A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study.
Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or
placebo, in addition to their standard of care or PAH-specific background therapy, as
applicable. The primary endpoint is the time (in days) from randomization to the first
adjudicated protocol-defined clinical worsening event. All primary endpoint events will be
adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects
who have a confirmed primary endpoint event adjudicated by the CEC at any time during the
study and all subjects on treatment at the conclusion of the study (after the target number
of events is achieved) will have the option to enroll in an open-label extension (OLE) study.
Subjects who do not choose to participate in the OLE study will discontinue study drug, and
should remain in the study for long-term follow-up of survival status and will receive
standard of care PAH treatment, at the discretion of the treating physician.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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