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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    193
  • sponsor
    United Therapeutics
Updated on 4 October 2022
exercise stress test
diuretics
cardiopulmonary exercise testing
stress test
endothelin
ralinepag
endothelin receptor antagonist

Summary

Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment

Description

ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 2:1 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. Subjects who discontinue study drug prior to Week 28, as well as those who complete Week 28 on study drug but choose not to participate in the OLE study, will be contacted every 6 months and at the end of the study to determine their survival status. Subjects who prematurely discontinue study drug or withdraw from the study for any reason will not be eligible to enter the OLE study.

Details
Condition PAH, Pulmonary Hypertension, Hypertension, Connective Tissue Disease, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease, Pulmonary Arterial Hypertension
Treatment Placebo, Ralinepag
Clinical Study IdentifierNCT04084678
SponsorUnited Therapeutics
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years of age
Signed informed consent form
Primary diagnosis of PAH
Has had a diagnostic RHC performed at or within 3 years before Screening (or at Screening if one is not available) that is consistent with the diagnosis of PAH
Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II to III symptoms
Must be on a stable dose of PAH-specific oral therapy, defined as no change in dose or regimen for at least 120 days prior to randomization. Allowable PAH-specific therapy is an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be on a stable dose of either a PDE5-I or a sGC stimulator, not both
Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening
Has a VE/VCO2 slope ≥38 during the Screening CPET, as assessed by the CPET core laboratory
Has a peak VO2 of ≥10 to <18 mL·kg-1·min-1 during the Screening CPET, as assessed by the CPET core laboratory
If the subject is taking concomitant medications that may affect the clinical manifestations of PAH, the subject must be on a stable dose for at least 30 days prior to randomization. The exception is that the dose of diuretics should remain stable for at least the 10 days prior to randomization and the dosage maintained throughout the study
Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to the Week 28 Visit/28-day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process during the study and for 30 days after the final dose of study drug. Eligible male subjects must agree not to participate in sperm donation for 90 days after the final dose of study drug
Women who are surgically sterile or postmenopausal are not considered to be of childbearing
potential. If of childbearing potential, female partners of male study participants should
agree to utilize medically acceptable methods of contraception for the duration of study
participation

Exclusion Criteria

Symptomatic coronary disease and/or myocardial infarction within past 6 months
Current symptomatic aortic or mitral valve disease
Requires use of supplemental oxygen during CPET
For subjects with known human immunodeficiency virus-associated PAH, a cluster
Has 3 or more left ventricular disease dysfunction risk factors
designation of differentiation 4 (CD4+) T-cell count <200/mm3 at Screening
Has evidence of more than mild lung disease on pulmonary function tests performed
within 1 year prior to, or during, Screening
Has evidence of thromboembolic disease as determined by ventilation-perfusion lung
scan or local standard of care diagnostic evaluation at or after diagnosis of PAH
Current diagnosis of ongoing and clinically significant sleep apnea as defined by the
Investigator
Confirmed active infection with hepatitis B virus or hepatitis C virus
Respiratory exchange ratio <1.0 at Screening CPET as determined by the CPET core
laboratory
Acute non-cardiac disorder that may affect exercise performance or be aggravated by
Hemoglobin concentration <9 g/dL at Screening
exercise (eg, infection, renal failure, thyrotoxicosis)
Male subjects with a QTcF >450 msec and female subjects with a QTcF >470 msec on
electrocardiogram (ECG) recorded at Screening and analyzed by the central ECG
Subject has pulmonary veno-occlusive disease
laboratory. Subjects with evidence of intraventricular conduction delay, defined as a
QRS interval >110 msec, will be excluded if QTcF is >500 msec for both males and
females
Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis
or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage
encephalopathy)
Known hypersensitivity to ralinepag or any of the excipients
Life expectancy <12 months based on the Investigator's opinion
Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the
Women who are pregnant, lactating, or breast-feeding
upper limit of normal or total bilirubin ≥2 times the upper limit of normal at
Screening
Chronic renal insufficiency as defined by an estimated glomerular filtration rate
using the Modification of Diet in Renal Disease Study equation of <30 mL/min/1.73 m^2
or requiring dialysis at Screening
Subjects treated with an intravenous or subcutaneous prostacyclin pathway agent (eg
epoprostenol, treprostinil, or iloprost) for PAH at any time (use in vasoreactive
testing is permitted)
Subjects currently on or who have been treated with an inhaled or oral prostacyclin
pathway agent (iloprost, treprostinil, beraprost, or selexipag) within 120 days prior
to randomization
Malignancy diagnosed and/or treated within 3 years of Screening, with the exception of
localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ
carcinoma of the cervix excised with curative intent
Subject tests positive for amphetamine, cocaine, methamphetamine
methylenedioxymethamphetamine, or phencyclidine in urine drug screen performed at
Screening, or has a recent history (6 months) of alcohol or drug abuse. Subjects will
not be excluded due to a positive drug screen caused by prescribed medications
Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon
exercise within 90 days prior to Screening and/or planned during study participation
Prior participation in any study of ralinepag or another interventional clinical study
with medicinal products within 30 days prior to Screening. Concurrent participation in
registry or observational studies is allowed, if the subject can fulfill all other
entry criteria and comply with all study procedures
Any reason that, in the opinion of the Investigator, precludes the subject from
participating in the study (eg, any previous or intercurrent medical condition) that
may increase the risk associated with study participation or that would confound study
analysis (eg, right-to-left shunt detected during CPET) or impair study participation
or cooperation
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