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

Part of paid clinical trials in Berkeley Heights, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07357727
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelabresib — DRUG
    Pelabresib monohydrate tablets
  • Ruxolitinib — DRUG
    Ruxolitinib phosphate tablets
  • Placebo — DRUG
    Matches pelabresib

Study Details

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.

Key Dates

Start date
May 27, 2026
Status verified
Jun 2026
Primary completion
May 17, 2028
Completion
Dec 27, 2030

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Pelabresib + Ruxolitinib
    Participants in this arm receive pelabresib (DAK539) orally once daily for 14 days of each 21-day cycle, in combination with ruxolitinib, which is taken orally twice daily throughout each cycle. Participants may continue receiving study treatment until they experience unacceptable toxicity, disease progression, or until either the investigator or the participant decides to discontinue treatment.
  • Placebo Comparator: Arm 2: Placebo + Ruxolitinib
    Participants in this arm receive a matching placebo orally once daily for 14 days of each 21-day cycle, together with ruxolitinib, which is also taken orally twice daily throughout each cycle. Participants may continue receiving study treatment until they experience unacceptable toxicity, disease progression, or until either the investigator or the participant decides to discontinue treatment.

Primary Outcome Measure

Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25 [ Time Frame: Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Summit Medical GroupBerkeley HeightsNew Jersey07922
Michelle Mackenzie
[email protected]
973-436-1755
Lalitha Anand (PRINCIPAL_INVESTIGATOR)

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By research site
Summit Medical Group· Berkeley Heights, NJ

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