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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).
90 patients around the world
Available in Spain, Brazil, United States
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. For more information please check
https://tropospahstudy.com/
Keros Therapeutics, Inc.
90Patients around the world
This study is for people with
Pulmonary hypertension
Pulmonary arterial hypertension
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.PAH associated with 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.
- 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.
SponsorKeros Therapeutics, Inc.
Conditions
Pulmonary arterial hypertension
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05975905
