COMFORT-I is a randomized, double-blind, placebo-controlled Phase III study of the oral JAK1/JAK2 inhibitor INCB018424 in patients with primary myelofibrosis (MF), post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
* Patients randomized to placebo will be eligible to cross over to INCB018424
- Proportion of subjects achieving >35% reduction in spleen volume from baseline to Week 24 as measured by MRI† (or CT‡ scan in applicable subjects)
- Duration of maintenance of a >35% reduction from baseline in spleen volume among subjects initially randomized to receive INCB018424
- Proportion of subjects with >50% reduction in total symptom score from baseline to Week 24 as measured by the modified MFSAF§ || v2.0 diary