Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

November 29, 2024 updated by: Aimmune Therapeutics, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
911

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Center
      • Hamilton, Ontario, Canada, L8S 1G5
        • Triple A Lab
      • Mississauga, Ontario, Canada, L5A 3V4
        • Cheema Research Inc.
      • Ottawa, Ontario, Canada, K1G 6C6
        • Ottawa Allergy Research Corp
      • Toronto, Ontario, Canada, M4V 1R2
        • Gordon Sussman Clinical Research
  • France
    • Cedex
      • Bordeaux, Cedex, France, 33076
        • Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants
      • Lille, Cedex, France, 59020
        • Hopital Saint Vincent de Paul- Service d'Allergologie
      • Lille, Cedex, France, 59037
        • Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center
      • Strasbourg, Cedex, France, 67091
        • Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitaetsmedizin Berlin
      • Frankfurt, Germany, 60590
        • University of Frankfurt
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Cork University Hospital, UCC Department of Paediatrics and Child Health
      • Dublin, Ireland, D12 V004
        • National Children's Research Centre, Our Lady's Children's Hospital Crumlin
  • Italy
    • Province Of Padua
      • Padova, Province Of Padua, Italy, 35128
        • Azienda Ospedaliera di Padova
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Groningen, Netherlands, 9700 RB
        • Beatrix Children's Hospital, University Medical Center Groningen
  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28009
        • H. Infantil Universitario Niño Jesús, Servicio de Alergia
      • Madrid, Spain, 28040
        • Madrid Hospital Clinico San Carlos, Servicio de Alergia
  • Sweden
      • Stockholm, Sweden, 118 83
        • Sachsska Children and Youth Hospital
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guy & St Thomas' NHS Foundation Trust, Children Allergies Department
      • London, United Kingdom, W2 1NY
        • St Mary's Hospital - Paediatric Research Unit
      • Manchester, United Kingdom, M13 9WL
        • Children's Clinical Research Facility, Royal Manchester Children's Hospital
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's Hospital
      • Southampton, United Kingdom, SO16 6YD
        • University Hospitals Southampton Foundation NHS Trust
      • Wythenshawe, United Kingdom, M23 9LT
        • Central Manchester University Hospitals
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
    • Norfolk
      • Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA
        • James Paget University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Alabama Allergy and Asthma Center
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Medical Research of Arizona, Allergy, Asthma & Immunology Associates
      • Tucson, Arizona, United States, 85724
        • Banner Univ. of Arizona Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Los Angeles, California, United States, 90025
        • Jonathan Corren, M.D., Inc.
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy
      • Mission Viejo, California, United States, 92691
        • Allergy & Asthma Associates of Southern California
      • Mountain View, California, United States, 94040
        • Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital
      • Palo Alto, California, United States, 94305
        • Stanford University
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group and Research Center
      • San Diego, California, United States, 92123
        • Rady Children's Hospital, Div. of Allergy & Immunology
      • San Francisco, California, United States, 95148
        • UCSF, Benioff Children's Hospital - Allergy and Immunology
      • San Jose, California, United States, 95117
        • Allergy & Asthma Associates of Santa Clara Valley Research Center
      • Santa Monica, California, United States, 90404
        • UCLA Medical Center, Santa Monica
      • Walnut Creek, California, United States, 94598
        • Bay Area Allergy
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Asthma & Allergy Associates
      • Denver, Colorado, United States, 80206
        • National Jewish Health
      • Denver, Colorado, United States, 80230
        • Colorado Allergy & Asthma Centers, P.C.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System
    • Florida
      • Largo, Florida, United States, 33778
        • Sher Allergy Specialists - Center for Cough
      • North Palm Beach, Florida, United States, 33408
        • Allergy Associates of the Palm Beaches
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
      • Tampa, Florida, United States, 33613
        • University of South Florida, Asthma Allergy & Immunology Clinical Research Unit
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta
      • Marietta, Georgia, United States, 30060
        • Atlanta Allergy & Asthma Clinic
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Idaho Allergy and Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine, Comer Children's Hospital
      • Chicago, Illinois, United States, 60611-2605
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze, & Itch Associates
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Riley Children's Specialists
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Family Allergy & Asthma Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Chesapeake Clinical Research, Inc.
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital, Pediatric Clinical Research Unit
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute Inc.
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Children's Mercy on Broadway
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Atlantic Research Center
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health System
      • New York, New York, United States, 10029
        • Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14642
        • Univ. of Rochester Medical Center, Golisano Children's Hosp.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Clinical & Translational Research Center
      • Charlotte, North Carolina, United States, 28277
        • Clinical Research of Charlotte
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73131
        • Oklahoma Institute of Allergy and Asthma Clinical Research
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Columbia Asthma & Allergy Clinic
      • Portland, Oregon, United States, 97223
        • Baker Allergy, Asthma and Dermatology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • National Allergy and Asthma Research, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Le Bonheur Children's Hospital, Outpatient Bldg.
    • Texas
      • Austin, Texas, United States, 78723
        • Specially for Children Allergy, Asthma and Immunology Clinic
      • Austin, Texas, United States, 78723
        • 'Specially for Children Allergy, Asthma and Immunology Clinic
      • Dallas, Texas, United States, 75235
        • Children's Health
      • El Paso, Texas, United States, 79903
        • Western Sky Medical Research
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital, Baylor College of Medicine
      • New Braunfels, Texas, United States, 78130
        • Central Texas Health Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98115-2024
        • ASTHMA, Inc. Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AR101
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
AR101

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)
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.
From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aimmune Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jen Garcia, Director, Clinical Operations

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARC008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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