To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Summary

The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.

Timeline

Start

2021-05-24

Primary completion

2023-08-03

Completion

2024-11-25

Outcome

Missed primary endpoint

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

registry analysis (superiority test); Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib; p = 0.4224; Odds Ratio (OR) 1.27 (95% CI 0.71 to 2.26) NCT04551066 ↗

Drugs

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

Indications