NCT04455841

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

Conditions

• Anemia
• Post-essential Thrombocythemia Myelofibrosis
• Post-polycythemia Vera Myelofibrosis

Interventions

Type	Name	Description
DRUG	INCB000928	INCB000928 will be administered at protocol defined dose.
DRUG	ruxolitinib	Ruxolitinib will be administered at protocol defined dose.

Timeline

• Start date: 2021-03-19
• Primary completion: 2025-04-01
• Completion: 2027-11-26
• First posted: 2020-07-02
• Last updated: 2025-12-23

Locations

34 sites across 6 countries: United States, Canada, France, Italy, Japan, United Kingdom

Regulatory

• FDA-regulated drug study