Peanut AllergyPhase 3PALISADENCT02635776
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
A Phase 3 study testing AR101 powder provided in capsules & sachets in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 69 sites in 10 countries.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults. Read more about this study
- Who is it for?
- Ages 4 to 55 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
- 555 participants
- Where
- 69 sitesin 10 countries
- Study dates
- 22 Dec 2015to 2 Jul 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 4 through 55 years
- Clinical history of allergy to peanuts or peanut-containing foods
- Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
- Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines
- Not be residing at the same address as another subject in this or any peanut OIT study
- UniCAP™: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies
- PRACTALL: PRACTical issues in ALLergology Joint United States/European Union Initiative
Who cannot join
- 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 DBPCFC
- History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
- 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 severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
- History of steroid medication use
Show all 9Show fewer
- History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
- Developing dose-limiting symptoms in reaction to the placebo part of the Screening DBPCFC
- Having the same place of residence as another subject in the study
Trial locations and contacts
69 sites in 10 countries.
69 sites in 10 countries
United States49 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
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
John Hopkins Hospital
Baltimore, Maryland, 21287
Asthma & Allergy Center, PC
Bellevue, Nebraska, 68123
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
IU North Riley Children's Specialists
Carmel, Indiana, 46032
Colorado Allergy & Asthma Centers, P.C.
Centennial, Colorado, 80112
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599
National Allergy and Asthma Research, LLC
Charleston, South Carolina, 29407
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Comer Children's Hospital
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Allergy Partners of North Texas Research
Dallas, Texas, 75230
Children's Medical Center
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206
Idaho Allergy LLC dba Idaho Research
Eagle, Idaho, 83616
Western Sky Medical Research
El Paso, Texas, 79903
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy on Broadway
Kansas City, Missouri, 64111
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Long Beach Memorial Medical Center / Miller Children's and Women's Hospital
Long Beach, California, 90806
UCLA Medical Center, Santa Monica
Los Angeles, California, 90404
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, 30060
LeBonheur Children's Hospital - Outpatient Building
Memphis, Tennessee, 38105
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, 92691
Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital
Mountain View, California, 94040
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Children's Hospital of Philadelphia: Allergy / Immunology
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Clinical Research Institute Inc.
Plymouth, Minnesota, 55441
Baker Allergy Asthma & Dermatology Research Center, LLC
Portland, Oregon, 97223
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
Sylvana Research
San Antonio, Texas, 78229
Allergy & Asthma Medical Group and Research Center, A.P.C
San Diego, California, 92123
Rady Children's Hospital
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94158
Windom Allergy, Asthma and Sinus
Sarasota, Florida, 34239
Virginia Mason Medical Center
Seattle, Washington, 98101
Northwest Asthma and Allergy Center
Seattle, Washington, 98115
University of South Florida Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, 33613
Banner University of Arizona Medical Center
Tucson, Arizona, 85724
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Canada5 sites
Ohayon
Hamilton, Ontario, L8S 1G5
Cheema Research, Inc.
Mississauga, Ontario, L5A 3V4
Montreal Children's Hospital
Montreal, Quebec, H4A3J1
Ottawa Allergy Research Corp
Ottawa, Ontario, K1G 6C6
Gordon Sussman Clinical Research, Inc.
Toronto, Ontario, M4V 1R2
Germany3 sites
Charite Universitaetsmedizin Berlin
Berlin, 13353
Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin
Frankfurt, 60590
Medaimun GmbH
Frankfurt am Main, 60596
Spain3 sites
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
Hospital Clinico San Carlos
Madrid, 28040
United Kingdom3 sites
Guy and St Thomas' NHS Foundation Trust
London, SE1 7EH
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility
Manchester, M23 9LT
Netherlands2 sites
Universitair medisch Centrum Groningen
Groningen, 9713GZ
University Medical Center Groningen
Groningen, 9713GZ
Denmark1 site
Odense Universitetshospital - Department of Dermatology and Allergy Center
Odense, DK5000
Italy1 site
Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,
Padova, 35128
Sweden1 site
Barnforskningscentrum, Sachs' Children and Youth Hospital
Stockholm, 118 83
About this study
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
Read the detailed description
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
- Conditions
- Peanut Allergy
- Being tested
- AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets
- Keywords
- AR101 (Characterized Peanut Allergen), Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Oral Immunotherapy, Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization
- 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 | Experimental | 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 Ages 4-17 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 symptoms at the Exit Oral Food Challenge.
Measured: 12 months
Secondary outcomes (3)
Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 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 symptoms at the Exit Oral Food Challenge.
Measured: 12 months
Percentage of Subjects Ages 4-17 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 symptoms at the Exit Oral Food Challenge.
Measured: 12 months
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (Severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower).
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 posted21 Dec 2015 (estimated)
- Study start22 Dec 2015
- Primary completion21 Dec 2017
- Study completion2 Jul 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 (5)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 555 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
- NCT02635776
- Sponsor's protocol ID
- ARC003
- Acronym
- PALISADE
- Status last verified
- Mar 2022
- First submitted
- 17 Dec 2015
- Last updated
- 17 Mar 2022
- 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, Vereda A, Borres MP, Andersson M, Sodergren E, Rudengren M, Smith A, Simon RJ, Ryan R, Fernandez-Rivas M, Adelman D, Vickery BP. Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial. Clin Transl Allergy. 2024 Jan;14(1):e12326. doi: 10.1002/clt2.12326.
PubMed 38282192Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
PubMed 36915184Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
PubMed 34389504Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
PubMed 34320250PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.
PubMed 30449234
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
- ClinicalTrials.gov ID
- NCT02635776
- Acronym / sponsor ID
- PALISADE / ARC003
- Conditions
- Peanut Allergy
- Keywords
- AR101 (Characterized Peanut Allergen), Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Oral Immunotherapy, Peanut Allergy, Allergy, Peanut-Allergic Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Posted 17 Mar 2022
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 demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
Detailed description
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR101 powder provided in capsules & sachets | Experimental | 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
- 4 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 4 through 55 years
- Clinical history of allergy to peanuts or peanut-containing foods
- Serum immunoglobulin E (IgE) to peanut ≥0.35 kUA/L (kilos of allergen-specific units per liter, determined by UniCAP™* within the past 12 months) and/or a skin prick test (SPT) to peanut ≥3 mm compared to control
- Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL** guidelines
- Not be residing at the same address as another subject in this or any peanut OIT study
Key exclusion criteria (9 listed)
- 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 DBPCFC
- History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
- 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 severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
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 Ages 4-17 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 symptoms at the Exit Oral Food Challenge.
3 secondary outcomes
Percentage of Subjects Ages 4-17 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
Percentage of Subjects Ages 4-17 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
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein 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 17 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38282192Nilsson C, Vereda A, Borres MP, Andersson M, Sodergren E, Rudengren M, Smith A, Simon RJ, Ryan R, Fernandez-Rivas M, Adelman D, Vickery BP. Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial. Clin Transl Allergy. 2024 Jan;14(1):e12326. doi: 10.1002/clt2.12326.
- Derived from this study: PubMed 36915184Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
- Derived from this study: PubMed 34389504Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
- Derived from this study: PubMed 34320250Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.
- Derived from this study: PubMed 30449234PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.
- 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.
69 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AR101 powder provided in capsules & sachets in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 69 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Canada, Germany, Spain, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 17 Mar 2022). 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 Ages 4-17 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 NCT02635776, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.