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New biologic KER-012 shows promise for Hard-to-Treat lung condition

NCT ID NCT05975905

Disease control Sponsor: Keros Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This phase 2 trial tested an experimental biologic called KER-012 in 113 adults with pulmonary arterial hypertension (PAH), a serious lung condition that makes it hard to breathe. Participants received either KER-012 or a placebo as a shot every 4 weeks, on top of their usual PAH medications. The study measured changes in lung blood pressure and exercise ability to see if the drug could improve symptoms and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KER-012 (a biologic drug given as a shot under the skin every 4 weeks)
What this could lead to
If it works, KER-012 could become a new add-on treatment to help people with pulmonary arterial hypertension breathe easier and be more active.
What could go wrong
This is a mid-stage trial with only 113 participants, so results may not apply to everyone. The drug is still experimental, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

113 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • Site PI TROPOS Study Site 104

    Stanford, California, 94305, United States

  • TROPOS Study Site 100

    Kansas City, Kansas, 66160, United States

  • TROPOS Study Site 101

    Ann Arbor, Michigan, 481091, United States

  • TROPOS Study Site 102

    Houston, Texas, 77030, United States

  • TROPOS Study Site 103

    Boston, Massachusetts, 02111, United States

  • TROPOS Study Site 105

    Torrance, California, 90502, United States

  • TROPOS Study Site 106

    Charleston, South Carolina, 29425, United States

  • TROPOS Study Site 107

    Tucson, Arizona, 85719, United States

  • TROPOS Study Site 108

    Jacksonville, Florida, 32224, United States

  • TROPOS Study Site 109

    Boston, Massachusetts, 02115, United States

  • TROPOS Study Site 110

    Louisville, Kentucky, 40202, United States

  • TROPOS Study Site 111

    Scottsdale, Arizona, 85258, United States

  • TROPOS Study Site 112

    Dallas, Texas, 75390, United States

  • TROPOS Study Site 113

    Cincinnati, Ohio, 45221, United States

  • TROPOS Study Site 114

    Albuquerque, New Mexico, 87106, United States

  • TROPOS Study Site 115

    St Louis, Missouri, 63110, United States

  • TROPOS Study Site 200

    Blumenau, 89030, Brazil

  • TROPOS Study Site 201

    São Paulo, 05403, Brazil

  • TROPOS Study Site 202

    Porto Alegre, 90020, Brazil

  • TROPOS Study Site 320

    Le Kremlin-Bicêtre, 94270, France

  • TROPOS Study Site 340

    Hanover, 30625, Germany

  • TROPOS Study Site 341

    Giesen, 35392, Germany

  • TROPOS Study Site 342

    Leipzig, 04103, Germany

  • TROPOS Study Site 343

    Heidelberg, 69120, Germany

  • TROPOS Study Site 344

    Homburg, 66424, Germany

  • TROPOS Study Site 345

    Regensburg, 93053, Germany

  • TROPOS Study Site 400

    Lisbon, 1769-001, Portugal

  • TROPOS Study Site 401

    Porto, 4099-001, Portugal

  • TROPOS Study Site 402

    Coimbra, 3000-075, Portugal

  • TROPOS Study Site 403

    Almada, 2805-267, Portugal

  • TROPOS Study Site 410

    Madrid, 28041, Spain

  • TROPOS Study Site 411

    Santander, 39008, Spain

  • TROPOS Study Site 412

    Barcelona, 39008, Spain

  • TROPOS Study Site 413

    Barcelona, 8035, Spain

  • TROPOS Study Site 440

    London, W12 0HS, United Kingdom

  • TROPOS Study Site 441

    Glasgow, G81 4DY, United Kingdom

  • TROPOS Study Site 442

    London, SW3 6NP, United Kingdom

  • TROPOS Study Site 701

    Krakow, 31-202, Poland

  • TROPOS Study Site 702

    Otwock, 05-400, Poland

  • TROPOS Study Site 703

    Poznan, 60-355, Poland

  • TROPOS Study Site 704

    Gdansk, 80-214, Poland

  • TROPOS Study Site 705

    Lodz, 91-347, Poland

  • TROPOS Study Site 706

    Poznan, 61-848, Poland

  • TROPOS Study Site 800

    Darlinghurst, 2010, Australia

  • TROPOS Study Site 801

    Sydney, 2095, Australia

  • TROPOS Study Site 803

    New Lambton Heights, 2305, Australia

  • TROPOS Study Site 804

    Camperdown, 2050, Australia

  • TROPOS Study Site 805

    Melbourne, Victoria, 3004, Australia

  • TROPOS Study Site 807

    Auchenflower, 4066, Australia

  • TROPOS Study Site 880

    Seoul, 06351, South Korea

  • TROPOS Study Site 881

    Incheon, 21565, South Korea

  • TROPOS Study Site 882

    Seoul, 03722, South Korea

  • TROPOS Study Site 883

    Seoul, 03080, South Korea

  • TROPOS Study Site 890

    Taipei, 11217, Taiwan

  • TROPOS Study Site 891

    Kaohsiung City, 81362, Taiwan

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