Phase 1 Study of PRT12396 in Patients with High‑Risk Polycythemia Vera and Post‑ET or Post‑PV Myelofibrosis and Intermediate/High‑Risk Primary Myelofibrosis

78 participants were enrolled, comprising both female and male patients identified as vulnerable. The cohort consisted of individuals diagnosed with myelofibrosis in various contexts, including post‑essential thrombocythemia, post‑polycythemia vera, and primary disease classified as intermediate‑1, intermediate‑2, or high‑risk, as well as high‑risk polycythemia vera. Age range codes 3 and 4 indicate inclusion of adult subjects spanning middle‑aged to older adults. Selection was based on confirmed diagnosis of the listed conditions; no additional lifestyle restrictions such as specific diet or physical activity regimens were stipulated in the provided information.

The study is a Phase 1 interventional trial evaluating PRT12396 in adults diagnosed with post‑essential thrombocythemia myelofibrosis, post‑polycythemia vera myelofibrosis, intermediate‑1, intermediate‑2, or high‑risk primary myelofibrosis, and high‑risk polycythemia vera. Enrollment is planned to begin on 1 August 2026 with an estimated completion date of 25 January 2028. After informed consent, participants attend a screening visit to confirm eligibility based on diagnostic criteria and baseline assessments. Eligible participants then receive the investigational product and return for scheduled follow‑up visits at defined intervals for safety monitoring, pharmacokinetic sampling, and disease evaluation. The final visit, designated as the end-of-study visit, occurs after the predetermined observation period to collect all remaining study data. Participant involvement spans the entire treatment and follow‑up schedule, encompassing the duration of the study as defined by the protocol.

No experimental medication or comparator details are provided in the source data.