ClinicalTrials.gov record NCT05895786
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 3 randomized, placebo-controlled study compares PF-06823859 (dazukibart) with placebo in adults who have active dermatomyositis or polymyositis. Study drug or placebo is given by intravenous infusion about once every 4 weeks through Week 48; total participation is about 13 months with roughly 15 site visits. The study collects clinical measures (muscle testing, skin scores), corticosteroid use, patient-reported outcomes, and safety data.
What it is studying. Whether PF-06823859, given by IV infusion, changes clinical measures and safety outcomes compared with placebo in adults with active dermatomyositis or polymyositis.
What the researchers hope to learn. To understand how PF-06823859 works in idiopathic inflammatory myopathies (DM and PM) and to evaluate its efficacy and safety. The study's scientific measurements include Total Improvement Score (primary), Manual Muscle Testing (MMT-8), skin activity scores (CDASI-A, IGA), corticosteroid dose changes, fatigue, itch, and patient-reported physical function.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- PF-06823859
- Placebo
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive either the study medicine (PF-06823859, also called dazukibart) or placebo by intravenous (IV) infusion at the study site about once every 4 weeks; each infusion takes about 1 hour and is given from Day 1 through Week 48. Participation lasts about 13 months and includes roughly 15 study visits for infusions, safety monitoring, and assessments. Assessments include tests of muscle strength, skin disease activity (for DM), questionnaires about physical function, fatigue and itch, monitoring of corticosteroid dose, and routine safety checks such as blood tests. The study compares the experiences of people receiving the medicine versus placebo and monitors participants closely for safety.
How the study is structured. Phase 3 interventional trial that randomly assigns participants to PF-06823859 or placebo in parallel groups. The study is quadruple-masked and placebo-controlled. Study medicine or placebo is given as an IV infusion roughly every 4 weeks from Day 1 to Week 48; total follow-up is about 13 months with around 15 visits at the study site.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- The listed sites are in Argentina, Bulgaria, China, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on polymyositis
This trial is also listed on this site under dermatomyositis.
Important dates
- Study start
- May 20, 2023
- Primary completion
- Jul 29, 2030 (estimated)
- Study completion
- Jul 29, 2030 (estimated)
- Target enrollment
- 318 participants (estimated)
- Last updated on registry
- Sep 15, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Pfizer
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Pfizer CT.gov Call Center 📞 1-800-718-1021 ✉ ClinicalTrials.gov_Inquiries@pfizer.com
Participating sites (138)
- Arizona Arthritis & Rheumatology Research, PLLCRecruiting
Glendale, Arizona, 85306 · United States
- Neuromuscular Research CenterRecruiting
Phoenix, Arizona, 85028 · United States
- Mayo Clinic HospitalRecruiting
Phoenix, Arizona, 85054 · United States
- Mayo Clinic in Arizona - ScottsdaleRecruiting
Scottsdale, Arizona, 85259 · United States
- 200 UCLA Medical PlazaRecruiting
Los Angeles, California, 90095 · United States
- UCLA Clinical & Translational Research Center (CTRC)Recruiting
Los Angeles, California, 90095 · United States
- UCLARecruiting
Los Angeles, California, 90095 · United States
- Center for Clinical Research - Chapman PavilionActive Not Recruiting
Orange, California, 92868 · United States
- UCI Douglas HospitalActive Not Recruiting
Orange, California, 92868 · United States
- UCI Health Center for Innovative Health TherapiesActive Not Recruiting
Orange, California, 92868 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- stable dose
- A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- immunosuppressant
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- investigational product
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- washout period
- A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
- prohibited medication
- A medicine that participants may not use during the study, usually because it could interfere with the study treatment or its measurement.
- screening assessments
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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