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NCT07357727 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
NCT07357727: Recruiting Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT07357727 is a Phase 3 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07357727, a Phase 3 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
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.
Primary Outcome
Spleen Response (SVR35) is defined as achieving a reduction of at least 35 percent in spleen volume from baseline to Week 24, as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and assessed by a centralized radiology review in participants with baseline TSS ≥ 25.
Interventions
- DRUG Placebo
- DRUG Pelabresib
- DRUG Ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2026-06-12 |
| Est. Completion | 2030-12-27 |
| Phase | Phase 3 |
What NCT07357727 shows while recruiting
NCT07357727 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07357727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07357727 about?
NCT07357727 is a clinical study titled "A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)". 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 ...
What is the current status of trial NCT07357727?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2026-06-12. Estimated completion is 2030-12-27.
What interventions are being tested in trial NCT07357727?
The interventions under investigation include: Placebo (DRUG), Pelabresib (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT07357727?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07357727's enrollment target sits among peer trials
460 823rd of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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