Randomized, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT00408187
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • voclosporin — DRUG
    voclosporin 0.4 mg/kg po BID
  • Ciclosporin — DRUG
    ciclosporin 1.5 mg/kg po BID
  • Placebo — DRUG
    Placebo

Study Details

The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.

Key Dates

Start date
Dec 31, 2006
Status verified
Jul 2009
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

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

Arms

  • Active Comparator: 1.
  • Placebo Comparator: 3.
  • Active Comparator: 2.

Primary Outcome Measure

Superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score [ Time Frame: Twelve weeks of treatment ]

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