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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)]

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started2023-05-20
View on ClinicalTrials.gov ↗
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.

Amendment history 6 changes detected by DataLookout

2026-09-16
minor
Trial sites reduced: 146 → 138 locations
2026-09-16
critical
Primary completion pushed: 2027-07-28 → 2030-07-29
2026-09-16
minor
Completion pushed: 2027-07-28 → 2030-07-29
2026-05-16
minor
Trial sites expanded: 66 → 146 locations
2026-05-12
minor
Trial sites reduced: 147 → 66 locations
2026-04-24
minor
Trial sites expanded: 138 → 147 locations
Trial Details
NCT Number NCT05895786
Lead Sponsor Pfizer
Conditions Myositis
Enrollment 318 participants
Start Date 2023-05-20
Primary Completion 2030-07-29 (estimated)
Study Completion 2030-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-15