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/NCT05984784</url>
    </required_header>
    <id_info>
      <org_study_id>IMG-007-201</org_study_id>
      <nct_id>NCT05984784</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)</brief_title>
    <official_title>A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inmagene LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inmagene LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study is to evaluate the safety of IMG-007 in adults with&#xD;
        moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and&#xD;
        efficacy of IMG-007 in AD patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of&#xD;
        multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with&#xD;
        three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week&#xD;
        follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three&#xD;
        IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and&#xD;
        placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to&#xD;
        receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of Adverse Events in Participants</measure>
      <time_frame>Baseline, Week 24</time_frame>
      <description>To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Characterization</measure>
      <time_frame>Baseline, Week 24</time_frame>
      <description>To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Characterization</measure>
      <time_frame>Baseline, Week 24</time_frame>
      <description>To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of Eczema Area and Severity Index (EASI)</measure>
      <time_frame>Baseline, Week 12</time_frame>
      <description>To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Atopic Dermatitis</condition>
    <condition>Moderate-to-severe Atopic Dermatitis</condition>
    <condition>AD</condition>
    <arm_group>
      <arm_group_label>IMG-007 Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IMG-007 Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo will be administered intravenously 3 times over 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Drug: Placebo Intravenous Infusion</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IMG-007</intervention_name>
      <description>Drug: IMG-007 Intravenous Infusion</description>
      <arm_group_label>IMG-007 Dose 1</arm_group_label>
      <arm_group_label>IMG-007 Dose 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female aged ≥ 18 and &lt; 75 years.&#xD;
  &#xD;
            -  Moderate-to-severe AD.&#xD;
  &#xD;
            -  Documented history of inadequate response or lack of tolerability to a stable regimen&#xD;
               of one or more topical treatment before the Screening visit, or for whom topical&#xD;
               treatments are otherwise inadvisable.&#xD;
  &#xD;
            -  Female participants who are not pregnant or breastfeeding and meet at least one of the&#xD;
               following conditions: not of childbearing potential or of childbearing potential and&#xD;
               agrees to use a highly effective method of contraception.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Known hepatitis B, hepatitis C, or human immunodeficiency virus infection.&#xD;
  &#xD;
            -  Evidence of active or latent tuberculosis (TB).&#xD;
  &#xD;
            -  History of untreated or inadequately treated TB infection.&#xD;
  &#xD;
            -  Active infection requiring treatment with systemic antibiotics, antivirals,&#xD;
               antifungals, antiparasitics or antiprotozoals at the Screening visit.&#xD;
  &#xD;
            -  Active unstable pruritic skin conditions in addition to AD that would interfere with&#xD;
               the assessment of AD based on the investigator's clinical judgement.&#xD;
  &#xD;
            -  Other conditions or laboratory abnormality that could increase the risk associated&#xD;
               with study participation or could interfere with the interpretation of study results&#xD;
               and, in the judgment of the investigator, would make the patient inappropriate for&#xD;
               entry into the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Carina Freedman, M.S.</last_name>
      <phone>858-346-6927</phone>
      <email>freedmanc@inmagenebio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical Research Center of Miami II Inc</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33134</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Revival Research Institute, LLC</name>
        <address>
          <city>Troy</city>
          <state>Michigan</state>
          <zip>48084</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Markowitz Medical, LLC</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10128</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Central Sooner Research</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73170</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Paddington Testing Co, Inc</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19103</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IMG-007</keyword>
    <keyword>Atopic Dermatitis</keyword>
    <keyword>Dermatitis, Atopic</keyword>
    <keyword>Dermatitis</keyword>
    <keyword>Eczema</keyword>
    <keyword>Skin Diseases</keyword>
    <keyword>Immune System Diseases</keyword>
    <keyword>Dermatologic Agents</keyword>
    <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>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05984784
  org study id: IMG-007-201
  nct id: NCT05984784
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study is to evaluate the safety of IMG-007 in adults with
        moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and
        efficacy of IMG-007 in AD patients.
  This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of
        multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with
        three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week
        follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three
        IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and
        placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to
        receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Evaluation of Adverse Events in Participants
  time frame: Baseline, Week 24
  description: To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
  measure: Pharmacokinetic Characterization
  time frame: Baseline, Week 24
  description: To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants
  measure: Pharmacokinetic Characterization
  time frame: Baseline, Week 24
  description: To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants
  measure: Evaluation of Eczema Area and Severity Index (EASI)
  time frame: Baseline, Week 12
  description: To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)
  arm group label: IMG-007 Dose 1
  arm group type: Experimental
  description: IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
  arm group label: IMG-007 Dose 2
  arm group type: Experimental
  description: IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo will be administered intravenously 3 times over 4 weeks
  intervention type: Drug
  intervention name: Placebo
  description: Drug: Placebo Intravenous Infusion
  arm group label: Placebo
  intervention type: Drug
  intervention name: IMG-007
  description: Drug: IMG-007 Intravenous Infusion
  arm group label: IMG-007 Dose 1
  arm group label: IMG-007 Dose 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 74 Years
  healthy volunteers: No
  last name: Carina Freedman, M.S.
  phone: 858-346-6927
  email: freedmanc@inmagenebio.com
  facility: 
  status: Recruiting
  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: Dermatitis
  mesh term: Eczema
  sharing ipd: Undecided