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New treatment option for Myositis
Official title A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
ClinicalTrials.gov ID: NCT05895786
What this study is testing
What is PF-06823859?
PF-06823859 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) 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.
- Phase 3: a large, late-stage study
- Time commitment: about 13 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- Jacksonville, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Allen, Texas, United States
+ 84 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 13 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Orange, California, United States; Jacksonville, Florida, United States and 98 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.