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A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
NotablePrimary and study completion pushed from Jul 28, 2027 to Jul 29, 2030
Trial sites reduced: 146 → 138 locations
Eligibility criteria expanded, about 26 words
Secondary endpoints: details revised at 4 of 9 entries
MinorStudy sites revised (146)v28
MinorTrial sites expanded: 66 → 146 locationsv27
MinorTrial sites reduced: 147 → 66 locationsv26
MinorTrial sites expanded: 138 → 147 locationsv25
Show 23 earlier versionsHide 23 earlier versions
MinorStudy sites: 139 to 138v24
MinorStudy sites: 128 to 139v23
NotablePrimary and study completion dates: Jul 28, 2026 to Jul 28, 2027
Study sites: 127 to 128
Secondary endpoints: details revised at 2 of 9 entries
v22
MinorEnrollment target: 270 to 318
Study sites: 126 to 127
v21
MinorStudy sites: 139 to 126
Primary and study completion dates: Jul 23, 2026 to Jul 28, 2026
v20
MinorStudy sites: 137 to 139v19
MinorStudy sites: 133 to 137v18
MinorStudy sites: 121 to 133v17
MinorStudy sites: 116 to 121v16
MinorStudy sites: 115 to 116v15
MinorStudy sites: 98 to 115v14
NotablePrimary and study completion dates: Dec 4, 2025 to Jul 23, 2026
Study sites: 97 to 98
Eligibility criteria expanded, about 35 words
v13
MinorStudy sites: 86 to 97v12
MinorStudy sites: 81 to 86v11
MinorStudy sites: 76 to 81v10
MinorStudy sites: 65 to 76v9
MinorStudy sites: 55 to 65v8
MinorStudy sites: 51 to 55v7
MinorStudy sites: 32 to 51v6
MinorStudy sites: 22 to 32v5
MinorStudy sites: 9 to 22v4
MinorStudy sites: 6 to 9v3
MinorStudy sites: 5 to 6v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.