Peanut AllergyPhase 3RAMSESNCT03126227
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 67 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children. 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?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 67 sitesin 2 countries
- Study dates
- 8 May 2017to 23 Sep 2018
- 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
- Ages 4 to 17 years, inclusive
- History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
- Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
- Written informed consent from the subject's parent/guardian
- Written assent from the subject as appropriate (per local regulatory requirements)
- Use of effective birth control by sexually active female subjects of childbearing potential
Who cannot join
- Subjects in whom the clinical diagnosis of peanut allergy is uncertain
- Severe or uncontrolled asthma
- History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
- History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
- History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
United States62 sites
University of Michigan Health System / Michigan Medicine
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic
Austin, Texas, 78723
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236
Johns Hopkins Hospital, Pediatric Clinical Research Unit
Baltimore, Maryland, 21287
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, 68123
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 (CTRC)
Chapel Hill, North Carolina, 27599
National Allergy and Asthma Research, LLC
Charleston, North Carolina, 29420
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Ann & Robert H. Lurie's 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, PC
Colorado Springs, Colorado, 80907
Children's Health
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206-2761
Colorado Allergy & Asthma Centers
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
University of Iowa
Iowa City, Iowa, 52242
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, PA
Marietta, Georgia, 30060
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
Mountain View, California, 94040
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, 73131
Children's Hospital of Philadelphia: Allergy/Immunology
Philadelphia, Pennsylvania, 19104
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441
Baker Allergy, Asthma and Dermatology Research Center
Portland, Oregon, 97223
University of Rochester Medical Center
Rochester, New York, 14642
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
Biogenics Research Institute
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, 92123
Rady Children's Hospital San Diego
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94158
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
Scottsdale, Arizona, 85251
Virginia Mason Medical Center
Seattle, Washington, 98101
ASTHMA Inc. Clinical Research Center
Seattle, Washington, 98115
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
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
Children's National Health System
Washington D.C., District of Columbia, 20010
Canada5 sites
Triple A Lab (Hamilton Allergy)
Hamilton, Ontario, L8S 1G5
McMaster University Medical Center
Hamilton, Ontario, L8S 4K1
Cheema Research Inc. (CRI)
Mississauga, Ontario, L5A 3V4
Ottawa Allergy Research Corp.
Ottawa, Ontario, K1G 6C6
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2
About this study
Official title: Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES)
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
Read the detailed description
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.
- Conditions
- Peanut Allergy
- Being tested
- AR101, Placebo
- Keywords
- AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARC007, Characterized Oral Desensitization Immunotherapy (CODIT™)
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR101Biological
AR101 powder provided in capsules
PlaceboBiological
Placebo powder provided in capsules
| Study group | Role | What they receive |
|---|---|---|
| AR101 Powder Provided in Capsules | Active comparator | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol Receives: Biological: AR101 |
| Placebo powder | Placebo comparator | Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period.
Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.
Measured: Approximately 6 months
Secondary outcomes (10)
Frequency of Premature Discontinuation of Dosing Due to Adverse Events
Measured: Approximately 6 months
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
Measured: Approximately 6 months
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
Measured: Approximately 6 months
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
Measured: Approximately 6 months
Frequency of Anaphylaxis as Defined in the Protocol
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
- 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).
- 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).
- 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
Frequency of Epinephrine Use as Rescue Medication
Measured: Approximately 6 months
Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods
Measured: Approximately 6 months
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11
The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control)
Measured: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17
The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).
Measured: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Frequency of 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.
- First posted24 Apr 2017
- Study start8 May 2017
- Primary completion31 Aug 2018
- Study completion23 Sep 2018
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization to AR101 or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director of Regulatory Affairs, Study chair, Aimmune Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126227
- Sponsor's protocol ID
- ARC007
- Acronym
- RAMSES
- Status last verified
- Oct 2021
- First submitted
- 20 Apr 2017
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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
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 Ages 4 to 17 Years (RAMSES)
- ClinicalTrials.gov ID
- NCT03126227
- Acronym / sponsor ID
- RAMSES / ARC007
- Conditions
- Peanut Allergy
- Keywords
- AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Peanut-Allergic Children, Desensitization, ARC007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 24 Apr 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 is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
Detailed description
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2:1 randomization to AR101 or placebo
| Arm | Type | Receives |
|---|---|---|
| AR101 Powder Provided in Capsules | Active comparator | Biological: AR101Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol |
| Placebo powder | Placebo comparator | Biological: PlaceboPlacebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ages 4 to 17 years, inclusive
- History of physician-diagnosed peanut allergy that includes allergic signs and symptoms within two hours of known oral exposure to peanut
- Mean peanut wheal diameter on SPT of at least 8mm and elevated psIgE of at least 14 kUA/L at screening
- Written informed consent from the subject's parent/guardian
- Written assent from the subject as appropriate (per local regulatory requirements)
Key exclusion criteria (7 listed)
- Subjects in whom the clinical diagnosis of peanut allergy is uncertain
- Severe or uncontrolled asthma
- History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
- History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
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 powder provided in capsules | Biological | AR101 Powder Provided in Capsules |
| PlaceboPlacebo powder provided in capsules | Biological | Placebo powder |
Primary outcome
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events
Time frame: Approximately 6 months
Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.
10 secondary outcomes
Frequency of Premature Discontinuation of Dosing Due to Adverse Events
Time frame: Approximately 6 months
Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events
Time frame: Approximately 6 months
Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing
Time frame: Approximately 6 months
Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment
Time frame: Approximately 6 months
Frequency of Anaphylaxis as Defined in the Protocol
Time frame: Approximately 6 months
Frequency of Epinephrine Use as Rescue Medication
Time frame: Approximately 6 months
Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods
Time frame: Approximately 6 months
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11
Time frame: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17
Time frame: Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months)
Frequency of Adverse Events That Led to Early Withdrawal
Time frame: Approximately 6 months
Results and safety
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
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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.
Director of Regulatory Affairs study chair
Aimmune Therapeutics, Inc.
67 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 67 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 6 inclusion and 7 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 67 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. Some participants in this study may receive a placebo. 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?
Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events (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 NCT03126227, 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.