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

NCT07357727 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Primary Myelofibrosis (PMF)
  • Post-polycythemia Vera Myelofibrosis (PPV-MF)
  • Post-essential Thrombocythemia Myelofibrosis (PET-MF)

Interventions

DRUG

Pelabresib

Pelabresib monohydrate tablets

DRUG

Ruxolitinib

Ruxolitinib phosphate tablets

DRUG

Placebo

Matches pelabresib

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-05-17
Completion
2030-12-27
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357727 on ClinicalTrials.gov