Trial Outcomes & Findings for Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) (NCT NCT03292484)
NCT ID: NCT03292484
Last Updated: 2024-12-19
Results Overview
An AE was any untoward medical occurrence in humans, whether or not considered related to the investigational product (IP), that occurred during the conduct of a clinical study. A SAE was any event that resulted in any of the following: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital abnormality or birth defect, or important medical event that did not result in one of the above outcomes, but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed above. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
COMPLETED
PHASE3
911 participants
From first dose of study drug through 30 days after last dose of study drug, up to 59 months
2024-12-19
Participant Flow
This Phase 3, open-label study was conducted in participants who participated in a prior AR101 study at 89 investigational sites in 10 countries (Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, and the United States).
A total of 911 participants were enrolled in this study. After enrolling in ARC008, all participants received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 milligrams (mg) per day.
Participant milestones
| Measure |
AR101
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Overall Study
STARTED
|
911
|
|
Overall Study
Safety Population
|
908
|
|
Overall Study
Participants Who Had an Open-label Food Challenge (OLFC)
|
517
|
|
Overall Study
Participants Who Had a Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
|
211
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
893
|
Reasons for withdrawal
| Measure |
AR101
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Overall Study
Participants did not have Disposition - Study Exit forms
|
415
|
|
Overall Study
Withdrew consent (unrelated to adverse event [AE])
|
86
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Investigator decision (unrelated to AE)
|
13
|
|
Overall Study
Sponsor decision
|
349
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Coronavirus Disease 2019
|
1
|
|
Overall Study
Other
|
20
|
Baseline Characteristics
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Baseline characteristics by cohort
| Measure |
AR101
n=911 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Age, Continuous
|
9.8 years
STANDARD_DEVIATION 4.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
552 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
842 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
664 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple Races Reported
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Collected
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An AE was any untoward medical occurrence in humans, whether or not considered related to the investigational product (IP), that occurred during the conduct of a clinical study. A SAE was any event that resulted in any of the following: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital abnormality or birth defect, or important medical event that did not result in one of the above outcomes, but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed above. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
866 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
42 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs
|
53 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Gastrointestinal (GI) AEs, typically chronic/recurrent GI AEs, that resulted in prolonged interruption of dosing are reported.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs
|
25 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Number of participants with TEAEs requiring dose interruption and dose reduction of study treatment are reported.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With TEAEs That Led to a Change in Treatment Regimen
TEAEs requiring dose interruption of study treatment
|
669 Participants
|
|
Number of Participants With TEAEs That Led to a Change in Treatment Regimen
TEAEs requiring dose reduction of study treatment
|
167 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With TEAEs That Led to Early Withdrawal
|
27 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
Anaphylaxis was defined by a number of signs and symptoms that occurred alone or in combination within minutes up to a few hours after exposure to a provoking agent. Treatment-emergent anaphylactic reactions included anaphylactic reactions that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding anaphylactic reactions that occurred during or related to a food challenge.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction
|
192 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With Use of Epinephrine as a Rescue Medication
|
234 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food challenge.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes
Accidental Food Allergy Episodes
|
208 Participants
|
|
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes
Non-accidental Food Allergy Episodes
|
35 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food challenge.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods
|
227 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 monthsPopulation: The safety population consisted of all participants who received AR101 during ARC008.
EoE was diagnosed by biopsy/endoscopy.
Outcome measures
| Measure |
AR101
n=908 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With Eosinophilic Esophagitis (EoE)
|
7 Participants
|
SECONDARY outcome
Timeframe: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)Population: The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported.
During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.
Outcome measures
| Measure |
AR101
n=517 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
OLFC: Tolerated a single highest dose of at least 300 mg
|
98.6 percentage of participants
Interval 97.2 to 99.5
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
OLFC: Tolerated a single highest dose of at least 600 mg
|
94.2 percentage of participants
Interval 91.8 to 96.1
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
OLFC: Tolerated a single highest dose of at least 1000 mg
|
78.7 percentage of participants
Interval 74.9 to 82.2
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
OLFC: Tolerated a single highest dose of at least 2000 mg
|
55.9 percentage of participants
Interval 51.5 to 60.2
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 3 mg
|
100.0 percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 10 mg
|
100.0 percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 30 mg
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 100 mg
|
99.1 percentage of participants
Interval 96.6 to 99.9
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 300 mg
|
94.8 percentage of participants
Interval 90.9 to 97.4
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 600 mg
|
88.2 percentage of participants
Interval 83.0 to 92.2
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 1000 mg
|
75.8 percentage of participants
Interval 69.5 to 81.4
|
|
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
DBPCFC: Tolerated a single highest dose of at least 2000 mg
|
60.2 percentage of participants
Interval 53.2 to 66.8
|
SECONDARY outcome
Timeframe: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)Population: The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported.
The maximum tolerated challenge dose for a food challenge was defined as the maximum single dose of peanut protein resulting in no more than mild symptoms and assessed by the investigator to have been tolerated (i.e., the participant did not experience any dose-limiting symptoms). During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.
Outcome measures
| Measure |
AR101
n=517 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Maximum Tolerated Challenge Dose at Each Food Challenge
OLFC
|
2000 mg
|
|
Maximum Tolerated Challenge Dose at Each Food Challenge
DBPCFC
|
2000 mg
|
SECONDARY outcome
Timeframe: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)Population: The safety population consisted of all participants who received AR101 during ARC008. Only those participants who had an OLFC or a DBPCFC are reported.
Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice. During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.
Outcome measures
| Measure |
AR101
n=517 Participants
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges
OLFC
|
110 Participants
|
|
Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges
DBPCFC
|
35 Participants
|
Adverse Events
AR101
Serious adverse events
| Measure |
AR101
n=908 participants at risk
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.88%
8/908 • Number of events 8 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Croup infectious
|
0.22%
2/908 • Number of events 2 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Enterovirus infection
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Gastroenteritis
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Gastroenteritis viral
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Influenza
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Meningitis
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Meningitis viral
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Pneumonia
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Rhinovirus infection
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Sinusitis
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Viral infection
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Immune system disorders
Anaphylactic reaction
|
0.88%
8/908 • Number of events 8 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
4/908 • Number of events 4 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
2/908 • Number of events 2 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Oral disorder
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.22%
2/908 • Number of events 2 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
General disorders
Pyrexia
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.11%
1/908 • Number of events 1 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
Other adverse events
| Measure |
AR101
n=908 participants at risk
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 mg per day until discontinuation criteria was met (maximum exposure: 4.8 years).
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
24.3%
221/908 • Number of events 474 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.5%
213/908 • Number of events 421 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Viral infection
|
15.7%
143/908 • Number of events 250 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Influenza
|
11.9%
108/908 • Number of events 134 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
COVID-19
|
11.2%
102/908 • Number of events 114 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Gastroenteritis viral
|
9.9%
90/908 • Number of events 117 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Gastroenteritis
|
9.7%
88/908 • Number of events 118 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Rhinitis
|
8.4%
76/908 • Number of events 171 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
54/908 • Number of events 79 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.9%
54/908 • Number of events 69 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Ear infection
|
5.5%
50/908 • Number of events 56 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Infections and infestations
Sinusitis
|
5.2%
47/908 • Number of events 60 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Vomiting
|
32.3%
293/908 • Number of events 769 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Abdominal pain
|
29.8%
271/908 • Number of events 2212 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Nausea
|
20.2%
183/908 • Number of events 1122 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
19.1%
173/908 • Number of events 684 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.3%
166/908 • Number of events 1028 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
127/908 • Number of events 272 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Oral pruritus
|
9.7%
88/908 • Number of events 739 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Lip swelling
|
7.5%
68/908 • Number of events 158 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
6.5%
59/908 • Number of events 1215 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Lip pruritus
|
5.8%
53/908 • Number of events 253 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
51/908 • Number of events 173 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
302/908 • Number of events 949 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
18.6%
169/908 • Number of events 2368 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.2%
165/908 • Number of events 363 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.0%
145/908 • Number of events 317 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
13.0%
118/908 • Number of events 413 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.6%
114/908 • Number of events 272 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.8%
107/908 • Number of events 287 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.4%
85/908 • Number of events 160 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
9.4%
85/908 • Number of events 466 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.6%
60/908 • Number of events 105 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.5%
59/908 • Number of events 131 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
5.5%
50/908 • Number of events 71 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
27.6%
251/908 • Number of events 862 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.0%
191/908 • Number of events 827 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
121/908 • Number of events 182 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.1%
74/908 • Number of events 143 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.2%
65/908 • Number of events 125 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
General disorders
Pyrexia
|
32.3%
293/908 • Number of events 597 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
General disorders
Illness
|
6.7%
61/908 • Number of events 118 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Nervous system disorders
Headache
|
26.4%
240/908 • Number of events 816 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Immune system disorders
Anaphylactic reaction
|
20.6%
187/908 • Number of events 334 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Immune system disorders
Seasonal allergy
|
5.5%
50/908 • Number of events 87 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Eye disorders
Eye pruritus
|
9.1%
83/908 • Number of events 163 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
|
Ear and labyrinth disorders
Ear pain
|
5.2%
47/908 • Number of events 65 • From first dose of study drug through 30 days after last dose of study drug, up to 59 months
The safety population consisted of all participants who received AR101 during ARC008.
|
Additional Information
Jay Patel
Aimmune Therapeutics, a Nestlé Health Science Company
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