BridgeMD
A study of pelabresib and ruxolitinib compared to placebo and ruxolitinib in adult patients with myelofibrosis who have not received prior treatment with a Janus kinase inhibitor.
EU CTIS ID: 2025-523555-66-00
What this study is testing
Primary objective in participants with TSS ≥25: To determine the efficacy of pelabresib + ruxolitinib compared with placebo +ruxolitinib with regard to spleen volume reduction and symptom improvement at Week 24 Primary objective in participants with TSS ≥ 15 (i.e., in the overall population): To determine the efficacy of pelabresib + ruxolitinib compared with placebo + ruxolitinib with regard to spleen volume reduction and symptom improvement at Week 24
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET Confidential Novartis Clinical Trial Protocol (Version No. 00) Page 13 of 132 Protocol No. CDAK539A12303 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 required for average calculation)
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Blasts <5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening
You likely can't join if
- Prior splenectomy at any time or splenic irradiation in the previous 6 months
- Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization
- Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation
- History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment
- Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer
- Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor
See the full eligibility criteria
- Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET Confidential Novartis Clinical Trial Protocol (Version No. 00) Page 13 of 132 Protocol No. CDAK539A12303 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 required for average calculation)
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Blasts <5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening
- Platelet count ≥ 100 x 10⁹//L in the absence of growth factors or transfusions for the previous 4 weeks
- Prior splenectomy at any time or splenic irradiation in the previous 6 months
- Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization
- Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation
- History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment
- Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer
- Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
- Brazil
- Argentina
- Canada
- Japan
- Malaysia
- India
- United Kingdom
- Taiwan
- Australia
- China
- Korea, Republic of
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey; Brazil; Argentina; Canada; Japan and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.