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).

June 29, 2026 updated by: Keros Therapeutics, Inc.

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 Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
        • TROPOS Study Site 807
      • Camperdown, Australia, 2050
        • TROPOS Study Site 804
      • Darlinghurst, Australia, 2010
        • TROPOS Study Site 800
      • New Lambton Heights, Australia, 2305
        • TROPOS Study Site 803
      • Sydney, Australia, 2095
        • TROPOS Study Site 801
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • TROPOS Study Site 805
  • Brazil
      • Blumenau, Brazil, 89030
        • TROPOS Study Site 200
      • Porto Alegre, Brazil, 90020
        • TROPOS Study Site 202
      • São Paulo, Brazil, 05403
        • TROPOS Study Site 201
  • France
      • Le Kremlin-Bicêtre, France, 94270
        • TROPOS Study Site 320
  • Germany
      • Giesen, Germany, 35392
        • TROPOS Study Site 341
      • Hanover, Germany, 30625
        • TROPOS Study Site 340
      • Heidelberg, Germany, 69120
        • TROPOS Study Site 343
      • Homburg, Germany, 66424
        • TROPOS Study Site 344
      • Leipzig, Germany, 04103
        • TROPOS Study Site 342
      • Regensburg, Germany, 93053
        • TROPOS Study Site 345
  • Poland
      • Gdansk, Poland, 80-214
        • TROPOS Study Site 704
      • Krakow, Poland, 31-202
        • TROPOS Study Site 701
      • Lodz, Poland, 91-347
        • TROPOS Study Site 705
      • Otwock, Poland, 05-400
        • TROPOS Study Site 702
      • Poznan, Poland, 60-355
        • TROPOS Study Site 703
      • Poznan, Poland, 61-848
        • TROPOS Study Site 706
  • Portugal
      • Almada, Portugal, 2805-267
        • TROPOS Study Site 403
      • Coimbra, Portugal, 3000-075
        • TROPOS Study Site 402
      • Lisbon, Portugal, 1769-001
        • TROPOS Study Site 400
      • Porto, Portugal, 4099-001
        • TROPOS Study Site 401
  • South Korea
      • Incheon, South Korea, 21565
        • TROPOS Study Site 881
      • Seoul, South Korea, 03080
        • TROPOS Study Site 883
      • Seoul, South Korea, 03722
        • TROPOS Study Site 882
      • Seoul, South Korea, 06351
        • TROPOS Study Site 880
  • Spain
      • Barcelona, Spain, 39008
        • TROPOS Study Site 412
      • Barcelona, Spain, 8035
        • TROPOS Study Site 413
      • Madrid, Spain, 28041
        • TROPOS Study Site 410
      • Santander, Spain, 39008
        • TROPOS Study Site 411
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • TROPOS Study Site 891
      • Taipei, Taiwan, 11217
        • TROPOS Study Site 890
  • United Kingdom
      • Glasgow, United Kingdom, G81 4DY
        • TROPOS Study Site 441
      • London, United Kingdom, SW3 6NP
        • TROPOS Study Site 442
      • London, United Kingdom, W12 0HS
        • TROPOS Study Site 440
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • TROPOS Study Site 111
      • Tucson, Arizona, United States, 85719
        • TROPOS Study Site 107
    • California
      • Stanford, California, United States, 94305
        • Site PI TROPOS Study Site 104
      • Torrance, California, United States, 90502
        • TROPOS Study Site 105
    • Florida
      • Jacksonville, Florida, United States, 32224
        • TROPOS Study Site 108
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • TROPOS Study Site 100
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • TROPOS Study Site 110
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TROPOS Study Site 103
      • Boston, Massachusetts, United States, 02115
        • TROPOS Study Site 109
    • Michigan
      • Ann Arbor, Michigan, United States, 481091
        • TROPOS Study Site 101
    • Missouri
      • St Louis, Missouri, United States, 63110
        • TROPOS Study Site 115
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • TROPOS Study Site 114
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • TROPOS Study Site 113
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • TROPOS Study Site 106
    • Texas
      • Dallas, Texas, United States, 75390
        • TROPOS Study Site 112
      • Houston, Texas, United States, 77030
        • TROPOS Study Site 102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
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
Biological: Dose A KER-012
Dose A KER-012 (Q4W);
Experimental: Arm 2
KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Biological: Dose B KER-012
Dose B KER-012 (Q4W);
Experimental: Arm 3
KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Biological: Dose C KER-012
Dose C KER-012 (Q4W);
Placebo Comparator: Arm 4
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Biological: Dose B KER-012
Dose B 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in PVR (Pulmonary Vascular Resistance)
Time Frame: Baseline and Week 24
Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the 6MWD
Time Frame: Through week 24 (primary treatment period)
Evaluate the effect of KER-012 on exercise capacity compared to Placebo in participants on background PAH therapy
Through week 24 (primary treatment period)
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)
Proportion of participants who achieved improvement from Baseline in NYHA FC/WHO at week 24. Improvement in WHO/NYHA FC (World Heath Association/New York Heart Association functional class) was defined as a decreased in functional class from baseline or maintenance of WHO/NYHA = 2 from baseline.
Up to week 24 (primary treatment period)
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)
Change from Baseline in NT-proBNP at week 24
Up to week 24 (primary treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Keros Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KER-012-A201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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