<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/NCT03298542</url>
  </required_header>
  <id_info>
    <org_study_id>CR108354</org_study_id>
    <secondary_id>2017-000225-12</secondary_id>
    <secondary_id>CNTO148DML1001</secondary_id>
    <nct_id>NCT03298542</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes</brief_title>
  <official_title>A Phase 1b Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and tolerability of golimumab in&#xD;
      children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus&#xD;
      (T1D).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Week 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Week 52</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment-Emergent Infections</measure>
    <time_frame>Up to Week 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment-Emergent Infections</measure>
    <time_frame>Up to Week 52</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Study Treatment Injection Site Reactions</measure>
    <time_frame>Up to Week 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78</measure>
    <time_frame>Week 52 to Week 78</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Concentration of Golimumab</measure>
    <time_frame>Through Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Antibodies to Golimumab</measure>
    <time_frame>Through Week 52</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Pre-Symptomatic Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Group 1: Golimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a SC matching placebo to golimumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golimumab</intervention_name>
    <description>Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.</description>
    <arm_group_label>Group 1: Golimumab</arm_group_label>
    <other_name>SIMPONI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo to golimumab.</description>
    <arm_group_label>Group 2: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is positive for at least 2 of the following diabetes-related autoantibodies obtained&#xD;
             at study screening: Glutamic acid decarboxylase-65 (GAD-65) Autoantibodies,&#xD;
             Insulinoma-associated 2 Autoantibodies (IA-2A), Zinc Transporter-8 (ZnT8), Islet Cell&#xD;
             Cytoplasmic Autoantibodies (ICA), or Insulin Autoantibodies (IAA). Participants with a&#xD;
             confirmed documented history of at least 2 positive diabetes-related autoantibodies&#xD;
             but who screen positive on only 1 autoantibody are considered to have met this&#xD;
             criteria&#xD;
&#xD;
          -  Has a plasma glucose of 7.8 to 11.0 millimoles per liter (mmol/L) (140 to 199&#xD;
             milligrams per deciliter (mg/dL)) at the 120-minute timepoint of a 2-hour(h)-oral&#xD;
             glucose tolerance test (OGTT), OR have a plasma glucose of greater than (&gt;) 200 mg/dL&#xD;
             (&gt; 11.1 mmol/L) at the 30, 60, or 90 minute timepoint of a 2h-OGTT OR have a&#xD;
             hemoglobin A1c (HbA1c) greater than or equal to (&gt;=) 5.7 percent (%) but less than (&lt;)&#xD;
             6.5% ([&gt;=] 39 to &lt;48 millimoles per moles [mmol/mol]) evaluated at screening&#xD;
&#xD;
          -  Is medically stable on the basis of physical examination, medical history, laboratory&#xD;
             results, and vital signs performed at screening&#xD;
&#xD;
          -  If a woman of childbearing potential must have a negative highly sensitive serum test&#xD;
             (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test&#xD;
             at the Week 0 visit&#xD;
&#xD;
          -  Must be up-to-date or have initiated catch up vaccines with routine age-appropriate&#xD;
             immunizations and have received vaccines, or at least initiated vaccine series and&#xD;
             have a completion plan, that are recommended for immune suppressed individuals&#xD;
             according to current local recommendations before the first dose of study treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a current or prior diagnosis of diabetes mellitus (Type 1, Type 2, or gestational)&#xD;
             or meet the metabolic criteria diagnostic of diabetes mellitus obtained at screening&#xD;
             including: hemoglobin A1c (HbA1c) greater than or equal to 6.5 (%) (48 mmol/mol), or&#xD;
             fasting plasma glucose (&gt;=) 7.0 mmol/L (126 mg/dL) (fasting: no intake &gt;= 8 hours), or&#xD;
             plasma glucose &gt;= 11.1 mmol/L (200 mg/dL) 2 hours post OGTT, or random plasma glucose&#xD;
             &gt;= 11.1 mmol/L (200 mg/dL) in those with symptoms consistent with hyperglycemia crisis&#xD;
&#xD;
          -  Has a presence or history of malignancy&#xD;
&#xD;
          -  Has an immune deficiency syndrome (for example, severe combined immunodeficiency&#xD;
             syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic&#xD;
             granulomatous disease), or bone marrow or organ transplantation, or a disease&#xD;
             associated with lymphopenia&#xD;
&#xD;
          -  Has other autoimmune diseases (for example, rheumatoid arthritis (RA), polyarticular&#xD;
             juvenile idiopathic arthritis (pJIA), psoriatic arthritis (PsA), ankylosing&#xD;
             spondylitis (AS), multiple sclerosis, celiac disease, systemic lupus erythematosus)&#xD;
             excluding clinically stable autoimmune thyroiditis whether treated or untreated&#xD;
&#xD;
          -  Has active infections, is prone to infections or has chronic, recurrent or&#xD;
             opportunistic infectious disease, including but not limited to, chronic renal&#xD;
             infection, chronic chest infection, sinusitis, recurrent urinary tract infection,&#xD;
             Pneumocystis carinii, aspergillosis, latent or active granulomatous infection,&#xD;
             histoplasmosis, or coccidioidomycosis or an open, draining, or infected non healing&#xD;
             skin wound or ulcer&#xD;
&#xD;
          -  Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV polymerase&#xD;
             chain reaction (PCR) viral load serology of &gt;= 10,000 copies per milliliter (mL) at&#xD;
             study screening&#xD;
&#xD;
          -  Has a clinically active infection with cytomegalovirus (CMV) or a CMV PCR viral load&#xD;
             serology of &gt;= 10,000 copies per mL at study screening&#xD;
&#xD;
          -  Is infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or&#xD;
             hepatitis C virus (HCV) or at screening tests positive for HIV, HBV, or HCV&#xD;
&#xD;
          -  Has any of the following tuberculosis (TB) screening criteria: a history of latent or&#xD;
             active TB prior to screening; signs or symptoms suggestive of active TB upon medical&#xD;
             history and/or physical examination; recent close contact (within 3 months) with a&#xD;
             person with known or suspected active TB; a positive QuantiFERON-TB test result at&#xD;
             screening, the participant should be excluded from the study; a chest radiograph taken&#xD;
             within 3 months prior to the first administration of study treatment read by a&#xD;
             qualified radiologist consistent with current, active TB or old, inactive TB&#xD;
&#xD;
          -  Has a current or prior use of any type and form of exogenous insulin or&#xD;
             oral/intravenous (IV) antihyperglycemic treatment&#xD;
&#xD;
          -  Has known or suspected intolerance or hypersensitivity to human proteins, antibody&#xD;
             fragments, or monoclonal antibodies, including golimumab or its excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulu University Hosp. - Oulu</name>
      <address>
        <city>Oulu</city>
        <zip>FI-90014</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>FI-33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkoping University Hospital</name>
      <address>
        <city>Linkoping</city>
        <zip>SE 58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lund University Hospital/Skåne</name>
      <address>
        <city>Lund/Malmo</city>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000225-12/results</url>
    <description>Link to results on EudraCT registry.</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 9, 2021</last_update_submitted>
  <last_update_submitted_qc>September 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Golimumab</mesh_term>
  </intervention_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/NCT03298542
org study id: CR108354
secondary id: 2017-000225-12
secondary id: CNTO148DML1001
nct id: NCT03298542
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine the safety and tolerability of golimumab in
      children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus
      (T1D).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up to Week 26
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up to Week 52
measure: Percentage of Participants With Treatment-Emergent Infections
time frame: Up to Week 26
measure: Percentage of Participants With Treatment-Emergent Infections
time frame: Up to Week 52
measure: Percentage of Participants With Study Treatment Injection Site Reactions
time frame: Up to Week 26
measure: Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78
time frame: Week 52 to Week 78
measure: Serum Concentration of Golimumab
time frame: Through Week 52
measure: Incidence of Antibodies to Golimumab
time frame: Through Week 52
arm group label: Group 1: Golimumab
arm group type: Experimental
description: Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
arm group label: Group 2: Placebo
arm group type: Placebo Comparator
description: Participants will receive a SC matching placebo to golimumab.
intervention type: Drug
intervention name: Golimumab
description: Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
arm group label: Group 1: Golimumab
other name: SIMPONI
intervention type: Drug
intervention name: Placebo
description: Matching placebo to golimumab.
arm group label: Group 2: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 21 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Finland
country: Sweden
country: United States
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000225-12/results
description: Link to results on EudraCT registry.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Golimumab