Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

Part of paid clinical trials in Irvine, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04156620
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    The subjects will receive secukinumab 6 mg/kg i.v. at randomization (Baseline (BSL) visit), followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
  • Placebo — DRUG
    The subjects will receive i.v. placebo at randomization (BSL visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)

Study Details

The purpose of this global study was to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in participants with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA ) at Week 16 despite current or previous non-steroidal anti inflammatory drugs (NSAID), disease-modifying antirheumatic drugs (DMARD) and/or anti Tumor Necrosis Factor (TNF) therapy. In addition, to further support efficacy and safety of an i.v. regimen, data was collected for up to 52 weeks of treatment.

Key Dates

Start date
Dec 11, 2019
Status verified
Jun 2024
Primary completion
Feb 17, 2022
Completion
Dec 20, 2022

Study Design

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

Arms

  • Experimental: Secukinumab
    Secukinumab intravenous (i.v.) regimen
  • Placebo Comparator: Placebo
    Placebo intravenous (i.v.) regimen

Primary Outcome Measure

Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria) [ Time Frame: Baseline to Week 16 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteIrvineCalifornia92604-
Novartis Investigative SiteLa MesaCalifornia91942-
Novartis Investigative SiteSan LeandroCalifornia94578-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteOcoeeFlorida34761-
Novartis Investigative SitePlantationFlorida33324-
Novartis Investigative SiteWinter ParkFlorida32789-
Novartis Investigative SiteBowling GreenKentucky42101-
Novartis Investigative SiteCumberlandMaryland21740-
Novartis Investigative SiteGrand BlancMichigan48439-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SitePotsdamNew York13676-
Novartis Investigative SiteGreensboroNorth Carolina27408-
Novartis Investigative SiteMiddleburg HeightsOhio44130-
Novartis Investigative SitePortlandOregon97239-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteColumbiaSouth Carolina29204-
Novartis Investigative SiteJacksonTennessee38305-
Novartis Investigative SiteMemphisTennessee38119-
Novartis Investigative SiteKatyTexas77494-
Novartis Investigative SiteSpringTexas77382-
Novartis Investigative SiteThe WoodlandsTexas77380-
Novartis Investigative SiteEverettWashington98208-
Novartis Investigative SiteSpokaneWashington99204-
Novartis Investigative SiteBeckleyWest Virginia25801-

Find similar trials in Irvine, CA

By research site
Novartis Investigative Site· Irvine, CANovartis Investigative Site· La Mesa, CANovartis Investigative Site· San Leandro, CANovartis Investigative Site· Upland, CANovartis Investigative Site· Ocoee, FLNovartis Investigative Site· Plantation, FL

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