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A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH

Title A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy
Therapeutic Area Pulmonary Hypertension
Principal Investigator Ioana Preston, MD
Min Age 18 Years
Max Age 80 Years
Gender All
Contact Mary Hays
617-636-1334
mhays@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04084678

Overview

ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study. Study visits will occur at Day 1 and every 4 weeks through Week 28, with weekly titration phone calls during the first 16 weeks. Approximately 193 subjects with WHO Group 1 PH and on stable background therapy are planned to be enrolled. Subjects who meet entry criteria will be randomly allocated (2:1 ratio) to receive ralinepag or placebo, in addition to their PAH-specific background therapy, as applicable. The primary endpoint is change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who complete the study on study drug through Week 28 will have the option to receive ralinepag in an open-label extension (OLE) study.

Study Details

Inclusion Criteria

  • Has a 6MWD of ≥150 meters at Screening.
  • Has a VE/VCO2 slope ≥38 during the Screening CPET, as assessed by the CPET core lab.
  • Has a peak VO2 of ≥10 to <18 mL·kg-1·min-1 during the Screening CPET, as assessed by the CPET core lab.

Exclusion Criteria

  • Current unstable angina
  • Symptomatic coronary disease and/or myocardial infarction within past 6 months.
  • Current symptomatic aortic or mitral valve disease.

Study Requirements

There will be a maximum of 9 visits with screening and baseline and then every 4 weeks. There is a V/Q lung scan at baseline if not performed within the past 5 years. There will be a blood collection at each clinic visit and about two tablespoons will be collected. There are no CT scans or MRIs.