Study of Secukinumab With 2 mL Pre-filled Syringes

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02748863
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
  • Secukinumab 2 mL form — DRUG
    Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
  • Secukinumab 1 mL form — DRUG
    Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48

Study Details

The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.

Key Dates

Start date
Dec 12, 2016
Status verified
Jul 2019
Primary completion
Aug 8, 2017
Completion
Jun 8, 2018

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
  • Experimental: Secukinumab 2 mL form
    Secukinumab 300 mg, provided in a 2 mL pre-filled syringe
  • Active Comparator: Secukinumab 1 mL form
    Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)

Primary Outcome Measure

Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment [ Time Frame: 12 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85032-
Novartis Investigative SiteFountain ValleyCalifornia92708-
Novartis Investigative SiteFremontCalifornia95438-
Novartis Investigative SiteMiamiFlorida33155-
Novartis Investigative SiteMariettaGeorgia30060-
Novartis Investigative SiteSavannahGeorgia31406-
Novartis Investigative SiteSaint JosephMissouri64506-
Novartis Investigative SiteVeronaNew Jersey07044-
Novartis Investigative SitePortlandOregon97210-
Novartis Investigative SitePortlandOregon97223-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78218-
Novartis Investigative SiteSugar LandTexas77479-
Novartis Investigative SiteNorfolkVirginia23507-
Novartis Investigative SiteTacomaWashington98405-

Find similar trials in Phoenix, AZ

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Fountain Valley, CANovartis Investigative Site· Fremont, CANovartis Investigative Site· Miami, FLNovartis Investigative Site· Marietta, GANovartis Investigative Site· Savannah, GA

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