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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
318
anti-interferon beta therapy
Placebo for PF-06823859
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States
RECRUITINGArizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, United States
RECRUITINGMayo Clinic Hospital
Phoenix, Arizona, United States
RECRUITINGMayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
Moderate change in Total Improvement Score (TIS)
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Time frame: 24 weeks outside of the United States (US) and 52 weeks in the US
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome
Time frame: 24 weeks outside of the US and 52 weeks in the US
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)
Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score ≥14 will be assessed.
Time frame: Week 24 outside the US
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis
Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA ≥2 will be assessed
Time frame: 24 and 52 weeks in the US only
Corticosteroid (CS) dose assessment
Normalized Area Under the Curve (AUC) of corticosteroid dose
Time frame: 52 weeks
Moderate change in Total Improvement Score
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Time frame: 24 weeks in the US and 52 weeks outside of the US
Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)
Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome
Time frame: 24 weeks outside of the US and 52 weeks in the US
Change from baseline in 5-D Itch Scale Score
5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score ≥14 will be assessed.
Time frame: 24 weeks outside of the US and 52 weeks in the US
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome
Time frame: 24 weeks outside of the US and 52 weeks in the US
Response in corticosteroid tapering
At least 50% reduction from baseline or reduction in corticosteroid (CS) dose to \<7.5 mg/day at Week 52 for participants with baseline CS dose ≥10 mg/day.
Time frame: 52 weeks US only
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200 UCLA Medical Plaza
Los Angeles, California, United States
RECRUITINGUCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, United States
RECRUITINGUCLA
Los Angeles, California, United States
RECRUITINGCenter for Clinical Research - Chapman Pavilion
Orange, California, United States
ACTIVE_NOT_RECRUITINGUCI Douglas Hospital
Orange, California, United States
ACTIVE_NOT_RECRUITINGUCI Health Center for Innovative Health Therapies
Orange, California, United States
ACTIVE_NOT_RECRUITING...and 118 more locations