A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Enrolling by invitation · Phase 3

Conditions studied: PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease

In brief

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Key facts

Study ID

NCT03683186

Run by

United Therapeutics

People needed

1000

Starts

2019-09-23

Expected to finish

2026-12-01

Last updated by the study team

2026-02-20

Who can join

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

You may qualify if…

• Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
• Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 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 (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.

You may not qualify if…

• Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study.
• Subjects who withdrew consent during participation in another ralinepag study.
• Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding.
• Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study.
• Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• UCSD Health Sciences — La Jolla, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• University of California, Irvine — Orange, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Piedmont Healthcare Pulmonary and Critical Care Research — Austell, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Ascension Alexian Brothers — Elk Grove Village, Illinois, United States
• Community Heart and Vascular Hospital — Indianapolis, Indiana, United States
• St. Vincent Medical Group, Inc. — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• St. Joseph's Hospital and Medical Center-Norton Thoracic Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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