At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓ECOG performance score ≤2
- ✓Life expectancy ≥12 months
- ✓Confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
- ✕Active infection requiring parenteral antibiotics within 28 days or oral antibiotics within 14 days of C1D1
- ✕NYHA Class 3 or 4 heart failure
- ✕QTcF >500 msec on screening or C1D1 ECG
- ✕Uncontrolled clinically significant arrhythmia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis
In Brief
A Phase 2 clinical trial evaluating Elritercept and Ruxolitinib for Myelofibrosis. Currently recruiting, targeting 135 participants across 46 sites in 7 countries.
Signals
Detailed Summary
The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib. Other aims are to learn about the effects of elritercept on the signs and symptoms of MF when taken with or without ruxolitinib and to learn how elritercept affects the body, how the body processes elritercept, and the effects of elritercept on anemia when taken with or without ruxolitinib The study will also check on how safe elritercept is and how well it is tolerated.
Study Details
Timeline
Interventions
Elritercept SC injection.
Ruxolitinib tablet.