<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/NCT02223039</url>
  </required_header>
  <id_info>
    <org_study_id>2014.002.01</org_study_id>
    <nct_id>NCT02223039</nct_id>
  </id_info>
  <brief_title>A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis</brief_title>
  <official_title>Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of AbGn-168H Administered by Intravenous Infusion to Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Double-blind, Placebo-controlled)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbGenomics B.V Taiwan Branch</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbGenomics B.V Taiwan Branch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center&#xD;
      study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The&#xD;
      objectives of this study is to investigate efficacy, safety, tolerability, and&#xD;
      pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients&#xD;
      with moderate to severe chronic plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>75% reduction in the Psoriasis Area Severity Index (PASI 75)</measure>
    <time_frame>at week 10</time_frame>
    <description>The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal Physical Examination finding</measure>
    <time_frame>At different time point for 20 weeks after the first treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>12 weeks after the first treatment</time_frame>
    <description>Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Vital Sign change</measure>
    <time_frame>At different time point for 20 weeks after the first treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal ECG finding</measure>
    <time_frame>At different time point for 20 weeks after the first treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal Clinical Laboratory parameters</measure>
    <time_frame>At different time point for 20 weeks after the first treatment</time_frame>
    <description>blood chemistry, hematology and urinalysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse Event</measure>
    <time_frame>At different time point for 20 weeks after the first treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2</measure>
    <time_frame>At different time point for 12 weeks after the first treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Moderate to Severe Chronic Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>AbGn-168H Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject to receive low dose of AbGn-168H intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AbGn-168H High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject to receive high dose of AbGn-168H intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subject to receive placebo intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AbGn-168H</intervention_name>
    <description>AbGn-168H monoclonal antibody</description>
    <arm_group_label>AbGn-168H High Dose</arm_group_label>
    <arm_group_label>AbGn-168H Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo of AbGn-168H</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 75 (inclusive), males or females&#xD;
&#xD;
          2. Body weight &lt; 140 kg&#xD;
&#xD;
          3. Patients with stable moderate to severe plaque-type psoriasis, no significant changes&#xD;
             within the past 6 months, involving ≥ 10% body surface area, with disease severity&#xD;
             PASI ≥ 10 at screening visit and visit 2.&#xD;
&#xD;
          4. Psoriasis disease duration of at least 6 months prior to screening&#xD;
&#xD;
          5. Patients must be candidates for systemic psoriasis treatment or phototherapy&#xD;
&#xD;
          6. Patient must give informed consent and sign an approved consent form prior to any&#xD;
             study procedures&#xD;
&#xD;
          7. Females of childbearing potential must have a negative pregnancy test result prior to&#xD;
             enrollment and agree to use a highly effective method of birth control during the&#xD;
             study. A highly effective method of birth control is defined as one which results in a&#xD;
             low failure rate (less than 1% per year).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with&#xD;
             drug-induced psoriasis&#xD;
&#xD;
          2. Evidence of current or previous clinically significant disease, medical condition&#xD;
             other than psoriasis, or finding of the medical examination (including vital signs and&#xD;
             ECG), that in the opinion of the Investigator, would compromise the safety of the&#xD;
             patient or the quality of the data. This criterion provides an opportunity for the&#xD;
             investigator to exclude patients based on clinical judgment, even if other eligibility&#xD;
             criteria are satisfied. (Psoriatic arthritis is not considered an exclusion)&#xD;
&#xD;
          3. HIV infection or a known HIV-related Malignancy.&#xD;
&#xD;
          4. Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and&#xD;
             undetectable anti-HBs Ab should also be excluded.&#xD;
&#xD;
          5. Tuberculosis or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects&#xD;
             previously received BCG vaccination or cannot receive TST can participate in the study&#xD;
             after showing negative responses in Interferon-Gamma Release Assays (IGRA).&#xD;
&#xD;
          6. History of malignancy in the past 5 years or suspicion of active malignant disease&#xD;
             except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ&#xD;
             of the cervix uteri.&#xD;
&#xD;
          7. History of allergy/hypersensitivity to a systemically administered biologic agent or&#xD;
             its excipients&#xD;
&#xD;
          8. Use of biologic agents or investigational drug within 8-12 weeks prior to treatment,&#xD;
             systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment,&#xD;
             or topical anti-psoriasis medications (except emollients) within 2 weeks prior to&#xD;
             treatment&#xD;
&#xD;
          9. Intake of restricted medications or other drugs considered likely to interfere with&#xD;
             the safe conduct of the study&#xD;
&#xD;
         10. Current alcohol abuse&#xD;
&#xD;
         11. Current drug abuse or positive drug screen at screening visit. Subjects with&#xD;
             legitimate medically supervised uses of the drugs which are not excluded for other&#xD;
             reasons can be enrolled.&#xD;
&#xD;
         12. Any blood donation or significant blood loss within 4 weeks prior to Visit 2&#xD;
&#xD;
         13. Excessive (e.g. competitive) physical activities (within 1 week prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
         14. Patients with any of the following laboratory values at screening and are considered&#xD;
             clinically significant by the investigators:&#xD;
&#xD;
               -  Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or&#xD;
                  neutrophil count, or platelet count &lt; LLN (below the lower limit of the reference&#xD;
                  normal range)&#xD;
&#xD;
               -  ALT, AST and/or total bilirubin &gt; 2.5xULN&#xD;
&#xD;
               -  Serum creatinine &gt; 1.5x ULN&#xD;
&#xD;
         15. Any clinically significant laboratory abnormalities other than those listed on&#xD;
             Exclusion Criteria 14, based on the investigator's medical assessment at screening&#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>Shih-Yao Lin, MD, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>AbGenmics B.V. Taiwan Branch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Lebwohl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alliance Dermatology &amp; MOHS Center, PC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest AR Clinical Trials Center, PLLC.</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DawesFretzin Clinical Research Group, LLC.</name>
      <address>
        <city>Indianaopolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Research</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research Practice PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Search of Rochester, Inc.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Trials Cente</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suzanne Bruce and Associates, P.A., The Center for Skin Research</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Dermatology School of Medicine Dermatology 4A330</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>May 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <disposition_first_submitted>February 17, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>March 15, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 14, 2016</disposition_first_posted>
  <last_update_submitted>March 15, 2016</last_update_submitted>
  <last_update_submitted_qc>March 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Dermatology</keyword>
  <keyword>Monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02223039
org study id: 2014.002.01
nct id: NCT02223039
lead sponsor: 
has dmc: No
This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center
      study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The
      objectives of this study is to investigate efficacy, safety, tolerability, and
      pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients
      with moderate to severe chronic plaque psoriasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 75% reduction in the Psoriasis Area Severity Index (PASI 75)
time frame: at week 10
description: The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.
measure: Number of participants with abnormal Physical Examination finding
time frame: At different time point for 20 weeks after the first treatment
measure: Cmax
time frame: 12 weeks after the first treatment
description: Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
measure: Number of participants with Vital Sign change
time frame: At different time point for 20 weeks after the first treatment
measure: Number of participants with abnormal ECG finding
time frame: At different time point for 20 weeks after the first treatment
measure: Number of participants with abnormal Clinical Laboratory parameters
time frame: At different time point for 20 weeks after the first treatment
description: blood chemistry, hematology and urinalysis
measure: Number of participants with Adverse Event
time frame: At different time point for 20 weeks after the first treatment
measure: T1/2
time frame: At different time point for 12 weeks after the first treatment
arm group label: AbGn-168H Low Dose
arm group type: Experimental
description: Subject to receive low dose of AbGn-168H intravenously
arm group label: AbGn-168H High Dose
arm group type: Experimental
description: Subject to receive high dose of AbGn-168H intravenously
arm group label: Placebo
arm group type: Placebo Comparator
description: Subject to receive placebo intravenously
intervention type: Biological
intervention name: AbGn-168H
description: AbGn-168H monoclonal antibody
arm group label: AbGn-168H High Dose
arm group label: AbGn-168H Low Dose
intervention type: Biological
intervention name: Placebo
description: Placebo of AbGn-168H
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shih-Yao Lin, MD, Ph.D
role: Study Director
affiliation: AbGenmics B.V. Taiwan Branch
last name: Mark Lebwohl, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Psoriasis