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