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).
About the 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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Pulmonary Arterial Hypertension
Age
18+
Phase
PHASE2
Participants Needed
90
Est. Completion Date
Jan 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Keros Therapeutics, Inc.
ClinicalTrials.gov NCT Identifier
NCT05975905
Study Number
KER-012-A201
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?