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/NCT06031844</url>
    </required_header>
    <id_info>
      <org_study_id>CDFV890F12201</org_study_id>
      <nct_id>NCT06031844</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease</brief_title>
    <official_title>A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</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>
        This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of&#xD;
        increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to&#xD;
        reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in&#xD;
        approximately 24 people with known heart disease and an elevated marker of inflammation,&#xD;
        hsCRP.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center, randomized, placebo-controlled, participant- and investigator-blinded&#xD;
        study to evaluate the efficacy, safety, and tolerability of intra-individual dose escalation&#xD;
        of DFV890 for inflammatory marker reduction in participants with coronary heart disease and&#xD;
        elevated hsCRP. The study consists of a screening period of up to 60 days, a treatment period&#xD;
        of approximately 12 weeks, an end of treatment (EOT) visit on Day 85, which is one day after&#xD;
        the last dose on Day 84, a follow-up period of approximately 1 week and a standard&#xD;
        safety-follow-up call approximately 30 days following the last dose. The overall study&#xD;
        duration is approximately 24 weeks and approximately 24 participants will be enrolled into&#xD;
        the trial.&#xD;
  &#xD;
        Participants meeting all eligibility criteria will be randomized in a 5:5:1:1 ratio to one of&#xD;
        four treatment sequences (three DFV890 treatment sequences or a placebo-only sequence). The&#xD;
        dose of DFV890 will be uptitrated (according to the specific treatment sequence that the&#xD;
        participant is assigned to) approximately every three weeks at the scheduled visits on Days&#xD;
        22, 43 and 64.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">May 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 12, 2025</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serum levels of IL-6 and IL-18</measure>
      <time_frame>From Day 22 to End of Study Visit (up to 92 days)</time_frame>
      <description>To evaluate the effect of various dose levels of DFV890 versus placebo to reduce circulating levels of inflammatory markers in participants with coronary heart disease and elevated hsCRP</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma trough concentrations (Ctrough) of DFV890 at steady state</measure>
      <time_frame>From Day 22 to End of Study Visit (up to 92 days)</time_frame>
      <description>To assess the pharmacokinetics of DFV890 in participants with coronary heart disease and elevated hsCRP</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Coronary Heart Disease</condition>
    <arm_group>
      <arm_group_label>Treatment Sequence 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be administered Placebo and different doses of DFV890</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment sequence 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be administered Placebo and different doses of DFV890</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment sequence 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be administered different doses of DFV890</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment sequence 4</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will be administered Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DFV890</intervention_name>
      <description>oral film-coated tablets</description>
      <arm_group_label>Treatment Sequence 1</arm_group_label>
      <arm_group_label>Treatment sequence 2</arm_group_label>
      <arm_group_label>Treatment sequence 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>oral film-coated tablets</description>
      <arm_group_label>Treatment Sequence 1</arm_group_label>
      <arm_group_label>Treatment sequence 2</arm_group_label>
      <arm_group_label>Treatment sequence 4</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female participants aged between 18 - 80 years (inclusive) at the start of&#xD;
               screening will be included.&#xD;
  &#xD;
            -  Subjects must have a body mass index (BMI) within the range of 18 - 40 kg/m2. BMI =&#xD;
               Body weight (kg) / [Height (m)]2&#xD;
  &#xD;
            -  Documented spontaneous myocardial infarction (MI) (diagnosed according to the&#xD;
               universal MI criteria with or without evidence of ST segment elevation) at least 30&#xD;
               days before the start of screening.&#xD;
  &#xD;
            -  Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening.&#xD;
               Screening values must be separated by a minimum of 8 days. The initial hsCRP value&#xD;
               must be a minimum of 30 days after the qualifying MI or after any percutaneous&#xD;
               coronary intervention (PCI) performed separately from the qualifying MI.&#xD;
  &#xD;
            -  For participants on statin therapy (HMG-CoA reductase inhibitor), as clinically&#xD;
               indicated, participants must be on a stable regimen (at least 4 weeks before&#xD;
               randomization), with no planned statin dose changes over the course of the trial&#xD;
               treatment period. Unplanned statin dose changes during the trial treatment period may&#xD;
               occur.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients receiving concomitant medications that are known to be strong or moderate&#xD;
               inducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, strong&#xD;
               inhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatment&#xD;
               cannot be discontinued or switched to a different medication within 5 half-lives or 1&#xD;
               week (whichever is longer) prior to Day 1 and for the duration of the study.&#xD;
  &#xD;
            -  Patients with suspected or proven immunocompromised state at screening&#xD;
  &#xD;
            -  History of ongoing, chronic, or major recurrent infectious disease, at the discretion&#xD;
               of the investigator, at the start of screening.&#xD;
  &#xD;
            -  Use of any biologic drugs targeting the immune system within 26 weeks of Day 1&#xD;
  &#xD;
            -  Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 3 years prior&#xD;
               to the start of screening.&#xD;
  &#xD;
            -  Symptomatic Class IV heart failure (New York Heart Association) at the start of&#xD;
               screening.&#xD;
  &#xD;
            -  Planned coronary revascularization (PCI or CABG) or any other major surgical procedure&#xD;
               during the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>1-888-669-6682</phone>
      <email>novartis.email@novartis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>+41613241111</phone>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>DFV890</keyword>
    <keyword>Phase 2a</keyword>
    <keyword>coronary heart disease</keyword>
    <keyword>elevated hsCRP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
  This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
    </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/NCT06031844
  org study id: CDFV890F12201
  nct id: NCT06031844
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of
        increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to
        reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in
        approximately 24 people with known heart disease and an elevated marker of inflammation,
        hsCRP.
  This is a multi-center, randomized, placebo-controlled, participant- and investigator-blinded
        study to evaluate the efficacy, safety, and tolerability of intra-individual dose escalation
        of DFV890 for inflammatory marker reduction in participants with coronary heart disease and
        elevated hsCRP. The study consists of a screening period of up to 60 days, a treatment period
        of approximately 12 weeks, an end of treatment (EOT) visit on Day 85, which is one day after
        the last dose on Day 84, a follow-up period of approximately 1 week and a standard
        safety-follow-up call approximately 30 days following the last dose. The overall study
        duration is approximately 24 weeks and approximately 24 participants will be enrolled into
        the trial.
  
        Participants meeting all eligibility criteria will be randomized in a 5:5:1:1 ratio to one of
        four treatment sequences (three DFV890 treatment sequences or a placebo-only sequence). The
        dose of DFV890 will be uptitrated (according to the specific treatment sequence that the
        participant is assigned to) approximately every three weeks at the scheduled visits on Days
        22, 43 and 64.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Serum levels of IL-6 and IL-18
  time frame: From Day 22 to End of Study Visit (up to 92 days)
  description: To evaluate the effect of various dose levels of DFV890 versus placebo to reduce circulating levels of inflammatory markers in participants with coronary heart disease and elevated hsCRP
  measure: Plasma trough concentrations (Ctrough) of DFV890 at steady state
  time frame: From Day 22 to End of Study Visit (up to 92 days)
  description: To assess the pharmacokinetics of DFV890 in participants with coronary heart disease and elevated hsCRP
  arm group label: Treatment Sequence 1
  arm group type: Experimental
  description: Participants will be administered Placebo and different doses of DFV890
  arm group label: Treatment sequence 2
  arm group type: Experimental
  description: Participants will be administered Placebo and different doses of DFV890
  arm group label: Treatment sequence 3
  arm group type: Experimental
  description: Participants will be administered different doses of DFV890
  arm group label: Treatment sequence 4
  arm group type: Placebo Comparator
  description: Participants will be administered Placebo
  intervention type: Drug
  intervention name: DFV890
  description: oral film-coated tablets
  arm group label: Treatment Sequence 1
  arm group label: Treatment sequence 2
  arm group label: Treatment sequence 3
  intervention type: Drug
  intervention name: Placebo
  description: oral film-coated tablets
  arm group label: Treatment Sequence 1
  arm group label: Treatment sequence 2
  arm group label: Treatment sequence 4
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  last name: Novartis Pharmaceuticals
  phone: 1-888-669-6682
  email: novartis.email@novartis.com
  last name: Novartis Pharmaceuticals
  phone: +41613241111
  responsible party type: Sponsor
  mesh term: Heart Diseases
  mesh term: Coronary Disease
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  sharing ipd: Yes
  ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
  This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com