drugset / Trial / NCT07357727

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

NCT07357727

Phase 3 Recruiting 460 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.

Timeline

Start
2026-06-16
Primary completion
2028-05-17
Completion
2030-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Pelabresib Small molecule Oral
Background Ruxolitinib Small molecule Oral