RecruitingPhase 3

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

United States318 participantsStarted 2023-05-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 lymphop…

What they're measuring

Moderate change in Total Improvement Score (TIS)

Timeframe: 24 weeks outside of the United States (US) and 52 weeks in the US

Trial details

NCT IDNCT05895786

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-28

Contact for this trial

Pfizer CT.gov Call Center

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