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Pulmonary Arterial HypertensionPhase 2NCT05975905

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).

A Phase 2 study testing Dose A KER-012, Dose B KER-012 and Dose C KER-012 in people with Pulmonary Arterial Hypertension, run by Keros Therapeutics, Inc. at 55 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Dose A KER-012, Dose B KER-012 and Dose C KER-012
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
55 sitesin 11 countries
Study dates
17 Oct 2023to 11 Mar 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

55 sites in 11 countries.

55 sites in 11 countries

United States16 sites

  • TROPOS Study Site 114

    Albuquerque, New Mexico, 87106

  • TROPOS Study Site 101

    Ann Arbor, Michigan, 481091

  • TROPOS Study Site 103

    Boston, Massachusetts, 02111

  • TROPOS Study Site 109

    Boston, Massachusetts, 02115

  • TROPOS Study Site 106

    Charleston, South Carolina, 29425

  • TROPOS Study Site 113

    Cincinnati, Ohio, 45221

  • TROPOS Study Site 112

    Dallas, Texas, 75390

  • TROPOS Study Site 102

    Houston, Texas, 77030

  • TROPOS Study Site 108

    Jacksonville, Florida, 32224

  • TROPOS Study Site 100

    Kansas City, Kansas, 66160

  • TROPOS Study Site 110

    Louisville, Kentucky, 40202

  • TROPOS Study Site 111

    Scottsdale, Arizona, 85258

  • TROPOS Study Site 115

    St Louis, Missouri, 63110

  • Site PI TROPOS Study Site 104

    Stanford, California, 94305

  • TROPOS Study Site 105

    Torrance, California, 90502

  • TROPOS Study Site 107

    Tucson, Arizona, 85719

Other trials in United States

Australia6 sites

  • TROPOS Study Site 807

    Auchenflower, 4066

  • TROPOS Study Site 804

    Camperdown, 2050

  • TROPOS Study Site 800

    Darlinghurst, 2010

  • TROPOS Study Site 805

    Melbourne, Victoria, 3004

  • TROPOS Study Site 803

    New Lambton Heights, 2305

  • TROPOS Study Site 801

    Sydney, 2095

Other trials in Australia

Germany6 sites

  • TROPOS Study Site 341

    Giesen, 35392

  • TROPOS Study Site 340

    Hanover, 30625

  • TROPOS Study Site 343

    Heidelberg, 69120

  • TROPOS Study Site 344

    Homburg, 66424

  • TROPOS Study Site 342

    Leipzig, 04103

  • TROPOS Study Site 345

    Regensburg, 93053

Other trials in Germany

Poland6 sites

  • TROPOS Study Site 704

    Gdansk, 80-214

  • TROPOS Study Site 701

    Krakow, 31-202

  • TROPOS Study Site 705

    Lodz, 91-347

  • TROPOS Study Site 702

    Otwock, 05-400

  • TROPOS Study Site 703

    Poznan, 60-355

  • TROPOS Study Site 706

    Poznan, 61-848

Other trials in Poland

Portugal4 sites

  • TROPOS Study Site 403

    Almada, 2805-267

  • TROPOS Study Site 402

    Coimbra, 3000-075

  • TROPOS Study Site 400

    Lisbon, 1769-001

  • TROPOS Study Site 401

    Porto, 4099-001

Other trials in Portugal

South Korea4 sites

  • TROPOS Study Site 881

    Incheon, 21565

  • TROPOS Study Site 883

    Seoul, 03080

  • TROPOS Study Site 882

    Seoul, 03722

  • TROPOS Study Site 880

    Seoul, 06351

Other trials in South Korea

Spain4 sites

  • TROPOS Study Site 412

    Barcelona, 39008

  • TROPOS Study Site 413

    Barcelona, 8035

  • TROPOS Study Site 410

    Madrid, 28041

  • TROPOS Study Site 411

    Santander, 39008

Other trials in Spain

Brazil3 sites

  • TROPOS Study Site 200

    Blumenau, 89030

  • TROPOS Study Site 202

    Porto Alegre, 90020

  • TROPOS Study Site 201

    São Paulo, 05403

Other trials in Brazil

United Kingdom3 sites

  • TROPOS Study Site 441

    Glasgow, G81 4DY

  • TROPOS Study Site 442

    London, SW3 6NP

  • TROPOS Study Site 440

    London, W12 0HS

Other trials in United Kingdom

Taiwan2 sites

  • TROPOS Study Site 891

    Kaohsiung City, 81362

  • TROPOS Study Site 890

    Taipei, 11217

Other trials in Taiwan

France1 site

  • TROPOS Study Site 320

    Le Kremlin-Bicêtre, 94270

Other trials in France

About this study

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 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.

Read the 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.

Being tested
Dose A KER-012, Dose B KER-012, Dose C KER-012, Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks
Keywords
Pulmonary arterial hypertension [PAH]
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dose A KER-012Biological

    Dose A KER-012 (Q4W);

  • Dose B KER-012Biological

    Dose B KER-012 (Q4W);

  • Dose C KER-012Biological

    Dose C KER-012 (Q4W);

  • Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeksBiological

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

Study groups in NCT05975905
Study groupRoleWhat they receive
Arm 1ExperimentalKER-012 (Dose A) subcutaneously (SC) (every 4 weeks [Q4W]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Receives: Biological: Dose A KER-012
Arm 2ExperimentalKER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Receives: Biological: Dose B KER-012
Arm 3ExperimentalKER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Receives: Biological: Dose C KER-012
Arm 4Placebo comparatorTreatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Receives: Biological: Dose B KER-012; Biological: Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in PVR (Pulmonary Vascular Resistance)

    Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy

    Measured: Baseline and Week 24

Secondary outcomes (3)

  1. Change From Baseline in the 6MWD

    Evaluate the effect of KER-012 on exercise capacity compared to Placebo in participants on background PAH therapy

    Measured: Through week 24 (primary treatment period)

  2. Evaluate Improvement in Functional Assessment of KER-012 Compared to Placebo in Participants on Background PAH Therapy

    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.

    Measured: Up to week 24 (primary treatment period)

  3. Evaluate the Changes From Baseline in the Concentration of the PAH Biomarker, NT-proBNP in Blood Samples

    Change from Baseline in NT-proBNP at week 24

    Measured: Up to week 24 (primary treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start17 Oct 2023
  3. Primary completion5 Mar 2025
  4. Study completion11 Mar 2025

Why it stopped: The study was voluntarily terminated early, following a safety review and observation of pericardial effusions.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 2:2:2:3 ratio to 1 of 4 treatment arms.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05975905
Sponsor's protocol ID
KER-012-A201
Status last verified
Jun 2026
First submitted
13 Jul 2023
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dose A KER-012, Dose B KER-012 and Dose C KER-012 in people with Pulmonary Arterial Hypertension, run by Keros Therapeutics, Inc. at 55 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Australia, Germany, Poland, Portugal and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in PVR (Pulmonary Vascular Resistance) (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05975905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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