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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

113

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

October 17, 2023

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

March 11, 2025

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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