<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/NCT03038971</url>
  </required_header>
  <id_info>
    <org_study_id>16-290-0010</org_study_id>
    <nct_id>NCT03038971</nct_id>
  </id_info>
  <brief_title>Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections</brief_title>
  <official_title>A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woodmont Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ORA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Woodmont Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic&#xD;
      injections of 2 different dose levels of the investigational short and tall ragweed product.&#xD;
      Biomarkers will be assessed at baseline and at multiple time points post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor withdrew IND from FDA&#xD;
  </why_stopped>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Actual">April 29, 2017</completion_date>
  <primary_completion_date type="Actual">April 29, 2017</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>Adverse events (reported, elicited and observed)</measure>
    <time_frame>47 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale</measure>
    <time_frame>47 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale</measure>
    <time_frame>47 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale</measure>
    <time_frame>47 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale</measure>
    <time_frame>47 weeks</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Conjunctival Allergen Challenge (CAC) Outcome; concentration of allergen required to elicit a positive ocular allergic reaction will be compared from baseline to 24 weeks</measure>
    <time_frame>Baseline and up to 24 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Nasal Allergen Challenge (NAC) Outcome; concentration of allergen required to elicit a positive nasal allergic reaction will be compared from baseline to 24 weeks</measure>
    <time_frame>Baseline and up to 24 weeks</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Concentration 1: Short and Tall Ragweed Mix</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Concentration 2: Short and Tall Ragweed Mix</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo: Saline with 0.4% Phenol</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dose Level 1</intervention_name>
    <description>Short and Tall Ragweed Mix</description>
    <arm_group_label>Concentration 1: Short and Tall Ragweed Mix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dose Level 2</intervention_name>
    <description>Short and Tall Ragweed Mix</description>
    <arm_group_label>Concentration 2: Short and Tall Ragweed Mix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline with 0.4% Phenol</description>
    <arm_group_label>Placebo: Saline with 0.4% Phenol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 16 and 65 years old&#xD;
&#xD;
          -  Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen&#xD;
&#xD;
          -  Positive skin test reaction at screening visit to short ragweed extract&#xD;
&#xD;
          -  Avoid disallowed medications&#xD;
&#xD;
          -  Females of childbearing potential must have pregnancy test and must agree to use an&#xD;
             acceptable method of birth control&#xD;
&#xD;
          -  Have blood and urine analysis within normal limits&#xD;
&#xD;
          -  Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen&#xD;
&#xD;
          -  Have a specific IgE ≥ 0.70 kU/L to short ragweed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have ocular or nasal conditions that could affect subject safety or trial parameters&#xD;
&#xD;
          -  Have a presence of an active sinus, nasal, or ocular infections&#xD;
&#xD;
          -  Have had allergy immunotherapy to ragweed pollen&#xD;
&#xD;
          -  Have a compromised lung function ≤80% of predicted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Schoemmell</last_name>
    <role>Study Director</role>
    <affiliation>ORA, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andover Eye Associates</name>
      <address>
        <city>Andover</city>
        <state>Massachusetts</state>
        <zip>01810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 21, 2018</last_update_submitted>
  <last_update_submitted_qc>February 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</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>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03038971
org study id: 16-290-0010
nct id: NCT03038971
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic
      injections of 2 different dose levels of the investigational short and tall ragweed product.
      Biomarkers will be assessed at baseline and at multiple time points post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events (reported, elicited and observed)
time frame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
time frame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
time frame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
time frame: 47 weeks
measure: Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
time frame: 47 weeks
measure: Conjunctival Allergen Challenge (CAC) Outcome; concentration of allergen required to elicit a positive ocular allergic reaction will be compared from baseline to 24 weeks
time frame: Baseline and up to 24 weeks
measure: Nasal Allergen Challenge (NAC) Outcome; concentration of allergen required to elicit a positive nasal allergic reaction will be compared from baseline to 24 weeks
time frame: Baseline and up to 24 weeks
arm group label: Concentration 1: Short and Tall Ragweed Mix
arm group type: Other
arm group label: Concentration 2: Short and Tall Ragweed Mix
arm group type: Other
arm group label: Placebo: Saline with 0.4% Phenol
arm group type: Other
intervention type: Biological
intervention name: Dose Level 1
description: Short and Tall Ragweed Mix
arm group label: Concentration 1: Short and Tall Ragweed Mix
intervention type: Biological
intervention name: Dose Level 2
description: Short and Tall Ragweed Mix
arm group label: Concentration 2: Short and Tall Ragweed Mix
intervention type: Biological
intervention name: Placebo
description: Saline with 0.4% Phenol
arm group label: Placebo: Saline with 0.4% Phenol
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Emily Schoemmell
role: Study Director
affiliation: ORA, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
sharing ipd: Undecided