At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PF-06823859 (drug), Placebo (drug)
- How long the study runs
- Study runs about 86 months (dates as stated)
- About the drug or intervention
- PF-06823859 — drug: anti-interferon beta therapy · Placebo — drug: Placebo for PF-06823859
- Patient visit burden
- "During this time, participants will have 15 study visits." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 318
- Started
- 2023-05-20
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for myositis
- • Phase3 - 318 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with myositis
Where?
- • Glasgow - Queen Elizabeth University Hospital
- • Salford - Salford Royal Hospital
- • Doncaster - Doncaster Royal Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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. * Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. * Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (dazukibart) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about 1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both dazukibart and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if dazukibart is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 the usual treatment (SOC) background medications at the time of enrollment.
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (3 UK sites)
Queen Elizabeth University Hospital
Glasgow G51 4TF, United Kingdom
Salford Royal Hospital
Salford M6 8HD, United Kingdom
Doncaster Royal Infirmary
Doncaster DN2 5LT, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
