<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/NCT03789643</url>
  </required_header>
  <id_info>
    <org_study_id>AT251-G-17-006</org_study_id>
    <nct_id>NCT03789643</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension</brief_title>
  <acronym>RELIEF-PAH</acronym>
  <official_title>A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akros Pharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akros Pharma Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251&#xD;
      administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of&#xD;
      JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH).&#xD;
      Participants completing this study (RELIEF-PAH) will be eligible to enroll in an open-label&#xD;
      extension study (RELIEF-PAH OLE) to evaluate the long-term efficacy, safety, tolerability and&#xD;
      pharmacokinetics of JTT-251 in participants with PAH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Corporate decision, priority change&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</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>Change in six-minute walk distance (6MWD) compared to baseline</measure>
    <time_frame>24 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in World Health Organization (WHO) functional classification compared to baseline</measure>
    <time_frame>24 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pulmonary vascular resistance (PVR) compared to baseline</measure>
    <time_frame>4, 12, 24 and 28 Weeks</time_frame>
    <description>Assessed by right heart catheterization (RHC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>28 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>JTT-251 trough plasma concentrations</measure>
    <time_frame>4, 12 and 24 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>JTT-251 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of study drug by mouth daily for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTT-251 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of study drug by mouth daily for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JTT-251 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of study drug by mouth daily for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One dose of study drug by mouth daily for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JTT-251</intervention_name>
    <description>Active drug tablets containing JTT-251</description>
    <arm_group_label>JTT-251 Dose 1</arm_group_label>
    <arm_group_label>JTT-251 Dose 2</arm_group_label>
    <arm_group_label>JTT-251 Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets matching in appearance to the active drug tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of PAH as classified by idiopathic, heritable, drug and toxin- induced,&#xD;
             congenital heart disease or associated with connective tissue disease (i.e., WHO Group&#xD;
             1)&#xD;
&#xD;
          -  Clinical diagnosis of PAH confirmed by RHC at any time prior to Visit 1&#xD;
&#xD;
          -  WHO functional status of Class II-IV at Visit 1&#xD;
&#xD;
          -  Two 6MWD test measurements between 100 and 450 meters with a relative difference of&#xD;
             ≤15%. The baseline 6MWD test must be performed at Visit 2 before randomization.&#xD;
&#xD;
          -  Have a qualifying RHC performed between Visit 1 and Visit 2&#xD;
&#xD;
          -  On stable dose(s) of guideline-directed medical therapy for PAH (endothelin receptor&#xD;
             antagonists, phosphodiesterase type-5 (PDE-5) inhibitors, soluble guanylate cyclase&#xD;
             stimulators and prostacyclin pathway analogs) for at least 90 days prior to the&#xD;
             qualifying RHC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PAH associated with portal hypertension, human immunodeficiency virus (HIV),&#xD;
             schistosomiasis or sickle cell disease as well as participants with pulmonary&#xD;
             parenchymal disease or thromboembolic disease&#xD;
&#xD;
          -  Known significant left heart disease including: left ventricular dysfunction (i.e.,&#xD;
             left ventricular ejection fraction &lt;35%); hemodynamically compromising, symptomatic,&#xD;
             or severe aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation&#xD;
&#xD;
          -  Pulmonary hypertension belonging to WHO groups 2 to 5&#xD;
&#xD;
          -  Moderate to severe obstructive lung disease defined as forced expiratory volume in 1&#xD;
             second (FEV1) &lt;55% of predicted value&#xD;
&#xD;
          -  Moderate to severe restrictive lung disease defined as total lung capacity (TLC) &lt;60%&#xD;
             of predicted value&#xD;
&#xD;
          -  Acute decompensated heart failure or hospital admission for worsening PAH symptoms&#xD;
             within 30 days prior to the qualifying RHC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JTT-251</keyword>
  <keyword>Pulmonary arterial hypertension</keyword>
  <keyword>RELIEF-PAH</keyword>
  <keyword>Six-minute walk distance (6MWD)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03789643
org study id: AT251-G-17-006
nct id: NCT03789643
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251
      administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)
This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of
      JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH).
      Participants completing this study (RELIEF-PAH) will be eligible to enroll in an open-label
      extension study (RELIEF-PAH OLE) to evaluate the long-term efficacy, safety, tolerability and
      pharmacokinetics of JTT-251 in participants with PAH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in six-minute walk distance (6MWD) compared to baseline
time frame: 24 Weeks
measure: Change in World Health Organization (WHO) functional classification compared to baseline
time frame: 24 Weeks
measure: Change in pulmonary vascular resistance (PVR) compared to baseline
time frame: 4, 12, 24 and 28 Weeks
description: Assessed by right heart catheterization (RHC)
measure: Number of adverse events
time frame: 28 Weeks
measure: JTT-251 trough plasma concentrations
time frame: 4, 12 and 24 Weeks
arm group label: JTT-251 Dose 1
arm group type: Experimental
description: One dose of study drug by mouth daily for 24 weeks
arm group label: JTT-251 Dose 2
arm group type: Experimental
description: One dose of study drug by mouth daily for 24 weeks
arm group label: JTT-251 Dose 3
arm group type: Experimental
description: One dose of study drug by mouth daily for 24 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: One dose of study drug by mouth daily for 24 weeks
intervention type: Drug
intervention name: JTT-251
description: Active drug tablets containing JTT-251
arm group label: JTT-251 Dose 1
arm group label: JTT-251 Dose 2
arm group label: JTT-251 Dose 3
intervention type: Drug
intervention name: Placebo
description: Placebo tablets matching in appearance to the active drug tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
sharing ipd: No