NCT04629508

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)

A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.

Conditions

• Myelofibrosis
• Polycythemia Vera
• Thrombocythemia

Interventions

Type	Name	Description
DRUG	itacitinib	itacitinb Immediate Release (IR) will be dosed orally twice a day

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2020-11-16
• Last updated: 2025-09-02
• Results posted: 2024-09-19

Locations

21 sites across 7 countries: United States, Austria, Belgium, Germany, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study