POIESIS
Official Title: A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Sponsor: Kartos Therapeutics, Inc.
Conditions: Myelofibrosis
Brief Summary: This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.
Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
Intervention / Treatment:
- Drug: Navtemadlin
- Drug: Navtemadlin placebo
- Drug: Ruxolitinib
Learn More: Additional details about this study are available on https://clinicaltrials.gov/study/NCT06479135
Questions or Interested in Participating? To learn more about participation at our site, please contact our study team:
(801) 584-5665 or submit an inquiry.