<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415593</url>
  </required_header>
  <id_info>
    <org_study_id>Peanuts protocol</org_study_id>
    <nct_id>NCT04415593</nct_id>
  </id_info>
  <brief_title>High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety</brief_title>
  <official_title>High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial the investigators aim to assess the effectiveness and safety of oral&#xD;
      immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with&#xD;
      peanuts allergy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peanut allergy is a significant clinical problem. Food immunotherapy provides the latest&#xD;
      approach to managing food allergy. Oral immunotherapy is considered as the most effective and&#xD;
      safe, according to current research. What is more, this type of therapy is easily available&#xD;
      and can be continued at patient's home. Obtaining and maintenance of tolerance to the&#xD;
      allergic food is the main goal of this procedure.&#xD;
&#xD;
      The study will include children with peanut allergy, confirmed during open oral food&#xD;
      challenge (OOFC) with peanut protein. First OOFC will be performed before immunotherapy,&#xD;
      second one at the end of procedure. Participants will be randomly assigned to two groups.&#xD;
      During the maintenance phase, the first group will receive low dose of peanut protein, which&#xD;
      amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral&#xD;
      immunotherapy with low and high dose of peanut protein in children randomly assigned to two&#xD;
      groups (1:1).&#xD;
&#xD;
      In the following phase, every two weeks the dose of ground roasted peanut will be increased&#xD;
      and applied to a child during hospitalization (1-day procedure). Precondition to increase of&#xD;
      dose is good tolerance of previous portion of peanut. The maximum time frame for this phase&#xD;
      is 14 months.&#xD;
&#xD;
      After achieving tolerance, immunotherapy will be continued for 2 months in maintenance phase,&#xD;
      with dose 150mg or 300 mg peanut protein, depending on a study group.&#xD;
&#xD;
      The dosage increasing phase will last maximally 14 months. If patients achieves the&#xD;
      maintenance dose earlier, this period may be shorter. Maintenance dose is determined by&#xD;
      random patients' assignment to one from study's group and amounts 150mg or 300 mg of peanut&#xD;
      protein, respectively.&#xD;
&#xD;
      The duration of the maintenance phase is 8 weeks (+/-2 weeks). After 2 months (8 weeks +/-2&#xD;
      weeks) of maintenance dose the final OOFC and evaluation of tolerance of peanut protein will&#xD;
      be performed. Confirmation of the total desensitization of peanut is the tolerance of a&#xD;
      single dose of 4500 mg peanut protein.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low (150mg) and high (300mg) dose of peanut protein in children randomly assigned to two groups (1:1).&#xD;
Patients will receive ground peanuts mixed with apple mousse (supposing apple tolerance). For the transparency of the study all patients will receive the same commercially prepared apple muss product.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerance of peanuts</measure>
    <time_frame>Up to 16 months after starting oral immunotherapy</time_frame>
    <description>Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Up to 16 months after starting oral immunotherapy</time_frame>
    <description>quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory data</measure>
    <time_frame>Up to 16 months after starting oral immunotherapy</time_frame>
    <description>difference in peanut serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin prick test (SPT)</measure>
    <time_frame>Up to 16 months after starting oral immunotherapy</time_frame>
    <description>change in skin prick test reactivity to peanut protein from baseline to end of treatment, compared between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>high dose of peanut</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low dose of peanuts</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High dose of peanuts</intervention_name>
    <description>Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product</description>
    <arm_group_label>high dose of peanut</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low dose of peanuts</intervention_name>
    <description>Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product</description>
    <arm_group_label>low dose of peanuts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical history of peanut allergy,&#xD;
&#xD;
          -  IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut&#xD;
             allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater&#xD;
             than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),&#xD;
&#xD;
          -  reaction to less than 100 mg of peanut protein during OOFC,&#xD;
&#xD;
          -  signed Informed Consent by parent/legal guardian and patient aged &gt;16 years old,&#xD;
&#xD;
          -  patient's/caregivers' cooperation with researcher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no confirmed peanut allergy,&#xD;
&#xD;
          -  negative oral food challenge with less than 100mg of peanut protein,&#xD;
&#xD;
          -  severe asthma,&#xD;
&#xD;
          -  uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)&lt;80%&#xD;
             (under 5. percentile), FEV1/forced vital capacity (FVC)&lt;75% (under 5. percentile),&#xD;
             hospitalization due to asthma exacerbation within last 12 months,&#xD;
&#xD;
          -  current oral/sublingual/subcutaneous immunotherapy with other allergen,&#xD;
&#xD;
          -  eosinophilic gastroenteritis,&#xD;
&#xD;
          -  a history of severe recurrent anaphylaxis episodes,&#xD;
&#xD;
          -  chronic diseases requiring continuous treatment, including heart disease, epilepsy,&#xD;
             metabolic diseases, diabetes,&#xD;
&#xD;
          -  medication:&#xD;
&#xD;
               -  oral, daily steroid therapy longer than 1 month within last 12 months,&#xD;
&#xD;
               -  at least two courses of oral steroid therapy (at least 7 days) within last 12&#xD;
                  months,&#xD;
&#xD;
               -  oral steroid therapy longer than 7 days within last 3 months,&#xD;
&#xD;
               -  biological treatment,&#xD;
&#xD;
               -  the need to constantly take antihistamines,&#xD;
&#xD;
               -  therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium&#xD;
                  channel inhibitors,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  no consent to participate in the study,&#xD;
&#xD;
          -  lack of patient cooperation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klementyna Łyżwa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wioletta Zagórska, PhD, MD</last_name>
    <phone>+48 22 3179431</phone>
    <email>wiola.zagorska@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katarzyna Grzela, PhD, MD</last_name>
    <phone>+48 22 3179431</phone>
    <email>kgrzela@wum.edu.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-091</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wioetta Zagórska, PhD, MD</last_name>
      <phone>+48 22 317 9431</phone>
      <email>wiola.zagorska@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.</citation>
    <PMID>29205393</PMID>
  </reference>
  <reference>
    <citation>Stiefel G, Anagnostou K, Boyle RJ, Brathwaite N, Ewan P, Fox AT, Huber P, Luyt D, Till SJ, Venter C, Clark AT. BSACI guideline for the diagnosis and management of peanut and tree nut allergy. Clin Exp Allergy. 2017 Jun;47(6):719-739. doi: 10.1111/cea.12957.</citation>
    <PMID>28836701</PMID>
  </reference>
  <reference>
    <citation>PALISADE 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.</citation>
    <PMID>30449234</PMID>
  </reference>
  <reference>
    <citation>Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW; ARC001 Study Group. Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):476-485.e3. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31.</citation>
    <PMID>29092786</PMID>
  </reference>
  <reference>
    <citation>Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma &amp; Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.</citation>
    <PMID>23195525</PMID>
  </reference>
  <reference>
    <citation>Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.</citation>
    <PMID>16597075</PMID>
  </reference>
  <reference>
    <citation>Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.</citation>
    <PMID>28065342</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>April 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>peanuts</keyword>
  <keyword>food allergy</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415593
org study id: Peanuts protocol
nct id: NCT04415593
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this trial the investigators aim to assess the effectiveness and safety of oral
      immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with
      peanuts allergy.
Peanut allergy is a significant clinical problem. Food immunotherapy provides the latest
      approach to managing food allergy. Oral immunotherapy is considered as the most effective and
      safe, according to current research. What is more, this type of therapy is easily available
      and can be continued at patient's home. Obtaining and maintenance of tolerance to the
      allergic food is the main goal of this procedure.

      The study will include children with peanut allergy, confirmed during open oral food
      challenge (OOFC) with peanut protein. First OOFC will be performed before immunotherapy,
      second one at the end of procedure. Participants will be randomly assigned to two groups.
      During the maintenance phase, the first group will receive low dose of peanut protein, which
      amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral
      immunotherapy with low and high dose of peanut protein in children randomly assigned to two
      groups (1:1).

      In the following phase, every two weeks the dose of ground roasted peanut will be increased
      and applied to a child during hospitalization (1-day procedure). Precondition to increase of
      dose is good tolerance of previous portion of peanut. The maximum time frame for this phase
      is 14 months.

      After achieving tolerance, immunotherapy will be continued for 2 months in maintenance phase,
      with dose 150mg or 300 mg peanut protein, depending on a study group.

      The dosage increasing phase will last maximally 14 months. If patients achieves the
      maintenance dose earlier, this period may be shorter. Maintenance dose is determined by
      random patients' assignment to one from study's group and amounts 150mg or 300 mg of peanut
      protein, respectively.

      The duration of the maintenance phase is 8 weeks (+/-2 weeks). After 2 months (8 weeks +/-2
      weeks) of maintenance dose the final OOFC and evaluation of tolerance of peanut protein will
      be performed. Confirmation of the total desensitization of peanut is the tolerance of a
      single dose of 4500 mg peanut protein.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low (150mg) and high (300mg) dose of peanut protein in children randomly assigned to two groups (1:1).
Patients will receive ground peanuts mixed with apple mousse (supposing apple tolerance). For the transparency of the study all patients will receive the same commercially prepared apple muss product.
primary purpose: Treatment
masking: None (Open Label)
measure: Tolerance of peanuts
time frame: Up to 16 months after starting oral immunotherapy
description: Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein
measure: Adverse event
time frame: Up to 16 months after starting oral immunotherapy
description: quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category
measure: Laboratory data
time frame: Up to 16 months after starting oral immunotherapy
description: difference in peanut serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment
measure: Skin prick test (SPT)
time frame: Up to 16 months after starting oral immunotherapy
description: change in skin prick test reactivity to peanut protein from baseline to end of treatment, compared between groups
arm group label: high dose of peanut
arm group type: Experimental
description: 20 patients
arm group label: low dose of peanuts
arm group type: Active Comparator
description: 20 patients
intervention type: Dietary Supplement
intervention name: High dose of peanuts
description: Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
arm group label: high dose of peanut
intervention type: Dietary Supplement
intervention name: Low dose of peanuts
description: Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
arm group label: low dose of peanuts
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: No
last name: Klementyna Łyżwa, MD
role: Principal Investigator
affiliation: Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
last name: Wioletta Zagórska, PhD, MD
phone: +48 22 3179431
email: wiola.zagorska@gmail.com
last name: Katarzyna Grzela, PhD, MD
phone: +48 22 3179431
email: kgrzela@wum.edu.pl
facility: 
status: Recruiting
contact: 
country: Poland
citation: Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
PMID: 29205393
citation: Stiefel G, Anagnostou K, Boyle RJ, Brathwaite N, Ewan P, Fox AT, Huber P, Luyt D, Till SJ, Venter C, Clark AT. BSACI guideline for the diagnosis and management of peanut and tree nut allergy. Clin Exp Allergy. 2017 Jun;47(6):719-739. doi: 10.1111/cea.12957.
PMID: 28836701
citation: PALISADE 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.
PMID: 30449234
citation: Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW; ARC001 Study Group. Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):476-485.e3. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31.
PMID: 29092786
citation: Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
PMID: 23195525
citation: Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
PMID: 16597075
citation: Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.
PMID: 28065342
responsible party type: Sponsor
mesh term: Peanut Hypersensitivity
sharing ipd: No