Understanding how PF-06823859 works in patients with muscle inflammation disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate the effects of the medication PF-06823859 in individuals diagnosed with active idiopathic inflammatory myopathies, specifically dermatomyositis and polymyositis. Participants must be adults aged 18 or older and currently receiving stable doses of corticosteroids or traditional immunosuppressants. The study will compare the effects of PF-06823859 against a placebo to assess its efficacy in reducing muscle inflammation and associated symptoms. The trial seeks to provide insights into the medication's mechanism of action and its potential benefits for patients suffering from these conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Arizona Arthritis & Rheumatology Research, PLLC
  Glendale, Arizona, United States Recruiting
• Neuromuscular Research Center
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic in Arizona - Scottsdale
  Scottsdale, Arizona, United States Recruiting
• 200 UCLA Medical Plaza
  Los Angeles, California, United States Recruiting
• UCLA Clinical & Translational Research Center (CTRC)
  Los Angeles, California, United States Recruiting

+88 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.