<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/NCT01714726</url>
  </required_header>
  <id_info>
    <org_study_id>D5170C00001</org_study_id>
    <secondary_id>EudraCT number: 2012-004098-26</secondary_id>
    <secondary_id>2012-004098-26</secondary_id>
    <nct_id>NCT01714726</nct_id>
  </id_info>
  <brief_title>Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.</brief_title>
  <official_title>A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MedImmune Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to&#xD;
      placebo. Investigational product will be administered as intravenous infusion in double-blind&#xD;
      period, and as a subcutaneous injection in open-label period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled,&#xD;
      treatment period followed by a 100-week, open label, treatment period to evaluate short-term&#xD;
      efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to&#xD;
      severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the&#xD;
      investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially&#xD;
      receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the&#xD;
      12-week, double-blind, placebo-controlled, treatment period. At the completion of the&#xD;
      double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option&#xD;
      to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070&#xD;
      (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28&#xD;
      weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after&#xD;
      their last dose of IP for safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">December 14, 2016</completion_date>
  <primary_completion_date type="Actual">May 20, 2014</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (&lt;)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CDAI-70 Point Improvement at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CDAI Response at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of &lt; 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CDAI Remission at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of &lt; 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CDAI-100 Point Improvement at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CDAI Total Score at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period</measure>
    <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
    <description>An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period</measure>
    <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
    <description>An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs in Open-label Period</measure>
    <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
    <description>An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TESAEs in Open-label Period</measure>
    <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
    <description>An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period</measure>
    <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
    <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period</measure>
    <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
    <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period</measure>
    <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
    <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period</measure>
    <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
    <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period</measure>
    <time_frame>Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8</time_frame>
    <description>Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Mean Serum Concentration of MEDI2070 in Open-label Period</measure>
    <time_frame>Pre-dose on Weeks 12, 24, and 112</time_frame>
    <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period</measure>
    <time_frame>Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)</time_frame>
    <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ADA Positive to MEDI2070 in Open-label Period</measure>
    <time_frame>Up to 28 week post last dose (approximately 140 weeks)</time_frame>
    <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MEDI2070 iv infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo iv infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open-label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI2070</intervention_name>
    <description>1 iv infusion on Week 0 and Week 4</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>open-label</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>1 iv infusion on Week 0 and Week 4</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.&#xD;
&#xD;
          -  Men or women age 18 - 65 years at the time of screening.&#xD;
&#xD;
          -  Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity&#xD;
             Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.&#xD;
&#xD;
          -  No known history of active tuberculosis (TB).&#xD;
&#xD;
          -  Received at least one anti-TNFα agent for the treatment of CD and did not initially&#xD;
             respond.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Presence of ileostomy and/or colostomy.&#xD;
&#xD;
          -  Short bowel syndrome.&#xD;
&#xD;
          -  Bowel perforation or obstruction.&#xD;
&#xD;
          -  History of cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hammond</city>
        <state>Louisiana</state>
        <zip>70403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belton</city>
        <state>Missouri</state>
        <zip>64012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <state>Ohio</state>
        <zip>45806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
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        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <reference>
    <citation>Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.</citation>
    <PMID>28390867</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>September 21, 2018</results_first_submitted>
  <results_first_submitted_qc>March 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2019</results_first_posted>
  <disposition_first_submitted>April 19, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>April 19, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 20, 2017</disposition_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MEDI2070</keyword>
  <keyword>inflammatory bowel disease</keyword>
  <keyword>moderate to severe Crohn's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Out of 174 screened subjects, 53 were considered screen failures. A total of 121 subjects were randomized, of which 2 did not receive study drug. Those 2 subjects were not included in the mITT population; therefore, those subjects are not counted in the participant flow.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
        </group>
        <group group_id="P2">
          <title>Experimental: MEDI2070 700mg</title>
          <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
        </group>
        <group group_id="P3">
          <title>Placebo/MEDI2070 210mg</title>
          <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
        </group>
        <group group_id="P4">
          <title>MEDI2070 700mg/MEDI2070 210mg</title>
          <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blinded Induction Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="59"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subject not in open label period</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <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="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other</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="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</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="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Developed specific withdrawal criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
        </group>
        <group group_id="B2">
          <title>Experimental: MEDI2070 700mg</title>
          <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
        </group>
        <group group_id="B3">
          <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="60"/>
            <count group_id="B2" value="59"/>
            <count group_id="B3" value="119"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="38.1" spread="10.7"/>
                    <measurement group_id="B2" value="34.8" spread="11.1"/>
                    <measurement group_id="B3" value="36.45" spread="10.9"/>
                  </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="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CDAI-70 Point Improvement at Week 8</title>
        <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
        <time_frame>Week 8</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CDAI-70 Point Improvement at Week 8</title>
          <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="52.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CDAI Response at Week 12</title>
        <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of &lt; 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
        <time_frame>Week 12</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CDAI Response at Week 12</title>
          <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of &lt; 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3"/>
                    <measurement group_id="O2" value="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8</title>
        <description>A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (&lt;)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.</description>
        <time_frame>Week 8</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8</title>
          <description>A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (&lt;)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7"/>
                    <measurement group_id="O2" value="49.2"/>
                  </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>=0.01</p_value>
            <method>Regression, Logistic</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>22.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.3</ci_lower_limit>
            <ci_upper_limit>36.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CDAI Remission at Week 8</title>
        <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of &lt; 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.</description>
        <time_frame>Week 8</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CDAI Remission at Week 8</title>
          <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of &lt; 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CDAI-100 Point Improvement at Week 8</title>
        <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
        <time_frame>Week 8</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CDAI-100 Point Improvement at Week 8</title>
          <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CDAI Total Score at Week 8</title>
        <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.</description>
        <time_frame>Week 8</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CDAI Total Score at Week 8</title>
          <description>The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-62.7" spread="13.5"/>
                    <measurement group_id="O2" value="-99.0" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period</title>
        <description>An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.</description>
        <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period</title>
          <description>An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period</title>
        <description>An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.</description>
        <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period</title>
          <description>An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs in Open-label Period</title>
        <description>An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
        <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
        <population>Value of 0 represents the double-blind portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs in Open-label Period</title>
          <description>An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
          <population>Value of 0 represents the double-blind portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TESAEs in Open-label Period</title>
        <description>An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
        <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
        <population>Value of 0 represents the double-blind portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TESAEs in Open-label Period</title>
          <description>An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
          <population>Value of 0 represents the double-blind portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period</title>
        <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.</description>
        <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period</title>
          <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine analysis Abnormal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Abnormality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine bilirubin increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Proteinuria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period</title>
        <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
        <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
        <population>Value of 0 represents the double-blind portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period</title>
          <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
          <population>Value of 0 represents the double-blind portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red cell distribution width increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chromaturia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood uric acid increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypokalaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic enzyme increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period</title>
        <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point.</description>
        <time_frame>From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period</title>
          <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period</title>
        <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
        <time_frame>From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)</time_frame>
        <population>Value of 0 represents the double-blind portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period</title>
          <description>The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.</description>
          <population>Value of 0 represents the double-blind portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period</title>
        <description>Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA).</description>
        <time_frame>Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8</time_frame>
        <population>Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the open-label portion of the trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period</title>
          <description>Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA).</description>
          <population>Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the open-label portion of the trial.</population>
          <units>mcg/ML</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 Post-dose (60, 58)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frame</measurement>
                    <measurement group_id="O2" value="186" spread="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 Pre-dose (54, 53)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frame</measurement>
                    <measurement group_id="O2" value="37.4" spread="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 Post-dose (52, 51)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frame</measurement>
                    <measurement group_id="O2" value="209" spread="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 Pre-dose (55, 51)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frame</measurement>
                    <measurement group_id="O2" value="39.2" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Mean Serum Concentration of MEDI2070 in Open-label Period</title>
        <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA).</description>
        <time_frame>Pre-dose on Weeks 12, 24, and 112</time_frame>
        <population>Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the double-blind portion of the trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Mean Serum Concentration of MEDI2070 in Open-label Period</title>
          <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA).</description>
          <population>Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the double-blind portion of the trial.</population>
          <units>mcg/ML</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 Pre-dose (51, 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="51"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="NA" spread="NA">Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames</measurement>
                    <measurement group_id="O4" value="16.7" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 Pre-dose (48, 43)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="14.5" spread="7.0"/>
                    <measurement group_id="O4" value="15.1" spread="6.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 112 Pre-dose (24, 20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="18.3" spread="7.73"/>
                    <measurement group_id="O4" value="22.4" spread="7.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period</title>
        <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.</description>
        <time_frame>Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)</time_frame>
        <population>Value of 0 represents the open-label portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period</title>
          <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.</description>
          <population>Value of 0 represents the open-label portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ADA Positive to MEDI2070 in Open-label Period</title>
        <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.</description>
        <time_frame>Up to 28 week post last dose (approximately 140 weeks)</time_frame>
        <population>Value of 0 represents the double-blind portion of the trial</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O2">
            <title>Experimental: MEDI2070 700mg</title>
            <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
          </group>
          <group group_id="O3">
            <title>Placebo/MEDI2070 210mg</title>
            <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
          </group>
          <group group_id="O4">
            <title>MEDI2070 700mg/MEDI2070 210mg</title>
            <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ADA Positive to MEDI2070 in Open-label Period</title>
          <description>The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.</description>
          <population>Value of 0 represents the double-blind portion of the trial</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From study drug administration (Day 1) to 36 weeks post last dose (approximately 148 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received IV placebo concentrate and solvent for injection/infusion at week 0 and week 4.</description>
        </group>
        <group group_id="E2">
          <title>Experimental: MEDI2070 700mg</title>
          <description>Participants received IV MEDI2070 700mg concentrate and solvent for injection/infusion at week 0 and week 4.</description>
        </group>
        <group group_id="E3">
          <title>Placebo/MEDI2070 210mg</title>
          <description>Participants randomized to placebo arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution injection/infusion every 4 week (Q4W) during the 100-week, open-label treatment period.</description>
        </group>
        <group group_id="E4">
          <title>MEDI2070 700mg/MEDI2070 210mg</title>
          <description>Subjects randomized to MEDI2070 700mg arm in double-blind period received 210 mg SC MEDI2070 concentrate and solvent for solution for injection/infusion Q4W during the 100-week, open-label treatment period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intestinal anastomosis complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Accidental exposure to product</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="38" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="43" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="42" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="59"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="59"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="59"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="52"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. (Note that this agreement language may appear in the study protocol)</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>A formal statistical analysis was not performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Study Information Center</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</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/NCT01714726
org study id: D5170C00001
secondary id: EudraCT number: 2012-004098-26
secondary id: 2012-004098-26
nct id: NCT01714726
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to
      placebo. Investigational product will be administered as intravenous infusion in double-blind
      period, and as a subcutaneous injection in open-label period
This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled,
      treatment period followed by a 100-week, open label, treatment period to evaluate short-term
      efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to
      severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the
      investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially
      receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the
      12-week, double-blind, placebo-controlled, treatment period. At the completion of the
      double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option
      to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070
      (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28
      weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after
      their last dose of IP for safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8
time frame: Week 8
description: A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.
measure: Percentage of Participants With CDAI-70 Point Improvement at Week 8
time frame: Week 8
description: The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.
measure: Percentage of Participants With CDAI Response at Week 12
time frame: Week 12
description: The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.
measure: Percentage of Participants With CDAI Remission at Week 8
time frame: Week 8
description: The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.
measure: Percentage of Participants With CDAI-100 Point Improvement at Week 8
time frame: Week 8
description: The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.
measure: Change From Baseline in CDAI Total Score at Week 8
time frame: Week 8
description: The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period
time frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
description: An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period
time frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
description: An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.
measure: Number of Participants With TEAEs in Open-label Period
time frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
description: An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
measure: Number of Participants With TESAEs in Open-label Period
time frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
description: An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
measure: Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period
time frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
description: The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period
time frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
description: The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
measure: Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period
time frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)
description: The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point.
measure: Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period
time frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)
description: The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.
measure: Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period
time frame: Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8
description: Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA).
measure: Maximum Mean Serum Concentration of MEDI2070 in Open-label Period
time frame: Pre-dose on Weeks 12, 24, and 112
description: The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA).
measure: Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period
time frame: Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)
description: The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.
measure: Number of Participants With ADA Positive to MEDI2070 in Open-label Period
time frame: Up to 28 week post last dose (approximately 140 weeks)
description: The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.
arm group label: 1
arm group type: Experimental
description: MEDI2070 iv infusion
arm group label: 2
arm group type: Placebo Comparator
description: placebo iv infusion
arm group label: open-label
arm group type: Experimental
description: MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
intervention type: Drug
intervention name: MEDI2070
description: 1 iv infusion on Week 0 and Week 4
arm group label: 1
arm group label: open-label
intervention type: Drug
intervention name: placebo
description: 1 iv infusion on Week 0 and Week 4
arm group label: 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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country: Canada
country: Czechia
country: France
country: Germany
country: Hungary
country: Italy
country: Poland
country: Spain
country: United States
country: Czech Republic
citation: Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.
PMID: 28390867
responsible party type: Sponsor
mesh term: Crohn Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A formal statistical analysis was not performed.
point of contact: 