<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/NCT01732510</url>
  </required_header>
  <id_info>
    <org_study_id>8226-003</org_study_id>
    <secondary_id>2012-005560-95</secondary_id>
    <nct_id>NCT01732510</nct_id>
  </id_info>
  <brief_title>A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003)</brief_title>
  <official_title>A Phase Ib Randomized, Double-Blinded, Placebo-Controlled Multiple Rising Dose Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MK-8226 in Patients With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK),&#xD;
      pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe&#xD;
      atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum&#xD;
      tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to&#xD;
      determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define&#xD;
      safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies.&#xD;
      The study was terminated early due to business reasons on 08 May 2014; final results from an&#xD;
      analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety,&#xD;
      immunogenicity) are summarized.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1 of the study is a multiple rising dose assessment of the safety, tolerability, and&#xD;
      pharmacokinetics of MK-8226 for a period of 12 weeks followed by a 20-week off-treatment&#xD;
      follow-up period.&#xD;
&#xD;
      Part 2 of the study is an assessment of the safety, tolerability, and efficacy of MK-8226 for&#xD;
      12 weeks followed by a 20-week off-treatment follow-up period.&#xD;
&#xD;
      In Part 3 of the study, participants will be treated with MK-8226 for a period of 12 weeks&#xD;
      followed by a 20-week off-treatment follow-up period to evaluate pharmacokinetic and&#xD;
      pharmacokinetic correlations to assist with modeling the dose range planned for further&#xD;
      studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was prematurely stopped due to business reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">December 21, 2012</start_date>
  <completion_date type="Actual">October 20, 2014</completion_date>
  <primary_completion_date type="Actual">October 20, 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced at Least One Adverse Event</measure>
    <time_frame>Up to 32 Weeks</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to 12 Weeks</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2</measure>
    <time_frame>Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16</time_frame>
    <description>CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2</measure>
    <time_frame>Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16</time_frame>
    <description>CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration</measure>
    <time_frame>Days 1, 3, 5, 9, 14, 70, 72, 74, 84</time_frame>
    <description>AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration</measure>
    <time_frame>Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224</time_frame>
    <description>AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration</measure>
    <time_frame>Days 1, 3, 5, 9, 14, 70, 72, 74, 84</time_frame>
    <description>Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration</measure>
    <time_frame>Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84</time_frame>
    <description>CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration</measure>
    <time_frame>Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224</time_frame>
    <description>Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration</measure>
    <time_frame>Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224</time_frame>
    <description>t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 24</time_frame>
    <description>The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, Week 24</time_frame>
    <description>Percentage of participants achieving an IGA of atopic dermatitis of &quot;clear-0&quot; or &quot;almost clear-1&quot;. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2</measure>
    <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
    <description>The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant Pruritus in Study Part 2</measure>
    <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
    <description>Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant Sleep Disturbance in Study Part 2</measure>
    <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
    <description>Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With &gt;=50% Improvement in EASI Score</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Positive for Anti-Drug Antibody (ADA) Formation</measure>
    <time_frame>Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224</time_frame>
    <description>Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2</measure>
    <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
    <description>Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).</description>
  </other_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Part 1: MK-8226 0.3 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: MK-8226 1 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: MK-8226 3 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: MK-8226 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Placebo (pooled)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: MK-8226 3 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MK-8226</intervention_name>
    <description>MK-8226 administered IV at a weight-based dose every 2 weeks for 12 weeks.</description>
    <arm_group_label>Part 1: MK-8226 0.3 mg/kg</arm_group_label>
    <arm_group_label>Part 1: MK-8226 1 mg/kg</arm_group_label>
    <arm_group_label>Part 1: MK-8226 10 mg/kg</arm_group_label>
    <arm_group_label>Part 1: MK-8226 3 mg/kg</arm_group_label>
    <arm_group_label>Part 2: MK-8226 3 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
    <arm_group_label>Part 1: Placebo (pooled)</arm_group_label>
    <arm_group_label>Part 2: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body weight &gt;=40 kg&#xD;
&#xD;
          -  Clinical diagnosis of atopic dermatitis for at least 6 months prior&#xD;
&#xD;
          -  Candidate for systemic or phototherapy (i.e., failed topical treatment)&#xD;
&#xD;
          -  Moderate-to-severe disease as defined by Body Surface Area (BSA) ≥10%, EASI ≥12, and&#xD;
             IGA ≥3&#xD;
&#xD;
          -  No clinically significant abnormality on electrocardiogram&#xD;
&#xD;
          -  No history of active or latent tuberculosis (TB) and no signs or symptoms suggestive&#xD;
             of TB&#xD;
&#xD;
          -  No history of active or latent TB and no signs or symptoms suggestive of TB&#xD;
&#xD;
          -  History of inadequate response to a stable (≥ 1 month) regimen of topical&#xD;
             corticosteroids or calcineurin inhibitors within 3 months before the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent significant skin disease&#xD;
&#xD;
          -  Any significant organ dysfunction within 6 months prior&#xD;
&#xD;
          -  History of clinically significant heart disease&#xD;
&#xD;
          -  History of neoplastic disease&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Infection requiring oral antibiotics within 2 weeks prior&#xD;
&#xD;
          -  Receipt of a live virus vaccine within 4 weeks prior&#xD;
&#xD;
          -  Inability to refrain from topical or systemic therapy during course of the study&#xD;
&#xD;
          -  Had major surgery or donated or lost &gt;=1 unit of blood within 4 weeks prior&#xD;
&#xD;
          -  Participation in another study within 4 weeks prior&#xD;
&#xD;
          -  Current or regular user of illicit drugs or a history of drug or alcohol abuse within&#xD;
             1 year prior&#xD;
&#xD;
          -  Pregnant, breast-feeding, or anticipated to conceive during the course of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>February 26, 2016</results_first_submitted>
  <results_first_submitted_qc>May 2, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 9, 2016</results_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants were screened for study eligibility over 4 weeks prior to first dosing. Additional inclusion and exclusion criteria applied.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: MK-8226 0.3 mg/kg</title>
          <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: MK-8226 1 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Part 1: MK-8226 3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Part 1: MK-8226 10 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="P5">
          <title>Part 1: Placebo (Pooled)</title>
          <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="P6">
          <title>Part 2: MK-8226 3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="P7">
          <title>Part 2: Placebo</title>
          <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="13"/>
                <participants group_id="P7" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="13"/>
                <participants group_id="P7" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </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="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1: MK-8226 0.3 mg/kg</title>
          <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: MK-8226 1 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Part 1: MK-8226 3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Part 1: MK-8226 10 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Part 1: Placebo (Pooled)</title>
          <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B6">
          <title>Part 2: MK-8226 3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B7">
          <title>Part 2: Placebo</title>
          <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="B8">
          <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="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="8"/>
            <count group_id="B6" value="13"/>
            <count group_id="B7" value="8"/>
            <count group_id="B8" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.0" spread="11.8"/>
                    <measurement group_id="B2" value="30.8" spread="13.4"/>
                    <measurement group_id="B3" value="41.6" spread="12.6"/>
                    <measurement group_id="B4" value="34.7" spread="10.2"/>
                    <measurement group_id="B5" value="37.8" spread="14.2"/>
                    <measurement group_id="B6" value="38.3" spread="11.5"/>
                    <measurement group_id="B7" value="33.9" spread="12.9"/>
                    <measurement group_id="B8" value="38.0" spread="12.9"/>
                  </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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced at Least One Adverse Event</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
        <time_frame>Up to 32 Weeks</time_frame>
        <population>The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo (Pooled)</title>
            <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced at Least One Adverse Event</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
          <population>The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="10"/>
                    <measurement group_id="O7" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
        <description>An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
        <time_frame>Up to 12 Weeks</time_frame>
        <population>The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo (Pooled)</title>
            <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
          <description>An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
          <population>The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="8"/>
              </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 group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1</title>
        <description>Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo (Pooled)</title>
            <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1</title>
          <description>Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
          <population>The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.77" spread="6.17"/>
                    <measurement group_id="O2" value="-8.40" spread="9.39"/>
                    <measurement group_id="O3" value="-10.20" spread="7.23"/>
                    <measurement group_id="O4" value="-7.78" spread="8.35"/>
                    <measurement group_id="O5" value="-0.38" spread="6.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.015</p_value>
            <method>Constrained longitudinal data analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.87</ci_lower_limit>
            <ci_upper_limit>-2.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2</title>
        <description>CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.</description>
        <time_frame>Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2</title>
          <description>CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2</title>
        <description>CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.</description>
        <time_frame>Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2</title>
          <description>CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration</title>
        <description>AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
        <time_frame>Days 1, 3, 5, 9, 14, 70, 72, 74, 84</time_frame>
        <population>The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration</title>
          <description>AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
          <population>The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.</population>
          <units>μg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,7,8,10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1000" spread="18.2"/>
                    <measurement group_id="O2" value="3300" spread="29.3"/>
                    <measurement group_id="O3" value="9300" spread="19.1"/>
                    <measurement group_id="O4" value="31400" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (n=8,5,6,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2310" spread="11"/>
                    <measurement group_id="O2" value="8530" spread="15.4"/>
                    <measurement group_id="O3" value="21100" spread="28.8"/>
                    <measurement group_id="O4" value="82100" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration</title>
        <description>AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
        <time_frame>Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224</time_frame>
        <population>The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration</title>
          <description>AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
          <population>The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.</population>
          <units>μg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6460" spread="34.3"/>
                    <measurement group_id="O2" value="22600" spread="65.8"/>
                    <measurement group_id="O3" value="47100" spread="97.2"/>
                    <measurement group_id="O4" value="264000" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration</title>
        <description>Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
        <time_frame>Days 1, 3, 5, 9, 14, 70, 72, 74, 84</time_frame>
        <population>The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration</title>
          <description>Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
          <population>The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,8,8,10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.12" spread="21.9"/>
                    <measurement group_id="O2" value="21.6" spread="26.0"/>
                    <measurement group_id="O3" value="60.3" spread="18.0"/>
                    <measurement group_id="O4" value="200" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (n=8,6,6,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="9.63"/>
                    <measurement group_id="O2" value="42.4" spread="20.1"/>
                    <measurement group_id="O3" value="106" spread="19.6"/>
                    <measurement group_id="O4" value="398" spread="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration</title>
        <description>CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
        <time_frame>Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84</time_frame>
        <population>The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration</title>
          <description>CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
          <population>The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.</population>
          <units>mL/day/kg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.04" spread="11"/>
                    <measurement group_id="O2" value="2.81" spread="15.4"/>
                    <measurement group_id="O3" value="3.33" spread="28.8"/>
                    <measurement group_id="O4" value="2.9" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration</title>
        <description>Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
        <time_frame>Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224</time_frame>
        <population>The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration</title>
          <description>Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
          <population>The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.</population>
          <units>mL/kg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103" spread="27.6"/>
                    <measurement group_id="O2" value="122" spread="26.8"/>
                    <measurement group_id="O3" value="102" spread="62.1"/>
                    <measurement group_id="O4" value="120" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration</title>
        <description>t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
        <time_frame>Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224</time_frame>
        <population>The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration</title>
          <description>t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.</description>
          <population>The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.</population>
          <units>days</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="33.5"/>
                    <measurement group_id="O2" value="30" spread="15.9"/>
                    <measurement group_id="O3" value="24.7" spread="51.3"/>
                    <measurement group_id="O4" value="28.7" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2</title>
        <description>The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
        <time_frame>Baseline, Week 4, Week 8, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2</title>
          <description>The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2</title>
        <description>Percentage of participants achieving an IGA of atopic dermatitis of &quot;clear-0&quot; or &quot;almost clear-1&quot;. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2</title>
          <description>Percentage of participants achieving an IGA of atopic dermatitis of &quot;clear-0&quot; or &quot;almost clear-1&quot;. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2</title>
        <description>The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score.</description>
        <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2</title>
          <description>The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score.</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant Pruritus in Study Part 2</title>
        <description>Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).</description>
        <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant Pruritus in Study Part 2</title>
          <description>Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant Sleep Disturbance in Study Part 2</title>
        <description>Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).</description>
        <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant Sleep Disturbance in Study Part 2</title>
          <description>Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2</title>
        <description>Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.</description>
        <time_frame>Up to Week 12</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2</title>
          <description>Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2</title>
        <description>Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).</description>
        <time_frame>Baseline, Week 4, Week 12, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2</title>
          <description>Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With &gt;=50% Improvement in EASI Score</title>
        <description>The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &gt;=50% Improvement in EASI Score</title>
          <description>The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).</description>
          <population>No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Positive for Anti-Drug Antibody (ADA) Formation</title>
        <description>Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).</description>
        <time_frame>Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224</time_frame>
        <population>The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: MK-8226 0.3 mg/kg</title>
            <description>MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: MK-8226 1 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: MK-8226 10 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Part 1: Placebo (Pooled)</title>
            <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.</description>
          </group>
          <group group_id="O6">
            <title>Part 2: MK-8226 3 mg/kg</title>
            <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Part 2: Placebo</title>
            <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Positive for Anti-Drug Antibody (ADA) Formation</title>
          <description>Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).</description>
          <population>The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non Treatment emergent ADA positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment emergent ADA positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive: Max titer 1:10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive: Max titer 1:50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive: Neutralizing response positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 32 Weeks</time_frame>
      <desc>An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: MK-8226 0.3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: MK-8226 1 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Part 1: MK-8226 3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Part 1: MK-8226 10 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Part 1: Placebo (Pooled)</title>
          <description>Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="E6">
          <title>Part 2: MK-8226 3 mg/kg</title>
          <description>MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.</description>
        </group>
        <group group_id="E7">
          <title>Part 2: Placebo</title>
          <description>Placebo administered IV every 2 weeks for a period of 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</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="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="8" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="13"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Oral mucosal blistering</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Palatal swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gravitational oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Herpes ophthalmic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="6" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Superinfection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Streptococcus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal weight gain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </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="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fracture pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia areata</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </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>The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01732510
org study id: 8226-003
secondary id: 2012-005560-95
nct id: NCT01732510
lead sponsor: 
has dmc: No
This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK),
      pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe
      atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum
      tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to
      determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define
      safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies.
      The study was terminated early due to business reasons on 08 May 2014; final results from an
      analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety,
      immunogenicity) are summarized.
Part 1 of the study is a multiple rising dose assessment of the safety, tolerability, and
      pharmacokinetics of MK-8226 for a period of 12 weeks followed by a 20-week off-treatment
      follow-up period.

      Part 2 of the study is an assessment of the safety, tolerability, and efficacy of MK-8226 for
      12 weeks followed by a 20-week off-treatment follow-up period.

      In Part 3 of the study, participants will be treated with MK-8226 for a period of 12 weeks
      followed by a 20-week off-treatment follow-up period to evaluate pharmacokinetic and
      pharmacokinetic correlations to assist with modeling the dose range planned for further
      studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Who Experienced at Least One Adverse Event
time frame: Up to 32 Weeks
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
time frame: Up to 12 Weeks
description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
measure: Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1
time frame: Baseline, Week 12
description: Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).
measure: Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2
time frame: Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16
description: CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.
measure: Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2
time frame: Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16
description: CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.
measure: Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration
time frame: Days 1, 3, 5, 9, 14, 70, 72, 74, 84
description: AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
measure: AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration
time frame: Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
description: AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
measure: Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration
time frame: Days 1, 3, 5, 9, 14, 70, 72, 74, 84
description: Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
measure: Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration
time frame: Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84
description: CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
measure: Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration
time frame: Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
description: Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
measure: Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration
time frame: Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
description: t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
measure: Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2
time frame: Baseline, Week 4, Week 8, Week 24
description: The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).
measure: Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2
time frame: Baseline, Week 4, Week 8, Week 12, Week 24
description: Percentage of participants achieving an IGA of atopic dermatitis of "clear-0" or "almost clear-1". The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).
measure: Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2
time frame: Baseline, Week 4, Week 12, Week 24
description: The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score.
measure: Change From Baseline in Participant Pruritus in Study Part 2
time frame: Baseline, Week 4, Week 12, Week 24
description: Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).
measure: Change From Baseline in Participant Sleep Disturbance in Study Part 2
time frame: Baseline, Week 4, Week 12, Week 24
description: Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).
measure: Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2
time frame: Up to Week 12
description: Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.
measure: Percentage of Participants With >=50% Improvement in EASI Score
time frame: Baseline, Week 12, Week 24
description: The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).
measure: Number of Participants Positive for Anti-Drug Antibody (ADA) Formation
time frame: Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224
description: Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).
measure: Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2
time frame: Baseline, Week 4, Week 12, Week 24
description: Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).
arm group label: Part 1: MK-8226 0.3 mg/kg
arm group type: Experimental
description: MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
arm group label: Part 1: MK-8226 1 mg/kg
arm group type: Experimental
description: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
arm group label: Part 1: MK-8226 3 mg/kg
arm group type: Experimental
description: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
arm group label: Part 1: MK-8226 10 mg/kg
arm group type: Experimental
description: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
arm group label: Part 1: Placebo (pooled)
arm group type: Placebo Comparator
description: Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
arm group label: Part 2: MK-8226 3 mg/kg
arm group type: Experimental
description: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
arm group label: Part 2: Placebo
arm group type: Placebo Comparator
description: Placebo administered IV every 2 weeks for a period of 12 weeks.
intervention type: Drug
intervention name: MK-8226
description: MK-8226 administered IV at a weight-based dose every 2 weeks for 12 weeks.
arm group label: Part 1: MK-8226 0.3 mg/kg
arm group label: Part 1: MK-8226 1 mg/kg
arm group label: Part 1: MK-8226 10 mg/kg
arm group label: Part 1: MK-8226 3 mg/kg
arm group label: Part 2: MK-8226 3 mg/kg
intervention type: Drug
intervention name: Placebo
description: Placebo administered IV every 2 weeks for a period of 12 weeks.
arm group label: Part 1: Placebo (pooled)
arm group label: Part 2: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Austria
country: Canada
country: Denmark
country: Finland
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 