xml: <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/NCT06005792</url>
    </required_header>
    <id_info>
      <org_study_id>XmAb27564-02</org_study_id>
      <nct_id>NCT06005792</nct_id>
    </id_info>
    <brief_title>Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis</brief_title>
    <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of Hte Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xencor, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xencor, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following&#xD;
        multiple doses among participants with plaque psoriasis and atopic dermatitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose&#xD;
        (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with&#xD;
        mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic&#xD;
        dermatitis. All patients will receive a total of 4 doses of study drug or placebo,&#xD;
        administered subcutaneously every 2 weeks. A one year, open-label extension is available to&#xD;
        qualifying patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 10, 2022</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">May 2026</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564</measure>
      <time_frame>Day 57</time_frame>
      <description>Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To characterize pharmacokinetics</measure>
      <time_frame>Day 57</time_frame>
      <description>Pharmacokinetics will be assessed by serum XmAb27564 concentrations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To characterize pharmacodynamics</measure>
      <time_frame>Day 57</time_frame>
      <description>Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Psoriasis</condition>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>Plaque Psoriasis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Atopic Dermatitis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>XmAb27564</intervention_name>
      <description>Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).</description>
      <arm_group_label>Atopic Dermatitis</arm_group_label>
      <arm_group_label>Plaque Psoriasis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).</description>
      <arm_group_label>Atopic Dermatitis</arm_group_label>
      <arm_group_label>Plaque Psoriasis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The main inclusion and exclusion criteria include, but are not limited to, the following:&#xD;
  &#xD;
            -  Have active mild-to-severe plaque psoriasis or moderate-to-severe atopic dermatitis&#xD;
               according to study-specific criteria&#xD;
  &#xD;
            -  Weight between 40 to 150 kg, inclusive&#xD;
  &#xD;
            -  No topical treatments for psoriasis or atopic dermatitis for 2 weeks before&#xD;
               randomization&#xD;
  &#xD;
            -  No phototherapy for psoriasis for 4 weeks before randomization&#xD;
  &#xD;
            -  Washout of oral treatments for psoriasis or atopic dermatitis for 4 weeks before&#xD;
               randomization&#xD;
  &#xD;
            -  Washout of biologic treatments for psoriasis or atopic dermatitis for 12 weeks before&#xD;
               randomization&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures (including skin biopsies) and&#xD;
               availability for the duration of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a history of active asthma within 5 years of screening, except those&#xD;
               that have well controlled asthma symptoms at screening visit.&#xD;
  &#xD;
            -  Patients who have had any prior investigational treatment with IL-2 therapies&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ralph Zitnik, MD</last_name>
      <role>Study Director</role>
      <affiliation>Executive Medical Director, Clinical Development, Xencor, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ralph Zitnik, MD</last_name>
      <phone>650 996 5321</phone>
      <email>rzitnik@xencor.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Seven Lueder-Powerss</last_name>
      <email>slueder-powers@xencor.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Clinical Trials Research Institute</name>
        <address>
          <city>Thousand Oaks</city>
          <state>California</state>
          <zip>91320</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>J&amp;S Studies, Inc</name>
        <address>
          <city>College Station</city>
          <state>Texas</state>
          <zip>77845</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Trials of Texas, LLC</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Center for Clinical Studies, LTD. LLP</name>
        <address>
          <city>Webster</city>
          <state>Texas</state>
          <zip>77598</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Psoriasis</keyword>
    <keyword>Plaque Psoriasis</keyword>
    <keyword>Atopic Dermatitis</keyword>
    <keyword>Eczema</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis, Atopic</mesh_term>
      <mesh_term>Psoriasis</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005792
  org study id: XmAb27564-02
  nct id: NCT06005792
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following
        multiple doses among participants with plaque psoriasis and atopic dermatitis.
  This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose
        (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with
        mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic
        dermatitis. All patients will receive a total of 4 doses of study drug or placebo,
        administered subcutaneously every 2 weeks. A one year, open-label extension is available to
        qualifying patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
  time frame: Day 57
  description: Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's
  measure: To characterize pharmacokinetics
  time frame: Day 57
  description: Pharmacokinetics will be assessed by serum XmAb27564 concentrations
  measure: To characterize pharmacodynamics
  time frame: Day 57
  description: Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood
  arm group label: Plaque Psoriasis
  arm group type: Experimental
  arm group label: Atopic Dermatitis
  arm group type: Experimental
  intervention type: Biological
  intervention name: XmAb27564
  description: Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).
  arm group label: Atopic Dermatitis
  arm group label: Plaque Psoriasis
  intervention type: Biological
  intervention name: Placebo
  description: Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).
  arm group label: Atopic Dermatitis
  arm group label: Plaque Psoriasis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ralph Zitnik, MD
  role: Study Director
  affiliation: Executive Medical Director, Clinical Development, Xencor, Inc.
  last name: Ralph Zitnik, MD
  phone: 650 996 5321
  email: rzitnik@xencor.com
  last name: Seven Lueder-Powerss
  email: slueder-powers@xencor.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Psoriasis
  mesh term: Dermatitis
  mesh term: Eczema