NCT04655118

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: Telios Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

Conditions

• Myelofibrosis
• Indolent Systemic Mastocytosis

Interventions

Type	Name	Description
DRUG	TL-895	TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
DRUG	Placebo	Placebo to match TL-895

Timeline

• Start date: 2020-10-22
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2020-12-07
• Last updated: 2024-05-10

Locations

52 sites across 13 countries: United States, Australia, Belgium, Brazil, Bulgaria, France, Germany, Hungary, Italy, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study