Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

Part of paid clinical trials in Miami, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03589885
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo 2 mL auto-injector — DRUG
    All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
  • Placebo 1 mL prefilled syringe — DRUG
    All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
  • Secukinumab 2 mL auto-injector — DRUG
    2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48
  • Secukinumab 1 mL prefilled syringe — DRUG
    2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Study Details

The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Key Dates

Start date
Dec 19, 2018
Status verified
Oct 2021
Primary completion
Nov 19, 2019
Completion
Aug 5, 2020

Study Design

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

Arms

  • Placebo Comparator: Placebo 2 mL auto-injector
    Placebo to secukinumab s.c., provided in 2 mL auto-injector form
  • Placebo Comparator: Placebo 1 mL prefilled syringe
    Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form
  • Experimental: Secukinumab 2 mL auto-injector
    Secukinumab 300 mg provided in 2 mL auto-injector form
  • Active Comparator: Secukinumab 1 mL prefilled syringe
    Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Primary Outcome Measure

PASI 75 Response After 12 Weeks of Treatment [ Time Frame: 12 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteMiamiFlorida33155-
Novartis Investigative SiteMariettaGeorgia30060-
Novartis Investigative SiteSaint JosephMissouri64506-
Novartis Investigative SiteVeronaNew Jersey07044-
Novartis Investigative SitePortlandOregon97210-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78218-
Novartis Investigative SiteSugar LandTexas77479-

Find similar trials in Miami, FL

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Psoriasis
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Novartis Investigative Site· Miami, FLNovartis Investigative Site· Marietta, GANovartis Investigative Site· Saint Joseph, MONovartis Investigative Site· Verona, NJNovartis Investigative Site· Portland, ORNovartis Investigative Site· Houston, TX

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