NCT05037760

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination With Ruxolitinib in Participants With Myelofibrosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib. Other aims are to learn about the effects of elritercept on the signs and symptoms of MF when taken with or without ruxolitinib and to learn how elritercept affects the body, how the body processes elritercept, and the effects of elritercept on anemia when taken with or without ruxolitinib The study will also check on how safe elritercept is and how well it is tolerated.

Detailed description

Elritercept is an investigational therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in participants with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF).

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Elritercept	Elritercept SC injection.
DRUG	Ruxolitinib	Ruxolitinib tablet.

Timeline

• Start date: 2021-12-16
• Primary completion: 2028-02-28
• Completion: 2030-02-28
• First posted: 2021-09-08
• Last updated: 2026-02-05

Locations

46 sites across 7 countries: Australia, Brazil, France, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study