Trials / Active Not Recruiting
Active Not RecruitingNCT04603495
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Myelofibrosis
- Primary Myelofibrosis
- Post-polycythemia Vera Myelofibrosis
- Post-essential Thrombocythemia Myelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pelabresib | Double-blind treatment (pelabresib or matching placebo) will be administered daily for 14 consecutive days followed by a 7-day break, which is considered 1 cycle of treatment (1 cycle = 21 days). Pelabresib is a small molecule inhibitor of BET proteins with a novel mechanism of action and potential for disease-modifying effects in MF. |
| DRUG | Ruxolitinib | Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF. |
| DRUG | Placebo | Placebo tablets are designed to match pelabresib tablets. Each placebo tablet contains no active pharmaceutical ingredient and is visibly identical to experimental drug in size, shape, and packaging. Placebo dosing follows the same dosing conventions as pelabresib. |
Timeline
- Start date
- 2021-04-09
- Primary completion
- 2023-08-23
- Completion
- 2027-06-30
- First posted
- 2020-10-26
- Last updated
- 2025-12-17
- Results posted
- 2024-10-28
Locations
156 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Malaysia, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04603495. Inclusion in this directory is not an endorsement.