Peanut AllergyPhase 3NCT03337542

AR101 Real-World Open-Label Extension Study

A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 60 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study. Read more about this study

Who is it for?: Ages 4 to 17 years
Conditions the study is for: Peanut Allergy
What is being tested?: AR101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 60 sitesin 2 countries
Study dates: 18 Oct 2017to 20 Sep 2019
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 4 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Received AR101 in study ARC007
Completed the ARC007 study
Use of effective birth control by sexually active female subjects of childbearing potential

Who cannot join

Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
Currently in the build-up phase of immunotherapy for any nonfood allergen.
Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

Trial locations and contacts

60 sites in 2 countries.

Country

City, postcode or hospital

60 sites in 2 countries

United States55 sites

University of Michigan Division of Allergy and Clinical Immunology
Ann Arbor, Michigan, 48106
Children's Hospital Colorado
Aurora, Colorado, 80045
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
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
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
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 Downtown
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
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, 30060
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital
Mountain View, California, 94040
Sneeze, Wheeze, & Itch Associates, LLC
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, LLC
Oklahoma City, Oklahoma, 73131
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441
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. Allergy & Immunology, UC San Diego
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 Windom Allergy, Asthma and Sinus
Sarasota, Florida, 34239
Medical Research of Arizona
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, and Immunology Clinical Research Unit
Tampa, Florida, 33613
Banner University of Arizona Medical Center
Tucson, Arizona, 85724
Bay Area Allergy
Walnut Creek, California, 94598
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Canada5 sites

McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5
Triple A Lab / Hamilton Allergy
Hamilton, Ontario, L8S 1G5
Cheema Research Inc. (CRI)
Mississauga, Ontario, L5A 3V4
Ottawa Allergy Research Corp
Ottawa, Ontario, K1G 6C6
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2

Other trials in Canada

About this study

Official title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Read the detailed description

This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.

Conditions: Peanut Allergy
Being tested: AR101
Keywords: AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, Food Allergy
Medical subject headings: Peanut Hypersensitivity, Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AR101Biological
AR101

Study groups in NCT03337542
Study group	Role	What they receive
Treatment arm description	Other	Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance. 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 (Safety and Tolerability)
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
Measured: Approximately 6 months

Secondary outcomes (10)

Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
Measured: Approximately 6 months
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Measured: Approximately 6 months
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Measured: Approximately 6 months
Number of Participants With Allergic Hypersensitivity Adverse Events
Measured: Approximately 6 months
Number of Participants With of Anaphylaxis as Defined in the Protocol
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence).
2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain).
3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or > 30% drop in systolic BP; Adults: systolic BP < 90 mm Hg or > 30% drop from their baseline.
Measured: Approximately 6 months
Number of Participants With Epinephrine Use as Rescue Medication
Measured: Approximately 6 months
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Measured: Approximately 6 months
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11
The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).
Measured: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17
The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).
Measured: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Number of Participants With Adverse Events That Led to Early Withdrawal
Measured: Approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 201720 Sep 2019

First posted9 Nov 2017
Study start18 Oct 2017
Primary completion20 Sep 2019
Study completion20 Sep 2019

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 (1)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: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03337542
Sponsor's protocol ID: ARC011
Status last verified: Oct 2021
First submitted: 6 Nov 2017
Last updated: 2 Nov 2021
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 34389504

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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Not yet recruitingPhase 2
UNC Cashew Sublingual Immunotherapy
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All Peanut Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
ClinicalTrials.gov ID: NCT03337542
Acronym / sponsor ID: ARC011
Conditions: Peanut Allergy
Keywords: AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, Food Allergy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 18 Oct 2017 (actual)
Primary completion: 20 Sep 2019 (actual)
Study completion: 20 Sep 2019 (actual)
First posted: 9 Nov 2017 (actual)
Results: Posted 2 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment arm description	Other	Biological: AR101Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Received AR101 in study ARC007
Completed the ARC007 study
Use of effective birth control by sexually active female subjects of childbearing potential

Key exclusion criteria (4 listed)

Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
Currently in the build-up phase of immunotherapy for any nonfood allergen.
Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

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	Treatment arm description

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Approximately 6 months
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)

10 secondary outcomes

Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
Time frame: Approximately 6 months
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Time frame: Approximately 6 months
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Time frame: Approximately 6 months
Number of Participants With Allergic Hypersensitivity Adverse Events
Time frame: Approximately 6 months
Number of Participants With of Anaphylaxis as Defined in the Protocol
Time frame: Approximately 6 months
Number of Participants With Epinephrine Use as Rescue Medication
Time frame: Approximately 6 months
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
Time frame: Approximately 6 months
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11
Time frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17
Time frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Number of Participants With Adverse Events That Led to Early Withdrawal
Time frame: Approximately 6 months

Results and safety

Results posted to the registry on 2 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AR101	243	222

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)

Time frame: Approximately 6 months. Count of participants. Unit: Participants

Measure	AR101 n = 242
Subjects with at least 1 Adverse Event (AE)	219
Mild AE	176
Moderate AE	43
Severe AE	0
Life-threatening AE	0
Death AE	0
Subjects with at least 1 Serious Adverse Event (SAE)	1
Mild SAE	0

Population analysed: Safety population defined as all subjects who received at least 1 dose of AR101.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm Description	1 of 242 (0.4%)	219 of 242 (90.5%)	0 of 242

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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.
Individual participant dataSharing planned: No

Related trials for Peanut Allergy

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
Not yet recruitingPhase 2
UNC Cashew Sublingual Immunotherapy
Cashew Nut Allergy, Tree Nut Allergies

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.

Director of Regulatory Affairs study director

Aimmune Therapeutics

60 sites in 2 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 60 sites in 2 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 4 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Canada. 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 2 Nov 2021). 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 (Safety and Tolerability) (time frame: Approximately 6 months). 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 NCT03337542, which also lists 1 linked publication.

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 2 Nov 2021.