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Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment

About COMFORT-I

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

Primary endpoint

  • Proportion of subjects achieving >35% reduction in spleen volume from baseline to Week 24 as measured by MRI† (or CT‡ scan in applicable subjects)

Secondary endpoints

  • 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
† Magnetic resonance imaging.
‡ Computed tomography.
§ Myelofibrosis Symptom Assessment Form.
|| Self-reported constitutional symptoms including fatigue, bone pain, fever, pruritus, night sweats, symptomatic splenomegaly, and weight loss (>10%).1

Reference: 1. Mesa RA, Schwager S, Radia D, et al. The myelofibrosis symptom assessment form (MFSAF): an evidence-based brief inventory to measure quality of life and symptomatic response to treatment in myelofibrosis. Leuk Res. 2009.doi:10.1016/j.leukres.2009.01.035.