Maintenance Visit 6 | 23.8 score on a scale | Standard Deviation 2.19 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Early Discontinuation | 21.5 score on a scale | Standard Deviation 4.95 |
| AR101 | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | Exit Visit | 23.5 score on a scale | Standard Deviation 2.58 |
Secondary
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11
The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).
Time frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Population: Safety population defined as all subjects who received at least 1 dose of AR101.~The C-ACT questionnaire was not completed by all subjects and/or parents/caregivers at all protocol-defined points of collection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Baseline | 24 score on a scale | Standard Deviation 2.58 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Maintenance Visit 1 | 24.4 score on a scale | Standard Deviation 2.7 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Maintenance Visit 2 | 25.0 score on a scale | Standard Deviation 1.97 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Maintenance Visit 3 | 25.0 score on a scale | Standard Deviation 2.49 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Maintenance Visit 4 | 25.3 score on a scale | Standard Deviation 1.88 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Maintenance Visit 5 | 24.8 score on a scale | Standard Deviation 2.36 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Maintenance Visit 6 | 24.9 score on a scale | Standard Deviation 2.31 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Early Discontinuation | 26.4 score on a scale | Standard Deviation 0.89 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Exit Visit | 24.2 score on a scale | Standard Deviation 3.15 |
| AR101 | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | Change from Baseline to Study Exit | 0.5 score on a scale | Standard Deviation 2.94 |
Secondary
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of AR101.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 | Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | 33 Participants |
Secondary
Number of Participants With 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 AR101.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 | Number of Participants With Adverse Events That Led to Early Withdrawal | 1 Participants |
Secondary
Number of Participants With Allergic Hypersensitivity Adverse Events
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of AR101.~Threshold of allergic hypersensitivity AE reporting ≥ 5%
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Oral pruritus | 14 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Rhinorrhoea | 14 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Throat irritation | 43 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Pruritus | 39 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Abdominal pain | 30 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Abdominal discomfort | 28 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Urticaria | 27 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Cough | 24 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Anaphylactic reaction | 21 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Nausea | 19 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Vomiting | 19 Participants |
| AR101 | Number of Participants With Allergic Hypersensitivity Adverse Events | Rash | 17 Participants |
Secondary
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of AR101
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 | Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | 1 Participants |
Secondary
Number of Participants With Epinephrine Use as Rescue Medication
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of AR101.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 | Number of Participants With Epinephrine Use as Rescue Medication | 19 Participants |
Secondary
Number of Participants With 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 AR101.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 | Number of Participants With of Anaphylaxis as Defined in the Protocol | 21 Participants |
Secondary
Number of Participants With 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 AR101
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AR101 | Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | 1 Participants |
Secondary
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Time frame: Approximately 6 months
Population: Safety population defined as all subjects who received at least 1 dose of AR101 Number of participants analyzed: subjects who discontinued dosing due to chronic/recurrent gastrointestinal adverse events.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AR101 | Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | < 2 weeks | 1 Participants |
| AR101 | Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | 2-4 weeks | 0 Participants |
| AR101 | Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | 4-12 weeks | 0 Participants |
| AR101 | Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | ≥ 12 weeks | 0 Participants |