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).

Overview

About this study

The purpose of this study is to compare  KER-012 to placebo in adult participants with a primary diagnosis of pulmonary arterial hypertension (PAH) on stable background PAH therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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-? 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/28/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

John Moss, M.D.

Open for enrollment

Contact information:

John Moss M.D.

(904) 953-2869

Moss.John@mayo.edu

More information

Publications

Publications are currently not available