This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03713619
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • secukinumab — DRUG
    Secukinumab 300mg every 2 or every 4 weeks
  • Placebo — DRUG
    Placebo 300mg every 2 or every 4 weeks

Study Details

The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study also assessed the safety and tolerability of secukinumab.

Key Dates

Start date
Jan 31, 2019
Status verified
Oct 2024
Primary completion
Oct 1, 2021
Completion
Jul 26, 2022

Study Design

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

Arms

  • Active Comparator: secukinumab 1
    Secukinumab 300mg every 2 weeks
  • Active Comparator: secukinumab 2
    Secukinumab 300mg every 4 weeks
  • Placebo Comparator: placebo 1
    Placebo group to secukinumab 300mg every 2 weeks
  • Placebo Comparator: placebo 2
    Placebo group to secukinumab 300mg every 4 weeks

Primary Outcome Measure

Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) [ Time Frame: 16 weeks ]

Locations (18)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBirminghamAlabama35205-
Novartis Investigative SiteRogersArkansas72758-
Novartis Investigative SiteAnaheimCalifornia92807-
Novartis Investigative SiteSan DiegoCalifornia92123-
Novartis Investigative SiteMiamiFlorida33125-
Novartis Investigative SiteTampaFlorida33612-
Novartis Investigative SiteGlenviewIllinois60077-
Novartis Investigative SiteWest DundeeIllinois60118-
Novartis Investigative SiteBostonMassachusetts02215-
Novartis Investigative SiteNew BrightonMinnesota55112-
Novartis Investigative SiteSaint JosephMissouri64506-
Novartis Investigative SiteChapel HillNorth Carolina27516-
Novartis Investigative SiteFairbornOhio45324-
Novartis Investigative SitePittsburghPennsylvania15213-3403-
Novartis Investigative SiteCharlestonSouth Carolina29407-
Novartis Investigative SiteGoodlettsvilleTennessee37072-2301-
Novartis Investigative SiteDallasTexas75246-1613-
Novartis Investigative SiteSan AntonioTexas78229-

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Novartis Investigative Site· Birmingham, ALNovartis Investigative Site· Rogers, ARNovartis Investigative Site· Anaheim, CANovartis Investigative Site· San Diego, CANovartis Investigative Site· Miami, FLNovartis Investigative Site· Tampa, FL

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