CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 430 enrolled
Drug / intervention
Pelabresib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04603495
NCT04603495Phase 3Active
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Oct 26, 2020·Updated Dec 17, 2025

In Brief

A Phase 3 clinical trial evaluating Pelabresib, Ruxolitinib, and 1 other intervention for Myelofibrosis and 3 related conditions. Active but no longer recruiting, targeting 430 participants across 156 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Malaysia, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
2021202220232024202520262027
First PostedOct 26, 2020
Enrollment StartApr 9, 2021
Primary CompletionAug 23, 2023
Study CompletionJun 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.7 years ago

Interventions

Pelabresibdrug

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.

Ruxolitinibdrug

Ruxolitinib is a JAK inhibitor and a current, approved treatment option for MF.

Placebodrug

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.