Actively Recruiting
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Effects of PF-06823859 in Adults With Active Idiopathic Inflammatory Myopathies Dermatomyositis and Polymyositis
Led by Pfizer · Updated on 2026-06-01
318
Participants Needed
146
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the study medicine PF-06823859 dazukibart works in adults with idiopathic inflammatory myopathies, specifically dermatomyositis DM and polymyositis PM. These conditions cause muscle inflammation leading to weakness and may include a skin rash in DM. The study aims to assess the safety and effects of dazukibart compared to a placebo in people receiving stable doses of corticosteroids or immunosuppressants. Participants will receive either the study medicine or a placebo through an intravenous infusion lasting about one hour. These infusions occur every four weeks from Day 1 through Week 48 at the study site. The study is randomized and double-blind, meaning neither participants nor researchers know who gets the medicine or placebo during the trial. Participants will be involved for about 13 months, attending 15 visits at the study site. During these visits, muscle strength, skin condition, physical function, fatigue, itch, and corticosteroid use are assessed. The main measurement is the Total Improvement Score at 24 or 52 weeks depending on location. Safety and other symptom measures will be monitored throughout the study period.
CONDITIONS
Brief Title
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults 18 years or older or minimum legal adult age as defined per local regulation
- Active dermatomyositis (DM) or polymyositis (PM) with age of onset 18 years or older
- Must be receiving a stable dose of standard of care background medications (one corticosteroid and/or one immunosuppressant) at enrollment
You will not qualify if you...
- Myositis due to non-idiopathic inflammatory myopathies
- 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 hospitalization for serious infections within 60 days prior to enrollment
- History of recurrent infections including bacterial, viral, fungal, or mycobacterial
- Clinically significant chest x-ray findings
- Current or history of cancer within 5 years of screening
- History of major organ transplant
- Acute coronary syndrome or significant cerebrovascular disease within 24 weeks of screening
- Preexisting demyelinating or severe neurological disorders
- Major surgery within 4 weeks of screening or scheduled during the study (excluding diagnostic surgery)
- Previous treatment with total lymphoid irradiation
- History of lymphoproliferative disorders such as Epstein Barr Virus, lymphoma, or leukemia
- Clinically significant depression or history of suicidal behavior
- Other medical or laboratory abnormalities increasing risk of study participation
- Previous investigational product use within 30 days prior to first study dose
- Current use or incomplete washout of prohibited medications or exposure to anti-interferon beta therapies
- Prior standard of care medication not meeting criteria
- Certain abnormal laboratory results at screening
- Investigator site staff, their family members, sponsor employees, and their families involved in the study conduct are excluded
Research Team
P
Pfizer CT.gov Call Center
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