INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Inclusion Criteria

• •Participants with MF who are transfusion-dependent or present with symptomatic anemia, defined as follows:
• •1. Anemia: An Hgb value \< 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: RBC transfusion must be at least 2 weeks before the Hgb measurement during screening).
• •2. Transfusion-dependent: Participant has received at least 4 units of RBC transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has received an average of at least 4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of \< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia. In addition, the most recent transfusion episode must have occurred in the 28 days before Cycle 1 Day 1.
• •ECOG performance status score of the following:
• •1. 0 or 1 for the dose-escalation stages.
• •2. 0, 1, or 2 for the dose-expansion stage.
• •Life expectancy is greater than 6 months
• •Agreement to avoid pregnancy or fathering children.
• •Ineligible to receive or have not responded to available therapies for anemia such as ESAs.
• •For TGA:
• •Participants previously treated with JAK inhibitors for at least 12 weeks.
• •Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
• •For TGB:
• •Participants must have been on a therapeutic and stable regimen of ruxolitinib for at least 12 consecutive weeks immediately preceding the first dose of study treatment.
• •Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.
• •For TGC:
• •Participants must be JAK inhibitor treatment naive (no prior treatment with any JAK inhibitor) and have an indication for initiation of ruxolitinib treatment.
• •Participants with intermediate-1, intermediate-2, or high DIPSS MF according to IWG-MRT criteria.