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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05895786

Public ClinicalTrials.gov record NCT05895786. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05895786
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
318 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 19, 2023
Primary completion
Jul 27, 2027
Completion
Jul 27, 2027
Last update posted
May 31, 2026

2023 – 2027

United States locations

U.S. sites
47
U.S. states
12
U.S. cities
25
Facility City State ZIP Site status
Arizona Arthritis & Rheumatology Research, PLLC Glendale Arizona 85306 Recruiting
Neuromuscular Research Center Phoenix Arizona 85028 Recruiting
Mayo Clinic Hospital Phoenix Arizona 85054 Recruiting
Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona 85259 Recruiting
200 UCLA Medical Plaza Los Angeles California 90095 Recruiting
UCLA Clinical & Translational Research Center (CTRC) Los Angeles California 90095 Recruiting
UCLA Los Angeles California 90095 Recruiting
Center for Clinical Research - Chapman Pavilion Orange California 92868 Active, not recruiting
UCI Douglas Hospital Orange California 92868 Active, not recruiting
UCI Health Center for Innovative Health Therapies Orange California 92868 Active, not recruiting
University of California - Irvine Orange California 92868 Active, not recruiting
Mayo Clinic in Florida Jacksonville Florida 32224 Recruiting
Lal Bhagchandani, M.D Margate Florida 33063 Active, not recruiting
University of Miami Miami Florida 33125 Recruiting
University of Miami Dermatology Clinical Trials Unit Miami Florida 33136 Recruiting
University of Miami Miami Florida 33136 Recruiting
Unviversity of Miami Miami Florida 33136 Recruiting
Omega Research Orlando Orlando Florida 32808 Active, not recruiting
IRIS Research and Development, LLC Plantation Florida 33324 Recruiting
West Broward Pulmonary Consultants Plantation Florida 33324 Recruiting
West Broward Rheumatology Associates Tamarac Florida 33321 Active, not recruiting
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Fairway Kansas 66205 Recruiting
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow Kansas City Kansas 66160 Recruiting
University of Kansas Medical Center - Hoglund Brain Imaging Center Kansas City Kansas 66160 Recruiting
University of Kansas Medical Center Kansas City Kansas 66160 Recruiting
Brigham and Women's Hospital Boston Massachusetts 02115 Recruiting
CTC - Brigham & Women's Hospital Boston Massachusetts 02115 Recruiting
CTH - Brigham & Women's Hospital Boston Massachusetts 02115 Recruiting
Washington University Pulmonary Function Laboratory St Louis Missouri 63110 Active, not recruiting
Washington University School of Medicine St Louis Missouri 63110 Active, not recruiting
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy New York New York 10016 Recruiting
NYU Langone Health Clinical Research Center New York New York 10016 Recruiting
NYU Langone Health New York New York 10016 Recruiting
NYU Langone Radiology New York New York 10016 Recruiting
Hospital for Special Surgery - Belaire New York New York 10021 Not yet recruiting
Hospital for Special Surgery New York New York 10021 Not yet recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
RAO Research LLC Oklahoma City Oklahoma 73116 Recruiting
UPMC Arthritis and Autoimmunity Center, Falk Clinic Pittsburgh Pennsylvania 15213 Recruiting
UPMC Montefiore Clinical and Translational Research Center (CTRC) Pittsburgh Pennsylvania 15213 Recruiting
UPMC Presbyterian Shadyside Hospital Pittsburgh Pennsylvania 15213 Recruiting
Arthritis & Rheumatology Research Institute, PLLC Allen Texas 75013 Recruiting
Integrative Rheumatology of South Texas Harlingen Texas 78550 Recruiting
Nerve & Muscle Center of Texas Houston Texas 77030 Recruiting
Biopharma Informatic, LLC Katy Texas 77494 Not yet recruiting
Pulmonary and Sleep Center of the Valley Weslaco Texas 78596 Recruiting
Rheumatology & Pulmonary Clinic Beckley West Virginia 25801 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05895786, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 31, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05895786 live on ClinicalTrials.gov.

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