Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05639114
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 or quarterly
  • Placebo — DRUG
    placebo s.c. monthly

Study Details

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

Key Dates

Start date
Mar 2, 2023
Status verified
Jun 2026
Primary completion
Mar 24, 2027
Completion
Mar 21, 2029

Study Design

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

Arms

  • Experimental: Ianalumab s.c. monthly
    Ianalumab s.c. monthly
  • Experimental: Ianalumab s.c. quarterly
    Ianalumab s.c. quarterly
  • Placebo Comparator: Placebo s.c. monthly
    placebo s.c. monthly

Primary Outcome Measure

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

Locations (22)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group LlcAnnistonAlabama36207-
Providence Medical CenterBurbankCalifornia91505-
University of California San DiegoLa JollaCalifornia92093-
Millennium Clinical TrialsWestlake VillageCalifornia91361-
University of ColoradoAuroraColorado80045-
Yale University School Of MedicineNew HavenConnecticut06520-
Clinical Res Of W FloridaClearwaterFlorida33765-
GNP ResearchCooper CityFlorida33024-
Clinical Research of West Florida IncTampaFlorida33603-
Parris and Associates RheumatologyLawrencevilleGeorgia30044-
Chicago Clinical Research InstChicagoIllinois60607-
Robert A Hozman MD SCSkokieIllinois60076-
Lake Cumberland Rheumatology and InNew AlbanyIndiana47150-
Henry Ford HealthDetroitMichigan48202-
Sahni Rheumatology and TherapyWest Long BranchNew Jersey07764-
Paramount Med Rsrch and Consult LLCMiddleburg HeightsOhio44130-
University Of PittsburghPittsburghPennsylvania15213-
Shelby Research LLCMemphisTennessee38119-
Accurate Clinical Research ResearchBaytownTexas77521-
Novel Research LLCBellaireTexas77401-
Accurate Clinical ResearchLeague CityTexas77573-
Epic Medical ResearchRed OakTexas75154-

Find similar trials in Anniston, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Pinnacle Research Group Llc· Anniston, ALProvidence Medical Center· Burbank, CAUniversity of California San Diego· La Jolla, CAMillennium Clinical Trials· Westlake Village, CAUniversity of Colorado· Aurora, COYale University School Of Medicine· New Haven, CT

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