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# Incyte Abandons Phase 3 Myelofibrosis Trial
- URL: https://www.fdaweb.com/incyte-abandons-phase-3-myelofibrosis-trial/
- Published: 2023-03-06T12:00:00.000Z
- Updated: 2026-09-14T18:18:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153906

Incyte says it will discontinue the Phase 3 LIMBER-304 myelofibrosis trial after a pre-planned interim analysis performed by an independent data monitoring committee determined that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. It says safety considerations were not a factor in the decision to stop the study.

LIMBER-304 was designed to evaluate the efficacy and safety of parsaclisib plus ruxolitinib (Jakafi) versus placebo plus ruxolitinib in adult patients living with myelofibrosis who have an inadequate response to ruxolitinib monotherapy. The primary endpoint was the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography.