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/NCT05975905</url>
    </required_header>
    <id_info>
      <org_study_id>KER-012-A201</org_study_id>
      <nct_id>NCT05975905</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS).</brief_title>
    <official_title>A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (TROPOS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Keros Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Keros Therapeutics, 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 KER-012-A201 is Phase 2, double-blind, randomized, placebo-controlled study to&#xD;
        determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH (WHO&#xD;
        Group 1 PH) on stable background PAH therapy. The study is divided into the Screening Period,&#xD;
        Treatment Period, Extension Period, and Follow-Up Period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, phase 2, double-blind, placebo-controlled study of KER-012 in&#xD;
        combination with background therapy in participants with PAH of World Health Organization&#xD;
        (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 2:2:2:3&#xD;
        ratio to receive KER-012 (Dose A), KER-012 (Dose B), KER-012 (Dose C), or placebo by&#xD;
        subcutaneous injection (SC) every 4 weeks for a period of 24 weeks in the placebo-controlled&#xD;
        treatment period of the study while on background therapy. Evaluations will include changes&#xD;
        in pulmonary vascular resistance (PVR), 6-minute walk distance (6MWD), and safety parameters.&#xD;
        Participants who have not discontinued early from the placebo-controlled treatment period and&#xD;
        have had their post-treatment period PVR assessment will be able to continue into the 72-week&#xD;
        extension period in which KER-012 treated participants will continue to receive their same&#xD;
        assigned dose level from the treatment period every 4 weeks and placebo treated participants&#xD;
        will receive KER-012 (Dose B) every 4 weeks while on background therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 27, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 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>
      <intervention_model_description>Participants will be randomly assigned in a 2:2:2:3 ratio to 1 of 4 treatment arms.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>This is a double-blind study in which treatment assignment will be blinded for the Investigators and any personnel (other than the unblinded pharmacist or designee) involved with the study conduct or evaluation at the investigational sites, the CRO, and the Sponsor.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline in PVR (Pulmonary Vascular Resistance)</measure>
      <time_frame>Baseline and Week 24</time_frame>
      <description>Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in the 6MWD</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>Evaluate the effect of KER-012 on exercise capacity compared to Placebo in participants on background PAH therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>A TEAE is any untoward medical occurrence in a study participant occurring after the initiation of a study treatment that does not necessarily have to have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of treatment-related TEAEs</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>A treatment-related TEAE is any untoward medical occurrence in a study participant occurring after the initiation of a study treatment that has a causal relationship with this treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of discontinuations due to TEAEs</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>A treatment-related TEAE is any untoward medical occurrence in a study participant occurring after the initiation of a study treatment that has a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Systolic and Diastolic Blood Pressure</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>Systolic and Diastolic blood pressure measured in mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in QTcF intervals</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>QTcF intervals measured in msec via ECGs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Antidrug Antibodies (ADA)</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>The amount of ADA measured in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the changes from baseline in the concentration of the PAH biomarker, NT-proBNP in blood samples</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Change from Baseline in NT-proBNP by visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background PAH therapy- mPAP</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Change from Baseline in mean pulmonary artery pressure (mPAP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background PAH therapy- CO</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Change from Baseline in cardiac output (CO)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background PAH therapy- PAWP</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Change from Baseline in pulmonary artery wedge pressure (PAWP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate improvement in functional assessment of KER-012 compared to Placebo in participants on background PAH therapy</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Proportion of participants who achieved improvement from Baseline in NYHA FC/WHO by visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who experienced events indicative of clinical worsening of pulmonary arterial hypertension (PAH)</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Events that indicate clinical worsening of PAH include death, non-elective PAH-related hospitalization and/or right heart failure inclusive of lung or heart/lung transplant, or atrial septostomy, need to initiate an approved PAH SOC rescue therapy, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Population PK predicted maximum concentration (Cmax) of KER-012</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>Cmax is a measure of the maximum concentration of a drug in the serum after the dose is given.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Population PK predicted Area under concentration curve (AUC) of KER-012</measure>
      <time_frame>Through week 24 (primary treatment period) and Through week 96 (extension period)</time_frame>
      <description>AUC is a measure of the area under the serum concentration curve after dose is given.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate improvement in risk stratifications of KER-012 in participants on background PAH therapy</measure>
      <time_frame>Up to week 24 (primary treatment period) and up to Week 96 (extension period)</time_frame>
      <description>Proportion of participants who achieve improvement/or maintain low risk in ESC/ ERC 4-strata risk category assessment</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Pulmonary Arterial Hypertension</condition>
    <arm_group>
      <arm_group_label>Arm 1 (N=20)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>KER-012 (Dose A) subcutaneously (SC) (every 4 weeks [Q4W]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2 (N=20)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 3 (N=20)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 4 (N=30)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Dose A KER-012</intervention_name>
      <description>Dose A KER-012 (Q4W);</description>
      <arm_group_label>Arm 1 (N=20)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Dose B KER-012</intervention_name>
      <description>Dose B KER-012 (Q4W);</description>
      <arm_group_label>Arm 2 (N=20)</arm_group_label>
      <arm_group_label>Arm 4 (N=30)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Dose C KER-012</intervention_name>
      <description>Dose C KER-012 (Q4W);</description>
      <arm_group_label>Arm 3 (N=20)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks</intervention_name>
      <description>Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)</description>
      <arm_group_label>Arm 4 (N=30)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult participants ≥ 18 years of age&#xD;
  &#xD;
            -  Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH)(PAH)&#xD;
               classified by one of the following subgroups:&#xD;
  &#xD;
                 -  Idiopathic pulmonary arterial hypertension (IPAH);&#xD;
  &#xD;
                 -  Heritable pulmonary arterial hypertension (HPAH);&#xD;
  &#xD;
                 -  Associated with drugs and toxins;&#xD;
  &#xD;
                 -  PAH associated with:&#xD;
  &#xD;
                      -  Connective tissue disease&#xD;
  &#xD;
                      -  Congenital systemic-pulmonary intracardiac shunt&#xD;
  &#xD;
            -  Has the following hemodynamic parameters that are consistent with the diagnosis of&#xD;
               PAH:&#xD;
  &#xD;
                 -  Mean pulmonary arterial pressure (mPAP) &gt; 20 mmHg at rest, AND&#xD;
  &#xD;
                 -  Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg, AND&#xD;
  &#xD;
                 -  PVR ≥ 5 Wood Units (400 dyn·sec·cm-5)&#xD;
  &#xD;
            -  Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as&#xD;
               assessed by the Investigator&#xD;
  &#xD;
            -  Must be on a stable PAH background therapy with either an endothelin-receptor&#xD;
               antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate&#xD;
               cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist&#xD;
               (oral/inhaled/SC/intravenous)&#xD;
  &#xD;
            -  6MWD ≥ 150 and ≤ 500 meters at screening&#xD;
  &#xD;
            -  Provide written (signed and dated) informed consent form before the initiation of any&#xD;
               Screening tests or procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Evidence or history of left ventricular dysfunction and/or clinically significant&#xD;
               cardiac disease&#xD;
  &#xD;
            -  Has pulmonary function tests (PFTs) with evidence of significant obstructive or&#xD;
               parenchymal lung disease&#xD;
  &#xD;
            -  Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan&#xD;
               or other local standard of care diagnostic evaluation at the time of PAH diagnosis or&#xD;
               after&#xD;
  &#xD;
            -  Has uncontrolled systemic hypertension&#xD;
  &#xD;
            -  Hemoglobin &lt; 9 g/dL at Screening&#xD;
  &#xD;
            -  Prior heart or heart-lung transplants, active on the lung transplant list, or life&#xD;
               expectancy of &lt; 12 months per Investigator assessment&#xD;
  &#xD;
            -  Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis&#xD;
  &#xD;
            -  Initiation or discontinuation of an exercise program for cardiopulmonary&#xD;
               rehabilitation within 90 days prior to Baseline or planned initiation during the study&#xD;
  &#xD;
            -  Prior participation in a KER-012 study or prior treatment with a therapy targeting&#xD;
               TGF-β superfamily (e.g. sotatercept)&#xD;
  &#xD;
            -  Prior participation in another interventional clinical study with medicinal products&#xD;
               within 30 days or 5 half-lives prior to Screening, whichever is longer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Keros Therapeutics, Inc.</last_name>
      <phone>+1 617 3146297</phone>
      <email>clinicalstudies@kerostx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Macquarie University</name>
        <address>
          <city>Sydney</city>
          <zip>2095</zip>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Site PI</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulmonary arterial hypertension [PAH]</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>Undecided</sharing_ipd>
    </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/NCT05975905
  org study id: KER-012-A201
  nct id: NCT05975905
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  Study KER-012-A201 is Phase 2, double-blind, randomized, placebo-controlled study to
        determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH (WHO
        Group 1 PH) on stable background PAH therapy. The study is divided into the Screening Period,
        Treatment Period, Extension Period, and Follow-Up Period.
  This is a randomized, phase 2, double-blind, placebo-controlled study of KER-012 in
        combination with background therapy in participants with PAH of World Health Organization
        (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 2:2:2:3
        ratio to receive KER-012 (Dose A), KER-012 (Dose B), KER-012 (Dose C), or placebo by
        subcutaneous injection (SC) every 4 weeks for a period of 24 weeks in the placebo-controlled
        treatment period of the study while on background therapy. Evaluations will include changes
        in pulmonary vascular resistance (PVR), 6-minute walk distance (6MWD), and safety parameters.
        Participants who have not discontinued early from the placebo-controlled treatment period and
        have had their post-treatment period PVR assessment will be able to continue into the 72-week
        extension period in which KER-012 treated participants will continue to receive their same
        assigned dose level from the treatment period every 4 weeks and placebo treated participants
        will receive KER-012 (Dose B) every 4 weeks while on background therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly assigned in a 2:2:2:3 ratio to 1 of 4 treatment arms.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: This is a double-blind study in which treatment assignment will be blinded for the Investigators and any personnel (other than the unblinded pharmacist or designee) involved with the study conduct or evaluation at the investigational sites, the CRO, and the Sponsor.
  measure: Change from Baseline in PVR (Pulmonary Vascular Resistance)
  time frame: Baseline and Week 24
  description: Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy
  measure: Change from Baseline in the 6MWD
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: Evaluate the effect of KER-012 on exercise capacity compared to Placebo in participants on background PAH therapy
  measure: Incidence of treatment-emergent adverse events (TEAEs)
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: A TEAE is any untoward medical occurrence in a study participant occurring after the initiation of a study treatment that does not necessarily have to have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
  measure: Number of treatment-related TEAEs
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: A treatment-related TEAE is any untoward medical occurrence in a study participant occurring after the initiation of a study treatment that has a causal relationship with this treatment.
  measure: Number of discontinuations due to TEAEs
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: A treatment-related TEAE is any untoward medical occurrence in a study participant occurring after the initiation of a study treatment that has a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
  measure: Change from baseline in Systolic and Diastolic Blood Pressure
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: Systolic and Diastolic blood pressure measured in mmHg
  measure: Change from baseline in QTcF intervals
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: QTcF intervals measured in msec via ECGs
  measure: Incidence of Antidrug Antibodies (ADA)
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: The amount of ADA measured in serum
  measure: Evaluate the changes from baseline in the concentration of the PAH biomarker, NT-proBNP in blood samples
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Change from Baseline in NT-proBNP by visit
  measure: Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background PAH therapy- mPAP
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Change from Baseline in mean pulmonary artery pressure (mPAP)
  measure: Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background PAH therapy- CO
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Change from Baseline in cardiac output (CO)
  measure: Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background PAH therapy- PAWP
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Change from Baseline in pulmonary artery wedge pressure (PAWP)
  measure: Evaluate improvement in functional assessment of KER-012 compared to Placebo in participants on background PAH therapy
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Proportion of participants who achieved improvement from Baseline in NYHA FC/WHO by visit
  measure: Number of participants who experienced events indicative of clinical worsening of pulmonary arterial hypertension (PAH)
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Events that indicate clinical worsening of PAH include death, non-elective PAH-related hospitalization and/or right heart failure inclusive of lung or heart/lung transplant, or atrial septostomy, need to initiate an approved PAH SOC rescue therapy, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).
  measure: Population PK predicted maximum concentration (Cmax) of KER-012
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: Cmax is a measure of the maximum concentration of a drug in the serum after the dose is given.
  measure: Population PK predicted Area under concentration curve (AUC) of KER-012
  time frame: Through week 24 (primary treatment period) and Through week 96 (extension period)
  description: AUC is a measure of the area under the serum concentration curve after dose is given.
  measure: Evaluate improvement in risk stratifications of KER-012 in participants on background PAH therapy
  time frame: Up to week 24 (primary treatment period) and up to Week 96 (extension period)
  description: Proportion of participants who achieve improvement/or maintain low risk in ESC/ ERC 4-strata risk category assessment
  arm group label: Arm 1 (N=20)
  arm group type: Experimental
  description: KER-012 (Dose A) subcutaneously (SC) (every 4 weeks [Q4W]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
  arm group label: Arm 2 (N=20)
  arm group type: Experimental
  description: KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
  arm group label: Arm 3 (N=20)
  arm group type: Experimental
  description: KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
  arm group label: Arm 4 (N=30)
  arm group type: Placebo Comparator
  description: Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
  intervention type: Biological
  intervention name: Dose A KER-012
  description: Dose A KER-012 (Q4W);
  arm group label: Arm 1 (N=20)
  intervention type: Biological
  intervention name: Dose B KER-012
  description: Dose B KER-012 (Q4W);
  arm group label: Arm 2 (N=20)
  arm group label: Arm 4 (N=30)
  intervention type: Biological
  intervention name: Dose C KER-012
  description: Dose C KER-012 (Q4W);
  arm group label: Arm 3 (N=20)
  intervention type: Biological
  intervention name: Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks
  description: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
  arm group label: Arm 4 (N=30)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Keros Therapeutics, Inc.
  phone: +1 617 3146297
  email: clinicalstudies@kerostx.com
  facility: 
  status: Recruiting
  investigator: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Pulmonary Arterial Hypertension
  mesh term: Familial Primary Pulmonary Hypertension
  mesh term: Hypertension
  sharing ipd: Undecided