NCT05895786 · Pfizer
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
What this study is about
The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM.
View original scientific description
The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: * Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater * Have active DM or active PM.
Interventions
DRUG
PF-06823859
anti-interferon beta therapy
DRUG
Placebo
Placebo for PF-06823859
Primary outcome measures
Moderate change in Total Improvement Score (TIS)
Time frame: 24 weeks outside of the United States (US) and 52 weeks in the US
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
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
- 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
Where
- Glendale, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Los Angeles, California
- Orange, California
- Jacksonville, Florida
- Margate, Florida
- Miami, Florida
- Orlando, Florida
- Plantation, Florida
- Tamarac, Florida
- Fairway, Kansas
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations