A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive
Novartis Pharmaceuticals
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.
Description
The study for each participant is composed of several distinct periods: a screening period, a study treatment period, and a post-treatment follow-up phase. 1. Screening Period: The screening period lasts for up to 28 days prior to Cycle 1 Day 1, which marks the beginning of treatment. During this time, the participant's eligibility for the study is confirmed, informed consent is obtained, and all required baseline assessments are completed. 2. Treatment Period: The treatment period begins on Cycle 1 Day 1, which is the point of randomization and the start of study treatment. This peri…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022 * DIPSS risk category of intermediate-1, intermediate-2 or high-risk * Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available) * Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments req…
Interventions
- DrugPelabresib
Pelabresib monohydrate tablets
- DrugRuxolitinib
Ruxolitinib phosphate tablets
- DrugPlacebo
Matches pelabresib
Locations (5)
- Summit Medical GroupBerkeley Heights, New Jersey
- Novartis Investigative SiteSeoul, Yangcheon Gu
- Novartis Investigative SiteSeoul
- Novartis Investigative SiteSeoul
- Novartis Investigative SiteSeoul