<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/NCT01689025</url>
  </required_header>
  <id_info>
    <org_study_id>NN8828-4002</org_study_id>
    <secondary_id>2011-005699-41</secondary_id>
    <secondary_id>U1111-1125-9646</secondary_id>
    <nct_id>NCT01689025</nct_id>
  </id_info>
  <brief_title>An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)</brief_title>
  <official_title>A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Europe and the United States of America (USA). The aim of the&#xD;
      trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic&#xD;
      lupus erythematosus (SLE) concomitantly treated with stable background therapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>From first administration of the trial product and up to week 26</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)</measure>
    <time_frame>After the last dosing (Week 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK endpoint from serum NNC0114-0006: Accumulation based on the concentration</measure>
    <time_frame>2 weeks after the first (week 2) and the last dose (week 8)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum levels of total IL-21 (Interleukin-21)</measure>
    <time_frame>Week 0, week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease activity (SELENA-SLEDAI)</measure>
    <time_frame>Week 0, week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in corticosteroid usage</measure>
    <time_frame>Week 0, week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Inflammation</condition>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>NNC0114-0006</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC0114-0006</intervention_name>
    <description>Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.</description>
    <arm_group_label>NNC0114-0006</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women (not pregnant and not nursing)&#xD;
&#xD;
          -  Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a&#xD;
             disease duration of at least 6 months&#xD;
&#xD;
          -  Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus&#xD;
             Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease&#xD;
             Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody&#xD;
             (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)&#xD;
&#xD;
          -  If taken, background medication must be stable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or history of active lupus nephritis (LN) within the last 4 months or active&#xD;
             central nervous system (CNS) disease within the last 12 months&#xD;
&#xD;
          -  Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Clinical Trial Call Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Clinical Trial Call Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznan</city>
        <zip>60-218</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>April 7, 2014</last_update_submitted>
  <last_update_submitted_qc>April 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 8, 2014</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>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Inflammation</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/NCT01689025
org study id: NN8828-4002
secondary id: 2011-005699-41
secondary id: U1111-1125-9646
nct id: NCT01689025
lead sponsor: 
has dmc: No
This trial is conducted in Europe and the United States of America (USA). The aim of the
      trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic
      lupus erythematosus (SLE) concomitantly treated with stable background therapies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of Adverse Events (AEs)
time frame: From first administration of the trial product and up to week 26
measure: PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)
time frame: After the last dosing (Week 6)
measure: PK endpoint from serum NNC0114-0006: Accumulation based on the concentration
time frame: 2 weeks after the first (week 2) and the last dose (week 8)
measure: Change in serum levels of total IL-21 (Interleukin-21)
time frame: Week 0, week 26
measure: Change in disease activity (SELENA-SLEDAI)
time frame: Week 0, week 12
measure: Change in corticosteroid usage
time frame: Week 0, week 12
arm group label: NNC0114-0006
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: NNC0114-0006
description: Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
arm group label: NNC0114-0006
intervention type: Drug
intervention name: placebo
description: Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hungary
country: Poland
country: Serbia
country: United States
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
mesh term: Inflammation