Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258713
Status:
COMPLETED
Last Update Posted:
2008-09-29
First Post:
2005-11-23
Brief Title:
A 36-Week Extension to Protocol ISA04-03
Sponsor:
Aurinia Pharmaceuticals Inc
Organization:
Aurinia Pharmaceuticals Inc
Study Overview
Official Title:
A 36-Week Extension to Protocol ISA04-03 to Evaluate the Safety and Efficacy of ISA247 in Patients With Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRIT
Brief Summary:
The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis
Detailed Description:
Psoriasis is a chronic skin condition that can have a significant impact on patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None