To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Summary

The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.

Timeline

Start

2021-05-26

Primary completion

2023-08-16

Completion

2024-08-21

Outcome

Missed primary endpoint

Stopped: “The study was terminated due to futility.”

registry analysis (superiority test); Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib; p = 0.2567; NCT04551053 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Parsaclisib	Unknown	—	Oral
Background	Ruxolitinib	Small molecule	—	Oral

Indications