A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS) - A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Kawai Norisuke0 个研究点目标入组 270 人开始时间: 2023年10月7日最近更新: 2024年5月27日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 270

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•Inclusion Criteria:
•*Male or female adults (>=18 years old)
•*Active dermatomyositis (DM) or polymyositis (PM) with age of onset
•o18 years old.
•*Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.

排除标准

•Exclusion Criteria:
•*Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
•*Existing diagnosis of inclusion body myositis (IBM)
•*Presence of immune-mediated necrotizing myositis (IMNM)
•*Myositis with end-stage organ involvement
•*Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment
•*Have cancer or a history of cancer within 5 years of screening
•*Significant current or prior disease conditions that may interfere with the response to or safety of the study medicine, including but not l limited to:
•*history of major organ transplant
•*acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening
•*preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder
•*major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery
•*history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease
•*Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors
•*Other medical or laboratory abnormality that may increase the risk of study participation
•*Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine
•*Current use or incomplete appropriate washout period of any prohibited medication(s), including known exposure to anti-interferon beta (PF-06823859) or any type of anti-interferon beta therapy
•*Prior SOC medication that does not fulfill the criteria
•*Certain laboratory results from screening assessments that may interfere with study participation.
•*Investigator site staff directly involved in the conduct of the study and their family members, site staff and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members

研究者

发起方

Kawai Norisuke

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