A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Launched by UNITED THERAPEUTICS · Sep 21, 2018
Trial Information
Current as of November 08, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study, called ROR-PH-303 ADVANCE EXTENSION, is a long-term, open-label extension of ralinepag for adults with a specific type of pulmonary arterial hypertension (PAH) – WHO Group 1 PAH (a form of high blood pressure in the lungs). It’s not a new treatment test for people who haven’t used ralinepag before. Instead, it lets participants who previously took part in another ralinepag study continue receiving the drug (in addition to their usual PAH medicines) to see how safe and tolerable it is over several years. For some participants coming from a double-blind trial, there will be a 16-week period to adjust the dose while they still don’t know whether they’re getting the drug or placebo; others will start directly on ralinepag at the dose they had in their prior study. The main goal is to track safety by counting any treatment-emergent adverse events for up to about 6 years.
Who can join and what to expect: Eligible adults are 18 or older, of any sex, who previously participated in a ralinepag study and can sign informed consent, comply with study visits and tests, and agree to contraception if pregnancy is possible. Key exclusions include stopping ralinepag in a prior trial due to safety concerns, pregnancy or breastfeeding, a lung transplant or certain long-term prostacyclin therapies started since their prior study, or having had an emergency unblinding in a prior trial. If enrolled, you’ll receive ralinepag in addition to your current PAH treatment and will be monitored regularly for safety and how well the drug works over the long term. The study is run at many sites worldwide, overseen by a data monitoring committee and regulated by the FDA.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 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.
- • 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- • 3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
- • 4. 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.
- Exclusion Criteria:
- • 1. 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.
- • 2. Subjects who withdrew consent during participation in another ralinepag study.
- • 3. 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.
- • 4. 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.
- • 5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
About United Therapeutics
United Therapeutics is a leading biotechnology company dedicated to addressing the unmet medical needs of patients with life-threatening conditions, particularly in the fields of pulmonary arterial hypertension and organ transplantation. Founded in 1996, the company focuses on the development and commercialization of innovative therapies that enhance patient quality of life and extend survival. With a robust pipeline and a commitment to scientific excellence, United Therapeutics partners with healthcare providers, researchers, and advocacy groups to drive advancements in treatment options and improve outcomes for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Rochester, New York, United States
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Orange, California, United States
Durham, North Carolina, United States
New York, New York, United States
Birmingham, Alabama, United States
Indianapolis, Indiana, United States
Scottsdale, Arizona, United States
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
Sacramento, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Edmonton, Alberta, Canada
Madrid, Spain
Dallas, Texas, United States
Stanford, California, United States
Pittsburgh, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Hobart, Tasmania, Australia
Rochester, New York, United States
Philadelphia, Pennsylvania, United States
St. Louis, Missouri, United States
Seoul, Korea, Republic Of
Miami, Florida, United States
Albuquerque, New Mexico, United States
Aurora, Colorado, United States
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Gainesville, Florida, United States
Los Angeles, California, United States
Baltimore, Maryland, United States
Tucson, Arizona, United States
Chicago, Illinois, United States
Singapore, Singapore
Boston, Massachusetts, United States
Dallas, Texas, United States
Portland, Oregon, United States
Houston, Texas, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Oklahoma City, Oklahoma, United States
Melbourne, Victoria, Australia
Camperdown, New South Wales, Australia
Woolloongabba, Queensland, Australia
Taipei, Taiwan
Los Angeles, California, United States
Greenville, North Carolina, United States
Charlottesville, Virginia, United States
Sydney, New South Wales, Australia
Jacksonville, Florida, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Philadelphia, Pennsylvania, United States
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
London, United Kingdom
Omaha, Nebraska, United States
Taipei, Taiwan
London, United Kingdom
Los Angeles, California, United States
Tainan, Taiwan
London, Greater London, United Kingdom
Hamburg, Germany
New York, New York, United States
Denver, Colorado, United States
Chermside, Queensland, Australia
Santa Barbara, California, United States
New Orleans, Louisiana, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Pittsburg, Pennsylvania, United States
Fitzroy, Victoria, Australia
Calgary, Alberta, Canada
Corrientes, Argentina
Seoul, Korea, Republic Of
Pavia, Italy
Amsterdam, Netherlands
Guangzhou, Guangdong, China
Buenos Aires, Argentina
Innsbruck, Austria
Changsha, Hunan, China
Orlando, Florida, United States
Milwaukee, Wisconsin, United States
Glasgow, United Kingdom
Göteborg, Sweden
Darlinghurst, New South Wales, Australia
Los Angeles, California, United States
Grand Rapids, Michigan, United States
Valencia, Spain
Knoxville, Tennessee, United States
Greifswald, Mecklenburg Vorpommern, Germany
Besançon Cedex, France
Copenhagen, Denmark
Austell, Georgia, United States
Los Angeles, California, United States
Dresden, Germany
Perth, Western Australia, Australia
Seoul, Jongno Gu, Korea, Republic Of
London, Ontario, Canada
Monza, Italy
Mineola, New York, United States
Québec, Quebec, Canada
Ciudad Autonoma Buenos Aires, Argentina
Mexico, Distrito Federal, Mexico
Sydney, New South Wales, Australia
Alexandroupolis, Greece
Indianapolis, Indiana, United States
South Portland, Maine, United States
Changsha, China
Seoul, Gangnam Gu, Korea, Republic Of
Innsbruck, Austria
Singapore, Singapore
Ciudad Autonoma Buenos Aires, Argentina
Cordoba, Argentina
Louisville, Kentucky, United States
Columbus, Ohio, United States
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
La Jolla, California, United States
New York, New York, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Knoxville, Tennessee, United States
Burlington, Vermont, United States
Caba, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Mar Del Plata, Argentina
Sante Fe, Argentina
Linz, Austria
Wien, Austria
Bruxelles, Belgium
Leuven, Belgium
Goiânia, Goias, Brazil
Belo Horizonte, Mg, Brazil
Porto Alegre, R.S, Brazil
Porto Alegre, Rs, Brazil
Botucatu, Sao Paulo, Brazil
Sao Paulo, Sp, Brazil
Sao Paulo, Sp, Brazil
Sofia, Bulgaria
Sofia, Bulgaria
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Providencia, Santiago De Chile, Chile
Beijing, Beijing, China
Shanghai, Shanghai, China
Beijing, China
Zagreb, Croatia
Zagreb, Croatia
Praha 2, Czechia
århus, Denmark
Strasbourg, Bas Rhin, France
Grenoble, Isere, France
Saint étienne, Loire, France
Vandoeuvre Les Nancy, Meurthe Et Moselle, France
Bron Cedex, Rhone, France
Rouen Cedex, Seine Maritime, France
Brest Cedex 2, France
Lille Cedex, France
Marseille, France
Heidelberg, Baden Württemberg, Germany
Mainz, Rheinland Pfalz, Germany
Homburg, Saarland, Germany
Leipzig, Sachsen, Germany
Donaueschingen, Germany
Athens, Greece
Chaidari, Greece
Thessaloniki, Greece
Pecs, Hungary
Haifa, Israel
Jerusalem, Israel
Kfar Sava, Israel
Petach Tikva, Israel
Tel Aviv, Israel
Foggia, Italy
Genova, Italy
Milano, Italy
Roma, Italy
Incheon, Namdong Gu, Korea, Republic Of
Mexico, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, N.L., Mexico
Bialystok, Poland
Krakow, Poland
Otwock, Poland
Poznan, Poland
Wroclaw, Poland
Almada, Portugal
Coimbra, Portugal
Lisboa, Portugal
Bucharest, Romania
Bucuresti, Romania
Cluj Napoca, Romania
Timisoara, Romania
Belgrade, Serbia
Belgrade, Serbia
Sremska Kamenica, Serbia
Barcelona, Spain
Barcelona, Spain
Linköping, Sweden
Umeå, Sweden
Bursa, Turkey
Istanbul, Turkey
Izmir, Turkey
Dnipro, Ukraine
Kyiv, Ukraine
Lviv, Ukraine
London, Greater London, United Kingdom
Newcastle Upon Tyne, Tyne & Wear, United Kingdom
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Córdoba, Argentina
Le Kremlin Bicêtre, Val De Marne, France
Roanoke, Virginia, United States
Budapest, Hungary
Eskişehir, Odumpazari, Turkey
Austin, Texas, United States
Ankara, Turkey
Milan, Italy
Zhengzhou, China
Mersin, Yenisehir, Turkey
Indianapolis, Indiana, United States
Palermo, Pa, Italy
Orlando, Florida, United States
Santa Fe, Santa Fe De La Vera Cruz, Argentina
Porto, Portugal
Adana, Saricam, Turkey
Elk Grove Village, Illinois, United States
Phoenix, Arizona, United States
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Heidelberg, Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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