Trial Outcomes & Findings for Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study (NCT NCT02198664)

NCT ID: NCT02198664

Last Updated: 2021-11-09

Results Overview

TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Up to 90 weeks

Results posted on

2021-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	ARC001 Placebo Group Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Overall Study STARTED	26	21
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	16	8

Reasons for withdrawal

Reasons for withdrawal
Measure	ARC001 Placebo Group Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	11	8
Overall Study Failure to tolerate	2	0
Overall Study Not stated	1	0

Baseline Characteristics

Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	Total n=47 Participants Total of all reporting groups
Age, Continuous	8.5 years n=5 Participants	8.0 years n=7 Participants	8.0 years n=5 Participants
Age, Customized 4-17 years	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Age, Customized 18-26 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 weeks

Population: The Safety Population (those who received any amount of AR101)

TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any TEAE	26 Participants	21 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any Grade 3 or Higher TEAE	1 Participants	1 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any TEAE Related to Study Treatment	25 Participants	15 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any TEAE Leading to Study Treatment Temporarily Withdrawn	12 Participants	15 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any TEAE Event Leading to Study Treatment Permanently Withdrawn	4 Participants	0 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any Treatment-Related Hypersensitivity Adverse Event	5 Participants	4 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any serious TEAE	0 Participants	1 Participants
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months Any Serious TEAE leading to Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 36 weeks

Population: The Safety Population (those who received any amount of AR101). Only results for the "ARC001 AR101 Group" is reported as only subjects in this group had Up-dosing DBPCFC in ARC002 study.

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC Up-dosing DBPCFC: Responder at 300 mg	20 Participants	—
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC Up-dosing DBPCFC: Responder at 600 mg	19 Participants	—

SECONDARY outcome

Timeframe: Up to 60 weeks.

Population: The Safety Population (those who received any amount of AR101). Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC.

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. Maintenance DBPCFC: Responder at 300 mg	20 Participants	20 Participants
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. Maintenance DBPCC: Responder at 600 mg	20 Participants	18 Participants
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. Maintenance DBPCC: Responder at 1000 mg	17 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

Population: Only includes food challenge completer population

The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein AR101 baseline (mg) [2]	38.90 mg Standard Deviation 4.37	NA mg Standard Deviation NA 1. Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002 2. The single highest tolerated dose from the ARC001 exit DBPCFC was defined as the AR101 baseline for subjects in the ARC001 placebo group.
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein Up-dosing DBPCFC	501.2 mg Standard Deviation 1.55	524.8 mg Standard Deviation 1.32
Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein Maintenance DBPCFC	776.2 mg Standard Deviation 1.41	758.6 mg Standard Deviation 1.55

SECONDARY outcome

Timeframe: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

Population: Only includes food challenge completer population

The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Up-dosing DBPCFC · 100 mg	1 Participants	0 Participants
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Up-dosing DBPCFC · 300 mg	3 Participants	4 Participants
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Up-dosing DBPCFC · 600 mg	17 Participants	17 Participants
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Up-dosing DBPCFC · 1000 mg	NA Participants Not administer 1000 mg dose at Up-dosing DBPCFC.	NA Participants Not administer 1000 mg dose at Up-dosing DBPCFC.
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Maintenance DBPCFC · 100 mg	0 Participants	0 Participants
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Maintenance DBPCFC · 300 mg	1 Participants	3 Participants
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Maintenance DBPCFC · 600 mg	8 Participants	4 Participants
Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated Maintenance DBPCFC · 1000 mg	11 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

Population: The Safety Population (those who received any amount of AR101)

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance Baseline: Peanut-specific IgE	56.826 kU/L Standard Deviation 2.8864	NA kU/L Standard Deviation NA \[1\] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance Up-dosing: Peanut-specific IgE	59.145 kU/L Standard Deviation 2.9154	29.964 kU/L Standard Deviation 4.4817
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance Extended maintenance: Peanut-specific IgE	14.880 kU/L Standard Deviation 6.7531	10.381 kU/L Standard Deviation 4.0149
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance Change from baseline: Peanut-specific IgE	0.387 kU/L Standard Deviation 2.2479	NA kU/L Standard Deviation NA \[1\] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance Change from up-dosing: Peanut-specific IgE	0.364 kU/L Standard Deviation 2.8292	0.228 kU/L Standard Deviation 2.0544

SECONDARY outcome

Timeframe: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

Population: The Safety Population (those who received any amount of AR101)

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance Baseline: Peanut-specific IgG4	0.538 μg/mL Standard Deviation 2.4351	NA μg/mL Standard Deviation NA Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance Up-dosing: Peanut-specific IgG4	3.004 μg/mL Standard Deviation 3.8962	4.096 μg/mL Standard Deviation 3.9749
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance Extended maintenance: Peanut-specific IgG4	5.755 μg/mL Standard Deviation 3.6328	12.429 μg/mL Standard Deviation 2.8292
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance Change from baseline: Peanut-specific IgG4	12.429 μg/mL Standard Deviation 2.2705	NA μg/mL Standard Deviation NA Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance Change from up-dosing: Peanut-specific IgG4	1.682 μg/mL Standard Deviation 3.1268	2.746 μg/mL Standard Deviation 3.4556

SECONDARY outcome

Timeframe: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

Population: The Safety Population (those who received any amount of AR101)

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Peanut wheal diameter; baseline	11.8 millimeter Standard Deviation 6.29	NA millimeter Standard Deviation NA Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Peanut wheal diameter; up-dosing	8.6 millimeter Standard Deviation 4.62	6.6 millimeter Standard Deviation 3.04
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Peanut wheal diameter; extended maintenance	9.0 millimeter Standard Deviation 5.77	5.1 millimeter Standard Deviation 3.40
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Change from baseline: Peanut wheal diameter	-1.5 millimeter Standard Deviation 6.52	NA millimeter Standard Deviation NA Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Change from up-dosing: Peanut wheal diameter	-0.8 millimeter Standard Deviation 4.72	-0.7 millimeter Standard Deviation 2.98
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Peanut erythema/flare; baseline	37.6 millimeter Standard Deviation 17.69	NA millimeter Standard Deviation NA Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Peanut erythema/flare; up-dosing	26.8 millimeter Standard Deviation 12.05	21.8 millimeter Standard Deviation 8.76
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Peanut erythema/flare; extended maintenance	28.2 millimeter Standard Deviation 19.73	14.7 millimeter Standard Deviation 11.62
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Change from baseline: peanut erythema/flare	-8.7 millimeter Standard Deviation 15.35	NA millimeter Standard Deviation NA Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance Change from up-dosing: peanut erythema/flare	-1.8 millimeter Standard Deviation 11.55	-5.4 millimeter Standard Deviation 9.79

SECONDARY outcome

Timeframe: Up to 36 weeks for up-dosing

Population: Only subjects who completed the food challenge at each challenge dose during the Up-dosing DBPCFC were analyzed

Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=21 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 3 mg · None	11 Participants	18 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 3 mg · Mild	0 Participants	3 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 3 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 3 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 3 mg · Missing	10 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 10 mg · None	10 Participants	21 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 10 mg · Mild	1 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 10 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 10 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 10 mg · Missing	10 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 30 mg · None	10 Participants	20 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 30 mg · Mild	2 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 30 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 30 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 30 mg · Missing	9 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 100 mg · None	11 Participants	18 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 100 mg · Mild	1 Participants	3 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 100 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 100 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 100 mg · Missing	9 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 300 mg · None	7 Participants	20 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 300 mg · Mild	4 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 300 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 300 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 300 mg · Missing	10 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 600 mg · None	6 Participants	12 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 600 mg · Mild	6 Participants	5 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 600 mg · Moderate	0 Participants	4 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 600 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC 600 mg · Missing	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

Population: Only subjects who completed the food challenge at each challenge dose during the Maintenance DBPCFC were analyzed

Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=20 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=20 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 600 mg · Missing	11 Participants	9 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 3 mg · None	7 Participants	9 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 3 mg · Mild	0 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 3 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 3 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 3 mg · Missing	13 Participants	10 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 10 mg · None	6 Participants	9 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 10 mg · Mild	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 10 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 10 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 10 mg · Missing	14 Participants	11 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 30 mg · None	6 Participants	9 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 30 mg · Mild	0 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 30 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 30 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 30 mg · Missing	14 Participants	10 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 100 mg · None	6 Participants	9 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 100 mg · Mild	1 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 100 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 100 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 100 mg · Missing	13 Participants	11 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 300 mg · None	6 Participants	8 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 300 mg · Mild	0 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 300 mg · Moderate	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 300 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 300 mg · Missing	14 Participants	11 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 600 mg · None	7 Participants	7 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 600 mg · Mild	2 Participants	3 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 600 mg · Moderate	0 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 600 mg · Severe	0 Participants	0 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 1000 mg · None	5 Participants	7 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 1000 mg · Mild	7 Participants	4 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 1000 mg · Moderate	2 Participants	2 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 1000 mg · Severe	0 Participants	1 Participants
Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC 1000 mg · Missing	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

Population: The Safety Population (those who received any amount of AR101)

A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.

Outcome measures

Outcome measures
Measure	ARC001 Placebo Group n=26 Participants Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 Participants Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. Baseline	36.4 score on a scale Standard Deviation 24.31	NA score on a scale Standard Deviation NA \[1\] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. Up-dosing	34.9 score on a scale Standard Deviation 21.42	25.6 score on a scale Standard Deviation 17.78
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. Extended maintenance	27.5 score on a scale Standard Deviation 25.03	20.1 score on a scale Standard Deviation 12.61
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. Change from baseline	-26.30 score on a scale Standard Deviation 34.50	NA score on a scale Standard Deviation NA \[1\] Baseline values for ARC001 AR101 group were already summarized in ARC001 and were not re-summarized in ARC002
Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. Change from up-dosing	-20.00 score on a scale Standard Deviation 38.87	-15.5 score on a scale Standard Deviation 20.56

Adverse Events

ARC001 Placebo Group

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

ARC001 AR101 Group

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARC001 Placebo Group n=26 participants at risk Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	ARC001 AR101 Group n=21 participants at risk Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Immune system disorders Anaphylactic reaction	0.00% 0/26 • 90 weeks A multi-page adverse event form was used allowing all adverse events to be submitted through a single reporting mechanism. Study investigators will provide the Coordinating Center with data of all SAEs as defined per the protocol on an ongoing basis, within 24 h of site awareness of the event. The sponsor's Medical Monitor will review each SAE report and will determine whether the SAE must be reported to FDA on an expedited basis.	4.8% 1/21 • 90 weeks A multi-page adverse event form was used allowing all adverse events to be submitted through a single reporting mechanism. Study investigators will provide the Coordinating Center with data of all SAEs as defined per the protocol on an ongoing basis, within 24 h of site awareness of the event. The sponsor's Medical Monitor will review each SAE report and will determine whether the SAE must be reported to FDA on an expedited basis.

Other adverse events

Additional Information

Director of Regulatory Affairs

Aimmune Therapeutics, Inc.

Phone: 650-409-5164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * Institutions cannot publish until the multi-center sponsor publication is published * Or, institutions cannot publish until 18 months after study completion * And Sponsor review of any publications is required prior to any institution publications according to contractual agreements
Publication restrictions are in place

Restriction type: OTHER