Trial · NCT03292484
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
NCT03292484, Phase 3, Completed, Aimmune Therapeutics, Inc.; results first posted 2024-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008). Trials, record NCT03292484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292484
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
- NCT number
- NCT03292484
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 911 participants, actual
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Conditions
- Peanut Allergy
- Interventions
- AR101
- First posted
- 2017-09-25
- Last updated
- 2024-12-19
- Results first posted
- 2024-12-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The safety population consisted of all participants who received AR101 during ARC008. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | AR101 | TEAEs | 866 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | AR101 | TESAEs | 42 | Participants | |
| Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs | AR101 | 53 | Participants | ||
| Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs | AR101 | 25 | Participants | ||
| Number of Participants With TEAEs That Led to a Change in Treatment Regimen | AR101 | TEAEs requiring dose interruption of study treatment | 669 | Participants | |
| Number of Participants With TEAEs That Led to a Change in Treatment Regimen | AR101 | TEAEs requiring dose reduction of study treatment | 167 | Participants | |
| Number of Participants With TEAEs That Led to Early Withdrawal | AR101 | 27 | Participants | ||
| Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction | AR101 | 192 | Participants | ||
| Number of Participants With Use of Epinephrine as a Rescue Medication | AR101 | 234 | Participants | ||
| Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes | AR101 | Accidental Food Allergy Episodes | 208 | Participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AR101 | 911 | |
| Overall Study | Safety Population | AR101 | 908 | |
| Overall Study | Participants Who Had an Open-label Food Challenge (OLFC) | AR101 | 517 | |
| Overall Study | Participants Who Had a Double-blind, Placebo-Controlled Food Challenge (DBPCFC) | AR101 | 211 | |
| Overall Study | COMPLETED | AR101 | 18 | |
| Overall Study | NOT COMPLETED | AR101 | 893 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | AR101 | 221 | 908 | 474 |
| other | Upper respiratory tract infection | Infections and infestations | AR101 | 213 | 908 | 421 |
| other | Viral infection | Infections and infestations | AR101 | 143 | 908 | 250 |
| other | Influenza | Infections and infestations | AR101 | 108 | 908 | 134 |
| other | COVID-19 | Infections and infestations | AR101 | 102 | 908 | 114 |
| other | Gastroenteritis viral | Infections and infestations | AR101 | 90 | 908 | 117 |
| other | Gastroenteritis | Infections and infestations | AR101 | 88 | 908 | 118 |
| other | Rhinitis | Infections and infestations | AR101 | 76 | 908 | 171 |
| other | Conjunctivitis | Infections and infestations | AR101 | 54 | 908 | 79 |
| other | Pharyngitis streptococcal | Infections and infestations | AR101 | 54 | 908 | 69 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AR101 | 0 | 908 |
| Total, other adverse events | AR101 | 865 | 908 |
| Total, serious adverse events | AR101 | 42 | 908 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03292484
GET https://conductscience.org/api/trials/v1/NCT03292484/results?page=2