An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

Summary

Participation Requirements

Description

Permitted Concomitant Medications and Procedures Subjects are receiving a JAK2 inhibitor for the treatment of MPN-associated MF that is approved in the country where the study is being conducted. JAK2 inhibitors are to be used according to their respective label and as prescribed as part of the subj...

Permitted Concomitant Medications and Procedures Subjects are receiving a JAK2 inhibitor for the treatment of MPN-associated MF that is approved in the country where the study is being conducted. JAK2 inhibitors are to be used according to their respective label and as prescribed as part of the subject's standard-of-care therapy as prescribed by their physician prior to study entry. Best supportive care (BSC) includes, but is not limited to, treatment with transfusions (eg, RBC, platelet, whole blood), ICTs, antibiotic, antiviral and/or antifungal therapy, and nutritional support as needed. Granulocyte colony-stimulating factors (ie, G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF]) are allowed only in cases of neutropenic fever or as clinically indicated per product label. Prophylactic antithrombotic therapy is permitted. Thrombopoietin and platelet transfusions are permitted. Treatment with systemic corticosteroids is permitted for nonhematological conditions providing the subject is receiving a constant dose equivalent to ? 10 mg prednisone during the study. Administration of attenuated vaccines (eg, influenza vaccine) is allowed if clinically indicated per Investigator discretion. Iron chelation therapy (ICT) is to be used according to the product label. If the label permits, the ICT dose should be stable during at least the first 24 weeks of IP. Initiation of ICT while within the first 24 weeks of IP should be clinically indicated to treat an AE. Prohibited Concomitant Medications The following concomitant medications are specifically excluded during the course of the study: Cytotoxic, chemotherapeutic, targeted, or investigational agents/therapies (excluding JAK2 inhibitor therapy) Azacitidine, decitabine, or other hypomethylating agents Lenalidomide, thalidomide, and pomalidomide Erythropoietin stimulating agents (ESAs) and other RBC hematopoietic growth factors (eg, IL-3) Hydroxyurea or other alkylating agents Androgens (unless given to treat hypogonadism) Oral retinoids (topical retinoids are permitted) Arsenic trioxide Interferon Anagrelide Systemic corticosteroids at a dose equivalent to > 10 mg prednisone Investigational products for the treatment of MPN-associated MF

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