Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02362789
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab — BIOLOGICAL
    150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
  • Placebo — BIOLOGICAL
    Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)

Study Details

The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.

Key Dates

Start date
Jan 4, 2015
Status verified
Jun 2018
Primary completion
Jul 15, 2016
Completion
Jul 15, 2016

Study Design

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

Arms

  • Experimental: Secukinumab
    300 mg secukinumab (administered as two injections of 150 mg each) at Weeks 16, 20, 24, and 28
  • Placebo Comparator: Placebo
    Inactive ingredients administered as a matching placebo at Weeks 16, 20, 24, and 28

Primary Outcome Measure

Pruritus Intensity Visual Analogue Scale Score at Week 32 [ Time Frame: Week 32 ]

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