A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Male or female adults (≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater)
Active dermatomyositis (DM) or polymyositis (PM) with age of onset
* 18 years old.
Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.
You may not be if
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
History of recurrent bacterial, viral, fungal, mycobacterial or other infections
Clinically significant finding on a chest x-ray
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 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
previous treatment with total lymphoid irradiation
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) or 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
Clareo Health | A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
