A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Inclusion Criteria

• Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria. - Male and female subjects aged 18 (or the country specific minimum age of consent >18) years or older. - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera. - At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization. - CBC values immediately prior to randomization: 1. Hematocrit <45%, 2. WBC 4000/μL to 20,000/μL (inclusive), and 3. Platelets 100,000/μL to 1,000,000/μL (inclusive) - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen. - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening. Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria. - Clinically meaningful laboratory abnormalities at Screening. - Subjects who require phlebotomy at hematocrit levels lower than 45%. - Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization. - Active or chronic bleeding within 2 months prior to randomization. - History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer. - Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization. - Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.