A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
- Registration Number
- NCT05895786
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to understand how the study medicine PF-06823859 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 (PF-06823859) 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 about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 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 PF-06823859 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 318
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-06823859 PF-06823859 Participants will receive PF-06823859 via intravenous infusion every 4 weeks. Placebo Placebo Participants will receive placebo via intravenous infusion every 4 weeks.
- Primary Outcome Measures
Name Time Method Moderate change in Total Improvement Score (TIS) 24 weeks outside of the United States (US) and 52 weeks in the US Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
- Secondary Outcome Measures
Name Time Method Moderate change in Total Improvement Score 24 weeks in the US and 52 weeks outside of the US Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) 24 weeks outside of the US and 52 weeks in the US Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) 24 weeks outside of the US and 52 weeks in the US Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) 24 weeks outside of the US and 52 weeks in the US Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM) Week 24 outside the US 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.
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis 24 and 52 weeks in the US only Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA ≥2 will be assessed
Change from baseline in 5-D Itch Scale Score 24 weeks outside of the US and 52 weeks in the US 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.
Response in corticosteroid tapering 52 weeks US only 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.
Corticosteroid (CS) dose assessment 52 weeks Normalized Area Under the Curve (AUC) of corticosteroid dose
Trial Locations
- Locations (124)
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
🇺🇸Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Glendale, Arizona, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Mayo Clinic in Arizona - Scottsdale
🇺🇸Scottsdale, Arizona, United States
200 UCLA Medical Plaza
🇺🇸Los Angeles, California, United States
UCLA Clinical & Translational Research Center (CTRC)
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Center for Clinical Research - Chapman Pavilion
🇺🇸Orange, California, United States
UCI Douglas Hospital
🇺🇸Orange, California, United States
UCI Health Center for Innovative Health Therapies
🇺🇸Orange, California, United States
Scroll for more (114 remaining)AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale🇺🇸Glendale, Arizona, United States