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NCT Number: NCT05895786

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

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.

Recruiting

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Key information

Conditions

Myositis Connective Tissue Diseases Dermatomyositis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Polymyositis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Investigaciones Clinicas Zarate, Zárate, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-06823859

Drug

anti-interferon beta therapy

Placebo

Drug

Placebo for PF-06823859

Primary outcomes

  1. Moderate change in Total Improvement Score (TIS)

    Time frame: 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 outcomes

  1. Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)

    Time frame: 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

  2. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)

    Time frame: 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.

  3. Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis

    Time frame: 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

  4. Corticosteroid (CS) dose assessment

    Time frame: 52 weeks

    Normalized Area Under the Curve (AUC) of corticosteroid dose

  5. Moderate change in Total Improvement Score

    Time frame: 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.

  6. Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)

    Time frame: 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

  7. Change from baseline in 5-D Itch Scale Score

    Time frame: 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.

  8. Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: 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

  9. Response in corticosteroid tapering

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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