Peanut Allergy
Conditions
Keywords
AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, PALISADE
Brief summary
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.
Detailed description
This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.
Interventions
BIOLOGICALAR101
AR101 powder provided in capsules & sachets
Sponsors
Aimmune Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Completion of the ARC003 study * Written informed consent and/or assent from subjects/guardians as appropriate * Use of effective birth control by sexually active female subjects of child-bearing potential Key
Exclusion criteria
* Early discontinuation from the ARC003 study * Meets any longitudinally applicable ARC003 study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Up to 126 weeks | Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Up to 126 weeks | The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years). |
Countries
Canada, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Placebo Crossovers) Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks) | 111 |
| Group 2: Cohort 1 (Active Rollovers) Received 300 mg/day (once daily, QD) peanut protein for 28 weeks | 117 |
| Group 2: Cohort 2 (Active Rollovers) Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks | 48 |
| Group 2: Cohort 3A (Active Rollovers) Received 300 mg/day peanut protein for 56 weeks | 35 |
| Group 2: Cohort 3B (Active Rollovers) Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks) | 34 |
| Group 2: Cohort 3C (Active Rollovers) Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks) | 36 |
| Total | 381 |
Baseline characteristics
| Characteristic | Total | Group 1 (Placebo Crossovers) | Group 2: Cohort 1 (Active Rollovers) | Group 2: Cohort 2 (Active Rollovers) | Group 2: Cohort 3A (Active Rollovers) | Group 2: Cohort 3B (Active Rollovers) | Group 2: Cohort 3C (Active Rollovers) |
|---|---|---|---|---|---|---|---|
| Age, Customized Age 18-55 years | 30 Participants | 11 Participants | 8 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants |
| Age, Customized Age 4-17 years | 351 Participants | 100 Participants | 109 Participants | 46 Participants | 31 Participants | 31 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 13 Participants | 9 Participants | 3 Participants | 4 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 350 Participants | 98 Participants | 108 Participants | 45 Participants | 31 Participants | 33 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 7 Participants | 14 Participants | 7 Participants | 3 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants | 15 Participants | 8 Participants | 7 Participants | 4 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 297 Participants | 86 Participants | 92 Participants | 33 Participants | 28 Participants | 30 Participants | 28 Participants |
| Sex: Female, Male Female | 162 Participants | 39 Participants | 55 Participants | 22 Participants | 16 Participants | 13 Participants | 17 Participants |
| Sex: Female, Male Male | 219 Participants | 72 Participants | 62 Participants | 26 Participants | 19 Participants | 21 Participants | 19 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 109 | 0 / 46 | 0 / 31 | 0 / 31 | 0 / 34 | 0 / 11 | 0 / 8 | 0 / 2 | 0 / 4 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 98 / 100 | 90 / 109 | 36 / 46 | 27 / 31 | 28 / 31 | 33 / 34 | 10 / 11 | 6 / 8 | 1 / 2 | 2 / 4 | 2 / 3 | 2 / 2 |
| serious Total, serious adverse events | 0 / 100 | 1 / 109 | 0 / 46 | 0 / 31 | 1 / 31 | 1 / 34 | 0 / 11 | 1 / 8 | 0 / 2 | 0 / 4 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
Time frame: Up to 126 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 2: Moderate | 58 Participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 1: Mild | 37 Participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 4: Life-Threatening | 0 Participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 3: Severe | 3 Participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 5: Death | 0 Participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | SAEs | 0 Participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | All AEs | 98 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | All AEs | 90 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 1: Mild | 58 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | SAEs | 1 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 2: Moderate | 29 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 4: Life-Threatening | 0 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 5: Death | 0 Participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 3: Severe | 3 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 1: Mild | 22 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | All AEs | 36 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 5: Death | 0 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | SAEs | 0 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 2: Moderate | 14 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 3: Severe | 0 Participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 4: Life-Threatening | 0 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 1: Mild | 15 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 5: Death | 0 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | SAEs | 0 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 4: Life-Threatening | 0 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | All AEs | 27 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 2: Moderate | 12 Participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 3: Severe | 0 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | All AEs | 28 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 1: Mild | 13 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 2: Moderate | 15 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 4: Life-Threatening | 0 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 3: Severe | 0 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 5: Death | 0 Participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | SAEs | 1 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 3: Severe | 3 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 5: Death | 0 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 1: Mild | 12 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | All AEs | 33 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 2: Moderate | 18 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Grade 4: Life-Threatening | 0 Participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | SAEs | 1 Participants |
Secondary
Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).
Time frame: Up to 126 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 1000 mg | 72.2 Percent of participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 2000 mg | 51.4 Percent of participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 300 mg | 98.6 Percent of participants |
| Group 1 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 600 mg | 86.1 Percent of participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 1000 mg | 80.6 Percent of participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 300 mg | 98.1 Percent of participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 2000 mg | 48.5 Percent of participants |
| Group 2: Cohort 1 (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 600 mg | 89.3 Percent of participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 2000 mg | 36.8 Percent of participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 1000 mg | 57.9 Percent of participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 600 mg | 71.1 Percent of participants |
| Group 2: Cohort 2 (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 300 mg | 94.7 Percent of participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 600 mg | 96.2 Percent of participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 1000 mg | 96.2 Percent of participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 2000 mg | 80.8 Percent of participants |
| Group 2: Cohort 3A (QD) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 300 mg | 100.0 Percent of participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 2000 mg | 45.5 Percent of participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 300 mg | 81.8 Percent of participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 1000 mg | 68.2 Percent of participants |
| Group 2: Cohort 3B (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 600 mg | 77.3 Percent of participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 2000 mg | 42.9 Percent of participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 600 mg | 76.2 Percent of participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 1000 mg | 66.7 Percent of participants |
| Group 2: Cohort 3C (Overall) | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Percentage (and 95% CI) tolerating 300 mg | 90.5 Percent of participants |