INCB 50465-304 Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis

What is the Purpose of this Study?

This study has 2 parts. If you choose to join:
- In Part 1, you will be randomly assigned (like a coin flip) to get either the study drug + ruxolitinib or placebo + ruxolitinib. After 24 weeks, you will move into Part 2.
- In Part 2, you will have the opportunity to take the study drug if you were assigned to receive placebo in Part 1.

The dose of ruxolitinib you take will depend on the amount you took before taking part in the study and will range from 5 mg to 25 mg. Participants will take ruxolitinib twice a day by mouth.
What is the Condition Being Studied?

Who Can Participate in this Study?

Adults who:

- Are diagnosed with myelofibrosis

- Have spleen enlargement from their therapy

For more information about who can join this study, please contact the study team at or 919-684-9220.

Age Group
Participating Institutions

What is Involved?

We are doing this study to find out if an investigational drug called parsaclisib (the study drug) is a safe and effective addition to ruxolitinib therapy in patients with myelofibrosis. We want to compare how the study drug works versus a placebo (inactive substance) for people who continue to have enlargement of the spleen while being treated with ruxolitinib for myelofibrosis.

Study Details

Full Title
A Randomized, Double-Blind, Placebo-Controlled Study of the PI3K? Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib
Principal Investigator

Protocol Number

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