Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Phase 3
Active, not recruiting
NCT04603495
| Condition | Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Novartis Pharmaceuticals |
|---|
| Status | Active, not recruiting |
|---|
| Enrollment | 430 participants |
|---|
| Interventions | Pelabresib, Ruxolitinib |
|---|
| Start date | Apr 9, 2021 |
|---|
| Completion date | Aug 23, 2023 |
|---|
| Results posted | Oct 28, 2024 |
|---|
Summary
A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
Number of Participants With Splenic Response by Central Radiology Reads at Week 24
Week 24 · Participants
| Pelabresib + Ruxolitinib (Experimental Arm) | 141 Participants |
|---|
| Placebo + Ruxolitinib (Control Arm) | 76 Participants |
|---|
| p-value | <0.001 |
|---|
| Difference in proportion | 30.4 (95% CI 21.6–39.3) |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.