A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
- Conditions
- Myositis
- Registration Number
- JPRN-jRCT2031230382
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 270
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Moderate change in Total Improvement Score (TIS) [Time Frame: 24 weeks outside of the United States (US) and 52 weeks in the US]<br>Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
- Secondary Outcome Measures
Name Time Method