Recruiting
Phase 3

PF-06823859

Sponsor:

Pfizer

Code:

NCT05895786

Conditions

Myositis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-06823859

Placebo

Study Details

Brief summary:

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.

Conditions

Myositis

Study ID

NCT05895786

Start date

May 20, 2023

Status verified date

May, 2026

Completion date

Jul 28, 2027

Anticipated

Primary completion date

Jul 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

318 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PF-06823859

Participants will receive PF-06823859 via intravenous infusion every 4 weeks.

placebo comparator: Placebo

Participants will receive placebo via intravenous infusion every 4 weeks.

Interventions

PF-06823859

anti-interferon beta therapy

Placebo

Placebo for PF-06823859

Primary outcome measure

  • Moderate change in Total Improvement Score (TIS) [ Time Frame: 24 weeks outside of the United States (US) and 52 weeks in the US ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Arizona Arthritis & Rheumatology Research, PLLC

Recruiting

Glendale, Arizona, United States, 85306

Neuromuscular Research Center

Recruiting

Phoenix, Arizona, United States, 85028

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic in Arizona - Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85259

200 UCLA Medical Plaza

Recruiting

Los Angeles, California, United States, 90095

UCLA Clinical & Translational Research Center (CTRC)

Recruiting

Los Angeles, California, United States, 90095

UCLA

Recruiting

Los Angeles, California, United States, 90095

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

University of Miami

Recruiting

Miami, Florida, United States, 33125

University of Miami Dermatology Clinical Trials Unit

Recruiting

Miami, Florida, United States, 33136

University of Miami

Recruiting

Miami, Florida, United States, 33136

Unviversity of Miami

Recruiting

Miami, Florida, United States, 33136

IRIS Research and Development, LLC

Recruiting

Plantation, Florida, United States, 33324

West Broward Pulmonary Consultants

Recruiting

Plantation, Florida, United States, 33324

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)

Recruiting

Fairway, Kansas, United States, 66205

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center - Hoglund Brain Imaging Center

Recruiting

Kansas City, Kansas, United States, 66160

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

CTC - Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

CTH - Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy

Recruiting

New York, New York, United States, 10016

NYU Langone Health Clinical Research Center

Recruiting

New York, New York, United States, 10016

NYU Langone Health

Recruiting

New York, New York, United States, 10016

NYU Langone Radiology

Recruiting

New York, New York, United States, 10016

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

RAO Research LLC

Recruiting

Oklahoma City, Oklahoma, United States, 73116

UPMC Arthritis and Autoimmunity Center, Falk Clinic

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Montefiore Clinical and Translational Research Center (CTRC)

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UPMC Presbyterian Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Arthritis & Rheumatology Research Institute, PLLC

Recruiting

Allen, Texas, United States, 75013

Integrative Rheumatology of South Texas

Recruiting

Harlingen, Texas, United States, 78550

Nerve & Muscle Center of Texas

Recruiting

Houston, Texas, United States, 77030

Pulmonary and Sleep Center of the Valley

Recruiting

Weslaco, Texas, United States, 78596

Rheumatology & Pulmonary Clinic

Recruiting

Beckley, West Virginia, United States, 25801

More Information

Sponsor

Pfizer

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • Dermatomyositis
  • Polymyositis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-06-01.