Not currently recruiting at University of California Health

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).

a study on High Blood Pressure Pulmonary Arterial Hypertension Pulmonary Hypertension

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Site PI (ucla)

Description

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 background PAH therapy. The study is divided into the Screening Period, Treatment Period, Extension Period, and Follow-Up Period.

Official Title

A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (TROPOS Study)

Details

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/

Keywords

Pulmonary Arterial Hypertension, Pulmonary arterial hypertension [PAH], Familial Primary Pulmonary Hypertension, Hypertension, Dose A KER-012, Dose B KER-012, Dose C KER-012, N=20, N=30

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult participants ≥ 18 years of age
  • Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH)(PAH) classified by one of the following subgroups:

  • 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 CAN'T join 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

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA not yet accepting patients
    Torrance California 90502 United States
  • The University of New Mexico - UNM Hospitals accepting new patients
    Albuquerque New Mexico 87106 United States
  • University of Kansas Medical Center accepting new patients
    Kansas City Kansas 66160 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Keros Therapeutics, Inc.
ID
NCT05975905
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated