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Looking for participantsPhase3

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

Sponsor: Pfizer

NCT ID: NCT05895786

View on ClinicalTrials.gov ↗

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.

Myositis

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What we know so far

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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
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 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

Where Is This Study? (3 UK sites)

Queen Elizabeth University Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Salford Royal Hospital

Salford M6 8HD, United Kingdom

Recruiting

Doncaster Royal Infirmary

Doncaster DN2 5LT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09