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Study of PF-06823859 for Idiopathic Inflammatory Myopathies

This study is looking into how a medicine called PF-06823859 works in people with active idiopathic inflammatory myopathies (IIM), specifically dermatomyositis (DM) and polymyositis (PM). These conditions cause muscle weakness and, for DM, can also cause a skin rash. Researchers want to see if PF-06823859 can help improve your symptoms. You might be eligible if you are 18 or older, have active DM or PM, and are currently taking a stable dose of certain medications like corticosteroids or immunosuppressants. The study will measure how much your symptoms improve over 24 or 52 weeks. The current recruitment status is unclear.

Study design
This is an interventional study comparing PF-06823859 to a placebo. It plans to enroll 318 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for 24 weeks if you are outside the US, or 52 weeks if you are in the US.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05895786

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~318 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:PF-06823859Placebo

At a glance

Recruiting sites
125 of 146 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Moderate change in Total Improvement Score (TIS)
Measured over 24 weeks outside of the United States (US) and 52 weeks in the US

Conditions

Myositis

Explore related trials

DermatomyositisPolymyositis

Where it's being run

146 sites across 79 states
Florida10
California7
New York6
Texas5
Lesser Poland Voivodeship5
Taiwan5
Arizona4
Kansas4

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Moderate change in Total Improvement Score (TIS)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.