Randomized Placebo-Controlled Study of ISA247 in Plaque Psoriasis (SPIRIT)
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ClinicalTrials.gov Identifier: NCT00244842 |
Recruitment Status :
Completed
First Posted : October 27, 2005
Last Update Posted : September 29, 2008
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | October 25, 2005 | |||||||||||||||
First Posted Date ICMJE | October 27, 2005 | |||||||||||||||
Last Update Posted Date | September 29, 2008 | |||||||||||||||
Study Start Date ICMJE | December 2004 | |||||||||||||||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin. [ Time Frame: Twelve Weeks ] | |||||||||||||||
Original Primary Outcome Measures ICMJE |
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of ISA247 | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Randomized Placebo-Controlled Study of ISA247 in Plaque Psoriasis | |||||||||||||||
Official Title ICMJE | A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients | |||||||||||||||
Brief Summary | The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo. | |||||||||||||||
Detailed Description | Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile. Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Psoriasis | |||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
451 | |||||||||||||||
Original Enrollment ICMJE |
450 | |||||||||||||||
Actual Study Completion Date ICMJE | October 2005 | |||||||||||||||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Canada | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00244842 | |||||||||||||||
Other Study ID Numbers ICMJE | ISA04-03 | |||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Current Responsible Party | Robert Huizinga, Isotechnika Inc | |||||||||||||||
Original Responsible Party | Not Provided | |||||||||||||||
Current Study Sponsor ICMJE | Aurinia Pharmaceuticals Inc. | |||||||||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||
Investigators ICMJE |
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PRS Account | Aurinia Pharmaceuticals Inc. | |||||||||||||||
Verification Date | September 2008 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |