Myelofibrosis | Phase 3 | NCT04551053 Ruxolitinib Plus Parsaclisib (PI3Kδi) in Patients With Suboptimal Response to Ruxolitinib A Randomized, Double-Blind, Placebo-Controlled Study

Randomization

Patients with MF with suboptimal response to ruxolitinib N≈212

Ruxolitinib + Parsaclisib Ruxolitinib + Placebo

Primary endpoint: Spleen volume reduction at week 24

Crossover to ruxolitinib + parsaclisib allowed after 24 weeks

Key secondary endpoints: TSS reduction at week 24, OS, safety

Select inclusion criteria:

Select exclusion criteria:

• Diagnosis of PMF, PPV-MF, or PET-MF • DIPSS risk category of intermediate-1, intermediate-2, or high • Platelet count ≥50×109/L1 • Palpable spleen ≥5 cm BLCM -and- active symptoms with TSS ≥10 • Treated with ruxolitinib for ≥3 months, with a stable dose for ≥8 weeks prior to day 1

• Prior use of any PI3Kδi • Prior use of experimental drug therapy or any other standard drug for MF within 3 months of starting study and/or lack of recovery from all toxicities from therapy to grade ≤1 • Recent history of inadequate bone marrow reserve • Inadequate hepatic or renal function at screening

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The efficacy and safety of the investigational compounds discussed have not been established. There is no guarantee that these compounds will become commercially available for the uses under investigation.

For more information, visit IncyteClinicalTrials.com or contact us at 1-855-4MED-INFO (855-463-3463) or [email protected]. BLCM, below left costal margin; DIPSS, Dynamic International Prognostic Scoring System; MF, myelofibrosis; OS, overall survival; PET, post–essential thrombocythemia; PI3Kδi, phosphoinositide 3 kinase delta inhibitor; PMF, primary myelofibrosis; PPV, post–polycythemia vera; TSS, total symptom score. Data on file, Incyte Corporation. This information is current as of October 24, 2022.

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