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 San Diego, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03713632
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 assessed the safety and tolerability of secukinumab.

Key Dates

Start date
Feb 25, 2019
Status verified
Oct 2024
Primary completion
Sep 23, 2021
Completion
Jul 19, 2022

Study Design

Enrollment
545 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 (15)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteSan DiegoCalifornia92103-
Novartis Investigative SiteWhittierCalifornia92677-
Novartis Investigative SiteCoral GablesFlorida33134-
Novartis Investigative SiteTampaFlorida33609-
Novartis Investigative SiteSandy SpringsGeorgia30328-
Novartis Investigative SiteIndianapolisIndiana46256-
Novartis Investigative SiteBostonMassachusetts02111-
Novartis Investigative SiteSt LouisMissouri63104-
Novartis Investigative SiteSt LouisMissouri63110-
Novartis Investigative SiteOmahaNebraska68144-
Novartis Investigative SiteNew YorkNew York10029-
Novartis Investigative SitePortlandOregon97239-
Novartis Investigative SiteBellaireTexas77401-
Novartis Investigative SitePflugervilleTexas78660-
Novartis Investigative SiteNorfolkVirginia23507-

Find similar trials in San Diego, CA

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Novartis Investigative Site· San Diego, CANovartis Investigative Site· Whittier, CANovartis Investigative Site· Coral Gables, FLNovartis Investigative Site· Tampa, FLNovartis Investigative Site· Sandy Springs, GANovartis Investigative Site· Indianapolis, IN

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