A 36-Week Extension to Protocol ISA04-03

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT00258713
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 66 Years
Healthy Volunteers
Not accepted

Interventions

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

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
Sep 30, 2005
Status verified
Sep 2008
Primary completion
Jul 31, 2006
Completion
Jul 31, 2006

Study Design

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

Arms

  • Active Comparator: 1
  • Active Comparator: 2
  • Active Comparator: 3

Primary Outcome Measure

To investigate long-term safety and tolerability of voclosporin [ Time Frame: Sixty weeks of continuous treatment ]

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