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 Study).

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult participants ≥ 18 years of age.
  • - Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH)(PAH) classified by one of the following subgroups: - Idiopathic pulmonary arterial hypertension (IPAH); - Heritable pulmonary arterial hypertension (HPAH); - Associated with drugs and toxins; - PAH associated with: - Connective tissue disease.
  • - Congenital systemic-pulmonary intracardiac shunt.
  • - Has the following hemodynamic parameters that are consistent with the diagnosis of PAH: - Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest, AND.
  • - Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg, AND.
  • - PVR ≥ 5 Wood Units (400 dyn·sec·cm-5) - Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as assessed by the Investigator.
  • - Must be on a stable PAH background therapy with either an endothelin-receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist (oral/inhaled/SC/intravenous) - 6MWD ≥ 150 and ≤ 500 meters at screening.
  • - Provide written (signed and dated) informed consent form before the initiation of any Screening tests or procedures.

Exclusion Criteria:

  • - Evidence or history of left ventricular dysfunction and/or clinically significant cardiac disease.
  • - Has pulmonary function tests (PFTs) with evidence of significant obstructive or parenchymal lung disease.
  • - Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or other local standard of care diagnostic evaluation at the time of PAH diagnosis or after.
  • - Has uncontrolled systemic hypertension.
  • - Hemoglobin < 9 g/dL at Screening.
  • - Prior heart or heart-lung transplants, active on the lung transplant list, or life expectancy of < 12 months per Investigator assessment.
  • - Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis.
  • - Initiation or discontinuation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to Baseline or planned initiation during the study.
- Prior participation in a KER-012 study or prior treatment with a therapy targeting TGF-β superfamily (e.g. sotatercept) - Prior participation in another interventional clinical study with medicinal products within 30 days or 5 half-lives prior to Screening, whichever is longer

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Keros Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Australia, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Additional Details

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. For more information please check https://tropospahstudy.com/

Arms & Interventions


Experimental: Arm 1 (N=20)

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

Experimental: Arm 2 (N=20)

KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks

Experimental: Arm 3 (N=20)

KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks

Placebo Comparator: Arm 4 (N=30)

Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks


Biological: - Dose A KER-012

Dose A KER-012 (Q4W);

Biological: - Dose B KER-012

Dose B KER-012 (Q4W);

Biological: - Dose C KER-012

Dose C KER-012 (Q4W);

Biological: - Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks

Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Torrance, California


Not yet recruiting


Lundquist Institute for Biomedical Innovation at Harbor UCLA

Torrance, California, 90502

University of Kansas Medical Center, Kansas City, Kansas




University of Kansas Medical Center

Kansas City, Kansas, 66160

Tufts Medical Center, Boston, Massachusetts


Not yet recruiting


Tufts Medical Center

Boston, Massachusetts, 02111

Albuquerque, New Mexico




The University of New Mexico - UNM Hospitals

Albuquerque, New Mexico, 87106

International Sites

The Alfred Hospital, Melbourne, Victoria, Australia


Not yet recruiting


The Alfred Hospital

Melbourne, Victoria, 3004

Royal Prince Alfred Hospital, Camperdown, Australia




Royal Prince Alfred Hospital

Camperdown, , 2050

St. Vincent Hospital Sydney, Darlinghurst, Australia




St. Vincent Hospital Sydney

Darlinghurst, , 2010

John Hunter Hospital, New Lambton Heights, Australia




John Hunter Hospital

New Lambton Heights, , 2305

Macquarie University, Sydney, Australia




Macquarie University

Sydney, , 2095

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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