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Clinical Trials in the UK / NCT05895786
Recruiting Phase 3

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

NCT05895786 · tracked via the Priya Life Science UK tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2023-05-20
Last updated
2026-09-15

Condition(s) studied

Myositis

Investigational drug(s) / intervention(s)

PF-06823859Placebo

PF-06823859: anti-interferon beta therapy

Placebo: Placebo for PF-06823859

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Male or female adults (≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater) * Active dermatomyositis (DM) or polymyositis (PM) with age of onset * 18 years old. * Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment. Exclusion Criteria: * Myositis due to non-Idiopathic inflammatory myopathies (non-IIM) * Existing diagnosis of inclusion body myositis (IBM) * Presence of immune-mediated necrotizing myositis (IMNM) * Myositis with end-stage organ involvement * Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment * History of recurrent bacterial, viral, fungal, mycobacterial or other infections * Clinically significant finding on a chest x-ray * Have cancer or a history of cancer within 5 years of screening * Significant current or prior disease conditions that may interfere with the response to or safety of the study medicine, including but not limited to: * history of major organ transplant * acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening * preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder * major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery * previous treatment with total lymphoid irradiation * history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease * Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors * Other medical or laboratory abnormality that may increase the risk of study participation * Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine * Current use or incomplete appropriate washout period of any prohibited medication(s) or known exposure to anti-interferon beta (PF-06823859) or any type of anti-interferon beta therapy * Prior SOC medication that does not fulfill the criteria * Certain laboratory results from screening assessments that may interfere with study participation. * Investigator site staff directly involved in the conduct of the study and their family members, site staff and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members

Primary outcome measure(s)

Trial sites (138)

FacilityCityRegionStatus
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.

Official registry record

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