<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/NCT02203799</url>
  </required_header>
  <id_info>
    <org_study_id>26819</org_study_id>
    <nct_id>NCT02203799</nct_id>
  </id_info>
  <brief_title>Peanut Oral Immunotherapy in Children With Peanut Allergy</brief_title>
  <acronym>PeanutFlour</acronym>
  <official_title>Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many children who are allergic to peanuts do not outgrow their allergy and have very severe&#xD;
      allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,&#xD;
      decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A&#xD;
      severe allergic reaction can lead to death if not treated appropriately.&#xD;
&#xD;
      The purpose of this study is to find out if there is a way to treat children with peanut&#xD;
      allergy to help lower the risk of severe allergic reactions and also cause them to lose their&#xD;
      allergy to peanuts. The approach that will used for this study is a process called&#xD;
      &quot;desensitization&quot;.&#xD;
&#xD;
      Oral immunotherapy involves eating gradually increasing amounts of a food over several&#xD;
      months. This is a research study because at this time peanut oral immunotherapy (OIT) is&#xD;
      investigational. Peanut OIT (study drug) is investigational because it is not currently&#xD;
      approved for clinical use by the Food and Drug Administration. There are no alternative safe&#xD;
      and effective treatments for peanut induced allergic reactions other than peanut avoidance&#xD;
      and treatment with medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I, open label study for the initial 12 month desensitization phase of peanut&#xD;
      oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine&#xD;
      the immune response during the administration of peanut OIT after the development of disease.&#xD;
      Cohort will include children age 5-16 years who have peanut allergy. The study will require&#xD;
      approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1&#xD;
      year), followed by the maintenance phase (2 years).&#xD;
&#xD;
      The primary objective of the OIT protocol is to desensitize subjects to peanut and this&#xD;
      occurs over the first 12 months of the study (build-up phase). The first dose will be based&#xD;
      on the amount at which the subject reacted during a double blind placebo controlled food&#xD;
      challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol&#xD;
      for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached.&#xD;
&#xD;
      The maintenance phase will continue from the end of the build-up phase until approximately 24&#xD;
      months. During this phase, the subject will switch to a peanut equivalent dose for the&#xD;
      maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative&#xD;
      challenges will be confirmed by open challenge. DBPCFC will be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2014</start_date>
  <completion_date type="Actual">February 11, 2020</completion_date>
  <primary_completion_date type="Actual">February 11, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Efficacy</measure>
    <time_frame>3 years</time_frame>
    <description>Determine whether peanut oral immunotherapy safely develops clinical tolerance in peanut allergic subjects by assessing the change of dose tolerated and to determine the percentage of subjects who can tolerate 6 g of peanut flour with absence of clinical symptoms during a food challenge following the initial desensitization phase of peanut flour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune Response</measure>
    <time_frame>3 years</time_frame>
    <description>To determine the immune mechanisms of clinical tolerance, using technology to identify T cell cytokine responses and subsets, as well as basophil activation responses as measured by flow cytometry. T and NKT cell function and intracellular cytokine expression will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Exposure</measure>
    <time_frame>3 years</time_frame>
    <description>To determine whether viral exposure potentiates response to in vitro peanut allergen exposure and to assess those changes during peanut OIT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Toleration</measure>
    <time_frame>3 years</time_frame>
    <description>To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Peanut Allergic Subjects</condition>
  <arm_group>
    <arm_group_label>Peanut Oral Immunotherapy (POIT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Peanut Oral Immunotherapy (POIT)</intervention_name>
    <description>The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.</description>
    <arm_group_label>Peanut Oral Immunotherapy (POIT)</arm_group_label>
    <other_name>Peanut Flour</other_name>
    <other_name>Peanut Oral Immunotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at&#xD;
             the time of the initial visit.&#xD;
&#xD;
          -  The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test&#xD;
             to peanuts (diameter of wheal &gt; 3.0 mm) and a positive in vitro IgE [CAP-FEIA] &gt; 7&#xD;
             kUA/L) measured within the past year.&#xD;
&#xD;
          -  Significant clinical symptoms occurring within 120 minutes after ingesting peanuts&#xD;
             during an observed DBPCFC. Patients who have not had previous oral exposure to peanut&#xD;
             will be observed for a longer duration of 150 minutes because they may demonstrate a&#xD;
             delayed immune response, given the lack of prior peanut exposure. Also, patients with&#xD;
             a history of prior anaphylaxis will be observed for 150 minutes.&#xD;
&#xD;
          -  Provide signed informed consent.&#xD;
&#xD;
          -  Ability to follow-up regularly for scheduled appointments.&#xD;
&#xD;
          -  Subjects will not be excluded if they are primarily Spanish speaking.&#xD;
&#xD;
          -  Females of childbearing potential must be willing to practice an acceptable form of&#xD;
             birth control throughout the protocol.&#xD;
&#xD;
          -  Epinephrine injection training provided. Participant has current in-date epinephrine&#xD;
             injector and parent/guardian demonstrates proper use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or&#xD;
             neurological compromise (Cyanosis or SpO2 &lt; 92% at any stage, hypotension, confusion,&#xD;
             collapse, loss of consciousness; or incontinence)&#xD;
&#xD;
          -  Currently participating in a study using an investigational new drug.&#xD;
&#xD;
          -  Participation in any interventional study for the treatment of food allergy in the&#xD;
             past 12 months or while participating in this study.&#xD;
&#xD;
          -  Poor control or persistent activation of atopic dermatitis.&#xD;
&#xD;
          -  Diagnosis of persistent asthma as defined by NHLBI criteria and currently being&#xD;
             treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more&#xD;
             than 2 days per week.&#xD;
&#xD;
          -  Inability to discontinue antihistamines for skin testing and Oral Food Challenges&#xD;
             (OFCs).&#xD;
&#xD;
          -  Pregnant female.&#xD;
&#xD;
          -  Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric&#xD;
             illness or history of substance abuse.&#xD;
&#xD;
          -  Active eosinophilic esophagitis requiring medication therapy during the past 12&#xD;
             months.&#xD;
&#xD;
          -  Subjects with known oat or wheat allergy&#xD;
&#xD;
          -  Subjects currently on the build-up phase of environmental allergy immunotherapy&#xD;
             injections&#xD;
&#xD;
          -  Live more than 175 miles away from Texas Children's Hospital located in the Medical&#xD;
             Center.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carla M Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Children's Hospital/Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Carla McGuire Davis</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Peanut Allergy</keyword>
  <keyword>Anaphylaxis</keyword>
  <keyword>Desensitization</keyword>
  <keyword>Food Allergy</keyword>
  <keyword>Oral Immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
    <mesh_term>Immunologic Factors</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 5, 2021</submitted>
    <returned>May 27, 2021</returned>
    <submitted>April 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02203799
org study id: 26819
nct id: NCT02203799
lead sponsor: 
has dmc: Yes
Many children who are allergic to peanuts do not outgrow their allergy and have very severe
      allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,
      decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A
      severe allergic reaction can lead to death if not treated appropriately.

      The purpose of this study is to find out if there is a way to treat children with peanut
      allergy to help lower the risk of severe allergic reactions and also cause them to lose their
      allergy to peanuts. The approach that will used for this study is a process called
      "desensitization".

      Oral immunotherapy involves eating gradually increasing amounts of a food over several
      months. This is a research study because at this time peanut oral immunotherapy (OIT) is
      investigational. Peanut OIT (study drug) is investigational because it is not currently
      approved for clinical use by the Food and Drug Administration. There are no alternative safe
      and effective treatments for peanut induced allergic reactions other than peanut avoidance
      and treatment with medications.
This is a phase I, open label study for the initial 12 month desensitization phase of peanut
      oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine
      the immune response during the administration of peanut OIT after the development of disease.
      Cohort will include children age 5-16 years who have peanut allergy. The study will require
      approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1
      year), followed by the maintenance phase (2 years).

      The primary objective of the OIT protocol is to desensitize subjects to peanut and this
      occurs over the first 12 months of the study (build-up phase). The first dose will be based
      on the amount at which the subject reacted during a double blind placebo controlled food
      challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol
      for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached.

      The maintenance phase will continue from the end of the build-up phase until approximately 24
      months. During this phase, the subject will switch to a peanut equivalent dose for the
      maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative
      challenges will be confirmed by open challenge. DBPCFC will be done.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Efficacy
time frame: 3 years
description: Determine whether peanut oral immunotherapy safely develops clinical tolerance in peanut allergic subjects by assessing the change of dose tolerated and to determine the percentage of subjects who can tolerate 6 g of peanut flour with absence of clinical symptoms during a food challenge following the initial desensitization phase of peanut flour
measure: Immune Response
time frame: 3 years
description: To determine the immune mechanisms of clinical tolerance, using technology to identify T cell cytokine responses and subsets, as well as basophil activation responses as measured by flow cytometry. T and NKT cell function and intracellular cytokine expression will be measured.
measure: Viral Exposure
time frame: 3 years
description: To determine whether viral exposure potentiates response to in vitro peanut allergen exposure and to assess those changes during peanut OIT.
measure: Dose Toleration
time frame: 3 years
description: To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness.
arm group label: Peanut Oral Immunotherapy (POIT)
arm group type: Experimental
description: The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day.
intervention type: Biological
intervention name: Peanut Oral Immunotherapy (POIT)
description: The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
arm group label: Peanut Oral Immunotherapy (POIT)
other name: Peanut Flour
other name: Peanut Oral Immunotherapy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Carla M Davis, MD
role: Principal Investigator
affiliation: Texas Children's Hospital/Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Carla McGuire Davis
investigator title: Associate Professor
mesh term: Peanut Hypersensitivity
mesh term: Immunomodulating Agents
mesh term: Immunologic Factors
submitted: May 5, 2021
returned: May 27, 2021
submitted: April 20, 2023