<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/NCT02243787</url>
  </required_header>
  <id_info>
    <org_study_id>COVA322-SAD-Psoriasis-001</org_study_id>
    <nct_id>NCT02243787</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis</brief_title>
  <official_title>A Randomised, Double-blind, Sequential, Ascending Single-dose Study to Evaluate Safety, Tolerability, Biological Activity, and Systemic Exposure of COVA322, a Bispecific TNF-α / IL-17A Antibody Fusion Protein, in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Covagen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Covagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomised, double-blind, placebo-controlled, sequential, ascending&#xD;
      single-dose, parallel group study to evaluate safety, tolerability, biological activity, and&#xD;
      systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A)&#xD;
      antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis.&#xD;
      Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v.&#xD;
      infusion, followed by 12 weeks of evaluation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical&#xD;
    study.&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <primary_completion_date type="Actual">September 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>The safety and tolerability of COVA322 will be assessed by monitoring the occurrence of local and systemic adverse events or abnormalities as identified by physical examinations, safety lab, vital parameters, ECG and immune response/antibodies to COVA322.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>COVA322</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single i.v. infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single i.v. infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COVA322</intervention_name>
    <arm_group_label>COVA322</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects of any ethnic origin; women must be of non-childbearing&#xD;
             potential&#xD;
&#xD;
          -  Aged between 18 to 65 yrs inclusive&#xD;
&#xD;
          -  Body weight of ≥ 40 kg and body mass index between 19 - 32 kg/m2 inclusive&#xD;
&#xD;
          -  Established diagnosis of moderate to severe plaque psoriasis for at least 6 months&#xD;
             prior to screening. The patients must meet all of the following criteria:&#xD;
&#xD;
          -  Psoriasis involving ≥ 10% of body surface area&#xD;
&#xD;
          -  Requirement of phototherapy or systemic therapy&#xD;
&#xD;
          -  Psoriasis Area and Severity Index (PASI) score of ≥ 10&#xD;
&#xD;
          -  Physician&quot;s Global Assessment (PGA) score of ≥ 3&#xD;
&#xD;
          -  stable disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically relevant allergies or idiosyncrasies to COVA322&#xD;
&#xD;
          -  Any history of clinically significant drug hypersensitivity following any therapy with&#xD;
             a therapeutical biologic, or asthma, urticaria, or other allergic diathesis&#xD;
&#xD;
          -  Clinically significant flare of psoriasis during the 12 weeks before randomization&#xD;
&#xD;
          -  Current evidence of non-plaque forms of psoriasis&#xD;
&#xD;
          -  Currently evidence of drug-induced psoriasis&#xD;
&#xD;
          -  Evidence of any serious systemic or local infection within 3 months before screening&#xD;
&#xD;
          -  Evidence of subclinical/latent tuberculosis infection&#xD;
&#xD;
          -  History or any signs of lymphoproliferative disease, or a known malignancy or a&#xD;
             history of malignancy within the previous 5 years&#xD;
&#xD;
          -  History or current evidence of autoimmune diseases other than psoriasis&#xD;
&#xD;
          -  Women of child-bearing potential&#xD;
&#xD;
          -  Recent previous exposure to systemic psoriasis treatments, including anti-TNF-α&#xD;
             therapies, immunosuppressive agents such as cyclosporine, mycophenolate, or&#xD;
             tacrolimus, and other medications affecting the immune function&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 2.5 times&#xD;
             the upper limit of normal (ULN) at screening&#xD;
&#xD;
          -  Serum creatinine level ≥ 1.5 times the ULN at screening&#xD;
&#xD;
          -  Positive results in any of the virology tests for HIV-Ab, hepatitis C-virus antibody&#xD;
             (HCV-Ab) and hepatitis B-virus surface antigen (HBsAg) or hepatitis B core antibody&#xD;
             (HBc-Ab)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristian Reich, Prof. Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sciderm GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité research organisation</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCIderm and Clinical Trial Center North</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>February 29, 2016</last_update_submitted>
  <last_update_submitted_qc>February 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 1, 2016</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>Psoriasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02243787
org study id: COVA322-SAD-Psoriasis-001
nct id: NCT02243787
lead sponsor: 
has dmc: Yes
This study is a randomised, double-blind, placebo-controlled, sequential, ascending
      single-dose, parallel group study to evaluate safety, tolerability, biological activity, and
      systemic exposure of COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A)
      antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis.
      Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v.
      infusion, followed by 12 weeks of evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of Adverse Events as a Measure of Safety and Tolerability
time frame: Up to 12 weeks
description: The safety and tolerability of COVA322 will be assessed by monitoring the occurrence of local and systemic adverse events or abnormalities as identified by physical examinations, safety lab, vital parameters, ECG and immune response/antibodies to COVA322.
arm group label: COVA322
arm group type: Experimental
description: single i.v. infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: single i.v. infusion
intervention type: Drug
intervention name: COVA322
arm group label: COVA322
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kristian Reich, Prof. Dr. med
role: Principal Investigator
affiliation: Sciderm GmbH
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Psoriasis