<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/NCT02237196</url>
  </required_header>
  <id_info>
    <org_study_id>DAIT ITN057AD</org_study_id>
    <secondary_id>CATNIP</secondary_id>
    <nct_id>NCT02237196</nct_id>
  </id_info>
  <brief_title>Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy</brief_title>
  <official_title>Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy (ITN057AD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Immune Tolerance Network (ITN)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</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>
      This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an&#xD;
      investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin]&#xD;
      antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat&#xD;
      allergen.The objective of the study is to determine whether one year of immunotherapy&#xD;
      combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will implement the concept referred to as &quot;allergen-plus,&quot; which aims to enhance&#xD;
      the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with&#xD;
      other anti-inflammatory or immune-modulating agents. Thymic stromal lymphopoietin (TSLP) is a&#xD;
      cytokine which appears to be instrumental in both initiating and maintaining allergic&#xD;
      sensitivity to antigens, and Immune Tolerance Network (ITN) investigators hypothesize that&#xD;
      blocking TSLP during the administration of cat immunotherapy will induce durable immune&#xD;
      changes that lead to tolerance.&#xD;
&#xD;
      CATNIP will be conducted at multiple sites in the US and enroll cat-allergic adults who will&#xD;
      be randomized to four possible treatment groups: immunotherapy plus MEDI9929/AMG 157,&#xD;
      immunotherapy plus placebo, placebo plus MEDI9929/AMG 157, or two corresponding placebos.&#xD;
      This study is specifically enrolling cat allergic individuals who do not live with cats in&#xD;
      order to limit exposure to the allergen outside of the study. Treatment will be given for&#xD;
      about one year, followed by one year off therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2015</start_date>
  <completion_date type="Actual">March 4, 2019</completion_date>
  <primary_completion_date type="Actual">March 4, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)</measure>
    <time_frame>0 to 1 hour of the NAC at Week 104</time_frame>
    <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin Prick Test Endpoint Titration</measure>
    <time_frame>15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104</time_frame>
    <description>A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Early Phase Response (EPR) to Intradermal Testing</measure>
    <time_frame>15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104</time_frame>
    <description>Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Late Phase Response (LPR) to Intradermal Testing</measure>
    <time_frame>6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104</time_frame>
    <description>Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)</measure>
    <time_frame>0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104</time_frame>
    <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)</measure>
    <time_frame>0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104</time_frame>
    <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)</measure>
    <time_frame>Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104</time_frame>
    <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)</measure>
    <time_frame>0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104</time_frame>
    <description>PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC</measure>
    <time_frame>Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104</time_frame>
    <description>PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Cat Allergy</condition>
  <condition>Cat Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>AMG 157+Cat Immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AMG 157 Placebo+Cat Immunotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AMG 157+Cat Immunotherapy Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo-Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AMG 157</intervention_name>
    <description>AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.</description>
    <arm_group_label>AMG 157+Cat Immunotherapy</arm_group_label>
    <arm_group_label>AMG 157+Cat Immunotherapy Placebo</arm_group_label>
    <other_name>MEDI9929/AMG 157</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cat Immunotherapy</intervention_name>
    <description>A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
    <arm_group_label>AMG 157 Placebo+Cat Immunotherapy</arm_group_label>
    <arm_group_label>AMG 157+Cat Immunotherapy</arm_group_label>
    <other_name>Cat Allergen Extract</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cat Immunotherapy Placebo</intervention_name>
    <description>Placebo for allergen-specific immunotherapy administered subcutaneously</description>
    <arm_group_label>AMG 157+Cat Immunotherapy Placebo</arm_group_label>
    <arm_group_label>Placebo-Placebo</arm_group_label>
    <other_name>Placebo for Cat Immunotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AMG 157 Placebo</intervention_name>
    <description>Placebo for AMG 157 administered intravenously</description>
    <arm_group_label>AMG 157 Placebo+Cat Immunotherapy</arm_group_label>
    <arm_group_label>Placebo-Placebo</arm_group_label>
    <other_name>Placebo for AMG157</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of moderate-severe allergic rhinitis caused by cat exposure for at least 2 yrs&#xD;
&#xD;
          -  Skin prick test wheal &gt;/=5 mm to standardized cat extract&#xD;
&#xD;
          -  Immunoglobulin E (IgE) &gt;/=0.7 kU/L (class 2) to cat extract&#xD;
&#xD;
          -  Screening nasal allergen challenge in which:&#xD;
&#xD;
             *TNSS is &lt;/= 3 after the 0 concentration (vehicle control only) dose,&#xD;
&#xD;
          -  TNSS increase is &lt;/=1 from the TNSS prior to allergen administration to the TNSS after&#xD;
             the 0 concentration (vehicle control only) dose,&#xD;
&#xD;
               -  TNSS is &gt;/=8 after the highest dose, and&#xD;
&#xD;
               -  Between the first non-zero dose and 10 minutes after the highest dose,either:&#xD;
&#xD;
          -  &gt;/=3 sneezes are counted or&#xD;
&#xD;
          -  &gt;20% drop in PNIF is recorded&#xD;
&#xD;
          -  Body mass index (BMI) between 1 and 32 kg/m^2, inclusive at screening&#xD;
&#xD;
          -  Clinically acceptable physical examination and electrocardiogram (ECG) results&#xD;
             (12-lead reporting RR, PR, QRS, QT and QTcF) prior to Day 0 based on the opinion of&#xD;
             the investigator&#xD;
&#xD;
          -  Adequate renal function (defined by creatinine clearance &gt;80 mL/min using the&#xD;
             Cockcroft Gault equation)&#xD;
&#xD;
          -  For women of childbearing age, a willingness to use a highly effective form of&#xD;
             contraception for five months after last dose of study medication. Highly effective&#xD;
             methods of birth control include abstinence, vasectomy by the male partner, or a&#xD;
             condom with spermicide in combination with either hormonal birth control, IUD or&#xD;
             barrier methods used by the woman.&#xD;
&#xD;
          -  For men with female partners of childbearing potential, agreement not to donate sperm&#xD;
             and to inform their female partner of their participation in this clinical study and&#xD;
             use highly effective methods of birth control for five months after last dose of study&#xD;
             medication. Highly effective methods of birth control include abstinence, vasectomy,&#xD;
             or a condom with spermicide in combination with either hormonal birth control,&#xD;
             Intrauterine device (IUD) or barrier methods used by the woman.&#xD;
&#xD;
          -  The ability to give informed consent and comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prebronchodilator Forced Expiratory Volume at one second (FEV1) less than 0% of&#xD;
             predicted value at screening visit&#xD;
&#xD;
          -  History of moderate or higher Allergic Rhinitis and its Impact on Asthma (ARIA)&#xD;
             severity classification for allergic rhinitis in the last year due to allergens other&#xD;
             than cat&#xD;
&#xD;
          -  History of asthma meeting the National Asthma Education and Prevention Program (NAEPP)&#xD;
             Expert Panel Report 3 (EPR3) classification of mild-persistent or worse in the past&#xD;
             year, other than with cat exposure, requiring regular inhaled corticosteroids for &gt;4&#xD;
             weeks per year&#xD;
&#xD;
          -  History of serious chronic medical conditions which might interfere with treatment or&#xD;
             assessments&#xD;
&#xD;
          -  History of emergency visit or hospital admission for asthma in the previous 12 months&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  History of significant recurrent acute sinusitis, defined as 2 episodes/yr for the&#xD;
             last 2 years, all of which required antibiotic treatment&#xD;
&#xD;
          -  History of chronic sinusitis, defined as a sinus symptoms lasting &gt;12 weeks that&#xD;
             includes &gt;/=2 major factors or 1 major factor and 2 minor factors. Major factors are&#xD;
             defined as facial pain or pressure, nasal obstruction or blockage, purulent or&#xD;
             discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of&#xD;
             smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain,&#xD;
             cough, and ear pain, pressure, or fullness.&#xD;
&#xD;
          -  History of systemic disease affecting the immune system such as autoimmune diseases,&#xD;
             immune complex disease, or immunodeficiency, where, in the opinion of the study&#xD;
             physician, participation in the trial would pose a risk or significant effect on the&#xD;
             immune system&#xD;
&#xD;
          -  Diabetes (Type I or II)&#xD;
&#xD;
          -  Evidence of any active or suspected bacterial, viral, fungal or parasitic infection(s)&#xD;
             within 30 days prior to randomization&#xD;
&#xD;
          -  High risk of parasitic disease as judged by the investigator&#xD;
&#xD;
          -  Positive QuantiFERON(R) tuberculin test UNLESS the potential subject has been treated&#xD;
             with appropriate chemoprophylaxis&#xD;
&#xD;
          -  Exposure to an individual with active tuberculosis within six months from&#xD;
             randomization&#xD;
&#xD;
          -  Subjects tested positive for HIV antibody, Hep B surface antigen, or Hep C antibody&#xD;
&#xD;
          -  At randomization, current symptoms of, or treatment for, upper respiratory tract&#xD;
             infection, acute sinusitis, acute otitis media, or other relevant infectious process;&#xD;
             serous otitis media is not an exclusion criterion. Participants may be re-evaluated&#xD;
             for eligibility after symptoms resolve.&#xD;
&#xD;
          -  History of malignancy of any type, including basal cell and squamous cell cancers of&#xD;
             the skin, within 5 years of enrollment&#xD;
&#xD;
          -  Tobacco smoking (ANY) within the last year or a history of &gt;/=10 pack years&#xD;
&#xD;
          -  Previous immunotherapy treatment with cat allergen within the previous 10 yrs&#xD;
&#xD;
          -  Any history of grade 4 anaphylaxis due to any cause as defined by the CTCAE grading&#xD;
             criteria for immunotherapy&#xD;
&#xD;
          -  History of bleeding disorders or treatment with anticoagulation therapy&#xD;
&#xD;
          -  Treatment with omalizumab within 6 months prior to randomization&#xD;
&#xD;
          -  Currently taking any of the following medications: beta blockers; tricyclic&#xD;
             antidepressants; monoamine oxidase inhibitors; or anti-IgE monoclonal antibody&#xD;
             treatment&#xD;
&#xD;
          -  Ongoing systemic immunosuppressive treatment&#xD;
&#xD;
          -  History of intolerance to the study therapy, rescue medications, or their excipients&#xD;
&#xD;
          -  For women of childbearing age a positive serum or urine pregnancy test with&#xD;
             sensitivity of &lt;50 mIU/mL within 72 hours before the start of study therapy&#xD;
&#xD;
          -  The use of any investigational drug within 6 months of randomization&#xD;
&#xD;
          -  The presence of any medical condition that the investigator deems incompatible with&#xD;
             participation in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Corren, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Asthma &amp; Allergy Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina, Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Prospects Clinical Research Institute, P.C.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASTHMA Inc. Clinical Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Wisconsin, Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.niaid.nih.gov/</url>
    <description>National Institute of Allergy and Infectious Diseases (NIAID)</description>
  </link>
  <link>
    <url>https://www.niaid.nih.gov/about/dait</url>
    <description>Division of Allergy, Immunology, and Transplantation (DAIT)</description>
  </link>
  <link>
    <url>http://www.immunetolerance.org/</url>
    <description>Immune Tolerance Network (ITN) Website</description>
  </link>
  <link>
    <url>https://www.aaaai.org/practice-resources/practice-tools/immunotherapy-forms/immunotherapy-systemic</url>
    <description>World Allergy Organization (WAO) Subcutaneous Immunotherapy Systemic Reaction Grading System</description>
  </link>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>March 18, 2020</results_first_submitted>
  <results_first_submitted_qc>April 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2020</results_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cat-allergic</keyword>
  <keyword>cat immunotherapy</keyword>
  <keyword>anti-thymic stromal lymphopoietin (anti-TSLP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The plan is to share data in upon completion of the study in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02237196/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02237196/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants ages 18 years to 65 years with a history of moderate to severe allergic rhinitis caused by cat exposure were recruited from 9 clinical centers in the United States from March 3, 2015 to March 21, 2017.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>AMG 157+Cat Immunotherapy</title>
          <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
        </group>
        <group group_id="P2">
          <title>AMG 157 Placebo+Cat Immunotherapy</title>
          <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
        </group>
        <group group_id="P3">
          <title>AMG 157+Cat Immunotherapy Placebo</title>
          <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
        </group>
        <group group_id="P4">
          <title>Placebo-Placebo</title>
          <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site Error</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AMG 157+Cat Immunotherapy</title>
          <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
        </group>
        <group group_id="B2">
          <title>AMG 157 Placebo+Cat Immunotherapy</title>
          <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
        </group>
        <group group_id="B3">
          <title>AMG 157+Cat Immunotherapy Placebo</title>
          <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
        </group>
        <group group_id="B4">
          <title>Placebo-Placebo</title>
          <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="28"/>
            <count group_id="B5" value="121"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.4" spread="10.52"/>
                    <measurement group_id="B2" value="30.4" spread="8.86"/>
                    <measurement group_id="B3" value="31.9" spread="9.92"/>
                    <measurement group_id="B4" value="30.5" spread="10.91"/>
                    <measurement group_id="B5" value="30.5" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)</title>
        <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.</description>
        <time_frame>0 to 1 hour of the NAC at Week 104</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)</title>
          <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.</description>
          <population>Intent-to-treat</population>
          <units>Total Nasal Symptom Score * Hour</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" lower_limit="1.73" upper_limit="3.19"/>
                    <measurement group_id="O2" value="2.81" lower_limit="2.13" upper_limit="3.49"/>
                    <measurement group_id="O3" value="3.66" lower_limit="2.74" upper_limit="4.59"/>
                    <measurement group_id="O4" value="3.10" lower_limit="2.11" upper_limit="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.314</p_value>
            <method>Longitudinal repeated measures analysis</method>
            <method_desc>Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.5038</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.51</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Prick Test Endpoint Titration</title>
        <description>A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application.</description>
        <time_frame>15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat population was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Prick Test Endpoint Titration</title>
          <description>A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat population was used in the reporting of secondary endpoints.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.11" lower_limit="40.74" upper_limit="49.49"/>
                    <measurement group_id="O2" value="46.29" lower_limit="38.88" upper_limit="53.69"/>
                    <measurement group_id="O3" value="45.01" lower_limit="40.17" upper_limit="49.84"/>
                    <measurement group_id="O4" value="44.49" lower_limit="38.25" upper_limit="50.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.92" lower_limit="38.08" upper_limit="53.77"/>
                    <measurement group_id="O2" value="50.25" lower_limit="42.22" upper_limit="58.28"/>
                    <measurement group_id="O3" value="43.33" lower_limit="38.20" upper_limit="48.47"/>
                    <measurement group_id="O4" value="44.06" lower_limit="38.31" upper_limit="49.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.24" lower_limit="33.48" upper_limit="45.00"/>
                    <measurement group_id="O2" value="35.44" lower_limit="29.39" upper_limit="41.49"/>
                    <measurement group_id="O3" value="44.01" lower_limit="38.56" upper_limit="49.47"/>
                    <measurement group_id="O4" value="41.58" lower_limit="35.59" upper_limit="47.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.12" lower_limit="23.94" upper_limit="36.30"/>
                    <measurement group_id="O2" value="22.08" lower_limit="16.33" upper_limit="27.84"/>
                    <measurement group_id="O3" value="45.85" lower_limit="40.13" upper_limit="51.57"/>
                    <measurement group_id="O4" value="44.74" lower_limit="39.09" upper_limit="50.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.96" lower_limit="16.41" upper_limit="27.51"/>
                    <measurement group_id="O2" value="22.21" lower_limit="14.45" upper_limit="29.98"/>
                    <measurement group_id="O3" value="43.93" lower_limit="38.13" upper_limit="49.72"/>
                    <measurement group_id="O4" value="43.40" lower_limit="37.27" upper_limit="49.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.34" lower_limit="15.48" upper_limit="27.19"/>
                    <measurement group_id="O2" value="16.84" lower_limit="12.69" upper_limit="20.99"/>
                    <measurement group_id="O3" value="34.92" lower_limit="27.39" upper_limit="42.45"/>
                    <measurement group_id="O4" value="39.64" lower_limit="30.51" upper_limit="48.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.21" lower_limit="16.31" upper_limit="28.11"/>
                    <measurement group_id="O2" value="25.13" lower_limit="20.18" upper_limit="30.08"/>
                    <measurement group_id="O3" value="32.28" lower_limit="24.67" upper_limit="39.90"/>
                    <measurement group_id="O4" value="39.32" lower_limit="30.39" upper_limit="48.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.88" lower_limit="19.95" upper_limit="33.81"/>
                    <measurement group_id="O2" value="26.67" lower_limit="21.68" upper_limit="31.66"/>
                    <measurement group_id="O3" value="39.82" lower_limit="32.24" upper_limit="47.39"/>
                    <measurement group_id="O4" value="36.19" lower_limit="29.33" upper_limit="43.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Early Phase Response (EPR) to Intradermal Testing</title>
        <description>Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application.</description>
        <time_frame>15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Early Phase Response (EPR) to Intradermal Testing</title>
          <description>Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.05" lower_limit="15.25" upper_limit="16.8"/>
                    <measurement group_id="O2" value="15.34" lower_limit="14.42" upper_limit="16.26"/>
                    <measurement group_id="O3" value="15.98" lower_limit="15.12" upper_limit="16.85"/>
                    <measurement group_id="O4" value="16.52" lower_limit="15.66" upper_limit="17.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.21" lower_limit="10.13" upper_limit="12.29"/>
                    <measurement group_id="O2" value="11.65" lower_limit="10.86" upper_limit="12.43"/>
                    <measurement group_id="O3" value="14.15" lower_limit="13.09" upper_limit="15.21"/>
                    <measurement group_id="O4" value="14.64" lower_limit="13.21" upper_limit="16.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.65" lower_limit="9.53" upper_limit="11.78"/>
                    <measurement group_id="O2" value="10.69" lower_limit="9.72" upper_limit="11.67"/>
                    <measurement group_id="O3" value="13.35" lower_limit="12.33" upper_limit="14.36"/>
                    <measurement group_id="O4" value="14.21" lower_limit="12.40" upper_limit="16.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.04" lower_limit="9.80" upper_limit="12.28"/>
                    <measurement group_id="O2" value="12.09" lower_limit="10.80" upper_limit="13.38"/>
                    <measurement group_id="O3" value="12.63" lower_limit="11.55" upper_limit="13.70"/>
                    <measurement group_id="O4" value="13.21" lower_limit="11.60" upper_limit="14.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Late Phase Response (LPR) to Intradermal Testing</title>
        <description>Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application.</description>
        <time_frame>6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Late Phase Response (LPR) to Intradermal Testing</title>
          <description>Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.62" lower_limit="26.62" upper_limit="38.62"/>
                    <measurement group_id="O2" value="23.41" lower_limit="17.23" upper_limit="29.59"/>
                    <measurement group_id="O3" value="27.22" lower_limit="19.33" upper_limit="35.11"/>
                    <measurement group_id="O4" value="34.65" lower_limit="27.27" upper_limit="42.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.50" lower_limit="8.41" upper_limit="18.59"/>
                    <measurement group_id="O2" value="13.83" lower_limit="8.93" upper_limit="18.74"/>
                    <measurement group_id="O3" value="26.44" lower_limit="18.68" upper_limit="34.20"/>
                    <measurement group_id="O4" value="31.28" lower_limit="23.01" upper_limit="39.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.67" lower_limit="9.17" upper_limit="18.18"/>
                    <measurement group_id="O2" value="10.06" lower_limit="6.12" upper_limit="13.99"/>
                    <measurement group_id="O3" value="23.23" lower_limit="16.17" upper_limit="30.28"/>
                    <measurement group_id="O4" value="29.36" lower_limit="18.62" upper_limit="40.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.58" lower_limit="11.05" upper_limit="20.12"/>
                    <measurement group_id="O2" value="14.48" lower_limit="10.37" upper_limit="18.59"/>
                    <measurement group_id="O3" value="25.40" lower_limit="18.27" upper_limit="32.53"/>
                    <measurement group_id="O4" value="32.38" lower_limit="21.08" upper_limit="43.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)</title>
        <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive.</description>
        <time_frame>0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)</title>
          <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>Peak Total Nasal Symptom Score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.31" lower_limit="8.92" upper_limit="9.71"/>
                    <measurement group_id="O2" value="9.52" lower_limit="9.05" upper_limit="9.98"/>
                    <measurement group_id="O3" value="9.17" lower_limit="8.76" upper_limit="9.57"/>
                    <measurement group_id="O4" value="8.96" lower_limit="8.59" upper_limit="9.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" lower_limit="2.74" upper_limit="4.55"/>
                    <measurement group_id="O2" value="5.41" lower_limit="4.30" upper_limit="6.52"/>
                    <measurement group_id="O3" value="6.78" lower_limit="5.63" upper_limit="7.92"/>
                    <measurement group_id="O4" value="7.96" lower_limit="7.04" upper_limit="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.04" lower_limit="2.16" upper_limit="3.91"/>
                    <measurement group_id="O2" value="4.73" lower_limit="3.63" upper_limit="5.83"/>
                    <measurement group_id="O3" value="6.09" lower_limit="4.78" upper_limit="7.39"/>
                    <measurement group_id="O4" value="6.75" lower_limit="5.72" upper_limit="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.24" lower_limit="3.33" upper_limit="5.15"/>
                    <measurement group_id="O2" value="4.80" lower_limit="3.63" upper_limit="5.97"/>
                    <measurement group_id="O3" value="6.82" lower_limit="5.32" upper_limit="8.32"/>
                    <measurement group_id="O4" value="5.83" lower_limit="4.58" upper_limit="7.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" lower_limit="3.59" upper_limit="5.74"/>
                    <measurement group_id="O2" value="6.16" lower_limit="5.13" upper_limit="7.19"/>
                    <measurement group_id="O3" value="6.85" lower_limit="5.30" upper_limit="8.40"/>
                    <measurement group_id="O4" value="6.12" lower_limit="4.46" upper_limit="7.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)</title>
        <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.</description>
        <time_frame>0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)</title>
          <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>Total Nasal Symptom Score * Hour</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.49" lower_limit="4.99" upper_limit="6.00"/>
                    <measurement group_id="O2" value="5.59" lower_limit="5.00" upper_limit="6.18"/>
                    <measurement group_id="O3" value="4.91" lower_limit="4.27" upper_limit="5.55"/>
                    <measurement group_id="O4" value="5.55" lower_limit="4.96" upper_limit="6.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" lower_limit="1.36" upper_limit="2.29"/>
                    <measurement group_id="O2" value="2.71" lower_limit="2.13" upper_limit="3.30"/>
                    <measurement group_id="O3" value="3.38" lower_limit="2.69" upper_limit="4.08"/>
                    <measurement group_id="O4" value="4.09" lower_limit="3.44" upper_limit="4.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" lower_limit="1.03" upper_limit="2.03"/>
                    <measurement group_id="O2" value="2.34" lower_limit="1.74" upper_limit="2.93"/>
                    <measurement group_id="O3" value="3.07" lower_limit="2.33" upper_limit="3.81"/>
                    <measurement group_id="O4" value="3.77" lower_limit="2.99" upper_limit="4.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.04" lower_limit="1.42" upper_limit="2.66"/>
                    <measurement group_id="O2" value="2.31" lower_limit="1.45" upper_limit="3.17"/>
                    <measurement group_id="O3" value="3.23" lower_limit="2.37" upper_limit="4.09"/>
                    <measurement group_id="O4" value="2.88" lower_limit="1.93" upper_limit="3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" lower_limit="1.73" upper_limit="3.19"/>
                    <measurement group_id="O2" value="2.81" lower_limit="2.13" upper_limit="3.49"/>
                    <measurement group_id="O3" value="3.66" lower_limit="2.74" upper_limit="4.59"/>
                    <measurement group_id="O4" value="3.10" lower_limit="2.11" upper_limit="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)</title>
        <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.</description>
        <time_frame>Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)</title>
          <description>TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>Total Nasal Symptom Score * Hour</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" lower_limit="0.86" upper_limit="1.86"/>
                    <measurement group_id="O2" value="1.52" lower_limit="0.86" upper_limit="2.17"/>
                    <measurement group_id="O3" value="1.13" lower_limit="0.70" upper_limit="1.57"/>
                    <measurement group_id="O4" value="1.25" lower_limit="0.81" upper_limit="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="0.13" upper_limit="0.47"/>
                    <measurement group_id="O2" value="0.67" lower_limit="0.29" upper_limit="1.05"/>
                    <measurement group_id="O3" value="0.54" lower_limit="0.11" upper_limit="0.97"/>
                    <measurement group_id="O4" value="0.90" lower_limit="0.50" upper_limit="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" lower_limit="0.18" upper_limit="0.78"/>
                    <measurement group_id="O2" value="0.60" lower_limit="0.20" upper_limit="0.99"/>
                    <measurement group_id="O3" value="0.24" lower_limit="0.06" upper_limit="0.42"/>
                    <measurement group_id="O4" value="0.73" lower_limit="0.14" upper_limit="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" lower_limit="0.21" upper_limit="1.17"/>
                    <measurement group_id="O2" value="1.02" lower_limit="0.26" upper_limit="1.78"/>
                    <measurement group_id="O3" value="0.53" lower_limit="0.20" upper_limit="0.85"/>
                    <measurement group_id="O4" value="0.76" lower_limit="-0.17" upper_limit="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)</title>
        <description>PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC.</description>
        <time_frame>0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)</title>
          <description>PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>L/min * Hour</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.14" lower_limit="-25.62" upper_limit="-4.66"/>
                    <measurement group_id="O2" value="-10.66" lower_limit="-20.28" upper_limit="-1.04"/>
                    <measurement group_id="O3" value="-12.48" lower_limit="-24.05" upper_limit="-0.91"/>
                    <measurement group_id="O4" value="-10.25" lower_limit="-20.01" upper_limit="-0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.88" lower_limit="-11.19" upper_limit="5.44"/>
                    <measurement group_id="O2" value="2.26" lower_limit="-6.53" upper_limit="11.05"/>
                    <measurement group_id="O3" value="-11.04" lower_limit="-20.13" upper_limit="-1.95"/>
                    <measurement group_id="O4" value="-8.02" lower_limit="-22.30" upper_limit="6.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.65" lower_limit="-19.69" upper_limit="2.39"/>
                    <measurement group_id="O2" value="-4.90" lower_limit="-14.67" upper_limit="4.86"/>
                    <measurement group_id="O3" value="-0.80" lower_limit="-10.86" upper_limit="9.25"/>
                    <measurement group_id="O4" value="-8.70" lower_limit="-17.90" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.35" lower_limit="-25.34" upper_limit="2.63"/>
                    <measurement group_id="O2" value="-11.90" lower_limit="-23.05" upper_limit="-0.75"/>
                    <measurement group_id="O3" value="-9.13" lower_limit="-24.08" upper_limit="5.83"/>
                    <measurement group_id="O4" value="-13.09" lower_limit="-30.47" upper_limit="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC</title>
        <description>PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.</description>
        <time_frame>Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104</time_frame>
        <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>AMG 157+Cat Immunotherapy</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>AMG 157 Placebo+Cat Immunotherapy</title>
            <description>Placebo for AMG 157 of similar appearance will be administered every four weeks.&#xD;
Cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
          <group group_id="O3">
            <title>AMG 157+Cat Immunotherapy Placebo</title>
            <description>AMG 157 will be administered every four weeks.&#xD;
Placebo for Cat immunotherapy will be administered weekly.&#xD;
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously</description>
          </group>
          <group group_id="O4">
            <title>Placebo-Placebo</title>
            <description>Placebo for AMG 157 will be administered every four weeks.&#xD;
Placebo for cat immunotherapy will be administered weekly.&#xD;
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously&#xD;
AMG 157 Placebo: Placebo for AMG 157 administered intravenously</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC</title>
          <description>PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.</description>
          <population>A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.</population>
          <units>L/min * Hour</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52.24" lower_limit="-64.31" upper_limit="-40.17"/>
                    <measurement group_id="O2" value="-53.44" lower_limit="-63.87" upper_limit="43.00"/>
                    <measurement group_id="O3" value="-42.49" lower_limit="-53.30" upper_limit="-31.68"/>
                    <measurement group_id="O4" value="-50.03" lower_limit="-62.32" upper_limit="-37.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.34" lower_limit="-29.10" upper_limit="-7.57"/>
                    <measurement group_id="O2" value="-17.35" lower_limit="-26.53" upper_limit="-8.17"/>
                    <measurement group_id="O3" value="-40.42" lower_limit="-52.09" upper_limit="-28.75"/>
                    <measurement group_id="O4" value="-53.97" lower_limit="-68.85" upper_limit="-39.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.29" lower_limit="-38.24" upper_limit="12.35"/>
                    <measurement group_id="O2" value="-23.42" lower_limit="-33.78" upper_limit="-13.07"/>
                    <measurement group_id="O3" value="-35.87" lower_limit="-51.51" upper_limit="-20.24"/>
                    <measurement group_id="O4" value="-44.71" lower_limit="-54.89" upper_limit="-34.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.93" lower_limit="-42.14" upper_limit="21.73"/>
                    <measurement group_id="O2" value="-24.55" lower_limit="-36.66" upper_limit="12.44"/>
                    <measurement group_id="O3" value="-37.56" lower_limit="-52.55" upper_limit="-22.57"/>
                    <measurement group_id="O4" value="-42.26" lower_limit="-59.70" upper_limit="-24.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.41" lower_limit="-61.54" upper_limit="-25.29"/>
                    <measurement group_id="O2" value="-35.98" lower_limit="-49.21" upper_limit="-22.75"/>
                    <measurement group_id="O3" value="-49.01" lower_limit="-62.18" upper_limit="-35.84"/>
                    <measurement group_id="O4" value="-52.42" lower_limit="-69.07" upper_limit="-35.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <desc>Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population.&#xD;
1. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).</desc>
      <group_list>
        <group group_id="E1">
          <title>AMG 157+Cat Immunotherapy</title>
          <description>AMG 157 administered every four weeks and Cat immunotherapy administered weekly</description>
        </group>
        <group group_id="E2">
          <title>AMG 157 Placebo+Cat Immunotherapy</title>
          <description>Placebo for AMG 157 administered every four weeks and Cat immunotherapy administered weekly</description>
        </group>
        <group group_id="E3">
          <title>AMG 157+Cat Immunotherapy Placebo</title>
          <description>AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly</description>
        </group>
        <group group_id="E4">
          <title>Placebo-Placebo</title>
          <description>Placebo for AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MEDDRA V17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>All-Cause Mortality</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDDRA V17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to animal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="36" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Injection site hypersensitivity</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E3" events="17" subjects_affected="9" subjects_at_risk="29"/>
                <counts group_id="E4" events="16" subjects_affected="9" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E3" events="10" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E2" events="7" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="12" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E3" events="15" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>None listed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director, Clinical Research Operations Program</name_or_title>
      <organization>DAIT/NIAID</organization>
      <phone>301-594-7669</phone>
      <email>DAITClinicalTrialsGov@niaid.nih.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02237196
org study id: DAIT ITN057AD
secondary id: CATNIP
nct id: NCT02237196
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an
      investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin]
      antibody being co-developed by Amgen and MedImmune) can lead to lasting tolerance to cat
      allergen.The objective of the study is to determine whether one year of immunotherapy
      combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
This study will implement the concept referred to as "allergen-plus," which aims to enhance
      the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with
      other anti-inflammatory or immune-modulating agents. Thymic stromal lymphopoietin (TSLP) is a
      cytokine which appears to be instrumental in both initiating and maintaining allergic
      sensitivity to antigens, and Immune Tolerance Network (ITN) investigators hypothesize that
      blocking TSLP during the administration of cat immunotherapy will induce durable immune
      changes that lead to tolerance.

      CATNIP will be conducted at multiple sites in the US and enroll cat-allergic adults who will
      be randomized to four possible treatment groups: immunotherapy plus MEDI9929/AMG 157,
      immunotherapy plus placebo, placebo plus MEDI9929/AMG 157, or two corresponding placebos.
      This study is specifically enrolling cat allergic individuals who do not live with cats in
      order to limit exposure to the allergen outside of the study. Treatment will be given for
      about one year, followed by one year off therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)
time frame: 0 to 1 hour of the NAC at Week 104
description: TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.
measure: Skin Prick Test Endpoint Titration
time frame: 15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104
description: A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application.
measure: Skin Early Phase Response (EPR) to Intradermal Testing
time frame: 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104
description: Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application.
measure: Skin Late Phase Response (LPR) to Intradermal Testing
time frame: 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104
description: Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application.
measure: Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
time frame: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104
description: TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive.
measure: Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
time frame: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104
description: TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.
measure: Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)
time frame: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104
description: TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.
measure: Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)
time frame: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104
description: PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC.
measure: Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
time frame: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104
description: PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.
arm group label: AMG 157+Cat Immunotherapy
arm group type: Experimental
description: AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
arm group label: AMG 157 Placebo+Cat Immunotherapy
arm group type: Active Comparator
description: Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
arm group label: AMG 157+Cat Immunotherapy Placebo
arm group type: Experimental
description: AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
arm group label: Placebo-Placebo
arm group type: Placebo Comparator
description: Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
intervention type: Biological
intervention name: AMG 157
description: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
arm group label: AMG 157+Cat Immunotherapy
arm group label: AMG 157+Cat Immunotherapy Placebo
other name: MEDI9929/AMG 157
intervention type: Biological
intervention name: Cat Immunotherapy
description: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
arm group label: AMG 157 Placebo+Cat Immunotherapy
arm group label: AMG 157+Cat Immunotherapy
other name: Cat Allergen Extract
intervention type: Biological
intervention name: Cat Immunotherapy Placebo
description: Placebo for allergen-specific immunotherapy administered subcutaneously
arm group label: AMG 157+Cat Immunotherapy Placebo
arm group label: Placebo-Placebo
other name: Placebo for Cat Immunotherapy
intervention type: Biological
intervention name: AMG 157 Placebo
description: Placebo for AMG 157 administered intravenously
arm group label: AMG 157 Placebo+Cat Immunotherapy
arm group label: Placebo-Placebo
other name: Placebo for AMG157
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jonathan Corren, MD
role: Study Chair
affiliation: University of California, Los Angeles
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.niaid.nih.gov/
description: National Institute of Allergy and Infectious Diseases (NIAID)
url: https://www.niaid.nih.gov/about/dait
description: Division of Allergy, Immunology, and Transplantation (DAIT)
url: http://www.immunetolerance.org/
description: Immune Tolerance Network (ITN) Website
url: https://www.aaaai.org/practice-resources/practice-tools/immunotherapy-forms/immunotherapy-systemic
description: World Allergy Organization (WAO) Subcutaneous Immunotherapy Systemic Reaction Grading System
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Immunomodulating Agents
mesh term: Immunologic Factors
sharing ipd: Yes
ipd description: The plan is to share data in upon completion of the study in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: None listed
point of contact: 