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).

Last updated: August 1, 2025
Sponsor: Keros Therapeutics, Inc.
Overall Status: Completed

Phase

2

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

Dose A KER-012

Dose B KER-012

Dose C KER-012

Clinical Study ID

NCT05975905
KER-012-A201
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofPAH:

  • 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 symptomsas assessed by the Investigator

  • Must be on a stable PAH background therapy with either an endothelin-receptorantagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or solubleguanylate 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 ofany Screening tests or procedures

Exclusion

Exclusion Criteria:

  • Evidence or history of left ventricular dysfunction and/or clinically significantcardiac disease

  • Has pulmonary function tests (PFTs) with evidence of significant obstructive orparenchymal lung disease

  • Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scanor other local standard of care diagnostic evaluation at the time of PAH diagnosisor after

  • Has uncontrolled systemic hypertension

  • Hemoglobin < 9 g/dL at Screening

  • Prior heart or heart-lung transplants, active on the lung transplant list, or lifeexpectancy of < 12 months per Investigator assessment

  • Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis

  • Initiation or discontinuation of an exercise program for cardiopulmonaryrehabilitation within 90 days prior to Baseline or planned initiation during thestudy

  • Prior participation in a KER-012 study or prior treatment with a therapy targetingTGF-β superfamily (e.g. sotatercept)

  • Prior participation in another interventional clinical study with medicinal productswithin 30 days or 5 half-lives prior to Screening, whichever is longer

Study Design

Total Participants: 113
Treatment Group(s): 4
Primary Treatment: Dose A KER-012
Phase: 2
Study Start date:
October 17, 2023
Estimated Completion Date:
March 11, 2025

Study 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.

Connect with a study center

  • TROPOS Study Site 805

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • TROPOS Study Site 807

    Auchenflower, 4066
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, 2050
    Australia

    Active - Recruiting

  • TROPOS Study Site 804

    Camperdown, 2050
    Australia

    Site Not Available

  • St. Vincent Hospital Sydney

    Darlinghurst, 2010
    Australia

    Active - Recruiting

  • TROPOS Study Site 800

    Darlinghurst, 2010
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton Heights, 2305
    Australia

    Active - Recruiting

  • TROPOS Study Site 803

    New Lambton Heights, 2305
    Australia

    Site Not Available

  • Macquarie University

    Sydney, 2095
    Australia

    Active - Recruiting

  • TROPOS Study Site 801

    Sydney, 2095
    Australia

    Site Not Available

  • TROPOS Study Site 200

    Blumenau, 89030
    Brazil

    Site Not Available

  • TROPOS Study Site 202

    Porto Alegre, 90020
    Brazil

    Site Not Available

  • TROPOS Study Site 201

    São Paulo, 05403
    Brazil

    Site Not Available

  • TROPOS Study Site 320

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • TROPOS Study Site 341

    Giesen, 35392
    Germany

    Site Not Available

  • TROPOS Study Site 340

    Hannover, 30625
    Germany

    Site Not Available

  • TROPOS Study Site 343

    Heidelberg, 69120
    Germany

    Site Not Available

  • TROPOS Study Site 344

    Homburg, 66424
    Germany

    Site Not Available

  • TROPOS Study Site 342

    Leipzig, 04103
    Germany

    Site Not Available

  • TROPOS Study Site 345

    Regensburg, 93053
    Germany

    Site Not Available

  • TROPOS Study Site 881

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • TROPOS Study Site 880

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • TROPOS Study Site 882

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • TROPOS Study Site 883

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • TROPOS Study Site 704

    Gdańsk, 80-214
    Poland

    Site Not Available

  • TROPOS Study Site 701

    Kraków, 31-202
    Poland

    Site Not Available

  • TROPOS Study Site 702

    Otwock, 05-400
    Poland

    Site Not Available

  • TROPOS Study Site 703

    Poznań, 60-355
    Poland

    Site Not Available

  • TROPOS Study Site 706

    Poznań, 61-848
    Poland

    Site Not Available

  • TROPOS Study Site 705

    Łódź, 91-347
    Poland

    Site Not Available

  • TROPOS Study Site 403

    Almada, 2805-267
    Portugal

    Site Not Available

  • TROPOS Study Site 402

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • TROPOS Study Site 400

    Lisboa, 1769-001
    Portugal

    Site Not Available

  • TROPOS Study Site 401

    Porto, 4099-001
    Portugal

    Site Not Available

  • TROPOS Study Site 412

    Barcelona, 39008
    Spain

    Site Not Available

  • TROPOS Study Site 413

    Barcelona, 8035
    Spain

    Site Not Available

  • TROPOS Study Site 410

    Madrid, 28041
    Spain

    Site Not Available

  • TROPOS Study Site 411

    Santander, 39008
    Spain

    Site Not Available

  • TROPOS Study Site 891

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • TROPOS Study Site 890

    Taipei, 11217
    Taiwan

    Site Not Available

  • TROPOS Study Site 441

    Glasgow, G81 4DY
    United Kingdom

    Site Not Available

  • TROPOS Study Site 440

    London, W12 0HS
    United Kingdom

    Site Not Available

  • TROPOS Study Site 442

    London, SW3 6NP
    United Kingdom

    Site Not Available

  • TROPOS Study Site 111

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • TROPOS Study Site 107

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Site PI TROPOS Study Site 104

    Stanford, California 94305
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA

    Torrance, California 90502
    United States

    Site Not Available

  • TROPOS Study Site 105

    Torrance, California 90502
    United States

    Site Not Available

  • TROPOS Study Site 108

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • TROPOS Study Site 100

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • TROPOS Study Site 110

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • TROPOS Study Site 103

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • TROPOS Study Site 109

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • TROPOS Study Site 101

    Ann Arbor, Michigan 481091
    United States

    Site Not Available

  • TROPOS Study Site 115

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • TROPOS Study Site 114

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • The University of New Mexico - UNM Hospitals

    Albuquerque, New Mexico 87106
    United States

    Active - Recruiting

  • TROPOS Study Site 113

    Cincinnati, Ohio 45221
    United States

    Site Not Available

  • TROPOS Study Site 106

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • TROPOS Study Site 112

    Dallas, Texas 75390
    United States

    Site Not Available

  • TROPOS Study Site 102

    Houston, Texas 77030
    United States

    Site Not Available

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