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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05895786
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Belgium, Bulgaria, China, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Slovakia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myositis

Arms & Interventions

Arms

Experimental: PF-06823859

Participants will receive PF-06823859 via intravenous infusion every 4 weeks.

Placebo Comparator: Placebo

Participants will receive placebo via intravenous infusion every 4 weeks.

Interventions

Drug: - PF-06823859

anti-interferon beta therapy

Drug: - Placebo

Placebo for PF-06823859

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Glendale, Arizona

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates- Glendale

Glendale, Arizona, 85306

Site Contact

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