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An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Primary Objective: To evaluate preliminary efficacy of itacitinib on SVR from baseline at Week 24 in the 2 following cohorts of MF subjects: Cohort A: in combination in subjects with ruxolitinib low dose (less than 20mg daily). Cohort B: as monotherapy in subjects who progressed (per revised ELN 2013 response criteria for MF) after initial reduction in spleen on ruxolitinib or discontinued for hematologic toxicities. Secondary Objectives (Cohorts A and B): To evaluate preliminary safety and tolerability of itacitinib alone. To evaluate preliminary safety and tolerability of itacitinib in combination with ruxolitinib. To evaluate preliminary efficacy of itacitinib alone or in combination with ruxolitinib on SVR from baseline at Week 12. To evaluate preliminary efficacy of itacitinib alone or in combination with ruxolitinib on spleen length reduction from baseline at Week 12 and Week 24. To evaluate preliminary efficacy of itacitinib alone or in combination with ruxolitinib with respect to MF symptoms at Week 12 and Week 24. To evaluate preliminary efficacy of itacitinib using IWG-MRT criteria. To assess the PK of itacitinib and ruxolitinib. To evaluate the relationship between blood biomarkers and clinical activity when treated with itacitinib alone or in combination with ruxolitinib. To evaluate the effects of itacitinib on bone marrow fibrosis grade, cytogenetics JAK2 V617F, MPL W515 and S505, CALR exon 9 mutations, or other mutations allele burden, when available. To evaluate the efficacy of itacitinib on RBC transfusion rates.

Primary Objective: To evaluate preliminary efficacy of itacitinib on SVR from baseline at Week 24 in the 2 following cohorts of MF subjects: Cohort A: in combination in subjects with ruxolitinib low dose (less than 20mg daily). Cohort B: as monotherapy in subjects who progressed (per revised ELN 2013 response criteria for MF) after initial reduction in spleen on ruxolitinib or discontinued for hematologic toxicities. Secondary Objectives (Cohorts A and B): To evaluate preliminary safety and tolerability of itacitinib alone. To evaluate preliminary safety and tolerability of itacitinib in combination with ruxolitinib. To evaluate preliminary efficacy of itacitinib alone or in combination with ruxolitinib on SVR from baseline at Week 12. To evaluate preliminary efficacy of itacitinib alone or in combination with ruxolitinib on spleen length reduction from baseline at Week 12 and Week 24. To evaluate preliminary efficacy of itacitinib alone or in combination with ruxolitinib with respect to MF symptoms at Week 12 and Week 24. To evaluate preliminary efficacy of itacitinib using IWG-MRT criteria. To assess the PK of itacitinib and ruxolitinib. To evaluate the relationship between blood biomarkers and clinical activity when treated with itacitinib alone or in combination with ruxolitinib. To evaluate the effects of itacitinib on bone marrow fibrosis grade, cytogenetics JAK2 V617F, MPL W515 and S505, CALR exon 9 mutations, or other mutations allele burden, when available. To evaluate the efficacy of itacitinib on RBC transfusion rates.