Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05624749
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • ianalumab — DRUG
    ianalumab s.c. monthly
  • placebo — DRUG
    placebo s.c. monthly

Study Details

The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Key Dates

Start date
Apr 21, 2023
Status verified
Jun 2026
Primary completion
Apr 12, 2027
Completion
Apr 9, 2029

Study Design

Enrollment
288 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ianalumab s.c. monthly
    ianalumab s.c. monthly
  • Placebo Comparator: placebo s.c. monthly
    placebo s.c. monthly

Primary Outcome Measure

Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [ Time Frame: Week 60 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group LLCAnnistonAlabama36207-5710-
Advanced Medical ResearchLa PalmaCalifornia90623-
University of California LALos AngelesCalifornia90095-
Homestead Assoc In Research IncHomesteadFlorida33033-
IRIS Research and DevelopmentPlantationFlorida33324-
Emory UniversityAtlantaGeorgia30307-
Willow Rheumatology WellnessWillowbrookIllinois60527-
Bluegrass Community Research IncLexingtonKentucky40504-
Accurate Clinical ResearchLake CharlesLouisiana70601-
UMC New OrleansNew OrleansLouisiana70112-
University Of MarylandBaltimoreMaryland21201-
Ahmed Arif Medical Research CenterGrand BlancMichigan48439-
Washington Univ School Of MedicineSt LouisMissouri63110-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
West Tennessee Research InstituteJacksonTennessee38305-
Novel Research LLCBellaireTexas77401-

Find similar trials in Anniston, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Pinnacle Research Group LLC· Anniston, ALAdvanced Medical Research· La Palma, CAUniversity of California LA· Los Angeles, CAHomestead Assoc In Research Inc· Homestead, FLIRIS Research and Development· Plantation, FLEmory University· Atlanta, GA

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