Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT00244842
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • voclosporin — DRUG
    voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
  • Placebo — DRUG
    Placebo

Study Details

The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.

Key Dates

Start date
Dec 31, 2004
Status verified
Mar 2023
Primary completion
Oct 31, 2005
Completion
Oct 31, 2005

Study Design

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

Arms

  • Placebo Comparator: Placebo Comparator: 1
    Placebo
  • Active Comparator: Voclosporin 0.2 mg/kg po BID
    Voclosporin 0.2 mg/kg po BID
  • Active Comparator: Voclosporin 0.3 mg/kg po BID
    Voclosporin 0.3 mg/kg po BID
  • Active Comparator: Voclosporin 0.4 mg/kg po BID
    Voclosporin 0.4 mg/kg po BID

Primary Outcome Measure

Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. [ Time Frame: Twelve Weeks ]

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