A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.

Key facts

Study ID

NCT04712669

Run by

Altavant Sciences GmbH

People needed

108

Starts

2021-03-15

Expected to finish

2023-08-28

Last updated by the study team

2025-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female 18 years or older 2. Body Mass Index (BMI) >18kg/m2 to <=40kg/m2 3. Symptomatic PAH belonging to one of the following 2018 WHO Clinical Group 1 subtypes:
• a. Idiopathic PAH b. Heritable PAH c. Drug- or toxin-induced d. PAH associated with:
• Connective tissue disease
• Congenital systemic to pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) repaired at least one year prior to Screening
• Human immunodeficiency virus (HIV) infection - if diagnosed with HIV, must have stable disease status defined as follows:
• stable treatment with HIV medications for at least 8 weeks prior to Screening
• no active opportunistic infection during the Screening Period
• no hospitalizations due to HIV for at least 4 weeks prior to Screening
• WHO FC II or III
• Confirmed diagnosis of PAH and meet all the following hemodynamic criteria by means of a screening RHC completed prior to randomization:
• mPAP of >20 mmHg
• PVR ≥ 350 dyne•sec/cm5
• Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 350 and < 500 dyne•sec/cm5, or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dyne•sec/cm5
• 6MWD of 100 to 550 meters at Screening
• Currently on a stable treatment regimen with one or more treatments approved for PAH. Stable therapy is defined as receiving the same medication(s) for ≥ 12 weeks prior to the screening RHC and at a stable dose level for each for ≥ 8 weeks prior to the screening RHC (see Protocol Section 6.6.2 for approved PAH medications). Any instances where doses of a medication have been missed prior to RHC must be discussed with the Medical Monitor prior to performing the RHC.
• Meet all of the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to Screening (performed with or without bronchodilation):
• Forced expiratory volume in one second (FEV1) ≥ 60% of predicted normal, and
• Total lung capacity (TLC) ≥ 70% of predicted normal or FVC ≥ 70% predicted if TLC is not available; For subjects with CTD associated PAH, if TLC is ≥ 60% of predicted but < 70% of predicted of if FVC ≥ 60% or predicted but < 70% of predicted, high resolution computed tomography [HRCT] obtained within 6 months of screening may be utilized to demonstrate limited interstitial lung disease
• If participating in an exercise program for pulmonary rehabilitation, the program must have been initiated ≥ 12 weeks prior to Screening, and patient must agree to maintain the current level of rehabilitation for the first 24 weeks of receiving IP. If not participating in an exercise training program for pulmonary rehabilitation, patient must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 24 weeks of receiving IP.

You may not qualify if…

• Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception
• WHO pulmonary hypertension (PH) Group 1 PAH associated with portal hypertension or schistosomiasis; PH due to left heart disease (WHO PH Group 2), lung diseases and/or hypoxia (WHO PH Group 3), chronic thromboembolic PH (WHO PH Group 4), or PH with unclear multifactorial mechanisms (WHO PH Group 5)
• PH associated with significant venous or capillary involvement (PCWP > 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD)
• Three or more of the following risk factors for left ventricular disease:
• BMI > 30 kg/m2
• Diagnosis of essential hypertension that is actively treated
• Diabetes mellitus
• History of significant coronary artery disease (e.g., chronic stable angina, history of coronary intervention within the last 3 months, or a stenosis > 70% at coronary angiography)
• Atrial fibrillation
• Left atrial volume index > 41 mL/m2 [or left atrial diameter (LA) > 4 cm if LAVi unavailable]
• Known genetic hypertrophic cardiomyopathy
• Known cardiac sarcoidosis or amyloidosis
• The patient has a history of, or currently has, a constrictive cardiomyopathy.
• Known history of any left ventricular ejection fraction (LVEF) < 40% by echocardiogram within 3 years of randomization (Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition [e.g., atrial fibrillation] is allowed).
• Hemodynamically significant valvular heart disease as determined by the Investigator, including:
• greater than mild aortic and/or mitral stenosis and/or
• severe mitral and/or aortic regurgitation (> Grade 3)
• Severe arthritis, musculoskeletal problems, or morbid obesity that, in the opinion of the Investigator, is the cause of the patient's functional limitation and would affect the patient's ability to perform or complete the 6MWT.

Where it is running

• University of California San Diego Health Sciences — La Jolla, California, United States
• VA Greater LA Healthcare System/UCLA — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Jeffrey S. Sager, MD Medical Corporation — Santa Barbara, California, United States
• University of Colorado — Aurora, Colorado, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Pulmonary Specialists — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital (BWH), Harvard Medical School — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of New Mexico Heath Science Center — Albuquerque, New Mexico, United States
• NYU Langone Health — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina Medical Center - Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati Physicians — Cincinnati, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Brown University - Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Arizona Pulmonary Specialists — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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