NCT04878003

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Kartos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Conditions

• Primary Myelofibrosis (PMF)
• Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
• Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)

Interventions

Type	Name	Description
DRUG	KRT-232	KRT-232, administration by mouth
DRUG	TL-895	TL-895, administration by mouth

Timeline

• Start date: 2021-04-13
• Primary completion: 2024-05-01
• Completion: 2025-10-01
• First posted: 2021-05-07
• Last updated: 2022-05-09

Locations

29 sites across 9 countries: United States, Belarus, Bulgaria, Georgia, Mexico, Poland, Russia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study