Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03066609
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab 150 mg s.c. — DRUG
    150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
  • Secukinumab 300 mg s.c. — DRUG
    300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
  • Placebo — DRUG
    Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48

Study Details

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Key Dates

Start date
Feb 28, 2017
Status verified
Dec 2019
Primary completion
Dec 21, 2017
Completion
Nov 20, 2018

Study Design

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

Arms

  • Experimental: Secukinumab 150mg
    Secukinumab 150mg s.c.
  • Experimental: Secukinumab 300mg
    Secukinumab 300mg s.c.
  • Placebo Comparator: Placebo
    Placebo to secukinumab s.c

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) [ Time Frame: Week 12 ]

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