Last updated 8 days ago
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
270 patients around the world
Available in Spain, Argentina, United States
Pfizer
1Research sites
270Patients around the world
This study is for people with
Inflammatory Myopathies
Dermatomyositis
Polymyositis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female adults (≥18 years old)Active dermatomyositis (DM) or polymyositis (PM) with age of onsetMust be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment
- 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 involvementActive bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollmentHave cancer or a history of cancer within 5 years of screeningSignificant 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 transplantAcute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screeningPreexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorderMajor surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgeryHistory of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid diseaseClinically significant depression, suicidal ideation, or previous history of suicidal behaviorsOther medical or laboratory abnormality that may increase the risk of study participationPrevious administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicineCurrent 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 therapyPrior SOC medication that does not fulfill the criteriaCertain laboratory results from screening assessments that may interfere with study participationInvestigator 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
Sites
Centro de Investigaciones Médicas Tucumán
SponsorPfizer
Conditions
DermatomyositisPolymyositis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05895786
