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PF-06823859

Phase 3

Myositis | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment318
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05895786A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]PHASE3 RECRUITING 318May 20, 2023Jul 28, 2027Jun 1, 2026146 United States, Argentina +18
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Study Endpoints
Primary Endpoints
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 Endpoints
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
24 weeks outside of the US and 52 weeks in the US
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
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis
24 and 52 weeks in the US only
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-06823859EXPERIMENTALParticipants will receive PF-06823859 via intravenous infusion every 4 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo via intravenous infusion every 4 weeks.
Interventions
NameTypeDescription
PF-06823859DRUGanti-interferon beta therapy
PlaceboDRUGPlacebo for PF-06823859
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites146

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...

Countries:United StatesArgentinaBulgariaChinaFranceGermanyHungaryIndiaIsraelItalyJapanMexicoPolandSlovakiaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT05895786lastUpdatePostDate: changed
LOWJun 2, 2026NCT05895786lastUpdatePostDate: changed
LOWJun 2, 2026NCT05895786lastUpdatePostDate: changed
LOWMay 26, 2026NCT05895786primaryCompletionDate: changed
LOWMay 24, 2026NCT05895786studyFirstPostDate: changed