At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 309 enrolled
Drug / intervention
Ruxolitinib +1 moredrug
Likely dose
Ruxolitinib 5 mgfrom 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.
A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
In Brief
A Phase 3 clinical trial evaluating Ruxolitinib and Placebo for MPN (Myeloproliferative Neoplasms). Completed, enrolled 309 participants across 112 sites in 3 countries.
Detailed Summary
This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMPN (Myeloproliferative Neoplasms)
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedAug 2009
Primary CompletionNov 2010
Study CompletionOct 2015
TodayJul 2026
First PostedAug 6, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2010
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.9 years ago
Interventions
Ruxolitinibdrug
Ruxolitinib phosphate tablets 5 mg administered as oral doses.
Placebodrug
Matching placebo tablets were administered as oral doses in the same manner as active drug.