Status:
COMPLETED
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).
Lead Sponsor:
Keros Therapeutics, Inc.
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 back...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT05975905
Start Date
October 17 2023
End Date
March 11 2025
Last Update
September 30 2025
Active Locations (55)
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1
TROPOS Study Site 111
Scottsdale, Arizona, United States, 85258
2
TROPOS Study Site 107
Tucson, Arizona, United States, 85719
3
Site PI TROPOS Study Site 104
Stanford, California, United States, 94305
4
TROPOS Study Site 105
Torrance, California, United States, 90502