Peanut AllergyPhase 3NCT03292484
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 93 sites in 10 countries.
Trial summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period. Read more about this study
- Who is it for?
- Ages 1 year to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- AR101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 911 participants
- Where
- 93 sitesin 10 countries
- Study dates
- 2 Nov 2017to 27 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
- Written informed consent and/or assent from subjects/guardians as appropriate
- Use of effective birth control by sexually active female subjects of childbearing potential
Who cannot join
- Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
- Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study
- Discontinued early from the parent study
Trial locations and contacts
93 sites in 10 countries.
93 sites in 10 countries
United States65 sites
Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
Ann Arbor, Michigan, 48106
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
'Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, 78723
Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, 78723
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236
Johns Hopkins Hospital, Pediatric Clinical Research Unit
Baltimore, Maryland, 21287
Alabama Allergy and Asthma Center
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Riley Children's Specialists
Carmel, Indiana, 46032
University of North Carolina at Chapel Hill, Clinical & Translational Research Center
Chapel Hill, North Carolina, 27599
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605
The University of Chicago Medicine, Comer Children's Hospital
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Columbia Asthma & Allergy Clinic
Clackamas, Oregon, 97015
Asthma & Allergy Associates
Colorado Springs, Colorado, 80907
Children's Health
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206
Colorado Allergy & Asthma Centers, P.C.
Denver, Colorado, 80230
Idaho Allergy and Research
Eagle, Idaho, 83616
Western Sky Medical Research
El Paso, Texas, 79903
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Northwell Health System
Great Neck, New York, 11021
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
Children's Mercy on Broadway
Kansas City, Missouri, 64111
Sher Allergy Specialists - Center for Cough
Largo, Florida, 33778
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Jonathan Corren, M.D., Inc.
Los Angeles, California, 90025
Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
Los Angeles, California, 90027
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, 30060
Le Bonheur Children's Hospital, Outpatient Bldg.
Memphis, Tennessee, 38105
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
Mountain View, California, 94040
Central Texas Health Research
New Braunfels, Texas, 78130
Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sneeze, Wheeze, & Itch Associates
Normal, Illinois, 61761
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408
Atlantic Research Center
Ocean City, New Jersey, 07712
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, 73131
Stanford University
Palo Alto, California, 94305
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Clinical Research Institute Inc.
Plymouth, Minnesota, 55441
Baker Allergy, Asthma and Dermatology
Portland, Oregon, 97223
Univ. of Rochester Medical Center, Golisano Children's Hosp.
Rochester, New York, 14642
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123
Rady Children's Hospital, Div. of Allergy & Immunology
San Diego, California, 92123
UCSF, Benioff Children's Hospital - Allergy and Immunology
San Francisco, California, 95148
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
Sarasota Clinical Research
Sarasota, Florida, 34239
Medical Research of Arizona, Allergy, Asthma & Immunology Associates
Scottsdale, Arizona, 85251
Virginia Mason Medical Center
Seattle, Washington, 98101
ASTHMA, Inc. Clinical Research Center
Seattle, Washington, 98115-2024
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
University of South Florida, Asthma Allergy & Immunology Clinical Research Unit
Tampa, Florida, 33613
Banner Univ. of Arizona Medical Center
Tucson, Arizona, 85724
Bay Area Allergy
Walnut Creek, California, 94598
Children's National Health System
Washington D.C., District of Columbia, 20010
United Kingdom8 sites
James Paget University Hospital
Gorleston-on-Sea, Norfolk, NR31 6LA
Leicester Royal infirmary
Leicester, Leicestershire, LE1 5WW
Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
London, SE1 7EH
St Mary's Hospital - Paediatric Research Unit
London, W2 1NY
Children's Clinical Research Facility, Royal Manchester Children's Hospital
Manchester, M13 9WL
Sheffield Children's Hospital
Sheffield, S10 2TH
University Hospitals Southampton Foundation NHS Trust
Southampton, SO16 6YD
Central Manchester University Hospitals
Wythenshawe, M23 9LT
Canada5 sites
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5
Triple A Lab
Hamilton, Ontario, L8S 1G5
Cheema Research Inc.
Mississauga, Ontario, L5A 3V4
Ottawa Allergy Research Corp
Ottawa, Ontario, K1G 6C6
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2
France4 sites
Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
Bordeaux, Cedex, 33076
Hopital Saint Vincent de Paul- Service d'Allergologie
Lille, Cedex, 59020
Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
Lille, Cedex, 59037
Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
Strasbourg, Cedex, 67091
Spain3 sites
Hospital General Universitario Gregorio Marañón
Madrid, 28007
H. Infantil Universitario Niño Jesús, Servicio de Alergia
Madrid, 28009
Madrid Hospital Clinico San Carlos, Servicio de Alergia
Madrid, 28040
Germany2 sites
Charité Universitaetsmedizin Berlin
Berlin, 13353
University of Frankfurt
Frankfurt, 60590
Ireland2 sites
Cork University Hospital, UCC Department of Paediatrics and Child Health
Cork, T12 DC4A
National Children's Research Centre, Our Lady's Children's Hospital Crumlin
Dublin, D12 V004
Netherlands2 sites
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, 9700 RB
University Medical Center Groningen
Groningen, 9713 GZ
About this study
Official title: A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Read the detailed description
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.
- Conditions
- Peanut Allergy
- Being tested
- AR101
- Keywords
- AR101, Characterized Peanut Allergen, OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, CPNA (Characterized Peanut Allergen)
- Medical subject headings
- Peanut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR101Biological
AR101
| Study group | Role | What they receive |
|---|---|---|
| AR101 | Experimental | 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). Receives: Biological: AR101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose of study drug through 30 days after last dose of study drug, up to 59 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start2 Nov 2017
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jen Garcia, Study chair, Director, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292484
- Sponsor's protocol ID
- ARC008
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2017
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
PubMed 34389504Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
PubMed 34320250
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study
- ClinicalTrials.gov ID
- NCT03292484
- Acronym / sponsor ID
- ARC008
- Conditions
- Peanut Allergy
- Keywords
- AR101, Characterized Peanut Allergen, OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AR101 | Experimental | Biological: AR101Eligible 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). |
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
- Written informed consent and/or assent from subjects/guardians as appropriate
- Use of effective birth control by sexually active female subjects of childbearing potential
Key exclusion criteria (3 listed)
- Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
- Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study
- Discontinued early from the parent study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR101AR101 | Biological | AR101 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: 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.
Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs
Time frame: 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 Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs
Time frame: 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.
Number of Participants With TEAEs That Led to a Change in Treatment Regimen
Time frame: 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.
Number of Participants With TEAEs That Led to Early Withdrawal
Time frame: 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 Who Experienced a Treatment-emergent Anaphylactic Reaction
Time frame: 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.
Number of Participants With Use of Epinephrine as a Rescue Medication
Time frame: 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.
Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes
Time frame: 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.
Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods
Time frame: 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.
Number of Participants With Eosinophilic Esophagitis (EoE)
Time frame: 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.
3 secondary outcomes
Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC)
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
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
Time frame: OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34389504Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
- Derived from this study: PubMed 34320250Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen Garcia study chair
Director, Clinical Operations
93 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 93 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, United Kingdom, Canada, France, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292484, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.