Myelofibrosis | Phase 1/2 | NCT04455841 INCB000928 (ALK2i) as Monotherapy or in Combination With Ruxolitinib in Patients With Anemia Due to MF An Open-Label Study

Part 1: Dose escalation

Patients with transfusiondependent or symptomatic anemia N≈100

Treatment group A: Prior JAKi treatment for ≥12 weeks INT-2 or high-DIPSS MF

Treatment group A: INCB000928 monotherapy

Treatment group B: Stable dose of ruxolitinib for ≥12 weeks INT-1, INT-2, or high-DIPSS MF

RDE

Treatment group B: INCB000928 + ruxolitinib

Primary endpoints: Safety and tolerability

Part 2: Dose expansion

Treatment group B: INCB000928 + ruxolitinib

Key secondary endpoints: Anemia response (all patients); spleen volume and symptom response rate treatment group B

Select inclusion criteria:

Select exclusion criteria:

• Patients with MF who: − Are transfusion dependent: have received 4 units of RBC transfusions in the past 28 days -or- ≥4 units in the past 8 weeks for an Hb level