16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02159053
Phase
PHASE3
Status
Completed

Conditions

  • Spondylitis, Ankylosing

Eligibility Criteria

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

Interventions

  • Secukinumab — BIOLOGICAL
    Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
  • Secukinumab — BIOLOGICAL
    Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
  • Placebo — BIOLOGICAL
    Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Study Details

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.

Key Dates

Start date
May 18, 2015
Status verified
Nov 2018
Primary completion
Feb 23, 2016
Completion
Jan 2, 2018

Study Design

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

Arms

  • Experimental: Secukinumab 150 mg s.c. with loading
    Secukinumab 150 mg at Baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
  • Experimental: Secukinumab 150 mg s.c. without loading
    Secukinumab 150 mg at Baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2, and 3.
  • Placebo Comparator: Placebo
    Placebo at Baseline, Weeks 1, 2, 3, 4, 8, and 12, followed by dosing with Secukinumab 150 mg every four weeks starting at Week 16.

Primary Outcome Measure

Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks [ Time Frame: 16 Weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteAnnistonAlabama36207-5710-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteAventuraFlorida33180-
Novartis Investigative SitePeoriaIllinois61602-
Novartis Investigative SiteShreveportLouisiana71101-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteVoorhees TownshipNew Jersey08043-
Novartis Investigative SiteOklahoma CityOklahoma73103-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteColumbiaSouth Carolina29204-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteSeattleWashington98101-

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Novartis Investigative Site· Anniston, ALNovartis Investigative Site· Upland, CANovartis Investigative Site· Aventura, FLNovartis Investigative Site· Peoria, ILNovartis Investigative Site· Shreveport, LANovartis Investigative Site· Lincoln, NE

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