A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Myositis
About this trial
This is an interventional treatment trial for Myositis focused on measuring Dermatomyositis, Polymyositis
Eligibility Criteria
Inclusion Criteria: Male or female adults (≥18 years old) 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. 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
Sites / Locations
- Arizona Arthritis & Rheumatology Associates, P.C.Recruiting
- Arizona Arthritis & Rheumatology Research, PLLCRecruiting
- Inland Rheumatology & Osteoporosis Medical GroupRecruiting
- Lal Bhagchandani, M.D
- Omega Research OrlandoRecruiting
- West Broward Rheumatology Associates
- KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
- KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
- University of Kansas Medical Center - Hoglund Brain Imaging Center
- University of Kansas Medical Center
- Brigham and Women's Hospital
- CTH - Brigham & Women's Hospital
- Washington University School of MedicineRecruiting
- Washington University Pulmonary Function LaboratoryRecruiting
- Washington University School of MedicineRecruiting
- Arthritis and Rheumatology Research InstituteRecruiting
- Rheumatology & Pulmonary ClinicRecruiting
- Anhui Provincial Hospital
- China-Japan Friendship Hospital
- Peking Union Medical College Hospital
- Guangdong Provincial People's Hospital
- Guangdong Provincial People's Hospital
- Qilu Hospital of Shandong University
- Shanghai Jiaotong University School of Medicine, Renji Hospital
- National Hospital Organization Asahikawa Medical Center
- National Hospital Organization Asahikawa Medical Center
- Hokkaido University HospitalRecruiting
- Tokyo Medical And Dental University Hospital
- Nippon Medical School HospitalRecruiting
- Tokyo Medical University Hospital
- Okayama City General Medical Center Okayama City Hospital
- Tokyo Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
PF-06823859
Placebo
Participants will receive PF-06823859 via intravenous infusion every 4 weeks.
Participants will receive placebo via intravenous infusion every 4 weeks.