A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)
A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)
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.
Study ROR-PH-303 is a multicenter, open-label extension (OLE) study for subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who qualify for entry based upon participation in the prior study. Subjects who discontinue participation in a prior study due to safety issues related to study medication or who fail to complete study procedures will not be eligible to enter Study ROR-PH-303. Subjects who meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their pre-existing PAH disease-specific background therapy.
For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study, a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE. Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE.
Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study.
All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AE/serious adverse event (SAE) or other reason, marketing approval of ralinepag is granted in the region in which the study is conducted, or the study is discontinued by the Sponsor.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85013, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1181ACH, Argentina
Caba, 1425, Argentina
Ciudad Autonoma Buenos Aires, 1280, Argentina
Ciudad Autonoma Buenos Aires, 1426, Argentina
Ciudad Autonoma Buenos Aires, C1093AAS, Argentina
Belo Horizonte, Minas Gerais 30441-070, Brazil
Porto Alegre, Rio Grande do Sul 90035-074, Brazil
Botucatu, São Paulo 18618-687, Brazil
Prague, 128 08, Czechia
Strasbourg, Bas Rhin 67091, France
Grenoble, Isere 38048, France
Vandœuvre-lès-Nancy, Meurthe Et Moselle 54511, France
Saint-Étienne-de-Montluc, Pays de la Loire Region 42005, France
Bron, Rhone 69677, France
Le Kremlin-Bicêtre, Val De Marne 94275, France
Heidelberg, Baden-Wurttemberg 69126, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Homburg, Saarland 66424, Germany
Athens, 17674, Greece
Thessaloniki, 54636, Greece
Petah Tikva, 4941492, Israel
Palermo, PA 90127, Italy
Foggia, 71100, Italy
Milan, 20122, Italy
Roma, 00161, Italy
Mexico City, Mexico City 14080, Mexico
Bialystok, 15-276, Poland
Krakow, 31-202, Poland
Poznan, 61-848, Poland
Lisbon, 1769-001, Portugal
Bucharest, 022328, Romania
Bucharest, 050159, Romania
Cluj-Napoca, 400001, Romania
Timișoara, 300310, Romania
Belgrade, 11080, Serbia
Barcelona, 08035, Spain
Istanbul, 34899, Turkey (Türkiye)
Izmir, 35340, Turkey (Türkiye)
Dnipro, 49070, Ukraine
Kyiv, 03680, Ukraine
Lviv, 79010, Ukraine
Newcastle upon Tyne, Tyne and Wear NE7 7DN, United Kingdom