Peanut AllergyPhase 3POSEIDONNCT03736447
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
A Phase 3 study testing AR101 powder provided in capsules & sachets in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 23 sites in 4 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- AR101 powder provided in capsules & sachets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 27 Dec 2018to 5 Jul 2022
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where required by local authorities). Provide assent where required and as appropriate per local requirements.
- Sensitivity to peanut, defined as one of the following:
- No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within 12 months before randomization.
- Documented history of physician-diagnosed IgE-mediated peanut allergy that includes the onset of characteristic* signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food, and has a mean wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained within 12 months before randomization.
- Development of age-appropriate dose-limiting allergy symptoms after consuming single doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for administering study product.
Who cannot join
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia (eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and Blood Institute [NHLBI], 2007).
Show all 26Show fewer
- Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to control based on NHLBI 2007 criteria.
- History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for > 3 days) by any route of administration as defined by any of the following:
- Steroid administered daily for > 1 month within 1 year before screening
- One steroid course within 6 months before screening
- More than 2 steroid courses ≥ 1 week in duration within 1 year before screening
- History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before screening.
- Recurrent urticaria.
- History of failure to thrive or any other form of abnormal growth, or developmental or speech delay that precludes age-appropriate communication.
- History of chronic disease (except mild intermittent asthma, mild persistent asthma that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen.
- Unable to discontinue antihistamines and other medications that could interfere with the assessment of an allergic reaction for 5 half-lives of the medication before the screening SPT, first day of dose escalation, and DBPCFCs.
- Use or anticipated use of a prohibited medication (eg, beta blockers [oral], angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other immunomodulatory therapy (including immunosuppressive medications).
- Treatment with any form of immunotherapy for any food allergy anytime before screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, before screening.
- Allergy to oat or rice.
- Hypersensitivity to epinephrine or any of the excipients in the epinephrine auto-injector.
- Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
- Unable to follow the protocol requirements.
- Any other condition (concurrent disease, infection, comorbidity, or psychiatric or psychological disorders) or reason that may interfere with the ability to participate in the study, cause undue risk, or complicate the interpretation of data, in the opinion of the investigator or medical monitor.
- Resides at the same place as another subject in any AR101 interventional trial.
- Lives in the same household and/or is a family member of a sponsor employee or site staff involved in conducting this study.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United States14 sites
University of Michigan Division of Allergy and Clinical Immunology
Ann Arbor, Michigan, 48106
Children's Center for Advanced Pediatrics Clinical Research Lab
Atlanta, Georgia, 30329
The John Hopkins Hospital
Baltimore, Maryland, 21287
UNC-CH School of Medicine, Pediatric Allergy, Immunology & Rheumatology, Food Allergy
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
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, 30060
Sean N. Parker Center for Allergy & Asthma Reseach, LPCH at El Camino Hospital
Mountain View, California, 94040
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Atlantic Research Center
Ocean City, New Jersey, 07712
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123
Virginia Mason Medical Center
Seattle, Washington, 98101
United Kingdom6 sites
James Paget University Hospital
Gorleston-on-Sea, Norfolk, NR31 6LA
Leicester Royal Infirmary
Leicester, LE1 5WW
Guy's and St. Thomas' NHS Foundation Trust, Snowy Owl, First Floor, Evelina Children's Hospital
London, SEI 7EH
Royal Manchester Children's Hospital Central Manchester University Hospitals
Manchester, M13 9WL
Sheffield Children's Hospital
Sheffield, S10 2TH
University Hospital Southampton Foundation NHS Trust Southampton General Hospital
Southampton, SO16 6YD
Germany2 sites
Charité Universitaetsmedizin Berlin
Berlin, 13353
University of Frankfurt
Frankfurt am Main, 60590
About this study
Official title: Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Read the detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled study conducted at 14 study sites in North America and 9 in Europe to evaluate the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut-allergic children aged 1 to < 4 years.
- Conditions
- Peanut Allergy
- Being tested
- AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets
- Keywords
- CODIT™ (characterized oral desensitization immunotherapy™), Peanut-Allergic Children, CPNA (Characterized Peanut Allergen), Desensitization, AR101, Allergy, Peanut Allergy, Characterized Peanut Allergen, Oral Immunotherapy
- 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.
AR101 powder provided in capsules & sachetsBiological
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules & sachetsBiological
Study product formulated to contain only inactive ingredients for use as defined in the protocol
| Study group | Role | What they receive |
|---|---|---|
| AR101 powder provided in capsules & sachets | Active comparator | Study product provided as peanut protein in pull-apart capsules or sachets Receives: Biological: AR101 powder provided in capsules & sachets |
| Placebo powder provided in capsules & sachets | Placebo comparator | Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients Receives: Biological: Placebo powder provided in capsules & sachets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Measured: 12 months
Secondary outcomes (3)
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) [Time Frame: 12 Months]
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Measured: 12 months
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Measured: 12 months
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
The maximum severity of symptoms that occurred at any challenge dose of peanut protein during the exit DBPCFC.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start27 Dec 2018
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 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 director, Aimmune Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736447
- Sponsor's protocol ID
- ARC005
- Acronym
- POSEIDON
- Status last verified
- Feb 2023
- First submitted
- 7 Nov 2018
- Last updated
- 2 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Du Toit G, Brown KR, Vereda A, Irani AM, Tilles S, Ratnayake A, Jones SM, Vickery BP. Oral Immunotherapy for Peanut Allergy in Children 1 to Less Than 4 Years of Age. NEJM Evid. 2023 Nov;2(11):EVIDoa2300145. doi: 10.1056/EVIDoa2300145. Epub 2023 Oct 23.
PubMed 38320526
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
- ClinicalTrials.gov ID
- NCT03736447
- Acronym / sponsor ID
- POSEIDON / ARC005
- Conditions
- Peanut Allergy
- Keywords
- CODIT™ (characterized oral desensitization immunotherapy™), Peanut-Allergic Children, CPNA (Characterized Peanut Allergen), Desensitization, AR101, Allergy, Peanut Allergy, Characterized Peanut Allergen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Posted 2 Mar 2023
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 determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.
Detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled study conducted at 14 study sites in North America and 9 in Europe to evaluate the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut-allergic children aged 1 to < 4 years.
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
| Arm | Type | Receives |
|---|---|---|
| AR101 powder provided in capsules & sachets | Active comparator | Biological: AR101 powder provided in capsules & sachetsStudy product provided as peanut protein in pull-apart capsules or sachets |
| Placebo powder provided in capsules & sachets | Placebo comparator | Biological: Placebo powder provided in capsules & sachetsPlacebo formulation in pull-apart capsules or sachets containing only inactive ingredients |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 1 to < 4 years at randomization.
- Written informed consent from the legal guardian/parent (or both parents where required by local authorities). Provide assent where required and as appropriate per local requirements.
- Sensitivity to peanut, defined as one of the following:
- Development of age-appropriate dose-limiting allergy symptoms after consuming single doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
- A palatable vehicle food to which the subject is not allergic must be available for administering study product.
Key exclusion criteria (26 listed)
- History of severe or life-threatening anaphylaxis anytime before the screening DBPCFC.
- History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension.
- History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia (eg, difficulty swallowing, food "getting stuck").
- Recurrent GI symptoms considered clinically significant in the opinion of the investigator.
- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
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 |
|---|---|---|
| AR101 powder provided in capsules & sachetsStudy product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Biological | AR101 powder provided in capsules & sachets |
| Placebo powder provided in capsules & sachetsStudy product formulated to contain only inactive ingredients for use as defined in the protocol | Biological | Placebo powder provided in capsules & sachets |
Primary outcome
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
Time frame: 12 months
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
3 secondary outcomes
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) [Time Frame: 12 Months]
Time frame: 12 months
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
Time frame: 12 months
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38320526Du Toit G, Brown KR, Vereda A, Irani AM, Tilles S, Ratnayake A, Jones SM, Vickery BP. Oral Immunotherapy for Peanut Allergy in Children 1 to Less Than 4 Years of Age. NEJM Evid. 2023 Nov;2(11):EVIDoa2300145. doi: 10.1056/EVIDoa2300145. Epub 2023 Oct 23.
- Individual participant dataSharing planned: Undecided
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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 director
Aimmune Therapeutics
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AR101 powder provided in capsules & sachets in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 23 sites in 4 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 7 inclusion and 26 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, United Kingdom, Germany, France. 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 Mar 2023). 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?
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) (time frame: 12 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 NCT03736447, 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 Mar 2023.