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

A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)

Phase 3 Interventional Pfizer · NCT05895786

This study is testing a new medication called PF-06823859 to see if it can help adults with muscle inflammation disorders like dermatomyositis and polymyositis feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment318 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Locations66 sites (Phoenix, Arizona and 65 other locations)
Trial IDNCT05895786 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with active dermatomyositis or polymyositis who are on stable doses of corticosteroids or immunosuppressants.

Not a fit: Patients with myositis due to non-idiopathic causes, inclusion body myositis, or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with muscle inflammation disorders, enhancing their quality of life.

How similar studies have performed: Other studies have explored treatments for idiopathic inflammatory myopathies, but the specific approach of PF-06823859 is novel and has not been extensively tested.

Eligibility criteria

Show full 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

Where this trial is running

Phoenix, Arizona and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MyositisDermatomyositisPolymyositis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.