A Phase 3 interventional study of AR101 in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc.. Completed at 93 sites in 10 countries. Open to participants aged 1 Year to 55 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Aimmune Therapeutics, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 911 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Aimmune Therapeutics, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants who participated in a prior AR101 study received or continued initial dose escalation, up-dosing, and maintenance of AR101 at 300 milligrams (mg) per day until discontinuation criteria was met (maximum exposure: 4.8 years).
Biological: AR101
Drug pages: Panobacumab · Iclaprim, (r)-
AR101
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs That Led to a Change in Treatment Regimen
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs That Led to Early Withdrawal
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Use of Epinephrine as a Rescue Medication
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods
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.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Number of Participants With Eosinophilic Esophagitis (EoE)
EoE was diagnosed by biopsy/endoscopy.
Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
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.
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Maximum Tolerated Challenge Dose at Each Food Challenge
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.
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges
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.
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
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).
| Milestone | AR101 |
|---|---|
| Started | 911 |
| Safety population | 908 |
| Participants who had an open-label food challenge (olfc) | 517 |
| Participants who had a double-blind, placebo-controlled food challenge (dbpcfc) | 211 |
| Completed | 18 |
| Not completed | 893 |
| Withdrew: Participants did not have disposition - study exit forms | 415 |
| Withdrew: Withdrew consent (unrelated to adverse event [ae]) | 86 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Investigator decision (unrelated to ae) | 13 |
| Withdrew: Sponsor decision | 349 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Coronavirus disease 2019 | 1 |
| Withdrew: Other | 20 |
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.
| Participants | AR101 |
|---|---|
| TEAEs | 866 |
| TESAEs | 42 |
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.
| Participants | AR101 |
|---|---|
| Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs | 53 |
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.
| Participants | AR101 |
|---|---|
| Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs | 25 |
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.
| Participants | AR101 |
|---|---|
| TEAEs requiring dose interruption of study treatment | 669 |
| TEAEs requiring dose reduction of study treatment | 167 |
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.
| Participants | AR101 |
|---|---|
| Number of Participants With TEAEs That Led to Early Withdrawal | 27 |
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.
| Participants | AR101 |
|---|---|
| Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction | 192 |
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.
| Participants | AR101 |
|---|---|
| Number of Participants With Use of Epinephrine as a Rescue Medication | 234 |
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.
| Participants | AR101 |
|---|---|
| Accidental Food Allergy Episodes | 208 |
| Non-accidental Food Allergy Episodes | 35 |
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.
| Participants | AR101 |
|---|---|
| Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods | 227 |
EoE was diagnosed by biopsy/endoscopy.
| Participants | AR101 |
|---|---|
| Number of Participants With Eosinophilic Esophagitis (EoE) | 7 |
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.
| percentage of participants | AR101 |
|---|---|
| OLFC: Tolerated a single highest dose of at least 300 mg | 98.6 (97.2 to 99.5) |
| OLFC: Tolerated a single highest dose of at least 600 mg | 94.2 (91.8 to 96.1) |
| OLFC: Tolerated a single highest dose of at least 1000 mg | 78.7 (74.9 to 82.2) |
| OLFC: Tolerated a single highest dose of at least 2000 mg | 55.9 (51.5 to 60.2) |
| DBPCFC: Tolerated a single highest dose of at least 3 mg | 100.0 (98.3 to 100.0) |
| DBPCFC: Tolerated a single highest dose of at least 10 mg | 100.0 (98.3 to 100.0) |
| DBPCFC: Tolerated a single highest dose of at least 30 mg | 99.5 (97.4 to 100.0) |
| DBPCFC: Tolerated a single highest dose of at least 100 mg | 99.1 (96.6 to 99.9) |
| DBPCFC: Tolerated a single highest dose of at least 300 mg | 94.8 (90.9 to 97.4) |
| DBPCFC: Tolerated a single highest dose of at least 600 mg | 88.2 (83.0 to 92.2) |
| DBPCFC: Tolerated a single highest dose of at least 1000 mg | 75.8 (69.5 to 81.4) |
| DBPCFC: Tolerated a single highest dose of at least 2000 mg | 60.2 (53.2 to 66.8) |
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.
| mg | AR101 |
|---|---|
| OLFC | 2000 |
| DBPCFC | 2000 |
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.
| Participants | AR101 |
|---|---|
| OLFC | 110 |
| DBPCFC | 35 |
Collected over From first dose of study drug through 30 days after last dose of study drug, up to 59 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AR101 | 0/908 (0%) | 42/908 (4.6%) | 865/908 (95.3%) |
| Event | AR101 |
|---|---|
| AppendicitisInfections and infestations | 8/908 |
| Anaphylactic reactionImmune system disorders | 8/908 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/908 |
| Croup infectiousInfections and infestations | 2/908 |
| Abdominal painGastrointestinal disorders | 2/908 |
| ConcussionInjury, poisoning and procedural complications | 2/908 |
| Enterovirus infectionInfections and infestations | 1/908 |
| GastroenteritisInfections and infestations | 1/908 |
| Gastroenteritis viralInfections and infestations | 1/908 |
| InfluenzaInfections and infestations | 1/908 |
| Event | AR101 |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 302/908 |
| VomitingGastrointestinal disorders | 293/908 |
| PyrexiaGeneral disorders | 293/908 |
| Abdominal painGastrointestinal disorders | 271/908 |
| UrticariaSkin and subcutaneous tissue disorders | 251/908 |
| HeadacheNervous system disorders | 240/908 |
| NasopharyngitisInfections and infestations | 221/908 |
| Upper respiratory tract infectionInfections and infestations | 213/908 |
| PruritusSkin and subcutaneous tissue disorders | 191/908 |
| Anaphylactic reactionImmune system disorders | 187/908 |
Analysis was performed on all enrolled participants.
| Age, Continuous(years) | AR101 |
|---|---|
| Mean | 9.8 ± 4.75 |
| Sex: Female, Male(Participants) | AR101 |
|---|---|
| Female | 359 |
| Male | 552 |
| Ethnicity (NIH/OMB)(Participants) | AR101 |
|---|---|
| Hispanic or Latino | 38 |
| Not Hispanic or Latino | 842 |
| Unknown or Not Reported | 31 |
| Race/Ethnicity, Customized(Participants) | AR101 |
|---|---|
| Asian | 106 |
| Black or African American | 18 |
| Native Hawaiian or Other Pacific Islander | 3 |
| White | 664 |
| Other | 65 |
| Multiple Races Reported | 53 |
| Not Collected | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Apr 2023, 65 months.
Results were first posted in Dec 2024, 1 year 7 months after primary completion.
Of 15 phase 3 interventional studies under Peanut Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 42. This study's 65 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Panobacumab · Iclaprim, (r)-
Aimmune Therapeutics, Inc.