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NCT04603495 · ClinicalTrials.gov record · last posted 2026-07-17

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

Study acronym: MANIFEST-2
StatusActive, Not Recruiting
PhasePhase 3
Started2021-04-09
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 52 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 52 times since 2020-10-21; most recent amendment 2026-07-15. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-04-04
Status change Recruiting→Active, Not Recruitingv41
2020-11-23
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT04603495
Lead Sponsor Novartis Pharmaceuticals
Conditions Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
Enrollment 430 participants
Start Date 2021-04-09
Primary Completion 2023-08-23 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17