This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.
WHO Group 1 PH: Pulmonary Arterial Hypertension;
WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;
Right heart catheterization (RHC) at screening (or within 3 months prior to screening);
Screening 6MWD >75 meters to ≤450 meters.
PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
Chronic thromboembolic or portopulmonary hypertension
Total Lung Capacity (TLC) <60% predicted;
FEV1/FVC <70% predicted or FEV1 <60% predicted;