<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/NCT03755713</url>
  </required_header>
  <id_info>
    <org_study_id>0892-CL-1002</org_study_id>
    <nct_id>NCT03755713</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine</brief_title>
  <official_title>A Phase 1, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of ASP0892 after&#xD;
      intradermal (ID) injection in adolescent participants with peanut allergy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">October 11, 2021</completion_date>
  <primary_completion_date type="Actual">October 11, 2021</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as assessed by Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to Day 576</time_frame>
    <description>Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs starting or worsening after the first dose of study drug up through study completion will be considered treatment-emergent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as assessed by local reactogenicity reactions</measure>
    <time_frame>Up to Day 50</time_frame>
    <description>Participants will be asked to record local reactogenicity (pain, tenderness; erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as assessed by systemic reactogenicity reactions</measure>
    <time_frame>Up to Day 50</time_frame>
    <description>Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with vital signs abnormalities and/or adverse events</measure>
    <time_frame>Up to Day 576</time_frame>
    <description>Number of participants with potentially clinically significant vital sign values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with laboratory value abnormalities and/or adverse events</measure>
    <time_frame>Up to Day 576</time_frame>
    <description>Number of participants with potentially clinically significant laboratory values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety assessed by Anti-LAMP-1 antibody</measure>
    <time_frame>Up to Day 576</time_frame>
    <description>Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>ASP0892 Low Dose (Cohort A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASP0892 High Dose (Cohort B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After all participants in cohort A complete study procedures, the DMC will review the safety and tolerability data and provide recommendations depending on the nature, frequency and severity of the safety profile reviewed. Recommendations will be to proceed with escalation to the next higher dose or stop dose escalation (i.e., no further dosing with study drug).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP0892</intervention_name>
    <description>Intradermal</description>
    <arm_group_label>ASP0892 High Dose (Cohort B)</arm_group_label>
    <arm_group_label>ASP0892 Low Dose (Cohort A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intradermal; normal saline solution</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a body mass index (BMI) ≥ 3rd percentile and ≤ 97th percentile.&#xD;
&#xD;
          -  Subject has a physician-diagnosed peanut allergy or history of peanut allergy.&#xD;
             Subjects with history of nonsevere anaphylaxis (Grade ≤ 3) to peanuts (including mild&#xD;
             wheezing or dyspnea without hypoxia) will be enrolled.&#xD;
&#xD;
          -  Subject has an anti-Ara h2 Immunoglobulin E (IgE) measured by ImmunoCAP &gt; 0.35 kU/L.&#xD;
&#xD;
          -  Subject has a positive Skin prick test (SPT) to peanut with a change in wheal diameter&#xD;
             ≥ 3 mm as compared to a negative control.&#xD;
&#xD;
          -  Subject has a positive peanut Double-blinded placebo-controlled food challenge&#xD;
             (DBPCFC) at Screen 2 visit with an eliciting dose ≤ 300 mg peanut protein (≤ 444 mg&#xD;
             cumulative reactive dose [CRD]).&#xD;
&#xD;
          -  Female subject must either:&#xD;
&#xD;
               -  Be of non-childbearing potential, clearly premenarchal; documented surgically&#xD;
                  sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).&#xD;
&#xD;
               -  Or, if of childbearing potential, agrees not to try to become pregnant during the&#xD;
                  study; and have a negative urine pregnancy test at screening and at day 1&#xD;
                  (predose); and if heterosexually active, agrees to consistently use 1 form of&#xD;
                  highly effective birth control starting at screening and throughout the study&#xD;
                  period.&#xD;
&#xD;
          -  Female subject must agree not to breastfeed starting at screening and throughout the&#xD;
             study period, and for 28 days after the final study drug administration.&#xD;
&#xD;
          -  Female subject must not donate ova starting at screening and throughout the study&#xD;
             period, and for 28 days after the final study drug administration.&#xD;
&#xD;
          -  A heterosexually active male subject with female partner(s) who are of childbearing&#xD;
             potential is eligible if:&#xD;
&#xD;
               -  Agrees to use a male condom starting at screening and continue throughout study&#xD;
                  treatment and for 28 days after the final study drug administration. If the male&#xD;
                  subject has not had a vasectomy or is not sterile, the subjects female partner(s)&#xD;
                  is utilizing 1 form of highly effective birth control starting at screening and&#xD;
                  continue throughout study treatment and for 90 days after the male subject&#xD;
                  receives his final study drug administration.&#xD;
&#xD;
          -  Male subject must not donate sperm starting at screening and throughout the study&#xD;
             period, and for 90 days after the final drug administration.&#xD;
&#xD;
          -  Subject and subject's parent(s) or legal guardian agree that the subject will not&#xD;
             participate in another interventional study while participating in the present study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has severe anaphylaxis to peanuts (Grades 4 or 5 including dyspnea associated&#xD;
             with hypoxia, cyanosis, hypotension or neurological compromise) per the Grading of&#xD;
             Food-Induced Anaphylaxis According to Severity of Clinical Symptoms based on&#xD;
             historical clinical symptoms.&#xD;
&#xD;
          -  Subject develops a Grade 4 or 5 reaction during the DBPCFC, per the Grading of Food-&#xD;
             Induced Anaphylaxis According to Severity of Clinical Symptoms based on historical&#xD;
             clinical symptoms.&#xD;
&#xD;
          -  Subject has received or is planning to receive administration of any vaccine (other&#xD;
             than injectable Influenza vaccine) from 28 days prior to the first dose through 2&#xD;
             weeks after the last dose of the study vaccine.&#xD;
&#xD;
          -  Subject received any specific immunotherapy for allergy (e.g., epicutaneous&#xD;
             immunotherapy [EPIT], sublingual immunotherapy [SLIT], Subcutaneous immunotherapy&#xD;
             [SCIT] and oral immunotherapy [OIT]) during the past 12 months, currently or plans to&#xD;
             receive during the course of the study.&#xD;
&#xD;
          -  Subject has used the following drug(s) prior to the dosing of the study vaccine:&#xD;
&#xD;
               -  Within 2 months prior to study vaccine administration: Systemic (or inhaled)&#xD;
                  steroid, chemical mediator-isolation inhibitor, T helper cell type 2 (Th2)&#xD;
                  cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor&#xD;
                  antagonist, β-blocker, angiotensin-converting enzyme inhibitors and/or&#xD;
                  angiotensin-receptor blockers&#xD;
&#xD;
               -  Within 3 months prior to study vaccine administration: Biologics and/or immune&#xD;
                  modulators (including anti-TNFα antibody and anti-IgE monoclonal antibody)&#xD;
&#xD;
          -  Subject has history of allergic reactions such as anaphylactic shock, angioedema with&#xD;
             airway constriction or hypotension caused by food other than peanut and/or medical&#xD;
             products (including vaccine) in the past.&#xD;
&#xD;
          -  Subject's laboratory test results at screening or prior to study drug dosing on day 1&#xD;
             are outside the normal limits and are considered clinically significant.&#xD;
&#xD;
          -  Subjects with anti-Lysosomal associated membrane protein (LAMP)-1 antibodies above the&#xD;
             cut-point for the Tier 1 assay and who are confirmed positive in the Tier 2 assay at&#xD;
             Screen 1 visit (baseline).&#xD;
&#xD;
          -  Subject had a positive test result for hepatitis B surface (HBs) antigen, hepatitis C&#xD;
             virus (HCV) antibody or human immunodeficiency virus (HIV) antigen/antibody.&#xD;
&#xD;
          -  Subject had a positive urine drug screen result.&#xD;
&#xD;
          -  Subject has immune disorders (including autoimmune disease) and/or diseases requiring&#xD;
             immunosuppressive drugs.&#xD;
&#xD;
          -  Subject was diagnosed with immunodeficiency in the past.&#xD;
&#xD;
          -  Subject has uncontrolled hypertension.&#xD;
&#xD;
          -  Subject has a history of cardiovascular disease, arrhythmias, chronic lung disease,&#xD;
             active eosinophilic gastrointestinal disease or any other medical or surgical&#xD;
             conditions, which, places the subject at increased risk for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Subject has a complication or medical history of respiratory disease, which requires&#xD;
             medical treatment.&#xD;
&#xD;
          -  Subject has a complication or medical history of malignant tumor.&#xD;
&#xD;
          -  Subject has mental conditions such as schizophrenia, bipolar disorder, dementia or&#xD;
             major depressive disorder.&#xD;
&#xD;
          -  Subject has severe or poorly controlled atopic dermatitis or generalized eczema.&#xD;
&#xD;
          -  Subject is unable to discontinue antihistamines within 7 days or 5 half-lives&#xD;
             (whichever duration is longer) prior to SPT and oral food challenge procedures.&#xD;
&#xD;
          -  Subject has asthma other than mild intermittent asthma (National Heart, Lung and Blood&#xD;
             Institute [NHLBI] Guidelines, July 2007) and has a forced expiratory volume in 1&#xD;
             second value &lt; 80% and/or requiring chronic maintenance treatment (i.e., inhaled&#xD;
             corticosteroids).&#xD;
&#xD;
          -  Subject has already received injection of Lysosomal associated membrane protein&#xD;
             (LAMP)-vax such as ASP0892.&#xD;
&#xD;
          -  Subject has received investigational therapy within 35 days or 5 half-lives, whichever&#xD;
             is longer, prior to screening.&#xD;
&#xD;
          -  Subject's parent(s) or legal guardian is an employee of the Astellas Group or vendors&#xD;
             involved in the study.&#xD;
&#xD;
          -  Subject has any condition, which, makes the subject unsuitable for study&#xD;
             participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor, Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Hospital Research Institute</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sean N Parker Center for Allergy &amp; Asthma Research, LPCH El Camino Hospital</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma, Inc.</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrials.astellas.com/study/0892-CL-1002/</url>
    <description>Link to results on the Astellas Clinical Study Results website.</description>
  </link>
  <link>
    <url>https://www.trialsummaries.com/Study/StudyDetails?id=14536&amp;tenant=MT_AST_9011</url>
    <description>Link to plain language summary of the study on the Trial Results Summaries website</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>September 18, 2022</last_update_submitted>
  <last_update_submitted_qc>September 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP0892</keyword>
  <keyword>Peanut Allergy</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>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on ww.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </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/NCT03755713
org study id: 0892-CL-1002
nct id: NCT03755713
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after
      intradermal (ID) injection in adolescent participants with peanut allergy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Safety as assessed by Treatment Emergent Adverse Events (TEAEs)
time frame: Up to Day 576
description: Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs starting or worsening after the first dose of study drug up through study completion will be considered treatment-emergent.
measure: Safety as assessed by local reactogenicity reactions
time frame: Up to Day 50
description: Participants will be asked to record local reactogenicity (pain, tenderness; erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
measure: Safety as assessed by systemic reactogenicity reactions
time frame: Up to Day 50
description: Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).
measure: Number of participants with vital signs abnormalities and/or adverse events
time frame: Up to Day 576
description: Number of participants with potentially clinically significant vital sign values.
measure: Number of participants with laboratory value abnormalities and/or adverse events
time frame: Up to Day 576
description: Number of participants with potentially clinically significant laboratory values.
measure: Safety assessed by Anti-LAMP-1 antibody
time frame: Up to Day 576
description: Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.
arm group label: ASP0892 Low Dose (Cohort A)
arm group type: Experimental
description: Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B.
arm group label: ASP0892 High Dose (Cohort B)
arm group type: Experimental
description: After all participants in cohort A complete study procedures, the DMC will review the safety and tolerability data and provide recommendations depending on the nature, frequency and severity of the safety profile reviewed. Recommendations will be to proceed with escalation to the next higher dose or stop dose escalation (i.e., no further dosing with study drug).
arm group label: Placebo
arm group type: Placebo Comparator
description: Each cohort will consist of 10 participants (ASP0892 n = 8 and placebo n = 2). The data will be assessed by the Data Monitoring Committee (DMC) after all enrolled cohort A participants complete visits through day 43. Assessments for safety, tolerability, and dose escalation will occur prior to beginning cohort B.
intervention type: Drug
intervention name: ASP0892
description: Intradermal
arm group label: ASP0892 High Dose (Cohort B)
arm group label: ASP0892 Low Dose (Cohort A)
intervention type: Drug
intervention name: Placebo
description: Intradermal; normal saline solution
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Medical Monitor, Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.clinicaltrials.astellas.com/study/0892-CL-1002/
description: Link to results on the Astellas Clinical Study Results website.
url: https://www.trialsummaries.com/Study/StudyDetails?id=14536&tenant=MT_AST_9011
description: Link to plain language summary of the study on the Trial Results Summaries website
responsible party type: Sponsor
mesh term: Peanut Hypersensitivity
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on ww.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."