PF-06823859: anti-interferon beta therapy
Placebo: Placebo for PF-06823859
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Glendale | Arizona | Recruiting |
| Neuromuscular Research Center | Phoenix | Arizona | Recruiting |
| Mayo Clinic Hospital | Phoenix | Arizona | Recruiting |
| Mayo Clinic in Arizona - Scottsdale | Scottsdale | Arizona | Recruiting |
| 200 UCLA Medical Plaza | Los Angeles | California | Recruiting |
| UCLA Clinical & Translational Research Center (CTRC) | Los Angeles | California | Recruiting |
| UCLA | Los Angeles | California | Recruiting |
| Center for Clinical Research - Chapman Pavilion | Orange | California | Active Not Recruiting |
| UCI Douglas Hospital | Orange | California | Active Not Recruiting |
| UCI Health Center for Innovative Health Therapies | Orange | California | Active Not Recruiting |
| University of California - Irvine | Orange | California | Active Not Recruiting |
| Samir Macwan, M.D., Inc. | Rancho Mirage | California | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | Recruiting |
| Lal Bhagchandani, M.D | Margate | Florida | Active Not Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| University of Miami Dermatology Clinical Trials Unit | Miami | Florida | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Unviversity of Miami | Miami | Florida | Recruiting |
| Omega Research Orlando | Orlando | Florida | Active Not Recruiting |
| IRIS Research and Development, LLC | Plantation | Florida | Recruiting |
| West Broward Pulmonary Consultants | Plantation | Florida | Recruiting |
| West Broward Rheumatology Associates | Tamarac | Florida | Active Not Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| CTC - Brigham & Women's Hospital | Boston | Massachusetts | Recruiting |
| CTH - Brigham & Women's Hospital | Boston | Massachusetts | Recruiting |
| Washington University Pulmonary Function Laboratory | St Louis | Missouri | Active Not Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Active Not Recruiting |
| NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy | New York | New York | Recruiting |
| NYU Langone Health Clinical Research Center | New York | New York | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| NYU Langone Radiology | New York | New York | Recruiting |
| Hospital for Special Surgery - Belaire | New York | New York | Not Yet Recruiting |
| Hospital for Special Surgery | New York | New York | Not Yet Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| RAO Research LLC | Oklahoma City | Oklahoma | Recruiting |
| UPMC Arthritis and Autoimmunity Center, Falk Clinic | Pittsburgh | Pennsylvania | Recruiting |
| UPMC Montefiore Clinical and Translational Research Center (CTRC) | Pittsburgh | Pennsylvania | Recruiting |
| UPMC Presbyterian Shadyside Hospital | Pittsburgh | Pennsylvania | Recruiting |
| Integrative Rheumatology of South Texas | Edinburg | Texas | Recruiting |
| Arthritis & Rheumatology Research Institute, PLLC | Frisco | Texas | Recruiting |
+ 98 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05895786 on ClinicalTrials.gov ↗ ← All trials in the UK