An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT05835310
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Anifrolumab — BIOLOGICAL
    Participants will receive anifrolumab via IV infusion.
  • Placebo — DRUG
    Participants will receive matching placebo via IV infusion

Study Details

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)

Key Dates

Start date
Mar 14, 2024
Status verified
May 2026
Primary completion
Oct 5, 2028
Completion
Jan 9, 2030

Study Design

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

Arms

  • Experimental: Anifrolumab
    Randomized participants will receive anifrolumab via intravenous (IV) infusion every 4 weeks
  • Placebo Comparator: Placebo
    Randomized participants will receive matching placebo via IV infusion

Primary Outcome Measure

Part A- Anifrolumab serum concentration [ Time Frame: Pre-dose Day 29 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85016-
Research SiteLos AngelesCalifornia90027-
Research SiteWashington D.C.District of Columbia20010-
Research SiteChicagoIllinois60611-
Research SiteChicagoIllinois60637-
Research SiteNew OrleansLouisiana70118-
Research SiteBethesdaMaryland20889-
Research SiteSaint PaulMinnesota55125-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10032-
Research SiteThe BronxNew York10467-
Research SiteValhallaNew York10595-
Research SiteDurhamNorth Carolina27710-
Research SiteCincinnatiOhio45229-
Research SiteClevelandOhio44109-
Research SiteColumbusOhio43203-
Research SitePortlandOregon97227-
Research SitePhiladelphiaPennsylvania19104-
Research SiteGreenvilleSouth Carolina29605-
Research SiteEl PasoTexas79902-
Research SiteHoustonTexas77030-
Research SiteSalt Lake CityUtah84108-

Find similar trials in Phoenix, AZ

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Research Site· Phoenix, AZResearch Site· Los Angeles, CAResearch Site· Washington D.C., DCResearch Site· Chicago, ILResearch Site· New Orleans, LAResearch Site· Bethesda, MD

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