<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/NCT02991885</url>
  </required_header>
  <id_info>
    <org_study_id>HAL-MPE1/0049</org_study_id>
    <nct_id>NCT02991885</nct_id>
  </id_info>
  <brief_title>HAL-MPE1 Safety and Tolerability Study</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multi-centre Study to Assess the Safety, Tolerability and Immunologic Effects of HAL-MPE1 Subcutaneous Immunotherapy in Adult and Paediatric Subjects With Peanut Allergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HAL Allergy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HAL Allergy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1&#xD;
      subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the&#xD;
      safety and tolerability in adolescents and children with peanut allergy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the time of the study there was no effective treatment available for peanut allergy other&#xD;
      than avoidance of peanut allergens. There was high unmet medical need for a disease modifying&#xD;
      treatment for peanut allergy, especially for peanut allergic children, since this age group&#xD;
      is at highest risk of peanut-related anaphylaxis requiring hospitalization. A chemically&#xD;
      modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous&#xD;
      administration has been developed. The safety and tolerability of HAL-MPE1 have been&#xD;
      established in a First-in-human (FIH) study in adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of local and systemic reactions</measure>
    <time_frame>within 30 minutes to &gt;4 hours</time_frame>
    <description>Occurrence of immediate (≤ hour), early (1-4) and late (&gt; 4 hours) local and systemic reactions reactions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of treatment emergent adverse events</measure>
    <time_frame>Throughout study completion, an average 16 weeks</time_frame>
    <description>Treatment emergent adverse events will be collected by reporting of adverse events and by clinical relevant changes in laboratory values, vital signs, lung function and aluminum levels in plasma and urine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes immunoglobulin levels</measure>
    <time_frame>Before and after 4, 8 and 16 weeks of treatment</time_frame>
    <description>Serum specific and component specific immunoglobulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in basophil activation</measure>
    <time_frame>Before and after 16 weeks treatment</time_frame>
    <description>In vitro determination of basophil activation upon antigen stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in histamine release test</measure>
    <time_frame>Before and after 16 weeks treatment</time_frame>
    <description>Determination of histamine release and total cellular histamine content induced by peanut</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>HAL-MPE1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HAL-MPE1 placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>HAL-MPE1 placebo without modified peanut extract</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HAL-MPE1</intervention_name>
    <description>Weekly subcutaneous administrations of HAL-MPE1</description>
    <arm_group_label>HAL-MPE1</arm_group_label>
    <other_name>Modified peanut extract</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HAL-MPE1 placebo</intervention_name>
    <description>Weekly subcutaneous administrations of HAL-MPE1 placebo</description>
    <arm_group_label>HAL-MPE1 placebo</arm_group_label>
    <other_name>Placebo for modified peanut extract</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent/assent&#xD;
&#xD;
          -  Male or female subjects aged 5- 50 years&#xD;
&#xD;
          -  A well-documented medical history of systemic reactions after ingestion of peanut&#xD;
&#xD;
          -  Positive serum specific anti-peanut (&gt;5.0 kU/L) and Ara h 2 Immunoglobulin E&#xD;
             (IgE)-test (&gt;2.0 kU/L)&#xD;
&#xD;
          -  Skin prick test (SPT) to peanut ≥3 mm compared to negative control within the last 2&#xD;
             years&#xD;
&#xD;
          -  Forced expiratory volume at first second (FEV1)&gt;80% predicted (adults and adolescents)&#xD;
             or Peak expiratory flow(PEF)&gt;80% predicted (children)&#xD;
&#xD;
          -  Negative pregnancy test at screening for females of childbearing potential&#xD;
&#xD;
        Females of childbearing age must be using an effective method of contraception to prevent&#xD;
        pregnancy and agree to continue to practice an acceptable method of contraception for the&#xD;
        duration of participation in the study. Contraceptive measures considered adequate are:&#xD;
&#xD;
          -  hormonal contraceptives such as contraceptive pills, transdermal patches, intrauterine&#xD;
             device (IUD), intrauterine system (IUS) implant, or vaginal ring (started - least 4&#xD;
             weeks prior to Investigational Medicinal Product (IMP) administration)&#xD;
&#xD;
          -  double barrier methods: e.g. condom or occlusive cap (diaphragm or cervical/vault&#xD;
             caps) plus spermicidal agent&#xD;
&#xD;
          -  surgical sterilization of the female participant (removal of the uterus or ovaries or&#xD;
             tubal ligation)&#xD;
&#xD;
          -  participants who are postmenopausal (12 consecutive months without a period) for at&#xD;
             least 2 years&#xD;
&#xD;
          -  male partner sterilization (vasectomy with documentation of azoospermia) prior to the&#xD;
             female patient's entry into trial and is the sole sexual partner for that female&#xD;
             patient&#xD;
&#xD;
          -  sexual abstinence or having no sexual relationship with a man.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of severe anaphylaxis to peanut with the following symptoms:&#xD;
             hypotension, neurological compromise (collapse, loss of consciousness or incontinence)&#xD;
             after ingestion of peanuts&#xD;
&#xD;
          -  Baseline serum tryptase level &gt;20 µg/l&#xD;
&#xD;
          -  Known allergy or hypersensitivity to an excipient in the study drug or placebo&#xD;
&#xD;
          -  Clinical features of moderate or severe persistent asthma (as guided by the 2007 NHLBI&#xD;
             Guidelines and according to the opinion of the investigator)&#xD;
&#xD;
          -  Asthma with FEV1&lt;80% predicted (adults, adolescents) or PEF &lt;80% predicted (children)&#xD;
&#xD;
          -  Asthma Control Test (ACT) ≤ 19&#xD;
&#xD;
          -  Asthma attack/exacerbation within the last 3 months&#xD;
&#xD;
          -  Hospitalization due to asthma within the last year&#xD;
&#xD;
          -  Two or more courses of oral steroids within the last 6 months&#xD;
&#xD;
          -  History of intubation /mechanical ventilation due to allergies or asthma&#xD;
&#xD;
          -  Participation in any interventional study with peanut immunotherapy in the last year&#xD;
&#xD;
          -  Any specific immunotherapy (SCIT, Sublingual Immunotherapy (SLIT) or OIT) during the&#xD;
             study period&#xD;
&#xD;
          -  Severe immune disorders (including autoimmune diseases) and/or diseases requiring&#xD;
             immunosuppressive drugs&#xD;
&#xD;
          -  Presence of chronic urticaria, atopic dermatitis with flare or atopic dermatitis with&#xD;
             SCORAD&gt;40&#xD;
&#xD;
          -  Active malignancies or any malignant disease within the past 5 years&#xD;
&#xD;
          -  Severe (uncontrolled) diseases that could increase the risk for subjects participating&#xD;
             in the study, including but not limited to: any severe or unstable lung diseases;&#xD;
             endocrine diseases; clinically significant renal or hepatic diseases, renal&#xD;
             impairment, haematological disorders; severe ongoing symptomatic allergic diseases&#xD;
&#xD;
          -  History of cardiovascular disease, uncontrolled hypertension or arrhythmias&#xD;
&#xD;
          -  Diseases with a contraindication for the use of epinephrine (e.g. hyperthyroidism,&#xD;
             glaucoma)&#xD;
&#xD;
          -  Use of systemic steroids within 4 weeks before start of the study and during the study&#xD;
&#xD;
          -  Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors&#xD;
&#xD;
          -  Vaccination within one week before start of therapy or during study unless considered&#xD;
             necessary based on the opinion of the investigator.&#xD;
&#xD;
          -  Anti-IgE/anti-Tumor Necrosis Factor (TNF)/omalizumab therapy or any biologic&#xD;
             immunomodulatory therapy within the 6 months prior to inclusion and during the study&#xD;
&#xD;
          -  Participation in a clinical study with a new investigational drug within the last 3&#xD;
             months or for a biological within the last 6 months prior to or during the study&#xD;
&#xD;
          -  For female adolescents and adults of childbearing potential: Pregnancy (test performed&#xD;
             at screening), lactation or inadequate contraceptive measures for women of&#xD;
             child-bearing age (contraceptive measures considered adequate are: intrauterine&#xD;
             devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal&#xD;
             patches, hormonal vaginal devices or injections with prolonged release, sexual&#xD;
             abstinence or having no sexual relationship with a man)&#xD;
&#xD;
          -  Alcohol, drug or medication abuse within the past year&#xD;
&#xD;
          -  Any clinically significant abnormal laboratory parameter at screening&#xD;
&#xD;
          -  Lack or expected lack of cooperation or compliance&#xD;
&#xD;
          -  Unable to use the epinephrine pen correctly&#xD;
&#xD;
          -  Severe psychiatric, psychological, or neurological disorders&#xD;
&#xD;
          -  Subjects who are employees of the sponsor, institution or 1st degree relatives or&#xD;
             partners of the investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Wood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>John Hopkins Hospital Unversity-Divison of Pediatric Allergy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Sicherer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edwin Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Rheumatolory Allergy &amp; Immunology Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Hopkins Hospital University-Divison of Pediatric Allergy</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaffe Food Allergy Institute, 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>UNC Rheumatolory Allergy &amp; Immunology Clinic</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy, Asthma and Immunology Center</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Allergy &amp; Asthma Medical Professionals (STAAMP)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma, Inc.</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inflamax Research Limited</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L4W 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 17, 2020</last_update_submitted>
  <last_update_submitted_qc>February 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <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/NCT02991885
org study id: HAL-MPE1/0049
nct id: NCT02991885
lead sponsor: 
has dmc: Yes
The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1
      subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the
      safety and tolerability in adolescents and children with peanut allergy.
At the time of the study there was no effective treatment available for peanut allergy other
      than avoidance of peanut allergens. There was high unmet medical need for a disease modifying
      treatment for peanut allergy, especially for peanut allergic children, since this age group
      is at highest risk of peanut-related anaphylaxis requiring hospitalization. A chemically
      modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous
      administration has been developed. The safety and tolerability of HAL-MPE1 have been
      established in a First-in-human (FIH) study in adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of local and systemic reactions
time frame: within 30 minutes to >4 hours
description: Occurrence of immediate (≤ hour), early (1-4) and late (> 4 hours) local and systemic reactions reactions
measure: Occurrence of treatment emergent adverse events
time frame: Throughout study completion, an average 16 weeks
description: Treatment emergent adverse events will be collected by reporting of adverse events and by clinical relevant changes in laboratory values, vital signs, lung function and aluminum levels in plasma and urine
measure: Changes immunoglobulin levels
time frame: Before and after 4, 8 and 16 weeks of treatment
description: Serum specific and component specific immunoglobulin levels
measure: Changes in basophil activation
time frame: Before and after 16 weeks treatment
description: In vitro determination of basophil activation upon antigen stimulation
measure: Changes in histamine release test
time frame: Before and after 16 weeks treatment
description: Determination of histamine release and total cellular histamine content induced by peanut
arm group label: HAL-MPE1
arm group type: Experimental
description: HAL-MPE1 is an off-white to white liquid suspension containing modified peanut extract
arm group label: HAL-MPE1 placebo
arm group type: Placebo Comparator
description: HAL-MPE1 placebo without modified peanut extract
intervention type: Biological
intervention name: HAL-MPE1
description: Weekly subcutaneous administrations of HAL-MPE1
arm group label: HAL-MPE1
other name: Modified peanut extract
intervention type: Drug
intervention name: HAL-MPE1 placebo
description: Weekly subcutaneous administrations of HAL-MPE1 placebo
arm group label: HAL-MPE1 placebo
other name: Placebo for modified peanut extract
criteria: 
gender: All
minimum age: 5 Years
maximum age: 50 Years
healthy volunteers: No
last name: Robert Wood, MD
role: Principal Investigator
affiliation: John Hopkins Hospital Unversity-Divison of Pediatric Allergy
last name: Scott Sicherer, MD
role: Principal Investigator
affiliation: Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
last name: Edwin Kim, MD
role: Principal Investigator
affiliation: UNC Rheumatolory Allergy & Immunology Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
sharing ipd: No