Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With TEAEs That Led to a Change in Treatment Regimen	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With TEAEs That Led to Early Withdrawal	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With Use of Epinephrine as a Rescue Medication	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	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.
Primary	Number of Participants With Eosinophilic Esophagitis (EoE)	From first dose of study drug through 30 days after last dose of study drug, up to 59 months	EoE was diagnosed by biopsy/endoscopy.
Secondary	Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)	OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)	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.
Secondary	Maximum Tolerated Challenge Dose at Each Food Challenge	OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)	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.
Secondary	Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges	OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)	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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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