A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06455449
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polymyositis, Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anifrolumab (blinded) — COMBINATION_PRODUCT
    Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
  • Placebo — OTHER
    Matched placebo delivered subcutaneously, once weekly for 52 weeks
  • Anifrolumab (unblinded, open label) — COMBINATION_PRODUCT
    At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks

Study Details

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Key Dates

Start date
Jun 20, 2024
Status verified
May 2026
Primary completion
May 14, 2027
Completion
Aug 4, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anifrolumab (subcutaneous weekly injection)
    Anifrolumab subcutaneous injection once weekly
  • Placebo Comparator: Placebo (subcutaneous weekly injection)
    Matched placebo control subcutaneous injection once weekly

Primary Outcome Measure

Total Improvement Score (TIS) ≥ 40 response [ Time Frame: 52 week ]

Central Contacts

Locations (43)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85032-
Research SiteIrvineCalifornia92617-
Research SiteAuroraColorado80045-
Research SiteDenverColorado80230-
Research SiteNew HavenConnecticut06519-
Research SiteWashington D.C.District of Columbia20037-
Research SiteBoca RatonFlorida33486-
Research SiteBoynton BeachFlorida33472-
Research SiteGainesvilleFlorida32603-
Research SiteMargateFlorida33063-
Research SiteMiamiFlorida33126-
Research SiteMiamiFlorida33133-
Research SiteOrlandoFlorida32819-
Research SitePalm Beach GardensFlorida33410-
Research SitePlant CityFlorida33563-
Research SiteAtlantaGeorgia30322-
Research SiteWillowbrookIllinois60527-
Research SiteFairwayKansas66205-
Research SiteBaltimoreMaryland21224-
Research SiteBostonMassachusetts02115-
Research SiteAnn ArborMichigan48109-
Research SiteSterling HeightsMichigan48313-
Research SiteGreat NeckNew York11021-
Research SiteCharlotteNorth Carolina28207-
Research SiteCharlotteNorth Carolina28211-
Research SiteDurhamNorth Carolina27710-
Research SiteClevelandOhio44195-
Research SiteMiddleburg HeightsOhio44130-
Research SitePhiladelphiaPennsylvania19107-
Research SitePittsburghPennsylvania15213-
Research SiteCharlestonSouth Carolina29425-
Research SiteSummervilleSouth Carolina29486-
Research SiteAllenTexas75013-
Research SiteAmarilloTexas79124-
Research SiteAustinTexas78759-
Research SiteColleyvilleTexas76034-
Research SiteEl PasoTexas79902-
Research SiteGalvestonTexas77555-
Research SiteHarlingenTexas78550-
Research SiteHoustonTexas77030-
Research SiteNorth Richland HillsTexas76180-
Research SiteBeckleyWest Virginia25801-
Research SiteMilwaukeeWisconsin53226-

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