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).

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT05975905

Run by

Keros Therapeutics, Inc.

People needed

113

Starts

2023-10-17

Expected to finish

2025-03-11

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• TROPOS Study Site 107 — Tucson, Arizona, United States
• Site PI TROPOS Study Site 104 — Stanford, California, United States
• TROPOS Study Site 105 — Torrance, California, United States
• TROPOS Study Site 108 — Jacksonville, Florida, United States
• TROPOS Study Site 100 — Kansas City, Kansas, United States
• TROPOS Study Site 110 — Louisville, Kentucky, United States
• TROPOS Study Site 103 — Boston, Massachusetts, United States
• TROPOS Study Site 109 — Boston, Massachusetts, United States
• TROPOS Study Site 101 — Ann Arbor, Michigan, United States
• TROPOS Study Site 115 — St Louis, Missouri, United States
• TROPOS Study Site 114 — Albuquerque, New Mexico, United States
• TROPOS Study Site 113 — Cincinnati, Ohio, United States
• TROPOS Study Site 106 — Charleston, South Carolina, United States
• TROPOS Study Site 112 — Dallas, Texas, United States
• TROPOS Study Site 102 — Houston, Texas, United States
• TROPOS Study Site 805 — Melbourne, Victoria, Australia
• TROPOS Study Site 807 — Auchenflower, Australia
• TROPOS Study Site 804 — Camperdown, Australia
• TROPOS Study Site 800 — Darlinghurst, Australia
• TROPOS Study Site 803 — New Lambton Heights, Australia
• TROPOS Study Site 801 — Sydney, Australia
• TROPOS Study Site 200 — Blumenau, Brazil
• TROPOS Study Site 202 — Porto Alegre, Brazil
• TROPOS Study Site 201 — São Paulo, Brazil
• TROPOS Study Site 111 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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